i BIDDING DOCUMENT (SINGLE-STAGE) Issued on: September 3, 2015 Delivery of Health Information Systems for health facilities of the RK IFB №: KHSTTIRP-D/SW-03- rebidding Project: Kazakhstan Health Sector Technology Transfer and Institutional Reform Project Purchaser: Ministry of Healthcare and Social Development of the Republic of Kazakhstan ASTANA 2015 CONTENTS Invitation for Bids (IFB) ..........................................................................................................1 Section I. Instructions to Bidders (ITB)................................................................................6 Table of Clauses ...................................................................................................................6 Section II. Bid Data Sheet (BDS) .........................................................................................37 Section III. Eligible Countries for the Provision of Goods, Works, and Services in Bank-Financed Procurement ..................................................................................................5 Section IV. General Conditions of Contract.........................................................................6 Section V. Special Conditions of Contract (SCC) ..............................................................79 Section VI. Technical requirements ..................................................................................102 Section VII. Sample Forms ................................................................................................483 Notes to Bidders on working with the Sample Forms .....................................................483 Table of Sample Forms ....................................................................................................486 INVITATION FOR BIDS (IFB) Republic of Kazakhstan Kazakhstan Health Sector Technology Transfer and Institutional Reform Project Unified Health Information Management System Loan 4883 –KZ Delivery of Health Information Systems for health facilities of the RK IFB No. KHSTTIRP-D/SW-03 – rebidding 1. This Invitation for Bids (IFB) follows the General Procurement Notice (GPN) for this Project that appeared in UN Development Business online № 2633470 as of June 02, 2008. 2. The Republic of Kazakhstan has received a loan from the International Bank for Reconstruction and Development toward the cost of Kazakhstan Health Sector Technology Transfer and Institutional Reform Project, and it intends to apply part of the proceeds of this loan to payments under the contract resulting from this IFB: Delivery of Health Information Systems for health facilities of the RK, Contract No. KHSTTIRP-D/SW-03-rebidding, includes the following lots: Lot № 1 «Delivery and implementation of Comprehensive Health Information System for Municipal hospital №1 Ust-Kamenogorsk city»; Lot № 2 «Delivery and implementation of Comprehensive Health Information System for Municipal Clinic Hospital №4 Almaty city»; Lot № 3 «Delivery and implementation of Comprehensive Health Information System for Mother and Child Center Ust-Kamenogorsk city»; Lot № 4 «Delivery and implementation of Comprehensive Health Information System for Municipal Policlinic №11 Almaty city»; Lot № 5 «Delivery and implementation of Comprehensive Health Information System for Regional Diagnostic Center Almaty city»; Lot № 6 «Delivery and implementation of Comprehensive Health Information System for Policlinic №1 Kostanay»; Lot № 7 «Delivery and implementation of Comprehensive Health Information System for Central rayon hospital, Zhualynsky rayon, Zhambul oblast»; Lot № 8 «Delivery and implementation of Comprehensive Health Information System for Municipal policlinic №7 Astana city»; Lot № 9 «Delivery and implementation of Comprehensive Health Information System for Municipal Hospital No. 1 of Astana city»; Lot № 10 «Health Information System for accounting donors and recipients». Bidders have the option to bid for any one or more lots. Bids will be evaluated lotwise, taking into account discounts offered for each lot separately or combination of lots, if any. The contract(s) will be awarded to the Bidder or Bidders offering the lowest evaluated cost to the Purchaser for combined lots, subject to the selected Bidder(s) meeting the required qualification criteria for lot or combination of lots as the case may be. The Purchaser shall award not more than three lots to one bidder even if the bidder is lowest and qualified. If the Bid of one or several Bidders receives the lowest evaluated cost for more than three lots then the criteria for selection of lots for the Purchaser shall be the best from the Purchaser’s point of view combination of total cost of all awarded lots. 3. The Ministry of Healthcare and Social Development of the Republic of Kazakhstan serves as the implementing agency for the Kazakhstan Health Sector Technology Transfer and Institutional Reform Project and now invites sealed bids from eligible Bidders for the supply, installation and commissioning of Health Information Systems for health facilities of the RK. Supply, installation and commissioning period for abovementioned is 54 weeks. 4. Bidding will be conducted using International Competitive Bidding (ICB) procedures specified in the World Bank’s Guidelines: Procurement under IBRD Loans and IDA Credits, edition of May 2004, Revised Oct 2006 and May 2010, and is open to all Bidders eligible as defined in these Guidelines, that meet the following minimum key qualification criteria: (a) The Bidder shall furnish documentary evidence that it meets the following financial requirement(s): - The average annual turnover in USD or equivalent the most recent three (3) (2012, 2013 and 2014) years: - at least US$1,500,000.00 (one million five hundred thousand) for Lot № 1 «Delivery and implementation of Comprehensive Health Information System for Municipal hospital №1 Ust-Kamenogorsk city»; - at least US$1,000,000.00 (one million ) for Lot № 2 «Delivery and implementation of Comprehensive Health Information System for Municipal Clinic Hospital №4 Almaty city»; - at least US$2,000,000.00 (two million) for Lot № 3 «Delivery and implementation of Comprehensive Health Information System for Mother and Child Center Ust-Kamenogorsk city»; - at least US$1,000,000.00 (one million) for Lot № 4 «Delivery and implementation of Comprehensive Health Information System for Municipal Policlinic №11 Almaty city»; - at least US$1,000,000.00 (one million) for Lot № 5 «Delivery and implementation of Comprehensive Health Information System for Regional Diagnostic Center Almaty city»; - at least US$1,000,000.00 (one million) for Lot № 6 «Delivery and implementation of Comprehensive Health Information System for Policlinic №1 Kostanay»; - at least US$1,000,000.00 (one million) for Lot № 7 «Delivery and implementation of Comprehensive Health Information System for Central rayon hospital, Zhualynsky rayon, Zhambul oblast»; - at least US$1,000,000.00 (one million) for Lot № 8 «Delivery and implementation of Comprehensive Health Information System for Municipal policlinic №7 Astana city»; - at least US$1,000,000.00 (one million) for Lot № 9 «Delivery and implementation of Comprehensive Health Information System for Municipal Hospital No. 1 of Astana city»; - at least US$1,500,000.00 (one million five hundred thousand) for Lot № 10 «Medical information system for registration of donors, recipients and individuals waiting for transplantation» Average Annual Turnover requirements should be consistently applied for all lots. Where the Bidder is a Joint Venture the sum of all Partners' average turnover amounts may be used. Also, where the Bidder is a Joint Venture the Partner in charge must have had an average annual turnover equivalent to at least half of the amount required for the most recent three (3) years, while every other partners – at least 10 % out of total required amount. The Bidder should provide audited financial statements and balance sheets (or some other documents according to legislation of Bidder’s country) for the last three (3) completed fiscal years demonstrating the soundness of the Bidder’s financial position and available resources necessary to handle the requirements of the proposed Contract. If the bidder wishes to qualify for award of contract for more than one lot then the bidder must demonstrate having required annual average turnover to meet the aggregate of the qualifying criteria for the individual lots. (b) Experience and Technical Capacity The Bidder shall furnish documentary evidence (including information about the completed contracts and contact information of clients from whom the references could be taken or whom the Purchaser may, when necessary, visit to learn the systems put into operation by the Bidder) to demonstrate that it meets the following requirements to experience: i. the Bidder should have been operating at minimum for 5 years with the basic activity being delivery and implementation of Information Systems for health facilities. ii. the Manufacturer(s) of Software shall have at least one certificate out of the following list: Capability Maturity Model Integration (CMMI) Maturity Level 3, ISO 9000 or ST RK ISO 9001:2009, or similar for quality management process. (The Bidder shall provide copy of certificate for compliance issued by authorized agency). iii. the Bidder shall have experience in training end-users and IT specialists. iv. the Bidder shall have proven experience in design of similar projects: at least 5 health facilities currently use systems designed and implemented by the Bidder (the scale of these health facilities shall be preferably correspondent to that of health facilities – beneficiaries under this Bidding or exceed it). “Proven” means Page 3 presentation of contracts, addresses, letters and other documents capable to confirm the use (and outcomes) of the System required under the Contract. v. The Bidder shall have own team of experts with the experience of implementation of similar projects. the Bidder shall present the Table containing the List of Staff with their CV to prove their experience and expertise. Detailed requirements to the team are set in Section VI «Technical Requirements» in item R10.4 for lots 1-9 and R11.4 for lot 10. The Bidder should provide two sets of CVs to win two lots and three sets of CVs to win three lots. vi. the Bidder shall forward all documents confirming the origin of all components and products including Manufacturer’s Authorization to use these products within this Contract or confirmation on ownership of the rights for the products (patent or any other documents) including Intellectual Property rights and other relevant rights. vii. the Bidders (or JV members) shall have proven experience of work with one or several standards used herein: HL7 v2, v3, FHIR, CDA (R2). IHE. 5. Interested eligible Bidders may obtain further information from the Ministry of Health and Social Development of the Republic of Kazakhstan - Department for Investment Projects and PPP Development, Project Implementation Support Team and inspect the bidding documents at the address given below: Astana, Imanova 19, floor 5, office 504 during office hours from 09:00-12:30 and 13:30-18:00., from Monday to Friday, except public holidays. 6. The Bidders will receive a complete set of bidding documents in English upon submission of the written application to the Project Implementation Support Team by the address: Astana, Imanova 19, office 504 during office hours from 09:00-12:30 and 13:30-18:00, from Monday to Friday, except public holidays. As an alternative, the set of bidding document in PDF and WORD format may be sent to interested Bidders upon submission of a written application to the Project Implementation Support Team by email: kazhealth.procurement@gmail.com. Complete set of Bidding Document could be downloaded in English (Word and PDF file) from Project web-site: healthproject.kz upon registration. The clarifications and amendments shall also be published in this website and also sent to the bidders by EM. If there is discrepancy between Word and PDF file, the PDF file will prevail. Besides interested Bidders can get complete set of Bidding Document in Russian in Word. In case of discrepancies between the English and Russian versions of the documents, the English version shall prevail. 7. Bids must be delivered to the address below at or before 15:30, on October 15, 2015. The amount of Bid Security required is: - 20 000 USD for Lot № 1 «Delivery and implementation of Comprehensive Health Information System for Municipal hospital №1 Ust-Kamenogorsk city»; - 10 000 USD for Lot № 2 «Delivery and implementation of Comprehensive Health Information System for Municipal Clinic Hospital №4 Almaty city»; - 30 000 USD for Lot № 3 «Delivery and implementation of Comprehensive Health Information System for Mother and Child Center of Ust-Kamenogorsk city»; - 10 000 USD for Lot № 4 «Delivery and implementation of Comprehensive Health Information System for Municipal Policlinic №11 Almaty city»; - 10 000 USD for Lot № 5 «Delivery and implementation of Comprehensive Health Information System for Regional Diagnostic Center Almaty city»; - 10 000 USD for Lot № 6 «Delivery and implementation of Comprehensive Health Information System for Policlinic №1 Kostanay»; -15000 USD for Lot № 7 «Delivery and implementation of Comprehensive Health Information System for Central rayon hospital, Zhualynsky rayon, Zhambul oblast»; - 10 000 USD for Lot № 8 «Delivery and implementation of Comprehensive Health Information System for Municipal policlinic №7 Astana city»; - 10 000 USD for Lot № 9 «Delivery and implementation of Comprehensive Health Information System for Municipal Hospital No. 1 of Astana city»; - 20 000 USD for Lot № 10 « Medical information system for registration of donors, recipients and individuals waiting for transplantation ». Late bids will be rejected. Bids will be opened in the presence of Bidders’ representatives who choose to attend the procedure by the address set below at 15:30, on October 15, 2015. 8. The attention of prospective Bidders is drawn to (i) the fact that they will be required to certify in their bids that all software is either covered by a valid license or was produced by the Bidder, and (ii) violation of this condition is considered as fraud, which can result in ineligibility to be awarded by World Bank-financed contracts. Ministry of Healthcare and Social Development of the Republic of Kazakhstan Department for Investment Projects and PPP Development, Project Implementation Support Team B. Tokezhanov – National Project Coordinator 010000, Kazakhstan, Astana city, Imanov Str. 19, floor 5, office 504, tel. + 7 7172 787235, fax. + 7172 787247 e-mail: kazhealth.procurement@gmail.com Page 5 SECTION I. INSTRUCTIONS TO BIDDERS (ITB) (Single-Stage Bidding) Table of Clauses A. General ............................................................................................................................... 8 1. 2. 3. 4. 5. 6. 7. 8. Scope of Bid and Bidding Process ............................................................................. 8 Source of Funds ......................................................................................................... 8 Fraud and Corruption ................................................................................................. 8 Eligible Bidders........................................................................................................ 10 Eligible Goods and Services .................................................................................... 12 Qualifications of the Bidder ..................................................................................... 12 Cost of Bidding ........................................................................................................ 15 Site Visit................................................................................................................... 15 B. The Bidding Documents .................................................................................................. 15 9. Content of Bidding Documents................................................................................ 15 10. Clarification of Bidding Documents and Pre-bid Meeting ...................................... 16 11. Amendment of Bidding Documents ........................................................................ 16 C. Preparation of Bids ......................................................................................................... 17 12. 13. 14. 15. 16. Language of Bid ....................................................................................................... 17 Documents Comprising the Bid ............................................................................... 17 Bid Prices ................................................................................................................. 18 Bid Currencies.......................................................................................................... 21 Documents Establishing the Conformity of the Information System to the Bidding Documents ............................................................................................................... 21 17. Securing the Bid ....................................................................................................... 22 18. Period of Validity of Bids ........................................................................................ 24 19. Format and Signing of Bid ....................................................................................... 25 D. Submission of Bids .......................................................................................................... 25 20. 21. 22. 23. Sealing and Marking of Bids ................................................................................... 25 Deadline for Submission of Bids ............................................................................. 26 Late Bids .................................................................................................................. 26 Withdrawal, Substitution, and Modification of Bids ............................................... 26 E. Bid Opening and Evaluation .......................................................................................... 27 24. 25. 26. 27. 28. 29. 30. Opening of Bids by Purchaser ................................................................................. 27 Clarification of Bids ................................................................................................. 28 Preliminary Examination of Bids ............................................................................. 28 Conversion to Single Currency ................................................................................ 29 Evaluation and Comparison of Bids ........................................................................ 29 Domestic Preference ................................................................................................ 34 Contacting the Purchaser ......................................................................................... 34 F. Postqualification and Award of Contract ..................................................................... 34 31. 32. 33. 34. Postqualification....................................................................................................... 34 Award Criteria.......................................................................................................... 34 Purchaser’s Right to Vary Quantities at Time of Award ......................................... 35 Purchaser’s Right to Accept Any Bid and to Reject Any or All Bids ..................... 35 35. 36. 37. 38. Notification of Award ............................................................................................... 35 Signing of Contract ................................................................................................... 36 Performance Security ............................................................................................... 36 Adjudicator ............................................................................................................... 36 Page 7 Instructions to Bidders A. GENERAL 1. Scope of Bid and Bidding Process 2. Source of Funds 3. Fraud and Corruption 1.1 The Purchaser named in the BDS and the SCC for GCC Clause 1.1 (b) (i), or its duly authorized Purchasing Agent if so specified in the BDS (interchangeably referred to as “the Purchaser” in these Bidding Documents), invites bids for the supply and installation of the Information System (IS), as briefly described in the BDS and specified in greater detail in these Bidding Documents. 1.2 The title and identification number of the Invitation for Bids (IFB) and resulting Contract(s) are provided in the BDS. 1.3 Throughout the Bidding Documents, the term "in writing" means communicated in written form (e.g. by mail, e-mail, fax, telex) with proof of receipt, and the term "days" means calendar days unless a different meaning is evident from the context. 1.4 If the BDS so provides, alternative procedures forming part or all of what is commonly known as e-Tendering are available to the extent specified in, or referred to by, the BDS. 2.1 The Borrower named in the BDS has applied for or received a loan or credit (as identified in the BDS, and called a “loan” in these Bidding Documents) from the International Bank for Reconstruction and Development or the International Development Association (called “the Bank” in these Bidding Documents) equivalent to the amount indicated in the BDS toward the cost of the Project specified in the BDS. The Borrower intends to apply a portion of the proceeds of this loan to eligible payments under the Contract for which these Bidding Documents are issued. 2.2 Payment by the Bank will be made only at the request of the Borrower, or the Borrower’s executing agency, and upon approval by the Bank in accordance with the terms and conditions of the Loan Agreement, and will be subject in all respects to the terms and conditions of that agreement. The Loan Agreement prohibits a withdrawal from the loan account for the purpose of any payment to persons or entities, or for any import of goods, if such payment or import, to the knowledge of the Bank, is prohibited by a decision of the United Nations Security Council taken under Chapter VII of the Charter of the United Nations. No party other than the Borrower shall derive any rights from the Loan Agreement or have any claim to the loan proceeds. 3.1 It is the Bank’s policy to require that Borrowers (including beneficiaries of Bank loans), as well as bidders, suppliers, and contractors and their subcontractors under Bank-financed contracts, observe the highest standard of ethics during the procurement and execution of such contracts.1 In pursuance of this policy, the Bank: (a) defines, for the purposes of this provision, the terms set forth below as follows: (i) “corrupt practice”2 is the offering, giving, receiving or soliciting, directly or indirectly, of anything of value to influence improperly the actions of another party; (ii) “fraudulent practice”3 is any act or omission, including a misrepresentation, that knowingly or recklessly misleads, or attempts to mislead, a party to obtain a financial or other benefit or to avoid an obligation; (iii) “collusive practice”4 is an arrangement between two or more parties designed to achieve an improper purpose, including to influence improperly the actions of another party; (iv) “coercive practice”5 is impairing or harming, or threatening to impair or harm, directly or indirectly, any party or the property of the party to influence improperly the actions of a party; (v) “obstructive practice” is (aa) deliberately destroying, falsifying, altering or concealing of evidence material to the investigation or making false statements to investigators in order to materially impede a Bank investigation into allegations of a corrupt, fraudulent, coercive or collusive practice; and/or threatening, harassing or intimidating any party to prevent it from disclosing its knowledge of matters relevant to the investigation or from pursuing the investigation; or (bb) acts intended to materially impede the exercise of the Bank’s inspection and audit rights 1 In this context, any action taken by a bidder, supplier, contractor, or a sub-contractor to influence the procurement process or contract execution for undue advantage is improper. 2 “Another party” refers to a public official acting in relation to the procurement process or contract execution]. In this context, “public official” includes World Bank staff and employees of other organizations taking or reviewing procurement decisions. 3 A “party” refers to a public official; the terms “benefit” and “obligation” relate to the procurement process or contract execution; and the “act or omission” is intended to influence the procurement process or contract execution. 4 “Parties” refers to participants in the procurement process (including public officials) attempting to establish bid prices at artificial, non competitive levels. 5 A “party” refers to a participant in the procurement process or contract execution. Page 9 provided for under sub-clause 3.1 (e) below. 4. Eligible Bidders (b) will reject a proposal for award if it determines that the bidder recommended for award has, directly or through an agent, engaged in corrupt, fraudulent, collusive, coercive or obstructive practices in competing for the contract in question; (c) will cancel the portion of the loan allocated to a contract if it determines at any time that representatives of the Borrower or of a beneficiary of the loan engaged in corrupt, fraudulent, collusive, or coercive practices during the procurement or the execution of that contract, without the Borrower having taken timely and appropriate action satisfactory to the Bank to address such practices when they occur; (d) will sanction a firm or individual, including declaring ineligible, either indefinitely or for a stated period of time, to be awarded a Bank-financed contract if it at any time determines that the firm has, directly or through an agent, engaged in corrupt, fraudulent, collusive, coercive or obstructive practices in competing for, or in executing, a Bank-financed contract; and (e) will have the right to require that a provision be included in bidding documents and in contracts financed by a Bank loan, requiring bidders, suppliers, and contractors and their sub-contractors to permit the Bank to inspect their accounts and records and other documents relating to the bid submission and contract performance and to have them audited by auditors appointed by the Bank. 3.2 Furthermore, Bidders shall be aware of the provision stated in Clause 9.8 and Clause 41.2 of the General Conditions of Contract. 3.3 Any communications between the Bidder and the Purchaser related to matters of alleged fraud or corruption must be made in writing. 3.4 By signing the Bid Submission Form, the Bidder represents that it either is the owner of the Intellectual Property Rights in the hardware, software or materials offered, or that it has proper authorization and/or license to offer them from the owner of such rights. For the purpose of this Clause, Intellectual Property Rights shall be as defined in GCC Clause 1.1 (c) (xvii). Willful misrepresentation of these facts shall be considered a fraudulent practice subject to the provisions of Clauses 3.1 through 3.4 above, without prejudice of other remedies that the Purchaser may take. 4.1 A Bidder, and all parties constituting the Bidder, may have the nationality of any country, subject to the restrictions specified in Section III, Eligible Countries. A Bidder shall be deemed to have the nationality of a country if the Bidder is a citizen or is constituted, incorporated, or registered and operates in conformity with the provisions of the laws of that country. 4.2 If a prequalification process has been undertaken for the Contract(s) for which these Bidding Documents have been issued, only those Bidders may participate that had been prequalified and continue to meet the eligibility criteria of this Clause. A prequalified Joint Venture may not change partners or its structure when submitting a bid. 4.3 A firm may be excluded from bidding if: (a) it was engaged by the Purchaser to provide consulting services for the preparation of the design, specifications, or other documents to be used for the procurement of the Information System described in these Bidding Documents; or (b) it is a government-owned enterprise in the Borrower’s country, unless it can establish that it (i) is legally and financially autonomous and (ii) operates under commercial law. No dependent agency of the Borrower or SubBorrower shall be permitted to bid. 4.4 A firm that has been determined to be ineligible by the Bank in relation to the Bank Guidelines On Preventing and Combating Fraud and Corruption in Projects Financed by IBRD Loans and IDA Credits and Grants shall be not be eligible to be awarded a contract. 4.5 A firm or individual is or will be disqualified from participation in this bidding if, at any time from advertisement of the bidding until and including contract award, the firm or individual is under: (a) a suspension by the Purchaser agreed by the Bank as a result of execution of a Bid-Securing Declaration pursuant to ITB Clause 17.6 in another Bank-financed procurement, or under a suspension by the Purchaser for other reasons that have been agreed by the Bank; or (b) a declaration of ineligibility by the Bank in accordance with ITB Clause 3.1 (d). The list of individuals and firms debarred from participating in World Bank projects is available at http://www.worldbank.org/debarr/, or (c) a sanction imposed by the United Nations Security Council, as mentioned in ITB Clause 2.2. 4.6 A firm or other entity that is ineligible according to any of the above provisions of this Clause, may also not participate as a Joint Venture partner, or as Subcontractor for or supplier of goods, works or services. If a bid becomes materially incomplete after removing ineligible entities, the bid may be disqualified. 4.7 Bidders shall provide such evidence of their continued eligibility satisfactory to the Purchaser, as the Purchaser shall reasonably request. Page 11 5. Eligible Goods and Services 6. Qualifications of the Bidder 5.1 For the purposes of these Bidding Documents, the Information System means all: (a) the required information technologies, including all information processing and communications-related hardware, software, supplies, and consumable items that the Supplier is required to supply and install under the Contract, plus all associated documentation, and all other materials and goods to be supplied, installed, integrated, and made operational (collectively called “the Goods” in some clauses of the ITB); and (b) the related software development, transportation, insurance, installation, customization, integration, commissioning, training, technical support, maintenance, repair, and other services necessary for proper operation of the Information System to be provided by the selected Bidder and as specified in the Contract. 5.2 Funds from Bank loans are disbursed only for expenditures for an Information System made up of goods and services provided by nationals of, and produced in or supplied from, eligible source countries as defined in Section III, Eligible Countries. An Information System is deemed to be produced in a certain country when, in the territory of that country, through software development, manufacturing, or substantial and major assembly or integration of components, a commercially recognized product results that is substantially different in basic characteristics or in purpose or utility from its components. 5.3 For purposes of this clause, the nationality of the Bidder is distinct from the country in which the Information System and its goods components are produced or from which the related services are supplied. 6.1 By submission of documentary evidence in its bid, the Bidder must establish to the Purchaser’s satisfaction: (a) that it has the financial, technical, and production capability necessary to perform the Contract, meets the qualification criteria specified in the BDS, and has a successful performance history. If a prequalification process has been undertaken for the Contract(s) for which these Bidding Documents have been issued, the Bidder shall, as part of its bid, update any information submitted with its application for prequalification; (For the purposes of establishing a Bidder’s qualifications, and unless stated to the contrary in the BDS, the experience and / or resources of any Subcontractor will not contribute to the Bidder’s qualifications; only those of a Joint Venture partner will be considered.) (b) that, in the case of a Bidder offering to supply key goods components of the Information System, as identified in the BDS, that the Bidder does not itself produce, the Bidder is duly authorized by the producer to supply those components in the Purchaser’s country under the Contract(s) that may result from this bidding; (This will be accomplished by including Manufacturer’s Authorizations in the bid, based on the sample found in Section VII.) 6.2 6.3 (c) that, if a Bidder proposes Subcontractors for key services if and as identified in the BDS, these Subcontractors have agreed in writing to serve for the Bidder under the Contract(s) that may result from this bidding; and (d) that, in the case of a Bidder not doing business within the Purchaser’s country, the Bidder is or will be (if awarded the Contract) represented by an Agent in that country who is equipped and able to carry out the Bidder’s maintenance, technical support, training, and repair obligations prescribed in the General and Special Conditions of Contract, and/or Technical Requirements. Bids submitted by a Joint Venture of two or more firms as partners shall also comply with the following requirements: (a) the bid shall be signed so as to be legally binding on all partners; (b) one of the partners shall be nominated as being in charge, and this nomination shall be evidenced by submitting a power of attorney signed by legally authorized signatories of all the partners; (c) the partner in charge shall be authorized to incur liabilities and receive instructions for and on behalf of any and all partners of the Joint Venture, and the entire execution of the Contract, including payment, shall be done exclusively with the partner in charge; (d) the partner or combination of partners that is responsible for a specific component of the Information System must meet the relevant minimum qualification criteria for that component; (e) a firm may submit bids either as a single Bidder on its own, or as partner in one, and only one, Joint Venture. If, as a result of the bid opening pursuant to ITB Clause 24, this requirement is not met, all bids involving the firm as a single Bidder or Joint Venture partner will be disqualified; (f) all partners of the Joint Venture shall be liable jointly and severally for the execution of the Contract in accordance with the Contract terms, and a statement to this effect shall be included in the authorization mentioned under ITB Clause 6.2 (b) above, in the bid as well as in the Contract (in case of a successful bid). If a Bidder intends to subcontract major items of supply or services, it shall include in the bid details of the name and nationality of the proposed Subcontractor for each of those items Page 13 and shall be responsible for ensuring that any Subcontractor proposed complies with the requirements of ITB Clause 4, and that any Goods or Services components of the Information System to be provided by the Subcontractor comply with the requirements of ITB Clause 5 and the related evidence required by ITB Clause 13.1 (e) (iii) is submitted. Bidders are free to list more than one Subcontractor against each item. Quoted rates and prices will be deemed to apply, whichever Subcontractor is appointed, and no adjustment of the rates or prices will be permitted. The Purchaser reserves the right to delete any proposed Subcontractor from the list. This shall be done prior to Contract signature, by deleting such unacceptable Subcontractors from Appendix 3 to the Contract Agreement, which shall list the approved Subcontractors for each item prior to Contract signature. Subsequent additions and deletions from the list of approved Subcontractors shall be performed in accordance with GCC Clause 20 (as revised in the SCC, if applicable) and Appendix 3 to the Contract Agreement. For the purposes of these Bidding Documents, a Subcontractor is any vendor or service provider with whom the Bidder contracts for the supply or execution of any part of the Information System to be provided by the Bidder under the Contract (such as the supply of major hardware, software, or other components of the required Information Technologies specified, or the performance of related Services, e.g., software development, transportation, installation, customization, integration, commissioning, training, technical support, maintenance, repair, etc.). 6.4 A firm which is a Bidder, whether as a single Bidder or as a partner in a Joint Venture, cannot be a Subcontractor in other bids, except for the supply of commercially available hardware or software by the firm, as well as purely incidental services such as installation/configuration, routine training, and ongoing maintenance/support. If the BDS for ITB Clause 6.1 (a) allows the qualification of Subcontractors nominated for certain components to be taken into account in assessing the Bidder’s overall qualifications, any Subcontractor so nominated by any Bidder is automatically disqualified from being a Bidder itself or a partner in a Joint Venture. The same will normally apply to firms that have provided Subcontractor agreements for certain services pursuant to ITB Clause 6.1 (c). Non-compliance may result in the rejection of all bids in which the affected firm participates as Bidder or as partner in a Joint Venture. As long as in compliance with these provisions, or as long as unaffected by them due to not participating as Bidder or as partner in a Joint Venture, a firm may be proposed as a Subcontractor in any number of bids. If the BDS for ITB 28.1 permits the submission of bids for Subsystems, lots, or slices, then the provisions of this Clause 6.4 apply only to bids for the same Subsystem(s), lot(s), or slice(s); 7. Cost of Bidding 7.1 The Bidder shall bear all costs associated with the preparation and submission of its bid, and the Purchaser will in no case be responsible or liable for those costs. 8. Site Visit 8.1 The Bidder may wish to visit and examine the site or sites of the Information System and obtain for itself, at its own responsibility and risk, all information that may be necessary for preparing the bid and entering into the Contract. The costs of visiting the site or sites shall be at the Bidder’s own expense. 8.2 The Purchaser will arrange for the Bidder and any of its personnel or agents to gain access to the relevant site or sites, provided that the Bidder gives the Purchaser adequate notice of a proposed visit of at least fourteen (14) days. Alternatively, the Purchaser may organize a site visit or visits concurrently with the pre-bid meeting, as specified in the BDS for ITB Clause 10.2. Failure of a Bidder to make a site visit will not be a cause for its disqualification. 8.3 No site visits shall be arranged or scheduled after the deadline for the submission of the Bids and prior to the award of Contract. B. THE BIDDING DOCUMENTS 9. Content of Bidding Documents 9.1 The contents of the Bidding Documents are listed below and should be read in conjunction with any addenda issued in accordance with ITB Clause 11: Section I Instructions to Bidders (ITB) Section II Bid Data Sheet (BDS) Section III Eligible Countries for the Provision of Goods, Works, and Services in Bank-Financed Procurement Section IV General Conditions of Contract (GCC) Section V Special Conditions of Contract (SCC) Section VI Technical Requirements (including Implementation Schedule) Section VII Sample Forms 9.2 Bidders are expected to examine all instructions, forms, terms, specifications, and other information in the Bidding Documents. Failure to furnish all information required by the Bidding Documents or to submit a bid not substantially responsive to the Bidding Documents in every respect will be at the Bidder’s risk and may result in the rejection of its bid. 9.3 The Invitation for Bids is not formally part of the Bidding Documents and is included for reference only. In case of inconsistencies, the actual Bidding Documents shall prevail. Page 15 10. Clarification of 10.1 A prospective Bidder requiring any clarification of the Bidding Documents may notify the Purchaser in writing at the Bidding Purchaser’s address and by one of the means indicated in the Documents BDS. Similarly, if a Bidder feels that any important provision in and Pre-bid the documents will be unacceptable, such an issue should be Meeting raised as soon as possible. The Purchaser will respond in writing to any request for clarification or modification of the Bidding Documents that it receives no later than twenty-one (21) days prior to the deadline for submission of bids prescribed by the Purchaser. Copies of the Purchaser’s response (including an explanation of the query but not identifying its source) will be sent to all prospective Bidders that received the Bidding Documents from the Purchaser. 10.2 When specified in the BDS, the Purchaser will organize and Bidders are welcome to attend a pre-bid meeting at the time and place indicated in the BDS. The purpose of the meeting will be to clarify issues and answer questions on any matter that may be raised at this stage, with particular attention to issues related to the Technical Requirements. Bidders are requested to submit any questions in writing to reach the Purchaser not later than one week before the meeting. Questions and answers will be transmitted in accordance with ITB Clause 10.1. Minutes of the meeting, including the questions raised and responses given, together with any responses prepared after the meeting, will be transmitted without delay to all those that received the Bidding Documents from the Purchaser. Any modification to the Bidding Documents listed in ITB Clause 9.1, which may become necessary as a result of the pre-bid meeting, shall be made by the Purchaser exclusively by issuing an Addendum pursuant to ITB Clause 11 and not through the minutes of the pre-bid meeting. 11. Amendment of Bidding Documents 11.1 At any time prior to the deadline for submission of bids, the Purchaser may, for any reason, whether at its own initiative or in response to a clarification requested by a prospective Bidder, amend the Bidding Documents. Later amendments on the same subject modify or replace earlier ones. 11.2 Amendments will be provided in the form of Addenda to the Bidding Documents, which will be sent in writing to all prospective Bidders that received the Bidding Documents from the Purchaser. Addenda will be binding on Bidders. Bidders are required to immediately acknowledge receipt of any such Addenda. It will be assumed that the amendments contained in such Addenda will have been taken into account by the Bidder in its bid. 11.3 In order to afford prospective Bidders reasonable time in which to take the amendment into account in preparing their bids, the Purchaser may, at its discretion, extend the deadline for the submission of bids, in which case, the Purchaser will notify all Bidders in writing of the extended deadline. C. PREPARATION OF BIDS 12. Language of Bid 12.1 The bid prepared by the Bidder and all correspondence and documents related to the bid exchanged by the Bidder and the Purchaser shall be written in the language specified in the BDS, or, if the BDS so provides, in either one of two languages specified there. Any printed literature furnished by the Bidder as part of its bid may be in a language not specified in the BDS, as long as such literature is accompanied by a translation of its pertinent passages into the language of the bid, in which case, for purposes of interpretation of the bid, the translation shall govern. 13. Documents Comprising the Bid 13.1 The bid submitted by the Bidder shall comprise: (a) Bid Submission Form completed and signed by a person or persons duly authorized to bind the Bidder to the Contract; (b) all Price Schedules duly completed in accordance with ITB Clauses 14, 15, and 18 and signed by a person or persons duly authorized to bind the Bidder to the Contract; (c) if required, Bid-securing Declaration or Bid Security furnished in accordance with ITB Clause 17; (d) written confirmation authorizing the signatory of the bid to commit the Bidder, in accordance with ITB Clause 19.2; (e) Attachments: (i) Attachment 1: Bidder’s Eligibility In the absence of prequalification, documents establishing to the Purchaser’s satisfaction the Bidder’s eligibility to bid, including but not limited to documentary evidence that the Bidder is legally incorporated in a territory of an eligible source country as defined under ITB Clause 4; (ii) Attachment 2: Bidder’s Qualifications Documentary evidence establishing to the Purchaser’s satisfaction, and in accordance with ITB Clause 6, that the Bidder is qualified to perform the Contract if its bid is accepted. In the case where prequalification of Bidders has been undertaken, and pursuant to ITB Clause 6.1 (a), the Bidder must provide evidence on any changes in the information submitted as the basis for prequalification or, if there has been no change at all in said information, a statement to this effect; Any Manufacturer’s Authorizations and Subcontractor agreements specified as required in the BDS for ITB Clauses 6.1 (b) and 6.1 (c); Page 17 (iii) Attachment 3: Eligibility of Goods and Services Documents establishing, to the Purchaser’s satisfaction, that the Goods and Services components of the Information System to be supplied, installed, and/or performed by the Bidder are eligible Goods and Services as defined under ITB Clause 5. If awarded the Contract, the Bidder shall submit for such components of the Information System evidence of eligibility, which shall be confirmed by a certificate of origin issued at the time of shipment; (iv) Attachment 4: Conformity of the Information System to the Bidding Documents Documentary evidence establishing to the Purchaser’s satisfaction, and in accordance with ITB Clause 16, that the Goods and Services components of the Information System to be supplied, installed, and/or performed by the Bidder conform to the Bidding Documents; (v) Attachment 5: Proposed Subcontractors A list of all major items of Goods or Services that the Bidder proposes to purchase or subcontract from others, and the name and nationality of the proposed Subcontractor, including vendors, for each of those items; (vi) Attachment 6: Intellectual Property A list of: (1) all Software included in the Bidder’s bid, assigning each item to one of the software categories defined in GCC Clause 1.1 (c): (A) System, General Purpose, and Application Software; and (B) Standard and Custom Software. (2) all Custom Materials, as defined in GCC Clause 1.1 (c), included in the Bidder’s bid. All Materials not identified as Custom Materials shall be deemed Standard Materials, as defined in GCC Clause 1.1 (c). Re-assignments among the Software and Materials categories, if necessary, will be made during the implementation of the Contract according to GCC Clause 39 (Changes to the System). 14. Bid Prices 14.1 All Goods and Services identified in the Supply and Installation Cost Sub-Table and the Recurrent Cost Sub-Table in Section VII (Forms 2.5 and 2.6), and all other Goods and Services proposed by the Bidder to fulfill the requirements of the Information System, must be priced separately in the format of the same tables and summarized in the corresponding Cost Summary Tables in the same Section. Prices must be quoted in accordance with the instructions provided in Section VII for the various cost tables, in the manner specified below. 14.2 The price of items that the Bidder has left blank in the cost tables provided in Section VII shall be assumed to be included in the price of other items. Items omitted altogether from the cost tables shall be assumed to be omitted from the bid and, provided that the bid is substantially responsive, an adjustment to the bid price will be made during evaluation in accordance with ITB Clause 28.6 (c) (iii). 14.3 Unit prices must be quoted at a level of detail appropriate for calculation of any partial deliveries or partial payments under the contract, in accordance with the Implementation Schedule in Section VI, and with GCC and SCC Clause 12 – Terms of Payment. Bidders may be required to provide a breakdown of any composite or lump-sum items included in the Cost Tables. 14.4 The prices for Goods components of the System are to be expressed and shall be defined and governed in accordance with the rules prescribed in the edition of Incoterms specified in the BDS, and quoted in the appropriate columns of the cost tables of Section VII as follows: (a) Goods supplied from outside the Purchaser’s country: Unless otherwise specified in the BDS, the prices shall be quoted on a CIP (named place of destination) basis, exclusive of all taxes, stamps, duties, levies, and fees imposed in the Purchaser’s country. The named place of destination and special instructions for the contract of carriage are as specified in the BDS. In quoting the price, the Bidder shall be free to use transportation through carriers registered in any eligible countries. Similarly, the Bidder may obtain insurance services from any eligible source country. (b) Locally supplied Goods: Unit prices of Goods offered from within the Purchaser’s Country, shall be quoted on an EXW (ex factory, ex works, ex warehouse or off-the-shelf, as applicable) basis, including all customs duties, levies, fees, sales and other taxes incurred until delivery of the Goods, but excluding all VAT or sales and other taxes and duties/fees incurred for the Goods at the time of invoicing or sales transaction, if the Contract is awarded. (c) Inland transportation: Unless otherwise stated in the BDS, inland transportation, insurance and related local costs incidental to the delivery of the Goods to the designated Project Sites must be quoted separately as a Service item in accordance with ITB Clause Page 19 14.5, whether the Goods are to be supplied locally or from outside the Purchaser’s country, except when these costs are already included in the price of the Goods, as is, e.g., the case, when ITB Clause 14.4 (a) specifies CIP, and the named places of destination are the Project Sites. 14.5 The price of Services shall be quoted in total for each service (where appropriate, broken down into unit prices), separated into their local and foreign currency components. Prices must include all taxes, duties, levies and fees whatsoever, except only VAT or other indirect taxes, or stamp duties, that may be assessed and/or apply in the Purchaser’s country on/to the price of the Services invoiced to the Purchaser, if the Contract is awarded. Unless otherwise specified in the BDS, the prices must include all costs incidental to the performance of the Services, as incurred by the Supplier, such as travel, subsistence, office support, communications, translation, printing of materials, etc. Costs incidental to the delivery of the Services but incurred by the Purchaser or its staff, or by third parties, must be included in the price only to the extent such obligations are made explicit in these Bidding Documents (as, e.g., a requirement for the Bidder to include the travel and subsistence costs of trainees). 14.6 Prices for Recurrent Costs beyond the scope of warranty services to be incurred during the Warranty Period, defined in SCC Clause 29.4 and prices for Recurrent Costs to be incurred during the Post-Warranty Period, defined in SCC Clause 1.1. (e) (xii), shall be quoted as Service prices in accordance with ITB Clause 14.5 on the Recurrent Cost Sub-Table in detail, and on the Recurrent Cost Summary Table in currency totals. Recurrent costs are all-inclusive of the costs of necessary Goods such as spare parts, software license renewals, labor, etc., needed for the continued and proper operation of the System and, if appropriate, of the Bidder’s own allowance for price increases. 14.7 Unless otherwise specified in the BDS, prices quoted by the Bidder shall be fixed during the Bidder’s performance of the Contract and not subject to increases on any account. Bids submitted that are subject to price adjustment will be rejected. 15. Bid Currencies 15.1 Prices shall be quoted in the following currencies: (a) The Bidder may quote its prices for all Information Technologies, associated Goods, and Services to be supplied from outside the Purchaser’s Country in the currencies of countries eligible according to Section III. If the Bidder wishes to be paid in a combination of different currencies, it must quote unit prices accordingly, but no more than three foreign currencies may be used. (b) Unless otherwise specified in the BDS, the Bidder shall express its prices for such Information Technologies, associated Goods, and Services to be supplied locally (i.e., from within the Purchaser’s Country) in the currency of the Purchaser’s Country. 16.1 Pursuant to ITB Clause 13.1 (e) (iv), the Bidder shall furnish, as 16. Documents part of its bid, documents establishing the conformity to the Establishing Bidding Documents of the Information System that the Bidder the Conformity proposes to supply and install under the Contract. of the Information 16.2 The documentary evidence of conformity of the Information System to the System to the Bidding Documents shall be in the form of written Bidding descriptions, literature, diagrams, certifications, and client Documents references, including: (a) the Bidder’s technical bid, i.e., a detailed description of the Bidder’s proposed technical solution conforming in all material aspects with the Technical Requirements (Section VI) and other parts of these Bidding Documents, overall as well as in regard to the essential technical and performance characteristics of each component making up the proposed Information System; (b) an item-by-item commentary on the Purchaser’s Technical Requirements, demonstrating the substantial responsiveness of the Information System offered to those requirements. In demonstrating responsiveness, the commentary shall include explicit cross references to the relevant pages in the supporting materials included in the bid. Whenever a discrepancy arises between the item-byitem commentary and any catalogs, technical specifications, or other preprinted materials submitted with the bid, the item-by-item commentary shall prevail; (c) a Preliminary Project Plan describing, among other things, the methods by which the Bidder will carry out its overall management and coordination responsibilities if awarded the Contract, and the human and other resources the Bidder proposes to use. The Plan should include a detailed Contract Implementation Schedule in bar chart form, showing the estimated duration, sequence, and interrelationship of all key activities needed to complete the Contract. The Preliminary Project Plan must also address any other topics specified in the BDS. In addition, Page 21 the Preliminary Project Plan should state the Bidder’s assessment of what it expects the Purchaser and any other party involved in the implementation of the Information System to provide during implementation and how the Bidder proposes to coordinate the activities of all involved parties; (d) a written confirmation that the Bidder accepts responsibility for the successful integration and interoperability of all components of the Information System as required by the Bidding Documents. 16.3 For purposes of the commentary to be furnished pursuant to ITB Clause 16.2 (b), the Bidder shall note that references to brand names or model numbers or national or proprietary standards designated by the Purchaser in its Technical Requirements are intended to be descriptive and not restrictive. Except where explicitly prohibited in the BDS for specific items or standards, the Bidder may substitute alternative brand/model names or standards in its bid, provided that it demonstrates to the Purchaser’s satisfaction that the use of the substitute(s) will result in the Information System being able to perform substantially equivalent to or better than that specified in the Technical Requirements. 17. Securing the Bid 17.1 The BDS for this Clause specifies whether bids must be secured, and if so, whether by a Bid-Securing Declaration or by a Bid Security. If a Bid Security is required or optional, the BDS also specifies the amount. 17.2 Securing the bids shall be substantially in accordance with the related sample forms included in Section VII or other forms approved by the Purchaser prior to bid submission. Bids must remain secured for a period of 28 days beyond the validity period of the bids, as extended, if applicable, in accordance with ITB Clause 18.2. In case of a Bid Security, it shall also: (a) at the Bidder’s option, be in the form of either a certified check, letter of credit, or a bank guarantee from a banking institution, or a bond issued by a surety; (b) be issued by a reputable institution selected by the Bidder and located in any eligible country; if the institution issuing the security is located outside the Purchaser’s Country, it shall have a correspondent financial institution located in the Purchaser’s Country to make the security enforceable; (c) be payable promptly upon written demand by the Purchaser in case any of the conditions listed in ITB Clause 17.6 is/are invoked; (d) be submitted in its original form; copies will not be accepted. 17.3 The Bid-Securing Declaration or the Bid Security of a Joint Venture shall be issued in the name of the Joint Venture submitting the bid provided the Joint Venture has legally been constituted, or else it shall be issued in the name of all partners proposed for the Joint Venture in the bid. Sanctions due to a breach of the terms of a Bid-Securing Declaration pursuant to ITB Clause 17.6 will apply to all partners to the Joint Venture. 17.4 If a Bid-Securing Declaration or Bid Security is required in accordance with ITB Clause 17.1, any bid not accompanied by a substantially acceptable Bid-Securing Declaration or Bid Security in accordance with ITB Clauses 17.2 and 17.3, shall be rejected by the Purchaser as non-responsive. 17.5 Unless executed or forfeited pursuant to ITB Clause 17.6, BidSecuring Declarations, if any, will expire for, or Bid Securities, if any, will be returned as promptly as possible to, (a) all Bidders upon annulment of the bidding pursuant to ITB Clause 34; (b) Bidders refusing a request to extend the period of validity of their bids pursuant to ITB Clause 18.2; (c) the successful Bidder once it has signed the Contract Agreement and furnished a valid Performance Security as required; (d) the unsuccessful Bidders at the same time as in (c), that is, when they are informed about the successful establishment of the contract with the successful Bidder. Page 23 17.6 The Bid-Securing Declaration, if any, may be executed, or the Bid Security, if any, may be forfeited: (a) if a Bidder withdraws its bid during the period of bid validity specified by the Bidder on the Bid Submission Form or any extension of validity the Bidder has agreed to pursuant to ITB Clause 18.2; or (b) in the case of the successful Bidder, if the Bidder fails to: (i) (ii) sign the Contract Agreement in accordance with ITB Clause 36; or furnish the Performance Security in accordance with ITB Clause 37. 17.7 If a bid security is not required in the BDS, and (a) if a Bidder withdraws its bid during the period of bid validity specified by the Bidder on the Letter of Bid Form, except as provided in ITB 18.2, or (b) if the successful Bidder fails to: sign the Contract in accordance with ITB 36; or furnish a performance security in accordance with ITB 37; the Borrower may, if provided for in the BDS, declare the Bidder disqualified to be awarded a contract by the Employer for a period of time as stated in the BDS. 18. Period of Validity of Bids 18.1 Bids shall remain valid, at a minimum, for the period specified in the BDS after the deadline date for bid submission prescribed by the Purchaser, pursuant to ITB Clause 21. A bid valid for a shorter period shall be rejected by the Purchaser as nonresponsive. For the convenience of Bidders, the BDS spells out the minimal original expiration dates for the validity of the bid and, if applicable pursuant to ITB Clause 17.1, for securing the bid. However, Bidders are responsible for adjusting the dates in the BDS in accordance with any extensions to the deadline date of bid submission pursuant to ITB Clause 21.2. 18.2 In exceptional circumstances, prior to expiry of the bid validity period, the Purchaser may request that the Bidders extend the period of validity for a specified additional period. The request and the responses to the request shall be made in writing. A Bidder may refuse the request without risking execution of the Bid-Securing Declaration or forfeiting the Bid Security, but in this case the bid will be out of the competition for the award. Except as provided in ITB Clause 18.3, a Bidder agreeing to the request will not be required or permitted to modify its bid, but will be required to ensure that the bid remains secured for a correspondingly longer period, pursuant to ITB Clause 17.2. 18.3 In the case of fixed price contracts, if the award is delayed by a period exceeding fifty-six (56) days beyond the expiry of the initial bid validity, the contract price will be adjusted as specified in the request for extension. Bid evaluation will be based on the bid prices without taking into consideration the above correction. 19. Format and Signing of Bid 19.1 The Bidder shall prepare an original and the number of copies/sets of the bid specified in the BDS, clearly marking each one as “ORIGINAL BID,” “COPY NO. 1,” “COPY NO. 2,” etc., as appropriate. In the event of any discrepancy between them, the original shall govern. 19.2 The original and all copies of the bid, each consisting of the documents listed in ITB Clause 13.1, shall be typed or written in indelible ink and shall be signed by a person or persons duly authorized to sign on behalf of the Bidder. The authorization must be in writing and included in the bid pursuant to ITB Clause 13.1 (d). The name and position held by each person signing the authorization must be typed or printed below the signature. All pages of the bid, except for unamended printed literature, shall be initialed by the person or persons signing the bid. 19.3 The bid shall contain no interlineations, erasures, or overwriting, except to correct errors made by the Bidder, in which case such corrections shall be initialed by the person or persons signing the bid. 19.4 The Bidder shall furnish in the Bid Submission Form (a sample of which is provided in the Sample Forms Section of the Bidding Documents) information regarding commissions or gratuities, if any, paid or to be paid to agents relating to this procurement and to the execution of the Contract should the Bidder be successful. D. SUBMISSION OF BIDS 20. Sealing and Marking of Bids 20.1 The Bidder shall seal the original and each copy of the bid in separate envelopes, duly marking the envelopes as “ORIGINAL BID” and “COPY NO. [number].” The envelopes shall then be sealed in an outer envelope. 20.2 The inner and outer envelopes shall (a) be addressed to the Purchaser at the address given in the BDS, and (b) bear the loan/Project name indicated in the BDS for ITB Clause 2.1, the Invitation for Bids title and number, and the Contract name(s), as indicated in the BDS for ITB Clause 1.2, and the statement “DO NOT OPEN BEFORE [ time and date],” to be completed with the time and date specified in the BDS for ITB Clause 24.1. 20.3 The inner envelopes shall also indicate the name and address of the Bidder so that the bid can be returned unopened in case it is declared “late.” Page 25 20.4 If the outer envelope is not sealed and marked as required by ITB Clause 20.2 above, the Purchaser will assume no responsibility for the bid’s misplacement or premature opening. If the outer envelope discloses the Bidder’s identity, the Purchaser will not guarantee the anonymity of the bid submission, but this disclosure will not constitute grounds for bid rejection. 21. Deadline for Submission of Bids 21.1 Bids must be received by the Purchaser at the address specified in the BDS for ITB Clause 20.2 no later than the time and date stated in the BDS. 21.2 The Purchaser may, at its discretion, extend this deadline for submission of bids by amending the Bidding Documents in accordance with ITB Clause 11.3, in which case all rights and obligations of the Purchaser and Bidders will thereafter be subject to the deadline as extended. 22. Late Bids 22.1 Any bid received by the Purchaser after the bid submission deadline prescribed by the Purchaser in the BDS for ITB Clause 21, will be rejected and returned unopened to the Bidder. 23.1 The Bidder may withdraw, substitute, or modify its bid after 23. Withdrawal, submission, provided that written notice of the withdrawal, Substitution, substitution, or modification is received by the Purchaser prior to and the deadline prescribed for bid submission. All notices must be Modification of duly signed by an authorized representative and shall include a Bids copy of the authorization (the power of attorney) in accordance with ITB Sub-Clause 19.2. 23.2 All notices of withdrawal, substitution, or modification shall (a) be addressed to the Purchaser at the address named in the BDS for ITB Clause 20.2 (a), and (b) bear the Contract name, the IFB Title and IFB Number, and the words “BID WITHDRAWAL NOTICE”, BID SUBSTITUTION NOTICE”, or “BID MODIFICATION NOTICE”. 23.3 A notice may also be sent by electronic means such as fax or email, but in this case must include a scan of the mailing receipt showing both the sender's and receiver's addresses for the signed hardcopy of the notice, and a scan of the power of attorney. 23.4 Bids requested to be withdrawn in accordance with ITB 23.1 shall be returned unopened to the Bidders. Bid withdrawal notices received after the bid submission deadline will be ignored, and the submitted bid will be deemed to be a validly submitted bid. 23.5 The substitution or modification of the bid shall be prepared, sealed, marked, and dispatched as follows: (a) The Bidders shall provide an original and the number of copies specified in the BDS for ITB Clause 19.1 of any substitution or modification to its bid, clearly identified as such, in two inner envelopes duly marked “BID SUBSTITUTION -- ORIGINAL” or “BID MODIFICATION -- ORIGINAL” and “BID SUBSTITUTION -- COPIES” or “BID MODIFICATION -- COPIES.” The inner envelopes shall be sealed in an outer envelope, which shall be duly marked “BID SUBSTITUTION” or “BID MODIFICATION”. (b) Other provisions concerning the marking and dispatch of a bid substitution or modification shall be in accordance with ITB Clauses 20.2, 20.3, and 20.4. 23.6 No bid may be withdrawn, substituted, or modified in the interval between the bid submission deadline and the expiration of the bid validity period specified by the Bidder in the Bid Submission Form, or any extension thereof agreed to by the Bidder. Withdrawal of a bid during this interval may result in the execution of the Bid-Securing Declaration, if any, or forfeiture of the Bid Security, if any, pursuant to ITB Clause 17.6. E. BID OPENING AND EVALUATION 24. Opening of Bids by Purchaser 24.1 The Purchaser will open all bids, including withdrawals, substitutions, and modifications, in public, in the presence of Bidders’ representatives who choose to attend, at the time, on the date and at the place specified in the BDS. Bidders’ representatives shall sign a register as proof of their attendance. 24.2 First, envelopes marked “BID WITHDRAWAL NOTICE” shall be opened and read out and the envelope with the corresponding bid shall not be opened, but returned to the Bidder. No bid withdrawal shall be permitted unless the corresponding withdrawal notice contains a valid authorization to request the withdrawal and is read out at bid opening. Next, envelopes marked “BID SUBSTITUTION NOTICE” shall be opened and read out and exchanged with the corresponding bid being substituted, and the substituted bid shall not be opened, but returned to the Bidder. No bid substitution shall be permitted unless the corresponding substitution notice contains a valid authorization to request the substitution and is read out at bid opening. Envelopes marked “BID MODIFICATION NOTICE” shall be opened and read out with the corresponding bid. No bid modification shall be permitted unless the corresponding modification notice contains a valid authorization to request the modification and is read out at bid opening. Only bids that are opened and read out at bid opening shall be considered further. 24.3 Bids shall be opened one at a time, reading out: the name of the Bidder and whether there is a modification; the total bid price including any unconditional discounts, and, if applicable, the prices and unconditional discounts for Subsystems, lots, or slices; the presence or absence of a Bid-Securing Declaration or a Bid Security if one was required; any conditional discounts offered for the award of more than one Subsystem, lot, or slice, if the BDS for ITB Clause 28.1 permits such discounts to be Page 27 considered in the bid evaluation; and any other such details as the Purchaser may consider appropriate. 24.4 Bids and modifications that are not opened and read out at bid opening shall not be considered for further evaluation, irrespective of the circumstances. These bids, including any bids validly withdrawn in accordance with ITB Clause 24.2, will promptly be returned, unopened, to their Bidders. 24.5 The Purchaser will prepare minutes of the bid opening, including the information disclosed to those present in accordance with ITB Clause 24.3. The minutes will promptly be distributed to all Bidders that met the deadline for submitting bids. 25. Clarification of 25.1 During the bid evaluation, the Purchaser may, at its discretion, ask the Bidder for a clarification of its bid. The request for Bids clarification and the response shall be in writing, and no change in the price or substance of the bid shall be sought, offered, or permitted. 26. Preliminary Examination of Bids 26.1 The Purchaser will examine the bids to determine whether they are complete, whether any computational errors have been made, whether required sureties have been furnished, whether the documents have been properly signed, and whether the bids are generally in order. In the case where a prequalification process has been undertaken for the Contract(s) for which these Bidding Documents have been issued, the Purchaser will ensure that each bid is from a prequalified Bidder, and in the case of a Joint Venture, that partners and structure of the Joint Venture are unchanged from those in the prequalification. 26.2 Arithmetical errors will be rectified on the following basis. If there is a discrepancy between the unit price and the total price, which is obtained by multiplying the unit price and quantity, or between added or subtracted subtotals and totals, the unit or subtotal price shall prevail and the total price shall be corrected, unless in the opinion of the Purchaser there is an obvious misplacement of the decimal point in the unit or subtotal prices, in which case the line item total as quoted shall govern and the unit price or sub-total shall be corrected. If there is a discrepancy between words and figures, the amount in words will prevail, unless the discrepancy is the result of a typo/error for which the correction is self-evident to the Purchaser. If the Bidder with the Lowest Evaluated Bid does not accept the correction of errors, the bid shall be rejected. 26.3 The Purchaser may waive any minor informality, nonconformity, or irregularity in a bid that does not constitute a material deviation, provided such waiver does not prejudice or affect the relative ranking of any Bidder. 26.4 Prior to the detailed evaluation, the Purchaser will determine whether each bid is of acceptable quality, is complete, and is substantially responsive to the Bidding Documents. For purposes of this determination, a substantially responsive bid is one that conforms to all the terms, conditions, and specifications of the Bidding Documents without material deviations, exceptions, objections, conditionalities, or reservations. A material deviation, exception, objection, conditionality, or reservation is one: (i) that limits in any substantial way the scope, quality, or performance of the Information System; or (ii) that limits, in any substantial way that is inconsistent with the Bidding Documents, the Purchaser’s rights or the successful Bidder’s obligations under the Contract; or (iii) the acceptance of which would unfairly affect the competitive position of other Bidders who have submitted substantially responsive bids. 26.5 If a bid is not substantially responsive, it will be rejected by the Purchaser and may not subsequently be made responsive by the Bidder by correction of the nonconformity. The Purchaser’s determination of bid responsiveness will be based on the contents of the bid itself. 27. Conversion to Single Currency 27.1 For evaluation and comparison purposes, the Purchaser shall convert all bid prices expressed in various currencies and amounts into a single currency specified in the BDS, using the selling exchange rate established by the source and on the date also specified in the BDS. 28. Evaluation and 28.1 The Purchaser will evaluate and compare the bids that have been determined to be substantially responsive, pursuant to ITB Comparison of Clause 26. The evaluation will be performed assuming either Bids that: (a) the Contract will be awarded to the lowest evaluated Bidder for the entire Information System; or (b) if specified in the BDS, Contracts will be awarded to the Bidders for each individual Subsystem, lot, or slice defined in the Technical Requirements whose bids result in the lowest combined evaluated price for the entire System. In the latter case, discounts that are conditional on the award of more than one Subsystem, lot, or slice may be offered in bids. However, such discounts will only be considered in the price evaluation if so confirmed in the BDS. 28.2 To be considered for Contract award, Bidders must have submitted bids (a) for which detailed bid evaluation using the same standards for compliance determination as listed in ITB Clauses 26.3 and 26.4 confirms that the bids are commercially and technically responsive, and include the hardware, Software, related equipment, products, Materials, and other Goods and Services components of the Information System in, substantially, the full required quantities for the entire Information System or, if allowed in the BDS for ITB Clause 28.1, the individual Subsystem, lot or slice bid on; and (b) that offer Information Technologies that are proven to Page 29 perform up to the standards promised in the bid by having successfully passed the performance, benchmark, and/or functionality tests the Purchaser may require, pursuant to ITB Clause 31.2. 28.3 The Purchaser’s evaluation of a bid will be made on the basis of prices quoted in accordance with ITB Clause 14 (Bid Prices). 28.4 If indicated by the BDS, the Purchaser’s evaluation of responsive bids will take into account technical factors, in addition to cost factors. An Evaluated Bid Score (B) will be calculated for each responsive bid using the following formula, which permits a comprehensive assessment of the bid price and the technical merits of each bid: B Clow T 1 X X C Thigh where C = Evaluated Bid Price C low = the lowest of all Evaluated Bid Prices among responsive bids T = the total Technical Score awarded to the bid Thigh = the Technical Score achieved by the bid that was scored highest among all responsive bids X = weight for the Price as specified in the BDS The bid with the highest Evaluated Bid Score (B) among responsive bids shall be termed the Lowest Evaluated Bid and is eligible for Contract award, provided the Bidder was prequalified and/or it was found to be qualified to perform the Contract in accordance with ITB Clause 31 (Postqualification). 28.5 If, in addition to the cost factors, the Purchaser has chosen to give weight to important technical factors (i.e., the price weight, X, is less than 1 in the evaluation), that cannot be reduced to life-cycle costs or pass/fail criteria, the Total Technical Points assigned to each bid in the Evaluated Bid Formula will be determined by adding and weighting the scores assigned by an evaluation committee to technical features of the bid in accordance with the criteria set forth below. (a) The technical features to be evaluated are generally defined below and specifically identified in the BDS: (i) Performance, capacity, or functionality features that either exceed levels specified as mandatory in the Technical Requirements; and/or influence the lifecycle cost and effectiveness of the Information System. (ii) Usability features, such as ease of use, ease of administration, or ease of expansion, which influence the life-cycle cost and effectiveness of the Information System. (iii) The quality of the Bidder’s Preliminary Project Plan as evidenced by the thoroughness, reasonableness, and responsiveness of: (a) the task and resource schedules, both general and specific, and (b) the proposed arrangements for management and coordination, training, quality assurance, technical support, logistics, problem resolution, and transfer of knowledge, and other such activities as specified by the Purchaser in Section VI (Technical Requirements) or proposed by the Bidder based on the Bidder’s experience. (b) Feature scores will be grouped into a small number of evaluation categories, generally defined below and specifically identified in the BDS, namely: (i) The technical features that reflect how well the Information System meets the Purchaser’s Business Requirements (including quality assurance and riskcontainment measures associated with the implementation of the Information System). (ii) The technical features that reflect how well the Information System meets the System’s Functional Performance Standards. (iii) The technical features that reflect how well the Information System meets the General Technical Requirements for hardware, network and communications, Software, and Services. (c) As specified in the BDS, each category will be given a weight and within each category each feature may also be given a weight. (d) During the evaluation process, the evaluation committee will assign each desirable/preferred feature a whole number score from 0 to 4, where 0 means that the feature is absent, and 1 to 4 either represent predefined values for desirable features amenable to an objective way of rating (as is the case for, e.g., extra memory, or extra mass storage capacity, etc., if these extras would be conducive for the utility of the system), or if the feature represents a desirable functionality (e.g., of a software package) or a quality improving the prospects for a successful implementation (such as the strengths of the proposed project staff, the methodology, the elaboration of the project plan, etc., in the bid), the scoring will be 1 for the feature being present but showing deficiencies; 2 for meeting the requirements; 3 for marginally exceeding the requirements; and 4 for significantly exceeding the requirements. Page 31 (e) The score for each feature (i) within a category (j) will be combined with the scores of features in the same category as a weighted sum to form the Category Technical Score using the following formula: k S j t ji w ji i 1 where: tji = the technical score for feature “i” in category “j” wji = the weight of feature “i” in category “j” k = the number of scored features in category “j” k w and i 1 (f) ji 1 The Category Technical Scores will be combined in a weighted sum to form the total Technical Bid Score using the following formula: n T S j Wj j 1 where: Sj = the Category Technical Score of category “j” Wj = the weight of category “j” as specified in the BDS n = the number of categories n and W j 1 j 1 28.6 The Evaluated Bid Price (C) for each responsive bid will be determined as the sum of the Adjusted Supply and Installation Costs (P) plus the Recurrent Costs (R); where the Adjusted Supply and Installation Costs (P) are determined as: (a) The price of the hardware, Software, related equipment, products, Materials and other Goods offered from within or from outside the Purchaser’s Country, in accordance with ITB 14.4; plus (b) The total price for all software development, transportation, insurance, installation, customization, integration, Commissioning, testing, training, technical support, repair, and other Services, in accordance with ITB 14.5; (c) with adjustments for: (i) Deviations proposed to the Implementation Schedule in the Technical Requirements resulting in delayed completion of the entire Information System, if permitted in the BDS and provided they do not exceed the maximum permissible delay period specified in the BDS. For evaluation purposes, a pro rata increase of the total Supply and Installation Costs will be added using the percentage(s) specified in the BDS for each week of delay. Bids offering deliveries beyond the maximum permissible delay specified may be rejected. (ii) Deviations taken to the Contract payment schedule specified in the SCC. If deviations are permitted in the BDS, for evaluation purposes the total Supply and Installation Costs will be increased pro rata by the amount of interest that could otherwise be earned on the amount of any payments that would fall due under the proposed schedule earlier than the schedule stipulated in the SCC, at the interest rate specified in the BDS. (iii) Goods and Services that are required for the Information System but have been left out or are necessary to correct minor deviations of the bid will be added to the total Supply and Installation Costs using costs taken from the highest prices from other responsive bids for the same Goods and Services, or in the absence of such information, the cost will be estimated at prevailing list prices. If the missing Goods and Services are a scored technical feature, the relevant score will be set at zero. (iv) Corrections to errors in arithmetic, in accordance with ITB Clause 26.2. (v) (d) Any discounts offered for the award of more than one Subsystem, lot, or slice, if the BDS for ITB Clause 28.1 permits the consideration of discounts in the price evaluation. The Recurrent Costs (R) are reduced to net present value and determined using the following formula: R NM R x x x 1 1 I where N = number of years of the Warranty Period, defined in SCC Clause 29.4 M = number of years of the Post-Warranty Services Period, as defined in SCC Clause 1.1.(e) (xii) x = an index number 1, 2, 3, ... N + M representing each year of the combined Warranty Service and Post-Warranty Service Periods. Rx = total Recurrent Costs for year “x,” as recorded in Page 33 the Recurrent Cost Sub-Table. I = discount rate to be used for the Net Present Value calculation, as specified in the BDS. 29. Domestic Preference 29.1 No margin of domestic preference will apply. 30. Contacting the Purchaser 30.1 From the time of bid opening to the time of Contract award, if any Bidder wishes to contact the Purchaser on any matter related to the bid, it should do so in writing. 30.2 If a Bidder tries to directly influence the Purchaser or otherwise interfere in the bid evaluation process and the Contract award decision, its bid may be rejected. F. POSTQUALIFICATION AND AWARD OF CONTRACT 31. Postqualification 31.1 The Purchaser will determine at its own cost and to its satisfaction whether the Bidder (including Joint Venture Partners, and any Subcontractors for which the BDS for ITB Clause 6.1 (a) permits that their qualifications count towards the required Bidder qualifications) that is selected as having submitted the Lowest Evaluated Bid is qualified to perform the Contract satisfactorily, in accordance with ITB Clause 6. If a prequalification process was undertaken for the Contract(s) for which these Bidding Documents were issued, the Purchaser will determine in the manner described above that no material changes have occurred after the prequalification that negatively affect the ability of the Bidder that has submitted the Lowest Evaluated Bid to perform the Contract. 31.2 Pursuant to ITB Clauses 6 and 16, and as additionally may be specified in the BDS, the determination will evaluate the Bidder’s financial, technical, design, integration, customization, production, management, and support capabilities and will be based on an examination of the documentary evidence of the Bidder’s qualifications, as well as other information the Purchaser deems necessary and appropriate. This determination may include visits or interviews with the Bidder’s clients referenced in its bid, site inspections, and any other measures. If so specified in the BDS, at the time of postqualification the Purchaser may also carry out tests to determine that the performance or functionality of the Information System offered meets those stated in the Technical Requirements. 31.3 An affirmative postqualification determination will be a prerequisite for award of the Contract to the Lowest Evaluated Bidder. A negative determination will result in rejection of the Bidder’s bid, in which event the Purchaser will proceed to the next lowest evaluated Bidder to make a similar determination of that Bidder’s capabilities to perform satisfactorily. 32. Award Criteria 32.1 Subject to ITB Clause 34, the Purchaser will award the Contract to the Bidder whose bid has been determined to be substantially responsive and the Lowest Evaluated Bid, provided further that the Bidder has been determined to be qualified to perform the Contract satisfactorily, pursuant to ITB Clause 31. 33. Purchaser’s Right to Vary Quantities at Time of Award 33.1 The Purchaser reserves the right at the time of Contract award to increase or decrease, by the percentage(s) indicated in the BDS, any of the following: (a) the quantity of substantially identical Subsystems; or (b) the quantity of individual hardware, Software, related equipment, Materials, products, and other Goods components of the Information System; or (c) the quantity of Installation or other Services to be performed, from that originally specified in the Technical Requirements (as amended by any Addenda issued pursuant to ITB Clause 11), without any change in unit prices or other terms and conditions. 34. Purchaser’s Right to Accept Any Bid and to Reject Any or All Bids 34.1 The Purchaser reserves the right to accept or reject any bid or to annul the bidding process and reject all bids at any time prior to Contract award, without thereby incurring any liability to the Bidders. 35. Notification of Award 35.1 Prior to the expiration of the period of bid validity, the Purchaser shall notify the successful Bidder, in writing, that its bid has been accepted. 35.2 Until a formal Contract is prepared and executed, the notification of award shall constitute a binding Contract. 35.3 The Purchaser shall promptly publish in UNDB online and in dgMarket the results, identifying the bid and lot numbers and the following information: (i) name of each Bidder who submitted a bid; (ii) bid prices as read out at bid opening; (iii) name, evaluated price and, if the bidding conditions included scoring for technical quality, the technical score of each bid that was evaluated; (iv) name of Bidders whose bids were rejected and the reasons for their rejection; and (v) name of the winning Bidder, the price it offered, as well as the duration and summary scope of the contract awarded. After publication of the award, unsuccessful Bidders may make a request in writing to the Purchaser for a debriefing seeking explanations on the grounds on which their bids were not selected. The Purchaser shall promptly respond in writing to any unsuccessful Bidder who, after publication of contract award, requests a debriefing. 35.4 Upon the successful Bidder furnishing the signed Contract Agreement and the Performance Security pursuant to ITB Clause 37, the Purchaser will promptly notify each unsuccessful Bidder, and will discharge all remaining Bid Securities, if any, Page 35 as provided in ITB Clause 17.5 (c) and (d). 36. Signing of Contract 36.1 At the same time as the Purchaser notifies the successful Bidder that its bid has been accepted, the Purchaser will send the Bidder the Contract Agreement provided in the Bidding Documents, incorporating all agreements between the parties. 36.2 As soon as practically possible, but no more than twenty-eight (28) days following receipt of the Contract Agreement, the successful Bidder shall sign and date it, and return it to the Purchaser. 37. Performance Security 37.1 As soon as practically possible, but no more than twenty-eight (28) days following receipt of notification of award from the Purchaser, the successful Bidder shall furnish the Performance Security in accordance with the GCC, using the Performance Security form provided in the Bidding Documents or another form acceptable to the Purchaser. 37.2 Failure of the successful Bidder to comply with the requirements of ITB Clause 36 or ITB Clause 37.1 shall constitute sufficient grounds for the annulment of the award and, if and as applicable, execution of the Bid-Securing Declaration or forfeiture of the Bid Security, in which event the Purchaser may make the award to the next lowest evaluated bid submitted by a qualified Bidder or call for new bids. 38. Adjudicator 38.1 Unless otherwise stated in the BDS, the Purchaser proposes that the person named in the BDS be appointed as Adjudicator under the Contract to assume the role of informal Contract dispute mediator, as described in GCC Clause 6. In this case, a résumé of the named person is attached to the BDS. The proposed hourly fee for the Adjudicator is specified in the BDS. The expenses that would be considered reimbursable to the Adjudicator are also specified in the BDS. If a Bidder does not accept the Adjudicator proposed by the Purchaser, it should state its non-acceptance in its Bid Submission Form and make a counterproposal of an Adjudicator and an hourly fee, attaching a résumé of the alternative. If the successful Bidder and the Adjudicator nominated in the BDS happen to be from the same country, and this is not the country of the Purchaser too, the Purchaser reserves the right to cancel the Adjudicator nominated in the BDS and propose a new one. If by the day the Contract is signed, the Purchaser and the successful Bidder have not agreed on the appointment of the Adjudicator, the Adjudicator shall be appointed, at the request of either party, by the Appointing Authority specified in the SCC clause relating to GCC Clause 6.1.4, or if no Appointing Authority is specified there, the Contract will be implemented without an Adjudicator. SECTION II. BID DATA SHEET (BDS) Bid Data Sheet The Section contains specific information relating to the Systems to be procured and the procurement procedures. Whenever there is a conflict, the provisions in the Bid Data Sheet (BDS) shall prevail over those in Bidding documentation. A. GENERAL ITB 1.1 Name of Purchaser: Ministry of Healthcare and Social Development of the Republic of Kazakhstan Description of the System for which bids are invited: Delivery of Health Information Systems for health facilities of the RK which consists of the following lots: Lot № 1 «Delivery and implementation of Comprehensive Health Information System for Municipal hospital №1 Ust-Kamenogorsk city»; Lot № 2 «Delivery and implementation of Comprehensive Health Information System for Municipal Clinic Hospital №4 Almaty city»; Lot № 3 «Delivery and implementation of Comprehensive Health Information System for Mother and Child Center Ust-Kamenogorsk city»; Lot № 4 «Delivery and implementation of Comprehensive Health Information System for Municipal Policlinic №11 Almaty city»; Lot № 5 «Delivery and implementation of Comprehensive Health Information System for Regional Diagnostic Center Almaty city»; Lot № 6 «Delivery and implementation of Comprehensive Health Information System for Policlinic №1 Kostanay»; Lot № 7 «Delivery and implementation of Comprehensive Health Information System for Central rayon hospital, Zhualynsky rayon, Zhambul oblast»; Lot № 8 «Delivery and implementation of Comprehensive Health Information System for Municipal policlinic №7 Astana city»; Lot № 9 «Delivery and implementation of Comprehensive Health Information System for Municipal Hospital No. 1 of Astana city»; Lot № 10 «Health Information System for accounting donors and recipients». ITB 1.2 Title of IFB: Delivery of Health Information Systems for health facilities of the RK Number of IFB: № KHSTTIRP-D/SW-03-rebidding Name of resulting Contract: KHSTTIRP-D/SW-03-rebidding “Delivery of Health Information Systems for health facilities of Page 37 the RK” ITB 1.4 Alternative e-Tendering procedures are not available in this procurement. ITB 2.1 Name of the Borrower: Republic of Kazakhstan Loan or credit number: Loan № 4883-KZ Loan or credit amount: US$ 117 700 000 Name of Project: Kazakhstan Health Sector Technology Transfer and Institutional Reform Project ITB 6.1 (a) Qualification requirements for Bidders are: (a) The Bidder shall furnish documentary evidence that it meets the following financial requirement(s): - The average annual turnover in USD or equivalent the most recent three (3) (2012, 2013 and 2014) years: - at least US$1,500,000.00 (one million five hundred thousand) for Lot № 1 «Delivery and implementation of Comprehensive Health Information System for Municipal hospital №1 Ust-Kamenogorsk city»; - at least US$1,000,000.00 (one million ) for Lot № 2 «Delivery and implementation of Comprehensive Health Information System for Municipal Clinic Hospital №4 Almaty city»; - at least US$2,000,000.00 (two million) for Lot № 3 «Delivery and implementation of Comprehensive Health Information System for Mother and Child Center UstKamenogorsk city»; - at least US$1,000,000.00 (one million) for Lot № 4 «Delivery and implementation of Comprehensive Health Information System for Municipal Policlinic №11 Almaty city»; - at least US$1,000,000.00 (one million) for Lot № 5 «Delivery and implementation of Comprehensive Health Information System for Regional Diagnostic Center Almaty city»; - at least US$1,000,000.00 (one million) for Lot № 6 «Delivery and implementation of Comprehensive Health Information System for Policlinic №1 Kostanay»; - at least US$1,000,000.00 (one million) for Lot № 7 «Delivery and implementation of Comprehensive Health Information System for Central rayon hospital, Zhualynsky rayon, Zhambul oblast»; - at least US$1,000,000.00 (one million) for Lot № 8 «Delivery and implementation of Comprehensive Health Information System for Municipal policlinic №7 Astana city»; - at least US$1,000,000.00 (one million) for Lot № 9 «Delivery and implementation of Comprehensive Health Information System for Municipal Hospital No. 1 of Astana city»; - at least US$1,500,000.00 (one million five hundred thousand) for Lot № 10 « Medical information system for registration of donors, recipients and individuals waiting for transplantation». Where the Bidder is a Joint Venture the sum of all Partners' average turnover amounts may be used. Also, where the Bidder is a Joint Venture the Partner in charge must have had an average annual turnover equivalent to at least half of the amount required for the most recent three (3) years, while every other partners – at least 10 % out of total required amount. The Bidder should provide audited financial statements and balance sheets (or some other documents according to legislation of Bidder’s country) for the last three (3) completed fiscal years demonstrating the soundness of the Bidder’s financial position and available resources necessary to handle the requirements of the proposed Contract. If the bidder wishes to qualify for award of contract for more than one lot then the bidder must demonstrate having required annual average turnover to meet the aggregate of the qualifying criteria for the individual lots. (b) Experience and Technical Capacity The Bidder shall furnish documentary evidence (including information about the completed contracts and contact information of clients from whom the references could be taken or whom the Purchaser may, when necessary, visit to learn the systems put into operation by the Bidder) to demonstrate that it meets the following requirements to experience: i. the Bidder should have been operating at minimum for 5 years with the basic activity being delivery and implementation of Information Systems for health facilities. ii. the Manufacturer(s) of Software shall have at least one certificate out of the following list: Capability Maturity Model Integration (CMMI) Maturity Level 3, ISO 9000 or ST RK ISO 9001:2009, or similar for quality management process. (The Bidder shall provide copy of certificate for compliance issued by authorized agency). iii. the Bidder shall have experience in training end-users and IT Page 39 specialists. iv. the Bidder shall have proven experience in design of similar projects: at least 5 health facilities currently use systems designed and implemented by the Bidder (the scale of these health facilities shall be preferably correspondent to that of health facilities – beneficiaries under this Bidding or exceed it). “Proven” means presentation of contracts, addresses, letters and other documents capable to confirm the use (and outcomes) of the System required under the Contract. v. The Bidder shall have own team of experts with the experience of implementation of similar projects. the Bidder shall present the Table containing the List of Staff with their CV to prove their experience and expertise. Detailed requirements to the team are set in Section VI «Technical Requirements» in item R10.4 for lots 1-9 and R11.4 for lot 10. The Bidder should provide two sets of CVs to win two lots and three sets of CVs to win three lots. vi. the Bidder shall forward all documents confirming the origin of all components and products including Manufacturer’s Authorization to use these products within this Contract or confirmation on ownership of the rights for the products (patent or any other documents) including Intellectual Property rights and other relevant rights. vii. the Bidders (or JV members) shall have proven experience of work with one or several standards used herein: HL7 v2, v3, FHIR, CDA (R2). IHE. ITB 6.1 (b) Manufacturer's Authorizations for Information Technologies except for those technologies which the Bidder itself manufactures are required for the following types/categories: for operation systems, proprietary software ITB 6.1 (c) If the Bidder proposes to use Subcontractors for the provision of certain key services, written agreements by the proposed firms to provide these services in case of contract resulting from this bidding are required for the following types/categories of services: software customization, training, and, in particular, warranty and postwarranty service of equipment. B. THE BIDDING DOCUMENTS ITB 10.1 Address: Project Implementation Support Team (PIST), 010000, Kazakhstan, Astana city, Imanov Str.19 office 504, tel. + 7172 787 235, fax. + 7172 787 247 e-mail: kazhealth.procurement@gmail.com Contact person: Bolat Tokezhanov – National Project Coordinator Complete set of Bidding Document could be downloaded in English (Word and PDF file) from Project web-site: www.healthproject.kz upon registration. If there is discrepancy between Word and PDF file, the PDF file will prevail. In addition interested Bidders can get complete set of Bidding Document in Russian in Word. In case of discrepancies between the English and Russian versions of the documents, the English version shall prevail Clarifications shall www.healthproject.kz also be published in this website ITB 10.2 Dates, times, and places for the pre-bid meeting: not applicable ITB 11.2 At the end of the para, add “In addition the amendments to bid documents shall also be published in www.healthproject.kz “ C. PREPARATION OF BIDS ITB 12.1 The language of the bid and of all correspondence and documents related to it is: English. To facilitate evaluation of bids, the Purchaser requests Bidders to also submit translations of their bids into Russian language. However, the lack of translation shall not be reason for rejection of bids or effect evaluation of the Bid. In case of discrepancies between English version and translation, the English version will prevail. ITB 14.1 Recurrent cost items are not required. ITB 14.4 The Incoterms edition is “Incoterms 2010 For the current version of Incoterms consult the ICC web site at http://www.iccwbo.org/index_incoterms.asp. ITB 14.4 (a) For foreign goods prices are quoted on delivery conditions based as follows: CIP-Astana for Lots №8, №9 and №10. CIP – Ust Kamenogorsk for Lots №1 and №3. CIP _ Almaty for Lots №2, №4 and №5. CIP – Kostanay for Lot №6. CIP – Taraz for Lot №7. (i) The contract of carriage shall include the cost of unloading the goods at destination, as well as payment by the Supplier of the cost of custom formalities, duties, taxes or other charges payable on the foreign Goods for their transit through any country other than the Purchaser's country. (ii) The named place of destination shall be the “Project Sites” Page 41 pointed out in the table named as List (lists) of the System sites ITB 14.4 (c) Not applicable ITB 14.7 Prices quoted by the Bidder shall be: fixed ITB 15.1 (b) The currency to be used for quoting prices of the Goods and Services components of the System offered locally (i.e., from within the Purchaser’s Country), as well as local currency expenditures for local technical support, training, maintenance, transportation, insurance, and other local services incidental to delivery, installation and operation of the System, is: Kazakhstan Tenge. ITB 16.2 (c) In addition to the stated in ITB 16.2 (c), in the Preliminary Project Plan the following issues should be addressed: (а) Plan of the Project management organization containing described roles and responsibilities of personnel of the Supplier, the names and the number of working hours (person-months), and what actions of management unit and staff of a health facility are necessary for successful implementation of the Project; (b) System (s) implementation Plan in a health facility that would prove that all Purchaser’s requirements for delivered Systems are met, and this is confirmed by facility - beneficiary, and that the systems are certified in accordance with the Purchaser’s requirements (c) Methodology and Plan for development / configuration, testing, installation, trial operation and certification of Systems supplied (d) Methodology and User training Plan specifying the methods and programs of study, the number of hours, training venue and transfer of technology for both users and managers of the enterprise. (e) Data migration Plan (if such data is available) (f) Response plans for warranty service, and provision of professional services for piloting: what is the response time to eliminate errors and queries, to indicate where the staff of the supplier will be, how many people will be involved, and on what schedule. (g) Methodology and support plan for all included software and component both during implementation and during the trial operation ITB 16.3 In the interest of effective integration, cost-effective technical support, and reduced re-training and staffing costs, Bidders are required to offer specific brand names and models for the following limited number of specific items: not applicable ITB 17.1 A bid security will be required in a form of bank guaranty. The amount of the Bid Security shall be: - 20 000 USD for Lot № 1 «Delivery and implementation of Comprehensive Health Information System for Municipal hospital №1 Ust-Kamenogorsk city»; - 10 000 USD for Lot № 2 «Delivery and implementation of Comprehensive Health Information System for Municipal Clinic Hospital №4 Almaty city»; - 30 000 USD for Lot № 3 «Delivery and implementation of Comprehensive Health Information System for Mother and Child Center of Ust-Kamenogorsk city»; - 10 000 USD for Lot № 4 «Delivery and implementation of Comprehensive Health Information System for Municipal Policlinic №11 Almaty city»; - 10 000 USD for Lot № 5 «Delivery and implementation of Comprehensive Health Information System for Regional Diagnostic Center Almaty city»; - 10 000 USD for Lot № 6 «Delivery and implementation of Comprehensive Health Information System for Policlinic №1 Kostanay»; - 15000 USD for Lot № 7 «Delivery and implementation of Comprehensive Health Information System for Central rayon hospital, Zhualynsky rayon, Zhambul oblast»; - 10 000 USD for Lot № 8 «Delivery and implementation of Comprehensive Health Information System for Municipal policlinic №7 Astana city»; - 10 000 USD for Lot № 9 «Delivery and implementation of Comprehensive Health Information System for Municipal Hospital No. 1 of Astana city»; - 20 000 USD for Lot № 10 «Medical information system for registration of donors, recipients and individuals waiting for transplantation». ITB 18.1 The bid validity period shall be one hundred twenty (120) days after the deadline for bid submission, as specified below in reference to ITB Clause 21. Accordingly, each bid shall be valid through February 10, 2016. The actual date of Bid Security expiration is March 9, 2016. ITB 19.1 Required number of bid copies, besides the original: 5 bid copies D. SUBMISSION OF BIDS ITB 20.2 (a) The address for bid submission is: 010000, Kazakhstan, Astana, Imanov Str. 19, office 504, Attn: Bolat Tokezhanov – National Project Coordinator ITB 21.1 Deadline for bid submission is: 15:30 hours, on October 15, 2015. E. BID OPENING AND EVALUATION ITB 24.1 Time, date, and place for bid opening are: 15:30 hours, on October 15, 2015 Page 43 010000 Kazakhstan, Astana, Imanov str. 19, office 504 ITB 27.1 The currency chosen for the purpose of converting to a common currency is: local currency, KZT The source of exchange rate is: National Bank of the Republic of Kazakhstan The date of exchange rate determination is: Bid opening date ITB 28.1 Bids for Subsystems, lots, or slices of the overall Information System will be accepted. The Bids will be evaluated on lot by lot basis. The bidders are not permitted to provide their technical solutions to other bidders who are participating in the same bidding If a Bidder wishes to offer an unconditional discount for any combination of two or three lots, such Bidder may do so by offering one, and only one, such discount, which shall be expressed as a percentage to be applied to the total value of any combination of two or three lots. Such offered discount will be taken into account for the purpose of determining the lowest evaluated price of the lot (contract) combinations. ITB 28.4 A Bidder may also offer individual unconditional discount(s) to the quoted price(s) for any one or more individual lot(s), in which case the respective discount so offered for each lot shall be considered for the purpose of evaluation. If such bidder also offered a single unconditional discount for a combination of two or three lots as described above, it shall be applied to the net bid price derived after subtracting the value of the offered individual unconditional discounts. The bid evaluation will not take into account technical factors in addition to cost factors. Price weight comprises 100%. ITB 28.6 (c) (i) The Purchaser will not accept deviations in the schedule of installation and commissioning specified in the Implementation Schedule. ITB 28.6 (c) (ii) The Purchaser will not accept deviations in the payment schedule in the SCC. F. POSTQUALIFICATION AND AWARD OF CONTRACT ITB 31.2 not applicable ITB 32.1 The contract(s) will be awarded to the Bidder or Bidders offering the lowest evaluated cost to the Purchaser for combined lots, subject to the selected Bidder(s) meeting the required qualification criteria for a lot or combination of lots as the case may be. The Purchaser shall award not more than three lots to one bidder even if the bidder is lowest and qualified. If the Bid of one or several Bidders receives the lowest evaluated cost for more than three lots then the criteria for selection of lots for the Purchaser shall be the best from the Purchaser’s point of view combination of total cost of all awarded lots. ITB 33.1 Percentage for quantity increase or decrease: 15% ITB 38.1 The proposed Adjudicator is: WEINHARA Michael, Master on Sicence in Health Informatics. CV is attached to this Bid Data Sheet. The proposed hourly fee is US$ 350 (three hundred fifty US dollars). The expenses that would be considered reimbursable to the Adjudicator are: all dispute-related telephone, fax, and other communications costs, as well as all costs associated with trips to the site(s), if any. Page 45 Annex to Section II. Bid Data Sheet (BDS) Clause ITB 3: The provisions in ITB 3.1 to 3.3 are replaced with the following, including relevant footnotes: 3. 3.1 It is the Bank’s policy to require that Borrowers (including beneficiaries of Bank loans), as well as bidders, suppliers, and contractors and their agents (whether declared or not), personnel, subcontractors, subconsultants, service providers and suppliers under Bank-financed contracts, observe the highest standard of ethics during the procurement and execution of such contracts.6 In pursuance of this policy, the Bank: Fraud and Corruption (a) defines, for the purposes of this provision, the terms set forth below as follows: (i) “corrupt practice” is the offering, giving, receiving or soliciting, directly or indirectly, of anything of value to influence improperly the actions of another party7; (ii) “fraudulent practice” is any act or omission, including a misrepresentation, that knowingly or recklessly misleads, or attempts to mislead, a party to obtain a financial or other benefit or to avoid an obligation8; (iii) “collusive practice” is an arrangement between two or more parties9 designed to achieve an improper purpose, including to influence improperly the actions of another party; (iv) “coercive practice” is impairing or harming, or threatening to impair or harm, directly or indirectly, any party or the property of the party to influence improperly the actions of a party10; (v) “obstructive practice” is (aa) deliberately destroying, falsifying, altering or concealing of evidence material to the investigation or making false statements to investigators in order to materially impede a Bank investigation into allegations of a corrupt, fraudulent, coercive or collusive practice; and/or threatening, harassing or intimidating any party to prevent it from disclosing its knowledge of matters relevant to the investigation or from pursuing the investigation; or (bb) acts intended to materially impede the exercise of the Bank’s inspection and audit rights provided for under sub-clause 3.2 below. (b) will reject a proposal for award if it determines that the bidder recommended for award has, directly or through an agent, engaged in corrupt, fraudulent, 6 In this context, any action taken by a bidder, supplier, contractor, or any of its personnel, agents, subcontractors, sub-consultants, service providers, suppliers and/or their employees to influence the procurement process or contract execution for undue advantage is improper. “Another party” refers to a public official acting in relation to the procurement process or contract execution. In this context, “public official” includes World Bank staff and employees of other organizations taking or reviewing procurement decisions. 7 “Party” refers to a public official; the terms “benefit” and “obligation” relate to the procurement process or contract execution; and the “act or omission” is intended to influence the procurement process or contract execution. 8 “Parties” refers to participants in the procurement process (including public officials) attempting to establish bid prices at artificial, non- competitive levels. 9 “Party” refers to a participant in the procurement process or contract execution. 10 collusive, coercive or obstructive practices in competing for the contract in question; (c) will cancel the portion of the loan allocated to a contract if it determines at any time that representatives of the Borrower or of a beneficiary of the loan engaged in corrupt, fraudulent, collusive, or coercive practices during the procurement or the execution of that contract, without the Borrower having taken timely and appropriate action satisfactory to the Bank to address such practices when they occur; and (d) will sanction a firm or an individual, at any time, in accordance with prevailing Bank’s sanctions proceduresa, including by publicly declaring such firm or individual ineligible, either indefinitely or for a stated period of time:(i) to be awarded a Bank-financed contract; and (ii) to be a nominatedb subcontractor, consultant, manufacturer or supplier, or service provider of an otherwise eligible firm being awarded a Bank-financed contract. 3.2 In further pursuance of this policy, Bidders shall permit the Bank to inspect any accounts and records and other documents relating to the Bid submission and contract performance, and to have them audited by auditors appointed by the Bank. 3.3 Furthermore, Bidders shall be aware of the provision stated in Clause 9.8 and Clause 41.2 in the General Conditions of Contract. Clause ITB 4 (Eligible bidders): The provision in ITB 4.3 is replaced with the following, including relevant footnotes: 4.3 Afirm that has been sanctioned by the Bank in accordance with the above ITB Clause 3.1 (d), or in accordance with the Bank’s Guidelines on Preventing and Combating Fraud and Corruption in Projects Financed by IBRD Loans and IDA Credits and Grants, shall be ineligible to be awarded a Bank-financed contract, or benefit from a Bank-financed contract, financially or otherwise, during such period of time as the Bank shall determine. The list of debarred firms is available at the electronic address specified in the BDS (http://web.worldbank.org/external/default/main?theSitePK=8426 6&contentMDK=64069844&menuPK=116730&pagePK=641489 89&piPK=64148984). CV Michael Weinhara a A firm or an individual may be declared ineligible to be awarded a Bank-financed contract upon completion of the Bank’s sanctions proceedings as per its sanctions procedures, including inter alia: (i) temporary suspension in connection with an ongoing sanctions proceeding; (ii) crossdebarment as agreed with other International Financial Institutions, including Multilateral Development Banks; and (iii) the World Bank Group corporate administrative procurement sanctions procedures for fraud and corruption. b A nominated sub-contractor, consultant, manufacturer or supplier, or service provider (different names are used depending on the particular bidding document) is one whicheither has been:(i) included by the bidder in its pre-qualification application or bid because it brings specific and critical experience and know-how that are accounted for in the evaluation of the bidder’s prequalification application or the bid; or (ii) appointed by the Borrower. Page 47 1. 2. 3. 4. 5. 6. Family name: WEINHARA First names: Michael Date of birth: 23/07/1962 Nationality: German Civil Status: Married, one daughter Education: Institution [ Date from - Date to ] Degree(s) or Diploma(s) obtained: Walden University, Baltimore, M.Sc. Health Informatics 02.2012 – 03.2014 TÜV- Rheinland-Group Academy, Cologne, Auditor for Health Institutions 04.2005 Steinbeis Vocational University, European EFQM Assessor Federation for Quality Management, Berlin, 10.2004 Moody International IRCA Cert, Pforzheim, QMS Auditor/Lead Auditor, ISO 9001 04.2003 Management and Economy Academy, B.A. Hospital Management Kempten, 08.1996 – 07.1998 Centre of Advanced Vocational Education, Staff-Management for Hospital Services Munich, 10.1990 – 09.1992 School of Nursing, Kaufbeuren , Registered Nurse 09.1979 – 08.1982 7. Language skills: Indicate competence on a scale of 1 to 5 (1 - excellent; 5 - basic) Language Reading Speaking Writing German native native native English 1 1 1 Albanian 5 5 5 Bahasa Indonesia 5 5 5 8. Membership of professional bodies: European Organisation for Quality EOQ, European Institute for Health Records (EuroRec), German Association for Medical Informatics (gmds), HL7, 9. Other skills: EHR architecture and functionality, Team leader for HIS implementing teams, Hospital Planning experience, Hospital Budget Calculation, Lecturing experience, Training Curriculum Development, Hospital Work Flow Analyses, FMEA experience, knowledge of labour union work, Quality Management System implementation experience, MS Office (expert knowledge), FTP, relational databases, Web-design, Adjudicator for Tonga Health Hospital Information System Module purchases, Adjudicator for Supply and installation of Equipment and Software for Moldova M-Cloud project. 10. Present position: Team Leader for Hospital Construction and Capacity Building project consultants 11. Years within the firm: 5+ years 12. Key qualifications: Senior consultant with 20 years of professional experience in hospital - and hospital qualit y management, health information system development, of which 12 years of experience as technical adviser in development projects all over the world Mayor focuses in consultancy, on:, ISO 9001 and EFQM compliant TOTAL QUALITY MANAGEMENT S ystems, Technical Maintenance of Hospitals, Workplace, Dut y-R oster and Job Description design, Hospital Information Management, Human Resource Planning, Budget Calculation, Highl y knowledgably in WHO and other international qualit y standards 13. Gaps and needs assessments as well as qualit y assessments as well as change management and its’ pro cesses Experience with Functional Hospital -layout planning, and user training in hospital facilit y management Experience in anal yse and updating of Nursing Education curricula, structured nursing care planning and documentation. Extensive experience in de velopment and implementation HMIS for all levels, including applied Telemedicine. Experience in analyse and upgrading of all processes related to hospital management Extensive experience in international medical coding system for primary, secondary, terti ary level Anal ysis of management structures, using performance indicators, improvement of existing data collection structures, reduction of redundant data collection structures Extensive and practical working experience in capacit y building including development and implementation of vocational trainings in comprehensive qualit y management, nursing care, information management, resource planning, of health facilities Strong working experience in development of standard operational procedures, job descriptions, and work flow planning. Experience in enforcement of work place discipline. Effective networking and negotiation, skills. Specific experience in the region: Country Date Country Date Uganda 1986 – 1987 Kosovo 2000 – 2006 Albania 2002 Vietnam 2003 – 2004 + 2010 – 2011 Indonesia 2005 – 2007 Syria 2006 Zambia 2007 – 2008 Serbia 2007 - 2008 Tajikistan 2010 Georgia 2009 Afghanistan 2008 – continuedPakistan Page 49 2013 - 2014 14. Date 08.2008 on-going 08.2013 03.2014 Professional experience: Location Afghanistan Mazar-eSharif Kunduz Pakistan Peshawar Company and Position Team Leader KfW German Development Bank two projects with overlap of 13 months. EPOS, Thomas Herzberg KfW North Afghanistan Thomas.Herzberg@kfw.de AGEG Consultants / KfW German Development Bank Clemens Lässing c.laessing@ageg.de Description Management and coordination of a € 13 Mio intervention Reconstruction of a Province Hospital in Mazar-e Sharif. 16.000m² new construction surface, with 360 beds. Overall project coordination between all involved parties, capacity building for the hospital management in all aspects of TQM, Budget and HR planning for sustainable service quality. Completed and opened December 2011. In addition since Nov. 2010 Team Leader of a € 32 Mio, 3 Hospital reconstruction project in North Afghanistan, plus one remote basic health station. Quality control, development of maintenance structures, introduction of applied Telemedicine and Tele-histopathology Short term consultant / Team leader Management of the support implementation for the national TB control programme, Supply of mobile health units, mother and child care, emergency care supply, consulting service on logistics and project coordination with the Federal Administration of Tribal Areas (FATA) in North Waziristan, South Waziristan and Khyber Pakhtunkhwa. € 5.3 Mio. Short term consultant / Team leader Short Term Consultant HMIS status assessment, inventory of work processes in data management at facility district, province hospitals and ministerial level: Development of a strategic plan of action on HMIS with technical solutions at different levels in coop. with MoH, in application of the WHO/HMN structures; Draft of ToR to tender a HMIS implementation program and required hardware. Technical Assistance in the Development and Introduction of a Health Management Information System in Primary Health Care Centres, Hospital Facilities and Oblast Health Departments. Focus on management indicators for primary and secondary facility managers and regional health department managers. Review of Structural requirements for Data quality improvement. Development of Policy Recommendations to support Development of Nursing Education; Assessment of the capacity of educational institutions delivering nursing education; formulating recommendations for competencies, professional standards in nursing education; Formulating recommendations for standards for institutions offering nursing education and required institutional change in the light of these new standards. Gap analyses on Quality Management structures in nursing education institutions. Technical Assistance to the Diagnostic Facilities and Blood Bank Directorate of the Ministry of Public Health of Afghanistan. FATA 11.2010 –04.2011 02.2010 – 11.2010 04.2009 – 11.2009 Vietnam Hanoi Tajikistan DushanbeKh ujand Georgia Tbilisi GFA Consulting Group EC Delegation Director Medical joachim.gromotka@gfa-group.de Euro Health Group /World Bank Marina Budeyeva Team Leader m_budeyeva@yahoo.com Sofreko, Conseil Santè , World Bank Maia Gogashvili University of Georgia Tbilisi gogashvilim@yahoo.com EPOS Health Management / 01.2010 – 12.2010 Afghanistan Kabul AFD French Development Bank Roger Fergusson Team Leader , Roger.Ferguson@epos.de 12.2007 -02.08 Germany Brandenburg 05.2007 07.2008 Serbia 05.2007 – 07.2008 Zambia 05.2005 to 10.2007 Indonesia 2005 2006 Germany 10.2006 11.2006 Syria AWO Königswuster-hausen Grit Marko head of TQM Telephone: +4933755144 90 Euro Health Group EAR Dr Matthias Reinicke Task Manager Health, European Agency for Reconstruction mwreinicke@googlemail.com CESO CI EUROPEAID/119860/ C/SV/multi Dr. Christopher Simoonga Ministry of Health, simoongachris@yahoo.com Saniplan EU IDN/AIDCO/2002/0409 Mr Philip Constable, Team Leader p.740@btinternet.com 5 Lakeside, Darlington, Co Durham, DL3 5TH, UK TÜV Rheinland Group / LGA InterCert Lead Auditor Barbara-Wagemann@t-online.de +491601490549 Options/GTZ/EPOS funded by EU (HSMP)SYR/AIDCO/2001/0215 Belgrade Lusaka Jakarta Sumatra Papua Multiple Damascus Short Term Consultant Short Term Consultant Coordination between architect and relevant Departments of the Ministry of Urban development and the MoPH to receive approval for the construction and functional design plans; Cooperation with Afghanistan Reconstruction and Development Services (ARDS) in tender preparation for construction and supplies. Consultant Support and coaching of the management in the establishment and implementation of ISO 9001:2000 and EFQM compliant structures in a pensioner’s home with 400 places at 4 locations in the region of Brandenburg. Team Leader Implementation of an Electronic Health Record (EHR) in Serbia: Overall responsibility for project management; technical assistance in the procurement of services, equipment and works to be contracted separately from the TA contract; Development and quality assurance testing of system architecture, software modules and databases; Deployment and integration of software modules and third party software components connectivity; Performance and monitoring of the operating environment; STE-Team Leader In-service and pre-service training needs assessment of HMIS, program staff at national provincial and district level; Review of existing HMIS training programs at all levels; Development of pre- and in-service training programs for all levels of the health sector; Support and monitoring of activities of HMIS pre- and in-service programs, at all levels; HIS Expert (short-term 200 days) Health Information Systems for the project “Support to Community Health Services in South Sumatra, Jambi and Papua, Indonesia”: Series of 15 field assignments to support the MoH Indonesia and District Health Directorates in 8 districts of Indonesia: Analysis of health information management structures from primary care to the Ministry level under decentralisation; Development of life-long health record systems for hospitals and health centres and pilot health record databases for 8 districts and 3 provinces; preparation of nation-wide roll-out; Definition of requirements for hardware and software, based on international standards. Development of an ICD10 mapping table and reporting formats. Organisation of HIM, change management, quality control, health record systems and statistics workshops. External Auditor for Quality Systems (approx. 5 times per year) in private and public health institutions, and homes for the elderly; assessment for TÜV Quality Certification meeting requirements of ISO 9001:2000 and EFQM. Stopped by time constraints in 2006. First Quality Audit and follow up-visitations for Quality Management Certificate renewal at in-patient, ambulatory and homecare Health Facilities in Germany. Short-term consultant to the Ministry of Health Syria for the preparation of tender documents for hospital information systems for three hospitals (Damascus, Daraa, and Latakkia: 500, 350, 200 beds) in Syria: Analysis of business processes (clinical, administrative), information structure, and reporting process; Definition of functional requirements for a hospital management information system; Development of a training programme Auditor Short Term Consultant Hospital 02.2002 to 03.2006 Kosovo 02.2006 to 10.2006 Kosovo 11.2004 Vietnam 05.2003 to 11.2004 Pristina Prizren Vinh Vietnam HoChiMin 02.2002 -07.02 Albania Bayram Curri 10.2001 01.2002 Kosovo 09.2000 09.2001 Kosovo Prizren 10.1992 – 09.2000 Germany Kempten 04.1990 -04.91 01.1988 - 03.90 08.1986 -09.87 Germany Kaufbeuren Germany Kaufbeuren Uganda Yumbe 04.1985 07.1986 Germany Füssen 02.198403.85 Germany Munich 09.1982 - 09.85 Germany Kaufbeuren 09.1982 -02.84 Germany Pristina Prof. Ulrich Laaser University of Bielefeld ulrich.laaser@uni-bielefeld.de Bernard Brunhes International, IRIS Conseil Santé, HLSP Dr Matthias Reinicke Task Manager Health, European Agency for Reconstruction mwreinicke@googlemail.com SOFRECO / Grand Duchy of Luxembourg YUG/00503229 A Mike Lamb Team Leader Mobile +44 (0) 7777685237 mikelamb230@hotmail.com Child Health Dev. Project Government of Finland Team Leader, hvouri@hotmail.com Saniplan EU ALA/97/012 Ronald M. Bauer Managing Director Ronald M. Bauer r.m.bauer@saniplan.de HCC, (NGO) ECHO, FPA number CCP N° 2000/0204 Dr Hristos Dagres hdagres@gmail.com Bernard Brunhes International Dr Matthias Reinicke European Agency for Reconstruction Task Manager Health mwreinicke@googlemail.com Kinderberg International Dr Uke Paloke Prizren Contact data in search University Teaching Hospital (650 beds)Renate Barn-steiner renate.barnsteiner@klinikumkempten.de District Hospital Nursing director Harald.keller@bkh-kaufbeuren.de District Hospital Nursing director Harald.keller@bkh-kaufbeuren.de Committee Cap Anamur NGO Edith Fischnaller Espenweg 19, 53127Bonn +492282433785 Regional Hospital (180 beds) Stadtbleiche 1 Füssen 08362 500-0 Mr Werner Huber University Hospital Marchioninistraße 15 Tel. 089/7095-0 Red Cross Emergency Service Managing director thomas.hofmann@kvostallgaeu.brk .de Marktoberdorf Regional Hospital Elke.Rieger@kliniken-oal-kf.de Information Systems 200 trainees (9 months programme); Development of cost estimates for initial investment, training needs, follow-up and maintenance for hardware and software HIS Consultant MoH, Team Leader Support to the Ministry of Health for re-organisation and updating of the country’s health information system, including: Health information system architecture; Information management; Procurement; and Training at health facility, Institute of Public Health and MoH level, funded by EAR: SCRE/111164/D/S/KOS and 01/KOS01/10/002 Hospital management Series of short-term missions to support management of a hospital for the implementation of a quality management system, with emphasis on outpatient management, patient and work flow, infrastructure management, and medical waste management Training in internal process audits, risk analysis, and change management; implementation of a waste and hazard inventory and early risk warning system (based on Waste Catalogue Ordinance 91/689/EEC, EU Directive on Hazardous Waste) Expert HIS/Audit Consultant Quality Management Consultant HIS Consultant Training Consultant Assessment of clinical, management and IT services for a regional paediatric 350-beds hospital (Vinh Nghe An Province), in the context of a quality audit. Analysis of management processes; Analyse of emergency preparedness and training requirements; Series of seminars to introduce international quality management standards ISO 9001/2000 and the processes for ISO certification Series of short-term missions to An Giang Province, Ba Rja Veng Tan Province, and Ho Chi Minh City, Vietnam Development of a 5 year action plan for the MoH to implement comprehensive hospital patient care systems; Analysis of training needs for hospital staff related to the management skills, HRM and total patient care ; Implementation of management training for middle level managers; Introduction of the international standard ISO 9001:2000 as an instrument towards quality management in the health sector; Training for hospital managers in methods of staff calculation based on performance indictors; Introduction of a comprehensive patient care and documentation system (bedside documentation) Implementation of a hospital management information and documentation system. Definition of database requirements; support to, and supervision of local database developers; Reorganization of hospital archives and introduction of comprehensive filing systems; Assessment of service quality in the provincial hospital. Management training for hospital and health facility managers (300 course participants, from 70 facilities) for all health facilities of Kosovo; Development of job and workplace descriptions, methods for work flow observation in health facilities; Quality control and quality management; Funded by EAR: EuropeAid/117556/D/SV/KOS Medical Coordinator 660 Bed Regional Hospital, implementation of an integrated in-patient documentation system, needs assessment and organisation of training for emergency preparedness, improvement of facility management, services for the paediatric department. Preparation of technical specifications for equipment purchase, refurbishment of wards, floor, sanitary units; supervision of refurbishment works Deputy Director of Nursing Services Assistant Lecturer Dep. Head Nurse Registered Nurse Coordination of merging two local hospitals under full operational condition; Permanent, administrative responsibility for 160, as deputy for 600 medical and nursing staff: Staff planning and budgeting based on performance indicators according to the legal framework with the health insurances. Chairman of IT evaluation and planning committees for the implementation of new working schedules. Introduction of quality assurance systems for clinical care standards; Coordination of emergency drills, GAP analyses. Kaufbeuren School of Nursing: Lecturer in general nursing. Research of medical information. On-the-job training for nursing students. Theatre / ICU Nurse Five operating theatres: day-to-day routine in use of surgical and gynaecological equipment, anaesthesia and emergency equipment. In charge of maintenance of anaesthesia machines and all emergency equipment ICU / Nurse Munich University Hospital (1200 beds): Cardio-Surgical ICU 10 beds. Member of the heart transplant team. Emergency medical technician Team leader on fully equipped mobile Emergency and mobile ICU vehicles. Trainer for emergency and resuscitation procedures; Special driving licence for emergency vehicles; Voluntarily work on free days, at weekends at night. General Nurse Marktoberdorf Regional Hospital (250 beds): ICU 5 beds, general care of all surgical and internal medicine patients Kaufbeuren District Hospital (700 beds): Staff planning. Refurbishment and investment planning. Management of day-to-day business for a 35-bed male ward for acute psychiatric diseases Emergency support to a 100-beds hospital of 100 beds under civil war conditions. Medical service to UNHCR refugee camps under emergency circumstances. Training of paramedical staff in hygiene. Development of treatment protocols 3 2009 WHO network access to HINARI online medical library for Regional Hospital Mazar-e-Sharif. 2009 Co-moderator supporting the Afghan participants of the telepathology network server at Basel University for a tele-histopathology cooperation 2003 Lecturer at the Economic Faculty Pristina, MBA Seminar Management in Public Health on Health Information Systems 2004 Lecturer at the Medical Faculty HoChiMinh City on hospital information management 1997/1999 Lecturer at the CTT-Academia Trier / Weiskirchen on: staff calculation; planning and management of staff in hospitals and nursing homes; preparation and execution of change management processes 1997/1998 Country tutor for Uganda at the ASA Program, an exchange programme for young professionals and students founded by the German Ministry of foreign affairs. 1994/1998 Member of the hospital workers committee 1993/1998 Lecturer at the Munich Centre for Advanced Vocational Education on hospital administration and managerial economics for nursing home managers and managers of ambulatory nursing-care organizations and on staff calculation by use of different indicators. 1979/2004 Member of the German Labour Union for the public sector Publications/Speeches (Author/Co-author): 2012 NATO Advanced Research Workshop Kabul “Creating Awareness for the Use of Open Source Systems in the Public Sector in Afghanistan” 2009 “Early Stage Testing of Users’ Satisfaction. After Implementation of a Central Electronic Health Record (EHR) System in Serbia” The Journal on Information Technology in Healthcare 2009; 7(2) 2009 “Interoperability, Integration and Risk Management in Creating Electronic Health Records: Serbia’s Approach” The Journal on Information Technology in Healthcare Volume 7 Issue 2 2009 2009 “Planning a new hospital in Afghanistan, the balancing act between Stone Age and 21st century high tech” 4 Section II. Bid Data Sheet NATO Regional Command North - International Security and Assistance Force (ISAF) – Camp Marmal Afghanistan 2008 “Electronic Health Records in Serbia, EU-Funded Project Delivers Results of Wider Interest”, Hospital Post Europe 5/2008 2008 “Approach and risks of EHR’s interoperability and integration with legacy healthcare ICT systems” 6th ICICTH Conference Samos Island - Greece 2008 “Design and implementation of a central electronic health record in Serbia: Early stage testing of Users’ satisfaction” 6th ICICTH Conference Samos Island - Greece 2008 “Electronic Health Record – Opportunities for the future in the Serbian Health System”, National Conference on Electronic Health Records, Belgrade - Serbia 2008 “Electronic health records – What can be done with it for a capitation system?” National conference for the capitation system, European Agency for Reconstruction, Belgrade- Serbia 2007 “Health Information System development in rural areas in Indonesia” National Conference for Health Information Systems SCHS Project Jakarta - Indonesia 2006 “Outsourcing Health Information Systems, an Option for Developing Countries”. 4th ICICTH Conference Samos Island - Greece 2001 “How telemedicine could contribute to the stabilisation of South-East-Europe”. American Telemedicine Association - Fort Lauderdale - USA 1998 “Legal consequences of the implementation of protocols for patient care in hospitals”. “Klinik Info” Bavaria, Landkreis Oberallgäu, Germany Michael Weinhara 5 SECTION III. ELIGIBLE COUNTRIES FOR THE PROVISION OF GOODS, WORKS, AND SERVICES IN BANK-FINANCED PROCUREMENT Eligible Countries for the Provision of Goods, Works and Services in Bank-Financed Procurement As of September 2007 1. Eligible for this procurement are the firms of, and goods manufactured in, all countries except countries, if any, listed in the following restrictions. 2. In accordance with Para 1.8 (a) of the Guidelines: Procurement under IBRD Loans and IDA Credits, dated May 2004, the Bank permits firms and individuals from all countries to offer goods, works and services for Bank-financed projects. As an exception, firms of a Country or goods manufactured in a Country may be excluded if: (i): as a matter of law or official regulation, the Borrower’s Country prohibits commercial relations with that Country, provided that the Bank is satisfied that such exclusion does not preclude effective competition for the supply of the Goods or Works required, or (ii): by an Act of Compliance with a Decision of the United Nations Security Council taken under Chapter VII of the Charter of the United Nations, the Borrower’s Country prohibits any import of goods from that Country or any payments to persons or entities in that Country. 3. For the information of borrowers and bidders, at the present time firms, goods and services from the following countries are excluded from this bidding: (a) With reference to paragraph 1.8 (a) (i) of the Guidelines: None (b) None With reference to paragraph 1.8 (a) (ii) of the Guidelines: 6 Section IV. General Conditions of Contract SECTION IV. GENERAL CONDITIONS OF CONTRACT Table of Clauses A. Contract and Interpretation .............................................................................................8 1. 2. 3. 4. 5. 6. Definitions...................................................................................................................8 Contract Documents..................................................................................................16 Interpretation .............................................................................................................16 Notices ......................................................................................................................18 Governing Law .........................................................................................................19 Settlement of Disputes ..............................................................................................20 B. Subject Matter of Contract .............................................................................................22 7. 8. 9. 10. Scope of the System ..................................................................................................22 Time for Commencement and Operational Acceptance ...........................................22 Supplier’s Responsibilities........................................................................................23 Purchaser’s Responsibilities .....................................................................................25 C. Payment.............................................................................................................................27 11. 12. 13. 14. Contract Price............................................................................................................27 Terms of Payment .....................................................................................................27 Securities ...................................................................................................................28 Taxes and Duties .......................................................................................................29 D. Intellectual Property ........................................................................................................30 15. Copyright ..................................................................................................................30 16. Software License Agreements ..................................................................................31 17. Confidential Information ..........................................................................................33 E. Supply, Installation, Testing, Commissioning, and Acceptance of the System ..........34 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. Representatives .........................................................................................................34 Project Plan ...............................................................................................................36 Subcontracting ..........................................................................................................37 Design and Engineering ............................................................................................38 Procurement, Delivery, and Transport ......................................................................41 Product Upgrades ......................................................................................................43 Implementation, Installation, and Other Services .....................................................44 Inspections and Tests ................................................................................................44 Installation of the System..........................................................................................45 Commissioning and Operational Acceptance ...........................................................46 F. Guarantees and Liabilities ...............................................................................................50 28. Operational Acceptance Time Guarantee .................................................................50 29. Defect Liability .........................................................................................................51 Section IV. General Conditions of Contract 30. 31. 32. 33. 7 Functional Guarantees ..............................................................................................54 Intellectual Property Rights Warranty ......................................................................54 Intellectual Property Rights Indemnity .....................................................................55 Limitation of Liability...............................................................................................58 G. Risk Distribution ..............................................................................................................58 34. 35. 36. 37. 38. Transfer of Ownership ..............................................................................................58 Care of the System ....................................................................................................58 Loss of or Damage to Property; Accident or Injury to Workers; Indemnification ...59 Insurances .................................................................................................................61 Force Majeure ...........................................................................................................63 H. Change in Contract Elements .........................................................................................65 39. 40. 41. 42. Changes to the System ..............................................................................................65 Extension of Time for Achieving Operational Acceptance ......................................69 Termination ...............................................................................................................70 Assignment ...............................................................................................................78 8 Section IV. General Conditions of Contract General Conditions of Contract A. CONTRACT AND INTERPRETATION 1. Definitions 1.1 In this Contract, the following terms shall be interpreted as indicated below. (a) contract elements (i) “Contract” means the Contract Agreement entered into between the Purchaser and the Supplier, together with the Contract Documents referred to therein. The Contract Agreement and the Contract Documents shall constitute the Contract, and the term “the Contract” shall in all such documents be construed accordingly. (ii) “Contract Documents” means the documents specified in Article 1.1 (Contract Documents) of the Contract Agreement (including any amendments to these Documents). (iii) “Contract Agreement” means the agreement entered into between the Purchaser and the Supplier using the form of Contract Agreement contained in the Sample Forms Section of the Bidding Documents and any modifications to this form agreed to by the Purchaser and the Supplier. The date of the Contract Agreement shall be recorded in the signed form. (iv) “GCC” means the General Conditions of Contract. (v) “SCC” means the Special Conditions of Contract. (vi) “Technical Requirements” means the Technical Requirements Section of the Bidding Documents. (vii) “Implementation Schedule” means the Implementation Schedule Sub-section of the Technical Requirements. viii) “Contract Price” means the price or prices defined in Article 2 (Contract Price and Terms of Payment) of the Contract Agreement. Section IV. General Conditions of Contract 9 (ix) “Procurement Guidelines” refers to the edition specified in the SCC of the World Bank Guidelines: Procurement under IBRD Loans and IDA Credits. (x) (b) “Bidding Documents” refers to the collection of documents issued by the Purchaser to instruct and inform potential suppliers of the processes for bidding, selection of the winning bid, and Contract formation, as well as the contractual conditions governing the relationship between the Purchaser and the Supplier. The General and Special Conditions of Contract, the Technical Requirements, and all other documents included in the Bidding Documents reflect the Procurement Guidelines that the Purchaser is obligated to follow during procurement and administration of this Contract. entities (i) “Purchaser” means the entity purchasing the Information System, as specified in the SCC. (ii) “Project Manager” means the person named as such in the SCC or otherwise appointed by the Purchaser in the manner provided in GCC Clause 18.1 (Project Manager) to perform the duties delegated by the Purchaser. (iii) “Supplier” means the firm or Joint Venture whose bid to perform the Contract has been accepted by the Purchaser and is named as such in the Contract Agreement. (iv) “Supplier’s Representative” means any person nominated by the Supplier and named as such in the Contract Agreement or otherwise approved by the Purchaser in the manner provided in GCC Clause 18.2 (Supplier’s Representative) to perform the duties delegated by the Supplier. (v) “Subcontractor” means any firm to whom any of the obligations of the Supplier, including preparation of any design or supply of any Information Technologies or other Goods or Services, is subcontracted directly or indirectly 10 Section IV. General Conditions of Contract by the Supplier. (vi) “Adjudicator” means the person named in Appendix 2 of the Contract Agreement, appointed by agreement between the Purchaser and the Supplier to make a decision on or to settle any dispute between the Purchaser and the Supplier referred to him or her by the parties, pursuant to GCC Clause 6.1 (Adjudication). (vii) “The World Bank” (also called “The Bank”) means the International Bank for Reconstruction and Development (IBRD) or the International Development Association (IDA). (c) scope (i) “Information System,” also called “the System,” means all the Information Technologies, Materials, and other Goods to be supplied, installed, integrated, and made operational (exclusive of the Supplier’s Equipment), together with the Services to be carried out by the Supplier under the Contract. (ii) “Subsystem” means any subset of the System identified as such in the Contract that may be supplied, installed, tested, and commissioned individually before Commissioning of the entire System. (iii) “Information Technologies” means all information processing and communicationsrelated hardware, Software, supplies, and consumable items that the Supplier is required to supply and install under the Contract. (iv) “Goods” means all equipment, machinery, furnishings, Materials, and other tangible items that the Supplier is required to supply or supply and install under the Contract, including, without limitation, the Information Technologies and Materials, but excluding the Supplier’s Equipment. (v) “Services” means all technical, logistical, management, and any other Services to be provided by the Supplier under the Contract to Section IV. General Conditions of Contract 11 supply, install, customize, integrate, and make operational the System. Such Services may include, but are not restricted to, activity management and quality assurance, design, development, customization, documentation, transportation, insurance, inspection, expediting, site preparation, installation, integration, training, data migration, Precommissioning, Commissioning, maintenance, and technical support. (vi) “The Project Plan” means the document to be developed by the Supplier and approved by the Purchaser, pursuant to GCC Clause 19, based on the requirements of the Contract and the Preliminary Project Plan included in the Supplier’s bid. The “Agreed and Finalized Project Plan” is the version of the Project Plan approved by the Purchaser, in accordance with GCC Clause 19.2. Should the Project Plan conflict with the Contract in any way, the relevant provisions of the Contract, including any amendments, shall prevail. (vii) “Software” means that part of the System which are instructions that cause information processing Subsystems to perform in a specific manner or execute specific operations. (viii) “System Software” means Software that provides the operating and management instructions for the underlying hardware and other components, and is identified as such in Appendix 4 of the Contract Agreement and such other Software as the parties may agree in writing to be Systems Software. Such System Software includes, but is not restricted to, micro-code embedded in hardware (i.e., “firmware”), operating systems, communications, system and network management, and utility software. (ix) “General-Purpose Software” means Software that supports general-purpose office and software development activities and is identified as such in Appendix 4 of the Contract Agreement and such other Software as the parties may agree in writing to be General- 12 Section IV. General Conditions of Contract Purpose Software. Such General-Purpose Software may include, but is not restricted to, word processing, spreadsheet, generic database management, and application development software. (x) “Application Software” means Software formulated to perform specific business or technical functions and interface with the business or technical users of the System and is identified as such in Appendix 4 of the Contract Agreement and such other Software as the parties may agree in writing to be Application Software. (xi) “Standard Software” means Software identified as such in Appendix 4 of the Contract Agreement and such other Software as the parties may agree in writing to be Standard Software. (xii) “Custom Software” means Software identified as such in Appendix 4 of the Contract Agreement and such other Software as the parties may agree in writing to be Custom Software. (xiii) “Source Code” means the database structures, dictionaries, definitions, program source files, and any other symbolic representations necessary for the compilation, execution, and subsequent maintenance of the Software (typically, but not exclusively, required for Custom Software). (xiv) “Materials” means all documentation in printed or printable form and all instructional and informational aides in any form (including audio, video, and text) and on any medium, provided to the Purchaser under the Contract. (xv) “Standard Materials” means all Materials not specified as Custom Materials. (xvi) “Custom Materials” means Materials developed by the Supplier at the Purchaser’s expense under the Contract and identified as such in Appendix 5 of the Contract Agreement and such other Materials as the parties may agree in writing to be Section IV. General Conditions of Contract 13 Custom Materials. Custom Materials includes Materials created from Standard Materials. (xvii) “Intellectual Property Rights” means any and all copyright, moral rights, trademark, patent, and other intellectual and proprietary rights, title and interests worldwide, whether vested, contingent, or future, including without limitation all economic rights and all exclusive rights to reproduce, fix, adapt, modify, translate, create derivative works from, extract or re-utilize data from, manufacture, introduce into circulation, publish, distribute, sell, license, sublicense, transfer, rent, lease, transmit or provide access electronically, broadcast, display, enter into computer memory, or otherwise use any portion or copy, in whole or in part, in any form, directly or indirectly, or to authorize or assign others to do so. (xviii) “Supplier’s Equipment” means all equipment, tools, apparatus, or things of every kind required in or for installation, completion and maintenance of the System that are to be provided by the Supplier, but excluding the Information Technologies, or other items forming part of the System. (d) activities (i) “Delivery” means the transfer of the Goods from the Supplier to the Purchaser in accordance with the current edition Incoterms specified in the Contract. (ii) “Installation” means that the System or a Subsystem as specified in the Contract is ready for Commissioning as provided in GCC Clause 26 (Installation). (iii) “Pre-commissioning” means the testing, checking, and any other required activity that may be specified in the Technical Requirements that are to be carried out by the Supplier in preparation for Commissioning of the System as provided in GCC Clause 26 (Installation). (iv) “Commissioning” means operation of the 14 Section IV. General Conditions of Contract System or any Subsystem by the Supplier following Installation, which operation is to be carried out by the Supplier as provided in GCC Clause 27.1 (Commissioning), for the purpose of carrying out Operational Acceptance Test(s). (v) “Operational Acceptance Tests” means the tests specified in the Technical Requirements and Agreed and Finalized Project Plan to be carried out to ascertain whether the System, or a specified Subsystem, is able to attain the functional and performance requirements specified in the Technical Requirements and Agreed and Finalized Project Plan, in accordance with the provisions of GCC Clause 27.2 (Operational Acceptance Test). (vi) “Operational Acceptance” means the acceptance by the Purchaser of the System (or any Subsystem(s) where the Contract provides for acceptance of the System in parts), in accordance with GCC Clause 27.3 (Operational Acceptance). (e) place and time (i) “Purchaser’s Country” is the country named in the SCC. (ii) “Supplier’s Country” is the country in which the Supplier is legally organized, as named in the Contract Agreement. (iii) “Project Site(s)” means the place(s) specified in the SCC for the supply and installation of the System. (iv) “Eligible Country” means the countries and territories eligible for participation in procurements financed by the World Bank as defined in the Procurement Guidelines. (Note: The World Bank maintains a list of countries from which Bidders, Goods, and Services are not eligible to participate in procurement financed by the Bank. The list is regularly updated and can be obtained from the Public Information Center of the Bank or its web site on procurement. A copy of the list is contained Section IV. General Conditions of Contract 15 in the Section of the Bidding Documents entitled “Eligible Countries for the Provision of Goods, Works, and Services in Bank-Financed Procurement”). (v) “Day” means calendar day of the Gregorian Calendar. (vi) “Week” means seven (7) consecutive Days, beginning the day of the week as is customary in the Purchaser’s Country. (vii) “Month” means calendar month of the Gregorian Calendar. (viii) “Year” means twelve (12) consecutive Months. (ix) “Effective Date” means the date of fulfillment of all conditions specified in Article 3 (Effective Date for Determining Time for Achieving Operational Acceptance) of the Contract Agreement, for the purpose of determining the Delivery, Installation, and Operational Acceptance dates for the System or Subsystem(s). (x) “Contract Period” is the time period during which this Contract governs the relations and obligations of the Purchaser and Supplier in relation to the System, as specified in the SCC. (xi) “Defect Liability Period” (also referred to as the “Warranty Period”) means the period of validity of the warranties given by the Supplier commencing at date of the Operational Acceptance Certificate of the System or Subsystem(s), during which the Supplier is responsible for defects with respect to the System (or the relevant Subsystem[s]) as provided in GCC Clause 29 (Defect Liability). (xii) “The Post-Warranty Services Period” means the number of years defined in the SCC (if any), following the expiration of the Warranty Period during which the Supplier may be obligated to provide Software licenses, maintenance, and/or technical support services for the System, either under this Contract or under separate contract(s). 16 Section IV. General Conditions of Contract (xiii) “The Coverage Period” means the Days of the Week and the hours of those Days during which maintenance, operational, and/or technical support services (if any) must be available. 2. Contract Documents 2.1 Subject to Article 1.2 (Order of Precedence) of the Contract Agreement, all documents forming part of the Contract (and all parts of these documents) are intended to be correlative, complementary, and mutually explanatory. The Contract shall be read as a whole. 3. Interpretation 3.1 Governing Language 3.1.1 All Contract Documents and related correspondence exchanged between Purchaser and Supplier shall be written in the language specified in the SCC, and the Contract shall be construed and interpreted in accordance with that language. 3.1.2 If any of the Contract Documents or related correspondence are prepared in a language other than the governing language under GCC Clause 3.1.1 above, the translation of such documents into the governing language shall prevail in matters of interpretation. The originating party, with respect to such documents shall bear the costs and risks of such translation. 3.2 Singular and Plural The singular shall include the plural and the plural the singular, except where the context otherwise requires. 3.3 Headings The headings and marginal notes in the GCC are included for ease of reference and shall neither constitute a part of the Contract nor affect its interpretation. 3.4 Persons Words importing persons or parties shall include firms, corporations, and government entities. 3.5 Incoterms Unless inconsistent with any provision of the Contract, the meaning of any trade term and the rights and obligations of parties thereunder shall be as prescribed by the current Incoterms (“Incoterms 2000” or a more recent version if Section IV. General Conditions of Contract 17 and as published). Incoterms are the international rules for interpreting trade terms published by the International Chamber of Commerce, 38 Cours Albert 1er, 75008 Paris, France. 3.6 Entire Agreement The Contract constitutes the entire agreement between the Purchaser and Supplier with respect to the subject matter of Contract and supersedes all communications, negotiations, and agreements (whether written or oral) of parties with respect to the subject matter of the Contract made prior to the date of Contract. 3.7 Amendment No amendment or other variation of the Contract shall be effective unless it is in writing, is dated, expressly refers to the Contract, and is signed by a duly authorized representative of each party to the Contract. 3.8 Independent Supplier The Supplier shall be an independent contractor performing the Contract. The Contract does not create any agency, partnership, joint venture, or other joint relationship between the parties to the Contract. Subject to the provisions of the Contract, the Supplier shall be solely responsible for the manner in which the Contract is performed. All employees, representatives, or Subcontractors engaged by the Supplier in connection with the performance of the Contract shall be under the complete control of the Supplier and shall not be deemed to be employees of the Purchaser, and nothing contained in the Contract or in any subcontract awarded by the Supplier shall be construed to create any contractual relationship between any such employees, representatives, or Subcontractors and the Purchaser. 3.9 Joint Venture If the Supplier is a Joint Venture of two or more firms, all such firms shall be jointly and severally bound to the Purchaser for the fulfillment of the provisions of the Contract and shall designate one of such firms to act as a leader with authority to bind the Joint Venture. The composition or constitution of the Joint Venture shall not be 18 Section IV. General Conditions of Contract altered without the prior consent of the Purchaser. 3.10 Nonwaiver 3.10.1 Subject to GCC Clause 3.10.2 below, no relaxation, forbearance, delay, or indulgence by either party in enforcing any of the terms and conditions of the Contract or the granting of time by either party to the other shall prejudice, affect, or restrict the rights of that party under the Contract, nor shall any waiver by either party of any breach of Contract operate as waiver of any subsequent or continuing breach of Contract. 3.10.2 Any waiver of a party’s rights, powers, or remedies under the Contract must be in writing, must be dated and signed by an authorized representative of the party granting such waiver, and must specify the right and the extent to which it is being waived. 3.11 Severability If any provision or condition of the Contract is prohibited or rendered invalid or unenforceable, such prohibition, invalidity, or unenforceability shall not affect the validity or enforceability of any other provisions and conditions of the Contract. 3.12 Country of Origin “Origin” means the place where the Information Technologies, Materials, and other Goods for the System were produced or from which the Services are supplied. Goods are produced when, through manufacturing, processing, Software development, or substantial and major assembly or integration of components, a commercially recognized product results that is substantially different in basic characteristics or in purpose or utility from its components. The Origin of Goods and Services is distinct from the nationality of the Supplier and may be different. 4. Notices 4.1 Unless otherwise stated in the Contract, all notices to be given under the Contract shall be in writing and shall be sent, pursuant to GCC Clause 4.3 below, by personal delivery, airmail post, special courier, cable, telegraph, telex, facsimile, electronic mail, or Electronic Data Interchange (EDI), with the following provisions. 4.1.1 Any notice sent by cable, telegraph, telex, facsimile, Section IV. General Conditions of Contract 19 electronic mail, or EDI shall be confirmed within two (2) days after dispatch by notice sent by airmail post or special courier, except as otherwise specified in the Contract. 4.1.2 Any notice sent by airmail post or special courier shall be deemed (in the absence of evidence of earlier receipt) to have been delivered ten (10) days after dispatch. In proving the fact of dispatch, it shall be sufficient to show that the envelope containing such notice was properly addressed, stamped, and conveyed to the postal authorities or courier service for transmission by airmail or special courier. 4.1.3 Any notice delivered personally or sent by cable, telegraph, telex, facsimile, electronic mail, or EDI shall be deemed to have been delivered on the date of its dispatch. 4.1.4 Either party may change its postal, cable, telex, facsimile, electronic mail, or EDI addresses for receipt of such notices by ten (10) days’ notice to the other party in writing. 5. Governing Law 4.2 Notices shall be deemed to include any approvals, consents, instructions, orders, certificates, information and other communication to be given under the Contract. 4.3 Pursuant to GCC Clause 18, notices from/to the Purchaser are normally given by, or addressed to, the Project Manager, while notices from/to the Supplier are normally given by, or addressed to, the Supplier's Representative, or in its absence its deputy if any. If there is no appointed Project Manager or Supplier's Representative (or deputy), or if their related authority is limited by the SCC for GCC Clauses 18.1 or 18.2.2, or for any other reason, the Purchaser or Supplier may give and receive notices at their fallback addresses. The address of the Project Manager and the fallback address of the Purchaser are as specified in the SCC or as subsequently established/amended. The address of the Supplier's Representative and the fallback address of the Supplier are as specified in Appendix 1 of the Contract Agreement or as subsequently established/amended. 5.1 The Contract shall be governed by and interpreted in accordance with the laws of the country specified in the SCC. 20 6. Settlement of Disputes Section IV. General Conditions of Contract 6.1 Adjudication 6.1.1 If any dispute of any kind whatsoever shall arise between the Purchaser and the Supplier in connection with or arising out of the Contract, including without prejudice to the generality of the foregoing, any question regarding its existence, validity, or termination, or the operation of the System (whether during the progress of implementation or after its achieving Operational Acceptance and whether before or after the termination, abandonment, or breach of the Contract), the parties shall seek to resolve any such dispute by mutual consultation. If the parties fail to resolve such a dispute by mutual consultation within fourteen (14) days after one party has notified the other in writing of the dispute, then, if the Contract Agreement in Appendix 2 includes and names an Adjudicator, the dispute shall, within another fourteen (14) days, be referred in writing by either party to the Adjudicator, with a copy to the other party. If there is no Adjudicator specified in the Contract Agreement, the mutual consultation period stated above shall last twenty-eight (28) days (instead of fourteen), upon expiry of which either party may move to the notification of arbitration pursuant to GCC Clause 6.2.1. 6.1.2 The Adjudicator shall give his or her decision in writing to both parties within twenty-eight (28) days of the dispute being referred to the Adjudicator. If the Adjudicator has done so, and no notice of intention to commence arbitration has been given by either the Purchaser or the Supplier within fifty-six (56) days of such reference, the decision shall become final and binding upon the Purchaser and the Supplier. Any decision that has become final and binding shall be implemented by the parties forthwith. 6.1.3 The Adjudicator shall be paid an hourly fee at the rate specified in the Contract Agreement plus reasonable expenditures incurred in the execution of duties as Adjudicator, and these costs shall be divided equally between the Purchaser and the Supplier. 6.1.4 Should the Adjudicator resign or die, or should the Purchaser and the Supplier agree that the Adjudicator is not fulfilling his or her functions in accordance with Section IV. General Conditions of Contract 21 the provisions of the Contract, a new Adjudicator shall be jointly appointed by the Purchaser and the Supplier. Failing agreement between the two within twenty-eight (28) days, the new Adjudicator shall be appointed at the request of either party by the Appointing Authority specified in the SCC, or, if no Appointing Authority is specified in SCC, the Contract shall, from this point onward and until the parties may otherwise agree on an Adjudicator or an Appointing Authority, be implemented as if there is no Adjudicator. 6.2 Arbitration 6.2.1 If (a) the Purchaser or the Supplier is dissatisfied with the Adjudicator’s decision and acts before this decision has become final and binding pursuant to GCC Clause 6.1.2, or (b) the Adjudicator fails to give a decision within the allotted time from referral of the dispute pursuant to GCC Clause 6.1.2, and the Purchaser or the Supplier acts within the following fourteen (14) days, or (c) in the absence of an Adjudicator from the Contract Agreement, the mutual consultation pursuant to GCC Clause 6.1.1 expires without resolution of the dispute and the Purchaser or the Supplier acts within the following fourteen (14) days, then either the Purchaser or the Supplier may act to give notice to the other party, with a copy for information to the Adjudicator in case an Adjudicator had been involved, of its intention to commence arbitration, as provided below, as to the matter in dispute, and no arbitration in respect of this matter may be commenced unless such notice is given. 6.2.2 Any dispute in respect of which a notice of intention to commence arbitration has been given, in accordance with GCC Clause 6.2.1, shall be finally settled by arbitration. Arbitration may be commenced prior to or after Installation of the Information System. 22 Section IV. General Conditions of Contract 6.2.3 Arbitration proceedings shall be conducted in accordance with the rules of procedure specified in the SCC. 6.3 Notwithstanding any reference to the Adjudicator or arbitration in this clause, (a) the parties shall continue to perform their respective obligations under the Contract unless they otherwise agree; (b) the Purchaser shall pay the Supplier any monies due the Supplier. B. SUBJECT MATTER OF CONTRACT 7. Scope of the System 8. Time for Commencement and Operational Acceptance 7.1 Unless otherwise expressly limited in the SCC or Technical Requirements, the Supplier’s obligations cover the provision of all Information Technologies, Materials and other Goods as well as the performance of all Services required for the design, development, and implementation (including procurement, quality assurance, assembly, associated site preparation, Delivery, Pre-commissioning, Installation, Testing, and Commissioning) of the System, in accordance with the plans, procedures, specifications, drawings, codes, and any other documents specified in the Contract and the Agreed and Finalized Project Plan. 7.2 The Supplier shall, unless specifically excluded in the Contract, perform all such work and / or supply all such items and Materials not specifically mentioned in the Contract but that can be reasonably inferred from the Contract as being required for attaining Operational Acceptance of the System as if such work and / or items and Materials were expressly mentioned in the Contract. 7.3 The Supplier’s obligations (if any) to provide Goods and Services as implied by the Recurrent Cost tables of the Supplier’s bid, such as consumables, spare parts, and technical services (e.g., maintenance, technical assistance, and operational support), are as specified in the SCC, including the relevant terms, characteristics, and timings. 8.1 The Supplier shall commence work on the System within the period specified in the SCC, and without prejudice to GCC Clause 28.2, the Supplier shall thereafter proceed with the System in accordance with the time schedule specified in the Section IV. General Conditions of Contract 23 Implementation Schedule in the Technical Requirements Section and any refinements made in the Agreed and Finalized Project Plan. 9. Supplier’s Responsibilities 8.2 The Supplier shall achieve Operational Acceptance of the System (or Subsystem(s) where a separate time for Operational Acceptance of such Subsystem(s) is specified in the Contract) within the time specified in the SCC and in accordance with the time schedule specified in the Implementation Schedule in the Technical Requirements Section and any refinements made in the Agreed and Finalized Project Plan, or within such extended time to which the Supplier shall be entitled under GCC Clause 40 (Extension of Time for Achieving Operational Acceptance). 9.1 The Supplier shall conduct all activities with due care and diligence, in accordance with the Contract and with the skill and care expected of a competent provider of information technologies, information systems, support, maintenance, training, and other related services, or in accordance with best industry practices. In particular, the Supplier shall provide and employ only technical personnel who are skilled and experienced in their respective callings and supervisory staff who are competent to adequately supervise the work at hand. 9.2 The Supplier confirms that it has entered into this Contract on the basis of a proper examination of the data relating to the System provided by the Purchaser and on the basis of information that the Supplier could have obtained from a visual inspection of the site (if access to the site was available) and of other data readily available to the Supplier relating to the System as at the date twenty-eight (28) days prior to bid submission. The Supplier acknowledges that any failure to acquaint itself with all such data and information shall not relieve its responsibility for properly estimating the difficulty or cost of successfully performing the Contract. 9.3 The Supplier shall be responsible for timely provision of all resources, information, and decision making under its control that are necessary to reach a mutually Agreed and Finalized Project Plan (pursuant to GCC Clause 19.2) within the time schedule specified in the Implementation Schedule in the Technical Requirements Section. Failure to provide such resources, information, and decision making may constitute grounds for termination pursuant to GCC Clause 41.2. 24 Section IV. General Conditions of Contract 9.4 The Supplier shall acquire in its name all permits, approvals, and/or licenses from all local, state, or national government authorities or public service undertakings in the Purchaser’s Country that are necessary for the performance of the Contract, including, without limitation, visas for the Supplier’s and Subcontractor’s personnel and entry permits for all imported Supplier’s Equipment. The Supplier shall acquire all other permits, approvals, and/or licenses that are not the responsibility of the Purchaser under GCC Clause 10.4 and that are necessary for the performance of the Contract. 9.5 The Supplier shall comply with all laws in force in the Purchaser’s Country. The laws will include all national, provincial, municipal, or other laws that affect the performance of the Contract and are binding upon the Supplier. The Supplier shall indemnify and hold harmless the Purchaser from and against any and all liabilities, damages, claims, fines, penalties, and expenses of whatever nature arising or resulting from the violation of such laws by the Supplier or its personnel, including the Subcontractors and their personnel, but without prejudice to GCC Clause 10.1. The Supplier shall not indemnify the Purchaser to the extent that such liability, damage, claims, fines, penalties, and expenses were caused or contributed to by a fault of the Purchaser. 9.6 The Supplier shall, in all dealings with its labor and the labor of its Subcontractors currently employed on or connected with the Contract, pay due regard to all recognized festivals, official holidays, religious or other customs, and all local laws and regulations pertaining to the employment of labor. 9.7 Any Information Technologies or other Goods and Services that will be incorporated in or be required for the System and other supplies shall have their Origin, as defined in GCC Clause 3.12, in a country that shall be an Eligible Country, as defined in GCC Clause 1.1 (e) (iv). 9.8 The Supplier shall permit the Bank and/or persons appointed by the Bank to inspect the Supplier’s offices and/or the accounts and records of the Supplier and its sub-contractors relating to the performance of the Contract, and to have such accounts and records audited by auditors appointed by the Bank if required by the Bank. The Supplier’s attention is drawn to Sub-Clause 41.2.1(c), which provides, inter alia, that acts intended to materially impede the exercise of the Section IV. General Conditions of Contract 25 Bank’s inspection and audit rights provided for under SubClause 9.8 constitute a prohibited practice subject to contract termination (as well as to a determination of ineligibility under the Procurement Guidelines) 9.9 10. Purchaser’s Responsibilities Other Supplier responsibilities, if any, are as stated in the SCC. 10.1 The Purchaser shall ensure the accuracy of all information and/or data to be supplied by the Purchaser to the Supplier, except when otherwise expressly stated in the Contract. 10.2 The Purchaser shall be responsible for timely provision of all resources, information, and decision making under its control that are necessary to reach an Agreed and Finalized Project Plan (pursuant to GCC Clause 19.2) within the time schedule specified in the Implementation Schedule in the Technical Requirements Section. Failure to provide such resources, information, and decision making may constitute grounds for Termination pursuant to GCC Clause 41.3.1 (b). 10.3 The Purchaser shall be responsible for acquiring and providing legal and physical possession of the site and access to it, and for providing possession of and access to all other areas reasonably required for the proper execution of the Contract. 10.4 If requested by the Supplier, the Purchaser shall use its best endeavors to assist the Supplier in obtaining in a timely and expeditious manner all permits, approvals, and/or licenses necessary for the execution of the Contract from all local, state, or national government authorities or public service undertakings that such authorities or undertakings require the Supplier or Subcontractors or the personnel of the Supplier or Subcontractors, as the case may be, to obtain. 10.5 In such cases where the responsibilities of specifying and acquiring or upgrading telecommunications and/or electric power services falls to the Supplier, as specified in the Technical Requirements, SCC, Agreed and Finalized Project Plan, or other parts of the Contract, the Purchaser shall use its best endeavors to assist the Supplier in obtaining such services in a timely and expeditious manner. 10.6 The Purchaser shall be responsible for timely provision of all resources, access, and information necessary for the Installation and Operational Acceptance of the System (including, but not limited to, any required telecommunications or electric power services), as identified 26 Section IV. General Conditions of Contract in the Agreed and Finalized Project Plan, except where provision of such items is explicitly identified in the Contract as being the responsibility of the Supplier. Delay by the Purchaser may result in an appropriate extension of the Time for Operational Acceptance, at the Supplier’s discretion. 10.7 Unless otherwise specified in the Contract or agreed upon by the Purchaser and the Supplier, the Purchaser shall provide sufficient, properly qualified operating and technical personnel, as required by the Supplier to properly carry out Delivery, Pre-commissioning, Installation, Commissioning, and Operational Acceptance, at or before the time specified in the Technical Requirements Section’s Implementation Schedule and the Agreed and Finalized Project Plan. 10.8 The Purchaser will designate appropriate staff for the training courses to be given by the Supplier and shall make all appropriate logistical arrangements for such training as specified in the Technical Requirements, SCC, the Agreed and Finalized Project Plan, or other parts of the Contract. 10.9 The Purchaser assumes primary responsibility for the Operational Acceptance Test(s) for the System, in accordance with GCC Clause 27.2, and shall be responsible for the continued operation of the System after Operational Acceptance. However, this shall not limit in any way the Supplier’s responsibilities after the date of Operational Acceptance otherwise specified in the Contract. 10.10 The Purchaser is responsible for performing and safely storing timely and regular backups of its data and Software in accordance with accepted data management principles, except where such responsibility is clearly assigned to the Supplier elsewhere in the Contract. 10.11 All costs and expenses involved in the performance of the obligations under this GCC Clause 10 shall be the responsibility of the Purchaser, save those to be incurred by the Supplier with respect to the performance of the Operational Acceptance Test(s), in accordance with GCC Clause 27.2. 10.12 Other Purchaser responsibilities, if any, are as stated in the SCC. Section IV. General Conditions of Contract 27 C. PAYMENT 11. Contract Price 11.1 The Contract Price shall be as specified in Article 2 (Contract Price and Terms of Payment) of the Contract Agreement. 11.2 The Contract Price shall be a firm lump sum not subject to any alteration, except: (a) in the event of a Change in the System pursuant to GCC Clause 39 or to other clauses in the Contract; (b) in accordance with the price adjustment formula (if any) specified in the SCC. 11.3 The Supplier shall be deemed to have satisfied itself as to the correctness and sufficiency of the Contract Price, which shall, except as otherwise provided for in the Contract, cover all its obligations under the Contract. 12. Terms of Payment 12.1 The Supplier’s request for payment shall be made to the Purchaser in writing, accompanied by an invoice describing, as appropriate, the System or Subsystem(s), Delivered, Precommissioned, Installed, and Operationally Accepted, and by documents submitted pursuant to GCC Clause 22.5 and upon fulfillment of other obligations stipulated in the Contract. The Contract Price shall be paid as specified in the SCC. 12.2 No payment made by the Purchaser herein shall be deemed to constitute acceptance by the Purchaser of the System or any Subsystem(s). 12.3 Payments shall be made promptly by the Purchaser, but in no case later than forty five (45) days after submission of a valid invoice by the Supplier. In the event that the Purchaser fails to make any payment by its respective due date or within the period set forth in the Contract, the Purchaser shall pay to the Supplier interest on the amount of such delayed payment at the rate(s) specified in the SCC for the period of delay until payment has been made in full, whether before or after judgment or arbitration award. 12.4 All payments shall be made in the currency(ies) specified in the Contract Agreement, pursuant to GCC Clause 11. For Goods and Services supplied locally, payments shall be made in the currency of the Purchaser’s Country, unless 28 Section IV. General Conditions of Contract otherwise specified in the SCC. 12.5 Unless otherwise specified in the SCC, payment of the foreign currency portion of the Contract Price for Goods supplied from outside the Purchaser’s Country shall be made to the Supplier through an irrevocable letter of credit opened by an authorized bank in the Supplier’s Country and will be payable on presentation of the appropriate documents. It is agre”ed that the letter of credit will be subject to Article 10 of the latest revision of Uniform Customs and Practice for Documentary Credits, published by the International Chamber of Commerce, Paris. 13. Securities 13.1 Issuance of Securities The Supplier shall provide the securities specified below in favor of the Purchaser at the times and in the amount, manner, and form specified below. 13.2 Advance Payment Security 13.2.1 As specified in the SCC, the Supplier shall provide a security equal in amount and currency to the advance payment, and valid until the System is Operationally Accepted. 13.2.2 The security shall be in the form provided in the Bidding Documents or in another form acceptable to the Purchaser. The amount of the security shall be reduced in proportion to the value of the System executed by and paid to the Supplier from time to time and shall automatically become null and void when the full amount of the advance payment has been recovered by the Purchaser. The way the value of the security is deemed to become reduced and, eventually, voided is as specified in the SCC. The security shall be returned to the Supplier immediately after its expiration. 13.3 Performance Security 13.3.1 The Supplier shall, within twenty-eight (28) days of the notification of Contract award, provide a security for the due performance of the Contract in the amount and currency specified in the SCC. 13.3.2 The security shall be a bank guarantee in the form provided in the Sample Forms Section of the Bidding Documents, or it shall be in another form acceptable Section IV. General Conditions of Contract 29 to the Purchaser. 13.3.3 The security shall automatically become null and void once all the obligations of the Supplier under the Contract have been fulfilled, including, but not limited to, any obligations during the Warranty Period and any extensions to the period. The security shall be returned to the Supplier no later than twenty-eight (28) days after its expiration. 13.3.4 Upon Operational Acceptance of the entire System, the security shall be reduced to the amount specified in the SCC, on the date of such Operational Acceptance, so that the reduced security would only cover the remaining warranty obligations of the Supplier. 14. Taxes and Duties 14.1 For Goods or Services supplied from outside the Purchaser’s country, the Supplier shall be entirely responsible for all taxes, stamp duties, license fees, and other such levies imposed outside the Purchaser’s country. Any duties, such as importation or customs duties, and taxes and other levies, payable in the Purchaser’s country for the supply of Goods and Services from outside the Purchaser’s country are the responsibility of the Purchaser unless these duties or taxes have been made part of the Contract Price in Article 2 of the Contract Agreement and the Price Schedule it refers to, in which case the duties and taxes will be the Supplier’s responsibility. 14.2 For Goods or Services supplied locally, the Supplier shall be entirely responsible for all taxes, duties, license fees, etc., incurred until delivery of the contracted Goods or Services to the Purchaser. The only exception are taxes or duties, such as value-added or sales tax or stamp duty as apply to, or are clearly identifiable, on the invoices and provided they apply in the Purchaser’s country, and only if these taxes, levies and/or duties are also excluded from the Contract Price in Article 2 of the Contract Agreement and the Price Schedule it refers to. 14.3 If any tax exemptions, reductions, allowances, or privileges may be available to the Supplier in the Purchaser’s Country, the Purchaser shall use its best efforts to enable the Supplier to benefit from any such tax savings to the maximum allowable extent. 14.4 For the purpose of the Contract, it is agreed that the Contract 30 Section IV. General Conditions of Contract Price specified in Article 2 (Contract Price and Terms of Payment) of the Contract Agreement is based on the taxes, duties, levies, and charges prevailing at the date twenty-eight (28) days prior to the date of bid submission in the Purchaser’s Country (also called “Tax” in this GCC Clause 14.4). If any Tax rates are increased or decreased, a new Tax is introduced, an existing Tax is abolished, or any change in interpretation or application of any Tax occurs in the course of the performance of the Contract, which was or will be assessed on the Supplier, its Subcontractors, or their employees in connection with performance of the Contract, an equitable adjustment to the Contract Price shall be made to fully take into account any such change by addition to or reduction from the Contract Price, as the case may be. D. INTELLECTUAL PROPERTY 15. Copyright 15.1 The Intellectual Property Rights in all Standard Software and Standard Materials shall remain vested in the owner of such rights. 15.2 The Purchaser agrees to restrict use, copying, or duplication of the Standard Software and Standard Materials in accordance with GCC Clause 16, except that additional copies of Standard Materials may be made by the Purchaser for use within the scope of the project of which the System is a part, in the event that the Supplier does not deliver copies within thirty (30) days from receipt of a request for such Standard Materials. 15.3 The Purchaser’s contractual rights to use the Standard Software or elements of the Standard Software may not be assigned, licensed, or otherwise transferred voluntarily except in accordance with the relevant license agreement or as may be otherwise specified in the SCC. 15.4 As applicable, the Purchaser’s and Supplier’s rights and obligations with respect to Custom Software or elements of the Custom Software, including any license agreements, and with respect to Custom Materials or elements of the Custom Materials, are specified in the SCC. Subject to the SCC, the Intellectual Property Rights in all Custom Software and Custom Materials specified in Appendices 4 and 5 of the Contract Agreement (if any) shall, at the date of this Contract or on creation of the rights (if later than the date of this Contract), vest in the Purchaser. The Supplier shall do Section IV. General Conditions of Contract 31 and execute or arrange for the doing and executing of each necessary act, document, and thing that the Purchaser may consider necessary or desirable to perfect the right, title, and interest of the Purchaser in and to those rights. In respect of such Custom Software and Custom Materials, the Supplier shall ensure that the holder of a moral right in such an item does not assert it, and the Supplier shall, if requested to do so by the Purchaser and where permitted by applicable law, ensure that the holder of such a moral right waives it. 15.5 The parties shall enter into such (if any) escrow arrangements in relation to the Source Code to some or all of the Software as are specified in the SCC and in accordance with the SCC. 16. Software License Agreements 16.1 Except to the extent that the Intellectual Property Rights in the Software vest in the Purchaser, the Supplier hereby grants to the Purchaser license to access and use the Software, including all inventions, designs, and marks embodied in the Software. Such license to access and use the Software shall: (a) be: (i) nonexclusive; (ii) fully paid up and irrevocable (except that it shall terminate if the Contract terminates under GCC Clauses 41.1 or 41.3); (iii) valid throughout the territory of the Purchaser’s Country (or such other territory as specified in the SCC); and (iv) subject to additional restrictions (if any) as specified in the SCC. (b) permit the Software to be: (i) used or copied for use on or with the computer(s) for which it was acquired (if specified in the Technical Requirements and/or the Supplier’s bid), plus a backup computer(s) of the same or similar capacity, if the primary is(are) inoperative, and during a reasonable transitional period when use is being transferred between primary and backup; 32 Section IV. General Conditions of Contract (ii) as specified in the SCC, used or copied for use on or transferred to a replacement computer(s), (and use on the original and replacement computer(s) may be simultaneous during a reasonable transitional period) provided that, if the Technical Requirements and/or the Supplier’s bid specifies a class of computer to which the license is restricted and unless the Supplier agrees otherwise in writing, the replacement computer(s) is(are) within that class; (iii) if the nature of the System is such as to permit such access, accessed from other computers connected to the primary and/or backup computer(s) by means of a local or wide-area network or similar arrangement, and used on or copied for use on those other computers to the extent necessary to that access; (iv) reproduced for safekeeping or backup purposes; (v) customized, adapted, or combined with other computer software for use by the Purchaser, provided that derivative software incorporating any substantial part of the delivered, restricted Software shall be subject to same restrictions as are set forth in this Contract; (vi) as specified in the SCC, disclosed to, and reproduced for use by, support service suppliers and their subcontractors, (and the Purchaser may sublicense such persons to use and copy for use the Software) to the extent reasonably necessary to the performance of their support service contracts, subject to the same restrictions as are set forth in this Contract; and (vii) disclosed to, and reproduced for use by, the Purchaser and by such other persons as are specified in the SCC (and the Purchaser may sublicense such persons to use and copy for use the Software), subject to the same restrictions as are set forth in this Contract. 16.2 The Standard Software may be subject to audit by the Supplier, in accordance with the terms specified in the SCC, to verify compliance with the above license agreements. Section IV. General Conditions of Contract 17. Confidential Information 33 17.1 Except if otherwise specified in the SCC, the "Receiving Party" (either the Purchaser or the Supplier) shall keep confidential and shall not, without the written consent of the other party to this Contract (“the Disclosing Party”), divulge to any third party any documents, data, or other information of a confidential nature (“Confidential Information”) connected with this Contract, and furnished directly or indirectly by the Disclosing Party prior to or during performance, or following termination, of this Contract. 17.2 For the purposes of GCC Clause 17.1, the Supplier is also deemed to be the Receiving Party of Confidential Information generated by the Supplier itself in the course of the performance of its obligations under the Contract and relating to the businesses, finances, suppliers, employees, or other contacts of the Purchaser or the Purchaser’s use of the System. 17.3 Notwithstanding GCC Clauses 17.1 and 17.2: (a) the Supplier may furnish to its Subcontractor Confidential Information of the Purchaser to the extent reasonably required for the Subcontractor to perform its work under the Contract; and (b) the Purchaser may furnish Confidential Information of the Supplier: (i) to its support service suppliers and their subcontractors to the extent reasonably required for them to perform their work under their support service contracts; and (ii) to its affiliates and subsidiaries, in which event the Receiving Party shall ensure that the person to whom it furnishes Confidential Information of the Disclosing Party is aware of and abides by the Receiving Party’s obligations under this GCC Clause 17 as if that person were party to the Contract in place of the Receiving Party. 17.4 The Purchaser shall not, without the Supplier’s prior written consent, use any Confidential Information received from the Supplier for any purpose other than the operation, maintenance and further development of the System. Similarly, the Supplier shall not, without the Purchaser’s prior written consent, use any Confidential Information received from the Purchaser for any purpose other than those that are required for the performance of the Contract. 34 Section IV. General Conditions of Contract 17.5 The obligation of a party under GCC Clauses 17.1 through 17.4 above, however, shall not apply to that information which: (a) now or hereafter enters the public domain through no fault of the Receiving Party; (b) can be proven to have been possessed by the Receiving Party at the time of disclosure and that was not previously obtained, directly or indirectly, from the Disclosing Party; (c) otherwise lawfully becomes available to the Receiving Party from a third party that has no obligation of confidentiality. 17.6 The above provisions of this GCC Clause 17 shall not in any way modify any undertaking of confidentiality given by either of the parties to this Contract prior to the date of the Contract in respect of the System or any part thereof. 17.7 The provisions of this GCC Clause 17 shall survive the termination, for whatever reason, of the Contract for three (3) years or such longer period as may be specified in the SCC. E. SUPPLY, INSTALLATION, TESTING,COMMISSIONING, AND ACCEPTANCE OF THE SYSTEM 18. Representatives 18.1 Project Manager If the Project Manager is not named in the Contract, then within fourteen (14) days of the Effective Date, the Purchaser shall appoint and notify the Supplier in writing of the name of the Project Manager. The Purchaser may from time to time appoint some other person as the Project Manager in place of the person previously so appointed and shall give a notice of the name of such other person to the Supplier without delay. No such appointment shall be made at such a time or in such a manner as to impede the progress of work on the System. Such appointment shall take effect only upon receipt of such notice by the Supplier. Subject to the extensions and/or limitations specified in the SCC (if any), the Project Manager shall have the authority to represent the Purchaser on all day-to-day matters relating to the System or arising from the Contract, and shall normally be the person giving or receiving notices on behalf of the Section IV. General Conditions of Contract 35 Purchaser pursuant to GCC Clause 4. 18.2 Supplier’s Representative 18.2.1 If the Supplier’s Representative is not named in the Contract, then within fourteen (14) days of the Effective Date, the Supplier shall appoint the Supplier’s Representative and shall request the Purchaser in writing to approve the person so appointed. The request must be accompanied by a detailed curriculum vitae for the nominee, as well as a description of any other System or non-System responsibilities the nominee would retain while performing the duties of the Supplier’s Representative. If the Purchaser does not object to the appointment within fourteen (14) days, the Supplier’s Representative shall be deemed to have been approved. If the Purchaser objects to the appointment within fourteen (14) days giving the reason therefor, then the Supplier shall appoint a replacement within fourteen (14) days of such objection in accordance with this GCC Clause 18.2.1. 18.2.2 Subject to the extensions and/or limitations specified in the SCC (if any), the Supplier’s Representative shall have the authority to represent the Supplier on all day-to-day matters relating to the System or arising from the Contract, and shall normally be the person giving or receiving notices on behalf of the Supplier pursuant to GCC Clause 4. 18.2.3 The Supplier shall not revoke the appointment of the Supplier’s Representative without the Purchaser’s prior written consent, which shall not be unreasonably withheld. If the Purchaser consents to such an action, the Supplier shall appoint another person of equal or superior qualifications as the Supplier’s Representative, pursuant to the procedure set out in GCC Clause 18.2.1. 18.2.4 The Supplier’s Representative and staff are obliged to work closely with the Purchaser’s Project Manager and staff, act within their own authority, and abide by directives issued by the Purchaser that are consistent with the terms of the Contract. The Supplier’s Representative is responsible for managing the activities of its personnel and any subcontracted 36 Section IV. General Conditions of Contract personnel. 18.2.5 The Supplier’s Representative may, subject to the approval of the Purchaser (which shall not be unreasonably withheld), at any time delegate to any person any of the powers, functions, and authorities vested in him or her. Any such delegation may be revoked at any time. Any such delegation or revocation shall be subject to a prior notice signed by the Supplier’s Representative and shall specify the powers, functions, and authorities thereby delegated or revoked. No such delegation or revocation shall take effect unless and until the notice of it has been delivered. 18.2.6 Any act or exercise by any person of powers, functions and authorities so delegated to him or her in accordance with GCC Clause 18.2.5 shall be deemed to be an act or exercise by the Supplier’s Representative. 18.3 Objections and Removals 18.3.1 The Purchaser may by notice to the Supplier object to any representative or person employed by the Supplier in the execution of the Contract who, in the reasonable opinion of the Purchaser, may have behaved inappropriately, be incompetent, or be negligent. The Purchaser shall provide evidence of the same, whereupon the Supplier shall remove such person from work on the System. 18.3.2 If any representative or person employed by the Supplier is removed in accordance with GCC Clause 18.3.1, the Supplier shall, where required, promptly appoint a replacement. 19. Project Plan 19.1 In close cooperation with the Purchaser and based on the Preliminary Project Plan included in the Supplier’s bid, the Supplier shall develop a Project Plan encompassing the activities specified in the Contract. The contents of the Project Plan shall be as specified in the SCC and/or Technical Requirements. 19.2 The Supplier shall formally present to the Purchaser the Project Plan in accordance with the procedure specified in the SCC. Section IV. General Conditions of Contract 37 19.3 If required, the impact on the Implementation Schedule of modifications agreed during finalization of the Agreed and Finalized Project Plan shall be incorporated in the Contract by amendment, in accordance with GCC Clauses 39 and 40. 19.4 The Supplier shall undertake to supply, install, test, and commission the System in accordance with the Agreed and Finalized Project Plan and the Contract. 19.5 The Progress and other reports specified in the SCC shall be prepared by the Supplier and submitted to the Purchaser in the format and frequency specified in the Technical Requirements. 20. Subcontracting 20.1 Appendix 3 (List of Approved Subcontractors) to the Contract Agreement specifies critical items of supply or services and a list of Subcontractors for each item that are considered acceptable by the Purchaser. If no Subcontractors are listed for an item, the Supplier shall prepare a list of Subcontractors it considers qualified and wishes to be added to the list for such items. The Supplier may from time to time propose additions to or deletions from any such list. The Supplier shall submit any such list or any modification to the list to the Purchaser for its approval in sufficient time so as not to impede the progress of work on the System. The Purchaser shall not withhold such approval unreasonably. Such approval by the Purchaser of a Subcontractor(s) shall not relieve the Supplier from any of its obligations, duties, or responsibilities under the Contract. 20.2 The Supplier may, at its discretion, select and employ Subcontractors for such critical items from those Subcontractors listed pursuant to GCC Clause 20.1. If the Supplier wishes to employ a Subcontractor not so listed, or subcontract an item not so listed, it must seek the Purchaser’s prior approval under GCC Clause 20.3. 20.3 For items for which pre-approved Subcontractor lists have not been specified in Appendix 3 to the Contract Agreement, the Supplier may employ such Subcontractors as it may select, provided: (i) the Supplier notifies the Purchaser in writing at least twenty-eight (28) days prior to the proposed mobilization date for such Subcontractor; and (ii) by the end of this period either the Purchaser has granted its approval in writing or fails to respond. The Supplier shall not engage any Subcontractor to which the Purchaser has objected in writing prior to the end of the notice period. The absence of a written objection by the Purchaser during the above 38 Section IV. General Conditions of Contract specified period shall constitute formal acceptance of the proposed Subcontractor. Except to the extent that it permits the deemed approval of the Purchaser of Subcontractors not listed in the Contract Agreement, nothing in this Clause, however, shall limit the rights and obligations of either the Purchaser or Supplier as they are specified in GCC Clauses 20.1 and 20.2, in the SCC, or in Appendix 3 of the Contract Agreement. 21. Design and Engineering 21.1 Technical Specifications and Drawings 21.1.1 The Supplier shall execute the basic and detailed design and the implementation activities necessary for successful installation of the System in compliance with the provisions of the Contract or, where not so specified, in accordance with good industry practice. The Supplier shall be responsible for any discrepancies, errors or omissions in the specifications, drawings, and other technical documents that it has prepared, whether such specifications, drawings, and other documents have been approved by the Project Manager or not, provided that such discrepancies, errors, or omissions are not because of inaccurate information furnished in writing to the Supplier by or on behalf of the Purchaser. 21.1.2 The Supplier shall be entitled to disclaim responsibility for any design, data, drawing, specification, or other document, or any modification of such design, drawings, specification, or other documents provided or designated by or on behalf of the Purchaser, by giving a notice of such disclaimer to the Project Manager. 21.2 Codes and Standards Wherever references are made in the Contract to codes and standards in accordance with which the Contract shall be executed, the edition or the revised version of such codes and standards current at the date twenty-eight (28) days prior to date of bid submission shall apply unless otherwise specified in the SCC. During Contract execution, any changes in such codes and standards shall be applied after approval by the Purchaser and shall be treated in accordance with GCC Clause 39.3. Section IV. General Conditions of Contract 39 21.3 Approval/Review of Technical Documents by the Project Manager 21.3.1 The Supplier shall prepare and furnish to the Project Manager the documents as specified in the SCC for the Project Manager’s approval or review. Any part of the System covered by or related to the documents to be approved by the Project Manager shall be executed only after the Project Manager’s approval of these documents. GCC Clauses 21.3.2 through 21.3.7 shall apply to those documents requiring the Project Manager’s approval, but not to those furnished to the Project Manager for its review only. 21.3.2 Within fourteen (14) days after receipt by the Project Manager of any document requiring the Project Manager’s approval in accordance with GCC Clause 21.3.1, the Project Manager shall either return one copy of the document to the Supplier with its approval endorsed on the document or shall notify the Supplier in writing of its disapproval of the document and the reasons for disapproval and the modifications that the Project Manager proposes. If the Project Manager fails to take such action within the fourteen (14) days, then the document shall be deemed to have been approved by the Project Manager. 21.3.3 The Project Manager shall not disapprove any document except on the grounds that the document does not comply with some specified provision of the Contract or that it is contrary to good industry practice. 21.3.4 If the Project Manager disapproves the document, the Supplier shall modify the document and resubmit it for the Project Manager’s approval in accordance with GCC Clause 21.3.2. If the Project Manager approves the document subject to modification(s), the Supplier shall make the required modification(s), and the document shall then be deemed to have been approved, subject to GCC Clause 21.3.5. The procedure set out in GCC Clauses 21.3.2 through 21.3.4 shall be repeated, as appropriate, until the Project Manager approves such documents. 40 Section IV. General Conditions of Contract 21.3.5 If any dispute occurs between the Purchaser and the Supplier in connection with or arising out of the disapproval by the Project Manager of any document and/or any modification(s) to a document that cannot be settled between the parties within a reasonable period, then, in case the Contract Agreement includes and names an Adjudicator, such dispute may be referred to the Adjudicator for determination in accordance with GCC Clause 6.1 (Adjudicator). If such dispute is referred to an Adjudicator, the Project Manager shall give instructions as to whether and if so, how, performance of the Contract is to proceed. The Supplier shall proceed with the Contract in accordance with the Project Manager’s instructions, provided that if the Adjudicator upholds the Supplier’s view on the dispute and if the Purchaser has not given notice under GCC Clause 6.1.2, then the Supplier shall be reimbursed by the Purchaser for any additional costs incurred by reason of such instructions and shall be relieved of such responsibility or liability in connection with the dispute and the execution of the instructions as the Adjudicator shall decide, and the Time for Achieving Operational Acceptance shall be extended accordingly. 21.3.6 The Project Manager’s approval, with or without modification of the document furnished by the Supplier, shall not relieve the Supplier of any responsibility or liability imposed upon it by any provisions of the Contract except to the extent that any subsequent failure results from modifications required by the Project Manager or inaccurate information furnished in writing to the Supplier by or on behalf of the Purchaser. 21.3.7 The Supplier shall not depart from any approved document unless the Supplier has first submitted to the Project Manager an amended document and obtained the Project Manager’s approval of the document, pursuant to the provisions of this GCC Clause 21.3. If the Project Manager requests any change in any already approved document and/or in any document based on such an approved document, the provisions of GCC Clause 39 (Changes to the System) shall apply to such request. Section IV. General Conditions of Contract 22. Procurement, Delivery, and Transport 41 22.1 Subject to related Purchaser's responsibilities pursuant to GCC Clauses 10 and 14, the Supplier shall manufacture or procure and transport all the Information Technologies, Materials, and other Goods in an expeditious and orderly manner to the Project Site. 22.2 Delivery of the Information Technologies, Materials, and other Goods shall be made by the Supplier in accordance with the Technical Requirements. 22.3 Early or partial deliveries require the explicit written consent of the Purchaser, which consent shall not be unreasonably withheld. 22.4 Transportation 22.4.1 The Supplier shall provide such packing of the Goods as is required to prevent their damage or deterioration during shipment. The packing, marking, and documentation within and outside the packages shall comply strictly with the Purchaser’s instructions to the Supplier. 22.4.2 The Supplier will bear responsibility for and cost of transport to the Project Sites in accordance with the terms and conditions used in the specification of prices in the Price Schedules, including the terms and conditions of the associated Incoterms. 22.4.3 Unless otherwise specified in the SCC, the Supplier shall be free to use transportation through carriers registered in any eligible country and to obtain insurance from any eligible source country. 22.5 Unless otherwise specified in the SCC, the Supplier will provide the Purchaser with shipping and other documents, as specified below: 22.5.1 For Goods supplied from outside the Purchaser’s Country: Upon shipment, the Supplier shall notify the Purchaser and the insurance company contracted by the Supplier to provide cargo insurance by telex, cable, facsimile, electronic mail, or EDI with the full details of the shipment. The Supplier shall promptly send the following documents to the Purchaser by mail or courier, as appropriate, with a copy to the cargo 42 Section IV. General Conditions of Contract insurance company: (a) two copies of the Supplier’s invoice showing the description of the Goods, quantity, unit price, and total amount; (b) usual transportation documents; (c) insurance certificate; (d) certificate(s) of origin; and (e) estimated time and point of arrival in the Purchaser’s Country and at the site. 22.5.2 For Goods supplied locally (i.e., from within the Purchaser’s country): Upon shipment, the Supplier shall notify the Purchaser by telex, cable, facsimile, electronic mail, or EDI with the full details of the shipment. The Supplier shall promptly send the following documents to the Purchaser by mail or courier, as appropriate: (a) two copies of the Supplier’s invoice showing the Goods’ description, quantity, unit price, and total amount; (b) delivery note, railway receipt, or truck receipt; (c) certificate of insurance; (d) certificate(s) of origin; and (e) estimated time of arrival at the site. 22.6 Customs Clearance (a) The Purchaser will bear responsibility for, and cost of, customs clearance into the Purchaser's country in accordance the particular Incoterm(s) used for Goods supplied from outside the Purchaser’s country in the Price Schedules referred to by Article 2 of the Contract Agreement. (b) At the request of the Purchaser, the Supplier will make available a representative or agent during the process of customs clearance in the Purchaser's country for goods supplied from outside the Purchaser's country. In the event of delays in customs clearance that are not the Section IV. General Conditions of Contract 43 fault of the Supplier: 23. Product Upgrades (i) the Supplier shall be entitled to an extension in the Time for Achieving Operational Acceptance, pursuant to GCC Clause 40; (ii) the Contract Price shall be adjusted to compensate the Supplier for any additional storage charges that the Supplier may incur as a result of the delay. 23.1 At any point during performance of the Contract, should technological advances be introduced by the Supplier for Information Technologies originally offered by the Supplier in its bid and still to be delivered, the Supplier shall be obligated to offer to the Purchaser the latest versions of the available Information Technologies having equal or better performance or functionality at the same or lesser unit prices, pursuant to GCC Clause 39 (Changes to the System). 23.2 At any point during performance of the Contract, for Information Technologies still to be delivered, the Supplier will also pass on to the Purchaser any cost reductions and additional and/or improved support and facilities that it offers to other clients of the Supplier in the Purchaser’s Country, pursuant to GCC Clause 39 (Changes to the System). 23.3 During performance of the Contract, the Supplier shall offer to the Purchaser all new versions, releases, and updates of Standard Software, as well as related documentation and technical support services, within thirty (30) days of their availability from the Supplier to other clients of the Supplier in the Purchaser’s Country, and no later than twelve (12) months after they are released in the country of origin. In no case will the prices for these Software exceed those quoted by the Supplier in the Recurrent Costs tables in its bid. 23.4 During the Warranty Period, unless otherwise specified in the SCC, the Supplier will provide at no additional cost to the Purchaser all new versions, releases, and updates for all Standard Software that are used in the System, within thirty (30) days of their availability from the Supplier to other clients of the Supplier in the Purchaser’s country, and no later than twelve (12) months after they are released in the country of origin of the Software. 23.5 The Purchaser shall introduce all new versions, releases or 44 Section IV. General Conditions of Contract updates of the Software within eighteen (18) months of receipt of a production-ready copy of the new version, release, or update, provided that the new version, release, or update does not adversely affect System operation or performance or require extensive reworking of the System. In cases where the new version, release, or update adversely affects System operation or performance, or requires extensive reworking of the System, the Supplier shall continue to support and maintain the version or release previously in operation for as long as necessary to allow introduction of the new version, release, or update. In no case shall the Supplier stop supporting or maintaining a version or release of the Software less than twenty four (24) months after the Purchaser receives a production-ready copy of a subsequent version, release, or update. The Purchaser shall use all reasonable endeavors to implement any new version, release, or update as soon as practicable, subject to the twenty-four-month-long stop date. 24. Implementation, Installation, and Other Services 24.1 The Supplier shall provide all Services specified in the Contract and Agreed and Finalized Project Plan in accordance with the highest standards of professional competence and integrity. 24.2 Prices charged by the Supplier for Services, if not included in the Contract, shall be agreed upon in advance by the parties (including, but not restricted to, any prices submitted by the Supplier in the Recurrent Cost Schedules of its Bid) and shall not exceed the prevailing rates charged by the Supplier to other purchasers in the Purchaser’s Country for similar services. 25. Inspections and Tests 25.1 The Purchaser or its representative shall have the right to inspect and/or test any components of the System, as specified in the Technical Requirements, to confirm their good working order and/or conformity to the Contract at the point of delivery and/or at the Project Site. 25.2 The Purchaser or its representative shall be entitled to attend any such inspections and/or tests of the components, provided that the Purchaser shall bear all costs and expenses incurred in connection with such attendance, including but not limited to all inspection agent fees, travel, and related expenses. 25.3 Should the inspected or tested components fail to conform to the Contract, the Purchaser may reject the component(s), and the Supplier shall either replace the rejected component(s), Section IV. General Conditions of Contract 45 or make alterations as necessary so that it meets the Contract requirements free of cost to the Purchaser. 25.4 The Project Manager may require the Supplier to carry out any inspection and/or test not specified in the Contract, provided that the Supplier’s reasonable costs and expenses incurred in the carrying out of such inspection and/or test shall be added to the Contract Price. Further, if such inspection and/or test impedes the progress of work on the System and/or the Supplier’s performance of its other obligations under the Contract, due allowance will be made in respect of the Time for Achieving Operational Acceptance and the other obligations so affected. 25.5 If any dispute shall arise between the parties in connection with or caused by an inspection and/or with regard to any component to be incorporated in the System that cannot be settled amicably between the parties within a reasonable period of time, either party may invoke the process pursuant to GCC Clause 6 (Settlement of Disputes), starting with referral of the matter to the Adjudicator in case an Adjudicator is included and named in the Contract Agreement. 26. Installation of the 26.1 As soon as the System, or any Subsystem, has, in the opinion of the Supplier, been delivered, Pre-commissioned, and System made ready for Commissioning and Operational Acceptance Testing in accordance with the Technical Requirements, the SCC and the Agreed and Finalized Project Plan, the Supplier shall so notify the Purchaser in writing. 26.2 The Project Manager shall, within fourteen (14) days after receipt of the Supplier’s notice under GCC Clause 26.1, either issue an Installation Certificate in the form specified in the Sample Forms Section in the Bidding Documents, stating that the System, or major component or Subsystem (if Acceptance by major component or Subsystem is specified pursuant to the SCC for GCC Clause 27.2.1), has achieved Installation by the date of the Supplier’s notice under GCC Clause 26.1, or notify the Supplier in writing of any defects and/or deficiencies, including, but not limited to, defects or deficiencies in the interoperability or integration of the various components and/or Subsystems making up the System. The Supplier shall use all reasonable endeavors to promptly remedy any defect and/or deficiencies that the Project Manager has notified the Supplier of. The Supplier shall then promptly carry out retesting of the System or 46 Section IV. General Conditions of Contract Subsystem and, when in the Supplier’s opinion the System or Subsystem is ready for Commissioning and Operational Acceptance Testing, notify the Purchaser in writing, in accordance with GCC Clause 26.1. The procedure set out in this GCC Clause 26.2 shall be repeated, as necessary, until an Installation Certificate is issued. 26.3 If the Project Manager fails to issue the Installation Certificate and fails to inform the Supplier of any defects and/or deficiencies within fourteen (14) days after receipt of the Supplier’s notice under GCC Clause 26.1, or if the Purchaser puts the System or a Subsystem into production operation, then the System (or Subsystem) shall be deemed to have achieved successful Installation as of the date of the Supplier’s notice or repeated notice, or when the Purchaser put the System into production operation, as the case may be. 27. Commissioning and Operational Acceptance 27.1 Commissioning 27.1.1 Commissioning of the System (or Subsystem if specified pursuant to the SCC for GCC Clause 27.2.1) shall be commenced by the Supplier: (a) immediately after the Installation Certificate is issued by the Project Manager, pursuant to GCC Clause 26.2; or (b) as otherwise specified in the Technical Requirement or the Agreed and Finalized Project Plan; or (c) immediately after Installation is deemed to have occurred, under GCC Clause 26.3. 27.1.2 The Purchaser shall supply the operating and technical personnel and all materials and information reasonably required to enable the Supplier to carry out its obligations with respect to Commissioning. Production use of the System or Subsystem(s) shall not commence prior to the start of formal Operational Acceptance Testing. 27.2 Operational Acceptance Tests 27.2.1 The Operational Acceptance Tests (and repeats of such tests) shall be the primary responsibility of the Purchaser (in accordance with GCC Clause 10.9), but shall be conducted with the full cooperation of the Section IV. General Conditions of Contract 47 Supplier during Commissioning of the System (or major components or Subsystem[s] if specified in the SCC and supported by the Technical Requirements), to ascertain whether the System (or major component or Subsystem[s]) conforms to the Technical Requirements and meets the standard of performance quoted in the Supplier’s bid, including, but not restricted to, the functional and technical performance requirements. The Operational Acceptance Tests during Commissioning will be conducted as specified in the SCC, the Technical Requirements and/or the Agreed and Finalized Project Plan. At the Purchaser’s discretion, Operational Acceptance Tests may also be performed on replacement Goods, upgrades and new version releases, and Goods that are added or field-modified after Operational Acceptance of the System. 27.2.2 If for reasons attributable to the Purchaser, the Operational Acceptance Test of the System (or Subsystem[s] or major components, pursuant to the SCC for GCC Clause 27.2.1) cannot be successfully completed within the period specified in the SCC, from the date of Installation or any other period agreed upon in writing by the Purchaser and the Supplier, the Supplier shall be deemed to have fulfilled its obligations with respect to the technical and functional aspects of the Technical Specifications, SCC and/or the Agreed and Finalized Project Plan, and GCC Clause 28.2 and 28.3 shall not apply. 27.3 Operational Acceptance 27.3.1 Subject to GCC Clause 27.4 (Partial Acceptance) below, Operational Acceptance shall occur in respect of the System, when (a) the Operational Acceptance Tests, as specified in the Technical Requirements, and/or SCC and/or the Agreed and Finalized Project Plan have been successfully completed; or (b) the Operational Acceptance Tests have not been successfully completed or have not been carried out for reasons that are attributable to the Purchaser within the period from the date of Installation or any other agreed-upon period as 48 Section IV. General Conditions of Contract specified in GCC Clause 27.2.2 above; or (c) the Purchaser has put the System into production or use for sixty (60) consecutive days. If the System is put into production or use in this manner, the Supplier shall notify the Purchaser and document such use. 27.3.2 At any time after any of the events set out in GCC Clause 27.3.1 have occurred, the Supplier may give a notice to the Project Manager requesting the issue of an Operational Acceptance Certificate. 27.3.3 After consultation with the Purchaser, and within fourteen (14) days after receipt of the Supplier’s notice, the Project Manager shall: (a) issue an Operational Acceptance Certificate; or (b) notify the Supplier in writing of any defect or deficiencies or other reason for the failure of the Operational Acceptance Tests; or (c) issue the Operational Acceptance Certificate, if the situation covered by GCC Clause 27.3.1 (b) arises. 27.3.4 The Supplier shall use all reasonable endeavors to promptly remedy any defect and/or deficiencies and/or other reasons for the failure of the Operational Acceptance Test that the Project Manager has notified the Supplier of. Once such remedies have been made by the Supplier, the Supplier shall notify the Purchaser, and the Purchaser, with the full cooperation of the Supplier, shall use all reasonable endeavors to promptly carry out retesting of the System or Subsystem. Upon the successful conclusion of the Operational Acceptance Tests, the Supplier shall notify the Purchaser of its request for Operational Acceptance Certification, in accordance with GCC Clause 27.3.3. The Purchaser shall then issue to the Supplier the Operational Acceptance Certification in accordance with GCC Clause 27.3.3 (a), or shall notify the Supplier of further defects, deficiencies, or other reasons for the failure of the Operational Acceptance Test. The procedure set out in this GCC Clause 27.3.4 shall be repeated, as necessary, until an Section IV. General Conditions of Contract 49 Operational Acceptance Certificate is issued. 27.3.5 If the System or Subsystem fails to pass the Operational Acceptance Test(s) in accordance with GCC Clause 27.2, then either: (a) the Purchaser may consider terminating the Contract, pursuant to GCC Clause 41.2.2; or (b) if the failure to achieve Operational Acceptance within the specified time period is a result of the failure of the Purchaser to fulfill its obligations under the Contract, then the Supplier shall be deemed to have fulfilled its obligations with respect to the relevant technical and functional aspects of the Contract, and GCC Clauses 30.3 not apply. 27.3.6 If within fourteen (14) days after receipt of the Supplier’s notice the Project Manager fails to issue the Operational Acceptance Certificate or fails to inform the Supplier in writing of the justifiable reasons why the Project Manager has not issued the Operational Acceptance Certificate, the System or Subsystem shall be deemed to have been accepted as of the date of the Supplier’s said notice. 27.4 Partial Acceptance 27.4.1 If so specified in the SCC for GCC Clause 27.2.1, Installation and Commissioning shall be carried out individually for each identified major component or Subsystem(s) of the System. In this event, the provisions in the Contract relating to Installation and Commissioning, including the Operational Acceptance Test, shall apply to each such major component or Subsystem individually, and Operational Acceptance Certificate(s) shall be issued accordingly for each such major component or Subsystem of the System, subject to the limitations contained in GCC Clause 27.4.2. 27.4.2 The issuance of Operational Acceptance Certificates for individual major components or Subsystems pursuant to GCC Clause 27.4.1 shall not relieve the Supplier of its obligation to obtain an Operational Acceptance Certificate for the System as an integrated whole (if so specified in the SCC for GCC Clauses 12.1 and 27.2.1) 50 Section IV. General Conditions of Contract once all major components and Subsystems have been supplied, installed, tested, and commissioned. 27.4.3 In the case of minor components for the System that by their nature do not require Commissioning or an Operational Acceptance Test (e.g., minor fittings, furnishings or site works, etc.), the Project Manager shall issue an Operational Acceptance Certificate within fourteen (14) days after the fittings and/or furnishings have been delivered and/or installed or the site works have been completed. The Supplier shall, however, use all reasonable endeavors to promptly remedy any defects or deficiencies in such minor components detected by the Purchaser or Supplier. F. GUARANTEES AND LIABILITIES 28. Operational Acceptance Time Guarantee 28.1 The Supplier guarantees that it shall complete the supply, Installation, Commissioning, and achieve Operational Acceptance of the System (or Subsystems, pursuant to the SCC for GCC Clause 27.2.1) within the time periods specified in the Implementation Schedule in the Technical Requirements Section and/or the Agreed and Finalized Project Plan pursuant to GCC Clause 8.2, or within such extended time to which the Supplier shall be entitled under GCC Clause 40 (Extension of Time for Achieving Operational Acceptance). 28.2 If the Supplier fails to supply, install, commission, and achieve Operational Acceptance of the System (or Subsystems pursuant to the SCC for GCC Clause 27.2.1) within the time for achieving Operational Acceptance specified in the Implementation Schedule in the Technical Requirement or the Agreed and Finalized Project Plan, or any extension of the time for achieving Operational Acceptance previously granted under GCC Clause 40 (Extension of Time for Achieving Operational Acceptance), the Supplier shall pay to the Purchaser liquidated damages at the rate specified in the SCC as a percentage of the Contract Price, or the relevant part of the Contract Price if a Subsystem has not achieved Operational Acceptance. The aggregate amount of such liquidated damages shall in no event exceed the amount specified in the SCC (“the Maximum”). Once the Maximum is reached, the Purchaser may consider termination of the Contract, pursuant to GCC Clause 41.2.2. 28.3 Unless otherwise specified in the SCC, liquidated damages Section IV. General Conditions of Contract 51 payable under GCC Clause 28.2 shall apply only to the failure to achieve Operational Acceptance of the System (and Subsystems) as specified in the Implementation Schedule in the Technical Requirements and/or Agreed and Finalized Project Plan. This Clause 28.3 shall not limit, however, any other rights or remedies the Purchaser may have under the Contract for other delays. 28.4 If liquidated damages are claimed by the Purchaser for the System (or Subsystem), the Supplier shall have no further liability whatsoever to the Purchaser in respect to the Operational Acceptance time guarantee for the System (or Subsystem). However, the payment of liquidated damages shall not in any way relieve the Supplier from any of its obligations to complete the System or from any other of its obligations and liabilities under the Contract. 29. Defect Liability 29.1 The Supplier warrants that the System, including all Information Technologies, Materials, and other Goods supplied and Services provided, shall be free from defects in the design, engineering, Materials, and workmanship that prevent the System and/or any of its components from fulfilling the Technical Requirements or that limit in a material fashion the performance, reliability, or extensibility of the System and/or Subsystems. Exceptions and/or limitations, if any, to this warranty with respect to Software (or categories of Software), shall be as specified in the SCC. Commercial warranty provisions of products supplied under the Contract shall apply to the extent that they do not conflict with the provisions of this Contract. 29.2 The Supplier also warrants that the Information Technologies, Materials, and other Goods supplied under the Contract are new, unused, and incorporate all recent improvements in design that materially affect the System’s or Subsystem’s ability to fulfill the Technical Requirements. 29.3 In addition, the Supplier warrants that: (i) all Goods components to be incorporated into the System form part of the Supplier’s and/or Subcontractor’s current product lines, (ii) they have been previously released to the market, and (iii) those specific items identified in the SCC (if any) have been in the market for at least the minimum periods specified in the SCC. 29.4 The Warranty Period shall commence from the date of Operational Acceptance of the System (or of any major component or Subsystem for which separate Operational 52 Section IV. General Conditions of Contract Acceptance is provided for in the Contract) and shall extend for the length of time specified in the SCC. 29.5 If during the Warranty Period any defect as described in GCC Clause 29.1 should be found in the design, engineering, Materials, and workmanship of the Information Technologies and other Goods supplied or of the Services provided by the Supplier, the Supplier shall promptly, in consultation and agreement with the Purchaser regarding appropriate remedying of the defects, and at its sole cost, repair, replace, or otherwise make good (as the Supplier shall, at its discretion, determine) such defect as well as any damage to the System caused by such defect. Any defective Information Technologies or other Goods that have been replaced by the Supplier shall remain the property of the Supplier. 29.6 The Supplier shall not be responsible for the repair, replacement, or making good of any defect or of any damage to the System arising out of or resulting from any of the following causes: (a) improper operation or maintenance of the System by the Purchaser; (b) normal wear and tear; (c) use of the System with items not supplied by the Supplier, unless otherwise identified in the Technical Requirements, or approved by the Supplier; or (d) modifications made to the System by the Purchaser, or a third party, not approved by the Supplier. 29.7 The Supplier’s obligations under this GCC Clause 29 shall not apply to: (a) any materials that are normally consumed in operation or have a normal life shorter than the Warranty Period; or (b) any designs, specifications, or other data designed, supplied, or specified by or on behalf of the Purchaser or any matters for which the Supplier has disclaimed responsibility, in accordance with GCC Clause 21.1.2. 29.8 The Purchaser shall give the Supplier a notice promptly following the discovery of such defect, stating the nature of any such defect together with all available evidence. The Purchaser shall afford all reasonable opportunity for the Section IV. General Conditions of Contract 53 Supplier to inspect any such defect. The Purchaser shall afford the Supplier all necessary access to the System and the site to enable the Supplier to perform its obligations under this GCC Clause 29. 29.9 The Supplier may, with the consent of the Purchaser, remove from the site any Information Technologies and other Goods that are defective, if the nature of the defect, and/or any damage to the System caused by the defect, is such that repairs cannot be expeditiously carried out at the site. If the repair, replacement, or making good is of such a character that it may affect the efficiency of the System, the Purchaser may give the Supplier notice requiring that tests of the defective part be made by the Supplier immediately upon completion of such remedial work, whereupon the Supplier shall carry out such tests. If such part fails the tests, the Supplier shall carry out further repair, replacement, or making good (as the case may be) until that part of the System passes such tests. The tests shall be agreed upon by the Purchaser and the Supplier. 29.10 If the Supplier fails to commence the work necessary to remedy such defect or any damage to the System caused by such defect within the time period specified in the SCC, the Purchaser may, following notice to the Supplier, proceed to do such work or contract a third party (or parties) to do such work, and the reasonable costs incurred by the Purchaser in connection with such work shall be paid to the Purchaser by the Supplier or may be deducted by the Purchaser from any monies due the Supplier or claimed under the Performance Security. 29.11 If the System or Subsystem cannot be used by reason of such defect and/or making good of such defect, the Warranty Period for the System shall be extended by a period equal to the period during which the System or Subsystem could not be used by the Purchaser because of such defect and/or making good of such defect. 29.12 Items substituted for defective parts of the System during the Warranty Period shall be covered by the Defect Liability Warranty for the remainder of the Warranty Period applicable for the part replaced or three (3) months, whichever is greater. 29.13 At the request of the Purchaser and without prejudice to any other rights and remedies that the Purchaser may have 54 Section IV. General Conditions of Contract against the Supplier under the Contract, the Supplier will offer all possible assistance to the Purchaser to seek warranty services or remedial action from any subcontracted thirdparty producers or licensor of Goods included in the System, including without limitation assignment or transfer in favor of the Purchaser of the benefit of any warranties given by such producers or licensors to the Supplier. 30. Functional Guarantees 30.1 The Supplier guarantees that, once the Operational Acceptance Certificate(s) has been issued, the System represents a complete, integrated solution to the Purchaser’s requirements set forth in the Technical Requirements and it conforms to all other aspects of the Contract. The Supplier acknowledges that GCC Clause 27 regarding Commissioning and Operational Acceptance governs how technical conformance of the System to the Contract requirements will be determined. 30.2 If, for reasons attributable to the Supplier, the System does not conform to the Technical Requirements or does not conform to all other aspects of the Contract, the Supplier shall at its cost and expense make such changes, modifications, and/or additions to the System as may be necessary to conform to the Technical Requirements and meet all functional and performance standards. The Supplier shall notify the Purchaser upon completion of the necessary changes, modifications, and/or additions and shall request the Purchaser to repeat the Operational Acceptance Tests until the System achieves Operational Acceptance. 30.3 If the System (or Subsystem[s]) fails to achieve Operational Acceptance, the Purchaser may consider termination of the Contract, pursuant to GCC Clause 41.2.2, and forfeiture of the Supplier’s Performance Security in accordance with GCC Clause 13.3 in compensation for the extra costs and delays likely to result from this failure. 31. Intellectual Property Rights Warranty 31.1 The Supplier hereby represents and warrants that: (a) the System as supplied, installed, tested, and accepted; (b) use of the System in accordance with the Contract; and (c) copying of the Software and Materials provided to the Purchaser in accordance with the Contract do not and will not infringe any Intellectual Property Rights held by any third party and that it has all necessary rights or Section IV. General Conditions of Contract 55 at its sole expense shall have secured in writing all transfers of rights and other consents necessary to make the assignments, licenses, and other transfers of Intellectual Property Rights and the warranties set forth in the Contract, and for the Purchaser to own or exercise all Intellectual Property Rights as provided in the Contract. Without limitation, the Supplier shall secure all necessary written agreements, consents, and transfers of rights from its employees and other persons or entities whose services are used for development of the System. 32. Intellectual Property Rights Indemnity 32.1 The Supplier shall indemnify and hold harmless the Purchaser and its employees and officers from and against any and all losses, liabilities, and costs (including losses, liabilities, and costs incurred in defending a claim alleging such a liability), that the Purchaser or its employees or officers may suffer as a result of any infringement or alleged infringement of any Intellectual Property Rights by reason of: (a) installation of the System by the Supplier or the use of the System, including the Materials, in the country where the site is located; (b) copying of the Software and Materials provided the Supplier in accordance with the Agreement; and (c) sale of the products produced by the System in any country, except to the extent that such losses, liabilities, and costs arise as a result of the Purchaser’s breach of GCC Clause 32.2. 32.2 Such indemnity shall not cover any use of the System, including the Materials, other than for the purpose indicated by or to be reasonably inferred from the Contract, any infringement resulting from the use of the System, or any products of the System produced thereby in association or combination with any other goods or services not supplied by the Supplier, where the infringement arises because of such association or combination and not because of use of the System in its own right. 32.3 Such indemnities shall also not apply if any claim of infringement: (a) is asserted by a parent, subsidiary, or affiliate of the Purchaser’s organization; 56 Section IV. General Conditions of Contract (b) is a direct result of a design mandated by the Purchaser’s Technical Requirements and the possibility of such infringement was duly noted in the Supplier’s Bid; or (c) results from the alteration of the System, including the Materials, by the Purchaser or any persons other than the Supplier or a person authorized by the Supplier. 32.4 If any proceedings are brought or any claim is made against the Purchaser arising out of the matters referred to in GCC Clause 32.1, the Purchaser shall promptly give the Supplier notice of such proceedings or claims, and the Supplier may at its own expense and in the Purchaser’s name conduct such proceedings or claim and any negotiations for the settlement of any such proceedings or claim. If the Supplier fails to notify the Purchaser within twentyeight (28) days after receipt of such notice that it intends to conduct any such proceedings or claim, then the Purchaser shall be free to conduct the same on its own behalf. Unless the Supplier has so failed to notify the Purchaser within the twenty-eight (28) days, the Purchaser shall make no admission that may be prejudicial to the defense of any such proceedings or claim. The Purchaser shall, at the Supplier’s request, afford all available assistance to the Supplier in conducting such proceedings or claim and shall be reimbursed by the Supplier for all reasonable expenses incurred in so doing. 32.5 The Purchaser shall indemnify and hold harmless the Supplier and its employees, officers, and Subcontractors from and against any and all losses, liabilities, and costs (including losses, liabilities, and costs incurred in defending a claim alleging such a liability) that the Supplier or its employees, officers, or Subcontractors may suffer as a result of any infringement or alleged infringement of any Intellectual Property Rights arising out of or in connection with any design, data, drawing, specification, or other documents or materials provided to the Supplier in connection with this Contract by the Purchaser or any persons (other than the Supplier) contracted by the Purchaser, except to the extent that such losses, liabilities, and costs arise as a result of the Supplier’s breach of GCC Clause 32.8. 32.6 Such indemnity shall not cover Section IV. General Conditions of Contract 57 (a) any use of the design, data, drawing, specification, or other documents or materials, other than for the purpose indicated by or to be reasonably inferred from the Contract; (b) any infringement resulting from the use of the design, data, drawing, specification, or other documents or materials, or any products produced thereby, in association or combination with any other Goods or Services not provided by the Purchaser or any other person contracted by the Purchaser, where the infringement arises because of such association or combination and not because of the use of the design, data, drawing, specification, or other documents or materials in its own right. 32.7 Such indemnities shall also not apply: (a) if any claim of infringement is asserted by a parent, subsidiary, or affiliate of the Supplier’s organization; (b) to the extent that any claim of infringement is caused by the alteration, by the Supplier, or any persons contracted by the Supplier, of the design, data, drawing, specification, or other documents or materials provided to the Supplier by the Purchaser or any persons contracted by the Purchaser. 32.8 If any proceedings are brought or any claim is made against the Supplier arising out of the matters referred to in GCC Clause 32.5, the Supplier shall promptly give the Purchaser notice of such proceedings or claims, and the Purchaser may at its own expense and in the Supplier’s name conduct such proceedings or claim and any negotiations for the settlement of any such proceedings or claim. If the Purchaser fails to notify the Supplier within twenty-eight (28) days after receipt of such notice that it intends to conduct any such proceedings or claim, then the Supplier shall be free to conduct the same on its own behalf. Unless the Purchaser has so failed to notify the Supplier within the twenty-eight (28) days, the Supplier shall make no admission that may be prejudicial to the defense of any such proceedings or claim. The Supplier shall, at the Purchaser’s request, afford all available assistance to the Purchaser in conducting such proceedings or claim and shall be reimbursed by the Purchaser for all reasonable expenses incurred in so doing. 58 33. Limitation of Liability Section IV. General Conditions of Contract 33.1 Provided the following does not exclude or limit any liabilities of either party in ways not permitted by applicable law: (a) the Supplier shall not be liable to the Purchaser, whether in contract, tort, or otherwise, for any indirect or consequential loss or damage, loss of use, loss of production, or loss of profits or interest costs, provided that this exclusion shall not apply to any obligation of the Supplier to pay liquidated damages to the Purchaser; and (b) the aggregate liability of the Supplier to the Purchaser, whether under the Contract, in tort or otherwise, shall not exceed the total Contract Price, provided that this limitation shall not apply to any obligation of the Supplier to indemnify the Purchaser with respect to intellectual property rights infringement. G. RISK DISTRIBUTION 34. Transfer of Ownership 34.1 With the exception of Software and Materials, the ownership of the Information Technologies and other Goods shall be transferred to the Purchaser at the time of Delivery or otherwise under terms that may be agreed upon and specified in the Contract Agreement. 34.2 Ownership and the terms of usage of the Software and Materials supplied under the Contract shall be governed by GCC Clause 15 (Copyright) and any elaboration in the Technical Requirements. 34.3 Ownership of the Supplier’s Equipment used by the Supplier and its Subcontractors in connection with the Contract shall remain with the Supplier or its Subcontractors. 35. Care of the System 35.1 The Purchaser shall become responsible for the care and custody of the System or Subsystems upon their Delivery. The Purchaser shall make good at its own cost any loss or damage that may occur to the System or Subsystems from any cause from the date of Delivery until the date of Operational Acceptance of the System or Subsystems, pursuant to GCC Clause 27 (Commissioning and Operational Acceptance), excepting such loss or damage arising from acts or omissions of the Supplier, its employees, or subcontractors. Section IV. General Conditions of Contract 59 35.2 If any loss or damage occurs to the System or any part of the System by reason of: (a) (insofar as they relate to the country where the Project Site is located) nuclear reaction, nuclear radiation, radioactive contamination, a pressure wave caused by aircraft or other aerial objects, or any other occurrences that an experienced contractor could not reasonably foresee, or if reasonably foreseeable could not reasonably make provision for or insure against, insofar as such risks are not normally insurable on the insurance market and are mentioned in the general exclusions of the policy of insurance taken out under GCC Clause 37; (b) any use not in accordance with the Contract, by the Purchaser or any third party; (c) any use of or reliance upon any design, data, or specification provided or designated by or on behalf of the Purchaser, or any such matter for which the Supplier has disclaimed responsibility in accordance with GCC Clause 21.1.2, the Purchaser shall pay to the Supplier all sums payable in respect of the System or Subsystems that have achieved Operational Acceptance, notwithstanding that the same be lost, destroyed, or damaged. If the Purchaser requests the Supplier in writing to make good any loss or damage to the System thereby occasioned, the Supplier shall make good the same at the cost of the Purchaser in accordance with GCC Clause 39. If the Purchaser does not request the Supplier in writing to make good any loss or damage to the System thereby occasioned, the Purchaser shall either request a change in accordance with GCC Clause 39, excluding the performance of that part of the System thereby lost, destroyed, or damaged, or, where the loss or damage affects a substantial part of the System, the Purchaser shall terminate the Contract pursuant to GCC Clause 41.1. 35.3 The Purchaser shall be liable for any loss of or damage to any Supplier’s Equipment which the Purchaser has authorized to locate within the Purchaser's premises for use in fulfillment of Supplier's obligations under the Contract, except where such loss or damage arises from acts or omissions of the Supplier, its employees, or subcontractors. 36. Loss of or 36.1 The Supplier and each and every Subcontractor shall abide 60 Section IV. General Conditions of Contract Damage to Property; Accident or Injury to Workers; Indemnification by the job safety, insurance, customs, and immigration measures prevalent and laws in force in the Purchaser’s Country. 36.2 Subject to GCC Clause 36.3, the Supplier shall indemnify and hold harmless the Purchaser and its employees and officers from and against any and all losses, liabilities and costs (including losses, liabilities, and costs incurred in defending a claim alleging such a liability) that the Purchaser or its employees or officers may suffer as a result of the death or injury of any person or loss of or damage to any property (other than the System, whether accepted or not) arising in connection with the supply, installation, testing, and Commissioning of the System and by reason of the negligence of the Supplier or its Subcontractors, or their employees, officers or agents, except any injury, death, or property damage caused by the negligence of the Purchaser, its contractors, employees, officers, or agents. 36.3 If any proceedings are brought or any claim is made against the Purchaser that might subject the Supplier to liability under GCC Clause 36.2, the Purchaser shall promptly give the Supplier notice of such proceedings or claims, and the Supplier may at its own expense and in the Purchaser’s name conduct such proceedings or claim and any negotiations for the settlement of any such proceedings or claim. If the Supplier fails to notify the Purchaser within twenty-eight (28) days after receipt of such notice that it intends to conduct any such proceedings or claim, then the Purchaser shall be free to conduct the same on its own behalf. Unless the Supplier has so failed to notify the Purchaser within the twenty-eight (28) day period, the Purchaser shall make no admission that may be prejudicial to the defense of any such proceedings or claim. The Purchaser shall, at the Supplier’s request, afford all available assistance to the Supplier in conducting such proceedings or claim and shall be reimbursed by the Supplier for all reasonable expenses incurred in so doing. 36.4 The Purchaser shall indemnify and hold harmless the Supplier and its employees, officers, and Subcontractors from any and all losses, liabilities, and costs (including losses, liabilities, and costs incurred in defending a claim alleging such a liability) that the Supplier or its employees, officers, or Subcontractors may suffer as a result of the death or personal injury of any person or loss of or damage to property of the Purchaser, other than the System not yet Section IV. General Conditions of Contract 61 achieving Operational Acceptance, that is caused by fire, explosion, or any other perils, in excess of the amount recoverable from insurances procured under GCC Clause 37 (Insurances), provided that such fire, explosion, or other perils were not caused by any act or failure of the Supplier. 36.5 If any proceedings are brought or any claim is made against the Supplier that might subject the Purchaser to liability under GCC Clause 36.4, the Supplier shall promptly give the Purchaser notice of such proceedings or claims, and the Purchaser may at its own expense and in the Supplier’s name conduct such proceedings or claim and any negotiations for the settlement of any such proceedings or claim. If the Purchaser fails to notify the Supplier within twenty-eight (28) days after receipt of such notice that it intends to conduct any such proceedings or claim, then the Supplier shall be free to conduct the same on its own behalf. Unless the Purchaser has so failed to notify the Supplier within the twenty-eight (28) days, the Supplier shall make no admission that may be prejudicial to the defense of any such proceedings or claim. The Supplier shall, at the Purchaser’s request, afford all available assistance to the Purchaser in conducting such proceedings or claim and shall be reimbursed by the Purchaser for all reasonable expenses incurred in so doing. 36.6 The party entitled to the benefit of an indemnity under this GCC Clause 36 shall take all reasonable measures to mitigate any loss or damage that has occurred. If the party fails to take such measures, the other party’s liabilities shall be correspondingly reduced. 37. Insurances 37.1 The Supplier shall at its expense take out and maintain in effect, or cause to be taken out and maintained in effect, during the performance of the Contract, the insurance set forth below. The identity of the insurers and the form of the policies shall be subject to the approval of the Purchaser, who should not unreasonably withhold such approval. (a) Cargo Insurance During Transport as applicable, 110 percent of the price of the Information Technologies and other Goods in a freely convertible currency, covering the Goods from physical loss or damage during shipment through receipt at the Project Site. 62 Section IV. General Conditions of Contract (b) Installation “All Risks” Insurance as applicable, 110 percent of the price of the Information Technologies and other Goods covering the Goods at the site from all risks of physical loss or damage (excluding only perils commonly excluded under “all risks” insurance policies of this type by reputable insurers) occurring prior to Operational Acceptance of the System. (c) Third-Party Liability Insurance On terms as specified in the SCC, covering bodily injury or death suffered by third parties (including the Purchaser’s personnel) and loss of or damage to property (including the Purchaser’s property and any Subsystems that have been accepted by the Purchaser) occurring in connection with the supply and installation of the Information System. (d) Automobile Liability Insurance In accordance with the statutory requirements prevailing in the Purchaser’s Country, covering use of all vehicles used by the Supplier or its Subcontractors (whether or not owned by them) in connection with the execution of the Contract. (e) Other Insurance (if any), as specified in the SCC. 37.2 The Purchaser shall be named as co-insured under all insurance policies taken out by the Supplier pursuant to GCC Clause 37.1, except for the Third-Party Liability, and the Supplier’s Subcontractors shall be named as co-insured under all insurance policies taken out by the Supplier pursuant to GCC Clause 37.1 except for Cargo Insurance During Transport. All insurer’s rights of subrogation against such co-insured for losses or claims arising out of the performance of the Contract shall be waived under such policies. 37.3 The Supplier shall deliver to the Purchaser certificates of insurance (or copies of the insurance policies) as evidence that the required policies are in full force and effect. 37.4 The Supplier shall ensure that, where applicable, its Subcontractor(s) shall take out and maintain in effect adequate insurance policies for their personnel and vehicles and for work executed by them under the Contract, unless Section IV. General Conditions of Contract 63 such Subcontractors are covered by the policies taken out by the Supplier. 37.5 If the Supplier fails to take out and/or maintain in effect the insurance referred to in GCC Clause 37.1, the Purchaser may take out and maintain in effect any such insurance and may from time to time deduct from any amount due the Supplier under the Contract any premium that the Purchaser shall have paid to the insurer or may otherwise recover such amount as a debt due from the Supplier. 37.6 Unless otherwise provided in the Contract, the Supplier shall prepare and conduct all and any claims made under the policies effected by it pursuant to this GCC Clause 37, and all monies payable by any insurers shall be paid to the Supplier. The Purchaser shall give to the Supplier all such reasonable assistance as may be required by the Supplier in connection with any claim under the relevant insurance policies. With respect to insurance claims in which the Purchaser’s interest is involved, the Supplier shall not give any release or make any compromise with the insurer without the prior written consent of the Purchaser. With respect to insurance claims in which the Supplier’s interest is involved, the Purchaser shall not give any release or make any compromise with the insurer without the prior written consent of the Supplier. 38. Force Majeure 38.1 “Force Majeure” shall mean any event beyond the reasonable control of the Purchaser or of the Supplier, as the case may be, and which is unavoidable notwithstanding the reasonable care of the party affected and shall include, without limitation, the following: (a) war, hostilities, or warlike operations (whether a state of war be declared or not), invasion, act of foreign enemy, and civil war; (b) rebellion, revolution, insurrection, mutiny, usurpation of civil or military government, conspiracy, riot, civil commotion, and terrorist acts; (c) confiscation, nationalization, mobilization, commandeering or requisition by or under the order of any government or de jure or de facto authority or ruler, or any other act or failure to act of any local state or national government authority; (d) strike, sabotage, lockout, embargo, import restriction, 64 Section IV. General Conditions of Contract port congestion, lack of usual means of public transportation and communication, industrial dispute, shipwreck, shortage or restriction of power supply, epidemics, quarantine, and plague; (e) earthquake, landslide, volcanic activity, fire, flood or inundation, tidal wave, typhoon or cyclone, hurricane, storm, lightning, or other inclement weather condition, nuclear and pressure waves, or other natural or physical disaster; (f) failure, by the Supplier, to obtain the necessary export permit(s) from the governments of the Country(s) of Origin of the Information Technologies or other Goods, or Supplier’s Equipment provided that the Supplier has made all reasonable efforts to obtain the required export permit(s), including the exercise of due diligence in determining the eligibility of the System and all of its components for receipt of the necessary export permits. 38.2 If either party is prevented, hindered, or delayed from or in performing any of its obligations under the Contract by an event of Force Majeure, then it shall notify the other in writing of the occurrence of such event and the circumstances of the event of Force Majeure within fourteen (14) days after the occurrence of such event. 38.3 The party who has given such notice shall be excused from the performance or punctual performance of its obligations under the Contract for so long as the relevant event of Force Majeure continues and to the extent that such party’s performance is prevented, hindered, or delayed. The Time for Achieving Operational Acceptance shall be extended in accordance with GCC Clause 40 (Extension of Time for Achieving Operational Acceptance). 38.4 The party or parties affected by the event of Force Majeure shall use reasonable efforts to mitigate the effect of the event of Force Majeure upon its or their performance of the Contract and to fulfill its or their obligations under the Contract, but without prejudice to either party’s right to terminate the Contract under GCC Clause 38.6. 38.5 No delay or nonperformance by either party to this Contract caused by the occurrence of any event of Force Majeure shall: Section IV. General Conditions of Contract 65 (a) constitute a default or breach of the Contract; (b) (subject to GCC Clauses 35.2, 38.3, and 38.4) give rise to any claim for damages or additional cost or expense occasioned by the delay or nonperformance, if, and to the extent that, such delay or nonperformance is caused by the occurrence of an event of Force Majeure. 38.6 If the performance of the Contract is substantially prevented, hindered, or delayed for a single period of more than sixty (60) days or an aggregate period of more than one hundred and twenty (120) days on account of one or more events of Force Majeure during the time period covered by the Contract, the parties will attempt to develop a mutually satisfactory solution, failing which, either party may terminate the Contract by giving a notice to the other. 38.7 In the event of termination pursuant to GCC Clause 38.6, the rights and obligations of the Purchaser and the Supplier shall be as specified in GCC Clauses 41.1.2 and 41.1.3. 38.8 Notwithstanding GCC Clause 38.5, Force Majeure shall not apply to any obligation of the Purchaser to make payments to the Supplier under this Contract. H. CHANGE IN CONTRACT ELEMENTS 39. Changes to the System 39.1 Introducing a Change 39.1.1 Subject to GCC Clauses 39.2.5 and 39.2.7, the Purchaser shall have the right to propose, and subsequently require, the Project Manager to order the Supplier from time to time during the performance of the Contract to make any change, modification, addition, or deletion to, in, or from the System (interchangeably called “Change”), provided that such Change falls within the general scope of the System, does not constitute unrelated work, and is technically practicable, taking into account both the state of advancement of the System and the technical compatibility of the Change envisaged with the nature of the System as originally specified in the Contract. A Change may involve, but is not restricted to, the substitution of updated Information Technologies 66 Section IV. General Conditions of Contract and related Services in accordance GCC Clause 23 (Product Upgrades). with 39.1.2 The Supplier may from time to time during its performance of the Contract propose to the Purchaser (with a copy to the Project Manager) any Change that the Supplier considers necessary or desirable to improve the quality or efficiency of the System. The Purchaser may at its discretion approve or reject any Change proposed by the Supplier. 39.1.3 Notwithstanding GCC Clauses 39.1.1 and 39.1.2, no change made necessary because of any default of the Supplier in the performance of its obligations under the Contract shall be deemed to be a Change, and such change shall not result in any adjustment of the Contract Price or the Time for Achieving Operational Acceptance. 39.1.4 The procedure on how to proceed with and execute Changes is specified in GCC Clauses 39.2 and 39.3, and further details and sample forms are provided in the Sample Forms Section in the Bidding Documents. 39.1.5 Moreover, the Purchaser and Supplier will agree, during development of the Project Plan, to a date prior to the scheduled date for Operational Acceptance, after which the Technical Requirements for the System shall be “frozen.” Any Change initiated after this time will be dealt with after Operational Acceptance. 39.2 Changes Originating from Purchaser 39.2.1 If the Purchaser proposes a Change pursuant to GCC Clauses 39.1.1, it shall send to the Supplier a “Request for Change Proposal,” requiring the Supplier to prepare and furnish to the Project Manager as soon as reasonably practicable a “Change Proposal,” which shall include the following: (a) brief description of the Change; (b) impact on the Time for Achieving Operational Acceptance; Section IV. General Conditions of Contract 67 (c) detailed estimated cost of the Change; (d) effect on Functional Guarantees (if any); (e) effect on any other provisions of the Contract. 39.2.2 Prior to preparing and submitting the “Change Proposal,” the Supplier shall submit to the Project Manager an “Change Estimate Proposal,” which shall be an estimate of the cost of preparing the Change Proposal, plus a first approximation of the suggested approach and cost for implementing the changes. Upon receipt of the Supplier’s Change Estimate Proposal, the Purchaser shall do one of the following: (a) accept the Supplier’s estimate with instructions to the Supplier to proceed with the preparation of the Change Proposal; (b) advise the Supplier of any part of its Change Estimate Proposal that is unacceptable and request the Supplier to review its estimate; (c) advise the Supplier that the Purchaser does not intend to proceed with the Change. 39.2.3 Upon receipt of the Purchaser’s instruction to proceed under GCC Clause 39.2.2 (a), the Supplier shall, with proper expedition, proceed with the preparation of the Change Proposal, in accordance with GCC Clause 39.2.1. The Supplier, at its discretion, may specify a validity period for the Change Proposal, after which if the Purchaser and Supplier has not reached agreement in accordance with GCC Clause 39.2.6, then GCC Clause 39.2.7 shall apply. 39.2.4 The pricing of any Change shall, as far as practicable, be calculated in accordance with the rates and prices included in the Contract. If the nature of the Change is such that the Contract rates and prices are inequitable, the parties to the Contract shall agree on other specific rates to be used for valuing the Change. 39.2.5 If before or during the preparation of the Change Proposal it becomes apparent that the aggregate impact of compliance with the Request for Change 68 Section IV. General Conditions of Contract Proposal and with all other Change Orders that have already become binding upon the Supplier under this GCC Clause 39 would be to increase or decrease the Contract Price as originally set forth in Article 2 (Contract Price) of the Contract Agreement by more than fifteen (15) percent, the Supplier may give a written notice of objection to this Request for Change Proposal prior to furnishing the Change Proposal. If the Purchaser accepts the Supplier’s objection, the Purchaser shall withdraw the proposed Change and shall notify the Supplier in writing of its acceptance. The Supplier’s failure to so object to a Request for Change Proposal shall neither affect its right to object to any subsequent requested Changes or Change Orders, nor affect its right to take into account, when making such subsequent objection, the percentage increase or decrease in the Contract Price that any Change not objected to by the Supplier represents. 39.2.6 Upon receipt of the Change Proposal, the Purchaser and the Supplier shall mutually agree upon all matters contained in the Change Proposal. Within fourteen (14) days after such agreement, the Purchaser shall, if it intends to proceed with the Change, issue the Supplier a Change Order. If the Purchaser is unable to reach a decision within fourteen (14) days, it shall notify the Supplier with details of when the Supplier can expect a decision. If the Purchaser decides not to proceed with the Change for whatever reason, it shall, within the said period of fourteen (14) days, notify the Supplier accordingly. Under such circumstances, the Supplier shall be entitled to reimbursement of all costs reasonably incurred by it in the preparation of the Change Proposal, provided that these do not exceed the amount given by the Supplier in its Change Estimate Proposal submitted in accordance with GCC Clause 39.2.2. 39.2.7 If the Purchaser and the Supplier cannot reach agreement on the price for the Change, an equitable adjustment to the Time for Achieving Operational Acceptance, or any other matters identified in the Change Proposal, the Change will not be Section IV. General Conditions of Contract 69 implemented. However, this provision does not limit the rights of either party under GCC Clause 6 (Settlement of Disputes). 39.3 Changes Originating from Supplier If the Supplier proposes a Change pursuant to GCC Clause 39.1.2, the Supplier shall submit to the Project Manager a written “Application for Change Proposal,” giving reasons for the proposed Change and including the information specified in GCC Clause 39.2.1. Upon receipt of the Application for Change Proposal, the parties shall follow the procedures outlined in GCC Clauses 39.2.6 and 39.2.7. However, should the Purchaser choose not to proceed or the Purchaser and the Supplier cannot come to agreement on the change during any validity period that the Supplier may specify in its Application for Change Proposal, the Supplier shall not be entitled to recover the costs of preparing the Application for Change Proposal, unless subject to an agreement between the Purchaser and the Supplier to the contrary. 40. Extension of Time for Achieving Operational Acceptance 40.1 The time(s) for achieving Operational Acceptance specified in the Schedule of Implementation shall be extended if the Supplier is delayed or impeded in the performance of any of its obligations under the Contract by reason of any of the following: (a) any Change in the System as provided in GCC Clause 39 (Change in the Information System); (b) any occurrence of Force Majeure as provided in GCC Clause 38 (Force Majeure); (c) default of the Purchaser; or (d) any other matter specifically mentioned in the Contract; by such period as shall be fair and reasonable in all the circumstances and as shall fairly reflect the delay or impediment sustained by the Supplier. 40.2 Except where otherwise specifically provided in the Contract, the Supplier shall submit to the Project Manager a notice of a claim for an extension of the time for achieving Operational Acceptance, together with particulars of the event or circumstance justifying such extension as soon as reasonably practicable after the commencement of such 70 Section IV. General Conditions of Contract event or circumstance. As soon as reasonably practicable after receipt of such notice and supporting particulars of the claim, the Purchaser and the Supplier shall agree upon the period of such extension. In the event that the Supplier does not accept the Purchaser’s estimate of a fair and reasonable time extension, the Supplier shall be entitled to refer the matter to the provisions for the Settlement of Disputes pursuant to GCC Clause 6. 40.3 The Supplier shall at all times use its reasonable efforts to minimize any delay in the performance of its obligations under the Contract. 41. Termination 41.1 Termination for Purchaser’s Convenience 41.1.1 The Purchaser may at any time terminate the Contract for any reason by giving the Supplier a notice of termination that refers to this GCC Clause 41.1. 41.1.2 Upon receipt of the notice of termination under GCC Clause 41.1.1, the Supplier shall either as soon as reasonably practical or upon the date specified in the notice of termination (a) cease all further work, except for such work as the Purchaser may specify in the notice of termination for the sole purpose of protecting that part of the System already executed, or any work required to leave the site in a clean and safe condition; (b) terminate all subcontracts, except those to be assigned to the Purchaser pursuant to GCC Clause 41.1.2 (d) (ii) below; (c) remove all Supplier’s Equipment from the site, repatriate the Supplier’s and its Subcontractors’ personnel from the site, remove from the site any wreckage, rubbish, and debris of any kind; (d) in addition, the Supplier, subject to the payment specified in GCC Clause 41.1.3, shall (i) deliver to the Purchaser the parts of the System executed by the Supplier up to the date of termination; (ii) to the extent legally possible, assign to the Section IV. General Conditions of Contract 71 Purchaser all right, title, and benefit of the Supplier to the System, or Subsystem, as at the date of termination, and, as may be required by the Purchaser, in any subcontracts concluded between the Supplier and its Subcontractors; (iii) deliver to the Purchaser all nonproprietary drawings, specifications, and other documents prepared by the Supplier or its Subcontractors as of the date of termination in connection with the System. 41.1.3 In the event of termination of the Contract under GCC Clause 41.1.1, the Purchaser shall pay to the Supplier the following amounts: (a) the Contract Price, properly attributable to the parts of the System executed by the Supplier as of the date of termination; (b) the costs reasonably incurred by the Supplier in the removal of the Supplier’s Equipment from the site and in the repatriation of the Supplier’s and its Subcontractors’ personnel; (c) any amount to be paid by the Supplier to its Subcontractors in connection with the termination of any subcontracts, including any cancellation charges; (d) costs incurred by the Supplier in protecting the System and leaving the site in a clean and safe condition pursuant to GCC Clause 41.1.2 (a); and (e) the cost of satisfying all other obligations, commitments, and claims that the Supplier may in good faith have undertaken with third parties in connection with the Contract and that are not covered by GCC Clauses 41.1.3 (a) through (d) above. 41.2 Termination for Supplier’s Default 41.2.1 The Purchaser, without prejudice to any other rights or remedies it may possess, may terminate the Contract forthwith in the following circumstances by giving a notice of termination and its reasons therefore to the Supplier, referring 72 Section IV. General Conditions of Contract to this GCC Clause 41.2: (a) if the Supplier becomes bankrupt or insolvent, has a receiving order issued against it, compounds with its creditors, or, if the Supplier is a corporation, a resolution is passed or order is made for its winding up (other than a voluntary liquidation for the purposes of amalgamation or reconstruction), a receiver is appointed over any part of its undertaking or assets, or if the Supplier takes or suffers any other analogous action in consequence of debt; (b) if the Supplier assigns or transfers the Contract or any right or interest therein in violation of the provision of GCC Clause 42 (Assignment); or (c) if the Supplier, in the judgment of the Purchaser, has engaged in corrupt, fraudulent, collusive, coercive or obstructive practices, in competing for or in executing the Contract, including but not limited to willful misrepresentation of facts concerning ownership of Intellectual Property Rights in, or proper authorization and/or licenses from the owner to offer, the hardware, software, or materials provided under this Contract. For the purposes of this Clause: (i) “corrupt practice”1 is the offering, giving, receiving or soliciting, directly or indirectly, of anything of value to influence improperly the actions of another party; (ii) “fraudulent practice”2 is any act or omission, including a misrepresentation, that knowingly or recklessly misleads, or attempts to mislead, a party to obtain a financial or other benefit or to avoid an 1 “Another party” refers to a public official acting in relation to the procurement process or contract execution]. In this context, “public official” includes World Bank staff and employees of other organizations taking or reviewing procurement decisions. 2 A “party” refers to a public official; the terms “benefit” and “obligation” relate to the procurement process or contract execution; and the “act or omission” is intended to influence the procurement process or contract execution. Section IV. General Conditions of Contract 73 obligation; (iii) “collusive practice”1 is an arrangement between two or more parties designed to achieve an improper purpose, including to influence improperly the actions of another party; (iv) “coercive practice”2 is impairing or harming, or threatening to impair or harm, directly or indirectly, any party or the property of the party to influence improperly the actions of a party; (v) “obstructive practice” is (aa) deliberately destroying, falsifying, altering or concealing of evidence material to the investigation or making false statements to investigators in order to materially impede a Bank investigation into allegations of a corrupt, fraudulent, coercive or collusive practice; and/or threatening, harassing or intimidating any party to prevent it from disclosing its knowledge of matters relevant to the investigation or from pursuing the investigation; or (bb) acts intended to materially impede the exercise of the Bank’s inspection and audit rights provided for under Sub-Clause 9.8. 41.2.2 If the Supplier: (a) has abandoned or repudiated the Contract; (b) has without valid reason failed to commence work on the System promptly; (c) persistently fails to execute the Contract in accordance with the Contract or persistently neglects to carry out its obligations under the 1 “Parties” refers to participants in the procurement process (including public officials) attempting to establish bid prices at artificial, non competitive levels. 2 A “party” refers to a participant in the procurement process or contract execution. 74 Section IV. General Conditions of Contract Contract without just cause; (d) refuses or is unable to provide sufficient Materials, Services, or labor to execute and complete the System in the manner specified in the Agreed and Finalized Project Plan furnished under GCC Clause 19 at rates of progress that give reasonable assurance to the Purchaser that the Supplier can attain Operational Acceptance of the System by the Time for Achieving Operational Acceptance as extended; then the Purchaser may, without prejudice to any other rights it may possess under the Contract, give a notice to the Supplier stating the nature of the default and requiring the Supplier to remedy the same. If the Supplier fails to remedy or to take steps to remedy the same within fourteen (14) days of its receipt of such notice, then the Purchaser may terminate the Contract forthwith by giving a notice of termination to the Supplier that refers to this GCC Clause 41.2. 41.2.3 Upon receipt of the notice of termination under GCC Clauses 41.2.1 or 41.2.2, the Supplier shall, either immediately or upon such date as is specified in the notice of termination: (a) cease all further work, except for such work as the Purchaser may specify in the notice of termination for the sole purpose of protecting that part of the System already executed or any work required to leave the site in a clean and safe condition; (b) terminate all subcontracts, except those to be assigned to the Purchaser pursuant to GCC Clause 41.2.3 (d) below; (c) deliver to the Purchaser the parts of the System executed by the Supplier up to the date of termination; (d) to the extent legally possible, assign to the Purchaser all right, title and benefit of the Supplier to the System or Subsystems as at the date of termination, and, as may be required by the Purchaser, in any subcontracts concluded Section IV. General Conditions of Contract 75 between the Supplier and its Subcontractors; (e) deliver to the Purchaser all drawings, specifications, and other documents prepared by the Supplier or its Subcontractors as at the date of termination in connection with the System. 41.2.4 The Purchaser may enter upon the site, expel the Supplier, and complete the System itself or by employing any third party. Upon completion of the System or at such earlier date as the Purchaser thinks appropriate, the Purchaser shall give notice to the Supplier that such Supplier’s Equipment will be returned to the Supplier at or near the site and shall return such Supplier’s Equipment to the Supplier in accordance with such notice. The Supplier shall thereafter without delay and at its cost remove or arrange removal of the same from the site. 41.2.5 Subject to GCC Clause 41.2.6, the Supplier shall be entitled to be paid the Contract Price attributable to the portion of the System executed as at the date of termination and the costs, if any, incurred in protecting the System and in leaving the site in a clean and safe condition pursuant to GCC Clause 41.2.3 (a). Any sums due the Purchaser from the Supplier accruing prior to the date of termination shall be deducted from the amount to be paid to the Supplier under this Contract. 41.2.6 If the Purchaser completes the System, the cost of completing the System by the Purchaser shall be determined. If the sum that the Supplier is entitled to be paid, pursuant to GCC Clause 41.2.5, plus the reasonable costs incurred by the Purchaser in completing the System, exceeds the Contract Price, the Supplier shall be liable for such excess. If such excess is greater than the sums due the Supplier under GCC Clause 41.2.5, the Supplier shall pay the balance to the Purchaser, and if such excess is less than the sums due the Supplier under GCC Clause 41.2.5, the Purchaser shall pay the balance to the Supplier. The Purchaser and the Supplier shall agree, in writing, on the computation described above and the manner in which any sums shall be paid. 76 Section IV. General Conditions of Contract 41.3 Termination by Supplier 41.3.1 If: (a) the Purchaser has failed to pay the Supplier any sum due under the Contract within the specified period, has failed to approve any invoice or supporting documents without just cause pursuant to the SCC, or commits a substantial breach of the Contract, the Supplier may give a notice to the Purchaser that requires payment of such sum, with interest on this sum as stipulated in GCC Clause 12.3, requires approval of such invoice or supporting documents, or specifies the breach and requires the Purchaser to remedy the same, as the case may be. If the Purchaser fails to pay such sum together with such interest, fails to approve such invoice or supporting documents or give its reasons for withholding such approval, fails to remedy the breach or take steps to remedy the breach within fourteen (14) days after receipt of the Supplier’s notice; or (b) the Supplier is unable to carry out any of its obligations under the Contract for any reason attributable to the Purchaser, including but not limited to the Purchaser’s failure to provide possession of or access to the site or other areas or failure to obtain any governmental permit necessary for the execution and/or completion of the System; then the Supplier may give a notice to the Purchaser of such events, and if the Purchaser has failed to pay the outstanding sum, to approve the invoice or supporting documents, to give its reasons for withholding such approval, or to remedy the breach within twenty-eight (28) days of such notice, or if the Supplier is still unable to carry out any of its obligations under the Contract for any reason attributable to the Purchaser within twenty-eight (28) days of the said notice, the Supplier may by a further notice to the Purchaser referring to this GCC Clause 41.3.1, forthwith terminate the Contract. 41.3.2 The Supplier may terminate the Contract immediately by giving a notice to the Purchaser to that effect, referring to this GCC Clause 41.3.2, if Section IV. General Conditions of Contract 77 the Purchaser becomes bankrupt or insolvent, has a receiving order issued against it, compounds with its creditors, or, being a corporation, if a resolution is passed or order is made for its winding up (other than a voluntary liquidation for the purposes of amalgamation or reconstruction), a receiver is appointed over any part of its undertaking or assets, or if the Purchaser takes or suffers any other analogous action in consequence of debt. 41.3.3 If the Contract is terminated under GCC Clauses 41.3.1 or 41.3.2, then the Supplier shall immediately: (a) cease all further work, except for such work as may be necessary for the purpose of protecting that part of the System already executed, or any work required to leave the site in a clean and safe condition; (b) terminate all subcontracts, except those to be assigned to the Purchaser pursuant to Clause 41.3.3 (d) (ii); (c) remove all Supplier’s Equipment from the site and repatriate the Supplier’s and its Subcontractor’s personnel from the site. (d) In addition, the Supplier, subject to the payment specified in GCC Clause 41.3.4, shall: (i) deliver to the Purchaser the parts of the System executed by the Supplier up to the date of termination; (ii) to the extent legally possible, assign to the Purchaser all right, title, and benefit of the Supplier to the System, or Subsystems, as of the date of termination, and, as may be required by the Purchaser, in any subcontracts concluded between the Supplier and its Subcontractors; (iii) to the extent legally possible, deliver to the Purchaser all drawings, specifications, and other documents prepared by the Supplier or its Subcontractors as of the date of termination in connection with the System. 78 Section IV. General Conditions of Contract 41.3.4 If the Contract is terminated under GCC Clauses 41.3.1 or 41.3.2, the Purchaser shall pay to the Supplier all payments specified in GCC Clause 41.1.3, and reasonable compensation for all loss, except for loss of profit, or damage sustained by the Supplier arising out of, in connection with, or in consequence of such termination. 41.3.5 Termination by the Supplier pursuant to this GCC Clause 41.3 is without prejudice to any other rights or remedies of the Supplier that may be exercised in lieu of or in addition to rights conferred by GCC Clause 41.3. 41.4 In this GCC Clause 41, the expression “portion of the System executed” shall include all work executed, Services provided, and all Information Technologies, or other Goods acquired (or subject to a legally binding obligation to purchase) by the Supplier and used or intended to be used for the purpose of the System, up to and including the date of termination. 41.5 In this GCC Clause 41, in calculating any monies due from the Purchaser to the Supplier, account shall be taken of any sum previously paid by the Purchaser to the Supplier under the Contract, including any advance payment paid pursuant to the SCC. 42. Assignment 42.l Neither the Purchaser nor the Supplier shall, without the express prior written consent of the other, assign to any third party the Contract or any part thereof, or any right, benefit, obligation, or interest therein or thereunder, except that the Supplier shall be entitled to assign either absolutely or by way of charge any monies due and payable to it or that may become due and payable to it under the Contract. Section V. Special Conditions of Contract 79 SECTION V. SPECIAL CONDITIONS OF CONTRACT (SCC) Table of Clauses A. Contract and Interpretation .......................................................................................... 81 1. 2. 3. 4. 5. 6. Definitions (GCC Clause 1) ..................................................................................... 81 Contract Documents (GCC Clause 2) ...................................................................... 81 Interpretation (GCC Clause 3) ................................................................................. 81 Notices (GCC Clause 4)........................................................................................... 82 Governing Law (GCC Clause 5).............................................................................. 82 Settlement of Disputes (GCC Clause 6) .................................................................. 82 B. Subject Matter of Contract ............................................................................................ 83 7. 8. 9. 10. Scope of the System (GCC Clause 7) ...................................................................... 83 Time for Commencement and Operational Acceptance (GCC Clause 8) ............... 83 Supplier’s Responsibilities (GCC Clause 9) ............................................................ 83 Purchaser’s Responsibilities (GCC Clause 10)........................................................ 83 C. Payment............................................................................................................................ 84 11. 12. 13. 14. Contract Price (GCC Clause 11) .............................................................................. 84 Terms of Payment (GCC Clause 12) ....................................................................... 84 Securities (GCC Clause 13) ..................................................................................... 85 Taxes and Duties (GCC Clause 14) ......................................................................... 85 D. Intellectual Property ....................................................................................................... 85 15. 16. 17. Copyright (GCC Clause 15)..................................................................................... 85 Software License Agreements (GCC Clause 16)..................................................... 86 Confidential Information (GCC Clause 17) ............................................................. 87 E. Supply, Installation, Testing, Commissioning, and Acceptance of the System ......... 87 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. Representatives (GCC Clause 18) ........................................................................... 87 Project Plan (GCC Clause 19) ................................................................................. 87 Subcontracting (GCC Clause 20)............................................................................. 89 Design and Engineering (GCC Clause 21) .............................................................. 89 Procurement, Delivery, and Transport (GCC Clause 22) ........................................ 89 Product Upgrades (GCC Clause 23) ......................... Error! Bookmark not defined. Implementation, Installation, and Other Services (GCC Clause 24) ....................... 90 Inspections and Tests (GCC Clause 25) .................................................................. 90 Installation of the System (GCC Clause 26) ............................................................ 90 Commissioning and Operational Acceptance (GCC Clause 27) ............................. 90 F. Guarantees and Liabilities .............................................................................................. 90 28. 29. Operational Acceptance Time Guarantee (GCC Clause 28) ................................... 90 Defect Liability (GCC Clause 29) ........................................................................... 91 80 Section VI. Technical Requirements 30. 31. 32. 33. Functional Guarantees (GCC Clause 30) ................................................................. 91 Intellectual Property Rights Warranty (GCC Clause 31) ......................................... 91 Intellectual Property Rights Indemnity (GCC Clause 32) ........................................ 91 Limitation of Liability (GCC Clause 33) ................................................................. 91 G. Risk Distribution ............................................................................................................. 92 34. 35. 36. 37. 38. Transfer of Ownership (GCC Clause 34) ................................................................. 92 Care of the System (GCC Clause 35) ....................................................................... 92 Loss of or Damage to Property; Accident or Injury to Workers; Indemnification (GCC Clause 36) ................................................................................................................. 92 Insurances (GCC Clause 37) .................................................................................... 92 Force Majeure (GCC Clause 38) .............................................................................. 92 H. Change in Contract Elements......................................................................................... 93 39. 40. 41. 42. Changes to the System (GCC Clause 39) ................................................................. 93 Extension of Time for Achieving Operational Acceptance (GCC Clause 40) ......... 93 Termination (GCC Clause 41) .................................................................................. 93 Assignment (GCC Clause 42) .................................................................................. 93 Section V. Special Conditions of Contract 81 Special Conditions of Contract The following Special Conditions of Contract (SCC) shall supplement or amend the General Conditions of Contract (GCC). Whenever there is a conflict, the provisions of the SCC shall prevail over those in the General Conditions of Contract. For the purposes of clarity, any referenced GCC clause numbers are indicated in the left column of the SCC. A. CONTRACT AND INTERPRETATION 1. Definitions (GCC Clause 1) GCC 1.1 (a) (ix) The applicable edition of the Procurement Guidelines is dated: May 2004, Revised Oct 2006 and May 2010. GCC 1.1 (b) (i) The Purchaser is: Ministry of Healthcare and Social Development of the Republic of Kazakhstan. GCC 1.1 (b) (ii) The Project Manager is: Tsoy Aleksey Vladimirovich, Vice Minister of Healthcare and Social Development of the Republic of Kazakhstan GCC 1.1 (e) (i) The Purchaser’s Country is: Republic of Kazakhstan. GCC 1.1 (e) (iii) The Project Site(s) is/are: as specified in the List of Project Sites in the Technical Requirements Section. GCC 1.1 (e) (x) The Contract shall continue in force until the Information System and all the Services have been provided unless the Contract is terminated earlier in accordance with the terms set out in the Contract. GCC 1.1. (e) (xii) The Post-Warranty Services Period is 0, starting with the completion of the Warranty Period. 2. GCC 2 Contract Documents (GCC Clause 2) There are no Special Conditions of Contract applicable to GCC Clause 2. 3. GCC 3.1.1 Interpretation (GCC Clause 3) The Contract's governing language is English. If the contract is awarded to the firm of Purchaser’s country, basing on bidders consent the Purchaser can conclude the contract in Russian. In this case the Purchaser shall furnish English version of the contract to 82 Section VI. Technical Requirements the Bank. 4. GCC 4.3 Notices (GCC Clause 4) Address of the Contract Manager: 010000, Astana, the Republic of Kazakhstan, Orynbor Str 8, 5-6th entrances, office 1128 , tel. + 7 (7172) 742906, fax: + 7172 743608, e-mail. sh.zhumabaeva@mzsr.gov.kz with copy to: 010000, Kazakhstan, Astana city, Imanov str 19, office 504, tel. + 7172 787 235, fax. + 7172 787 247, e-mail: kazhealth.procurement@gmail.com 5. GCC 5.1 The Contract shall be interpreted in accordance with laws of the Republic of Kazakhstan 6. GCC 6.1.4 GCC 6.2.3 Governing Law (GCC Clause 5) Settlement of Disputes (GCC Clause 6) International non-profit association "European Arbitration Chamber" Belgium, Brussels, Avenue Louise 146 Tel.\Fax +38 044-581-30-77 / 55 secretary@chea-taic.be The rules of procedure for arbitration proceedings are: (a) if the Supplier is foreign (including a Joint Venture when at least one partner is foreign): Any dispute, controversy or claim arising out of or relating to this Contract, or breach, termination or invalidity thereof, shall be settled by arbitration in accordance with the UNCITRAL Arbitration Rules as at present in force. The place of arbitration shall not be in the Purchaser’s or Supplier’s country; (b) if the Supplier is a national of the Purchaser’s country: Any dispute between the Purchaser and a Supplier who is a national of the Purchaser’s country arising in connection with the present Contract shall be referred to adjudication or arbitration in accordance with the laws of the Purchaser’s country. Section V. Special Conditions of Contract 83 B. SUBJECT MATTER OF CONTRACT 7. GCC 7.3 Scope of the System (GCC Clause 7) No recurrent costs. At the same time, the Supplier shall before entering into the Contract to provide a letter of guarantee that, if necessary, the Purchaser may hire the Supplier for provision of services in the post-warranty period at the rates specified in the bid. 8. Time for Commencement and Operational Acceptance (GCC Clause 8) GCC 8.1 The Supplier shall commence work on the System within: 15 days from the Effective Date of the Contract. GCC 8.2 Operational Acceptance will occur on or before: Operational Acceptance date consistent with the Implementation Schedule in the Technical Requirements Section. 9. GCC 9.9 Supplier’s Responsibilities (GCC Clause 9) The Supplier shall have the following additional responsibilities: - Purchase and provision of licenses database management systems used in the proposed decision. - Purchase and provision of licenses for all third-party information systems and applications. - Provide technical support and warranty for 3 years. - If annual license is required for any part, the cost of these licenses for the first 3 years should be scheduled in the cost of technical support. - Training of Purchaser’s staff on how to use and configure all components, applications, services, solutions. 10. GCC 10.12 Purchaser’s Responsibilities (GCC Clause 10) The Purchaser shall have the following additional responsibilities: none. 84 Section VI. Technical Requirements C. PAYMENT 11. GCC 11.2 (b) Adjustments to the Contract Price shall be as follows: none 12. GCC 12.1 Contract Price (GCC Clause 11) Terms of Payment (GCC Clause 12) Subject to the provisions of GCC Clause 12 (Terms of Payment), the Purchaser shall pay the Contract Price to the Supplier according to the categories and in the manner specified below. Only the categories Advance Payment and Complete System Integration relate to the entire Contract Price. In other payment categories, the term "total Contract Price" means the total cost of goods or services under the specific payment category as defined in the “Price Schedule Forms”. Within each such category, the Contract Implementation Schedule may trigger pro-rata payments for the portion of the total Contract Price for the category corresponding to the goods or services actually Delivered, Installed, or Operationally Accepted, at unit prices and in the currencies specified in the Price Schedules of the Contract Agreement. (a) Advance Payment Ten percent (10%) of the entire Contract Price shall be paid against receipt of a claim accompanied by the Advance Payment Security specified in GCC Clause 13.2. (b) Information technology, materials and other goods, including customized software products and customized materials: forty percent (40%) of pro-rata Contract Price is paid for this category upon delivery; thirty percent (30%) of pro-rata Contract Price is paid for this category upon installation; (c) Services: seventy percent (70%) of pro-rata Contract Price for provided services is paid against System installation. the list of services is set in R12 of Section VI “Technical Requirements” for lots # 1-9 and R13 of Section VI “Technical Requirements” for lot # 10. (d) Complete System Integration twentypercent (20%) of the entire Contract Price (without accounting all recurrent costs) shall be paid as a final tranche against Section V. Special Conditions of Contract 85 operational acceptance of the system as Entire Integrated System GCC 12.3 The Purchaser shall pay to the Supplier interest on the delayed payments at a rate of: 0.01 % of delayed amount per day for every day of delay GCC 12.4 The Supplier will invoice the Purchaser in the currency used in the Contract Agreement and the Price Schedules it refers to. 13. Securities (GCC Clause 13) GCC 13.2.1 The Supplier shall provide within twenty-eight (28) days of the notification of Contract award an Advance Payment Security in the amount and currency of the Advance Payment specified in SCC for GCC Clause 12.1 above. GCC 13.2.2 The reduction in value of the Advance Payment Security are calculated as follows: P*a/(100-a), where “P” is the sum of all payments effected so far to the Supplier (excluding the Advance Payment), and “a” is the Advance Payment expressed as a percentage of the Contract Price pursuant to the SCC for GCC 12.1. GCC 13.3.1 The Performance Security shall be denominated in Contract’s currency for an amount equal to 10 (ten) percent of the Contract Price. GCC 13.3.4 During the Warranty Period (i.e., after Operational Acceptance of the System), the Performance Security shall be reduced to 5 (five) percent of the Contract Price. 14. GCC 14 Taxes and Duties (GCC Clause 14) There are no Special Conditions of Contract applicable to GCC Clause 14. D. INTELLECTUAL PROPERTY 15. GCC 15.3 Copyright (GCC Clause 15) The Purchaser may assign, license, or otherwise voluntarily transfer its contractual rights to use the Standard Software or elements of the 86 Section VI. Technical Requirements Standard Software, without the Supplier’s prior written consent, under the following circumstances: to the Purchaser’s structural units (oblast and rayon health facilities) and all successors in case of any reorganizations of the Purchaser in accordance with legislative acts of the Purchaser’s Country. GCC 15.4 The Purchaser’s and Supplier’s rights and obligations with respect to Custom materials or their components are as follows: none GCC 15.5 No software escrow contract is required for the execution of the Contract 16. GCC 16.1 (a) (iii) Software License Agreements (GCC Clause 16) The Standard Software license shall be valid: throughout the territory of the Purchaser’s Country GCC 16.1 (a) (iv) Use of the software shall be subject to the following additional restrictions: none GCC 16.1 (b) (vi) The Software license shall permit the Software to be disclosed to and reproduced for use (including a valid sublicense) by support service suppliers or their subcontractors, exclusively for such suppliers or subcontractors in the performance of their support service contracts as well as the playback of software products for use by specified persons (as well as on the basis of the current sublicense), subject to the same restrictions set forth in this Contract. GCC 16.1 (b) (vii) In addition to the persons specified in GCC Clause 16.1 (b) (vi), the Software data may be disclosed to, and reproduced for use by for those involved in the development of UHIMS, subject to the same restrictions as are set forth in this Contract. GCC 16.2 The Supplier’s right to audit the Standard Software will be subject to the following terms: if on-site audits are acceptable, the Purchaser may specify conditions on the duration and number of audits per year; the hours or days during which audits may be conducted; the categories of software subject to audit; the procedures for access to Purchaser’s hardware or software; the number and affiliation of individual auditors; the timing and terms of advance notice; the indemnity by Supplier for losses, liabilities, and costs incurred by the Purchaser as a direct result of the audit; etc. Section V. Special Conditions of Contract 17. 87 Confidential Information (GCC Clause 17) GCC 17.1 There are no modifications to the confidentiality terms expressed in GCC Clause 17.1 GCC 17.7 The provisions of this GCC Clause 17 shall survive the termination, for whatever reason, of the Contract for the period specified in the GCC. E. SUPPLY, INSTALLATION, TESTING, COMMISSIONING, AND ACCEPTANCE OF THE SYSTEM 18. Representatives (GCC Clause 18) GCC 18.1 The Purchaser’s Contract Manager shall have the following additional powers and / or limitations to his or her authority to represent the Purchaser in matters relating to the Contract: no additional powers or limitations. GCC 18.2.2 The Supplier’s Representative shall have the following additional powers and / or limitations to his or her authority to represent the Supplier in matters relating to the Contract: no additional powers or limitations. 19. GCC 19.1 Project Plan (GCC Clause 19) Chapters in the Project Plan shall address the following subjects: (а) Plan of the Project management organization containing described roles and responsibilities of personnel of the Supplier, the names and the number of working hours (person-months), and what actions of management unit and staff of a health facility are necessary for successful implementation of the Project; (b) System (s) implementation Plan in a health facility that would prove that all Purchaser’s requirements for delivered Systems are met, and this is confirmed by facility beneficiary, and that the systems are certified in accordance with the Purchaser’s requirements (c) Methodology and Plan for development / configuration, testing, installation, trial operation and certification of Systems supplied (d) Methodology and User training Plan specifying the methods and programs of study, the number of hours, training venue and transfer of technology for both users and managers of 88 Section VI. Technical Requirements the enterprise. (e) Data migration Plan (if such data is available) (f) Response plans for warranty service, and provision of professional services for piloting: what is the response time to eliminate errors and queries, to indicate where the staff of the supplier will be, how many people will be involved, and on what schedule. (g) Methodology and support plan for all included software and component both during implementation and during the trial operation GCC 19.2 Within thirty (30) days from the Effective Date of the Contract, the Supplier shall present a Project Plan to the Purchaser. The Purchaser shall, within fourteen (14) days of receipt of the Project Plan, notify the Supplier of any respects in which it considers that the Project Plan does not adequately ensure that the proposed program of work, proposed methods, and/or proposed Information Technologies will satisfy the Technical Requirements and/or the SCC (in this Clause 19.2 called “non-conformities” below). The Supplier shall, within: seven (7) days of receipt of such notification, correct the Project Plan and resubmit to the Purchaser. The Purchaser shall, within seven (7) days of resubmission of the Project Plan, notify the Supplier of any remaining non-conformities. This procedure shall be repeated as necessary until the Project Plan is free from non-conformities. When the Project Plan is free from non-conformities, the Purchaser shall provide confirmation in writing to the Supplier. This approved Project Plan (“the Agreed and Finalized Project Plan”) shall be contractually binding on the Purchaser and the Supplier. GCC 19.5 The Supplier shall submit to the Purchaser the following progress reports, summarizing: (a) quarterly quarterly progress reports, summarizing: (i) results accomplished during the prior period; (ii) cumulative deviations to date from schedule of progress milestones as specified in the Agreed and Finalized Project Plan; (iii) corrective actions to be taken to return to planned schedule of progress; proposed revisions to planned schedule; (iv) other issues and outstanding problems; proposed actions to be taken; (v) resources that the Supplier expects to be provided by the Purchaser and/or actions to be taken by the Section V. Special Conditions of Contract 89 Purchaser in the next reporting period; (vi) other issues or potential problems the Supplier foresees that could impact on project progress and/or effectiveness. (b) reports on training activities and outcomes (assessment) (c) Implementation Completion Report (d) monthly magazines with registration of requests on outcomes of challenge solution (e) report on outcomes of testing and certification 20. GCC 20 Subcontracting (GCC Clause 20) “There are no Special Conditions of Contract applicable to GCC Clause 20.” 21. Design and Engineering (GCC Clause 21) GCC 21.2 The Contract shall be executed in accordance with the edition or the revised version of all referenced codes and standards current at the date 60 (sixty) days before bid submission. GCC 21.3.1 The Supplier shall prepare and furnish to the Project Manager the following documents for which the Supplier must obtain the Project Manager’s approval before proceeding with work on the System or any Subsystem covered by the documents: none 22. Procurement, Delivery, and Transport (GCC Clause 22) GCC 22.4.3 The Supplier shall be free to use transportation through carriers registered in any eligible country and shall obtain insurance from any eligible source country. GCC 22.5 The Supplier shall provide the Purchaser with documents as specified in the GCC as well as the following documents: Equipment Quantity Evaluation Certificate signed by Contract parties. 90 Section VI. Technical Requirements 24. Implementation, Installation, and Other Services (GCC Clause 24) GCC 24 There are no Special Conditions of Contract applicable to GCC Clause 24. 25. GCC 25 Inspections and Tests (GCC Clause 25) There are no Special Conditions of Contract applicable to GCC Clause 25. 26. GCC 26 Installation of the System (GCC Clause 26) Necessary and reasonable provisions: none 27. GCC 27.2.1 Commissioning and Operational Acceptance (GCC Clause 27) Operational Acceptance Testing shall be conducted in accordance with the following: pre-operational testing of System and its sub-systems on sites shall be done in line with the section of Technical Requirements: R14 – for lots №1-9 and R15 – for lot №10. GCC 27.2.2 If the Operational Acceptance Test of the System, or Subsystem(s), cannot be successfully completed within ninety (90) days from the date of Installation or any other period agreed upon by the Purchaser and the Supplier, then GCC Clause 27.3.5 (a) or (b) shall apply, as the circumstances may dictate. F. GUARANTEES AND LIABILITIES 28. GCC 28.2 Operational Acceptance Time Guarantee (GCC Clause 28) Liquidated damages shall be assessed at 1 percent per week. The maximum liquidated damages are 10 percent of the Contract Price, or relevant part of the Contract Price as defined in the price schedule if the liquidated damages apply to an activity/component. Terms of Delivery and Installation of equipment are specified in Section VI «Technical Requirements», in Implementation Schedule table. Section V. Special Conditions of Contract GCC 28.3 91 Liquidated damages shall be assessed with respect to the stage of Operational acceptance basing on provisions set in Section VI, Chapter D. 29. Defect Liability (GCC Clause 29) GCC 29.1 For Software, exceptions or limitations to the Supplier’s warranty obligations shall be as follows: None. GCC 29.3 (iii) The Supplier warrants that the following items have been released to the market for the following specific minimum time periods: “No specific minimum time requirements are established for this Contract other than that the Information Technologies must have been previously released to the market” GCC 29.4 The Warranty Period (N) shall begin from the date of Operational Acceptance of the System or Subsystem and extend for 3 years in accordance with R12.4. and R13.4 respectively GCC 29.10 During the Warranty Period, the Supplier must commence the work necessary to remedy defects or damage within 15 (working) days of notification. 30. GCC 30 There are no Special Conditions of Contract applicable to GCC Clause 30. 31. GCC 31 Intellectual Property Rights Warranty (GCC Clause 31) There are no Special Conditions of Contract applicable to GCC Clause 31. 32. GCC 32 Intellectual Property Rights Indemnity (GCC Clause 32) There are no Special Conditions of Contract applicable to GCC Clause 32. 33. GCC 33 Functional Guarantees (GCC Clause 30) Limitation of Liability (GCC Clause 33) There are no Special Conditions of Contract applicable to GCC Clause 33. 92 Section VI. Technical Requirements G. RISK DISTRIBUTION 34. GCC 34 Transfer of Ownership (GCC Clause 34) There are no Special Conditions of Contract applicable to GCC Clause 34. 35. GCC 35 36. Care of the System (GCC Clause 35) There are no Special Conditions of Contract applicable to GCC Clause 35. Loss of or Damage to Property; Accident or Injury to Workers; Indemnification (GCC Clause 36) GCC 36 There are no Special Conditions of Contract applicable to GCC Clause 36. 37. GCC 37.1 (c) GCC 37.1 (e) The Supplier shall obtain Third-Party Liability Insurance in the amount of 150 000 USD with deductible limits of no more than 10 000 USD. The insured Parties shall be staff of the Ministry of Health and Social Development of the Republic of Kazakhstan, local MHSD objects, Health Informatization Center, sub-contractors of enlisted above agencies and all Parties of Consultants and Suppliers. The Insurance shall cover the period from the beginning date, in terms of the date of Contract Effectiveness until expiration date. There are no Special Conditions of Contract applicable to GCC Clause 37.1 (e). 38. GCC 38 Insurances (GCC Clause 37) Force Majeure (GCC Clause 38) There are no Special Conditions of Contract applicable to GCC Clause 38. Section V. Special Conditions of Contract 93 H. CHANGE IN CONTRACT ELEMENTS 39. GCC 39 40. GCC 40 Changes to the System (GCC Clause 39) There are no Special Conditions of Contract applicable to GCC Clause 39. Extension of Time for Achieving Operational Acceptance (GCC Clause 40) There are no Special Conditions of Contract applicable to GCC Clause 40. 41. GCC 41 There are no Special Conditions of Contract applicable to GCC Clause 41. 42. GCC 42 Termination (GCC Clause 41) Assignment (GCC Clause 42) There are no Special Conditions of Contract applicable to GCC Clause 42. Annex to Section V. Special Conditions of Contract Clause GCC 41.2.1: The provisions in clause GCC 41.2.1 (c) of Section IV. General Conditions of Contract are replaced with the following: 94 Fraud Corruption Section VI. Technical Requirements and 41.2.1 (c) If the Purchaser determines that the Supplier and/or any of its personnel, or its agents, or its Subcontractors, consultants, service providers, suppliers and/or their employees has engaged in corrupt, fraudulent, collusive, coercive or obstructive practices, in competing for or in executing the Contract, then the Purchaser may, after giving 14 days notice to the Supplier, terminate the Supplier's employment under the Contract and cancel the contract, and the provisions of GCC Clause 41.1 shall apply as if such expulsion had been made under GCC Sub-Clause 41.1.2. (a) For the purposes of this Sub-Clause: (i) “corrupt practice” is the offering, giving, receiving or soliciting, directly or indirectly, of anything of value to influence improperly the actions of another party1; (ii) “fraudulent practice” is any act or omission, including a misrepresentation, that knowingly or recklessly misleads, or attempts to mislead, a party to obtain a financial or other benefit or to avoid an obligation2; (iii) “collusive practice” is an arrangement between two or more parties3 designed to achieve an improper purpose, including to influence improperly the actions of another party; (iv) “coercive practice” is impairing or harming, or threatening to impair or harm, directly or indirectly, any party or the property of the party to influence improperly the actions of a party4; (v) “obstructive practice” is (aa) deliberately destroying, falsifying, altering or concealing of evidence material to the investigation or making false statements to 1 “Another party” refers to a public official acting in relation to the procurement process or contract execution. In this context, “public official” includes World Bank staff and employees of other organizations taking or reviewing procurement decisions. 2 “Party” refers to a public official; the terms “benefit” and “obligation” relate to the procurement process or contract execution; and the “act or omission” is intended to influence the procurement process or contract execution. 3 “Parties” refers to participants in the procurement process (including public officials) attempting to establish bid prices at artificial, non competitive levels. “Party” refers to a participant in the procurement process or contract execution. 4 Section V. Special Conditions of Contract 95 investigators in order to materially impede a Bank investigation into allegations of a corrupt, fraudulent, coercive or collusive practice; and/or threatening, harassing or intimidating any party to prevent it from disclosing its knowledge of matters relevant to the investigation or from pursuing the investigation; or (bb) acts intended to materially impede the exercise of the Bank’s inspection and audit rights provided for under GCC Clause 9.8. Should any employee of the Supplier be determined to have engaged in corrupt, fraudulent, collusive, coercive, or obstructive practice during the purchase of the Goods, then that employee shall be removed. Clause GCC 9.8: The provisions in clause GCC 9.8 of Section IV. General Conditions of Contract are replaced with the following: 9.8 The Supplier shall permit, and shall cause its Subcontractors and Inspections and 9.8 Audit by the consultants to permit, the Bank and/or persons appointed by the Bank to inspect the Supplier’s offices and all accounts and records relating to the Bank performance of the Contract and the submission of the bid, and to have such accounts and records audited by auditors appointed by the Bank if requested by the Bank. The Supplier’s and its Subcontractors and consultants’ attention is drawn to GCC Clause 41.2.1 (c), which provides, inter alia, that acts intended to materially impede the exercise of the Bank’s inspection and audit rights provided for under this GCC Sub-Clause 9.8 constitute a prohibited practice subject to contract termination (as well as to a determination of ineligibility pursuant to the Bank’s prevailing sanctions procedures). 96 Section VI. Technical Requirements SECTION VI. TECHNICAL REQUIREMENTS (INCLUDING IMPLEMENTATION SCHEDULE) - FOR LOTS NO. 1-9 A. Background 0.1 The Purchaser 0.1.1 The Implementing Agency of this contract is the Ministry of Healthcare and Social Development of the Republic of Kazakhstan. The Ministry of Healthcare and Social Development of the Republic of Kazakhstan (MHSD) is a state agency of the Republic of Kazakhstan implementing regulation in healthcare, medical and pharmaceutical science and education, sanitary and epidemiological welfare of population, turnover of medicines, care quality control. MHSD acts according to the Constitution of the Republic of Kazakhstan and its Laws, Acts of the President and the Government of Kazakhstan (GOK), other regulatory acts as well as Regulation on the MHSD of the Republic of Kazakhstan ratified by the Decree of the GOK dated September 23, 2014, No. 1005. 0.1.2 Stakeholders of the project implemented as the result of this contract are as follows: - MHSD defines e-health strategy and provides the Supplier with required regulations and official documents for successful Contract implementation and is to adjust legal background if required. - Health facilities in Kazakhstan as beneficiaries of the Contract shall apply Contract outcomes in practice. Detailed information on a certain health facility shall be presented to the Bidders upon request. 0.2 Objectives of the Purchaser 0.2.1 MHSD general objective in e-health area is as follows: E-health implementation shall provide an option of getting automated up-to-date, accurate and complete information to ensure safe, fair, high quality, reliable patient need oriented health system. It will be achieved through provision of health facilities and MHSD departments with secure and high-speed access to completely interoperable systems of e-healthcare, based on paperless technologies using the unified system of the Electronic Health Records (EHR). National e-healthcare repository will be created on a central level and contain: 1) EHR as a central component promoting integration of IS in health facilities. 2) Data repository with accumulated high-quality statistic data, analytical and financial data. Section VI. Technical requirements 97 “Comprehensive Health Information Systems for out-patient clinics, hospitals and mixed health facilities” (the Systems) purchased under the Contract shall greatly contribute to this vision. The Systems shall automate clinical and non-clinical processes undergoing in various health facilities, namely in policlinics, hospitals and mixed health facilities. 0.2.2 Objectives of Kazakhstan e-health. Based on priority needs of Kazakhstan health system, defined in the State Health Development Program "Salamatty Kazakhstan 2011–2015" and priorities defined in health section of "Kazakhstan Strategy 2050", for e-health the following objectives are defined: 1. Support of clinical (medical) decision-making. 2. Reduction of medical mistakes. 3. Increasing availability and improving continuity of health services; 4. Improvement of health services quality; 5. Improving quality and efficiency of taken financial, managerial, politic decisions; 6. Ensuring environment for continuous professional growth in health area; 7. Improving public access to information about health and management of their privacy; 8. Increase of profitability and efficiency of investments and operational expenditures related to healthcare. 0.2.3 The System purchased within this Contract shall allow: - Increasing readiness and accuracy of reports submitted to health departments; Reduce ineffective work time devoted to documentation (making discharge lists, filling in registers, reports forming); Increase quality of taken managerial decisions based on evidence as well as their monitoring; Increase quality of care due to informational support to medical actions and as a result reducing the number of professional errors; Improving links between care phases through e-referrals, prescriptions, notifications for continuous and qualitative care achieving; Savings in clinic-diagnostic studies due to reduced number of repeated ad irrational actions; Saving costs for lab and radiological studies through effective use of expensive equipment; Saving costs for drugs and medical devices through rational use of drugs, strict control over their dissemination and planning of procurement procedures; Improving performance of health facilities (increasing throughput capacity, care waiting time decrease as well as cure time, complications and death cases); - Reducing forfeit amounts imposed in case of defects revealed during care provision; - Control over targeted use of health resources; 98 Section VI. Technical Requirements Increasing efficiency in getting outcomes of studies from labs and other diagnostic departments; - Removing double entry of similar information; Better control over the use of drugs and reducing side effect and drug incompatibility cases. Patient safety assurance through transparency of diagnostic processes and prescribed treatment; as well as confidentiality of patient data. 0.2.4. Potential Beneficiaries from the System. Potential direct beneficiaries are: Health professionals – doctors and nurses using the System for patient data keeping during clinical decisions (context aid as clinical guidelines and diagnostic and treatment protocols and etc.); - Health managers using data collected out of various sources and objects; MHSD experts using data for political decision making and regulatory framework amending basing on evidence as well as adequate health service funding; All IS in e-health environment using EHR, data, classifiers, services within SOA architecture; - Third-party IS using data stored in e-health applications; Potential indirect beneficiaries are: - All Kazakhstan citizens served by health specialists using the System; - Researchers that use data on care and prophylactic process received through the System. Potential number of work places by Modules is set in Annex 2. 0.2.5. Information systems of the MHSD The following systems belong to IS of the MHSD: 1. IS «Hospitalization Bureau» 2. IS «Additional component to PHC tariff» 3. IS «Drug provision» 4. IS «Register of pregnant and fertile age women» 5. IS «Health service quality management system» 6. IS «Medical equipment management system» 7. IS «Resource management system» 8. IS «E-register of dispensary patients» 9. IS «E-register of cancer patients» Section VI. Technical requirements 99 10. IS «E-register of hospital patients» 11. IS «Out-patient care» 12. IS «Register of attached population» 13. IS «Register of patients with renal failure» 14. IS «Register of patients with mental diseases» 15. IS «Register of narcological patients» 16. Drug provision management system 17. AIS «Policlinics» 18. IS «National Register of TB patients» 19. IS «National Register «Diabetes»» 20. Health Informatization and Interoperability Platform Interaction with IS of MHSD (above indicated IS in para.1-19) shall be done using service of Health Informatization and Interoperability Platform. 0.3 Acronyms used in the Technical Specifications Term Meaning HB Hospitalization Bureau DB Data Base HIV Human immunodeficiency virus MCB Medical Consultative Board Tertiary care Tertiary care ACPCT Additional component of per capita tariff RCSA Healthy life style Register of civil status acts Healthy life style IIN ICT Individual Identification Number Information and Communication Technology Medical devices Medical devices IS MHSD RK IS Information Systems of the Ministry of Healthcare and Social Development of the Republic of Kazakhstan Information System Interoperability Feature or option of different systems to work together 100 Section VI. Technical Requirements Term Meaning CDS Consulting Diagnostic services LIS Lab Information System CPF Curative prevention facility Drugs Drugs MHSD Ministry of Healthcare and Social Development HIS Health Information Systems ICD INN International Classification of Disease International non-proprietary name of drugs MSE Medical and Social Expertise Side effect of drugs Side effect of drugs Platform PHC Health Informatization and Interoperability Platform Primary Health care RK Republic of Kazakhstan ADSP Average duration of stay of patient P4P Capitation Pay for performance Care subject Care subject CQMS Care quality management system Full name EMR Full name Electronic Medical Record EHR Electronic Health Record ERDP E-Register of Dispensary patients ERHP DS E-Register of Hospital patients Digital signature ADO.NET Technology ensuring access to data for applications based on Microsoft .NET. It is not a development of earlier technology ADO. ASP Active Server Page – a technology proposed by Microsoft 1996 BAM Business activity monitoring BP Business Process BPM Business Process Management bps Bits per second Section VI. Technical requirements Term 101 Meaning BRMS Business Rule Management System is an IS used for entry, maintenance and execution of business rules of the firm CDA Clinical Document Architecture CPU Central Processing Unit CRUD Create Read, Update, Delete operations CSS Cascading Style Sheets — a formal language of description of external view of the document written using markup language DICOM Digital Imaging and Communication in Medicine is a Sectoral standard for creation, storage, transmission and visualization of medical images and documents of examined patients DOM Document Object Model — is an interface independent from Platform and the language which allows the software and scripts to get access to the content of HTML, XHTML and XML-documents as well as to change the content, structure and arranging of such documents ESB Enterprise Service Bus FHIR Standard of electronic exchange of health information. Standard FHIR – is a new specification from HL7 based on advanced approaches in ehealth area which nevertheless accounts total accumulated experience (real needs, successful solutions and typical challenges) of defining and implementing standards HL7 v2, HL7 v3, CDA. (Fast Healthcare Interoperability Resources) GB Gigabyte GUI Graphical User Interface HC Healthcare Help Desk Maintenance which summarizes and covers a lot of services used by enterprises to help the users of technology products and services HL7 Standard of e-health data exchange, management and integration (Health Level 7) HTML Hypertext Markup Language IaaS Infrastructure as a Service ICPC International Classification in Primary Care IDE Integrated Development Environment IHE Integrating Healthcare Enterprise IP Internet Protocol 102 Section VI. Technical Requirements Term Meaning ISO International Standards Organization ITI IT Infrastructure JDBC Platform independent industrial standard of interaction of Javaapplications with various DBMS (Java Database Connectivity) KB Kilobyte LAN Local area network LDAP Lightweight Directory Access Protocol to the service of catalogues X.500 developed by IETF as a simplified version of designed ITU-T protocol DAP LOINC Universal standard for identification of medical and lab outcomes (Logical Observation Identifiers Names and Codes) MB Megabyte MDX the language for simple, effective access to multidimensional structures of data like the language SQL for relational data bases (MultiDimensional eXpressions Language) ODBC Program interface for access to data bases developed by Microsoft in cooperation with Simba Technologies basing on specifications Call Level Interface, which were developed by SQL Access Group, X/Open and Microsoft. (Open Database Connectivity) OLAP Data processing technology aimed at preparing summary data based on great massive of data structured according to multi-dimensional principal (Online Analytical Processing) OLTP Transactional system – processing of transactions in real time. A method of organizing a database in which the system works with small size transactions, but reaching a large flow, and thus the client requires a minimum of system response time (Online Transactional Processing) OWASP Open Web Application Security Project PaaS Platform as a Service PDQ Patient Demographic Query PIX Patient Identifier Cross-Reference (IHE profile) PKI Public Key Infrastructure PMI Patient Master Index RAM One of types of computer memory that allows simultaneous access to any cell by its address to read or write (Random Access memory) REST Representational State Transfer Section VI. Technical requirements Term 103 Meaning SaaS Software as a Service SAML Security Assertion Markup Language SDK Software development kit that enables software professionals to create applications for a certain software package, software, basic software development, hardware platform, computer system, video game consoles, operating systems and other platforms (Software Development Kit). SNOMED-CT Systematized Nomenclature Of Medicine Clinical Terms SOA Service-oriented architecture SOAP Protocol of exchange of structured messages in distributed computing environment (Simple Object Access Protocol) SQL Universal computer language used to create, modify and manage data in relational databases (Structured Query Language) SSL Cryptographic protocol that provides secure communication. It uses asymmetric cryptography to authenticate the key exchange, symmetric encryption for confidentiality (Secure Sockets Layer) SSO Single Sign On – is a technology, using which a user moves from one section of the portal to another without re-authentication TCP One of basic communication protocols, Internet data, for controlling the transfer of data in networks and subnetworks TCP / IP. It serves as the transport layer protocol in stack of TCP / IP protocols (Transmission Control Protocol) TCP/IP Set of protocols to control data exchange between computers with access to Internet (Transmission Control Protocol / Internet Protocol) TLS The level of Secure Sockets Layer - cryptographic protocols that provide a protected communications between nodes on the Internet (Transport Layer Security) UML Graphic description language for object modeling in the field of software development (Unified Modeling Layer) Unicode The standard of character encoding, which allows to introduce signs of almost all written languages (Unicode) URL standardized method of recording the address of the resource on the Internet (Uniform resource locator) VPN Generalized name of technologies to provide one or more network connections over a different network. (англ. Virtual Private Network) 104 Section VI. Technical Requirements Term Meaning WADL XML description for web applications operating according to HTTP protocol (as a rule, REST web services). It is positioned as the equivalent of WSDL for REST. WADL models recourses supplied by the server and their interaction (Web Application Description Language) WCAG Web Content Accessibility Guidelines WLAN Wireless LAN WS Web Service WSDL Web Services Description Language and their access based on XML XCA Cross-Community Access (profile IHE) XD-LAB Cross Enterprise Document Sharing of Lab Reports (profile IHE) XDS Cross-Enterprise Document Sharing (profile IHE) XDS-MS Cross Enterprise Document Sharing of Medical Summaries (profile IHE) XML Markup language recommended by Consortium of Internet (Extensible Markup Language) XPHR Exchange of Personal Health Records XSL Recommendations of consortium W3C describing the languages of transformation and visualization of XML-documents (Extensible Style sheet Language) B. BUSINESS FUNCTION AND PERFORMANCE REQUIREMENTS The aim of the Section is to define business requirements and functional requirements for the purchase of the System. 1.1 Business requirements to the System 1.1.1 Current situation in MHSD ICT area 1.1.1.1. MHSD policy in e-health area Government of Kazakhstan approved a new strategy "Concept for E-health Development for 2013-2020 years" which specifies key areas of focus for Kazakhstan e-health transformation. In compliance with this strategy, it is expected that transformation will be based on a new architecture, which has the following basic features: E-health will be based on collaboration framework consisting of such components as: common terminology and data glossaries; common classifiers and references aimed at creation of common information/semantic interoperability in e-health environment, etc.; Section VI. Technical requirements - - - 105 Generation of common indexes, used in entire e-healthcare environment: Main patient index, Index of healthcare professionals, Index of medical facilities, indexes of the other resources; Creation of unified detachable Electronic Health Records (EHR) system, which would be centralized and contain health records (electronic records) of all patients with an option of replication to local servers, if necessary, and assure collection, storage and use of lifelong information by this bringing to continuous medical service provision; Set-up computing infrastructure consisting of two Data Centers able to interchange each other automatically to provide high resilience; Install a background for possible use of cloud computing technology in future to automate computing services: Infrastructure as a Service (Infrastructure as a Service – IaaS), Platform as a Service (Platform as a Service – PaaS), Software as a Service (Software as a Service – SaaS); Operating based on service-oriented architecture (SOA) and provision of re-usage of existing system functionality, including links to e-government services; Integration of existing systems and web-applications (portals) on a new Health Informatization and Interoperability Platform and etc. New approaches to e-health systems generation shall address the following issues: - Information systems for e-health will not be developed only by funds from central budget, health facilities are to participate as they are to purchase IS and applications at national market; For interoperability ensuring, a set of interoperability requirements is to be developed (Book of IT rules for e-health) and all information systems shall be certified to comply to these rules; To develop local market, government shall provide special grants for development of IT sector of health facilities and define co-financing rules; The government will assess and monitor potential risks and make decisions on risk prevention (such as unsatisfactory traffic-carrying capacity, ICT aligning to health needs, support and provision of interoperability, etc.); MHSD shall accelerate the process of rules, standards and regulations design and approval to improve interaction between e-health participants; General architecture of National EHR system is demonstrated in Pic. 1 below. The System purchased under this Bidding is coded as CHIS (in pink color) in a yellow square in right lower part of Pic. 1. 106 Section VI. Technical Requirements Patient’s Personal Cabinet Personal health professional’s cabinet e-Government services BI and Analytical tools Classifiers and Nomenclatures Management Existing Information systems RAP OPC MSQMS RMS DPMS RPWFA ERHP ACPCT MEMS ERDP HB DIS Single data repository EHR Repository Analytical warehouse Master patient index, healthcare facilities index, healthcare professionals index Classifiers and nomenclatures e-Government Gate Integration bus ERCP NRD Integration bus External Information systems Health facility level modules (within this contract) District doctor Admission Meals Pharmacy Human Resources Hospital Doctor Reception Day-hospital Hospital administrator Profile specialist Procedures and manipulations Hospital nurse Diagnostic studies Admin Prophylactic exams Lab IS PACS (Picture Archiving and Communication System) Medical statistics of policlinic Head of Policlinic department Head of hospital department Medical Statistics for Hospital Legend Existing information systems Platform components e-Government Gate and services Health facility level modules Pic. 1.Architecture of purchased CHIS interlinks with national recourses of e-health. More details can be found in the document "Concept for E-health Development for 2013–2020 years", accessible on MHSD web-site. Section VI. Technical requirements 107 1.1.2 Principles for System design The following principles shall be applied in design, configuration and use of the System: Principle of Legality that presupposes design, use and maintenance of IS in line with national legal background and international standards; - Data Security Principle – System data entry only through checked authorized channels; Information Security Principle – assuring appropriate level of integrity, selectivity, accessibility and efficiency for data protection from loss, modification, destruction and unauthorized access; Data Confidentiality Principle – guaranty access to data only in line with national policy and international standards to confidentiality of personal data, access by patient consent, possibility to code saved data; Transparency - the System is a modular structure that shall use transparent / open standards in ICT area; Enlargement Principle – that means extension and improving the System by new options and improving current functionality; First Person Priority Principle/Unique Center – existence of high level official who has rights enough to make decisions and coordinate activities for System design, integration and application; Scalability Principle – permanent efficiency of applications and interlinks with growing data and patient scope; User Simplicity and Convenience – System functions and tools for targeted roles shall be based on visual instruments, ergonomic and intuitively clear. 1.1.3. Business requirements to the System Note 1. The following keywords (i.e., normative verbs) SHALL be used to convey conformance requirements. • SHALL – to indicate a mandatory requirement to be followed (implemented) in order to conform. Synonymous with ‘is REQUIRED to’. Another used synonym is MUST . • SHALL NOT –to indicate a prohibited action. Synonymous with ‘prohibited’. • SHOULD - to indicate an optional recommended action, one that is particularly suitable, without mentioning or excluding others. Synonymous with ‘is permitted and recommended’. • MAY- to indicate an optional, permissible action. Synonymous with ‘is permitted’. Note 2. In tables with business and functional requirements the following categories (types ) are used: M – means minimal mandatory requirement; delivered solution shall obligatory correspond to such requirement; full or partial lack of compliance to such requirement shall lead to rejection of Bid. 108 Section VI. Technical Requirements D – means desirable requirement; lack of compliance to such requirement shall not lead to Bid rejection, however, its correspondence allows to heighten Bid competitiveness. I – information to clear up other requirements. Reference to requirements in the text shall clearly differ from references to sections and parts: Reference to requirements shall clearly indicate the word «Requirement», «req.» or R, as R1.1 – reference to Requirement 1.1; References to sections shall be with prefix «Chapter», «Section» or р, as «p.1.1.1» indicates reference to Section 1.1.1 and is not a Requirement. Table below has list of business requirements to be followed by the System and related systems/services. 1.1.3.1. General business requirements R1 General business requirements R1.1 M Licensing mechanism for the System under this contract shall provide the right to use all modules and compounds in the concrete Health Facility for number of users sufficient for full scale functioning of a health facility (size of health facility could be evaluated basing on description in the Annex 2), for unlimited time, unlimited number of servers, and excluding any other possible limitations. It is not accepted annual license fees; the only cost for license is the initial license cost, which includes all costs. R1.2 M Within this Contract System interoperability shall be assured with national ehealth system according to requirement R 7. General scheme of interaction with national e-health system is set in the Pic. 1 R1.3 M The System shall correspond to general architecture of Comprehensive Health Information System set in Pic. 2 R1.4 M System modules and/or its compounds shall have option of data exchange using http(s) - protocol R1.5 M the System shall have SOA-oriented architecture that supports only defined and platform independent interfaces for interaction R1.6 M At least following functional assigned for use by wide range of users (patients, distanced doctors, managers) shall be implemented as web-application: - patient’s demographic data - patient complaints - entry of allergic anamnesis Section VI. Technical requirements 109 - entry of life anamnesis - entry of suffered diseases - entry of anamnesis of current illness - entry of objective state of patient examination - entry data on reactions to drugs - entry referrals to lab studies - entry prescriptions - entry referrals to diagnostic services - review lab studies results - review diagnostic results - reporting - doctor’s records keeping R1.7 M The System shall have fine configuration to assure adjusting to health facility needs without design of a new system (or small refinement of the System) R1.8 M The Supplier under this Contract shall carry out works to ensure interoperability of the System with National EHR (EHR repository, national classifiers and indicators, analytic repository, EHR-web-services) according to requirement R7 R1.9 M System integration shall be ensured with introduced accounting system 1C. Level of integration shall be determined during implementation of the Contract and agreed with the agency where System is introduced. R1.10 M The System shall ensure confidentiality of personal data: encryption of personal data in DB, encryption data while transmission by channels, use of safe transmission protocols and etc. R1.11 M The System shall use digital signature to sign and authorize e-documents, files and parts of the documents. Need in digital signature shall be configurable at System admin level. More details on requirements to digital signature are set in R 5.15. R1.12 M The system shall be entirely operational “on turnkey basis” according to R 14.2. For this the Supplier shall if it is necessary add missing parts, functionality and solutions including cost of missing parts in Price Table in item for «others» R1.13 M The Supplier shall provide at least, but not limited to configuration, roll-out, installation, testing of the System. The Supplier shall provide trainings for users 110 Section VI. Technical Requirements and administrators (and other staff if needed) R1.14 M The Supplier shall take part in System attestation together with the Supplier of Platform to check and certify interoperability with national resources and EHR tools during procedures of System attestation and testing. R1.15 M The Supplier shall provide warranty service for the System within 3 years from the acceptance date according to R 12.4. R1.16 M If additional software is required for System operation “on a turnkey basis” the Supplier shall provide licenses (for complete System operating “on a turnkey basis”) at his own expense and delivery it to the Purchaser ownership within this Contract. R1.17 M The Supplier shall deliver System configuration to health facilities according to Table 1. System components are set in Table 2. R1.18 M Minimal requirements for each module shall correspond to Section R2 R1.19 M In Bidding Documentation the Bidder shall present edited technical specification set within the format and structure of this Technical Requirements R1.20 М The system shall be able to integrate with development environments (IDE), at least for Java and Net Framework. The system shall have a complete development kits (SDK), which includes: documentation, sample code at least for Java and Net Framework, to configure the system functions. An Option shall be available to extend functionality of systems using development tools (SDK), included into the system. R1.21 М Mechanism of licensing for System under this contract should not limit the changes made with the help of development tools (SDK), included into the System. entering Changes using development tools (SDK), included into the System, should not affect the terms of warranty service for System. Changes to the System by experts of the Client shall be allowed after system commissioning. R1.22 M The Supplier shall provide service and technical support, including provision of new versions of the products (according to R12.3). R1.23 М Response time services and system components shall be no more than 3-5 seconds, for at least 80% cases of input data or requests for data browsing (at a rate of channel 1 Mb / s and a response time of less than 100 ms). Section VI. Technical requirements 111 R1.24 I Option of automated notification of patients (using e-mail and/or SMS) means available functionality for this in the System. This requirement does not cover payment of costs for SMS sending and/or arranging access to Internet. R1.25 М The supplier shall document and transmit electronically the configuration files and source code, components, systems developed under this contract R1.26 М The system shall have Thin Client to communicate with the equipment allowed to use the Thick client. R1.27 M The System shall meet following requirements to reporting: All analytic forms and reporting forms shall have option of export into formats .xls, xlsx, .docx, doc, .pdf, .csv, .html, .xml. Time for formulation of analytic and reporting forms shall not exceed 1 min. While for 95 % of cases time for formulation of analytic and reporting forms shall not exceed 30 seconds. The System shall have an option to make up analytic and reporting forms according to set timetable. The System shall have an option to send created analytic and reporting form to specified e-mail address. 112 Section VI. Technical Requirements application Целевая архитектура е-здравоохранения Patient’s Personal Cabinet Personal health professional’s cabinet BI and Analytical tools e-Government services Classifiers and Nomenclatures Management Existing information systems Single data repository RAP OPC MSQMS RMS DPMS RPWFA ERHP ACPCT EHR Repository Analytical warehouse Master patient index, healthcare facilities index, healthcare professionals index Classifiers and nomenclatures e-Government Gate MEMS ERDP HB DIS NRD ERCP Acute coronary syndrome register Automated information system policlinic Integration bus Integration bus External Information systems LIS RPCRF HIS Unified payment system Legend Existing Information systems Platform components e-Government Gate and services External Information systems HIS (Health information system) Pic.2. Summarized architecture of Comprehensive Health Information System Table 1. Type of delivered configuration for health facilities – beneficiaries Lot Title of health № facility – beneficiary 1 Address and contact Municipal Starokozhev Yury hospital №1 Ust- 8-7232-75-28-87 Kamenogorsk city EKO, UstKamenogorsk Abai str, 18 Type of System configuration (according to table 2) Hospital Notes Section VI. Technical requirements 113 2 Amanov Anuar Municipal Clinic +7 (727) 3003601 Hospital №4 Almaty, Turksib Almaty city rayon, Papanin str., 220 Hospital 3 Mother and Child Rakhimova Raya Center Ust8-7232-57-38-76, Kamenogorsk city Ust-Kamenogorsk city, Utepova Str., 35, 37 Hospital + Outpatient clinic 4 Municipal Policlinic №11 Almaty city Outpatient clinic Karibayeva Gulzhan 8-7272-52-21-21 Almaty, Zhetysu rayon, Zhumabayeva str., 87 5 Regional Kuralbayev Diagnostic Center Bekmakhan Almaty city 8-7273-75-26-12 Almaty, Auezova Str., 57 Outpatient clinic 6 Policlinic №1 Kostanay Igimbayeva Olga Outpatient clinic Central rayon hospital, Zhualynsky rayon, Zhambul oblast Zhumashev Seitkhan 7 8 7142 56-82-23 Kostanay, Alfarabi, 112 Hospital + Outpatient clinic (8-726-35) 2-2149, 2-21-98 Zhualynsky rayon, Zhambul oblast, B.Momyshuly village, S.Beybarys Str, 1 8 Policlinic № 7 Astana city Kuanysheva Aigul Outpatient clinic 8-7172-79-36-23 Astana, Sh. Kudaiberdyuly av., 25,29 consists of 36 remote branches situated in one rayon 114 9 Section VI. Technical Requirements Municipal Hospital No. 1 of Astana city Abduov Marat, 8-7172-23-16-01 Hospital + Outpatient clinic Astana, Koshkarbayev av., 66 Table 2. Modular composition of HIS for various health facilities Module Hospital Policlinic Module «1. Reception » - + Module «2. District doctor» - + Module «3. Prophylactic exams» - + Module «4. Profile specialist» - + Module «5. Head of Policlinic department» - + Module «6. Medical statistics of policlinic» - + Module «7. Admission» + - Module «8. Hospital Doctor» + - Module «9. Hospital nurse» + - Module «10. Meals» + - Module «11. Day-hospital» + + Module «12. Head of hospital department» + + Module «13. Hospital administrator» + + Module «14. Medical Statistics for Hospital» + + Module «15.Procedures and manipulations» + + Module «16. Admin» + + Module «17. Lab IS» + + Module «18. PACS» (Picture Archiving and Communication System) + + Section VI. Technical requirements 115 Module «19. Diagnostic studies» + + Module «20. Pharmacy» + + Module «21. Human Resources» + + 1.1.3.2. Requirements to processes supported and automated by the System Note 1: Division into modules is rather conditional and not mandatory for strict execution. Mandatory requirement is obligatorily presence of these functions. Note 2: Forms referred to with the prefix /у relate to (primary) accounting forms approved by MOH order №907 as of 23.11.2010 «On approval of forms of primary medical documentation for health facilities». Forms referred to without the prefix /у relate to (secondary) accounting forms (monthly, quaterly, annual) approved by MOH order №128 as of 06.03.2013 «On approval of forms for collection of administrative data of health facilities». R2 Requirements to automated processes R2.1 Module 1 «Reception» R2.1.1 М Management of doctor’s schedule of work, services, equipment use. This process includes: R2.1.1.1 M Making schedule of doctor work with possibility to choose doctor data (name, position, specialty, department) out of list of specialists R2.1.1.2 M Check for availability of already made schedule for this period of time (date, time), for this doctor, room, equipment, and informing the user if it is available while making up the schedule for doctor work, service provision or equipment use R2.1.1.3 M Search for schedule among already existing by date, time, doctor, doctor specialty, service, equipment or their combinations R2.1.1.4 M While making up the schedule for doctor work, service provision or equipment use to set an option to interlink doctor, service and equipment. This interlink is 116 Section VI. Technical Requirements not mandatory for filling in. R2.1.1.5 M while making up the schedule for service provision to plan the option of service selection out of service list for which health facility or a doctor has the right R2.1.1.6 M While making schedule for equipment use to have option to choose equipment out of list of the health facility R2.1.1.7 M Option of schedule generation, edition and removal R2.1.1.8 M While schedule removal or editing if the patients are attached thereto, to have an option of automated choice of possible nearest time at similar specialist and option of choice of definite time by user R2.1.1.9 M While schedule removal or editing to have an option of automated notification of patient on changed date, time, place of admission by e-mail and/or SMS R2.1.1.10 M Making up following reports: 1. Summary information on schedule of work of doctors by subdivisions, shifts, service provision, equipment use 2. Report on changes in patient records due to changed schedules. R2.1.2 М Registration for doctor examination with handed out admission card. This process includes at least: R2.1.2.1 M Registration of the patient by receptionist, by doctor during examination, by Patient through Internet with issuance of admission card R2.1.2.2 M Registration of new patients with filling in personal data, including transferring these data from IS MHSD RK R2.1.2.3 M Choice of patient out of patient DB of Health Facility by name, IIN, date of birth R2.1.2.4 M Printing routing chart for issued cards with indication of doctor, room, date and time of examination, some specific additional information (way of getting ready for exam for patient and other). R2.1.2.5 M Registration of patient’s ambulatory card handing out and receiving R2.1.2.6 M Cancellation of registration by receptionist, doctor, patient by Internet Section VI. Technical requirements 117 R2.1.2.7 M Making up «Waiting list» to take vacant place because of cancellation of time for doctor examination with automated notification of the patient by e-mail and SMS in case of registration for vacant place R2.1.2.8 M Option to book time for examination in a schedule (solely or in group) with regulated time to cancel reservation R2.1.2.9 M Automated preventing of patient registration to several doctors by the same time, and prevention of registration of several patients to one and the same doctor R2.1.2.10 M Search of time for registration in existing schedules by date, time, doctor, specialty, services, equipment and their combinations R2.1.2.11 M Following Reports making: 1. Report on number of registered (by doctor, service, equipment, department, health facility) 2. Report on number of free places (by doctor, service, equipment, department, health facility) 3. Report on cancelled visits 4. Report on not appeared patients 5. Report on preservation of visits. 6. Report on visited patients (within reported period, by referred health facilities, by specialists, services) R2.1.3 M Management of Book for calls at home. This process includes at least: R2.1.3.1 M Registration of call at home accepted by phone, by Internet and patient’s visit to a health facility R2.1.3.2 M Registration of cancel of call at home initiated by the patient R2.1.3.3 M Registration of transferring call at home to the doctor R2.1.3.4 M Registration of execution of the call with details R2.1.3.5 M Registration of need in second visit and its date R2.1.3.6 M Making up the list of non-distributed calls: by districts, by health facility in general 118 Section VI. Technical Requirements R2.1.3.7 M Making up the list of calls for the doctor with indication of patients name, diagnosis, address, phone, notes R2.1.3.8 M Report making: 1. Report on calls at home (opened, accepted, executed, cancelled) by doctor, patient, district 2. Report on time of calls accepted and executed R2.1.4 M Record keeping in the Book of active information (calls at patient’s home by initiative of medical specialists). It includes, at least: R2.1.4.1 M Dividing active information by groups – hospital, policlinic, newborn, emergency, pregnant women, newly born women R2.1.4.2 M Registration of active information received by phone, Internet R2.1.4.3 M Registration of active information group by file import – table of established type R2.1.4.4 M Registration of active information cancel R2.1.4.5 M Registration of transferring active information to the doctor R2.1.4.6 M Registration of the fact of execution with outcome details R2.1.4.7 M Registration of the need in second visit and its date R2.1.4.8 M Making up the list of non-distributed active information by districts, health facility R2.1.4.9 M Making up the list of active information for the doctor with indication of patients name, diagnosis, address, phone, notes R2.1.4.10 M Reports making: 1. Report on active information (opened, accepted, executed, cancelled) in a breakdown by doctor, patient, district 2. Report on time of active information accepted and executed. R2.1.5 M Management of primary accounting documents at the level of Reception in line with normative legal acts of the RK. It includes the following registration Section VI. Technical requirements 119 formats: R2.1.5.1 M Form 040/y Form 025-4/ у Form 025-9/у Form 025-5/у Form 031/у R2.1.6 M Analytic tables formation on the Reception level as well as statistic tables in line with current legal acts of the RK R2.1.7 M Interaction with IS MHSD RK, it includes at least: R2.1.7.1 M Transfer of information on schedules of doctor’s work, service provision, equipment use R 2. 18 M Registration of facts of population attachment/ detachment from a health facility R2.2 Module 2 «District doctor» R2.2.1 М Patient’s ambulatory card management. It includes, at least: R2.2.1.1 M Review of patients list that appointed time for doctor exam R2.2.1.2 M Making up Patient’s ambulatory card R2.2.1.3 M Making up and editing templates such as making medical papers and records, consultations, exam protocols, diary records using templates and option to attach files (images, video, audio) with link of user template to user account R2.2.1.4 M Making medical records basing on standard and user’s templates R2.2.1.5 M Editing and removal of medical records signed by digital signature shall be blocked R2.2.1.6 M Printing filled in medical records to form paper version of ambulatory card R2.2.1.7 M Option of selection of medical records by certain parameters (visits, diagnosis, date, diagnostic studies, lab analysis, service, funding source and etc.) 120 Section VI. Technical Requirements R2.2.1.8 M Report on changes in patient’s numerical data by time (anthropometric index, functional index, lab data and etc.) R2.2.2 M Making up internal (within one health facility) and external (to other health facilities) referrals to consulting and diagnostic services. This includes, at least: R2.2.2.1 M Making referrals to consulting and diagnostic services within one health facility with possibility to register by certain time R2.2.2.2 M Making referrals to consulting and diagnostic services to other health facilities with possibility to register by certain time R2.2.2.3 M Agreement of referrals for certain types of services with the Head of Department R2.2.2.4 M Recommendations making up to get prepared to consulting and diagnostic services basing on standard templates R2.2.2.5 M Removal of referrals (wrong, by patient’s initiative, automatically due to patient’s absence) R2.2.2.6 M Control over execution of consulting and diagnostic services prescribed for a patient, review data on executed prescription including its results. R2.2.2.7 M Agreement and rejection of requests for additional consulting and diagnostic services R2.2.2.8 M Report forming: 1. Report on referrals created (internal, external) by services, funding source, level of care provision (rayon, oblast/city, national) 2. List of patients by names referred to consulting and diagnostic services 3. Report on referrals (opened, executed, rejected, internal, external) R2.2.3 M Making up planned hospitalization (24 hours hospital and substitute care). This includes, at least: R2.2.3.1 M Making up patient summary from ambulatory card (Form 027/у) R2.2.3.2 M Making up of: - templates on minimal standards of studies at pre-hospital stages by levels of health facilities Section VI. Technical requirements 121 - referral and card for planned hospitalization R2.2.4 M Making up doctor prescriptions for drugs and/or procedures, manipulations. This includes at least: R2.2.4.1 M Creation of prescriptions (paid, unpaid) for medicines and narcotic drugs with limited access of a certain category of doctors and with description of uptake method and doses and etc. R2.2.4.2 M Control over prescriptions basing on set max once-only doses depending on age, sex, weight and etc. R2.2.4.3 M Control over prescriptions basing on formulary of a health facility and republican drug formulary. Results of Benefit Drug provision to dispensary patients and other categories of population R2.2.4.4 M Signing prescriptions by digital signature R2.2.4.5 M Check for drug availability in pharmacy. Such requirement shall be implemented through interaction with Module “Pharmacy”. R2.2.4.6 M Making up referrals to procedures with specification of medicines and their doses R2.2.4.7 M Making up recommendations to prepare to procedures basing on standard templates R2.2.4.8 M Control over prescription execution and drug release R2.2.4.9 M Submission of reference information by recommended prescriptions according to approved clinical guidelines and diagnostic and treatment protocols R2.2.4.10 M Making up the list of doctor’s prescriptions (Form 004-1/у) R2.2.4.11 M Report making: 1. Report on generated receipts (INN, form, dose, uptake method, and etc.) 2. List of patients by names who got receipts 3. List of patients by names who got receipts under benefit category R2.2.5 M Management of initial registration documentation at district doctor level basing on regulatory norms of the RK. This includes the following forms, at least: 122 R2.2.5.1 Section VI. Technical Requirements M 001-2/у, 001-3/у, 001-4/у, 001-5/у, 001-6/у, 003-2/у, 004-1/у, 025/у (025-1, 025-2, 025-3, 025-4), 025-2/у, 025-3/у, 025-5/у, 025-7/у, 025-8/у, 026/у, 026-1/у, 026-2/у, 030/у, 032/у, 036/у, 038/у, 038-1/у, 038-2/у, 039/у, 040/у, 052/у, 053/у, 054/у, 058/у, 060/у, 063/у, 064/у, 070/у, 072/у, 075/у, 076/у, 086/у, 088/у 088-1/у, 094/у, 095/у 095-1/у, 106/у-12, 106-2/у-12, 112/у, 130/у, 132/у, 133/у, 138/у, 278/у, ТB 15/у, ТB 05/у, R2.2.6 M Making up analytic tables at district doctor level as well as statistic tables basing on regulatory norms. This includes the following forms, at least: R2.2.7 M 1. Statement for accounting patient visits to policlinic, dispensary, consultations and at home (039/у) including in breakdown by district doctors at PHC level 2. Report on executed screenings according to MOH order № 685 as of 10.11.2009 including in breakdown by district doctors at PHC level 3. Monitoring of execution of annual mandatory fluorography inspections for population including in breakdown by district doctors at PHC level 4. Monitoring of execution of monthly and annual plans on immune prophylactic actions by Form №5, 6 MOH order No.128 as of 6.03.2013 including in breakdown by district doctors at PHC level 5. Report post vaccination complications in the context of primary care physicians by types of prophylactic vaccinations by age and outcomes, including in the context of district doctors at PHC 6. Report on dispensary patients flow including in breakdown by district doctors at PHC level 7. Report on flow of dispensary patients with chronic renal insufficiency with indication of substitute therapy (gemodialiaz or peritoneal, kidney transplantation, etc.) including in breakdown by district doctors at PHC level 8. Report on birth rate including in breakdown by district doctors at PHC level 9. Report on mortality including in breakdown by district doctors at PHC level 10. Report on invalid patients including in breakdown by district doctors at PHC level 11. Report on referral and hospitalization including planned hospitalization in breakdown by district doctors at PHC level 12. Report on Healthy life style actions including in breakdown by district Section VI. Technical requirements 123 doctors at PHC level 13. Report on quantity and structure of attached population including in breakdown by district doctors at PHC level 14. Report on quantity of diseases of patients living in the district attached to a health facility and cohort of patients under dispensary control (Form 56, 12) including in breakdown by district doctors at PHC level 15. Report on cohort of patients receiving hospital substitute care (Form 24) including in breakdown by district doctors at PHC level 16. Report on care to children (Form 31) including in breakdown by district doctors at PHC level 17. Report on child disability (Form 52) including in breakdown by district doctors at PHC level 18. Report on use of bed fund of health facility (hospital and day care) (Form 21) including in breakdown by district doctors at PHC level 19. Report on patients brought by emergency care staff including in breakdown by district doctors at PHC level R2.2.8 M Management of lists of temporary disability (sick lists). This includes at least: R2.2.8.1 M Registration of list of temporary disability R2.2.8.2 M Prolongation of list of temporary disability R2.2.8.3 M Closing of list of temporary disability R2.2.8.4 M Sending the list of temporary disability to Head of Department or Medical Consultative Board for approval R2.2.8.5 M Making up referral to MSE (Form 088/у) R2.2.8.6 M Reports making up: 1. Report on issued lists of temporary disability 2. Report on referrals to MSE R2.2.9 M Interaction with IS MHSD RK. It includes at least: R2.2.9.1 M Data exchange according to EMR and EHR standards. More details in R7.2.1 R2.2.9.2 M Data exchange on hospitalization R2.2.9.3 M Data exchange on executed services 124 Section VI. Technical Requirements R2.2.9.4 M Clinical information exchange (conclusive diagnosis, consultations, screenings, etc.) R2.2.9.5 M Data exchange on referrals to consulting and diagnostic services R2.2.9.6 M Data exchange on assigned procedures R2.2.9.7 M Data exchange on receipts R2.3 Module 3 «Prophylactic screening» R2.3.1 М Forming contingents subject to preventive exams from targeted group of population (screening) and register its performance basing on regulatory norms. This includes at least: R2.3.1.1 M Making up lists of patients by names for preventive examination (screening) out of population attached to a health facility in line with regulatory documents R2.3.1.2 M Option of automated notification of patients (by e-mail and/or SMS) on necessity to pass screening R2.3.1.3 M Make up router list for screening passing R2.3.1.4 M Mark on execution of studies in screening with indication of outcomes and/or conclusion R2.3.1.5 M Automated making up of referrals to specialists under the screening framework R2.3.1.6 M Filling in card of screening R2.3.1.7 M Making up conclusion on passed screening R2.3.1.8 M Reports: 1. Report on cohort of population subject to screening (by types of screening, district, age-sex structure) 2. Report on passed screening 3. Report on diseases revealed during screening R2.3.2 M registration of other types of preventive examination, regular and periodic, used for employment. It includes at least: Section VI. Technical requirements 125 R2.3.2.1 M Making up lists of patients by names for preventive exams R2.3.2.2 M Making up router lists for preventive exams R2.3.2.3 M Mark on execution of studies in preventive exam with indication of outcomes and/or conclusion R2.3.2.4 M Automated forming of referrals to specialists to pass preventive exam R2.3.2.5 M Fill in card of preventive exam R2.3.2.6 M Making up conclusion on passed preventive exam with issuance of certificate R2.3.2.7 M Reports: 1. Report on passed preventive exams (by types of screening, district, age-sex structure) 2. Report on diseases revealed during preventive exam 3. Report on cohort of population subject to regular screening R2.3.3 M Management on initial registration documentation at doctor level basing on regulatory norms. This includes at least the following forms: R2.3.3.1 M 025/у, 025-1/у, 025-2/у, 025-4/у, 025-5/у, 025-7/у, 025-8/у, 030/у, 032/ у, 040/у, 086/у, 108/у, 108-1/у, 112/у, 131/у, 245/у R2.4 Module 4 «Profile specialist» R2.4.1 М Patient’s ambulatory card management using data of national EHR. This includes at least: R2.4.1.1 M Review of patients lists appointed for exam R2.4.1.2 M Templates making up and editing including medical statements and records, consultations, exam protocols, diaries and option of file attachment (image, video, audio) with link to user account R2.4.1.3 M Making medical records using standard or user templates R2.4.1.4 M Medical records editing and removal of those which are not signed 126 Section VI. Technical Requirements R2.4.1.5 M Printing of filled in medical records for paper version of ambulatory card R2.4.1.6 M Option to select medical records by certain parameters (encounters, diagnosis, dates, diagnostic studies, lab analysis, services, funding source and etc.) R2.4.1.7 M Report on changes in patient’s numerical signs by time (anthropometric index, functional index, lab data, etc.) R2.4.2 M Making up internal (within one health facility) and external (to the other health facilities) referrals to consultative and diagnostic services. This includes at least: R2.4.2.1 M Making up referrals to additional consultative and diagnostic services by referrals issued by PHC department within a facility with option to appoint time R2.4.2.2 M Adding additional consultative and diagnostic services without agreement with PHC department R2.4.2.3 M Making up an request for additional types of studies to be approved by PHC department R2.4.2.4 M Mark on performed consultative and diagnostic services R2.4.2.5 M Making up protocols of consultations, exam, operation basing on standard and user templates R2.4.2.6 M Formulate recommendations on getting prepared to consultative and diagnostic services R2.4.2.7 M Removal of referrals (wrong, by patients initiative, automated if the patient did not appear) R2.4.2.8 M Control over consultative and diagnostic services execution. Registration of firstly coming dispensary patient and transferring this data to district doctor, recommendations on periodicity of monitoring and examination R2.4.2.9 M Reports: 1. Report on created referrals (internal, external) by services, funding sources 2. List of patients by names referred to consultative and diagnostic services 3. Report on rendered consultative and diagnostic services Section VI. Technical requirements 127 4. List of patients by names which got consultative and diagnostic services R2.4.3 M Make up doctor prescriptions for drugs and/or procedures and manipulations. It includes at least: R2.4.3.1 M Making up receipts for drugs (paid, unpaid) with description of uptake method, dosing and etc. R2.4.3.2 M Control over prescriptions in line with set maximal once-only doses depending upon age, sex, weight and etc. R2.4.3.3 M Control over prescriptions basing on health facility and republican drug formulary R2.4.3.4 M Signing prescriptions by digital signature R2.4.3.5 M Check for drug availability in pharmacy R2.4.3.6 M Making up referrals to procedures R2.4.3.7 M Making up recommendations to prepare to procedures basing on standard templates. R2.4.3.8 M Control over prescription execution and drug release R2.4.3.9 M Submission of reference information by recommended prescriptions according to approved clinical guidelines and diagnostic and treatment protocols R2.4.3.10 M Report making: 1. Report on generated receipts (INN, form, dose, uptake method, and etc.) 2. List of patients by names who got receipts 3. List of patients by names who got receipts under benefit category 4. List of patients by names who got medical devices 5. List of patients by names referred to consultative and diagnostic service 6. Report on referrals to procedures (opened, under execution, executed, rejected, external, internal). R2.4.4 M Management of initial registration documentation at profile specialist level basing on regulatory norms. This includes the following forms, at least: 128 R2.4.5 Section VI. Technical Requirements M 001-3/у, 001-4/у, 001-5/у, 001-6/у, 001-7/у, 025/у, 025-1/у, 025-2/у, 025-3/у, 025-4/у, 025-5/у, 025-7/у, 025-8/у, 025-9/у, 027-2/у, 030/у, 030-1/у, 030-2/у, 030-6/у, 036/у, 037/у, 037-1/у, 039/у, 039-2/у, 039-3/у 040/у, 045/у, 048/у, 052/у, 053/у, 054/у, 058/у, 060/у, 065/у, 065-1/у, 069/у, 070/у, 071/у, 073/у, 083/у, 084/у, 086/у, 088/у, 089/у, 090/у, 094/у, 095/у, 095-1/у, 098/у, 111/у, 112/у, 128/у, 130/у, 132/у, 133/у, 138/у, 278/у, R2.4.6 M Management of lists of temporary disability. This includes at least: R2.4.7 M Registration of list of temporary disability R2.4.7.1 M Prolongation of list of temporary disability R2.4.7.2 M Closing of list of temporary disability R2.4.7.3 M Sending the list of temporary disability to Head of Department or Medical Consultative Board for approval. R2.4.7.4 M To make up a report on issued lists of temporary R2.4.7.5 M To draw a referral to Medical Social-Expert Commission (MSEC), creation and editing templates for MSEC R2.4.8 M Making up analytic tables at profile specialist level as well as statistic tables basing on regulatory norms. This includes the following forms, at least: R2.4.8.1 M 1. Statement for accounting patient visits to policlinic, dispensary, consultations and at home (039/у) 2. Report on executed screenings according to MOH order № 685 as of 10.11.2009 3. Report on dispensary patients flow 4. Report on invalid patients 5. Report on adult invalid patients 6. Report on planned hospitalization 7. Report on quantity of diseases of patients living in attached district and cohort of patients under dispensary control (Form 56, 12 8. Report on cohort of patients who get substitute care (Form 24) 9. Report on care to children (Form 31) Section VI. Technical requirements 129 10.Report on child disability (Form 52) 11. Report on use of bed fund of health facility (hospital and day care) (Form 21) R2.5 Module 5 «Head of Department in Policlinic» R2.5.1 М Confirming or rejection of referrals for certain types of services using digital signature R2.5.2 М Management of initial registration documentation at Head of Department level basing on regulatory norms. This includes the following forms, at least: R2.5.2.1 M 1. 035/у 2. 035-1/у 3. 035-2/у 4. 035-3/у 5. 095/у 6. 094/у R2.5.3 М Making up analytic tables at Head of Department level as well as statistic tables basing on regulatory norms. This includes the following forms, at least: R2.5.3.1 M Report making up: 1. Making up analytic tables in a breakdown similar to the tables of department staff 2. Report on attached population by districts 3. Report on age-sex structure of attached population 4. Report on staff composition of districts doctors 5. Report on main district performance indexes 6. Form 12 7. Report on the structure of visits (in terms of disease, preventive screenings, dispensary patients, for a visit to doctor examination, at home, providing substitute care technology, visits to nursing staff, in first aid room, a treatment room, on preventive vaccination) 8. Report on hospitalization of people from attached to a health facility area 9. Structure of consulting exams by profile specialists in breakdown by the districts of attached population 130 Section VI. Technical Requirements R2.5.4 М Agreement of list of temporary disability, minutes of MCB. This includes, at least: R2.5.4.1 M Agreement of long-term lists of temporary disability R2.5.4.2 M Creation of MCB minutes R2.5.4.3 M Make up MCB conclusions R2.5.4.4 M Signing of MCB conclusion by digital signature R2.5.4.5 M Reports: 1. Report on issued lists of temporary disability 2. Report on quantity of patients passed through MCB 3. Report on quantity of patients referred to re-certification in MSE R2.6 Module 6 «Medical Statistics in Policlinics» R2.6.1 M Monitoring of initial registration documentation management in a health facility R2.6.2 M Making up analytic tables at the level of a specialist in health statistics as well as statistic tables basing on regulatory norms. This includes at least the following: R2.6.2.1 M Constructor of reports with option to generate new reports and edit existing ones R2.6.2.2 M Report making up: 1. Form 039/у 2. Form 007/у 3. Report on attached population and its age-sex structure 4. Report on executed screenings 5. Report on staff composition of participants 6. Report on activities to attach population to a district 7. Reporting forms 21, 12, 17, 24, 30, 31, 32, 43, 47, 52, 59, 4, 5, 6 R2.7 R2.7.1 Module 7 «Admission» М Registration of patients addresses. This process includes, at least: Section VI. Technical requirements 131 R2.7.1.1 M Demographic data adjusting R2.7.1.2 M Data check and entry on insurance category and payment R2.7.1.3 M Registration of medical referral and/or rejection in care provision R2.7.1.4 M Medical documents making up and issuance R2.7.1.5 M Setting links between referrals doubles R2.7.1.6 M Distribution of patients by specialised departments and rooms R2.7.1.7 M Preliminary attachment of a patient to doctor in charge R2.7.1.8 M Confirming readiness to accept the patient R2.7.2 M Management of patients EMR. It includes, at least: R2.7.2.1 M Full description of processes and requirements to EMR management in line with national standard of EMR (approved by MOH order №75 as of 10.02.2014 «On approval of technical documentation in e-health issues») R2.7.2.2 M Minimal obligatory set of data from EMR is given to national EHR basing on national standard of EHR R2.7.3 M Clarification of services carried out before hospitalization. It includes at least: R2.7.3.1 M Review of patients EHR from national EHR repository R2.7.3.2 M Registration of diagnosis, procedures, prescriptions and other data on medical services carried out prior to hospitalization but not entered into the System R2.7.4 M Management of initial registration documentation at Admission level basing on regulatory norms. This includes the following forms, at least: R2.7.4.1 M 001/у, 003/у, 003-3/у, 004-1/у, 045/у, 058/у, 060/у, 069/у, 264/у R2.7.5 M Making up analytic tables at Admission department level. This includes the following forms, at least: R2.7.5.1 M Reports: 132 Section VI. Technical Requirements 1. Report on scope of performed services, manipulations, exams 2. Report on drugs and vaccination 3. Report on performed work (quantity of applied patients, quantity of hospitalized patients in planned and extraordinary way, to day hospital, rejections from hospitalization, patients delivered by emergency care, sent by PHC or self-reversal patients) 4. Report on active information submitted to policlinic 5. Tables of bed fund of a health facility with indication of vacant beds R2.7.6 M Interaction with IS MHSD RK. It includes, at least: R2.7.6.1 M Data exchange on executed services in admission department before hospitalization R2.7.6.2 M Data exchange on hospitalization and rejection from it R2.7.6.3 M Data exchange on state of bed fund R2.7.6.4 M Data exchange with IS MHSD RK according to interoperability requirements of MHSD R2.8 Module 8 «Hospital Doctor» R2.8.1 М Management of patients EMR. It includes, at least: R2.8.1.1 M Full description of processes and requirements to EMR management in line with national standard of EMR (approved by MOH order №75 as of 10.02.2014 «on approval of technical documentation in e-health issues R2.8.1.2 M Minimal obligatory set of data from EMR is given to national EHR basing on national standard of EHR R2.8.1.3 M Disease case study based on a standard template for the appropriate number of beds (personal data, medical history, personal history, past illnesses, the results of the initial inspection, prescriptions) R2.8.1.4 M Preliminary plan of treatment and additional studies if required R2.8.1.5 M Registration of patients visits and examination by doctor in charge R2.8.2 M Management of referrals to consultative and diagnostic services. It includes, at Section VI. Technical requirements 133 least: R2.8.2.1 M Adjusting plan of treatment, use plan during treatment, changes in plan if required R2.8.2.2 M Make up referrals to lab studies, study results and (if required) interpretations giving R2.8.2.3 M Make up referrals to diagnostic services, study results and (if required) interpretations giving R2.8.2.4 M Make up referrals to other doctors, study conclusion of specialists R2.8.2.5 M Monitoring of referrals state and identification of delays and rejections R2.8.3 M Diagnosis putting. It includes at least: R2.8.3.1 M Case review from national EHR repository R2.8.3.2 M Analysis results review R2.8.3.3 M Diagnosis adjusting and registration: diagnosis of sent health facility (referral), admission diagnosis (preliminary), the final clinical diagnosis, complications, comorbidities, the final, anatomopathological diagnosis R2.8.3.4 M Monitoring of execution of plan of treatment and its adjusting R2.8.4 M Make up doctor prescriptions for drugs and/or procedures and manipulations. It includes at least: R2.8.4.1 M Study patients allergy R2.8.4.2 M Check for drug compatibility R2.8.4.3 M Make up prescriptions on drug using R2.8.4.4 M treatment and diagnostic procedures assigning R2.8.4.5 M Monitoring of prescriptions executed in a right way and in time by nurse and involved into care parties R2.8.4.6 M Registration of side effect of drugs and complications from drugs and 134 Section VI. Technical Requirements procedures R2.8.5 M Patient discharge. It includes at least: R2.8.5.1 M Determination of final diagnosis R2.8.5.2 M Make up Form 066/у R2.8.5.3 M Patient discharge making up R2.8.5.4 M Registration of vacant bed R2.8.6 M Making up analytic tables at doctor level. It includes at least: R2.8.6.1 M Reports: 1. Report on carried out work (number of cases with outcomes) 2. Report on number of carried out operations (including those with complications) 3. Report on number of carried out manipulations Report on bed fund (bed operating, average duration of patient use of bed, execution of bed-days, death cases) 4. 5. Report on use of diagnostic studies 6. Report on rehabilitation procedures R2.8.6.2 M Analytic tables making up R2.8.7 M Management of initial registration documentation at hospital doctor level basing on regulatory norms. This includes the following forms, at least: R2.8.7.1 M 003/у, 003-3/у, 004-1/у, 005/у, 008/у, 011/у, 011-1/у, 011-2/у, 011-3/у,027/у, 066/у, 066-4/у, R2.9 Module 9 «Hospital Nurse» R2.9.1 M Management of patients EMR. It includes, at least: R2.9.1.1 M Full description of processes and requirements to EMR management in line with national standard of EMR (approved by MOH order №75 as of 10.02.2014 “On approval of technical documentation in e-health issues”) Section VI. Technical requirements 135 R2.9.1.2 M Minimal obligatory set of data from EMR is given to national EHR basing on national standard of EHR (approved by MOH order №75 as of 10.02.2014 “On approval of technical documentation in e-health issues”) R2.9.1.3 M Demographic data adjusting R2.9.1.4 M Case treatment plan study R2.9.1.5 M Registration on required referrals (appointing to doctor for exam) to lab, diagnostic rooms and other specialists according to referrals and doctor prescriptions R2.9.1.6 M Reports: 1. Report on drugs and medical devices 2. Report on carried out procedures 3. Report of dressing/aid room R2.9.2 M Mark on execution of prescriptions and care plan, it includes, at least: R2.9.2.1 M Mark on drugs taken by patients R2.9.2.2 M Report on made procedures (for extraordinary cases when there are no work places in treatment room) R2.9.2.3 M Mark on made operations (for extraordinary cases when there are no work places in operating room) R2.9.2.4 M Entry of results of lab analysis and diagnostic tests (if there are no work places in relevant rooms for registration of results) R2.9.3 M Monitoring of patient state. It includes, at least: R2.9.3.1 M Mark on made assessment over patient state (temperature, complaints and etc.) R2.9.3.2 M Monitoring of treatment plan execution R2.9.3.3 M Warning in urgent cases R2.9.4 M Management of initial registration documentation at nurse level. This includes, at least: 136 Section VI. Technical Requirements R2.9.4.1 M R2.9.4.2 M Printing of referrals and plan of treatment The System shall be able to manage following registration forms: 1. 004/у, 004-1/у, 007/у, 009/у, 029/у, 2. Register for blood intake for HIV 3. Register for recipients transfer to policlinic 4. Register of medication 5. Register of dressing material 6. Requirements to pharmacy 7. Register for ethanol 8. Register for narcotic drug, psychotropic substances and precursors (Decree of GOK № 396 as of 30.03.2012) R2.9.5 M Analytic tables making at nurse level. R2.9.5.1 M Drawing up the following reports: R2.10 1. Report on used medications, including drugs and ethanol 2. Report on used medical devices 3. Report on identification of Blood group 4. Report on revealed infectious patients 5. Report on transfusion of blood and blood products 6. Report on blood sampling and other parts of organism for study 7. Report on biopsy sampling 8. Report on referrals to external studies Module «10 Meals» R2.10.1 M Every day menu forming. It includes, at least: R2.10.1.1 M Forming menu – requirement, editing, protection from editing upon approval R2.10.1.2 M Forming menu handed out to tables with indication of dishes, editing and protection from editing upon approval R2.10.1.3 M Review of list of dishes for each type diet (Table) Section VI. Technical requirements 137 R2.10.1.4 M Review of patients selected by diets, rooms, departments and etc. R2.10.1.5 M Review of patients and medical staff comments towards meal quality R2.10.2 M Calculator of every day, monthly consumption of food for menu. It includes, at least: R2.10.2.1 M Calculation of required food products for each day, given listed quantity of patients in a health facility R2.10.2.2 M Adjusting number of portions (with logging of changes) for each type of diet R2.10.2.3 M Automated estimation of required food quantity and composition R2.10.2.4 M Printing order for food delivery R2.10.2.5 M Review of above data for previous periods (data adjusting is possible by special permission of Hospital Administrator given for limited time period) R2.10.2.6 M Possibility to review log in case of manual changes in quantity of portions R2.10.3 M Estimation of nutrition value of dishes in ration. This includes, at least: R2.10.3.1 M Estimation of dish nutrition value given standard of waist and loss during culinary processing R2.10.3.2 M Automated prompting on composition and food value for various diets R2.10.3.3 M Report on feed value by each diet and assigning recommended standards for each diet R2.10.4 M Making references of food products. It includes, at least: R2.10.4.1 M Handbook of basic food products and semi-finished products R2.10.4.2 M Reference of dish cards and composition R2.10.4.3 M Reference of dieted dish (tables 1-15) R2.10.5 M Patients diet management 138 Section VI. Technical Requirements R2.10.5.1 M Review of recommendations on diets from specialists and care doctors for each patient R2.10.5.2 M Diet prescription (Table number) R2.10.5.3 M Diet change R2.10.5.4 M Review of patients and medical staff references on food quality R2.10.6 M Analytic tables forming for meals R2.11 Module «11 Day Hospital» R2.11.1 M Management of patients EMR. It includes, at least: R2.11.1.1 M Full description of processes and requirements to EMR management in line with national standard of EMR (approved by MOH order №75 as of 10.02.2014 “On approval of technical documentation in e-health issues”) R2.11.1.2 M Minimal obligatory set of data from EMR is given to national EHR basing on national standard of EHR (approved by MOH order №75 as of 10.02.2014 “On approval of technical documentation in e-health issues”) R2.11.1.3 M Disease case study R2.11.1.4 M Preliminary plan of treatment R2.11.1.5 M Registration of patients visits and examination by doctor in charge R2.11.2 M Creation of referrals to consultative and diagnostic services. It includes, at least: R2.11.2.1 M Adjusting plan of treatment, use plan during treatment, changes in plan if required R2.11.2.2 M Make up referrals to lab studies, study results and (if required) interpretations giving R2.11.2.3 M Make up referrals to diagnostic services, study results and interpretations giving R2.11.2.4 M Make up referrals to other doctors, study conclusion of specialists R2.11.2.5 M Monitoring of referrals state and identification of delays and rejections Section VI. Technical requirements 139 R2.11.3 M Registration of doctor prescriptions and execution. It includes at least: R2.11.3.1 M Study patients allergy anamnesis R2.11.3.2 M Check for drug compatibility R2.11.3.3 M Make up prescriptions on drug using R2.11.3.4 M Procedures assigning R2.11.3.5 M Mark on execution of procedures R2.11.3.6 M Monitoring of prescriptions executed in a right way and in time by nurse or helping persons R2.11.3.7 M Registration of side effect of drugs and complications from medicines and procedures R2.11.4 M Management of initial registration documentation at Day Hospital level basing on regulatory norms. This includes the following forms, at least: R2.11.4.1 M 001-3/у, 001-4/у, 003-2/у, 004-1/у, 027/у, 029/у, 066-4/у R2.11.5 M Making up analytic and statistic tables at Day Hospital level in line with normative legal acts. It includes at least: R2.11.5.1 M Reports: 1. Report on carried out work (number of cases with outcomes) 2. Report on number of carried out operations (including those with complications) 3. Report on number of carried out manipulations 4. Invoice for reported period specifying cost of treatment by nosology forms 5. Report on average duration of stay in hospital R2.11.6 M Interaction with IS MHSD RK. It includes at least: R2.11.6.1 M Data exchange on executed services R2.11.6.2 M Clinical information exchange (diagnosis, consultations and examinations results, etc.) 140 Section VI. Technical Requirements R2.11.6.3 M Data exchange on referrals R2.11.6.4 M Data exchange on receipts R2.12 Module «12 Head of Hospital Department» R2.12.1 M Confirming or rejection of referrals for certain types of services using digital signature R2.12.2 M Management of initial registration documentation at Head of Department level basing on regulatory norms. This includes the following forms, at least: R2.12.2.1 M The System shall be able to register information of following initial accounting forms: 035/у, 035-1/у, 035-2/у, 035-3/у, 094/у, 095/у R2.12.3 M Making up analytic tables at Head of Department level as well as statistic tables basing on regulatory norms by forms and similar tables of department specialists. List of analytic and statistic forms shall be agreed with the Client at the stage of System design. R2.12.4 M Agreement of lists of disability, records of council of physicians. It includes at least: R2.12.4.1 M Agreement of long-term lists of disability R2.12.4.2 M Creation of records of council of physicians R2.12.4.3 M Make up council of physicians conclusions R2.12.4.4 M Signing council of physicians conclusion by digital signature R2.12.4.5 M Reports: 1. Report on issued lists of temporary disability 2. Report on patients passed through council of physicians 3. Report on operating factors of bed fund of a department 4. Report on treated patients 5. Structure of treated cases by groups of nosology and age 6. Report on services rendered by codes of tarrificator Section VI. Technical requirements R2.13 141 Module 13 «Hospital Administrator» R2.13.1 M Making up analytic tables at Hospital Administrator level as well as statistic tables basing on regulatory norms. List of analytic and statistic forms shall be agreed with the Client at the stage of System design. This includes the following forms, at least: R2.13.1.1 M Monitoring of initial documentation maintenance in a health facility R2.13.1.2 M Analytic tables and reports accessible to all health facility departments by division into departments R2.14 Module 14 «Medical Statistics for Hospital» R2.14.1 M Bed fund management. It includes, at least: R2.14.1.1 M Management of bed fund referral by units, rooms, beds R2.14.1.2 M Setting up bed fund use (bed installing, bed folding, temporary beds, setting maximal number of beds in room, management of information on bed profiles, bed profile change, bed closing and reducing) R2.14.1.3 M Entry of additional information on bed, room (male, female) R2.14.2 M Making up analytic tables at Medical statistic level as well as statistic tables basing on regulatory norms. R2.14.2.1 M Forming initial reports and forms: 1. Every day :007/у, 007-1/у, 2. Monthly: 016/у 3. Form 21 4. Form 14 annual (ICD-10 and ICD-9) 5. Form 32 annual 6. Form 30 annual 7. List of cured cases at tertiary level with indication of operations 8. Hospital activity report 9. Work of departments by bed profiles; 10. Composition of patients, terms and outcomes; 142 Section VI. Technical Requirements 11. Main indicators for hospital work; 12. Information on structure of all types of secondary care; 13. Composition of patients by groups of diagnosis; 14. Composition of cured patients by outcomes; 15. Statistic data on work of resident doctors; 16. Surgery work by departments; 17. Analysis of surgery activity; 18. Summary information on operated patients by bed profiles; 19. Information on pre-surgical state; 20. Operations by surgery units; 21. composition of patients for surgical departments ; 22. analysis of activity of intensive care unit; 23. analysis of mortality and matches in clinical and post-mortem diagnoses; 24. analysis of diagnosis coincidence by referral and final one; 25. data on treated patients by districts and regions; 26. data on treated patients by referrals for “HB" ; 27. data on the types of injuries; 28. data on patients received in alcoholic state; 29. list of patients treated; 30. List of patients in the hospital; 31. list of the dead to be submitted to the registration service 32. list of the dead in the hospital at district level; 33. List of deaths by age; 34. information on treated villager inhabitants; 35 List of operated patients by departments; 36. list of patients operated on by doctors of the Department; 37. list of patients in breakdown by selected diagnoses; 38. list of patients with complications after surgery; 39. list of patients passing through resuscitation; 40. list of patients transferred to other hospital 41. list of treated patients who appeared to be healthy ; 42. list of patients having preferential category; Section VI. Technical requirements 143 43. list of patients admitted again within a month; 44. sex and age composition of treated patients by profiles; 45. report on services delivered by diagnostic departments; 46. Structure of patients with circulatory diseases in breakdown by nosology, age and outcome. 47. report on cured cases in breakdown by DRG. R2.14.2.2 M Monitoring of primary records maintenance of a health facility R2.14.2.3 M Report Designer with the ability to create new reports and modify existing R2.15 Module 15 «Procedures and manipulations » R2.15.1 M Management of patients EMR. It includes, at least: R2.15.1.1 M Full description of processes and requirements to EMR management in line with national standard of EMR (approved by MOH order №75 as of 10.02.2014 “On approval of technical documentation in e-health issues”) R2.15.1.2 M Minimal obligatory set of data from EMR is given to national EHR basing on national standard of EHR (approved by the same order) R2.15.1.3 M Patient identifier R2.15.1.4 M Mark on executed procedures R2.15.1.5 M Appointing the patient by time if there is a need to get services again R2.15.2 M Management of initial documentation for rendered services and manipulations according to regulations. It includes at least: R2.15.2.1 M 029/у, 042/у,044/у, 046/у, 047/у, 058/у, 063/у, 064/у, 064-1/у, 064-2/у, 069/у, 150/у R2.15.3 M Making up analytic tables on carried out procedures and manipulations and statistic tables according to regulations. It includes R2.15.3.1 M Reports: Report on carried out services (by used equipment, executers, funding sources types of services) 144 Section VI. Technical Requirements R2.16 Module 16 «Admin» R2.16.1 M Database management. This process includes, at least: R2.16.1.1 M Monitor and optimize of database performance R2.16.1.2 M Database Management: Configuration of repository, database extension R2.16.1.3 M Managing users and passwords of database R2.16.1.4 M Access rights management to database in accordance with Annex 1 R2.16.1.5 M Backing up data for a certain period of time R2.16.1.6 M Restoring the backup data on separate servers to find old data. R2.16.2 M Creating user groups and individual users of the system. This process includes, as a minimum: R2.16.2.1 M Create, delete, and edit user accounts; R2.16.2.2 M Create, delete, and modify user roles; R2.16.2.3 M Attaching roles to specific users (the same user can have multiple roles) R2.16.2.4 M Add, change, or delete access rights of roles to modules, initial rights shall be assigned in accordance with Annex 1. R2.16.2.5 M Temporary ban for user access to the System R2.16.3 M Manage authentication types (password, digital signature) This process includes, at least: R2.16.3.1 M Initial password creation R2.16.3.2 M Change passwords for those users who are not able to change them R2.16.3.3 M Change Password Management Policy R2.16.3.4 M Using foreign keys Section VI. Technical requirements 145 R2.16.3.5 M View attempts to access with an invalid key R2.16.4 M Maintain system logs. This process includes, as a minimum: R2.16.4.1 M Log of created, modified, and deleted records in the database R2.16.4.2 M Log of the users input history R2.16.4.3 M Log of receiving reports R2.16.4.4 M Log of data viewing R2.16.4.5 M Log of archiving actions R2.16.4.6 M Log of Errors and emergency program stops R2.16.4.7 M Log of synchronization with external (national) directories, classifications, indexes and registers R2.16.5 M Customization of medical records templates. This process includes, at least: R2.16.5.1 M Creating new templates R2.16.5.2 M Change (creating new versions) of existing templates R2.16.5.3 M Attaching templates to modules and their detachment R2.16.5.4 M The following functions are used when creating and editing the templates: • change the font settings (style, size, bold, underline, italics, etc. ) • changing the font color • the creation of complex patterns with subsections • the ability to use any directory in the system for filling in fields in the template • the ability to use any entity in the database for filling in fields in the template • the ability to use any data selection from the database for filling in fields in the template • forming fill rules: only from the list, from the list with possible matches, in free format, from the samples, etc. • creating new directories used when completing the template 146 Section VI. Technical Requirements R2.16.6 M Customizing user interface. This process includes, at least: R2.16.6.1 M Controlling access to interface tools depending on user access rights R2.16.6.2 M Change the style (for example: colors, size of fields, fonts) R2.16.6.3 M Option of making up individual templates for each user including assigning defaults to separate fields in pattern of this user R2.16.7 M Configuring user access. This process includes, at least: R2.16.7.1 M Adding, modifying, and deleting user rights on actions in the System R2.16.7.2 M Manage (add, edit and delete) access to data in the context of organizational structure of enterprise: within structural unit attached to the user, within the entire health facility, in accordance with organization structure of enterprise R2.16.7.3 M Fixing the right for user for view, creation, change and removal of data in certain structural units R2.16.7.4 M Add, change, or delete user access to reports R2.16.7.5 M Time Management - Schedule of work of employees, during which the user has access rights to the System R2.16.7.6 M Controlling access to patient data in accordance with the privacy policy of personal data approved by MHSD RK. R2.16.7.7 M Installation privacy indication for those personal data that must be stored in a database in encrypted form R2.16.7.8 M Viewing logs with the actions of specific users for a certain period of time R2.16.7.9 M Archiving and cleaning logs with data about user activity for a certain period in accordance with the policies of MHSD RK R2.16.7.10 M Viewing log files R2.16.8 M Setting of connection to external programs. This process includes, at least: R2.16.8.1 M Allowing access for certain IP addresses Section VI. Technical requirements 147 R2.16.8.2 M Resolution of certain programs and services R2.16.8.3 M Change access passwords of external programs R2.16.9 M Managing directories (references). This process includes, at least: R2.16.9.1 M Changing content (add, edit) of local directories of the system R2.16.9.2 M Monitoring the synchronization of external (national) directories, indexes and registers R2.16.9.3 M Monitoring of correctness (or potential problems ) of data exchange with external data sources (national EHR, national analytical repository) R2.16.9.4 M Change the synchronization schedule with external information resources R2.16.10 M Create, edit reports using the Report Master, which allow create and edit of reports with using of fields from System data base. This process includes, at least: R2.16.10.1 M Creating Reports R2.16.10.2 M editing reports R2.16.10.3 M Deleting reports R2.16.10.4 M Setting user rights to use reports R2.17 Module 17 «Lab IS» R2.17.1 M Registration of received material with the possibility of rejection. This process includes, at least: R2.17.1.1 M Doing personified account of ongoing research, support of patient cards in the LIS database R2.17.1.2 M Creating a new patient card by assigning a unique identification number after: automatically retrieve of data from other modules on the flow of new patient, automatically after receiving (reading) the referral, entry of patient data from the referral manually R2.17.1.3 M Reading standard forms using: optical recognition of symbols, optical 148 Section VI. Technical Requirements recognition of marks R2.17.1.4 M Registration of received material with reference to the patient R2.17.1.5 M Assigning a unique identification number to each material R2.17.1.6 M Ability to reject Receipt stating the reason (from the directory and / or manually) R2.17.1.7 M Generating reports: 1. Report on the quantity of incoming material 2. Report on quantity of rejected material for various reasons R2.17.2 M Barcoding material (creating barcode, identification by barcode). This process includes, as a minimum: R2.17.2.1 M Assigning a barcode for material R2.17.2.2 M Assigning a barcode for individual samples R2.17.2.3 M Read barcode using stationary and portable bar code scanners R2.17.2.4 M Support for processing the data on the basis of the majority of these bar codes: Code 39, Code 93, Code 128, Codebar, European Article Number (EAN), ITF14, MSI Barcode, Universal Product Code, as well as two-dimensional codes PDF417, Aztec Code, Data Matrix, Maxi Code, QR-code, Microsoft Tag R2.17.3 M Formation of worksheets for laboratory analyzers and executors. This process includes, at least: R2.17.3.1 M Formation of orders for analysis based on referrals received from HIS R2.17.3.2 M Formation of orders for analysis based on manual data entry R2.17.3.3 M Inclusion of several materials to one order R2.17.3.4 M Using of service profiles for ordering (multiple studies) R2.17.3.5 M Order of integrated services (one service with multiple materials) R2.17.3.6 M Automatic distribution of analysis on worksheets based on configurable criteria (type of analysis, analysis time , executor) Section VI. Technical requirements 149 R2.17.3.7 M Manual distribution of analysis on work places R2.17.3.8 M Redistribution of analysis from selected worksheets to other worksheets R2.17.3.9 M Changing the executor in a worksheet R2.17.3.10 M Prints worksheets to perform manual research R2.17.4 M Interaction with laboratory equipment (export referrals to analysis, import of analysis results). This process includes, at least: R2.17.4.1 M Connecting analyzers , sample preparation stations and other equipment that have the ability to connect to LIS R2.17.4.2 M Submit orders to analyzers R2.17.4.3 M Getting results from the analyzers and their distribution in the patient cards R2.17.4.4 M Getting results of internal quality control from analyzers R2.17.4.5 M Viewing, editing, deleting, editing, approving of the results R2.17.5 M Manual entry of laboratory results. This process includes, at least: R2.17.5.1 M Setting up a result templates R2.17.5.2 M Manual entry of finished research results R2.17.5.3 M Adjustable calculation algorithm of the finished results based on input data R2.17.5.4 M Processing of the results of bacteriological analysis: • The processing system must be open and allow the user within embedded in the system classification to add independently the sections such as: antibiotics, diagnoses, biomaterials, micro-organisms, • A list of diagnoses in the system shall be composed by ICD-10, the list of antimicrobials shall be drawn up according to international classification, the list of taxons - on the latest edition of "Bergey's Manual of Determinative Bacteriology" • antibiogram shall be built based on the data entered by the user and received by any of the methods (disk diffusion, by limiting concentrations or when determining the minimum inhibitory concentration) 150 Section VI. Technical Requirements • The processing system, based on embedded data on the natural stability of individual organisms or their groups, on distribution among them acquired resistance, as well as information about clinical efficiency of antimicrobial agents, shall interpret the results of studies of antibiotic susceptibility, obtained in vitro, to the degree of sensitivity (S, I, R) and, if necessary , correct them or generate an error message R2.17.5.5 M Forming of reports: 1. Report on completed analysis 2. Report on antibiotic resistance of isolates (in general in a health facility and by its units) 3. Report on types of lab studies (clinic, biochemical, hematological, immunological, bacteriological and etc.) 4. 261 / y 5. 262 / y 6. Form # 1 POA (Report expensive services compared with plan) R2.17.6 M Validation of the results of laboratory research laboratories by authorized employee. This process includes, at least: R2.17.6.1 M Viewing results of an analysis execution R2.17.6.2 M Comparison with the reference values with visual indication of deviations R2.17.6.3 M Construction of control charts to evaluate the quality of results R2.17.7 M Laboratory quality control (intralaboratory, interlaboratory, external). This process includes, at least: R2.17.7.1 M Registration of the daily results of the control materials study R2.17.7.2 M Register reference values of control materials R2.17.7.3 M Comparison of obtained values with the reference values R2.17.7.4 M Formation of control materials research protocols for interlaboratory and external comparisons Section VI. Technical requirements 151 R2.17.8 M Printing the results on the basis of approved legal acts for initial records . This process includes, at least: R2.17.8.1 M Creating and editing templates, forms and logs R2.17.8.2 M Print the results in accordance with the approved (R2.18.10.1) and user’s forms R2.17.8.3 M Print the logs in accordance with the approved forms (R2.18.10.1) R2.17.9 M Input of laboratory reference values for all patients, by age and sex. This process includes, at least: R2.17.9.1 M Input of reference values by age and sex R2.17.9.2 M Formation of the reference values of individual indicators based on statistical processing of laboratory results R2.17.9.3 M Generating reports: Laboratory reference values (by groups of patients and types of lab studies) R2.17.10 M R2.17.10.1 M 1. Management of initial registration documentation at laboratory level basing on regulatory norms. This includes at least: 014/у, 027-3/у, 200/у, 201/у, 202/у, 204/у, 205/у, 206/у, 207/у, 208/у, 210/у, 211/у, 214/у, 215/у, 216/у, 216-1/у, 216-2/у, 217/у, 218/у, 219/у, 220/у, 221/у, 222-1/у, 223/у, 224/у, 227/у, 228/у, 230/у, 232/у, 233/у, 234/у, 235/у, 236/у, 237/у, 238/у, 239/у, 240/у, 240-4/у, 240-5/у, 240-6/у, 240-7/у, 240-8/у, 240-10/у, 240-11/у, 240-12/у, 241/у, 242/у, 244/у, 244-1/у, 244-2/у, 244-3/у, 245/у, 245-1/у, 248/у, 249/у,250/у, 252/у, 253/у, 253-1/у, 253-2/у, 254/у, 260/у, 251/у, 257/у, 259/у, 261/у, 262/у,280/у, R2.17.11 M Formation of analytical tables at the laboratory level, as well as statistical tables in accordance with the legal regulations. This process includes, at least: R2.17.11.1 M Generating a report on completed analysis (Form 30) R2.17.12 The ability to integrate the System with independent laboratory information systems. This process presupposes compliance with required profiles of IHE M 152 R2.17.13 Section VI. Technical Requirements M The transmission of information on completed research to EMR and EHR. This process includes, at least: R2.17.13.1 M Transmission of data about laboratory tests performed and their results to EHR in accordance with the standard requirements for EHR, approved by Order of the Acting Minister of Health of 10.02.2014 № 75 "On approval of technical documentation related to e-health" R2.17.13.2 M Transmission of laboratory tests performed and their results to the EMR in accordance with the standard requirements for EMRs, approved by Order of the Acting Minister of Health of 10.02.2014 № 75 "On approval of technical documentation related to e-health" R2.18 Module 18 «PACS» (Picture Archiving and Communication System) R2.18.1 M Data exchange with medical equipment. It includes at least: R2.18.1.1 M Data import pursuant to standard DICOM (sectoral standard for health image creation, storage, transmission and visualization). R2.18.1.2 M Import directly from video outputs (if the necessary equipment is in place) R2.18.2 M Interaction with other modules and systems based on IHE profiles. R2.18.3 M Import / export of images. This process includes, at least: R2.18.3.1 M Supporting of at least DICOM, BMP, JPEG formats R2.18.3.2 M Support for at least DICOM Modality Worklist R2.18.3.3 M Ability to save images as attachments to CDA documents R2.18.3.4 M Supports scanning of paper and film images to produce an electronic archive R2.18.3.5 M Audit of imports and exports cases R2.18.4 M Working with images. This process includes, at least: R2.18.4.1 M Viewing single and series of images, R2.18.4.2 M Calling from the archive and the appearance of the image on the screen is not later than 3-5 seconds after the request Section VI. Technical requirements 153 R2.18.4.3 M Identification of areas of interest in the image , R2.18.4.4 M Overlay comments R2.18.4.5 M Image processing to improve the quality R2.18.4.6 M Quick search of patient data and images of the patient R2.18.4.7 M Interlinks between patient metadata and images R2.18.4.8 M Connection images with interpretation and diagnostic results R2.18.4.9 M Audit of Imagines View and Edit R2.18.5 M Maintain archive of images. This process includes, at least: R2.18.5.1 M The possibility of long-term storage of images R2.18.5.2 M Keeping the identity of the patient to avoid errors in assigning images to other patients. R2.18.5.3 M The ability to integrate with other systems in health facility R2.18.5.4 M The ability to transmit image (if necessary) to other systems and to the national EHR repository R2.19 Module 19 «Diagnostic studies» R2.19.1 M View records on schedule of patients. This process includes, at least: R2.19.1.1 M View the schedule of patients R2.19.1.2 M Viewing of referrals to the diagnostic studies R2.19.1.3 M Getting a list of patients recorded to the study R2.19.1.4 M Cancellation or postponement of time of studies with indication of reasons for the delay and stakeholders notification R2.19.1.5 M Reports generating: 1. Report on appointments 154 Section VI. Technical Requirements 2. Report on the canceled visits 3. Report on the services performed 4. Report on radiation doses for staff and patient 5. Report on priorities and term of waiting for diagnostic studies 6. Forming the list of patients in breakdown by rendered services by codes of tarrificator R2.19.2 M Enter the results of research based on templates. This process includes, at least: R2.19.2.1 M Creating and editing templates for consultation, conclusions, results of research R2.19.2.2 M Filling of research results based on templates R2.19.2.3 M Search of previous patient conclusions R2.19.2.4 M Printing of research results according to approved forms R2.19.2.5 M Reports forming: 1. Report on services rendered (by equipment, executors, funding sources, research types, referred divisions) 2. Report on radiation doses for staff and patient 3. List of patients in breakdown by rendered services by codes of tarrificator R2.19.3 M Management of initial registration documentation on diagnostic studies basing on regulatory norms. This includes at least: R2.19.3.1 M 001-4/у, 001-5/у, 028/у, 039-5/у, 039-7/у, 039-8/у, 050/у, 202/у, 203/у, 212/у, 213/у, 225/у, 226/у, 229/у, 231/у, 243/у, 243-1/у, 246/у, 247/у, 247-1/у, 2472/у, 247-3/у, 247-3/1/у ,247-3/2/у, 247-4/у, 247-5/у, 247-6/у, 247-7/у, R2.19.3.2 M Protocol for measuring individual doses (MOH order №902 as of 20.12.11) R2.19.4 M Formation of analytical tables for diagnostic tests, as well as statistical tables in accordance with the legal regulations. The list of analytic and statistic forms shall be agreed with the Client at the stage of System design R2.19.5 M The transmission of information on completed research to EHR and EMR. This process includes, at least: R2.19.5.1 M Transmission of information on diagnostic tests performed and their results in Section VI. Technical requirements 155 EHR in accordance with the standard for EHR approved by Order Acting Minister of Health of 10.02.2014 № 75 "On approval of technical documentation related to e-health " R2.19.5.2 M Transmission of information on diagnostic tests performed and their results in the EMR in accordance with the standard requirements for EMRs , approved by Order of the Acting Minister of Health of 10.02.2014 № 75 "On approval of technical documentation related to e-health" R2.19.5.3 M Implementation of the exchange in accordance with IHE profiles R2.20 Module 20 «Pharmacy» R2.20.1 M Record keeping for medicines at different levels: nurse’s station, office, pharmacy warehouse (one or more), health facility. This process includes, at least: R2.20.1.1 M Maintain full inventory control on one or more central warehouses R2.20.1.2 M Maintain full inventory control for each responsible person R2.20.1.3 M View stored remainings in each stock (by group of medicines, by pharmacological and pharmacotoxic groups, on medicines, by supplier, by department) R2.20.1.4 M Setting the number of minimum balances for each medication R2.20.1.5 M Establishing the baseline medication lists for each department R2.20.1.6 M Control over the implementation of minimum balances R2.20.2 M Automatic write-off of drugs when prescription is executed R2.20.3 M Ability to track expiration dates of medicines and medical devices. R2.20.4 M The possibility of forming a list of medicines (medical devices) required to purchase in health facility. R2.20.5 M Formation of order to the pharmacy to get drugs (automatic urgent order if medicine is in the treatment sheet but lack in the department, in case of reducing the stock below the critical minimum). This includes at least: 156 Section VI. Technical Requirements R2.20.6 M Getting information about the presence of the drug in the departments. This includes at least: R2.20.7 M Maintenance of the drug formulary of health facility. This process includes, at least: R2.20.7.1 M Creation of the formulary of a health facility R2.20.7.2 M Adding medications into the formulary of a health facility with indication of justification document R2.20.7.3 M Exclusion of drugs from formulary of a health facility with indication of justification document R2.20.8 M Register of side effects of the drug. This process includes, at least: R2.20.8.1 M Forming of card-message (form №192-1/у by MOH order as of 3.11.2009, №647) R2.20.8.2 M Register case in Log for revealed cases of side effect from drugs (Form №1923/у MOH order as of 03.11. 2009, № 647) R2.20.8.3 M Reports: 1. Making up statistic reports on revealed cases of side effect from drugs and lack of effectiveness of the drug in medical and pharmaceutical agency (Form №192-4/у MOH order as of 03.11. 2009, №647) R2.20.9 M Monitoring of prescriptions of drugs. This process includes, at least: R2.20.9.1 M Viewing prescriptions of drugs in units of a health facility R2.20.9.2 M Sorting prescriptions by date, doctor, diagnosis, and other parameters R2.20.9.3 M View the links between diagnosis and drugs R2.20.9.4 M Enter the data about drugs, recommended clinical guidelines and protocols of diagnosis and treatment R2.20.9.5 M Entering data on interaction of drugs to prevent joint prescription R2.20.9.6 M Comparison of prescriptions with the list in accordance with clinical protocols and guidelines Section VI. Technical requirements 157 R2.20.9.7 M Sending messages with the recommendation to replace the drugs R2.20.10 M Setting maximum dosages for control purposes. This process includes, at least: R2.20.10.1 M Setting the maximum dosage in various forms (kg per body mass, single, daily, etc.) R2.20.10.2 M Setting maximum dosages for different groups of patients with various age and sex R2.20.10.3 M Setting maximum dosages for individual diseases R2.20.10.4 M Viewing applications for exceeding the specified maximum dosages R2.20.10.5 M Permission to exceed the specified maximum dosages with reasons R2.20.11 Registration and execution of credit and debit invoices of hospital units and pharmacies in accordance with the regulations. This process includes, at least: M R2.20.11.1 M Create, edit, and check invoices R2.20.11.2 M Creating, editing and recording of credit and debit invoices R2.20.11.3 M Formation of requirements for medicines from senior nurses of a department, including on the basis of registered prescriptions R2.20.11.4 M Making consignment statement for medicines and supplies according to the requirements for the supply of medicines from senior nurses of departments R2.20.11.5 M Create, edit, and register the return of medicines from departments to the warehouse R2.20.11.6 M Creating, editing and recording of orders to suppliers R2.20.11.7 M Creating, editing and recording of deferred credit and debit invoices to fulfill orders for medicines R2.20.12 M Management of initial registration documentation on pharmacy level in accordance with legal regulations. R2.20.13 M Formation of analytical tables at the pharmacy level, as well as statistic tables in accordance with the legal regulations. The list of analytic and statistic forms 158 Section VI. Technical Requirements shall be agreed with the Client at the stage of System design. R2.20.14 M Forming application for required medicines at the level of a department, outpatient clinic, hospital basing on served area R2.20.15 M Forming report on planning expenditures for medicines given the benefit medicines R2.20.16 M Interaction with other Modules in case of need to exchange data on drugs R2.21 Module 21 «Human Resources R2.21.1 M Communication with national indexes. It includes at least following indexes: R2.21.1.1 M “Register of Healthcare professionals” R2.21.1.2 M “Register of Health facilities” R2.21.1.3 M “Register of Addresses” R2.21.1.4 M “Health specialties” R2.21.1.5 M “List of positions (duties)” R2.21.1.6 M “List of medical services” R2.21.2 M Maintenance of organizational structure of health facility. It includes at least: R2.21.2.1 M Making up, editing, removal of units in health facilities (rooms, units, departments, and etc. in line with organizational structure of facility) R2.21.2.2 M Maintenance of health facility staff schedule R2.21.2.3 M Making up statements for substitution of officials R2.21.2.4 M Linkages between rooms/ offices and specialists R2.21.2.5 M Linkage of units with the list of provided services R2.21.3 M Maintenance of doctors (health facility staff) registration card. It includes at least: Section VI. Technical requirements R2.21.3.1 M Employment of specialist R2.21.3.2 M Enter of following minimal information about the employee: 159 The history of labor relations, episodes of employment, personal information (ID number , the number of the pension contract, marital status, family, place of residence, place of registration, contact information, number of children, relation to military service, the number of individual employment contract), information about participation in hostilities, emergency response, disaster relief, promotion, levy, knowledge of languages, information on social rewards, education, professional certifications, trainings, academic degrees, science degrees. R2.21.3.3 M Registration of employees’ liability for damage R2.21.3.4 M Employment for the additional position R2.21.3.5 M Transfer to another position within the health facility R2.21.3.6 M Dismissal of an employee R2.21.3.7 M Management of Capacity building schedule R2.21.3.8 M View and print a list of employees selected according to certain criteria R2.21.4 M Keeping employees work mode. This process includes, at least: R2.21.4.1 M Planning and accounting of days off and vacations of employees R2.21.4.2 M Compilation of working regime given the weekends and holidays R2.21.4.3 M Accounting replacements and unscheduled absence R2.21.4.4 M Printing regime of work and schedule of vocations by individuals, rooms (health service provision points), by departments, by facility R2.21.4.5 M Printing statement on actually period of work, vocation by individuals, rooms (health service provision points), by departments, by facility R2.21.5 M Reference of services management. It includes, at least: R2.21.5.1 M Links with national index of services 160 Section VI. Technical Requirements R2.21.5.2 M Adding and removal of services out of facility service reference R2.21.5.3 M Service attaching to facility units R2.21.5.4 M Review and printing of list of services for each unit and facility R2.21.6 M Interaction with accounting IS (at list with «1C» software). It includes, at least: R2.21.6.1 M Data transfer on new specialists R2.21.6.2 M Data transfer on changed positions R2.21.6.3 M Data transfer on worked days (hours) R2.21.6.4 M Data exchange on vocations of specialists R3 Requirements to System configuration R3.1 Configuration to health facility needs R3.1.1 М Delivered system shall contain mandatory modules in its composition in accordance with Table 1, depending on the type of health facility: Hospital, Policlinic, Mixed type (Hospital+ Policlinic) (see also R1.17-R1.18) R3.1.2 М The System shall provide ability to control access to functionality based on roles. The system shall allow to add / delete / edit the role and assign / cancel the right of access to the system functionality R3.1.3 М The System shall have preset role in accordance with Table 3, with further changes (adding new roles, edit or delete). R3.1.4 М Access rights to different modules and functions of the System shall be preinstalled in accordance with Table 4 with the ability to change access rights (add, delete) R3.1.5 М Access right shall be configurable at least on the following aspects: all rights, to create, to modify, to delete, to view Table 3. System roles description Section VI. Technical requirements № 1. Roles Composer of schedules Specialist is responsible for the formation of schedules of services (counseling, equipment work). Position: medical registration expert, senior nurse, head of the department. Specialist in outpatient registration unit in a health facility. Performs the functions of reference as well as an appointment to district doctors and profile specialists. Receives and records the calls at home and transferred active information. Position: Nurse, medical registration expert. Senior nurse Specialist who coordinates nursing staff in department or organization. Keeps track of spending medicines and medical devices in department, draws requirements for delivery of drugs and medical devices. May do functions of nurse. Position: Chief Nurse, senior nurse, Deputy Chief of Nursing 3. 5. Description Medical receptionist 2. 4. 161 Head of policlinic department District doctor 6. Preventive department doctor 7. Profile specialist Specialist to coordinate the work of medical staff in the department. Approves issuance of sheets of temporary disability, involved into the work of MCB. Position: Head of Department PHC specialist. Manages EHR, provides professional care, performs treatment and preventive measures as outpatients in the clinic and at home. If necessary, creates a referral to consultative and diagnostic care. Makes prescriptions for free of charge drugs. Makes application for hospitalization. Title: GPs, district therapist, district pediatrician Preventive department doctor for targeted screening of population, professional exams and other preventive examinations. If necessary, creates a referral to consultative and diagnostic care. Profile specialist can be both therapeutic (GPs) and specialized. Position: doctor in preventive unit, ophthalmologist, otolaryngologist , gynecologist, therapist, urologist, psychiatrist, dermatovenerologist, pathologist, surgeon, etc. Profile specialist provides specialized care on outpatient 162 Section VI. Technical Requirements level. Oversees dispensary treatment groups (target groups of patients). If necessary, creates referrals to consultative and diagnostic care. Position: ophthalmologist, otolaryngologist , gynecologist, therapist, urologist, psychiatrist, dermatovenerologist, pathologist, surgeon, etc. 8. 9. 10. 11. 12. Health facility administrator (chief doctor) Medical statistic specialist in policlinic District doctor’s nurse Preventive department nurse Nurse of specialist The first head of the organization. Takes management decisions, determines policy of organization. Manages personnel structure. Has the right to sign financial documents Position: Chief Doctor, General Director, Chairman of the Board Medical statistic specialist. Collecting, processing and analysis of statistical data on the basis of primary records. Generates accounting documents for submission to authorities. Position: Medical statistics, assistant medical statistics, deputy chief physician for organizational and methodological work, manager of organizational and methodical department. Specialist performing treatment and preventive measures to population attached to the district under supervision of district doctor Position: nurse, paramedic Specialist performing preventive measures to population attached to the district under supervision of preventive department doctor or profile doctor. Position: nurse, paramedic Specialist performing preventive measures to population attached to the district under supervision of profile doctor. Position: nurse, paramedic, obstetrician 13. Doctor at admission’s Specialist performs patient hospitalization into hospitals. Produces hospitalization procedure and rejection in it. Produces primary clinical examination and establishes disease history. Position: doctor, Head of Department 14. Nurse at admission’s Specialist helping in patient hospitalization, acts under admission doctor governance. Position: nurse, chief nurse Section VI. Technical requirements 15. Head of Hospital department 16. Medical statistic specialist in hospital 17. Hospital doctor 18. Hospital nurse 19. Specialist in feeding department 20. Admin 21. Lab specialist’ assistant 22. Lab specialist 23. Laboratory Doctor 24. Diagnostic department doctor 163 Specialist who coordinates work of medical staff in department. Approves lists of temporary disability, takes part in medical consultations. Position: Head of Department Specialist in medical statistics. Collecting, processing and analysis of statistical data on the basis of primary records. Generates accounting documents for submission to the authorities. Position: Medical statistics, assistant medical statistics, deputy chief doctor for organizational and methodological work, head of organizational and methodical office. Specialist for provision of secondary and tertiary care in hospital. If necessary, creates a referral to consultative and diagnostic assistance in the hospital. Prepares documents for hospitalization (disease history, form 066/y, discharge summary) Position: therapist, pediatrician, ophthalmologist, gynecologist, internist, urologist, psychiatrist, skin and venereal diseases, pathologist, surgeon, etc. Specialist that performs prescription and direct care for the patient. Position: nurse in the medical point, nurse in treatment room , nurse of specialist, senior nurse, chief nurse, obstetrician Specialist for estimation and preparing meals for patients. Position: nutritionist, a nurse of nutritionist, cook Specialist provides technical support for the system and its configuration. Position: Information Systems Specialist, Systems Administrator, Programmer Specialist performs laboratory tests under the supervision of laboratory specialist or laboratory doctor Position: laboratory technician, laboratory paramedic Specialist performs laboratory tests under the supervision of laboratory doctor Position: Laboratory Specialist, paramedic Specialist performing laboratory tests and control over their reliability and quality. Position: Laboratory Doctor Specialist performs diagnostic tests according to doctors referrals. Position: radiologist, doctor of functional diagnostics, ultrasound doctor 164 Section VI. Technical Requirements 25. Pharmacist 26. Chief Pharmacist 27. Clinical pharmacologist 28. 1.1.4 HR specialist Specialist in production, storage and sale of drugs working under the supervision of chief pharmacist. Position: pharmacist Specialist in production, storage and sale of drugs. Position: chief pharmacist Specialist to assess the impact of drugs on the body of sick person. Advises doctors about prescribing and adjusting treatments. Position: clinical pharmacologist Specialist in registration of labor relations, personnel records and their data Position: Head of HR department, HR Specialist Legal background Minimal package of legal documents to be followed herein: 1) Law of the RK «On national Security of the RK» № 527-IV as of January (http://online.zakon.kz/Document/?doc_id=31106860); 6, 2012 2) Decree of the President of the RK as of November 14, 2011, № 174 " On Concept of national Security of the RK till 2016» (http://ru.government.kz/docs/u110000017420111114.htm); 3) Code of the RK N 193-IV as of 18.09.2009 “On Health of population and Healthcare system”; 4) Law of the RK “on personal data and their protection” N 94-V as of 21 May (http://online.zakon.kz/Document/?doc_id=31396226); 2013 5) MOH RK order as of 23.11.2010, № 907 «On approval of forms of initial medical documentation for health facilities» 6) MOH RK order №75 as of 10.02.2014 г «On approval of technical documentation in ehealth». (https://www.mzsr.gov.kz/node/319759) 1.2 Requirements to functional features of the System 1.2.2. Non-functional requirements 1.2.2.1. Requirements to System feedback Section VI. Technical requirements 165 The table below contains a list of functional requirements for system performance, which shall be followed by delivered systems and related systems / services Type Requirement M Patient search by name or IIN and patient-related data (results of the survey, the results of laboratory tests, etc.) shall take no more than 3-5 seconds for 80% of cases М Potential Supplier during warranty period shall ensure the functioning of the following options: R4.2.1 М The total downtime of System for the reason related to its operability shall not exceed 24 hours per year. R4.2.2 М Onetime of System downtime for the reason related to its operability shall not exceed 2 hours. R4.2 1.2.2.2. R5 Requirements to Informational Security Requirements to Informational Security R5.1. M Security requirements are defined by current legislation of the Republic of Kazakhstan. The system shall meet requirements of information security to ensure access threshold, protection from unauthorized access, etc. R5.2. M The system shall provide protection of information from unauthorized access, namely: R5.3. M User authentication based on checking the name (login) and password R5.4. M Ability to identify user based on digital certificates of open key infrastructure R5.5. M User authorization for access to system information and computing resources requiring appropriate permissions R5.6. M Personalized definition of the rights of users to input , corrections , viewing of data 166 Section VI. Technical Requirements R5.7. M Personalized definition of the rights of users to access system resources R5.8. M Differentiation of system user rights by roles, groups and access levels based on hierarchy of objects and attachment to organizational structure. R5.9. M Logging of users work with system critical features and applications R5.10. M Protect the system files from modification / damage by unauthorized users and software processes R5.11. M Control log shall be maintained of all updates of the system software libraries R5.12. M The system shall implement at least the following backup: - Automatic backup with option to plan it - Remote control over backup making - Full and partial backups R5.13. M The system shall ensure data integrity. R5.14. M The system shall provide tools for encrypting sensitive data during storage and during transmission to other systems. R5.15. M Digital signature (registration certificate of user by National Authorizing Center of the RK) shall be issued by NAC RK. The system shall provide the tools for digitally signing of documents (objects) or portions of documents, when / if it is needed, and the tools for authenticating signatures. This feature shall be implemented in system services (if necessary). To ensure confirmation of digital signature authenticity and validity of opened key of digital signature, the System shall provide check for e-signature authenticity using services of NAC RK (http://pki.gov.kz/index.php/ru/). R5.16. M System shall comply with the principle of "single access point" - the architecture of the information infrastructure allows to have a common access point (technology Single Sign On) to all its components and resources that allows you to enter the username and password once and gain access to all system components without re-entering the password. R5.17. M The System shall provide authorization of users in the system, distinction between the rights of users of the system by roles, groups and access levels Section VI. Technical requirements 167 based on hierarchy of objects and accessories to organizational structure. R5.18. M In accordance with legal and technical documentation for information security, approved by the MHSD RK the following shall be implemented: - The length of the password shall be at least 8 characters, numbers and letters shall be present in upper and lower case; - Forced password change function; - Barring use as a password of "empty" password; - password change independently by user; - If wrong password is entered more than three times CAPTCHA method shall be implemented; - Journal of logging activities of all users for viewing the history of changes of main event of the System; - Function of interrupting session when inactive after N period of time 1.2.2.3. N Type R6 Requirements to System quality attributes Requirement Requirements to System quality attributes R6.1. M The system shall support input, transmitting and receiving data necessary for operation of MHSD information systems used by the health facility and eliminating the needs to re-enter data. R6.2. M The system shall ensure preservation of all accumulated information at the time of the refusal or failure in case of failure of any component of the system, regardless of its destination, with recovery of data after repair and restoration works R6.3. M The system shall have flexibility to change settings in external environment and specific user tasks without replacing modules. R6.4. M The system shall be highly scalable and allow to work in an unlimited number of users. Constraints can be driven only by technical characteristics of the equipment, not by characteristics of System R6.5. M All functional capabilities of the system shall be designed in the form of services. 168 Section VI. Technical Requirements R6.6. M Web services of the System shall be designed in accordance with SOA architecture. R6.7. М When implementing services interaction it is necessarily stick to the standard of MHSD RK concerning information systems interaction R6.8. M The system shall enable construction of templates for approved medical forms available within the solution itself, which can be automated without programming or changes of the program code. R6.9. M The system shall be capable of resolving conflicts when parallel processing system objects. R6.10. M Requirements for user interfaces R6.10.1 M The interface shall be designed for the preferential use of manipulator "mouse" , i.e., the system control shall be carried out using a set of onscreen menu, buttons, icons and similar items R6.10.2 M Keyboard input mode shall be used primarily during filling and / or editing text and numeric fields screen forms. It shall also provide hotkeys to switch between filled files. R6.10.3 M Ergonomic solutions and interface design as much as possible shall be uniform for all system components and modules R6.10.4 M User interface systems shall be multilingual and organized with the support of at least state (Kazakh) and Russian languages. Exceptions can only be system messages not localized or standard administrative applications that make up the system software R6.10.5 M Access to electronic operational documentation shall be available R6.10.6 M The context- sensitive help system shall be implemented in the System, accessible from any web application, where links shall be submitted to information (user manual , instructions , etc.), with possibility of configuration without involvement of potential suppliers at the Purchaser level; R6.10.7 M The UI system shall provide visual selection of screen attributes which are available to the operator as read-only Section VI. Technical requirements 169 R6.10.8 M The UI system shall provide visual selection of screen attributes which are mandatory for filling in R6.10.9 M The system shall ensure correct handling of emergencies caused by incorrect user actions, incorrect format or invalid values input. In these cases the system shall give the user a relevant message, and then return to the operating state prior to incorrect (invalid) command or data entry R6.10.10 M System shall not allow duplication and repeated (incorrect) input of homogeneous information. The system should ensure elimination of duplication and re-enter the information contained in public databases and information systems of state bodies R6.10.11 M The system shall provide the format-logical control of input data for all values in the system. Format logical control of entered data means control over format and content of entered data. The System shall provide protection against erroneous actions: - Choose only available to the user (in accordance with permissions) functions; - Enter only available to the user (in accordance with permissions) data values; - Input only certain format (eg, inability to input character data in the format field "Date" or "Number"). 1.3 № Requirements to System interoperability Type Requirement R7 Requirements to System interoperability R7.1. General Requirements to System interoperability R7.1.1 M System solutions and application shall meet standards of interoperability, including national standards and accepted international standards listed in this chapter (and in this document). R7.1.2 M System components must conform to the national instruments of semantics: o References and classifiers o Requirements for reference services 170 Section VI. Technical Requirements o Requirements for registers and registers services o Requirements for resource management and accounting Details on the requirements for these instruments are given later in this section (R7.3). R7.1.3 I R7.2. R7.2.1 Some of interoperability tools, described below, are in the process of development and the latest versions are available on request to potential suppliers. Basic standards are listed on the MHSD site (Order №75 as of 10.02.2014 https://www.mzsr.gov.kz/node/319759 Compliance with standards M System components shall be compatible at least with the following standards of MHSD RK: 1) Standard requirements for the electronic health record (requiring compliance with EN 13940 ) 2) Standard requirements for electronic medical records (requiring compliance with EN 13940 ) 3) Standard requirements for identification of stakeholders of health systems used in e-health systems 4) Technical requirements for the interaction (communication) with the information systems of e-health 5) Regulation on information 6) Standard requirements for single classifier of medicines, medical devices and medical equipment 7) Standard requirements for implementation and management of electronic directions 8) Regulation of interaction of stakeholders in order to ensure interoperability of information systems and information management 9) Standard for regulation of e-receipts management 10) Standard for management of e-processes of diagnostic studies and cure procedures 11) Standard for regulation of e-preventing of diseases These standards and regulations https://www.mzsr.gov.kz/taxonomy/term/619 R7.2.2 M are available on System components shall be compatible with following international Section VI. Technical requirements 171 standards: a. EN 13940(regarding the need to comply with EHR and EMR) b. HL7 v3 (ISO/HL7 27831), HL7 (v2 or V3 or FHIR); c. HL7 CDA R2 (ISO/ HL7 27932) d. R7.2.3 M DICOM the System shall meet the requirements of standards on Information Security: - ST RK ISO /IEC 27001-2008 «Security assurance methods and means for Information Security Management System. Requirements»; - ST RK ISO /IEC 27002-2009 «Information Technology. Support means, Code of rules on information protection management». R7.3. R7.3.1 Requirements for compatibility with national standard identifiers and classifiers / references M System components shall support and comply with the national identifiers: - Patient Identifier - Identifier of health facilities - Identifier of health specialists - Identifier of medical equipment R7.3.2 M System components shall support and comply with at least the following national classifiers and references: 1) The National Classification of medicines and medical supplies (mapped to the ATC-DDD) 2) Classification of health services (based on ICD-9, a section on services and manipulations) 3) Classification of laboratory results 4) Classification of services and their costs 5) Classification of diagnoses (ICD- 10) 6) Classification of primary care (ICPC- 2) 7) Mapping of ICPC- 2 and ICD-10 8 ) SNOMED, (only for the purpose of coding the connection between the System and EHR Repository) 172 Section VI. Technical Requirements 9) Improved classification system must be determined at a later stage to control diagnostic services; 10) Realized by MHSD national DRG system for classifying patients (for specialized care); 11) Classification of registers of target groups of patients (dispensary group) 12) care tarrificator; 13) Specialties in healthcare 14) List of positions. R7.4. R7.4.1 Requirements to compatibility / correspondence of data M System components shall provide a link between systems and National Health Information and Interoperability Platform containing Repository EHR based on the following data: - The minimum data set for EHR (set in National Standards for EHR and EMR) - Other data not covered by semantic standards, but necessary under the normative legal acts of the MHSD, such as Attached Special Records (documents based on CDA) R7.4.2 M The system shall provide access to data stored in the EHR repository, according to two types of EHR: Full EHR, short EHR. Details are described in National Standard for EHR. R7.4.3 M Data is transferred between the system and Repository EHR in CDA format R7.4.4 M Information transmitted in the EHR repository is organized on the basis of ICPC- 2 codes that are used in encounters (and contacts in general) and mapped to the ICD-10 for the purpose of statistics collecting. In EMR information systems (except EHR/ PHC systems) professionals use ICD10 for diagnosis coding and mapping in the reverse direction is not required, but desirable. R7.4.5 I Systems may have additional databases and repositories needed for full implementation of functionality (called EMRs in MHSD context), but they are kept separately from EHR repository database. EHR Repository content shall strictly regulate the national standard for EHR . R7.4.6 M The system shall be opened enough to be able to provide interoperability with existing IS, applications and services of IS MHSD (see also Section Section VI. Technical requirements 173 1.4.2). R7.5. Requirements to information exchange R7.5.1 M The system shall interact with national system of EHR according to National standards for EHR and EMR R7.5.2 M The system shall support (at least) interaction with the following sets of services of e-health: - Services of EHR Repository; - Services of reference information; - Services of registration and registers; - Services of Clinical Nomenclature and classification of data; - Services of safe exchange of data and messaging; - Services of identification and authentication; - Services for the monitoring and auditing of information exchange. R7.5.3 M The system shall correspond to at least following profiles of IHE a) Infrastructural profiles of IHE: - ATNA; - XDS.b; - PDQ; - PIX; b) lab profiles of IHE: - LBL; - LWT. R7.5.4 M The system should provide opportunities for interaction / integration with at least the following protocols and specifications: - Communication via SOAP (SOAP message and application), REST, Message Transmission Optimization Mechanism; - Support for standards and specifications of Web services (WS-Security, WS-Addressing, WS-Reliable Messaging, WS-coordination, WSTransaction, WS-Secure Conversation); - meet the standards of XML (XML, XSL, ebXML, and others.); - maintain SSO and access control across the SAML v2, JWT; 174 Section VI. Technical Requirements - supports common standards such as HTTP, HTTPS, TCP / IP, the protocols Secure Sockets Layer (SSL v3) and TLS; - allowing the use of WSDL, WADL; - X.509; - The digital signature (of NAC RK) R7.5.5 M the system shall support coding of at least UTF8 R7.5.6 M The system shall interact with the Platform services at channel speed of 1 Mb / s and the response time less than 100 ms R7.5.7 M The system shall interact with Platform services in terms of: - transmit / receive notifications and other information of informative character on the gateway of "electronic government"; - sending of SMS-notifications, and other types of distribution via SMS gateway of system of mobile government; - sending emails to patients through a single e-mail system; - information about the powers of attorney out of the state information system Single Notary Information System; - obtain information from the records to the doctor; - obtain minimal information about the employee M R7.5.8 Information on main HIS is set in Annex 3 1.4 Associated information on technology of some issues 1.4.1 Use of national e-health resources and HII Platform tools The System shall be able to use national resources and published services of Kazakhstan ehealth № Type Requirement R8 Use of national e-health resources and HII Platform tools R8.1. M System shall be able to operate in line with general e-health architecture (Pic 2) R8.2. M The system shall be able to use functionality and web services, published at the national level to communicate with e- Health resources R8.3. M The system shall be able to use EHR repository, national classifications and indexes (at least, Master Patient index, index of health facility units, healthcare professional index, index of buildings, address index, index of Section VI. Technical requirements 175 motor vehicles, medical equipment index), analytical repository and other national resources required for integration of " turn-key " according to national standards (listed in MoH order No. 75 from 10.02.2014) R8.4. M The system shall maintain local copies of national resources and be able to synchronize them on a regular basis (in accordance with a custom schedule) or online. The system shall contain only information relating to the activities of health facility. For example, Master patient index shall be kept locally for only the list of patients served by this health facility. 1.4.2 № Interaction with parties involved into certification process type R9 Requirement Interaction with parties involved into certification process R9.1. I Contract associated with the delivery of HII Platforms and national e-Health resources is held in parallel with this contract. Access to national e-Health resources will be provided to the System Supplier only after successful implementation of HII Platform Contract. In order to facilitate parallel implementation it is necessary to synchronize / coordinate joint actions. The interaction of the parties involved is shown in Pic. 3. Actions taken by the Supplier are described in column 4 «Private IT company» R9.2. M System Supplier shall interact with the HII platform supplier, health facility and MHSD for testing and certification of interoperability with national resources and services. R9.3. M System supplier shall coordinate the interaction of the parties involved in accordance with Figure 3. Certification means to verify the installed system for compliance with R7.2. The Client authorizes a special commission, which together with the Platform provider and the supplier of the system, shall conduct tests on compliance to standards of MHSD RK, to meet the requirements of interoperability in accordance with national standards, including the ability of correct interaction of delivered system with national resources available within the Platform. R9.4. M At the phase of System design (action 4.4) the Supplier shall comply with the "Rules for Web Services development" and "Requirements for interaction with the EHR Repository" provided by the Supplier of the HII Platform. Supplier of System may request additional information if necessary to develop interaction with e-Health resources. R9.5. M During the testing / certification phase (action 4.6) System Supplier shall meet requirements and standards of e-health R7.2. 176 Section VI. Technical Requirements R9.6. M The Supplier shall certify the System before its acceptance into operation R9.7. M In case of circumstances that hinder fulfillment of R9.6 occurred by no fault from Supplier’s party, Acts of System acceptance shall be signed without certification. With it, System Supplier is bounded to certify the System when conditions for certifications appear, without any additional costs from the Purchaser’s party Section VI. Technical requirements 177 Pic 3. Interaction of parties involved into System implementation and certification 1.5. Requirements to Suppliers N type Requirement 178 Section VI. Technical Requirements R10 Requirements to Suppliers R10.1. M Supplier shall supply his own System (components or products of its) or be authorized by the developer / owner of the System (components or products of its) to provide, design, installation, maintenance of production in accordance with this Contract. R10.2. M Supplier shall provide training in Purchaser’s country, associated with the operation and administration of the system, as well as for all developed and installed products. Language of trainings will be the state and Russian. Details on training given in R12.2 R10.3. M Supplier shall have an office in the Purchaser's country or have a partner that is registered as a legal entity in the Purchaser's country having official status of a developer / provider partner, or having a consortium agreement associated with this Contract. This is necessary during the implementation, deployment, training, and warranty period for smooth and reliable implementation of the Contract. R10.4. M Supplier shall have team of experts for the Project, consisting of at least the following specialists (if necessary, two positions can be taken by one person, provided that the skills will be proved, but no more than 2 positions per a specialist): 1) Business Analyst with experience of at least 3 years in IT projects in ehealth and experience in at least one similar project; 2) Project manager (team leader), with experience of at least 3 years in project management and experience of more than 1 year in the project, where the proposed solution has been implemented, Project manager shall be certified in project management (eg, PMP or IPMI); 3) Specialist on DBMS who has at least 3 years of experience with database work; 4) professionals with experience in work with standards for at least 2 years: HL7, DICOM, CDA (R2), IHE; 5) User Interface Designer, with experience of at least 3 years; 6) Technical writer, who has worked for at least 2 years; 7) Specialist on Relations with experience in this area and at least 3 years of general experience in IT, with an excellent command of English, Russian and Kazakh languages; 8) Specialist on Testing with at least 3 years of experience in software testing; 9) Specialist on Training with at least 3 years of experience in education; All proposed experts shall have a degree in IT or related fields, Master's degree preferred. The Supplier shall submit a list of experts, with applied Section VI. Technical requirements 179 resumes, certificates to prove the experience and qualifications. R10.5. M the Supplier shall provide all documents (patents, licenses, certificate of state registration of rights to the object of copyright, etc.) on the System (for all components and products), demonstrating the owner's permission to use the products for the contract or demonstrate ownership of the products R10.6. M Plan - schedule of services shall be authorized by the Purchaser and signed by the Purchaser within twenty (20) business days after signing the contract. Supplier shall promptly provide services by approved schedule. R10.7. M In the case of foreign companies participation, consortium is the most likely appropriate form of participation in the tender (although not mandatory), because some of the requirements involve knowledge and skills that international suppliers may not have – experience of work in the country. R10.8. M Vendors shall have at least on certificate out of the following list: Capability Maturity Model Integration (CMMI), ISO 9000 series, ST RK ISO 9001: 2009 or equivalent for quality management (Bidder shall submit copies of Certificate on compliance issued by the authorized body). R10.9. M The Supplier shall provide service and technical support and warranty, including new versions of the products in accordance with the R12.3 and R12.4. R10.10. M The Supplier shall prepare appropriate guidance for all components of the System in English, Kazakh and Russian languages R10.11. M The Supplier shall have proven track record of working with the standards used in this document: HL7 (v2, V3, FHIR), CDA (R2), IHE R10.12. I The contract related to supply HII Platform is carried out in parallel with the present contract R10.13. M System Supplier shall have access to national resources of e-Health only after the parallel contract is successfully implemented. In order to facilitate parallel implementation it is necessary to synchronize / coordinate joint actions with the Platform provider. If the circumstances do not allow to meet the requirements for interaction with the Platform due to delayed implementation of contract for delivery of Platform, the System Supplier undertakes to implement the interaction, when there will be conditions, without additional cost to the Purchaser. C. Technical specification 180 Section VI. Technical Requirements 2.1. GENERAL TECHNICAL SPECIFICATIONS TO THE SYSTEM N Type Requirement GENERAL TECHNICAL SPECIFICATIONS TO THE SYSTEM R11 R11.1. M System shall be able to work with a local server via a local area network used in one health facility R11.2. M The server part of System shall be running at least on Windows operating systems family. R11.3. M The client part of the System shall be running at least in the operating systems of Windows (2008/VISTA/7/8) (x86/x64) R11.4. M A relational database shall be used to save the information in the system R11.5. M Database systems shall support the standard SQL, compliant with the ANSI / ISO / IEC 9075-1992 R11.6. M Supplier shall provide service and technical support, including provision of new product releases prior to the expiration of warranty service. R11.7. M The system shall provide the ability to operate on a remote infrastructure and cloud (virtualized) Operating Environment R11.8. M The System shall provide an option of authentication using SSO technology 2.2 SERVICE SPECIFICATION R12 Specification of services R12.1. Requirements to inherit data and functionality. R12.1.1 M In the case of supply and implementation of the System different from those operating by the Purchaser the Supplier provides a full range of necessary work on the inheritance of data and functions of the Information System modules used by the Purchaser with connection to the System of used by the Purchaser software and hardware means of automatization, medical and laboratory equipment. R12.1.2 M All costs associated with providing inheritance of data and functionality are paid by Supplier. R12.2. Trainings and training materials Section VI. Technical requirements R12.2.1 M 181 the Supplier shall prepare a training plan for the following groups: a) System users; b) System admins c) developers, d) admins of databases. Training plan and training materials for each group shall be agreed with the Purchaser prior to the training start. The Supplier shall provide equipment, presentation materials, and guidelines needed for training R12.2.2 M R12.2.3 M System Supplier shall provide educational materials in the form of manuals, books, presentations, knowledge bases in the Kazakh and Russian languages. R12.2.4 M Supplier shall provide training for at least 80 hours for each group of admins of the System, developers, admins of database and 20 hours for users of each health facility, which implements systems. The number of hours can be increased and shall be sufficient for the transfer of knowledge and skills R12.2.5 M Supplier shall conduct a separate training for users and system administrators, developers and admins of databases. Indicative number of students is determined by multiplying the total number by 2 of general number of workstations from Appendix 2. Location of training legal address of the healthcare facility - the beneficiary. Groups of students should include no more than 10 people R12.2.6 M Training plan for the group (a) - users of the system - shall contain a detailed explanation of automated business processes, the use of all components of the system, a detailed description of the functions and interactions between the different users and roles; statements and other necessary information. Training will also include practical training for understanding of the material. R12.2.7 M Training plan for the group (b) - System administrators - shall contain description of administration tools of system components including the important issues of systems support, and aspects of technical support R12.2.8 M The Supplier shall conduct for the group (c) designers – one introductory course and capacity building course on provided tools of development and components planned as part of this contract R12.2.9 M The Supplier shall conduct for the group (d) DB admins - one introductory and one advanced training course on provided DBMS R12.2.10 M Training for groups (a) - (d) shall be conducted in Russian or state language specified by the Purchaser. R12.2.11 M All trainings shall be conducted by trainers in Astana or in another place specified by the Purchaser 182 Section VI. Technical Requirements R12.2.12 M For all carried out training sessions, the Supplier shall conduct the appropriate tests and issue certificates R12.2.13 I The above number and duration of training are minimum requirements. Supplier at the request of the Purchaser can increase these values (in hours) to achieve an adequate level of skills for the staff at no additional cost to the Purchaser. During the preparation phase of the project the exact number of hours, groups and content of the courses will be agreed with the Supplier. R12.3. User Support Service R12.3.1 M Supplier shall arrange a user support service to advise on matters arising during the operation, for the duration of implementation and warranty services providing R12.3.2 M Support System and its users should be carried out by the Supplier in operation regime of 24 hours a day, 7 days a week, for 2 years from the date of signing the acts system commissioning R12.4. Warranty service R12.4.1 M Supplier of the System shall provide warranty service to the Purchaser within three years, starting immediately after approval of the Operational Acceptance Certificate by Purchaser R12.4.2 M R12.4.3 M The Supplier shall provide the resolution of queries: a) for the critical issues relating to operability of systems and leading to data corruption, the problem should be solved by no more than 2 hours; b) for non-critical problems to 2 days Warranty service will include, but not limited to, following categories of services: - correction of errors in the System; - help the health facility to correctly all problems with data, arising as result of mistaken function of applications; - technical support in adjustment, configuration of applications or changing default parameters; - provide necessary technical assistance to trained staff and re-train, if disclosed that they cannot solve all problems after received training R12.4.4 R12.4.5 M M The forms of intervention can be one of the following most appropriate from the viewpoint of quality and efficiency: - telephone calls; - e-mail; - Skype or other video messenger; - On-site work; - Remote work. The Supplier shall provide during the warranty period a team of Section VI. Technical requirements 183 consultants available in Purchaser’s country including one manager and at least one specialist, and provide all necessary specialists from the distance for remote help (per needs). R12.4.6 M The total System downtime due to reasons related to its capacity for work should not exceed 24 hours per year. R12.4.7 M Time of a single system downtime due to reasons related to its capacity for work should not exceed 2:00 2.3. Requirements to documentation N Type R13 R13.1 Requirement Requirements to documentation M The Supplier shall provide the following documents : - Program and methods of testing ; - Form (main characteristics, completeness and information on the operation of the deposited software); - Description of the most common mistakes and how to prevent them; - Description of the structure of the database; - Guide to install the software; - Administrator's Guide; - User’s Guide. R13.2 M Language of the document shall be at least the Kazakh and Russian. R13.3 M The Supplier shall provide 5 sets of documents in paper and electronic form in English, Russian and Kazakh languages. Electronic versions should support the ability to search basing on context R13.4 M the Supplier shall prepare an information system and regulatory and methodological documentation for attestation for compliance with information security requirements in accordance with Article 5 of the Law of the Republic of Kazakhstan dated January 11, 2007 "On Informatization" and Decree of the Government of the Republic of Kazakhstan dated December 30, 2009 № 2280 "On approval of Rules for provision of certification of government information systems and nongovernment information systems integrated with public information systems for compliance with information security requirements and accepted on the territory of the Republic of Kazakhstan standards "and to be commissioned in accordance with Article 17 of the Law of the Republic of Kazakhstan dated January 11, 2007" On informatization ". 184 Section VI. Technical Requirements D. Testing and requirements to quality 3.1. System testing and Requirements to Quality R14 System testing and Requirements to Quality R14.1. Pre-commissioning R14.1.1 M System Supplier shall perform standard installation tests to verify the correctness of System installation R14.1.2 M Supplier shall offer in the technical offers a list of tests, test conditions, success criteria and other for the System testing. R14.1.3 I Quality of testing is one of the criteria for technical evaluation. The list of tests will include tests for each module and tests for the whole System. R14.1.4 M Systems Supplier shall held detailed milestone tests, including tests of performance, response time, System throughput, together with an organization authorized by the Purchaser, according to tests provided by the Supplier. R14.1.5 М The supplier shall hold a demonstration of the System with the participation of representatives of the Purchaser and the organization authorized by the Purchaser according to the scenario of System testing. R14.1.6 М Suppliers shall draw up the demonstration results in the form of demonstrations Protocol agreed with the Purchaser. The protocol shall be signed by all participants of demonstration. Place of demonstration shall be agreed with the Purchaser and organization authorized by the Purchaser. R14.1.7 М The Supplier shall fix a troubles detected during the demonstration and repeat demonstration as often as needed to have a Protocol of successful demonstration. Timeframe for fixing the troubles shall be agreed with Purchaser. R14.1.8 M Testing shall be conducted in accordance with one of the standards IEEE 829/1009, BS 7925, ISO / AS 9100 and developed document "Program and methods of testing" ST RK 1089-2002 R14.1.9 M The supplier shall test the system in accordance with the Web Content Accessibility Guidelines (WCAG) 2.0. the Supplier shall provide detailed information on the results of testing R14.1.10 M The Supplier shall test the system security in accordance with the OWASP Top 10 vulnerabilities. Supplier shall provide detailed information on the results of testing R14.1.11 M the Supplier shall agree with the Purchaser the test script and provide a Section VI. Technical requirements 185 report on the results of each test R14.2. Acceptance into operation R14.2.1 M Certificate of acceptance is signed by the Purchaser based on the trouble-free operation under normal operating conditions for the System within three months. In case of errors in the functioning of the period Supplier shall make the necessary changes and re- operation of the system within three months. Operating errors are critical errors which do not allow to run the System R14.2.2 M The Supplier must commence the work necessary to remedy defects or damage within 10 working days for non-critical errors. For critical errors the supplier must commence the work necessary to remedy defects or damage within 3 working days, provide fixing time and report on fixing progress hourly during the operational as well as warranty period. Critical errors: System is not operational or stable. Important functional component is down or un-available. Loss of Data or interruption in the main process flow. System component unusable due to failure or incorrect functionality. Users are not able to perform any work. R14.2.3 M Mandatory condition for acceptance into operation is certification of the System pursuant to requirements of R.9 3.2. REQUIREMENTS TO CONTROL BY PURCHASER R15 Requirements to control assurance by the Purchaser R15.1 М Supplier shall at intervals specified in the schedule provide Purchaser a progress report during the period. R15.2 М The report shall contain information on the works of the Supplier for the period, in accordance with the approved schedule including warranty service with attached approved documents, including official correspondence in paper and electronic form (at least in PDF format). R15.3 М The report shall be agreed with organization authorized by the Purchaser. R15.4 М Purchaser may at any time of the Contract implementation carry out control over the contract to check Supplier measures and quality of services under the contract 186 Section VI. Technical Requirements E. IMPLEMENTATION SCHEDULE Implementation Schedule Table procurement of lots 1-9 Line Item No. Subsystem / Item Configuratio n Table No. Site / Site Code Delivery (Bidder to specify in the Preliminar y Project Plan) Installation (weeks from Effective Date) Acceptance (weeks from Effective Date) Liquidate d Damages Milestone 1 Delivery and implementation of Comprehensive Health Information System for Municipal hospital №1 Ust-Kamenogorsk city 41 54 Yes 2 Delivery and implementation of Comprehensive Health Information System for Municipal Clinic Hospital №4 Almaty city 41 54 Yes Section VI. Technical Requirements 187 3 Delivery and implementation of Comprehensive Health Information System for Mother and Child Center UstKamenogorsk city 41 54 Yes 4 Delivery and implementation of Comprehensive Health Information System for Municipal Policlinic №11 Almaty city 41 54 Yes 5 Delivery and implementation of Comprehensive Health Information System for Regional Diagnostic Center Almaty city 41 54 Yes 6 Delivery and implementation of Comprehensive Health Information System for Policlinic №1 Kostanay 41 54 Yes 7 Delivery and implementation of Comprehensive Health Information System for Central rayon hospital, Zhualynsky rayon, Zhambul oblast 41 54 Yes 8 Delivery and implementation of Comprehensive Health Information System for Municipal policlinic №7 Astana city 41 54 Yes 188 9 Section VI. Technical Requirements Delivery and implementation of Comprehensive Health Information System for Municipal Hospital No. 1 of Astana city 41 54 Yes Section VI. Technical requirements 189 System Inventory Table (Supply and Installation Cost Items) 0 System, Subsystem, or lot number: Lots 1-9 Component No. Component Relevant Technical Specifications No. Additional Site Information (e.g., building, floor, department, etc.) Quantity 1 Delivery and implementation of Comprehensive Health Information System for Municipal hospital №1 UstKamenogorsk city 1 2 Delivery and implementation of Comprehensive Health Information System for Municipal Clinic Hospital №4 Almaty city 1 3 Delivery and implementation of Comprehensive Health Information System for Mother and Child Center UstKamenogorsk city 1 4 Delivery and implementation of Comprehensive Health Information System for Municipal Policlinic №11 Almaty city 1 5 Delivery and implementation of Comprehensive Health Information System for Regional Diagnostic Center Almaty city 1 6 Delivery and implementation of Comprehensive Health Information System for Policlinic №1 Kostanay 1 7 Delivery and implementation of Comprehensive Health Information System for Central rayon hospital, Zhualynsky rayon, Zhambul oblast 1 190 Section VI. Technical Requirements Component No. Component Relevant Technical Specifications No. Additional Site Information (e.g., building, floor, department, etc.) Quantity 8 Delivery and implementation of Comprehensive Health Information System for Municipal policlinic №7 Astana city 1 9 Delivery and implementation of Comprehensive Health Information System for Municipal Hospital No. 1 of Astana city 1 Section VI. Technical requirements 191 Site Table(s) System, Subsystem, or lot number: Procurement of entire System Site Code Site Ust- City / Town / Region Primary Street Address EKO, Ust-Kamenogorsk Abai str, 18 Almaty Turksib rayon, Papanin str., 220 EKO, Ust-Kamenogorsk Utepova Str., 35, 37 1 Municipal hospital №1 Kamenogorsk city 2 Municipal Clinic Hospital №4 Almaty city 3 Mother and Child Center Kamenogorsk city 4 Municipal Policlinic №11 Almaty city Almaty Zhetysu rayon, Zhumabayeva str., 87 5 Regional Diagnostic Almaty city Almaty Auezova Str., 57 6 Policlinic №1 Kostanay Kostanay Al-farabi, 112 7 Central rayon Zhualynsky rayon, oblast Ust- Center hospital, Zhualynsky rayon, Zhambul Zhambul oblast B.Momyshuly village, S.Beybarys Str, 1 8 Municipal policlinic №7 Astana city Astana Sh. Kudaiberdyuly 25, 29 9 Municipal Hospital No. 1 of Astana city Astana Koshkarbayev str, 66 Drawing Reference No. (if any) 192 Section VI. Technical Requirements Holidays and other days-off Month 2015 2016 1 1, 2, 7 1, 2, 7 8, 21, 22, 23 8, 21, 22, 23 1, 7, 9 1, 7, 9 7 6 6 8 30 30 16, 17 16, 17 2 3 4 5 6 9 10 11 12 Section VI. Technical Requirements 193 G. Technical Responsiveness Checklist Note to Bidders: The following Checklist is provided to help the Bidder organize and consistently present its Technical Bid. For each of the following Technical Requirements, the Bidder shall describe how its Technical Bid responds to each Requirement. In addition, the Bidder shall provide cross references to the relevant supporting information, if any, included in the bid. The cross reference should identify the relevant document(s), page number(s), and paragraph(s). The Technical Responsiveness Checklist does not supersede the rest of the Technical Requirements (or any other part of the Bidding Documents). If a requirement is not mentioned in the Checklist, that does not relieve the Bidder from the responsibility of including supporting evidence of compliance with that other requirement in its Technical Bid. One- or two-word responses (e.g. “Yes,” “No,” “Will comply,” etc.) are normally not sufficient to confirm technical responsiveness with Technical Requirements. 194 Section VI. Technical Requirements Technical Responsiveness Checklist Number R1 R1.1 R1.2 R1.3 R1.4 Description General business requirements Licensing mechanism for the System under this contract shall provide the right to use all modules and compounds in the concrete Health Facility for number of users sufficient for full scale functioning of a health facility (size of health facility could be evaluated basing on description in the Annex 2), for unlimited time, unlimited number of servers, and excluding any other possible limitations. It is not accepted annual license fees; the only cost for license is the initial license cost, which includes all costs. Within this Contract System interoperability shall be assured with national e-health system according to requirement R 7. General scheme of interaction with national e-health system is set in the Pic. 1 The System shall correspond to general architecture of Comprehensive Health Information System set in Pic. 2 System modules and/or its compounds shall have option of data exchange using Mandatory (M)/ Clause Desirable (D) Number M M M M Bidder’s technical reasons supporting compliance: Bidder’s references supporting information Technical Bid: cross to in Section VI. Technical Requirements R1.5 R1.6 R1.7 R1.8 http(s) - protocol the System shall have SOA-oriented architecture that supports only defined and platform independent interfaces for interaction At least following functional assigned for use by wide range of users (patients, distanced doctors, managers) shall be implemented as web-application: - patient’s demographic data - patient complaints - entry of allergic anamnesis - entry of life anamnesis - entry of suffered diseases - entry of anamnesis of current illness - entry of objective state of patient examination - entry data on reactions to drugs - entry referrals to lab studies - entry prescriptions - entry referrals to diagnostic services - review lab studies results - review diagnostic results - reporting - doctor’s records keeping The System shall have fine configuration to assure adjusting to health facility needs without design of a new system (or small refinement of the System) The Supplier under this Contract shall carry out works to ensure interoperability of the System with National EHR (EHR 195 M M M M 196 R1.9 R1.10 R1.11 R1.12 R1.13 Section VI. Technical Requirements repository, national classifiers and indicators, analytic repository, EHR-webservices) according to requirement R7 The System integration shall be ensured with introduced accounting system 1C. Level of integration shall be determined during implementation of the Contract and agreed with the agency where System is introduced. The System shall ensure confidentiality of personal data: encryption of personal data in DB, encryption data while transmission by channels, use of safe transmission protocols and etc. The System shall use digital signature to sign and authorize e-documents, files and parts of the documents. Need in digital signature shall be configurable at System admin level. More details on requirements to digital signature are set in R 5.15. The system shall be entirely operational “on turnkey basis” according to R 14.2. For this the Supplier shall if it is necessary add missing parts, functionality and solutions including cost of missing parts in Price Table in item for «others» The Supplier shall provide at least, but not limited to configuration, roll-out, installation, testing of the System. The Supplier shall provide trainings for users and administrators (and other staff if needed) M M M M M Section VI. Technical Requirements R1.14 R1.15 R1.16 R1.17 R1.18 R1.19 R1.20 The Supplier shall take part in System attestation together with the Supplier of Platform to check and certify interoperability with national resources and EHR tools during procedures of System attestation and testing. The Supplier shall provide warranty service for the System within 3 years from the acceptance date according to R 12.4. If additional software is required for System operation “on a turnkey basis” the Supplier shall provide licenses (for complete System operating “on a turnkey basis”) at his own expense and delivery it to the Purchaser ownership within this Contract. The Supplier shall deliver System configuration to health facilities according to Table 1. System components are set in Table 2. Minimal requirements for each module shall correspond to Section R2 In Bidding Documentation the Bidder shall present edited technical specification set within the format and structure of this Technical Requirements The system shall be able to integrate with development environments (IDE), at least for Java and Net Framework. The system shall have a complete development kits (SDK), which includes: documentation, sample code at least for Java and Net 197 M M M M M M М 198 R1.21 R1.22 R1.23 R1.25 R1.26 Section VI. Technical Requirements Framework, to configure the system functions. An Option shall be available to extend functionality of systems using development tools (SDK), included into the system. Mechanism of licensing for System under this contract should not limit the changes made with the help of development tools (SDK), included into the System. entering Changes using development tools (SDK), included into the System, should not affect the terms of warranty service for System. Changes to the System by experts of the Client shall be allowed after system commissioning. The Supplier shall provide service and technical support, including provision of new versions of the products (according to R12.3). Response time services and system components shall be no more than 3-5 seconds, for at least 80% cases of input data or requests for data browsing (at a rate of channel 1 Mb / s and a response time of less than 100 ms). The supplier shall document and transmit electronically the configuration files and source code, components, systems developed under this contract The system shall have Thin Client to communicate with the equipment allowed to use the Thick client. M M М М М Section VI. Technical Requirements R.1.27 R2 R2.1 R2.1.1 R2.1.1.1 R2.1.1.2 The System shall meet following requirements to reporting: • All analytic forms and reporting forms shall have option of export into formats .xls, xlsx, .docx, doc, .pdf, .csv, .html, .xml. • Time for formulation of analytic and reporting forms shall not exceed 1 min. While for 95 % of cases time for formulation of analytic and reporting forms shall not exceed 30 seconds. • The System shall have an option to make up analytic and reporting forms according to set timetable. The System shall have an option to send created analytic and reporting form to specified e-mail address Requirements to automated processes Module 1 «Reception» Management of doctor’s schedule of М work, services, equipment use. This process includes: Making schedule of doctor work with M possibility to choose doctor data (name, position, specialty, department) out of list of specialists Check for availability of already made M schedule for this period of time (date, time), for this doctor, room, equipment, and informing the user if it is available while making up the schedule for doctor work, service provision or equipment use 199 200 R2.1.1.3 R2.1.1.4 R2.1.1.5 R2.1.1.6 R2.1.17 R2.1.1.8 R2.1.1.9 R2.1.1.10 Section VI. Technical Requirements Search for schedule among already existing by date, time, doctor, doctor specialty, service, equipment or their combinations While making up the schedule for doctor work, service provision or equipment use to set an option to interlink doctor, service and equipment. This interlink is not mandatory for filling in. while making up the schedule for service provision to plan the option of service selection out of service list for which health facility or a doctor has the right While making schedule for equipment use to have option to choose equipment out of list of the health facility Option of schedule generation, edition and removal While schedule removal or editing if the patients are attached thereto, to have an option of automated choice of possible nearest time at similar specialist and option of choice of definite time by user While schedule removal or editing to have an option of automated notification of patient on changed date, time, place of admission by e-mail and/or SMS Making up following reports: 1. Summary information on schedule of work of doctors by subdivisions, shifts, service provision, equipment use M M M M M M M M Section VI. Technical Requirements 201 2. Report on changes in patient records due to changed schedules. R2.1.2 R2.1.2.1 R2.1.2.2 R2.1.2.3 R2.1.2.4 R2.1.2.5 R2.1.2.6 R2.1.2.7 R2.1.2.8 Registration for doctor examination with handed out admission card. This process includes at least: Registration of the patient by receptionist, by doctor during examination, by Patient through Internet with issuance of admission card Registration of new patients with filling in personal data, including transferring these data from IS MHSD RK Choice of patient out of patient DB of Health Facility by name, IIN, date of birth Printing routing chart for issued cards with indication of doctor, room, date and time of examination, some specific additional information (way of getting ready for exam for patient and other). Registration of patient’s ambulatory card handing out and receiving Cancellation of registration by receptionist, doctor, patient by Internet Making up «Waiting list» to take vacant place because of cancellation of time for doctor examination with automated notification of the patient by e-mail and SMS in case of registration for vacant place Option to book time for examination in a schedule (solely or in group) with М M M M M M M M M 202 R2.1.2.9 R2.1.2.10 R2.1.2.11 R2.1.3 R2.1.3.1 R2.1.3.2 R2.1.3.3 Section VI. Technical Requirements regulated time to cancel reservation Automated preventing of patient registration to several doctors by the same time, and prevention of registration of several patients to one and the same doctor Search of time for registration in existing schedules by date, time, doctor, specialty, services, equipment and their combinations Following Reports making: 1. Report on number of registered (by doctor, service, equipment, department, health facility) 2. Report on number of free places (by doctor, service, equipment, department, health facility) 3. Report on cancelled visits 4. Report on not appeared patients 5. Report on preservation of visits. 6. Report on visited patients (within reported period, by referred health facilities, by specialists, services) Management of Book for calls at home. This process includes at least: Registration of call at home accepted by phone, by Internet and patient’s visit to a health facility Registration of cancel of call at home initiated by the patient Registration of transferring call at home to the doctor M M M M M M M Section VI. Technical Requirements R2.1.3.4 R2.1.3.5 R2.1.3.6 R2.1.3.7 R2.1.3.8 Registration of execution of the call with details Registration of need in second visit and its date Making up the list of non-distributed calls: by districts, by health facility in general Making up the list of calls for the doctor with indication of patients name, diagnosis, address, phone, notes Report making: 1. Report on calls at home (opened, accepted, executed, cancelled) by doctor, patient, district 203 M M M M M 2. Report on time of calls accepted and executed R2.1.4 R2.1.4.1 R2.1.4.2 R2.1.4.3 R2.1.4.4 R2.1.4.5 R2.1.4.6 Record keeping in the Book of active information (calls at patient’s home by initiative of medical specialists). It includes, at least: Dividing active information by groups – hospital, policlinic, newborn, emergency, pregnant women, newly born women Registration of active information received by phone, Internet Registration of active information group by file import – table of established type Registration of active information cancel Registration of transferring active information to the doctor Registration of the fact of execution with M M M M M M M 204 R2.1.4.7 R2.1.4.8 R2.1.4.9 R2.1.4.10 R2.1.5 R2.1.5.1 Section VI. Technical Requirements outcome details Registration of the need in second visit and its date Making up the list of non-distributed active information by districts, health facility Making up the list of active information for the doctor with indication of patients name, diagnosis, address, phone, notes Reports making: 1. Report on active information (opened, accepted, executed, cancelled) in a breakdown by doctor, patient, district 2. Report on time of active information accepted and executed. Management of primary accounting documents at the level of Reception in line with normative legal acts of the RK. It includes the following registration formats: Form 040/y M M M M M M Form 025-4/ у Form 025-9/у Form 025-5/у Form 031/у R2.1.6 R2.1.7 Analytic tables formation on the M Reception level as well as statistic tables in line with current legal acts of the RK Interaction with IS MHSD RK, it includes M at least: Section VI. Technical Requirements R2.1.7.1 R2.1.8 R2.2 R2.2.1 R2.2.1.1 R2.2.1.2 R2.2.1.3 R2.2.1.4 R2.2.1.5 R2.2.1.6 R2.2.1.7 R2.2.1.8 Transfer of information on schedules of doctor’s work, service provision, equipment use Registration of facts of population attachment/ detachment from a health facility Module 2 «District doctor» Patient’s ambulatory card management. It includes, at least: Review of patients list that appointed time for doctor exam Making up Patient’s ambulatory card Making up and editing templates such as making medical papers and records, consultations, exam protocols, diary records using templates and option to attach files (images, video, audio) with link of user template to user account Making medical records basing on standard and user’s templates Editing and removal of medical records signed by digital signature shall be blocked Printing filled in medical records to form paper version of ambulatory card Option of selection of medical records by certain parameters (visits, diagnosis, date, diagnostic studies, lab analysis, service, funding source and etc.) Report on changes in patient’s numerical data by time (anthropometric index, functional index, lab data and etc.) 205 M M М M M M M M M M M 206 R2.2.2 R2.2.2.1 R2.2.2.2 R2.2.2.3 R2.2.2.4 R2.2.2.5 R2.2.2.6 R2.2.2.7 R2.2.2.8 Section VI. Technical Requirements Making up internal (within one health facility) and external (to other health facilities) referrals to consulting and diagnostic services. This includes, at least: Making referrals to consulting and diagnostic services within one health facility with possibility to register by certain time Making referrals to consulting and diagnostic services to other health facilities with possibility to register by certain time Agreement of referrals for certain types of services with the Head of Department Recommendations making up to get prepared to consulting and diagnostic services basing on standard templates Removal of referrals (wrong, by patient’s initiative, automatically due to patient’s absence) Control over execution of consulting and diagnostic services prescribed for a patient, review of data on execution of prescription including its results Agreement and rejection of requests for additional consulting and diagnostic services Report forming: 1. Report on referrals created (internal, external) by services, funding source, level of care provision (rayon, oblast/city, national) M M M M M M M M M Section VI. Technical Requirements R2.2.3 R2.2.3.1 R2.2.3.2 R2.2.4 R2.2.4.1 R2.2.4.2 R2.2.4.3 R2.2.4.4 2. List of patients by names referred to consulting and diagnostic services 3. Report on referrals (opened, executed, rejected, internal, external) Making up planned hospitalization (24 hours hospital and substitute care). This includes, at least: Making up patient summary from ambulatory card (Form 027/у) Making up of: - templates on minimal standards of studies at pre-hospital stages by levels of health facilities - referral and card for planned hospitalization Making up doctor prescriptions for drugs and/or procedures, manipulations. This includes at least: Creation of prescriptions (paid, unpaid) for medicines and narcotic drugs with limited access of a certain category of doctors and with description of uptake method and doses and etc. Control over prescriptions basing on set max once-only doses depending on age, sex, weight and etc. Control over prescriptions basing on formulary of a health facility and republican drug formulary. Results of Benefit Drug provision to dispensary patients and other categories of population Signing prescriptions by digital signature 207 M M M M M M M M 208 R2.2.4.5 R2.2.4.6 R2.2.4.7 R2.2.4.8 R2.2.4.9 R2.2.4.10 R2.2.4.11 R2.2.5 R2.2.5.1 Section VI. Technical Requirements Check for drug availability in pharmacy. Such requirement shall be implementing using interaction with Module “Pharmacy” Making up referrals to procedures with specification of medicines and their doses Making up recommendations to prepare to procedures basing on standard templates Control over prescription execution and drug release Submission of reference information by recommended prescriptions according to approved clinical guidelines and diagnostic and treatment protocols Making up the list of doctor’s prescriptions (Form 004-1/у) Report making: 1. Report on generated receipts (INN, form, dose, uptake method, and etc.) 2. List of patients by names who got receipts 3. List of patients by names who got receipts under benefit category Management of initial registration documentation at district doctor level basing on regulatory norms of the RK. This includes the following forms, at least: 001-2/у, 001-3/у, 001-4/у, 001-5/у, 0016/у, 003-2/у, 004-1/у, 025/у (025-1, 0252, 025-3, 025-4), 025-2/у, 025-3/у, 0255/у, 025-7/у, 025-8/у, 026/у, 026-1/у, M M M M M M M M M Section VI. Technical Requirements R2.2.6 R2.2.7 026-2/у, 030/у, 032/у, 036/у, 038/у, 0381/у, 038-2/у, 039/у, 040/у, 052/у, 053/у, 054/у, 058/у, 060/у, 063/у, 064/у, 070/у, 072/у, 075/у, 076/у, 086/у, 088/у 088-1/у, 094/у, 095/у 095-1/у, 106/у-12, 106-2/у-12, 112/у, 130/у, 132/у, 133/у, 138/у, 278/у, ТB 15/у, ТB 05/у, Making up analytic tables at district M doctor level as well as statistic tables basing on regulatory norms. This includes the following forms, at least: 1. Statement for accounting patient M visits to policlinic, dispensary, consultations and at home (039/у) including in breakdown by district doctors at PHC level 2. Report on executed screenings according to MOH order № 685 as of 10.11.2009 including in breakdown by district doctors at PHC level 3. Monitoring of execution of annual mandatory fluorography inspections for population including in breakdown by district doctors at PHC level 4. Monitoring of execution of monthly and annual plans on immune prophylactic actions by Form №5, 6 MOH order No.128 as of 6.03.2013 including in breakdown by district doctors at PHC level 5. Report post vaccination 209 210 Section VI. Technical Requirements complications in the context of primary care physicians by types of prophylactic vaccinations by age and outcomes, including in the context of district doctors at PHC 6. Report on dispensary patients flow including in breakdown by district doctors at PHC level 7. Report on flow of dispensary patients with chronic renal insufficiency with indication of substitute therapy (gemodialiaz or peritoneal, kidney transplantation, etc.) including in breakdown by district doctors at PHC level 8. Report on birth rate including in breakdown by district doctors at PHC level 9. Report on mortality including in breakdown by district doctors at PHC level 10. Report on invalid patients including in breakdown by district doctors at PHC level 11. Report on referral and hospitalization including planned hospitalization in breakdown by district doctors at PHC level 12. Report on Healthy life style actions including in breakdown by district doctors at PHC level 13. Report on quantity and structure of Section VI. Technical Requirements R2.2.8 R2.2.8.1 R2.2.8.2 attached population including in breakdown by district doctors at PHC level 14. Report on quantity of diseases of patients living in the district attached to a health facility and cohort of patients under dispensary control (Form 56, 12) including in breakdown by district doctors at PHC level 15. Report on cohort of patients receiving hospital substitute care (Form 24) including in breakdown by district doctors at PHC level 16. Report on care to children (Form 31) including in breakdown by district doctors at PHC level 17. Report on child disability (Form 52) including in breakdown by district doctors at PHC level 18. Report on use of bed fund of health facility (hospital and day care) (Form 21) including in breakdown by district doctors at PHC level 19. Report on patients brought by emergency care staff including in breakdown by district doctors at PHC level Management of lists of temporary M disability (sick lists). This includes at least: Registration of list of temporary disability M Prolongation of list of temporary M 211 212 R2.2.8.3 R2.2.8.4 R2.2.8.5 R2.2.8.6 R2.2.9 R2.2.9.1 R2.2.9.2 R2.2.9.3 R2.2.9.4 R2.2.9.5 R2.2.9.6 R2.2.9.7 R2.3 R2.3.1 R2.3.1.1 Section VI. Technical Requirements disability Closing of list of temporary disability Sending the list of temporary disability to Head of Department or Medical Consultative Board for approval Making up referral to MSE (Form 088/у) Reports making up: 1. Report on issued lists of temporary disability 2. Report on referrals to MSE Interaction with IS MHSD RK. It includes at least: Data exchange according to EMR and EHR standards. More details in R7.2.1 Data exchange on hospitalization Data exchange on executed services Clinical information exchange (conclusive diagnosis, consultations, screenings, etc.) Data exchange on referrals to consulting and diagnostic services Data exchange on assigned procedures Data exchange on receipts Module 3 «Prophylactic screening» Forming contingents subject to preventive exams from targeted group of population (screening) and register its performance basing on regulatory norms. This includes at least: Making up lists of patients by names for preventive examination (screening) out of population attached to a health facility in M M M M M M M M M M M M М M Section VI. Technical Requirements R2.3.1.2 R2.3.1.3 R2.3.1.4 R2.3.1.5 R2.3.1.6 R2.3.1.7 R2.3.1.8 R2.3.2 R2.3.2.1 R2.3.2.2 R2.3.2.3 R2.3.2.4 line with regulatory documents Option of automated notification of patients (by e-mail and/or SMS) on necessity to pass screening Make up router list for screening passing Mark on execution of studies in screening with indication of outcomes and/or conclusion Automated making up of referrals to specialists under the screening framework Filling in card of screening Making up conclusion on passed screening Reports: 1. Report on cohort of population subject to screening (by types of screening, district, age-sex structure) 2. Report on passed screening 3. Report on diseases revealed during screening Registration of other types of preventive examination, regular and periodic, used for employment. It includes at least: Making up lists of patients by names for preventive exams Making up router lists for preventive exams Mark on execution of studies in preventive exam with indication of outcomes and/or conclusion Automated forming of referrals to specialists to pass preventive exam 213 M M M M M M M M M M M M 214 R2.3.2.5 R2.3.2.6 R2.3.2.7 R2.3.3 R2.3.3.1 R2.4 R2.4.1 R2.4.1.1 R2.4.1.2 R2.4.1.3 Section VI. Technical Requirements Fill in card of preventive exam Making up conclusion on passed preventive exam with issuance of certificate Reports: 1. Report on passed preventive exams (by types of screening, district, age-sex structure) 2. Report on diseases revealed during preventive exam 3. Report on cohort of population subject to regular screening Management on initial registration documentation at doctor level basing on regulatory norms. This includes at least the following forms: 025/у, 025-1/у, 025-2/у, 025-4/у, 025-5/у, 025-7/у, 025-8/у, 030/у, 032/ у, 040/у, 086/у, 108/у, 108-1/у, 112/у, 131/у, 245/у Module 4 «Profile specialist» Patient’s ambulatory card management using national EHR data. This includes at least: Review of patients lists appointed for exam Templates making up and editing including medical statements and records, consultations, exam protocols, diaries and option of file attachment (image, video, audio) with link to user account Making medical records using standard or user templates M M M M M М M M M Section VI. Technical Requirements R2.4.1.4 R2.4.1.5 R2.4.1.6 R2.4.1.7 R2.4.2 R2.4.2.1 R2.4.2.2 R2.4.2.3 R2.4.2.4 R2.4.2.5 R2.4.2.6 Medical records editing and removal of those which are not signed Printing of filled in medical records for paper version of ambulatory card Option to select medical records by certain parameters (encounters, diagnosis, dates, diagnostic studies, lab analysis, services, funding source and etc.) Report on changes in patient’s numerical signs by time (anthropometric index, functional index, lab data, etc.) Making up internal (within one health facility) and external (to the other health facilities) referrals to consultative and diagnostic services. This includes at least: Making up referrals to additional consultative and diagnostic services by referrals issued by PHC department within a facility with option to appoint time Adding additional consultative and diagnostic services without agreement with PHC department Making up an request for additional types of studies to be approved by PHC department Mark on performed consultative and diagnostic services Making up protocols of consultations, exam, operation basing on standard and user templates Formulate recommendations on getting prepared to consultative and diagnostic 215 M M M M M M M M M M M 216 R2.4.2.7 R2.4.2.8 R2.4.2.9 R2.4.3 R2.4.3.1 R2.4.3.2 R2.4.3.3 R2.4.3.4 Section VI. Technical Requirements services Removal of referrals (wrong, by patients initiative, automated if the patient did not appear) Control over consultative and diagnostic services execution. Registration of firstly coming dispensary patient and transferring this data to district doctor, recommendations on periodicity of monitoring and examination Reports: 1. Report on created referrals (internal, external) by services, funding sources 2. List of patients by names referred to consultative and diagnostic services 3. Report on rendered consultative and diagnostic services 4. List of patients by names which got consultative and diagnostic services Make up doctor prescriptions for drugs and/or procedures and manipulations. It includes at least: Making up receipts for drugs (paid, unpaid) with description of uptake method, dosing and etc. Control over prescriptions in line with set maximal once-only doses depending upon age, sex, weight and etc. Control over prescriptions basing on health facility and republican drug formulary Signing prescriptions by digital signature M M M M M M M M Section VI. Technical Requirements R2.4.3.5 R2.4.3.6 R2.4.3.7 R2.4.3.8 R2.4.3.9 R2.4.3.10 R2.4.4 R2.4.5 Check for drug availability in pharmacy Making up referrals to procedures Making up recommendations to prepare to procedures basing on standard templates. Control over prescription execution and drug release Submission of reference information by recommended prescriptions according to approved clinical guidelines and diagnostic and treatment protocols Report making: 1. Report on generated receipts (INN, form, dose, uptake method, and etc.) 2. List of patients by names who got receipts 3. List of patients by names who got receipts under benefit category 4. List of patients by names who got medical devices 5. List of patients by names referred to consultative and diagnostic service 6. Report on referrals to procedures (opened, under execution, executed, rejected, external, internal Management of initial registration documentation at profile specialist level basing on regulatory norms. This includes the following forms, at least: 001-3/у, 001-4/у, 001-5/у, 001-6/у, 0071/у, 025/у, 025-3/у, 025-4/у, 025-5/у, 025-7/у, 025-8/у, 0259/у, 027-2/у, 030/у, 030-1/у, 030-2/у, 217 M M M M M M M M 218 R2.4.6 R2.4.7 R2.4.7.1 R2.4.7.2 R2.4.7.3 R2.4.7.4 R2.4.7.5 R2.4.8 R2.4.8.1 Section VI. Technical Requirements 030-6/у, 036/у, 037/у, 037-1/у, 039/у, 039-2/у, 039-3/у 040/у, 045/у, 048/у, 052/у, 053/у, 054/у, 058/у, 060/у, 065/у, 065-1/у, 069/у, 070/у, 071/у, 073/у, 083/у, 084/у, 086/у, 088/у, 089/у, 090/у, 094/у, 095/у, 098/у, 111/у, 112/у, 128/у, 130/у, 132/у, 133/у, 138/у, 278/у, Management of lists of temporary disability. This includes at least: Registration of list of temporary disability Prolongation of list of temporary disability Closing of list of temporary disability Sending the list of temporary disability to Head of Department or Medical Consultative Board for approval. To make up a report on issued lists of temporary To draw a referral to Medical SocialExpert Commission (MSEC), creation and editing templates for MSEC Making up analytic tables at profile specialist level as well as statistic tables basing on regulatory norms. This includes the following forms, at least: 1. Statement for accounting patient visits to policlinic, dispensary, consultations and at home (039/у) 2. Report on executed screenings according to MOH order № 685 as of 10.11.2009 M M M M M M M M M Section VI. Technical Requirements R2.5 R2.5.1 R2.5.2 R2.5.2.1 R2.5.3 3. Report on dispensary patients flow 4. Report on invalid patients 5. Report on adult invalid patients 6. Report on planned hospitalization 7. Report on quantity of diseases of patients living in attached district and cohort of patients under dispensary control (Form 56, 12 8. Report on cohort of patients who get substitute care (Form 24) 9. Report on care to children (Form 31) 10.Report on child disability (Form 52) 11. Report on use of bed fund of health facility (hospital and day care) (Form 21) Module 5 «Head of Department in Policlinic» Confirming or rejection of referrals for certain types of services using digital signature Management of initial registration documentation at Head of Department level basing on regulatory norms. This includes the following forms, at least: 1. 035/у 2. 035-1/у 3. 035-2/у 4. 035-3/у 5. 095/у 6. 094/у Making up analytic tables at Head of Department level as well as statistic tables basing on regulatory norms. This includes 219 М М M М 220 R2.5.3.1 R2.5.4 R2.5.4.1 R2.5.4.2 Section VI. Technical Requirements the following forms, at least: Report making up: 1. Making up analytic tables in a breakdown similar to the tables of department staff 2. Report on attached population by districts 3. Report on age-sex structure of attached population 4. Report on staff composition of districts doctors 5. Report on main district performance indexes 6. Form 12 7. Report on the structure of visits (in terms of disease, preventive screenings, dispensary patients, for a visit to doctor examination, at home, providing substitute care technology, visits to nursing staff, in first aid room, a treatment room, on preventive vaccination) 8. Report on hospitalization of people from attached to a health facility area 9. Structure of consulting exams by profile specialists in breakdown by the districts of attached population Agreement of list of temporary disability, minutes of MCB. This includes, at least: Agreement of long-term lists of temporary disability Creation of MCB minutes M М M M Section VI. Technical Requirements R2.5.4.3 R2.5.4.4 R2.5.4.5 R2.6 R2.6.1 R2.6.2 R2.6.2.1 R2.6.2.2 Make up MCB conclusions Signing of MCB conclusion by digital signature Reports: 1. Report on issued lists of temporary disability 2. Report on quantity of patients passed through MCB 3. Report on quantity of patients referred to re-certification in MSE Module 6 «Medical Statistics in Policlinics» Monitoring of initial registration documentation management in a health facility Making up analytic tables at the level of a specialist in health statistics as well as statistic tables basing on regulatory norms. This includes at least the following: Constructor of reports with option to generate new reports and edit existing ones Report making up: 1. Form 039/у 2. Form 007/у 3. Report on attached population and its age-sex structure 4. Report on executed screenings 5. Report on staff composition of participants 6. Report on activities to attach 221 M M M M M M M 222 R2.7 R2.7.1 R2.7.1.1 R2.7.1.2 R2.7.1.3 R2.7.1.4 R2.7.1.5 R2.7.1.6 R2.7.1.7 R2.7.1.8 R2.7.2 R2.7.2.1 R2.7.2.2 R2.7.3 Section VI. Technical Requirements population to a district 7. Reporting forms 21, 12, 17, 24, 30, 31, 32, 43, 47, 52, 59, 4, 5, 6 Module 7 «Admission» Registration of patients addresses. This process includes, at least: Demographic data adjusting Data check and entry on insurance category and payment Registration of medical referral and/or rejection in care provision Medical documents making up and issuance Setting links between referrals doubles Distribution of patients by specialised departments and rooms Preliminary attachment of a patient to doctor in charge Confirming readiness to accept the patient Management of patients EMR. It includes, at least: Full description of processes and requirements to EMR management in line with national standard of EMR (approved by MOH order №75 as of 10.02.2014 «On approval of technical documentation in ehealth issues») Minimal obligatory set of data from EMR is given to national EHR basing on national standard of EHR Clarification of services carried out before hospitalization. It includes at least: М M M M M M M M M M M M M Section VI. Technical Requirements R2.7.3.1 R2.7.3.2 R2.7.4 R2.7.4.1 R2.7.5 R2.7.5.1 R2.7.6 Review of patients EHR from national EHR repository Registration of diagnosis, procedures, prescriptions and other data on medical services carried out prior to hospitalization but not entered into the System Management of initial registration documentation at Admission level basing on regulatory norms. This includes the following forms, at least: 001/у, 003/у, 004-1/у, 045/у, 058/у, 060/у, 069/у, 264/у Making up analytic tables at Admission department level. This includes the following forms, at least: Reports: 1. Report on scope of performed services, manipulations, exams 2. Report on drugs and vaccination 3. Report on performed work (quantity of applied patients, quantity of hospitalized patients in planned and extraordinary way, to day hospital, rejections from hospitalization, patients delivered by emergency care, sent by PHC or selfreversal patients) 4. Report on active information submitted to policlinic 5. Tables of bed fund of a health facility with indication of vacant beds Interaction with IS MHSD RK. It 223 M M M M M M M 224 R2.7.6.1 R2.7.6.2 R2.7.6.3 R2.7.6.4 R2.8 R2.8.1 R2.8.1.1 R2.8.1.2 R2.8.1.3 R2.8.1.4 R2.8.1.5 R2.8.2 Section VI. Technical Requirements includes, at least: Data exchange on executed services in admission department before hospitalization Data exchange on hospitalization and rejection from it Data exchange on state of bed fund Data exchange with IS MHSD RK according to interoperability requirements of MHSD Module 8 «Hospital Doctor» Management of patients EMR. It includes, at least: Full description of processes and requirements to EMR management in line with national standard of EMR (approved by MOH order №75 as of 10.02.2014 «on approval of technical documentation in ehealth issues Minimal obligatory set of data from EMR is given to national EHR basing on national standard of EHR Disease case study based on a standard template for the appropriate number of beds (personal data, medical history, personal history, past illnesses, the results of the initial inspection, prescriptions) Preliminary plan of treatment and additional studies if required Registration of patients visits and examination by doctor in charge Management of referrals to consultative M M M M М M M M M M M Section VI. Technical Requirements R2.8.2.1 R2.8.2.2 R2.8.2.3 R2.8.2.4 R2.8.2.5 R2.8.3 R2.8.3.1 R2.8.3.2 R2.8.3.3 R2.8.3.4 R2.8.4 R2.8.4.1 R2.8.4.2 and diagnostic services. It includes, at least: Adjusting plan of treatment, use plan during treatment, changes in plan if required Make up referrals to lab studies, study results and (if required) interpretations giving Make up referrals to diagnostic services, study results and (if required) interpretations giving Make up referrals to other doctors, study conclusion of specialists Monitoring of referrals state and identification of delays and rejections Diagnosis putting. It includes at least: Case review from national EHR repository Analysis results review Diagnosis adjusting and registration: diagnosis of sent health facility (referral), admission diagnosis (preliminary), the final clinical diagnosis, complications, comorbidities, the final, anatomopathological diagnosis Monitoring of execution of plan of treatment and its adjusting Make up doctor prescriptions for drugs and/or procedures and manipulations. It includes at least: Study patients allergy Check for drug compatibility 225 M M M M M M M M M M M M M 226 R2.8.4.3 R2.8.4.4 R2.8.4.5 R2.8.4.6 R2.8.5 R2.8.5.1 R2.8.5.2 R2.8.5.3 R2.8.5.4 R2.8.6 R2.8.6.1 R2.8.6.2 R2.8.7 Section VI. Technical Requirements Make up prescriptions on drug using treatment and diagnostic procedures assigning Monitoring of prescriptions executed in a right way and in time by nurse and involved into care parties Registration of side effect of drugs and complications from drugs and procedures Patient discharge. It includes at least: Determination of final diagnosis Make up Form 066/у Patient discharge making up Registration of vacant bed Making up analytic tables at doctor level. It includes at least: Reports: 1. Report on carried out work (number of cases with outcomes) 2. Report on number of carried out operations (including those with complications) 3. Report on number of carried out manipulations 4. Report on bed fund (bed operating, average duration of patient use of bed, execution of bed-days, death cases) 5. Report on use of diagnostic studies 6. Report on rehabilitation procedures Analytic tables making up Management of initial registration documentation at hospital doctor level M M M M M M M M M M M M M Section VI. Technical Requirements R2.8.7.1 R2.9 R2.9.1 R2.9.1.1 R2.9.1.2 R2.9.1.3 R2.9.1.4 R2.9.1.5 R2.9.1.6 R2.9.2 basing on regulatory norms. This includes the following forms, at least: 003/у, 004-1/у, 005/у, 008/у, 011/у, 0112/у, 011-3/у,027/у, 066/у, 066-4/у Module 9 «Hospital Nurse» Management of patients EMR. It includes, at least: Full description of processes and requirements to EMR management in line with national standard of EMR (approved by MOH order №75 as of 10.02.2014 “On approval of technical documentation in ehealth issues”) Minimal obligatory set of data from EMR is given to national EHR basing on national standard of EHR (approved by MOH order №75 as of 10.02.2014 “On approval of technical documentation in ehealth issues”) Demographic data adjusting Case treatment plan study Registration on required referrals (appointing to doctor for exam) to lab, diagnostic rooms and other specialists according to referrals and doctor prescriptions Reports: 1. Report on drugs and medical devices 2. Report on carried out procedures 3. Report of dressing/aid room Mark on execution of prescriptions and 227 M M M M M M M M M 228 R2.9.2.1 R2.9.2.2 R2.9.2.3 R2.9.2.4 R2.9.3 R2.9.3.1 R2.9.3.2 R2.9.3.3 R2.9.4 R2.9.4.1 R2.9.4.2 Section VI. Technical Requirements care plan, it includes, at least: Mark on drugs taken by patients Report on made procedures (for extraordinary cases when there are no work places in treatment room) Mark on made operations (for extraordinary cases when there are no work places in operating room) Entry of results of lab analysis and diagnostic tests (if there are no work places in relevant rooms for registration of results) Monitoring of patient state. It includes, at least: Mark on made assessment over patient state (temperature, complaints and etc.) Monitoring of treatment plan execution Warning in urgent cases Management of initial registration documentation at nurse level. This includes, at least: Printing of referrals and plan of treatment The System shall be able to manage following registration forms: 1. 004/у, 004-1/у, 007/у, 009/у, 029/у, 2. Register for blood intake for HIV 3. Register for recipients transfer to policlinic 4. Register of medication M M M M M M M M M M M Section VI. Technical Requirements R2.9.5 R2.9.5.1 R2.10 R2.10.1 R2.10.1.1 R2.10.1.2 R2.10.1.3 5. Register of dressing material 6. Requirements to pharmacy 7. Register for ethanol 8. Register for narcotic drug, psychotropic substances and precursors (Decree of GOK № 396 as of 30.03.2012) Analytic tables making at nurse level. Drawing up the following reports: 1. Report on used medications, including drugs and ethanol 2. Report on used medical devices 3. Report on identification of Blood group 4. Report on revealed infectious patients 5. Report on transfusion of blood and blood products 6. Report on blood sampling and other parts of organism for study 7. Report on biopsy sampling 8. Report on referrals to external studies Module «10 Meals» Every day menu forming. It includes, at least: Forming menu – requirement, editing, protection from editing upon approval Forming menu handed out to tables with indication of dishes, editing and protection from editing upon approval Review of list of dishes for each type diet 229 M М M M M M 230 R2.10.1.4 R2.10.1.5 R2.10.2 R2.10.2.1 R2.10.2.2 R2.10.2.3 R2.10.2.4 R2.10.2.5 R2.10.2.6 R2.10.3 R2.10.3.1 R2.10.3.2 R2.10.3.3 Section VI. Technical Requirements (Table) Review of patients selected by diets, rooms, departments and etc. Review of patients and medical staff comments towards meal quality Calculator of every day, monthly consumption of food for menu. It includes, at least: Calculation of required food products for each day, given listed quantity of patients in a health facility Adjusting number of portions (with logging of changes) for each type of diet Automated estimation of required food quantity and composition Printing order for food delivery Review of above data for previous periods (data adjusting is possible by special permission of Hospital Administrator given for limited time period) Possibility to review log in case of manual changes in quantity of portions Estimation of nutrition value of dishes in ration. This includes, at least: Estimation of dish nutrition value given standard of waist and loss during culinary processing Automated prompting on composition and food value for various diets Report on feed value by each diet and assigning recommended standards for each diet M M M M M M M M M M M M M Section VI. Technical Requirements R2.10.4 R2.10.4.1 R2.10.4.2 R2.10.4.3 R2.10.5 R2.10.5.1 R2.10.5.2 R2.10.5.3 R2.10.5.4 R2.10.6 R2.11 R2.11.1 R2.11.1.1 R2.11.1.2 R2.11.1.3 Making references of food products. It includes, at least: Handbook of basic food products and semi-finished products Reference of dish cards and composition Reference of dieted dish (tables 1-15) Patients diet management Review of recommendations on diets from specialists and care doctors for each patient Diet prescription (Table number) Diet change Review of patients and medical staff references on food quality Analytic tables forming for meals Module «11 Day Hospital» Management of patients EMR. It includes, at least: Full description of processes and requirements to EMR management in line with national standard of EMR (approved by MOH order №75 as of 10.02.2014 “On approval of technical documentation in ehealth issues”) Minimal obligatory set of data from EMR is given to national EHR basing on national standard of EHR (approved by MOH order №75 as of 10.02.2014 “On approval of technical documentation in ehealth issues”) Disease case study 231 M M M M M M M M M M M M M M 232 R2.11.1.4 R2.11.1.5 R2.11.2 R2.11.2.1 R2.11.2.2 R2.11.2.3 R2.11.2.4 R2.11.2.5 R2.11.3 R2.11.3.1 R2.11.3.2 R2.11.3.3 R2.11.3.4 R2.11.3.5 R2.11.3.6 R2.11.3.7 R2.11.4 Section VI. Technical Requirements Preliminary plan of treatment Registration of patients visits and examination by doctor in charge Creation of referrals to consultative and diagnostic services. It includes, at least: Adjusting plan of treatment, use plan during treatment, changes in plan if required Make up referrals to lab studies, study results and (if required) interpretations giving Make up referrals to diagnostic services, study results and interpretations giving Make up referrals to other doctors, study conclusion of specialists Monitoring of referrals state and identification of delays and rejections Registration of doctor prescriptions and execution. It includes at least: Study patients allergy anamnesis Check for drug compatibility Make up prescriptions on drug using Procedures assigning Mark on execution of procedures Monitoring of prescriptions executed in a right way and in time by nurse or helping persons Registration of side effect of drugs and complications from medicines and procedures Management of initial registration M M M M M M M M M M M M M M M M M Section VI. Technical Requirements R2.11.4.1 R2.11.5 R2.11.5.1 R2.11.6 R2.11.6.1 R2.11.6.2 R2.11.6.3 R2.11.6.4 R2.12 R2.12.1 documentation at Day Hospital level basing on regulatory norms. This includes the following forms, at least: 001-3/у, 001-4/у, 003-2/у, 004-1/у, 027/у, 029/у, 066-4/у Making up analytic and statistic tables at Day Hospital level in line with normative legal acts. It includes at least: Reports: 1. Report on carried out work (number of cases with outcomes) 2. Report on number of carried out operations (including those with complications) 3. Report on number of carried out manipulations 4. Invoice for reported period specifying cost of treatment by nosology forms 5. Report on average duration of stay in hospital Interaction with IS MHSD RK. It includes at least: Data exchange on executed services Clinical information exchange (diagnosis, consultations and examinations results, etc.) Data exchange on referrals Data exchange on receipts Module «12 Head of Hospital Department» Confirming or rejection of referrals for certain types of services using digital 233 M M M M M M M M M 234 R2.12.2 R2.12.2.1 R2.12.3 R2.12.4 R2.12.4.1 R2.12.4.2 R2.12.4.3 R2.12.4.4 R2.12.4.5 Section VI. Technical Requirements signature Management of initial registration documentation at Head of Department level basing on regulatory norms. This includes the following forms, at least: The System shall be able to register information of following initial accounting forms: 035/у, 035-1/у, 035-2/у, 035-3/у, 094/у, 095/у Making up analytic tables at Head of Department level as well as statistic tables basing on regulatory norms by forms and similar tables of department specialists. List of analytic and statistic forms shall be agreed with the Client at the stage of System design. Agreement of lists of disability, records of council of physicians. It includes at least: Agreement of long-term lists of disability Creation of records of council of physicians Make up council of physicians conclusions Signing council of physicians conclusion by digital signature Reports: 1. Report on issued lists of temporary disability 2. Report on patients passed through council of physicians 3. Report on operating factors of bed M M M M M M M M M Section VI. Technical Requirements R2.13 R2.13.1 R2.13.1.1 R2.13.1.2 R2.14 R2.14.1 R2.14.1.1 R2.14.1.2 R2.14.1.3 fund of a department 4. Report on treated patients 5. Structure of treated cases by groups of nosology and age 6. Report on services rendered by codes of tarrificator Module 13 «Hospital Administrator» Making up analytic tables at Hospital Administrator level as well as statistic tables basing on regulatory norms. List of analytic and statistic forms shall be agreed with the Client at the stage of System design. This includes the following forms, at least: Monitoring of initial documentation maintenance in a health facility Analytic tables and reports accessible to all health facility departments by division into departments Module 14 «Medical Statistics for Hospital» Bed fund management. It includes, at least: Management of bed fund referral by units, rooms, beds Setting up bed fund use (bed installing, bed folding, temporary beds, setting maximal number of beds in room, management of information on bed profiles, bed profile change, bed closing and reducing) Entry of additional information on bed, 235 M M M M M M M 236 R2.14.2 R2.14.2.1 Section VI. Technical Requirements room (male, female) Making up analytic tables at Medical M statistic level as well as statistic tables basing on regulatory norms. Forming initial reports and forms: M 1. Every day :007/у, 007-1/у, 2. Monthly: 016/у 3. Form 21 4. Form 14 annual (ICD-10 and ICD-9) 5. Form 32 annual 6. Form 30 annual 7. List of cured cases at tertiary level with indication of operations 8. Hospital activity report 9. Work of departments by bed profiles; 10. Composition of patients, terms and outcomes; 11. Main indicators for hospital work; 12. Information on structure of all types of secondary care; 13. Composition of patients by groups of diagnosis; 14. Composition of cured patients by outcomes; 15. Statistic data on work of resident doctors; 16. Surgery work by departments; 17. Analysis of surgery activity; 18. Summary information on operated patients by bed profiles; 19. Information on pre-surgical state; 20. Operations by surgery units; Section VI. Technical Requirements 21. composition of patients for surgical departments 22. analysis of activity of intensive care unit; 23. analysis of mortality and matches in clinical and post-mortem diagnoses; 24. analysis of diagnosis coincidence by referral and final one; 25. data on treated patients by districts and regions; 26. data on treated patients by referrals for “HB" ; 27. data on the types of injuries; 28. data on patients received in alcoholic state; 29. list of patients treated; 30. List of patients in the hospital; 31. list of the dead to be submitted to the registration service 32. list of the dead in the hospital at district level; 33. List of deaths by age; 34. information on treated villager inhabitants; 35 List of operated patients by departments; 36. list of patients operated on by doctors of the Department; 37. list of patients in breakdown by selected diagnoses; 38. list of patients with complications after surgery; 237 238 R2.14.2.2 R2.14.2.3 R2.15 R2.15.1 R2.15.1.1 Section VI. Technical Requirements 39. list of patients passing through resuscitation; 40. list of patients transferred to other hospital 41. list of treated patients who appeared to be healthy ; 42. list of patients having preferential category; 43. list of patients admitted again within a month; 44. sex and age composition of treated patients by profiles; 45. report on services delivered by diagnostic departments; 46. Structure of patients with circulatory diseases in breakdown by nosology, age and outcome 47. Report on cured cases in breakdown by DRG. Monitoring of primary records maintenance of a health facility Report Designer with the ability to create new reports and modify existing Module 15 «Procedures and manipulations» Management of patients EMR. It includes, at least: Full description of processes and requirements to EMR management in line with national standard of EMR (approved by MOH order №75 as of 10.02.2014 “On approval of technical documentation in e- M M M M Section VI. Technical Requirements R2.15.1.2 R2.15.1.3 R2.15.1.4 R2.15.1.5 R2.15.2 R2.15.2.1 R2.15.3 R2.15.3.1 R2.16 R2.16.1 R2.16.1.1 R2.16.1.2 R2.16.1.3 health issues”) Minimal obligatory set of data from EMR is given to national EHR basing on national standard of EHR (approved by the same order) Patient identifier Mark on executed procedures Appointing the patient by time if there is a need to get services again Management of initial documentation for rendered services and manipulations according to regulations. It includes at least: 029/у, 042/у,044/у, 046/у, 047/у, 058/у, 063/у, 064/у, 064-1/у, 064-2/у, 069/у, 150/у Making up analytic tables on carried out procedures and manipulations and statistic tables according to regulations. It includes Reports: Report on carried out services (by used equipment, executers, funding sources types of services) Module 16 «Admin» Database management. This process includes, at least: Monitor and optimize of database performance Database Management: Configuration of repository, database extension Managing users and passwords of database 239 M M M M M M M M M M M M 240 R2.16.1.4 R2.16.1.5 R2.16.1.6 R2.16.2 R2.16.2.1 R2.16.2.2 R2.16.2.3 R2.16.2.4 R2.16.2.5 R2.16.3 R2.16.3.1 R2.16.3.2 R2.16.3.3 R2.16.3.4 R2.16.3.5 R2.16.4 R2.16.4.1 Section VI. Technical Requirements Access rights management to database in accordance with Annex 1 Backing up data for a certain period of time Restoring the backup data on separate servers to find old data. Creating user groups and individual users of the system. This process includes, as a minimum: Create, delete, and edit user accounts; Create, delete, and modify user roles; Attaching roles to specific users (the same user can have multiple roles) Add, change, or delete access rights of roles to modules, initial rights shall be assigned in accordance with Annex 1. Temporary ban for user access to the System Manage authentication types (password, digital signature) This process includes, at least: Initial password creation Change passwords for those users who are not able to change them Change Password Management Policy Using foreign keys View attempts to access with an invalid key Maintain system logs. This process includes, as a minimum: Log of created, modified, and deleted M M M M M M M M M M M M M M M M M Section VI. Technical Requirements R2.16.4.2 R2.16.4.3 R2.16.4.4 R2.16.4.5 R2.16.4.6 R2.16.4.7 R2.16.5 R2.16.5.1 R2.16.5.2 R2.16.5.3 R2.16.5.4 records in the database Log of the users input history Log of receiving reports Log of data viewing Log of archiving actions Log of Errors and emergency program stops Log of synchronization with external (national) directories, classifications, indexes and registers Customization of medical records templates. This process includes, at least: Creating new templates Change (creating new versions) of existing templates Attaching templates to modules and their detachment The following functions are used when creating and editing the templates: •change the font settings (style, size, bold, underline, italics, etc. ) • changing the font color • the creation of complex patterns with subsections • the ability to use any directory in the system for filling in fields in the template • the ability to use any entity in the database for filling in fields in the template • the ability to use any data selection from the database for filling in fields in the template 241 M M M M M M M M M M M 242 R2.16.6 R2.16.6.1 R2.16.6.2 R2.16.6.3 R2.16.7 R2.16.7.1 R2.16.7.2 R2.16.7.3 R2.16.7.4 R2.16.7.5 Section VI. Technical Requirements • forming fill rules: only from the list, from the list with possible matches, in free format, from the samples, etc. • creating new directories used when completing the template Customizing user interface. This process includes, at least: Controlling access to interface tools depending on user access rights Change the style (for example: colors, size of fields, fonts) Option of making up individual templates for each user including assigning defaults to separate fields in pattern of this user Configuring user access. This process includes, at least: Adding, modifying, and deleting user rights on actions in the System Manage (add, edit and delete) access to data in the context of organizational structure of enterprise: within structural unit attached to the user, within the entire health facility, in accordance with organization structure of enterprise Fixing the right for user for view, creation, change and removal of data in certain structural units Add, change, or delete user access to reports Time Management - Schedule of work of employees, during which the user has access rights to the System M M M M M M M M M M Section VI. Technical Requirements R2.16.7.6 R2.16.7.7 R2.16.7.8 R2.16.7.9 R2.16.7.10 R2.16.8 R2.16.8.1 R2.16.8.2 R2.16.8.3 R2.16.9 R2.16.9.1 R2.16.9.2 R2.16.9.3 R2.16.9.4 Controlling access to patient data in accordance with the privacy policy of personal data approved by MHSD RK. Installation privacy indication for those personal data that must be stored in a database in encrypted form Viewing logs with the actions of specific users for a certain period of time Archiving and cleaning logs with data about user activity for a certain period in accordance with the policies of MHSD RK Viewing log files Setting of connection to external programs. This process includes, at least: Allowing access for certain IP addresses Resolution of certain programs and services Change access passwords of external programs Managing directories (references). This process includes, at least: Changing content (add, edit) of local directories of the system Monitoring the synchronization of external (national) directories, indexes and registers Monitoring of correctness (or potential problems ) of data exchange with external data sources (national EHR, national analytical repository) Change the synchronization schedule with 243 M M M M M M M M M M M M M M 244 R2.16.10 R2.16.10.1 R2.16.10.2 R2.16.10.3 R2.16.10.4 R2.17 R2.17.1 R2.17.1.1 R2.17.1.2 R2.17.1.3 R2.17.1.4 R2.17.1.5 R2.17.1.6 Section VI. Technical Requirements external information resources Create, edit reports using the Report Master, which allow create and edit of reports with using of fields from System data base. This process includes, at least: Creating Reports editing reports Deleting reports Setting user rights to use reports Module 17 «Lab IS» Registration of received material with the possibility of rejection. This process includes, at least: Doing personified account of ongoing research, support of patient cards in the LIS database Creating a new patient card by assigning a unique identification number after: automatically retrieve of data from other modules on the flow of new patient, automatically after receiving (reading) the referral, entry of patient data from the referral manually Reading standard forms using: optical recognition of symbols, optical recognition of marks Registration of received material with reference to the patient Assigning a unique identification number to each material Ability to reject Receipt stating the reason (from the directory and / or manually) M M M M M M M M M M M M Section VI. Technical Requirements R2.17.1.7 R2.17.2 R2.17.2.1 R2.17.2.2 R2.17.2.3 R2.17.2.4 R2.17.3 R2.17.3.1 R2.17.3.2 R2.17.3.3 R2.17.3.4 R2.17.3.5 Generating reports: 1. Report on the quantity of incoming material 2. Report on quantity of rejected material for various reasons Barcoding material (creating barcode, identification by barcode). This process includes, as a minimum: Assigning a barcode for material Assigning a barcode for individual samples Read barcode using stationary and portable bar code scanners Support for processing the data on the basis of the majority of these bar codes: Code 39, Code 93, Code 128, Codebar, European Article Number (EAN), ITF-14, MSI Barcode, Universal Product Code, as well as two-dimensional codes PDF417, Aztec Code, Data Matrix, Maxi Code, QR-code, Microsoft Tag Formation of worksheets for laboratory analyzers and executors. This process includes, at least: Formation of orders for analysis based on referrals received from HIS Formation of orders for analysis based on manual data entry Inclusion of several materials to one order Using of service profiles for ordering (multiple studies) Order of integrated services (one service 245 M M M M M M M M M M M M 246 R2.17.3.6 R2.17.3.7 R2.17.3.8 R2.17.3.9 R2.17.3.10 R2.17.4 R2.17.4.1 R2.17.4.2 R2.17.4.3 R2.17.4.4 R2.17.4.5 R2.17.5 R2.17.5.1 R2.17.5.2 R2.17.5.3 Section VI. Technical Requirements with multiple materials) Automatic distribution of analysis on worksheets based on configurable criteria (type of analysis, analysis time , executor) Manual distribution of analysis on work places Redistribution of analysis from selected worksheets to other worksheets Changing the executor in a worksheet Prints worksheets to perform manual research Interaction with laboratory equipment (export referrals to analysis, import of analysis results). This process includes, at least: Connecting analyzers , sample preparation stations and other equipment that have the ability to connect to LIS Submit orders to analyzers Getting results from the analyzers and their distribution in the patient cards Getting results of internal quality control from analyzers Viewing, editing, deleting, editing, approving of the results Manual entry of laboratory results. This process includes, at least: Setting up a result templates Manual entry of finished research results Adjustable calculation algorithm of the finished results based on input data M M M M M M M M M M M M M M M Section VI. Technical Requirements R2.17.5.4 R2.17.5.5 Processing of the results of bacteriological M analysis: • The processing system must be open and allow the user within embedded in the system classification to add independently the sections such as: antibiotics, diagnoses, biomaterials, micro-organisms, • A list of diagnoses in the system shall be composed by ICD-10, the list of antimicrobials shall be drawn up according to international classification, the list of taxons - on the latest edition of "Bergey's Manual of Determinative Bacteriology" • antibiogram shall be built based on the data entered by the user and received by any of the methods (disk diffusion, by limiting concentrations or when determining the minimum inhibitory concentration) • The processing system, based on embedded data on the natural stability of individual organisms or their groups, on distribution among them acquired resistance, as well as information about clinical efficiency of antimicrobial agents, shall interpret the results of studies of antibiotic susceptibility, obtained in vitro, to the degree of sensitivity (S, I, R) and, if necessary , correct them or generate an error message, Forming of reports: M 247 248 R2.17.6 R2.17.6.1 R2.17.6.2 R2.17.6.3 R2.17.7 R2.17.7.1 R2.17.7.2. R2.17.7.3 R2.17.7.4 R2.17.8 Section VI. Technical Requirements 1. Report on completed analysis 2. Report on antibiotic resistance of isolates (in general in a health facility and by its units) 3. Report on types of lab studies (clinic, biochemical, hematological, immunological, bacteriological and etc.) 4. 261 / y 5. 262 / y 6. Form # 1 POA (Report expensive services compared with plan) Validation of the results of laboratory research laboratories by authorized employee. This process includes, at least: Viewing results of an analysis execution Comparison with the reference values with visual indication of deviations Construction of control charts to evaluate the quality of results Laboratory quality control (intralaboratory, interlaboratory, external). This process includes, at least: Registration of the daily results of the control materials study Register reference values of control materials Comparison of obtained values with the reference values Formation of control materials research protocols for interlaboratory and external comparisons Printing the results on the basis of M M M M M M M M M M Section VI. Technical Requirements R2.17.8.1 R2.17.8.2 R2.17.8.3 R2.17.9 R2.17.9.1 R2.17.9.2 R2.17.9.3 R2.17.10 R2.17.10.1 approved legal acts for initial records . This process includes, at least: Creating and editing templates, forms and logs Print the results in accordance with the approved (R2.18.10.1) and user’s forms Print the logs in accordance with the approved forms (R2.18.10.1) Input of laboratory reference values for all patients, by age and sex. This process includes, at least: Input of reference values by age and sex Formation of the reference values of individual indicators based on statistical processing of laboratory results Generating reports: Laboratory reference values (by groups of patients and types of lab studies) Management of initial registration documentation at laboratory level basing on regulatory norms. This includes at least: 014/у, 027-3/у, 200/у, 201/у, 202/у, 204/у, 205/у, 206/у, 207/у, 208/у, 210/у, 211/у, 214/у, 215/у, 216/у, 216-1/у, 2162/у, 217/у, 218/у, 219/у, 220/у, 221/у, 222-1/у, 223/у, 224/у, 227/у, 228/у, 230/у, 232/у, 233/у, 234/у, 235/у, 236/у, 237/у, 238/у, 239/у, 240/у, 240-4/у, 2405/у, 240-6/у, 240-7/у, 240-8/у, 240-10/у, 240-11/у, 240-12/у, 241/у, 242/у, 244/у, 244-1/у, 244-2/у, 244-3/у, 249 M M M M M M M M M 250 R2.17.11 R2.17.11.1 R2.17.12 R2.17.13 R2.17.13.1 R2.17.13.2 Section VI. Technical Requirements 245/у, 245-1/у, 248/у, 249/у,250/у, 252/у, 253/у, 253-1/у, 253-2/у, 254/у, 260/у, 257/у, 259/у, 261/у, 262/у,280/у, Formation of analytical tables at the laboratory level, as well as statistical tables in accordance with the legal regulations. This process includes, at least: Generating a report on completed analysis (Form 30) The ability to integrate the System with independent laboratory information systems. This process presupposes compliance with required profiles of IHE The transmission of information on completed research to EMR and EHR. This process includes, at least: Transmission of data about laboratory tests performed and their results to EHR in accordance with the standard requirements for EHR, approved by Order of the Acting Minister of Health of 10.02.2014 № 75 "On approval of technical documentation related to ehealth" Transmission of laboratory tests performed and their results to the EMR in accordance with the standard requirements for EMRs, approved by Order of the Acting Minister of Health of 10.02.2014 № 75 "On approval of technical documentation related to e- M M M M M M Section VI. Technical Requirements R2.18 R2.18.1 R2.18.1.1 R2.18.1.2 R2.18.2 R2.18.3 R2.18.3.1 R2.18.3.2 R2.18.3.3 R2.18.3.4 R2.18.3.5 R2.18.4 R2.18.4.1 R2.18.4.2 R2.18.4.3 health" Module 18 «PACS» (Picture Archiving and Communication System) Data exchange with medical equipment. It includes at least: Data import pursuant to standard DICOM (sectoral standard for health image creation, storage, transmission and visualization). Import directly from video outputs (if the necessary equipment is in place) Interaction with other modules and systems based on IHE profiles. Import / export of images. This process includes, at least: Supporting of at least DICOM, BMP, JPEG formats Support for at least DICOM Modality Worklist Ability to save images as attachments to CDA documents Supports scanning of paper and film images to produce an electronic archive Audit of imports and exports cases Working with images. This process includes, at least: Viewing single and series of images, Calling from the archive and the appearance of the image on the screen is not later than 3-5 seconds after the request Identification of areas of interest in the 251 M M M M M M M M M M M M M M 252 R2.18.4.4 R2.18.4.5 R2.18.4.6 R2.18.4.7 R2.18.4.8 R2.18.4.9 R2.18.5 R2.18.5.1 R2.18.5.2 R2.18.5.3 R2.18.5.4 R2.19 R2.19.1 R2.19.1.1 R2.19.1.2 R2.19.1.3 R2.19.1.4 Section VI. Technical Requirements image , Overlay comments Image processing to improve the quality Quick search of patient data and images of the patient Interlinks between patient metadata and images Connection images with interpretation and diagnostic results Audit of Imagines View and Edit Maintain archive of images. This process includes, at least: The possibility of long-term storage of images Keeping the identity of the patient to avoid errors in assigning images to other patients. The ability to integrate with other systems in health facility The ability to transmit image (if necessary) to other systems and to the national EHR repository Module 19 «Diagnostic studies» View records on schedule of patients. This process includes, at least: View the schedule of patients Viewing of referrals to the diagnostic studies Getting a list of patients recorded to the study Cancellation or postponement of time of M M M M M M M M M M M M M M M M Section VI. Technical Requirements R2.19.1.5 R2.19.2 R2.19.2.1 R2.19.2.2 R2.19.2.3 R2.19.2.4 R2.19.2.5 R2.19.3 studies with indication of reasons for the delay and stakeholders notification Reports generating: 1. Report on appointments 2. Report on the canceled visits 3. Report on the services performed 4. Report on radiation doses for staff and patient 5. Report on priorities and term of waiting for diagnostic studies 6. Forming the list of patients in breakdown by rendered services by codes of tarrificator Enter the results of research based on templates. This process includes, at least: Creating and editing templates for consultation, conclusions, results of research Filling of research results based on templates Search of previous patient conclusions Printing of research results according to approved forms Reports forming: 1. Report on services rendered (by equipment, executors, funding sources, research types, referred divisions) 2. Report on radiation doses for staff and patient 3. List of patients in breakdown by rendered services by codes of tarrificator Management of initial registration 253 M M M M M M M M 254 R2.19.3.1 R2.19.3.2 R2.19.4 R2.19.5 R2.19.5.1 R2.19.5.2 Section VI. Technical Requirements documentation on diagnostic studies basing on regulatory norms. This includes at least: 001-4/у, 001-5/у, 028/у, 039-5/у, 039-7/у, 039-8/у, 050/у, 202/у, 203/у, 212/у, 213/у, 225/у, 226/у, 229/у, 231/у, 243/у, 243-1/у, 246/у, 247/у, 247-1/у, 247-2/у, 247-3/у, 247-3/1/у ,247-3/2/у, 247-4/у, 247-5/у, 247-6/у, 247-7/у, Protocol for measuring individual doses (MOH order №902 as of 20.12.11) Formation of analytical tables for diagnostic tests, as well as statistical tables in accordance with the legal regulations. The list of analytic and statistic forms shall be agreed with the Client at the stage of System design The transmission of information on completed research to EHR and EMR. This process includes, at least: Transmission of information on diagnostic tests performed and their results in EHR in accordance with the standard for EHR approved by Order Acting Minister of Health of 10.02.2014 № 75 "On approval of technical documentation related to ehealth " Transmission of information on diagnostic tests performed and their results in the EMR in accordance with the standard requirements for EMRs , approved by Order of the Acting Minister of Health of M M M M M M Section VI. Technical Requirements R2.19.5.3 R2.20 R2.20.1 R2.20.1.1 R2.20.1.2 R2.20.1.3 R2.20.1.4 R2.20.1.5 R2.20.1.6 R2.20.2 R2.20.3 R2.20.4 R2.20.5 10.02.2014 № 75 "On approval of technical documentation related to ehealth" Implementation of the exchange in accordance with IHE profiles Module 20 «Pharmacy» Record keeping for medicines at different levels: nurse’s station, office, pharmacy warehouse (one or more), health facility. This process includes, at least: Maintain full inventory control on one or more central warehouses Maintain full inventory control for each responsible person View stored remainings in each stock (by group of medicines, by pharmacological and pharmacotoxic groups, on medicines, by supplier, by department) Setting the number of minimum balances for each medication Establishing the baseline medication lists for each department Control over the implementation of minimum balances Automatic write-off of drugs when prescription is executed Ability to track expiration dates of medicines and medical devices. The possibility of forming a list of medicines (medical devices) required to purchase in health facility. Formation of order to the pharmacy to get 255 M M M M M M M M M M M M 256 R2.20.6 R2.20.7 R2.20.7.1 R2.20.7.2 R2.20.7.3 R2.20.8 R2.20.8.1 R2.20.8.2 R2.20.8.3 Section VI. Technical Requirements drugs (automatic urgent order if medicine is in the treatment sheet but lack in the department, in case of reducing the stock below the critical minimum). This includes at least: Getting information about the presence of the drug in the departments. This includes at least: Maintenance of the drug formulary of health facility. This process includes, at least: Creation of the formulary of a health facility Adding medications into the formulary of a health facility with indication of justification document Exclusion of drugs from formulary of a health facility with indication of justification document Register of side effects of the drug. This process includes, at least: Forming of card-message (form №192-1/у by MOH order as of 3.11.2009, №647) Register case in Log for revealed cases of side effect from drugs (Form №192-3/у MOH order as of 03.11. 2009, № 647) Reports: 1. Making up statistic reports on revealed cases of side effect from drugs and lack of effectiveness of the drug in medical and pharmaceutical agency (Form №192-4/у MOH order as of 03.11. 2009, M M M M M M M M M Section VI. Technical Requirements R2.20.9 R2.20.9.1 R2.20.9.2 R2.20.9.3 R2.20.9.4 R2.20.9.5 R2.20.9.6 R2.20.9.7 R2.20.10 R2.20.10.1 R2.20.10.2 R2.20.10.3 R2.20.10.4 R2.20.10.5 №647) Monitoring of prescriptions of drugs. This process includes, at least: Viewing prescriptions of drugs in units of a health facility Sorting prescriptions by date, doctor, diagnosis, and other parameters View the links between diagnosis and drugs Enter the data about drugs, recommended clinical guidelines and protocols of diagnosis and treatment Entering data on interaction of drugs to prevent joint prescription Comparison of prescriptions with the list in accordance with clinical protocols and guidelines Sending messages with the recommendation to replace the drugs Setting maximum dosages for control purposes. This process includes, at least: Setting the maximum dosage in various forms (kg per body mass, single, daily, etc.) Setting maximum dosages for different groups of patients with various age and sex Setting maximum dosages for individual diseases Viewing applications for exceeding the specified maximum dosages Permission to exceed the specified 257 M M M M M M M M M M M M M M 258 R2.20.11 R2.20.11.1 R2.20.11.2 R2.20.11.3 R2.20.11.4 R2.20.11.5 R2.20.11.6 R2.20.11.7 R2.20.12 R2.20.13 Section VI. Technical Requirements maximum dosages with reasons Registration and execution of credit and debit invoices of hospital units and pharmacies in accordance with the regulations. This process includes, at least: Create, edit, and check invoices Creating, editing and recording of credit and debit invoices Formation of requirements for medicines from senior nurses of a department, including on the basis of registered prescriptions Making consignment statement for medicines and supplies according to the requirements for the supply of medicines from senior nurses of departments Create, edit, and register the return of medicines from departments to the warehouse Creating, editing and recording of orders to suppliers Creating, editing and recording of deferred credit and debit invoices to fulfill orders for medicines Management of initial registration documentation on pharmacy level in accordance with legal regulations. Formation of analytical tables at the pharmacy level, as well as statistic tables in accordance with the legal regulations. The list of analytic and statistic forms M M M M M M M M M M Section VI. Technical Requirements R2.20.14 R2.20.15 R 2.20.16 R2.21 R2.21.1 R2.21.1.1 R2.21.1.2 R2.21.1.3 R2.21.1.4 R2.21.1.5 R2.21.1.6 R2.21.2 R2.21.2.1 R2.21.2.2 R2.21.2.3 R2.21.2.4 shall be agreed with the Client at the stage of System design. Forming application for required medicines at the level of a department, out-patient clinic, hospital basing on served area Forming report on planning expenditures for medicines given the benefit medicines Interaction with other Modules in case of need in exchange of information on drugs Module 21 “Human Resources” Communication with national indexes. It includes at least following indexes: “Register of Healthcare professionals” “Register of Health facilities” “Register of Addresses” “Health specialties” “List of positions (duties)” “List of medical services” Maintenance of organizational structure of health facility. It includes at least: Making up, editing, removal of units in health facilities (rooms, units, departments, and etc. in line with organizational structure of facility) Maintenance of health facility staff schedule Making up statements for substitution of officials Linkages between rooms/ offices and specialists 259 M M M M M M M M M M M M M M 260 R2.21.2.5 R2.21.3 R2.21.3.1 R2.21.3.2 R2.21.3.3 R2.21.3.4 R2.21.3.5 R2.21.3.6 R2.21.3.7 R2.21.3.8 Section VI. Technical Requirements Linkage of units with the list of provided services Maintenance of doctors (health facility staff) registration card. It includes at least: Employment of specialist Enter of following minimal information about the employee: The history of labor relations, episodes of employment, personal information (ID number , the number of the pension contract, marital status, family, place of residence, place of registration, contact information, number of children, relation to military service, the number of individual employment contract), information about participation in hostilities, emergency response, disaster relief, promotion, levy, knowledge of languages, information on social rewards, education, professional certifications, trainings, academic degrees, science degrees Registration of employees’ liability for damage Employment for the additional position Transfer to another position within the health facility Dismissal of an employee Management of Capacity building schedule View and print a list of employees selected according to certain criteria M M M M M M M M M M Section VI. Technical Requirements R2.21.4 R2.21.4.1 R2.21.4.2 R2.21.4.3 R2.21.4.4 R2.21.4.5 R2.21.5 R2.21.5.1 R2.21.5.2 R2.21.5.3 R2.21.5.4 R2.21.6 R2.21.6.1 R2.21.6.2 R2.21.6.3 R2.21.6.4 R3 Keeping employees work mode. This process includes, at least: Planning and accounting of days off and vacations of employees Compilation of working regime given the weekends and holidays Accounting replacements and unscheduled absence Printing regime of work and schedule of vocations by individuals, rooms (health service provision points), by departments, by facility Printing statement on actually period of work, vocation by individuals, rooms (health service provision points), by departments, by facility Reference of services management. It includes, at least: Links with national index of services Adding and removal of services out of facility service reference Service attaching to facility units Review and printing of list of services for each unit and facility Interaction with accounting IS (at list with «1C» software). It includes, at least: Data transfer on new specialists Data transfer on changed positions Data transfer on worked days (hours) Data exchange on vocations of specialists Requirements to System configuration 261 M M M M M M M M M M M M M M M M 262 R3.1 R3.1.1 R3.1.2 R3.1.3 R3.1.4 R3.1.5 R4.1 R4.2 Section VI. Technical Requirements Configuration to health facility needs Delivered system shall contain mandatory modules in its composition in accordance with Table 1, depending on the type of health facility: Hospital, Policlinic, Mixed type (Hospital+ Policlinic) (see also R1.17-R1.18) The System shall provide ability to control access to functionality based on roles. The system shall allow to add / delete / edit the role and assign / cancel the right of access to the system functionality The System shall have preset role in accordance with Table 3, with further changes (adding new roles, edit or delete). Access rights to different modules and functions of the System shall be preinstalled in accordance with Table 4 with the ability to change access rights (add, delete) Access right shall be configurable at least on the following aspects: all rights, to create, to modify, to delete, to view Patient search by name or IIN and patientrelated data (results of the survey, the results of laboratory tests, etc.) shall take no more than 3-5 seconds for 80% of cases Potential Supplier during warranty period shall ensure the functioning of the following options: М М М М М M М Section VI. Technical Requirements R4.2.1 R4.2.2 R5 R5.1. R5.2. R5.3. R5.4. R5.5. R5.6. R5.7. R5.8. The total downtime of System for the reason related to its operability shall not exceed 24 hours per year. Onetime of System downtime for the reason related to its operability shall not exceed 2 hours. Requirements to Informational Security Security requirements are defined by current legislation of the Republic of Kazakhstan. The system shall meet requirements of information security to ensure access threshold, protection from unauthorized access, etc. The system shall provide protection of information from unauthorized access, namely: User authentication based on checking the name (login) and password Ability to identify user based on digital certificates of open key infrastructure User authorization for access to system information and computing resources requiring appropriate permissions Personalized definition of the rights of users to input , corrections , viewing of data Personalized definition of the rights of users to access system resources Differentiation of system user rights by roles, groups and access levels based on hierarchy of objects and attachment to organizational structure. 263 М М M M M M M M M M 264 R5.9. R5.10. R5.11. R5.12. R5.13. R5.14. R5.15. R5.16. Section VI. Technical Requirements Logging of users work with system critical features and applications Protect the system files from modification / damage by unauthorized users and software processes Control log shall be maintained of all updates of the system software libraries The system shall implement at least the following backup: - Automatic backup with option to plan it - Remote control over backup making - Full and partial backups The system shall ensure data integrity. The system shall provide tools for encrypting sensitive data during storage and during transmission to other systems. Digital signature (registration certificate of user by National Authorizing Center of the RK) shall be issued by NAC RK. The system shall provide the tools for digitally signing of documents (objects) or portions of documents, when / if it is needed, and the tools for authenticating signatures. This feature shall be implemented in system services (if necessary). To ensure confirmation of digital signature authenticity and validity of opened key of digital signature, the System shall provide check for e-signature authenticity using services of NAC RK (http://pki.gov.kz/index.php/ru/) System shall comply with the principle of M M M M M M M M Section VI. Technical Requirements R5.17. R5.18. "single access point" - the architecture of the information infrastructure allows to have a common access point (technology Single Sign On) to all its components and resources that allows you to enter the username and password once and gain access to all system components without re-entering the password. The System shall provide authorization of M users in the system, distinction between the rights of users of the system by roles, groups and access levels based on hierarchy of objects and accessories to organizational structure. In accordance with legal and technical M documentation for information security, approved by the MHSD RK the following shall be implemented: - The length of the password shall be at least 8 characters, numbers and letters shall be present in upper and lower case; - Forced password change function; - Barring use as a password of "empty" password; - password change independently by user; - If wrong password is entered more than three times CAPTCHA method shall be implemented; - Journal of logging activities of all users for viewing the history of changes of main event of the System; - Function of interrupting session when 265 266 R6 R6.1. R6.2. R6.3. R6.4. R6.5. R6.6. R6.7. R6.8. Section VI. Technical Requirements inactive after N period of time. Requirements to System quality attributes The system shall support input, transmitting and receiving data necessary for operation of MOH information systems used by the health facility and eliminating the needs to re-enter data. The system shall ensure preservation of all accumulated information at the time of the refusal or failure in case of failure of any component of the system, regardless of its destination, with recovery of data after repair and restoration works The system shall have flexibility to change settings in external environment and specific user tasks without replacing modules. The system shall be highly scalable and allow to work in an unlimited number of users. Constraints can be driven only by technical characteristics of the equipment, not by characteristics of System All functional capabilities of the system shall be designed in the form of services. Web services of the System shall be designed in accordance with SOA architecture. When implementing services interaction it is necessarily stick to the standard of MHSD RK concerning information systems interaction The system shall enable construction of M M M M M M М M Section VI. Technical Requirements R6.9. R6.10. R6.10.1 R6.10.2 R6.10.3 R6.10.4 R6.10.5 R6.10.6 templates for approved medical forms available within the solution itself, which can be automated without programming or changes of the program code. The system shall be capable of resolving conflicts when parallel processing system objects. Requirements for user interfaces The interface shall be designed for the preferential use of manipulator "mouse" , i.e., the system control shall be carried out using a set of on-screen menu, buttons, icons and similar items Keyboard input mode shall be used primarily during filling and / or editing text and numeric fields screen forms. It shall also provide hotkeys to switch between filled files. Ergonomic solutions and interface design as much as possible shall be uniform for all system components and modules User interface systems shall be multilingual and organized with the support of at least state (Kazakh) and Russian languages. Exceptions can only be system messages not localized or standard administrative applications that make up the system software Access to electronic operational documentation shall be available The context- sensitive help system shall be implemented in the System, accessible 267 M M M M M M M M 268 R6.10.7 R6.10.8 R6.10.9 R6.10.10 R6.10.11 Section VI. Technical Requirements from any web application, where links shall be submitted to information (user manual , instructions , etc.), with possibility of configuration without involvement of potential suppliers at the Purchaser level; The UI system shall provide visual selection of screen attributes which are available to the operator as read-only The UI system shall provide visual selection of screen attributes which are mandatory for filling in The system shall ensure correct handling of emergencies caused by incorrect user actions, incorrect format or invalid values input. In these cases the system shall give the user a relevant message, and then return to the operating state prior to incorrect (invalid) command or data entry System shall not allow duplication and repeated (incorrect) input of homogeneous information. The system should ensure elimination of duplication and re-enter the information contained in public databases and information systems of state bodies The system shall provide the formatlogical control of input data for all values in the system. Format logical control of entered data means control over format and content of entered data. The System shall provide protection against erroneous M M M M M Section VI. Technical Requirements R7 R7.1. R7.1.1 R7.1.2 R7.2. R7.2.1 actions: - Choose only available to the user (in accordance with permissions) functions; - Enter only available to the user (in accordance with permissions) data values; - Input only certain format (eg, inability to input character data in the format field "Date" or "Number"). Requirements to System interoperability General Requirements to System interoperability System solutions and application shall M meet standards of interoperability, including national standards and accepted international standards listed in this chapter (and in this document). System components must conform to the M national instruments of semantics: o References and classifiers o Requirements for reference services o Requirements for registers and registers services o Requirements for resource management and accounting Details on the requirements for these instruments are given later in this section (R7.3). Compliance with standards System components shall be compatible at M least with the following standards of MHSD RK: 1) Standard requirements for the 269 270 Section VI. Technical Requirements electronic health record (requiring compliance with EN 13940 ) 2) Standard requirements for electronic medical records (requiring compliance with EN 13940 ) 3) Standard requirements for identification of stakeholders of health systems used in e-health systems 4) Technical requirements for the interaction (communication) with the information systems of e-health 5) Regulation on information 6) Standard requirements for single classifier of medicines, medical devices and medical equipment 7) Standard requirements for implementation and management of electronic directions 8) Regulation of interaction of stakeholders in order to ensure interoperability of information systems and information management 9) Standard for regulation of e-receipts management 10) Standard for management of eprocesses of diagnostic studies and cure procedures 11) Standard for regulation of epreventing of diseases These standards and regulations are available on https://www.mzsr.gov.kz/node/319759 Section VI. Technical Requirements R7.2.2 R7.2.3 R7.3. R7.3.1 R7.3.2 System components shall be compatible with following international standards: a. EN 13940(regarding the need to comply with EHR and EMR) b. HL7 v3 (ISO/HL7 27831), HL7 (v2 or V3 or FHIR); c. HL7 CDA R2 (ISO/ HL7 27932) d. DICOM the System shall meet the requirements of standards on Information Security: - ST RK ISO /IEC 27001-2008 «Security assurance methods and means for Information Security Management System. Requirements»; - ST RK ISO /IEC 27002-2009 «Information Technology. Support means, Code of rules on information protection management Requirements for compatibility with national standard identifiers and classifiers / references System components shall support and comply with the national identifiers: - Patient Identifier - Identifier of health facilities - Identifier of health specialists - Identifier of medical equipment System components shall support and comply with at least the following national classifiers and references: 1) The National Classification of medicines and medical supplies (mapped 271 M M M M 272 R7.4. R7.4.1 Section VI. Technical Requirements to the ATC-DDD) 2) Classification of health services (based on ICD-9, a section on services and manipulations) 3) Classification of laboratory results 4) Classification of services and their costs 5) Classification of diagnoses (ICD- 10) 6) Classification of primary care (ICPC2) 7) Mapping of ICPC- 2 and ICD-10 8 ) SNOMED, (only for the purpose of coding the connection between the System and EHR Repository) 9) Improved classification system must be determined at a later stage to control diagnostic services; 10) Realized by MHSD national DRG system for classifying patients (for specialized care); 11) Classification of registers of target groups of patients (dispensary group) 12) care tarrificator; 13) Specialties in healthcare 14) List of positions Requirements to compatibility / correspondence of data System components shall provide a link M between systems and National Health Information and Interoperability Platform containing Repository EHR based on the following data: Section VI. Technical Requirements R7.4.2 R7.4.3 R7.4.4 R7.4.6 R7.5. R7.5.1 - The minimum data set for EHR (set in National Standards for EHR and EMR) - Other data not covered by semantic standards, but necessary under the normative legal acts of the MHSD, such as Attached Special Records (documents based on CDA) The system shall provide access to data stored in the EHR repository, according to two types of EHR: Full EHR, short EHR. Details are described in National Standard for EHR. Data is transferred between the system and Repository EHR in CDA format Information transmitted in the EHR repository is organized on the basis of ICPC- 2 codes that are used in encounters (and contacts in general) and mapped to the ICD-10 for the purpose of statistics collecting. In EMR information systems (except EHR/ PHC systems) professionals use ICD-10 for diagnosis coding and mapping in the reverse direction is not required, but desirable. The system shall be opened enough to be able to provide interoperability with existing IS, applications and services of IS MHSD (see also Section 1.4.2). Requirements to information exchange The system shall interact with national system of EHR according to National standards for EHR and EMR 273 M M M M M 274 R7.5.2 R7.5.3 R7.5.4 Section VI. Technical Requirements The system shall support (at least) M interaction with the following sets of services of e-health: - Services of EHR Repository; - Services of reference information; - Services of registration and registers; - Services of Clinical Nomenclature and classification of data; - Services of safe exchange of data and messaging; - Services of identification and authentication; - Services for the monitoring and auditing of information exchange. The system shall correspond to at least M following profiles of IHE a) Infrastructural profiles of IHE: - ATNA; - XDS.b; - PDQ; - PIX; b) lab profiles of IHE: - LBL; - LWT. The system should provide opportunities М for interaction / integration with at least the following protocols and specifications: - Communication via SOAP (SOAP message and application), REST, Message Transmission Optimization Mechanism; - Support for standards and specifications of Web services (WS-Security, WS- Section VI. Technical Requirements R7.5.5 R7.5.6 R7.5.7 Addressing, WS-Reliable Messaging, WS-coordination, WS-Transaction, WSSecure Conversation); - meet the standards of XML (XML, XSL, ebXML, and others.); - maintain SSO and access control across the SAML v2, JWT; - supports common standards such as HTTP, HTTPS, TCP / IP, the protocols Secure Sockets Layer (SSL v3) and TLS; - allowing the use of WSDL, WADL; - X.509; - The digital signature (of NAC RK). the system shall support coding of at least М UTF8 The system shall interact with the М Platform services at channel speed of 1 Mb / s and the response time less than 100 ms The system shall interact with Platform М services in terms of: - transmit / receive notifications and other information of informative character on the gateway of "electronic government"; - sending of SMS-notifications, and other types of distribution via SMS gateway of system of mobile government; - sending emails to patients through a single e-mail system; - information about the powers of attorney out of the state information system Single 275 276 R8 R8.1. R8.2. R8.3. R8.4. Section VI. Technical Requirements Notary Information System; - obtain information from the records to the doctor; - obtain minimal information about the employee. Use of national e-health resources and HII Platform tools System shall be able to operate in line with general e-health architecture (Pic 2) The system shall be able to use functionality and web services, published at the national level to communicate with e- Health resources The system shall be able to use EHR repository, national classifications and indexes (at least, Master Patient index, index of health facility units, healthcare professional index, index of buildings, address index, index of motor vehicles, medical equipment index), analytical repository and other national resources required for integration of " turn-key " according to national standards (listed in MoH order No. 75 from 10.02.2014) The system shall maintain local copies of national resources and be able to synchronize them on a regular basis (in accordance with a custom schedule) or online. The system shall contain only information relating to the activities of health facility. For example, Master patient index shall be kept locally for only M M M M Section VI. Technical Requirements R9 R9.2. R9.3. R9.4. the list of patients served by this health facility. Interaction with parties involved into certification process System Supplier shall interact with the M HII platform supplier, health facility and MHSD for testing and certification of interoperability with national resources and services. System supplier shall coordinate the M interaction of the parties involved in accordance with Figure 3. Certification means to verify the installed system for compliance with R7.2. The Client authorizes a special commission, which together with the Platform provider and the supplier of the system, shall conduct tests on compliance to standards of MHSD RK, to meet the requirements of interoperability in accordance with national standards, including the ability of correct interaction of delivered system with national resources available within the Platform. At the phase of System design (action 4.4) M the Supplier shall comply with the "Rules for Web Services development" and "Requirements for interaction with the EHR Repository" provided by the Supplier of the HII Platform. Supplier of System may request additional information if necessary to develop 277 278 R9.5. R9.6. R9.7. R10 R10.1. R10.2. R10.3. Section VI. Technical Requirements interaction with e-Health resources. During the testing / certification phase (action 4.6) System Supplier shall meet requirements and standards of e-health R7.2. The Supplier shall certify the System before its acceptance into operation In case of circumstances that hinder fulfillment of R9.6 occurred by no fault from Supplier’s party, Acts of System acceptance shall be signed without certification. With it, System Supplier is bounded to certify the System when conditions for certifications appear, without any additional costs from the Purchaser’s party Requirements to Suppliers Supplier shall supply his own System (components or products of its) or be authorized by the developer / owner of the System (components or products of its) to provide, design, installation, maintenance of production in accordance with this Contract. Supplier shall provide training in Purchaser’s country, associated with the operation and administration of the system, as well as for all developed and installed products. Language of trainings will be the state and Russian. Details on training given in R12.2 Supplier shall have an office in the M M M M M M Section VI. Technical Requirements R10.4. Purchaser's country or have a partner that is registered as a legal entity in the Purchaser's country having official status of a developer / provider partner, or having a consortium agreement associated with this Contract. This is necessary during the implementation, deployment, training, and warranty period for smooth and reliable implementation of the Contract. Supplier shall have team of experts for the M Project, consisting of at least the following specialists (if necessary, two positions can be taken by one person, provided that the skills will be proved, but no more than 2 positions per a specialist): 1) Business Analyst with experience of at least 3 years in IT projects in e-health and experience in at least one similar project; 2) Project manager (team leader), with experience of at least 3 years in project management and experience of more than 1 year in the project, with proposed solution, Project manager shall be certified in project management (eg, PMP or IPMI); 3) Specialist on DBMS who has at least 3 years of experience with database work; 4) professionals with experience in work with standards for at least 2 years: HL7, DICOM, CDA (R2), IHE; 5) User Interface Designer, with 279 280 Section VI. Technical Requirements experience of at least 3 years; 6) Technical writer, who has worked for at least 2 years; 7) Specialist on Relations with experience in this area and at least 3 years of general experience in IT, with an excellent command of English, Russian and Kazakh languages; 8) Specialist on Testing with at least 3 years of experience in software testing; 9) Specialist on Training with at least 3 years of experience in education; All proposed experts shall have a degree in IT or related fields, Master's degree preferred. The Supplier shall submit a list of experts, with applied resumes, certificates to prove the experience and qualifications. R10.5. R10.6. the Supplier shall provide all documents M (patents, licenses, certificate of state registration of rights to the object of copyright, etc.) on the System (for all components and products), demonstrating the owner's permission to use the products for the contract or demonstrate ownership of the products Plan - schedule of services shall be M authorized by the Purchaser and signed by the Purchaser within twenty (20) business days after signing the contract. Supplier shall promptly provide services by Section VI. Technical Requirements R10.8 R10.9 R10.10 R10.11 R10.13 approved schedule. Vendors must be certified for Capability Maturity Model Integration (CMMI), ISO 9000 series, ST RK ISO 9001: 2009 or equivalent for quality management (Bidder shall submit copies of Certificate on compliance issued by the authorized body). The Supplier shall provide service and technical support and warranty, including new versions of the products in accordance with the R12.3 and R12.4. The Supplier shall prepare appropriate guidance for all components of the System in English, Kazakh and Russian languages The Supplier shall have proven track record of working with the standards used in this document: HL7 (v2, V3, FHIR), CDA (R2), IHE System Supplier shall have access to national resources of e-Health only after the parallel contract is successfully implemented. In order to facilitate parallel implementation it is necessary to synchronize / coordinate joint actions with the Platform provider. If the circumstances do not allow to meet the requirements for interaction with the Platform due to delayed implementation of contract for delivery of Platform, the System Supplier undertakes to implement 281 M M M M M 282 R11 R11.1. R11.2. R11.3. R11.4. R11.5. R11.6. R11.7. R11.8. R12 R12.1. Section VI. Technical Requirements the interaction, when there will be conditions, without additional cost to the Purchaser. GENERAL TECHNICAL SPECIFICATIONS TO THE SYSTEM System shall be able to work with a local server via a local area network used in one health facility The server part of System shall be running at least on Windows operating systems family. The client part of the System shall be running at least in the operating systems of Windows (2008/VISTA/7/8) (x86/x64) A relational database shall be used to save the information in the system Database systems shall support the standard SQL, compliant with the ANSI / ISO / IEC 9075-1992 Supplier shall provide service and technical support, including provision of new product releases prior to the expiration of warranty service. The system shall provide the ability to operate on a remote infrastructure and cloud (virtualized) Operating Environment The System shall provide an option of authentication using SSO technology Specification of services Requirements to inherit data and functionality. M M M M M M M M Section VI. Technical Requirements R12.1.1 R12.1.2 R12.2. R12.2.1 R12.2.2 R12.2.3 R12.2.4 In the case of supply and implementation of the System different from those operating by the Purchaser the Supplier provides a full range of necessary work on the inheritance of data and functions of the Information System modules used by the Purchaser with connection to the System of used by the Purchaser software and hardware means of automatization, medical and laboratory equipment. All costs associated with providing inheritance of data and functionality are paid by Supplier. Trainings and training materials The Supplier shall prepare a training plan for the following groups: a. System users; b. System admins c. developers, d. admins of databases. Training plan and training materials for each group shall be agreed with the Purchaser prior to the training start. The Supplier shall provide equipment, presentation materials, and guidelines needed for training System Supplier shall provide educational materials in the form of manuals, books, presentations, knowledge bases in the Kazakh and Russian languages. Supplier shall provide training for at least 80 hours for each group of admins of the 283 M M M M M M 284 R12.2.5 R12.2.6 R12.2.7 Section VI. Technical Requirements System, developers, admins of database and 20 hours for users of each health facility, which implements systems. The number of hours can be increased and shall be sufficient for the transfer of knowledge and skills Supplier shall conduct a separate training M for users and system administrators, developers and admins of databases. Indicative number of students is determined by multiplying the total number by 2 of general number of workstations from Appendix 2. Location of training - legal address of the healthcare facility - the beneficiary. Groups of students should include no more than 10 people Training plan for the group (a) - users of M the system - shall contain a detailed explanation of automated business processes, the use of all components of the system, a detailed description of the functions and interactions between the different users and roles; statements and other necessary information. Training will also include practical training for understanding of the material. Training plan for the group (b) - System M administrators - shall contain description of administration tools of system components including the important issues of systems support, and aspects of Section VI. Technical Requirements R12.2.8 R12.2.9 R12.2.10 R12.2.11 R12.2.12 R12.2.13 R12.3. R12.3.1 technical support The Supplier shall conduct for the group (c) designers – one introductory course and capacity building course on provided tools of development and components planned as part of this contract The Supplier shall conduct for the group (d) DB admins - one introductory and one advanced training course on provided DBMS Training for groups (a) - (d) shall be conducted in Russian or state language specified by the Purchaser. All trainings shall be conducted by trainers in Astana or in another place specified by the Purchaser For all carried out training sessions, the Supplier shall conduct the appropriate tests and issue certificates The above number and duration of training are minimum requirements. Supplier at the request of the Purchaser can increase these values (in hours) to achieve an adequate level of skills for the staff at no additional cost to the Purchaser. During the preparation phase of the project the exact number of hours, groups and content of the courses will be agreed with the Supplier. User Support Service Supplier shall arrange a user support service to advise on matters arising during 285 M M M M M I M 286 R12.3.2 R12.4. R12.4.1 R12.4.2 R12.4.3 Section VI. Technical Requirements the operation, for the duration of implementation and warranty services providing Support System and its users should be carried out by the Supplier in operation regime of 24 hours a day, 7 days a week, for 2 years from the date of signing the acts system commissioning Warranty service Supplier of the System shall provide warranty service to the Purchaser within three years, starting immediately after approval of the Operational Acceptance Certificate by Purchaser The Supplier shall provide the resolution of queries: a) for the critical issues relating to operability of systems and leading to data corruption, the problem should be solved by no more than 2 hours; b) for non-critical problems to 2 days Warranty service will include, but not limited to, following categories of services: - correction of errors in the System; - help the health facility to correctly all problems with data, arising as result of mistaken function of applications; - technical support in adjustment, configuration of applications or changing default parameters; - provide necessary technical assistance to M M M M Section VI. Technical Requirements R12.4.4 R12.4.5 R12.4.6 R12.4.7 R13 R13.1 trained staff and re-train, if disclosed that they cannot solve all problems after received training; The forms of intervention can be one of the following most appropriate from the viewpoint of quality and efficiency: - telephone calls; - e-mail; - Skype or other video messenger; - On-site work; - Remote work. The Supplier shall provide during the warranty period a team of consultants available in Purchaser’s country including one manager and at least one specialist, and provide all necessary specialists from the distance for remote help (per needs). The total System downtime due to reasons related to its capacity for work should not exceed 24 hours per year. Time of a single system downtime due to reasons related to its capacity for work should not exceed 2:00 Requirements to documentation The Supplier shall provide the following documents: - Program and methods of testing ; Form (main characteristics, completeness and information on the operation of the deposited software); - Description of the most common mistakes and how to prevent them; 287 M M M M M 288 R13.2 R13.3 R13.4 Section VI. Technical Requirements - Description of the structure of the database; - Guide to install the software; - Administrator's Guide; - User’s Guide. Language of the document shall be at least M the Kazakh and Russian. The Supplier shall provide 5 sets of M documents in paper and electronic form in English, Russian and Kazakh languages. Electronic versions should support the ability to search basing on context the Supplier shall prepare an information M system and regulatory and methodological documentation for attestation for compliance with information security requirements in accordance with Article 5 of the Law of the Republic of Kazakhstan dated January 11, 2007 "On Informatization" and Decree of the Government of the Republic of Kazakhstan dated December 30, 2009 № 2280 "On approval of Rules for provision of certification of government information systems and non-government information systems integrated with public information systems for compliance with information security requirements and accepted on the territory of the Republic of Kazakhstan standards "and to be commissioned in accordance with Article 17 of the Law of the Republic of Section VI. Technical Requirements R14 R14.1 R14.1.1 R14.1.2 R14.1.4 R14.1.5 R14.1.6 R14.1.7 Kazakhstan dated January 11, 2007" On informatization ". System testing and Requirements to Quality Pre-commissioning System Supplier shall perform standard installation tests to verify the correctness of System installation Supplier shall offer in the technical offers a list of tests, test conditions, success criteria and other for the System testing. Systems Supplier shall held detailed milestone tests, including tests of performance, response time, System throughput, together with an organization authorized by the Purchaser, according to tests provided by the Supplier. The supplier shall hold a demonstration of the System with the participation of representatives of the Purchaser and the organization authorized by the Purchaser according to the scenario of System testing. Suppliers shall draw up the demonstration results in the form of demonstrations Protocol agreed with the Purchaser. The protocol shall be signed by all participants of demonstration. Place of demonstration shall be agreed with the Purchaser and organization authorized by the Purchaser. The Supplier shall fix a troubles detected 289 M M M М М М 290 R14.1.8 R14.1.9 R14.1.10 R14.1.11 R14.2 R14.2.1 Section VI. Technical Requirements during the demonstration and repeat demonstration as often as needed to have a Protocol of successful demonstration. Timeframe for fixing the troubles shall be agreed with Purchaser. Testing shall be conducted in accordance with one of the standards IEEE 829/1009, BS 7925, ISO / AS 9100 and developed document "Program and methods of testing" ST RK 1089-2002 The supplier shall test the system in accordance with the Web Content Accessibility Guidelines (WCAG) 2.0. the Supplier shall provide detailed information on the results of testing The Supplier shall test the system security in accordance with the OWASP Top 10 vulnerabilities. Supplier shall provide detailed information on the results of testing the Supplier shall agree with the Purchaser the test script and provide a report on the results of each test Acceptance into operation Certificate of acceptance is signed by the Purchaser based on the trouble-free operation under normal operating conditions for the System within three months. In case of errors in the functioning of the period Supplier shall make the necessary changes and reoperation of the system within three М М М М M Section VI. Technical Requirements R14.2.2 R14.2.3 R15 R15.1 R15.2 months. Operating errors are critical errors which do not allow to run the System The Supplier must commence the work necessary to remedy defects or damage within 10 working days for non-critical errors. For critical errors the supplier must commence the work necessary to remedy defects or damage within 3 working days, provide fixing time and report on fixing progress hourly during the operational as well as warranty period. Critical errors: System is not operational or stable. Important functional component is down or un-available. Loss of Data or interruption in the main process flow. System component unusable due to failure or incorrect functionality. Users are not able to perform any work Mandatory condition for acceptance into operation is certification of the System pursuant to requirements of R.9 Requirements to control assurance by the Purchaser Supplier shall at intervals specified in the schedule provide Purchaser a progress report during the period. The report shall contain information on the works of the Supplier for the period, in accordance with the approved schedule including warranty service with attached approved documents, including official 291 M M М М 292 R15.3 R15.4 Section VI. Technical Requirements correspondence in paper and electronic form (at least in PDF format). The report shall be agreed with М organization authorized by the Purchaser. Purchaser may at any time of the Contract М implementation carry out control over the contract to check Supplier measures and quality of services under the contract Section VI. Technical Requirements 293 H. Annexes Annex 1 Roles’ access right to Modules functions 1. 1.1. Module «Reception» Roles Management of doctors’ work schedule, service Schedule composer provision, equipment use time Medical receptionist Chief nurse Head of outpatient clinic department 1.2. Registration of a patient for doctor’ examination, to Patient (through Internet) hand out a card for exam District doctor Doctor from preventive medicine department Profile specialist Medical receptionist 1.3. Management of Register for calls at home Medical receptionist District doctor Profile specialist Head of outpatient clinic department Chief nurse 1.4. Management of Registers for active information Medical receptionist (calls at home initiated by medical men) District doctor Head of outpatient clinic department Chief nurse 1.5. Management of primary accounting documentation Medical receptionist at Reception level according to regulatory papers District doctor Doctor from preventive medicine department Profile specialist Head of outpatient clinic department 293 294 Section VI. Technical Requirements Chief nurse 1.6. Making analytic tables at Reception level and Medical receptionist statistic tables according to regulatory acts District doctor Doctor from preventive medicine department Profile specialist Hospital administrator Medical statistician in polyclinic Head of outpatient clinic department Chief nurse 2. Module «District doctor» 2.1. Patient’s ambulatory card District doctor Doctor from preventive medicine department Profile specialist District doctor’s nurse Profile specialist Head of outpatient clinic department 2.2. Generation of referrals to consulting and diagnostic District doctor services internal (within one health facility) and Doctor from preventive medicine external (in other health facilities) department Profile specialist District doctor’s nurse Head of outpatient clinic department 2.3. Creation of planned hospitalization (24 hour hospital District doctor and substitute technology) Doctor from preventive medicine department Profile specialist District doctor’s nurse Head of outpatient clinic department Section VI. Technical Requirements 2.4. 295 Creation of doctor’s prescriptions for drugs and/or District doctor procedures and manipulations Profile specialist Head of outpatient clinic department 2.5. Management of primary accounting documentation District doctor at district doctor level according to regulatory acts Doctor from preventive medicine department Profile specialist District doctor’s nurse Head of outpatient clinic department 2.6. Making analytic tables at district doctor level and District doctor statistic tables according to regulatory acts Doctor from preventive medicine department Profile specialist Nurse Head of outpatient clinic department Medical statistician in polyclinic 2.7. Management of temporary disability leave District doctor Profile specialist Head of outpatient clinic department 2.8. Interoperability with IS MHSD RK relating to data exchange on performed services, clinical information, referrals, prescriptions according to regulatory acts 3. Module «Preventive examinations» 3.1. Making up cohorts of targeted groups subject to District doctor preventive exam (screening) and registering its Doctor from preventive medicine performance according to regulatory acts department Profile specialist Nurse from preventive medicine department Head of outpatient clinic department 295 296 3.2. Section VI. Technical Requirements Registration of other type preventive exams District doctor Doctor from preventive medicine department Profile specialist Nurse from preventive medicine department Head of outpatient clinic department 3.3. Management of primary accounting documentation District doctor at doctor level according to regulatory acts Doctor from preventive medicine department Profile specialist Nurse from preventive medicine department Head of outpatient clinic department 4. Module «Profile specialist » 4.1. Patient’s ambulatory card Profile specialist Specialist’s nurse Head of outpatient clinic department 4.2. Generation of referrals to consulting and diagnostic Profile specialist services internal (within one health facility) and Specialist’s nurse external (in other health facilities) Head of outpatient clinic department 4.3. Creation of doctor’s prescriptions for drugs and/or Profile specialist procedures and manipulations Head of outpatient clinic department 4.4. Management of primary accounting documentation Profile specialist at profile specialist level according to regulatory Nurse acts Head of outpatient clinic department 4.5. Management of temporary disability leave Profile specialist Head of outpatient clinic department 4.6. Making analytic tables at profile specialist level and Profile specialist statistic tables according to regulatory acts Section VI. Technical Requirements 297 Head of outpatient clinic department Hospital administrator Medical statistician in polyclinic 5. Module «Head of Polyclinic department» 5.1. Confirming or rejection for referrals for some types Head of outpatient clinic department of services by using digital signature 5.2. Management of primary accounting documentation Head of outpatient clinic department at the level of Head of Polyclinic department according to regulatory acts 5.3. Making analytic tables at the level of Head of Head of outpatient clinic department Polyclinic department and statistic tables according Medical statistician in polyclinic to regulatory acts 5.4. Approval for temporary management of MCB records 6. Module «Medical statistics in Polyclinics» 6.1. Monitoring of primary accounting documentation Medical statistician in polyclinic management in a health facility Head of outpatient clinic department disability leave, Head of outpatient clinic department Hospital administrator 6.2. Making analytic tables at the level of Medical Medical statistician in polyclinic statistician in polyclinic and statistic tables Head of outpatient clinic department according to regulatory acts Hospital administrator 7. Module «Admission» 7.1. Registration of patients admission Doctor from Admission Nurse from Admission Head of hospital department 7.2. Management of patients EMR Doctor from Admission Nurse from Admission Head of hospital department 297 298 7.3. Section VI. Technical Requirements Clarification of hospitalization services performed before Doctor from Admission Nurse from Admission Head of hospital department 7.4. Management of primary accounting documentation Doctor from Admission at Admission level according to regulatory acts Nurse from Admission Head of hospital department Medical statistician in hospital 7.5. Making analytic tables at Admission level and Doctor from Admission statistic tables according to regulatory acts Nurse from Admission Head of hospital department Medical statistician in hospital 7.6. Interoperability with MOH IS 8. Module «Doctor in hospital» 8.1. Patient’s EHR management Doctor in hospital Head of hospital department 8.2. 8.3. Management for referrals diagnostic services to consulting Diagnosis and Doctor in hospital Head of hospital department Doctor in hospital Head of hospital department 8.4. Creation of doctor’s prescriptions for drugs and/or Doctor in hospital procedures and manipulations Head of hospital department 8.5. Patient discharge Doctor in hospital Head of hospital department 8.6. Making analytic tables at doctor level Doctor in hospital Head of hospital department Medical statistician in hospital 8.7. Management of primary accounting documentation Doctor in hospital Section VI. Technical Requirements at hospital doctor level 299 Head of hospital department Medical statistician in hospital 9. Module «Nurse in hospital» 9.1. Patient’s EHR management Nurse in hospital 9.2. Mark on performed prescription and treatment Nurse in hospital 9.3. Monitoring of patient’s state Nurse in hospital 9.4. Management of primary accounting documentation Nurse in hospital at hospital nurse level 9.5. Making analytic tables at nurse level and statistic Nurse in hospital tables according to regulatory acts of the RK Medical statistician in hospital 10. Module «Meals» 10.1. Make up a daily menu Doctor in hospital Head of hospital department Nurse in hospital Specialist in nourishment department 10.2. Calculator of every day, month spending of food for Specialist in nourishment department menu 10.3. Estimation of food value in ration Specialist in nourishment department 10.4. Making up the reference for main food products Specialist in nourishment department 10.5. Patients’ diet management Specialist in nourishment department 10.6. Making up analytic tables for food Specialist in nourishment department Medical statistician in hospital 11. Module «Day hospital» 11.1. Patient’s EMR management Doctor in hospital Nurse in hospital 299 300 Section VI. Technical Requirements Profile specialist Specialist’s nurse Head of outpatient clinic department Head of hospital department 11.2. Making up referrals to consulting and diagnostic Doctor in hospital services Profile specialist Head of outpatient clinic department Head of hospital department 11.3. Registration of prescriptions and execution Doctor in hospital Nurse in hospital Profile specialist Specialist’s nurse Head of outpatient clinic department Head of hospital department 11.4. Management of primary accounting documentation Doctor in hospital at day hospital level according to regulatory Nurse in hospital documents Profile specialist Specialist’s nurse Head of outpatient clinic department Head of hospital department 11.5. Making analytic tables at day hospital level and Doctor in hospital statistic tables according to regulatory acts Nurse in hospital Profile specialist Specialist’s nurse Head of outpatient clinic department Head of hospital department 11.6. Interaction with MOH IS 12. Module «Head of hospital department» 12.1. Confirming or rejection for referrals for some types Head of hospital department Section VI. Technical Requirements 301 of services by using digital signiture 12.2. Management of primary accounting documentation Head of hospital department at the level of Head of hospital department according to regulatory acts 12.3. Making analytic tables at the level of Head of Head of hospital department hospital department and statistic tables according to regulatory acts 12.4. Approval of disability leave, medical consultation Head of hospital department records 13. Module « Hospital administrator » 13.1. Making analytic tables at the level of Hospital Hospital administrator administrator and statistic tables according to regulatory acts 14. Module «Medical statistics in hospital» 14.1. Bed fund management 14.2. Making analytic tables at the level of medical Hospital administrator statistics office and statistic tables according to Head of hospital department regulatory acts Medical statistician in hospital 15. Module «Procedures and manipulations» 15.1. Patient’s EMR management Medical statistician in hospital Doctor in hospital Nurse in hospital Head of hospital department 15.2. Management of primary accounting documentation Doctor in hospital on provided procedures and manipulations Nurse in hospital according to regulatory acts Head of hospital department 15.3. Making analytic tables on provided procedures and Doctor in hospital manipulations and statistic tables according to Nurse in hospital regulatory acts Head of hospital department 301 302 Section VI. Technical Requirements Medical statistician in hospital 16. Module «Admin» 16.1. Data Base management 16.2. To make up user groups and some independent Admin System users 16.3. Management of authentication types (password, Admin digital signiture) 16.4. System logs management Admin 16.5. Adjusting patterns of medical documentation Admin 16.6. Adjusting user interface Admin 16.7. Adjusting user access Admin 16.8. Set-up of external programs connection Admin 16.9. Reference management Admin Admin 16.10. Report making, editing user Report Master Admin 17. Module “Lab Information System” 17.1. Registration of received material with option to Technician screening Lab specialist Doctor – laboratory assistant 17.2. Bar-coding for material identification by bar-code) (making bar-code, Technician Lab specialist Doctor – laboratory assistant 17.3. Making up business sheets for lab analyzers and Technician executors Lab specialist Doctor – laboratory assistant 17.4. Interaction with lab equipment (export of referrals to Section VI. Technical Requirements 303 examination, import of exam results) 17.5. Manual entry of lab research results Technician Lab specialist Doctor – laboratory assistant 17.6. Confirmation for lab research results validity by lab Lab specialist specialist Doctor – laboratory assistant 17.7. Quality control for lab studies (intralab, interlab, Lab specialist external) Doctor – laboratory assistant 17.8. Option of results printing according to approved Technician regulatory documents for primary accounting Lab specialist documents Doctor – laboratory assistant 17.9. Making reference values for lab for all patients and Lab specialist by age-sex groups Doctor – laboratory assistant 17.10. Management of primary accounting documentation Technician at lab level according to regulatory acts Lab specialist Doctor – laboratory assistant 17.11. Making analytic tables at lab level and statistic Technician tables according to regulatory acts Lab specialist Doctor – laboratory assistant Medical statistician in hospital 17.12. Option of system integration with independent Lab IS 17.13. Transfer of information on made studies into EHR and EMR 18. Module «PACS» (Picture Archiving and Communication System) 18.1. Exchange of data with medical equipment 303 304 Section VI. Technical Requirements 18.2. Interaction with other modules and systems basing on rules for IHE profiles 18.3. Image import/export 18.4. Work with images District doctor Profile specialist Head of outpatient clinic department Doctor in hospital Head of hospital department 18.5. Making archive of images 19. Module «Diagnostic studies» 19.1. View of patients registered according to the Doctor from diagnostic department schedule Specialist’s nurse Head of hospital department 19.2. Entry of studies results using patterns Doctor from diagnostic department Specialist’s nurse Head of hospital department 19.3. Management of primary accounting documentation Doctor from diagnostic department on diagnostic studies according to regulatory acts Specialist’s nurse Head of hospital department 19.4. Making analytic tables on diagnostic studies and Doctor from diagnostic department statistic tables according to regulatory acts Specialist’s nurse Head of hospital department Medical statistician in hospital 19.5. Data transfer on made studies into EHR and EMR 20. Module «Pharmacy» 20.1. Drug registration at different levels: point, room, Pharmacy technician department, pharmaceutical storehouse (one of Pharmacist several), health facility Clinical pharmacologist Section VI. Technical Requirements 305 20.2. Automated charge-off drugs when the prescription is executed 20.3. Option to trace terms of drugs and medical devises Pharmacy technician validity Pharmacist Clinical pharmacologist 20.4. Option to form the list of drugs (medical devices) Pharmacy technician required for procurement in health facilities Pharmacist Clinical pharmacologist 20.5. Making requirements for pharmacy to procure drugs Specialist’s nurse (automated urgent requirements for drugs) District doctor’s nurse Nurse in hospital Pharmacy technician Pharmacist Clinical pharmacologist 20.6. Getting information on availability of drug in health Specialist’s nurse facilities District doctor’s nurse Nurse in hospital Pharmacy technician Pharmacist Clinical pharmacologist 20.7. Drug formulary management in health facility Pharmacy technician Pharmacist Clinical pharmacologist 20.8. Registration of side effect of drug according to procedures set in regulation documents District doctor Profile specialist Head of outpatient clinic department Doctor in hospital Head of hospital department Doctor from diagnostic department 305 306 20.9. Section VI. Technical Requirements Monitoring of drug prescriptions Clinical pharmacologist 20.10. Setting maximal doses for control over prescriptions Clinical pharmacologist 20.11. Registration of incoming and outcoming documentation of the department and pharmacy according to regulatory acts District doctor’s nurse Specialist’s nurse Nurse in hospital District doctor Profile specialist Head of outpatient clinic department Doctor in hospital Head of hospital department Doctor from diagnostic department 20.12. Management of primary accounting documentation Pharmacy technician at pharmacy level according to regulatory acts Pharmacist Clinical pharmacologist 20.13. Making analytic tables at pharmacy level and Pharmacy technician statistic tables according to regulatory acts Pharmacist Clinical pharmacologist Medical statistician in hospital 21. Module «Human resources» 21.1. Communication with national indexes HR specialist 21.2. Management of organizational structure of health facility HR specialist 21.3. Management of doctor’s accounting card (health facility employee) HR specialist 21.4. Management of work schedule HR specialist 21.5. Management of service references HR specialist 21.6. Interlink with Accounting IS HR specialist Section VI. Technical Requirements 307 Annex 2 Approximate composition and quantity of System Modules for health facilities Municipal hospital №1 Ust-Kamenogorsk city Module Quantity of AWP Module «Reception » Module «District doctor» Module «Prophylactic exams» Module «Profile specialist» Module «Head of Policlinic department» Module «Medical statistics of policlinic» Module «Admission» 8 Module «Hospital Doctor» 72 Module «Hospital nurse» 42 Module «Meals» 5 Module «Day-hospital» 8 Module «Head of hospital department» 25 Module «Hospital administrator» 6 Module «Medical Statistics for Hospital» 10 Module «Procedures and manipulations» 25 Module «Admin» 5 Module «Lab IS» 17 307 308 Section VI. Technical Requirements Module «PACS» (Picture Archiving and Communication System) 8 Module «Diagnostic studies» 17 Module «Pharmacy» 5 Module «Human Resources» 5 Total 258 Municipal Clinic Hospital №4 Almaty city Module Quantity of AWP Module «Reception » Module «District doctor» Module «Prophylactic exams» Module «Profile specialist» Module «Head of Policlinic department» Module «Medical statistics of policlinic» Module «Admission» 15 Module «Hospital Doctor» 31 Module «Hospital nurse» 12 Module «Meals» 2 Module «Day-hospital» 3 Module «Head of hospital department» 13 Module «Hospital administrator» 7 Module «Medical Statistics for Hospital» 6 Section VI. Technical Requirements 309 Module «Procedures and manipulations» 13 Module «Admin» 2 Module «Lab IS» 5 Module «PACS» (Picture Archiving and Communication System) 4 Module «Diagnostic studies» 4 Module « Pharmacy» 2 Module «Human Resources» 4 Total 123 Mother and Child Center Ust-Kamenogorsk city Module Quantity of AWP Module «Reception » 15 Module «District doctor» 11 Module «Prophylactic exams» 32 Module «Profile specialist» 32 Module «Head of Policlinic department» 5 Module «Medical statistics of policlinic» 8 Module «Admission» 34 Module «Hospital Doctor» 75 Module «Hospital nurse» 48 Module «Meals» 8 Module «Day-hospital» 13 309 310 Section VI. Technical Requirements Module «Head of hospital department» 22 Module «Hospital administrator» 1 Module «Medical Statistics for Hospital» 12 Module «Procedures and manipulations» 26 Module «Admin» 4 Module «Lab IS» 18 Module «PACS» (Picture Archiving and Communication System) 11 Module «Diagnostic studies» 16 Module «Pharmacy» 9 Module «Human Resources» 5 Total 405 Municipal Policlinic №11 Almaty city Module Quantity of AWP Module «Reception » 10 Module «District doctor» 31 Module «Prophylactic exams» 6 Module «Profile specialist» 37 Module «Head of Policlinic department» 13 Module «Medical statistics of policlinic» 11 Module «Admission» - Module «Hospital Doctor» - Section VI. Technical Requirements 311 Module «Hospital nurse» - Module «Meals» - Module «Day-hospital» 3 Module «Head of hospital department» Module «Hospital administrator» 9 Module «Medical Statistics for Hospital» - Module «Procedures and manipulations» 6 Module «Admin» 1 Module «Lab IS» 10 Module «PACS» (Picture Archiving and Communication System) Module «Diagnostic studies» 5 Module «Pharmacy» 1 Module «Human Resources» 2 145 Total Regional Diagnostic Center Almaty city Module Module «Reception » Quantity of AWP 9 Module «District doctor» Module «Prophylactic exams» Module «Profile specialist» 32 Module «Head of Policlinic department» 10 311 312 Section VI. Technical Requirements Module «Medical statistics of policlinic» 8 Module «Admission» 1 Module «Hospital Doctor» 6 Module «Hospital nurse» 3 Module «Meals» 1 Module «Day-hospital» 7 Module «Head of hospital department» 1 Module «Hospital administrator» 4 Module «Medical Statistics for Hospital» 1 Module «Procedures and manipulations» 1 Module «Admin» 2 Module «Lab IS» 7 Module «PACS» (Picture Archiving and Communication System) 6 Module «Diagnostic studies» 37 Module «Pharmacy» 1 Module «Human Resources» 2 139 Total Policlinic №1 Kostanay Module Quantity of AWP Module «Reception » 14 Module «District doctor» 34 Section VI. Technical Requirements 313 Module «Prophylactic exams» 7 Module «Profile specialist» 17 Module «Head of Policlinic department» 8 Module «Medical statistics of policlinic» 11 Module «Admission» Module «Hospital Doctor» Module «Hospital nurse» Module «Meals» Module «Day-hospital» 7 Module «Head of hospital department» Module «Hospital administrator» 3 Module «Medical Statistics for Hospital» Module «Procedures and manipulations» 7 Module «Admin» 3 Module «Lab IS» 15 Module «PACS» (Picture Archiving and Communication System) 7 Module «Diagnostic studies» 27 Module « Pharmacy» 3 Module «Human Resources» 2 Total 165 Central rayon hospital, Zhualynsky rayon, Zhambul oblast 313 314 Section VI. Technical Requirements Module Quantity of AWP Module «Reception » 4 Module «District doctor» 24 Module «Prophylactic exams» 49 Module «Profile specialist» 25 Module «Head of Policlinic department» 2 Module «Medical statistics of policlinic» 9 Module «Admission» 2 Module «Hospital Doctor» 13 Module «Hospital nurse» 13 Module «Meals» 1 Module «Day-hospital» 2 Module «Head of hospital department» 8 Module «Hospital administrator» 1 Module «Medical Statistics for Hospital» 3 Module «Procedures and manipulations» 9 Module «Admin» 5 Module «Lab IS» 3 Module «PACS» (Picture Archiving and Communication System) 1 Module «Diagnostic studies» 7 Module « Pharmacy» 2 Section VI. Technical Requirements 315 Module «Human Resources» 2 185 Total Municipal Policlinic №7 Astana city Module Quantity of AWP Module «Reception » 6 Module «District doctor» 26 Module «Prophylactic exams» 3 Module «Profile specialist» 40 Module «Head of Policlinic department» 12 Module «Medical statistics of policlinic» 8 Module «Admission» - Module «Hospital Doctor» Module «Hospital nurse» Module «Meals» Module «Day-hospital» 3 Module «Head of hospital department» Module «Hospital administrator» 1 Module «Medical Statistics for Hospital» Module «Procedures and manipulations» 4 Module «Admin» 2 315 316 Section VI. Technical Requirements Module «Lab IS» 8 Module «PACS» (Picture Archiving and Communication System) 3 Module «Diagnostic studies» 16 Module «Pharmacy» 2 Module «Human Resources» 3 137 Total Municipal Hospital No.1 of Astana city Module Quantity of AWP Module «Reception » Module «District doctor» Module «Prophylactic exams» Module «Profile specialist» Module «Head of Policlinic department» Module «Medical statistics of policlinic» Module «Admission» 20 Module «Hospital Doctor» 65 Module «Hospital nurse» 22 Module «Meals» Module «Day-hospital» Module «Head of hospital department» 22 Module «Hospital administrator» 8 Module «Medical Statistics for Hospital» 6 Section VI. Technical Requirements 317 Module «Procedures and manipulations» Module «Admin» 5 Module «Lab IS» 4 Module «PACS» (Picture Archiving and Communication System) 14 Module «Diagnostic studies» 10 Module «Pharmacy» 4 Module «Human Resources» 5 185 Total Annex 3 Server hardware and software for health facilities Server M001 Quantity of servers : 1 M002 Performance per a server : rack, at least 2U M003 Number of processors on one server bit: at least 2, at least 8-core processor 2,6 GHz. M004 Installed operating memory per one server: at least 64 GB M005 Max scope of memory per one server : at least 768 GB, at least 24 slots of memory M006 Type of RAM on the server unit: PC3-12800RDIMMDDR3-16000 МГц, ECCcorrection of multi-bit error, mode lock-step. Support modules UDIMM. M007 RAID controller in the server unit: SAS, not less than 8 ports, 512MB cache memory, 317 318 M008 M009 M010 Section VI. Technical Requirements support for RAID levels 0, 1 + 0; failover ROM, online migration between the levels of RAID, increasing the capacity of non-stop work, online increasing the size of existing logical volumes. Support for up to 2GB flash cash memory Disk sub-system per a server: at least 2 х 300GB 10KSAS 2.5 “. Type of supported disks: SAS, SATA, SSDSAS, SSDSATA. max number of disks: at least 25 disks of format 2.5" (SFF) or at least 12 disks of format 3.5" (LFF). M011 FC adapter per a server : at least 2-х 8Gbit SingleportFibre Channel Adapter M012 max number of slots per a server : at least 6 PCI-Express M013 network interface per a server: at least 4 installed ports 1GbEthernet M014 Management: Tools for remote control and monitoring of the server: independent of operating system remote text and video console, virtual media, support scripts to automate software updates, power management, command line and web-based interface, dedicated port 10/100, supporting SSH, SSL for a secure connection to the server, support for DHCP / DNS / WINS Proactive monitoring of RAM and hard drives. Remote management of mobile devices based on the operating system iOS, Android. Remote monitoring without pre agents under OS. M015 Video subscription per a server: integrated M016 Parameters of supply per a server: at least two pieces 750Vatt, hot replacement of at least N + 1. Support for power supplies to be connected to the DC or AC. Support of supply units is at least 1200 W M017 Interface : at least seven units of USB, one unit of SD, one unit of Serial, two units of Video. M018 Licensed Software: the operating system Microsoft Windows Server Standard 2012 R2, the virtualization software licenses for 2 processors. The software must be installed, registered and activated M019 Requirements for the contents of your package: package includes a complete set of Section VI. Technical Requirements 319 drivers for the installed devices, CD-ROMs for the operating system distributions MicrosoftWindowsServerStandard 2012. The kit should include all necessary cables for supplying electric power. LAN switch: M020 quantity: at least 1 pc. M021 quantity of ports: at least 24 pc. M022 Port rate : at least 10/100/1000 EthernetGbit/s. M023 Memory and processor : at least 1 GB SDRAM, size of package buffer: 4 MB, flesh memory 512 MB M024 Throughput capacity: at least 155 mln packages per a sec M025 Performance: at least 208Gbps M026 M027 Quantity of MAC-addresses: at least 32000 Size of rout table: at least 16000 lines M028 Functions: Layer 2 and Layer 3. UPS M029 quantity: 1 M030 performance: to install into server board M031 max output capacity per one UPS : at least 3000W/3300VA 319 320 Section VI. Technical Requirements M032 Nominal output voltage per one UPS : at least 230V+/- 10 M033 Performance: at least 95%. M034 Output frequency (synchronized with current network): 50/60 Hz -10%, + 6% M035 Work time under load 50%: at least 12 min Data storage system for server M036 Performance: to install into server board . M037 Quantity and type of installed disks: at least 8 disks 300GB 15KrpmSAS 6 Gb/s M038 Max volume of disk subsystem: at least 192 TB M039 The controller for connecting disk rack to the server: At least 2 active controllers, support RAID levels 0, 1, 3, 5, 6, 10, 50; support of expansion for up to at least 48- hard drives 3.5 ", hard drives 99 , 2.5”. M040 Cache memory: cache size per controller - not less than 4GB. The cache memory should be used only for storing data and control information, the cache memory cannot be used for operating system tasks array. The cache must be mirrored between controllers through internal channels (use of access channels to the disks for mirroring cache is not allowed). Unrestricted by time support of safety of content of cache - in the event of a power failure (the use of disk space to store cache is not allowed). Cache array must support ECC error correction M041 Supported disks: two port disks : 146/300/450/600/900/1000/1200 GB 2,5” SAS, 1/2/3/4 TB 3,5” SAS. M042 Interface of controller: FC, 8 Гб/с. at least 2 ports. Section VI. Technical Requirements 321 M043 Quantity of supported hosts: Support simultaneous connection to 64-servers M044 Support of logic disks: Simultaneously to at least 512 logical drives; The ability to create logical drives up to at least 128 TB. M045 Software: M046 The array must be maintained at the hardware level to create local copies of volumes of two types - snapshot (snapshot) and snapclone (complete copy). Support of at least 512 "snapshots" of the data. The structure includes a license for 64 snapshots. The array must support at hardware-level replication of data between two arrays of the same type in asynchronous mode. The array must support replication "many-to-one": up to 4 storage systems from remote locations to one. The disk array management software must support the integration VMwarevCenter, disk array administrator shall be able to create / expand / delete repository of array and create virtual machines from vCenter. It should be possible to track the current status and performance of the array from vCenter. Capacity of array: In order to reduce energy consumption disk array must maintain the ability to automatically stop or slow the rotation of the drive (if for some time the disks are not being accessed). Support for redundant disks (sparedisks), both global and dedicated for a specific RAIDgroup. The array must be able to connect servers at least two ways to duplicate the access channels (pathfailover), load balancing should also be supported between different access paths (loadbalancing). The required software for the duplication and balancing channels should be included in the package. The array shall support update from previous generation by replacing the controller, while the drives and shelves from the previous generation must be fully supported by the new controllers; M047 Fail safety: The array must have a fully redundant architecture, the array have complete redundancy of all active components and access paths. As a minimum, controllers should be duplicated as well as input-output units, fans and power supplies, channel of connection of a controller shelf with disk shelf of expansion. M048 Fans and power supplies: Dual hot-swappable. The array must be able to support connecting to networks of alternating current and direct current networks. Server board 321 322 Section VI. Technical Requirements M049 Server board shall be on floor to install equipment 19'' M050 Hieght: not more 21U M051 dimensions: no more 600х1000 mm. M052 configuration: front side: o single-wing door - the glass in a steel frame o Swivel handle with profile standard DIN o universal key type EK 333, o multi-point locking mechanism, opening 180 degrees back side: o single-wing door - solid steel sheet; o Swivel handle with profile standard DIN, o universal key type EK 333, o multi-point locking mechanism o 2 side panels, steel carcas of 2 mm, o universal key o without a roof, the bottom - type Z, o it should be ready for the installation of air conditioning, the degree of protection of at least IP54 o 19 'vertical guides not more than two pairs of A-type o it shall be equipped with grounding kit, o at least 28 mounting kits o Load: not less than 1500 kg Bottom: o to have rectangular hole (max 300x100 mm) for cable entry o closed by removable steel caps M053 The framework for the separation of cold air: the framework for separation of cold zone in front of 19 "guides for cabinets with guide of A-type, changeable depth of cold zone for enclosures with a minimum height of 21U, width of at least 600 mm M054 Air Flow deflector: available deflector airflow for cooling unit AC, installed in the cabinet with a minimum width of 600 mm; compatible with the separation frame 150mm M055 Delivered package: switch board shall be delivered in package with a set of systems of at least : Cooling System Section VI. Technical Requirements 323 Local fire-fighting system Monitoring System Access Control System Requirements to cooling system M056 Type: Board (installation on the roof of the switching board), direct cooling, no external power M057 Cooling capacity: at least 5 200 Vt M058 Max operating current: no more 4,6 M059 energy consumption: at least 2 540 M060 Air consumption in board: at least 1 720 liters M061 Fan: radial M062 Heat exchanger: is available Requirements to local system of fire-fighting M063 Local fire-extinguishing system should include the main unit (MASTER), including the control panel, at least two sensors and cylinder with extinguishing mixture: • Sensors located inside the cabinet should detect a fire without delay and at an early stage • The procedure for extinguishing should start immediately after the discovery of fire. • The process of extinguishing should be safe for the equipment. • Ease of installation must allow easy connection to a power supply system of the cabinet. • The system should be recommended for use in cabinets IP30 protection level and higher. • due to ability to gain access to the detector and the modular structure of the system it shall simplify the procedure for inspection and maintenance. • The main unit must be equipped with a detailed easy-to-read LED display board • size of the device must not exceed a height of 3U cabinet 19 " • There should be a built-in rechargeable battery provides operation of the system during 323 324 Section VI. Technical Requirements a power failure M064 width of device: no more 19" M065 height of device: no more 2,5U M066 Depth of basic part: no more 382 mm M067 Max depth of device (in case of pulling back console with) : no more 750 mm M068 range of operating temperature: from ‑5 °C to +50 °C M069 relative humidity of air: no more 95 % without condensate M070 Operating mode: constant M071 Input capacity: no more 40ВА M072 Protection degree: at least IP30 M073 Voltage of main supply unit: no more 230 V ± 15 % M074 frequency of main supply unit: no more 50 Hz M075 Max current supplied by main unit: no more 1,25 A M076 Current in waiting mode: no more 210 мА M077 Current consumption in preliminary alarm mode : no more 300 мА Section VI. Technical Requirements 325 M078 Current consumption in alarm mode : no more 2 A M079 Max consumption of current in waiting mode : no more 40 мА M080 Maximum current consumption in alarm output: no more 0,5 A M081 The maximum output voltage at the terminal X32 (recharge the internal battery): up to 13,7 V M082 Maximum current from the terminal X32 (recharge the internal battery): 200 mA M083 Redundant power supply: 12V / 7,2Ach M084 Maximum volume of the board (degree of protection - min. IP30): not more than 1.5 m3 M085 Maximum volume of the board (closed) : not more 3 м3 Requirements to monitoring system Controller M086 Intelligent ports (Input/output): at least 8 M087 front panel expansion: at least 4 M088 port Modbus (RS-485): Yes M089 port USB 2.0 for connection of GSM-modem, adapter Bluetooth or Wi-Fi: Yes 325 326 Section VI. Technical Requirements M090 Installing height: no more 1U M091 Voltage: no more 7 – 9 V of current, 3 A M092 Energy consumption: not more than 5.025 W 0,67 A M093 Memory card slot (SD): on the front M094 Power is provided by all accessories: Controller M095 Built-in TCP / IP protocol and a Web server M096 available virtual sensors to monitor the power of third-party devices on the Modbus or SNMP M097 accuracy of the system time and date is provided by built-in rechargeable battery M098 Full support of Modbus: Modbus Master/Slave, Modbus RTU, Modbus on TCP/IP M099 Integration into the network management system: Yes M0100 Sensor: 1-wire temperature and humidity sensor (Cable - 30cm, coupling RJ-45) M0101 It should unite all the existing monitoring system on 10 objects into a single system M0102 License: up to 99 sensors M0103 Support renewal: no less than 5 years Section VI. Technical Requirements 327 M0104 Visualization: The software must support the loading of the image / map and location of the object icons sensors / detectors on the map M0105 Access control: no less than full control of individual user accounts and user groups M0106 Integration into the network management system by: at least SNMPv1 and EncryptedSNMPv3. Requirements for access control system into the board Controller M0107 Control RDU extension modules per controller: max 100 RDU M0108 in series RDU connection to one expansion port: no more 25 RDU M0109 Intelligent Sensor port: no more 2х Electronic door lock M0110 Electronic door lock: available electronic door lock with profile half-cylinder and built-card reader (EM & HIDProx format 125kHz), with a cable of at least 4.5 m M0111 (Optional) Expander for connecting: an option should be able to install the expander to connect at least two locks in one port M0112 Reader Programming: USBDesktopCardReader (EM & HIDformat 125kHz) for programming cards; M0113 Access Map: HIDProxCards, 125kHz of at least 30 pieces per set of equipment 327 328 Section VI. Technical Requirements M0114 Requirements for experts on this type of equipment: potential supplier shall have for at least 2 certified experts on the proposed equipment for the following equipment: a disk array, server equipment, active network equipment. M0115 Installation: Installation of all equipment under “a turnkey basis” in the server room of a health facility by certified professionals. M0116 Warranty: At least 3 years of 24 hours warranty, including holidays, reaction time not exceeding 4 hours during 24 hours a day for equipment. Section VI. Technical Requirements 329 Technical requirements (including implementation schedule) – Lot № 10 «Medical information system for registration of donors, recipients and individuals waiting for transplantation» Technical requirements A. Background 0.1 Purchaser 0.1.1 Implementing entity of the present contract is the Ministry of Health and social development of the Republic of Kazakhstan. Ministry of Health and social development of the Republic of Kazakhstan is central executive body of the Republic of Kazakhstan, implementing state regulation in the area of population health care, medical and pharmaceutical science, sanitary epidemiological wellbeing of population, drugs circulation, control over quality of medical services. The Ministry carries out its activity according to Constitution and laws of the Republic of Kazakhstan, enactments of President, Government of the Republic of Kazakhstan, other regulatory acts, as well as Provisions on the Ministry of the Republic of Kazakhstan approved by Decree N 1005 of the Government of the Republic of Kazakhstan dated 23 September 2014. 0.1.2 Project stakeholders, which will be realized as a result of this tender are the following: MHSD of the RK (https://www.mzsr.gov.kz/), which will define e-health strategy, and provide the supplier with required regulatory acts and corresponding orders for successful contract implementation and refinement of regulations if necessary. Health facilities of the Republic of Kazakhstan, which will be beneficiaries of the Contract, and will be using results of the Contract in practical activity (hereinafter – facility). Additional details on engagement of stakeholders into contract implementation are presented in the following chapters. 0.2 Purchaser’s goals 0.2.1 General goal of the MHSD of the RK in the area of e-health: Provide computerized support of collecting actual, precise and full information to ensure safe, equitable, high standard and sustainable health system, oriented at patient needs. It will be reached by providing to the health facilities and departments of the MHSD of the RK of high performance access to fully functional interoperable ehealth systems based on paperless technologies using unified e-health record. At central level national e-health repository will be set, it will contain: (I) e-health record as a central component of data integration from scattered health facility information 329 330 Section VI. Technical Requirements systems and (II) storage of high standard statistical analytical and financial information. «Medical information system» to register donors, recipients and individuals waiting for transplantation (hereinafter the System), purchased under existing contract and it will contribute considerably to achieve this vision. The system is provided to automate processes of e-register of donors, patients in the waiting list, and recipients, automation of coordination service business processes on transplantation, automation of processes of matching donor-recipient pair. 0.2.2 Main goals of the Republic of Kazakhstan e-health. Based on analysis of priority needs of Kazakhstan health system outlined by main directions of State health development program Salamatti Kazakhstan for 2011-2015, and key priorities, stated in «Kazakhstan strategy by 2050», in relation to healthcare, the following main tasks are set for e-health: 1. support to clinical (medical) decision making process; 2. medical errors reduction; 3. increasing accessibility and refining medical care continuity; 4. increasing medical services quality; 5. improving quality and effectiveness of political, managerial and financial decision making; 6. ensuring conditions for continuous professional health development; 7. increasing access of population to information about their health and to their confidentiality management issues; 8. increasing profitability and effectiveness of investments and operational expenses in the health care. 0.2.3 System, supplied within this tender will ensure such advantages as follows: Effective information collection about tissues, donors, recipients and persons needed transplantation; Currency of information about available tissues and organs; Statistical information accumulation; ordinary monitoring of current recipients’ state; ordinary monitoring of current state, patients needed in transplantation; automation of building register of donors, patients, needed transplantation and recipients; automation of transplantation coordination service business processes, automation of donor-recipient pair matching processes. 0.2.4. System potential beneficiaries. The system direct potential beneficiaries are the following: medical staff-doctors, nurses, using system for storage and use of information about patients in clinical decision making using contextual help in the form of clinical protocols etc. health managers, using information, collected from different data sources and different facilities; MHSD of the RK staff, using data for political decision making and incorporating amendments to regulatory framework based on evidences for correct financing of medical services; external information systems, using data, stored in e-health applications; Section VI. Technical Requirements 331 System following potential indirect beneficiaries: all Kazakhstan citizens, served by medical staff using the System; researchers, using data about curative preventive process obtained with the help of the System. 0.2.5. Information systems of the MHSD The following systems belong to IS of the MHSD: 1. IS «Hospitalization Bureau» 2. IS «Additional component to PHC tariff» 3. IS «Drug provision» 4. IS «Register of pregnant and fertile age women» 5. IS «Health service quality management system» 6. IS «Medical equipment management system» 7. IS «Resource management system» 8. IS «E-register of dispensary patients» 9. IS «E-register of cancer patients» 10. IS «E-register of hospital patients» 11. IS «Out-patient care» 12. IS «Register of attached population» 13. IS «Register of patients with renal failure» 14. IS «Register of patients with mental diseases» 15. IS «Register of narcological patients» 16. Drug provision management system 17. AIS «Policlinics» 18. IS «National Register of TB patients» 19. IS «National Register «Diabetes»» 20. Health Informatization and Interoperability Platform Interaction with IS of MHSD (above indicated IS in para.1-19) shall be done using service of Health Informatization and Interoperability Platform. 0.3 Acronyms, used in these technical requirements Term Description DB Data base IIN Individual identification number ICT Information communication technologies IS Information system DRG Diagnosis related group CPF Curative preventive facility MOH Ministry of health and social development of the Republic of Kazakhstan ICD International classification of diseases RF Regulatory framework RITD Resuscitation and intensive therapy department PHC Primary health care SW software RK Republic of Kazakhstan 331 332 Section VI. Technical Requirements Term Interoperability SOA TSS FN EMR EHR EDS ADO.NET ASP BAM Description Feature or capability of various systems jointly operate Service oriented architecture Provider technical support service Full name Electronic medical record Electronic health record Electronic digital signature Technology that provides data access to applications based on Microsoft .NET. it is not development of earlier ADO technology. Active Server Page Business activity monitoring BP BPM bps BRMS Business Process Business Process Management Bits per second Business Rule Management System CDA Clinical Document Architecture CPU Central Processing Unit CRUD CSS DICOM Create Read, Update, Delete operations Cascading Style Sheets Digital Imaging and Communication in Medicine DOM Document Object Model ESB Enterprise Service Bus FHIR Fast Healthcare Interoperability Resources – a standard created by the High Level Seven International GB Gigabyte Section VI. Technical Requirements GUI Graphical User Interface HC Healthcare Help Desk Help desk. HL7 HTML Health Level 7 Hypertext Markup Language IaaS Infrastructure as a Service ICPC International Classification in Primary Care IDE Integrated Development Environment IHE Integrating Healthcare Enterprise IP Internet Protocol ISO International Standards Organization ITI IT Infrastructure JDBC KB Java Database Connectivity Kilobyte LAN Local area network LDAP Lightweight Directory Access Protocol LOINC Logical Observation Identifiers Names and Codes MB Megabyte MDX Multi-Dimensional eXpressions Language ODBC Open Database Connectivity OLAP Online Analytical Processing OLTP Online Transactional Processing OWASP 333 Open Web Application Security Project PaaS Platform as a Service PDQ Patient Demographic Query 333 334 Section VI. Technical Requirements PIX Patient Identifier Cross-Reference PKI Public Key Infrastructure PMI Patient Master Index RAM Random Access memory REST Representational State Transfer SaaS Software as a Service SAML SDK SNOMED-CT Security Assertion Markup Language Software Development Kit Systematized Nomenclature Of Medicine Clinical Terms SOA Service-oriented architecture SOAP Simple Object Access Protocol SQL Structured Query Language SSL Secure Sockets Layer SSO Single Sign On TCP Transmission Control Protocol TCP/IP Transmission Control Protocol / Internet Protocol TLS Transport Layer Security UML Unified Modeling Layer Unicode Unicode URL Uniform resource locator VPN Virtual Private Network WADL Web Application Description Language WCAG Web Content Accessibility Guidelines WLAN Wireless LAN WS Web Service Section VI. Technical Requirements WSDL XCA XD-LAB XDS XDS-MS Web Services Description Language Cross-Community Access Cross Enterprise Document Sharing of Lab Reports Cross-Enterprise Document Sharing Cross Enterprise Document Sharing of Medical Summaries XML Extensible Markup Language XPHR Exchange of Personal Health Records XSL 335 Extensible Style sheet Language 335 336 Section VI. Technical Requirements B. BUSINESS FUNCTIONS AND PERFORMANCE REQUIREMENTS The goal of this section is to define key business and functional requirements to supply and installation of the System. 1.1. System business requirements 1.1.1. ICT of the MHSD of the RK current state 1.1.1.1. Proposed Kazakhstan e-heath changes Government of the RK adopted a new strategy “Kazakhstan e-health development concept” for 2013-2020, which defines main directions of e-health changes. According to this strategy, it is expected that new architecture will serve as a basis for all transformations. Main new solution properties are narrated: - E-health will be based on principles of interoperability, including: general dictionaries, classifiers, nomenclature, aimed at creating unified information/semantic interoperability in e-health area; - Creation of common and jointly used identifiers for Kazakhstan e-health: Identifier of patients, medical staff (specialists), health facilities, other resources; - Creation of common e-health record system which will be located in the center and contains all patient health records and if necessary will be replicated to local servers; - Provision of computing infrastructure consisting of 2 database processing centers capable to substitute other in case of incidents; - Setting cloud computing technology, enabling to provide corresponding cloud services: infrastructure as a service (IaaS), platform as a service (PaaS) and software as a service (SaaS); - Maintenance based on service oriented infrastructure, enabling to reuse functional capabilities of existing systems and provide connection to Kazakhstan e-government; - Integration of existing systems and web applications in health integration/interoperability platform (hereinafter, platform) etc. Some of approaches on building e-health provide the following: - E-health systems will be developed not only centralized out of republican budget, but health facilities will have possibility to purchase information systems and applictions out of their own funds; - To ensure interoperability, a set of compatibility requirements will be developed and information systems will be certified for compliance with standards of the MHSD of the RK; - To stimulate e-health market development, government will set up special grants and co-financing regulations for health facilities which are intended to computerize their medical activity; - Government will evaluate and control potential risks and take decisions which will mitigate risk (for example, communication channels capacity, alignment between ICT and health sector needs, ensuring compatibility etc.); - The MHSD will speed up process for setting regulations and standards for enhanced interoperability between e-health process participants. Section VI. Technical Requirements Patient’s Personal Cabinet Personal health professional’s cabinet 337 BI and Analytical tools e-Government services Classifiers and Nomenclatures Management Existing Information systems Single data repository RAP OPC MSQMS RMS DPMS RPWFA ERHP ACPCT MEMS ERDP HB DIS NRD ERCP EHR Repository Analytical warehouse Master patient index, healthcare facilities index, healthcare professionals index Classifiers and nomenclatures e-Government Gate Integration bus Integration bus External Information systems RPCRF LIS HIS Legend Existing Information systems Platform components e-Government Gate and services External information systems HIS (Health information system) Fig.1. General national e-health architecture More detailed description is in the Kazakhstan e-health development concept for 2013-2020, accessible on the MHSD of the RK website. 1.1.2. The System’s principles to be complied with The following principles are applied to development, configuration and use of the System: Legality principle, which assumes creation, use and maintenance of information systems according to national legal framework and international standards and regulations in this area; Multi-level architecture principle, which assumes sub-systems self-development according to each level interface standards; Data security principle, which ensures data management in to the System only through secured, authorized channels; Information security principle, which assumes ensuring adequate integrity, selectivity, accessibility and effectiveness to secure data from failure, changes, deletion and unsanctioned access; 337 338 Section VI. Technical Requirements Data confidentiality principle, which assumes performing procedures which will guarantee access to data only according to national policy and international standards to personal data confidentiality, access according to patient consent, option to code saved data; Transparency principle, which assumes, that the System is module structure and it will use ICT transparent/open standards; Extension principle, which assumes extension and improvement of the System with a help of new functions and improvements of existing functionality; First person/unique center priority principle, which assumes existence of high ranked official entitled to make decisions and coordinate activities on creation, integration and use of the System; Scalability principle, which assumes uniform performance of applications and linkages with data and user augmentation; Simplicity and user friendly principles, which assumes that all functions and tools available for target roles are based on visual tools, they are ergonomic and intuitively comprehensible. 1.1.3. Business requirements to the System Note 1. The following key words (normative verbs) SHALL BE used, to communicate compliance requirements. • SHALL – to indicate mandatory requirement, subject to execution (implementation) for compliance. Synonym is «REQUIRED». Another used synonym is «MUST». • SHALL NOT – to indicate prohibited action. The synonym is «forbidden». • SHOULD - to indicate additional recommended action, which fits without reference or exclusion of others. Synonym is «allowed and recommended». • MAY – to indicate non mandatory, admissible actions. Synonym is «allowed». Note 2. In tables with business and functional requirements the following categories are used (types) or requirements: M – means minimal mandatory requirement; such requirement, supplied solution is to be complied therewith; full or partial absence of compliance with such requirement may result in participant’s proposal rejection. D – desirable requirements; absence of compliance with the requirement shall not result in participant’s proposal rejection, and compliance will enable to increase proposal competitiveness. I – means information, is added for clarification of other requirements. Reference to requirements in the text will be different from reference to chapters and parts explicitly: Reference to requirements explicitly will contain word «requirement», «req.» or R, for example, R1.1 - Reference to requirements 1.1; - reference to chapter will be with prefix «chapter», «section», or р, for example, «p.1.1.1» indicates section 1.1.1 and is not requirement. Table below contains list of business requirements, which shall conform to supplied System and related systems/services. 1.1.3.1. General business requirements № type requirement Section VI. Technical Requirements 339 R 1. R 1.1. M Licensing mechanism for the System under this contract shall provide the right to use all modules and compounds for a number of users, which allow full functioning of the Health Facility (approximate scope of Health Facilities is given in description of Appendix 17) for unlimited time, unlimited number of servers, and excluding any other possible limitations. Annual license fees are not admitted; full license cost includes all costs for system licensing. R 1.2. M Within this Contract an interoperability of the System with national e-health system shall be ensured according to requirement R7. General interaction scheme with national e-health system is represented in Fig.1. R 1.3. М Generalized comprehensive health information system architecture the system shall comply with is shown in Fig 2 R 1.4. М System shall be represented as a web application R 1.5. М System shall have capability of fine tuning to provide configuration for specific needs of concrete facility without necessity to develop new one (or including minor development) R 1.6. М Supplier under this Contract shall ensure System interoperability with national EHR tools (EHR repository, national classifiers and identifiers, analytical storage, EHR web services) according to R8 R 1.7. М System shall ensure confidentiality of personal data in the process of saving and sending: coding of confidentially data in database, data coding during transmission via channels, use of secure transmission protocols etc. R 1.8. М System shall ensure using a digital signature for signing and authentication of e-documents, files and parts of documents. The need to use digital signature shall be configurable at the level of system administrator. R 1.9. М System shall be fully “turnkey” operational according to R15.2. R 1.10. М The Supplier shall provide at least, but not limited to configuration, deployment, installation, testing of the System. The Supplier shall provide trainings for users and administrators (and other staff if needed) R 1.11. М Supplier shall participate in the process of certification of the System jointly with Supplier of Platform to test and certify interoperability with national resources and EHR tools as well as participate in General business requirements 339 340 Section VI. Technical Requirements attestation and testing of the system R 1.12. М Supplier shall provide guaranteed service of the system within 3 years from the date of the system operational acceptance by the Purchaser according to R13.4. R 1.13. М If additional licensed software is required for the system turn-key operation the Supplier shall ensure availability of all licenses at the expense of Supplier and their transfer to the Purchaser’s ownership under this contract. R 1.14. М Minimum requirements for each module must comply with requirements of section R2 R 1.15. D System shall have capabilities of integration with development environment (IDE) at least for Java and Net framework. System shall have in a package development tools (SDK) including documents, examples of code for at least Java and Net Framework for configuration of system unction. An option of extending system functionality shall be available using development tools (SDK) which are included into the system composition. R 1.16. M Licensing mechanism for the system within this contract shall not restrict changes which are made using development tools (SDK) that are included into the system composition. Making changes using development tools (SDK) which are included into the system composition shall not have effect on guarantee service of the system. Making changes into the system by specialists of the Purchaser is allowed upon the system operational acceptance. R 1.17. M Supplier shall ensure service and technical support including provision of new product versions (according to R13.3). R 1.18. M Service response tome and system components response time shall not be more than 3-5 seconds for not least 80% of cases of data entry or inquiries for data view (under channel speed 1 Mb/s and response time not more than 100 ms). R 1.19. M Supplier shall document and submit in electronic format configuration files, original code of system components developed within this contract. R 1.20. M System shall have thin client for interaction with equipment it is allowed to use thick client. Section VI. Technical Requirements Patient’s Personal Cabinet Personal health professional’s cabinet 341 e-Government services BI and Analytical tools Classifiers and Nomenclatures Management Existing Information systems RAP OPC MSQMS RMS DPMS RPWFA ERHP ACPCT MEMS ERDP HB DIS Single data repository EHR Repository Analytical warehouse Master patient index, healthcare facilities index, healthcare professionals index Classifiers and nomenclatures e-Government Gate Integration bus ERCP NRD Integration bus External information systems Health facility lev el modules (w ithin this contract) Monitoring of individuals who were performed transplantation Inpatient transplantation coordinator Generation of analytical and statistical tables Administration Registration of Individual needed transplantation Lab testing Republican transplantation coordinator Transplantation brigade Regional transplantation coordinator Legend Existing Information systems Platform components e-Government Gate and services Health facility level modules Fig.2. generalized System architecture. 1.1.3.2. Requirements to composition of processes, maintained and automated by the System Republican coordinating center on transplantation (hereinafter RCCT) is health facility which coordinates health facilities in the area of tissue transplantation and/or organs (parts of organs). Brief information about RCCT is attached in Appendix 1 to the technical specification. Note 1: 341 342 Section VI. Technical Requirements Division to modules is provisional and not mandatory for strict adherence. Mandatory is availability of these functions. Note 2: Forms with prefix “/у” are account forms that approved by order of acting minister of health №907 dated 23 November 2010 “on approval of primary medical document forms of health facilities” Note 3: Possible donor – patient with severe injury/disease of brain with artificial pulmonary ventilation. Potential donor – patient suspected for brain death or with injury/disease incompatible with life instable hemodynamics against conducted complex resuscitation and intensive therapy with occurring brain death diagnostics. Actual donor – donor with established brain death or irreversible blood circulation stagnation and with obtained written consent of donor legal representatives to recover tissues and (or) organs (parts of organs) Health facility in the Republic of Kazakhstan which carries out coordination of health facilities in tissue and (or) organs (part of organs) transplantation is the Republican coordination center of transplantation” (hereinafter RCCT). Information about RCCT is stated in Appendix 1 to the present technical specification. Note 1: Division into modules is conditional and not mandatory for strict compliance. The requirement is presence of these functions. Note 2: While referring to the forms with prefix “/у” registered forms approved by order of the acting minister of health of the RK №907 of November 23, 2010 «On approving primary medical documentation forms of health facilities» have been described Note 3. The following terminology is used in the text: - - - Possible donor – patient with severe injury/brain disease, who is under artificial lung ventilation. Potential donor – patient with suspicion for death of brain or with injury/disease incompatible with life, instable hemodynamics who has been undertaken complex resuscitation care and supporting intensive therapy with commenced diagnostics of brain death. Actual donor – donor with confirmed death of brain or irreversible blood circulatory arrest with a received written consent for tissue and (or) organs (parts of organs) extraction received from authorized donor representatives. Management –create, entry, view, edit, delete data. № R2 R2.1 Тyp e Requirement Requirements to automated processes Module «Administration» Section VI. Technical Requirements R2.1.1 М Adjustment of system user accounts. This process includes as minimum: R2.1.1.1 M Create user accounts R2.1.1.2 M Edit user accounts R2.1.1.3 M Delete user accounts R2.1.2 М 343 Adjustment of system users’ rights and strict designation of responsibilities based on regional and administrative criteria. This process includes as minimum: R2.1.2.1 M Personalized designation of user access rights R2.1.2.2 M Designation of system user rights based on roles, groups and access level with regard to hierarchy of objects and ownership to organizational structure R2.1.2.3 M Edit user access rights R2.1.2.4 M Delete user access rights М Configuration of criteria for automatic selection of appropriate recipient from the waiting list. This process includes as minimum the following: R2.1.3.1 M Edit (add/delete) criteria for automatic selection of appropriate recipient from the waiting list R2.1.3.2 M Edit weight coefficients (score points) of criteria for automatic selection of appropriate recipient from the waiting list М Configuration of recipient/donor registration forms. This process includes as minimum the following: R2.1.4.1 M Edit (add/delete fields, edit existing fields) in the entry forms for registration of recipient/donors/individuals needed transplantation R2.1.4.2 M Add/delete entry forms for registration of recipient/donor/individuals needed transplantation R2.1.4.3 M Use of the following functions to create, edit the entry forms to register recipient/donor/individuals needed transplantation: R2.1.3 R2.1.4 343 344 Section VI. Technical Requirements Change in font setting (style, size, bold, underline, italic etc.) Change font color Create complicated entry forms with subsections Possibility of using any reference book in the system for filling in the field in the entry form Possibility of using any content in the database for filling in the field in the entry form Possibility of using any sampling from the database for filling in the field in the entry form Setting rules for filling in the entry form: only from the list, from the list with possibility of add-in in a free form, from the sample etc. Create new reference books, used in filling in the entry form R2.1.5 М Import data into the system from at least xls, xml file formats. R2.1.6 M System journal management. This process includes as minimum the following: R2.1.7 M Journal to create, change and delete data in the database R2.1.8 M Journal of user’s entry history R2.1.9 M Journal of received reporting forms R2.1.10 M Journal of data view R2.1.11 M Journal of data processing (create, change, delete) R2.1.12 M Journal of archive history R2.1.13 M Journal of program errors and emergency shut down R2.1.14 M Journal of synchronization with external (national) reference books, classifiers, indexes and registers R2.1.15 M Journal archiving R2.2 R2.2.1 Module «Registration of an individual needed transplantation» М Registration in the «waiting list» of an individual, needed Section VI. Technical Requirements 345 transplantation according to Appendices 1-1, 1-2, 1-3 to the present technical specification. Possibility of registration of one patient in several waiting lists. This process includes as minimum the following: R2.2.1.1 M Registration in the «waiting list» of an individual needed transplantation according to the form of Appendix 1-1 to the present technical specification R2.2.1.2 M Registration in the «waiting list» of an individual needed liver transplantation according to the form of Appendix 1-2 to the present technical specification R2.2.1.3 M Registration in the «waiting list» of an individual needed kidney transplantation according to the form of Appendix 1-3 to the present technical specification R2.2.1.4 M Registration of one patient in several waiting lists (if necessary) R2.2.1.5 M Possibility of printing patient information according to Appendices 1-1, 1-2, 1-3 to the present technical specification. R2.2.1.6 M Possibility of export patient information according to Appendices 1-1, 1-2, 1-3 to the present technical specification to at least pdf, xls, doc format documents. R2.2.2 M Automated receipt of information about necessity to be registered in the waiting list of an individual needed transplantation based on the information received from IS of the MHSD of the RK (this functionality shall be implemented as soon as required functionality of the stated above IS will be ready for interaction). This process includes as minimum the following: R2.2.2.1 M Automated receipt of information from IS of the MHSD of the RK about the necessity for the patient to be registered in the waiting list R2.2.2.2 M Patient registration in the waiting list according to Appendices 1-1, 1-2, 1-3 to the present technical specification based on information of IS of the MHSD of the RK R2.2.2.3 M Registration of one patient in several waiting lists (if necessary). R2.2.2.4 M Possibility of printing patient information according to Appendices 1-1, 1-2, 1-3 to the present technical specification. 345 346 Section VI. Technical Requirements R2.2.2.5 M Possibility of export patient information according to Appendices 1-1, 1-2, 1-3 to the present technical specification to at least pdf, xls, doc format documents. М Manage information about current state of individual needed transplantation (improving or worsening of the course of the disease with regard to progress, development of complications, concomitant disease and other). This process includes as minimum the following: R2.2.3.1 M Search of patient based on full name, IIN, organ/part of organ and/or tissue, blood group, Rh and other criteria. R2.2.3.2 M Manage information about current state (improving or worsening of the course of the disease with regard to progress, development of complications, concomitant disease and other). R2.2.3.3 M Store in the system of the history of changes in the patient condition R2.2.3.4 M View the history of changes in the patient condition R2.2.3.5 M Option to print information about the patient condition. R2.2.3.6 M Option to print the history of changes in the patient condition. R2.2.3.7 M Option to export information about patient condition to at least pdf, xls, doc format documents. R2.2.3.8 M Option to export the history of changes in the patient condition to at least pdf, xls, doc format documents. М Waiting list monitoring. This process includes as minimum the following: R2.2.4.1 M Search patient based on full name, IIN, organ/part of organ and/or tissue, blood group, Rh and other criteria. R2.2.4.2 M View waiting list (including generation of daily information by regions about the number of adult and child patients, number of dropped from the waiting list with a reason indication, number of new cases). R2.2.3 R2.2.4 Section VI. Technical Requirements 347 R2.2.4.3 M Sort and filtrate the «waiting list» based on patient full name, patient age, sex, date of patient entry to the waiting list, region, health facility, organ/tissue to be transplanted and another criterion. R2.2.4.4 M Option to print the waiting list (including filtrated and/or sorted). R2.2.4.5 M Option to export the waiting list (including filtrated and/or sorted) into at least pdf, xls, doc format documents. R2.3 Module «Inpatient transplantation coordinator» М Registration of possible donor under a form according to Appendix 2 to the present technical specification. This process includes as minimum the following: R2.3.1.1 M Registration of possible donor according to Appendix 2 to the present technical documentation R2.3.1.2 M Manage information about possible donor examination results R2.3.1.3 M View of earlier registered possible donors with possibility of sorting and filtration by patient age, sex, diagnosis, entry date and other criteria. R2.3.1.4 M Possibility of printing information about possible donor. R2.3.1.5 M Possibility of export of possible donor information into at least pdf, xls, doc format documents. М Registration of potential donors under form according to Appendix 2 to present technical specification. This process includes as minimum the following: R2.3.2.1 М Registration of potential donor according to Appendix 2 to the present technical specification R2.3.2.2 М Manage information about potential donor examination results R2.3.2.3 М View of earlier registered potential donors with possibility of sorting and filtration based on patient age, sex, intensive therapy department admission date, tissue/organ to be extracted and other criteria. R2.3.1 R2.3.2 347 348 Section VI. Technical Requirements R2.3.2.4 М Possibility of setting summary reporting forms of registered potential donors over a certain period of time R2.3.2.5 M Possibility of printing summary reporting forms of registered potential donors over certain period of time R2.3.2.6 Possibility of printing potential donor information R2.3.2.7 М Possibility of export of summary reporting forms of registered potential donors over a certain period of time into at least pdf, xls, doc format documents R2.3.2.8 М Possibility of export of potential donor information into at least pdf, xls, doc format documents М Registration of actual donor under a form according to Appendix 2 to the present technical specification. This process includes as minimum the following: R2.3.3.1 М Registration of actual donor according to Appendix 2 to the present technical specification R2.3.3.2 М Manage information about actual donor examination results R2.3.3.3 М View of earlier registered actual donors with possibility of sorting and filtration based on patient full name, age, sex, organ/tissue, to be extracted and other criteria. R2.3.3.4 М Setting summary reporting forms of registered actual donors over a certain time period R2.3.3.5 М Possibility of printing summary reporting forms of registered actual donors over certain time period R2.3.3.6 М Possibility of printing information about actual donor R2.3.3.7 М Possibility of export of summary reporting forms on registered actual donors into at least pdf, xls, doc format documents R2.3.3.8 М Possibility of export of actual donor information into at least pdf, xls, doc format documents М Manage information about current objective donor status (possible, potential, actual) This process includes as minimum the following: R2.3.3 R2.3.4 Section VI. Technical Requirements 349 R2.3.4.1 M Manage information about current objective donor status R2.3.4.2 M View of donor objective status change history R2.3.4.3 M Possibility of printing information about donor objective status R2.3.4.4 M Possibility of printing donor objective status change history R2.3.4.5 M Possibility of exporting information about donor objective status into at least pdf, xls, doc format documents. R2.3.4.6 M Possibility of export donor objective status change history into at least pdf, xls, doc format documents. R2.4 Module «lab testing» М Managing performed lab testing results including but not limited to the information about high, medium, low performance immunological tissue typing testing results of individuals recommended for transplantation and potential donors (form №410-10/у), information about individual cross match results of potential donors and individuals recommended for transplantation (form №410-11/у), leucocyte antibodies testing results of candidates for transplantation (form №4109/у). This process includes as minimum the following: R2.4.1.1 M Search of patient based on full name, IIN, organ/part of organ and/or tissue, blood group, Rh and other criteria. R2.4.1.2 M Manage performed lab testing results including but not limited to the information about high, medium, low performance tissue immunological typing testing results of individuals recommended for transplantation and potential donors (form №410-10/у), information about individual cross match results of potential donors and individuals recommended for transplantation (form №410-11/у), leucocyte antibodies testing results of candidates for transplantation (form №4109/у). Entry of performed lab testing results R2.4.1.3 M View earlier entered lab testing results R2.4.1 349 350 Section VI. Technical Requirements R2.4.1.4 M Option of printing lab testing results including but not limited to the information about high, medium, low performance tissue immunological typing molecular & serological testing results of individuals recommended for transplantation and potential donors (form №410-10/у), information about individual cross match testing results of potential donors and individuals recommended for transplantation (form №410-11/у), leucocyte antibodies testing results of candidates for transplantation (form №410-9/у). R2.4.1.5 M Option of export lab testing results into at least pdf, xls, doc format documents. R2.5 Module «regional transplantation coordinator» М Setting request to be dropped from the waiting list with a reason indication (death, change of place of living, no need in transplantation, contradictions to transplantation etc). This process includes as minimum the following: R2.5.1.1 M Entry request to be dropped from the waiting list with a reason indication (death, change of place of living, no need in transplantation, contradiction to transplantation, rejection to have transplantation etc.) R2.5.1.2 M Edit/delete request to be dropped from the waiting list which was not sent to the republican transplantation coordinator R2.5.1.3 M Sending a request to be dropped from the waiting list to the republican transplantation coordinator for consideration R2.5.1.4 M Option of printing request to be dropped from the waiting list. R2.5.1.5 M Option of export the request to be dropped from the waiting list into at least pdf, xls, doc format document. М Monitoring of donors (possible, potential, actual, as well as voluntary). This process includes as minimum the following: R2.5.2.1 M View a list of possible donors with option of sorting and filtration based on patient age, sex, diagnosis, admission date, other criteria. R2.5.2.2 M View a list of potential donors with option of sorting and filtration based on patient age, sex, intensive therapy department admission date, tissue/organ to be extracted and other criteria. R2.5.1 R2.5.2 Section VI. Technical Requirements 351 R2.5.2.3 M View a list of actual donors with possibility of sorting and filtration based on patient full name, age, sex, organ/tissue to be extracted and other criteria. R2.5.2.4 M View a list of voluntary donors with option of sorting and filtration based on patient age, sex, registration date and other criteria. R2.5.2.5 M Search patient based on full name, IIN, organ/part of organ and/or tissue, blood group, Rh and other criteria. R2.5.2.6 M View a list of individuals who were dropped from the list of voluntary donors (rejection to donate, contradictions to donation, death and other reasons). R2.5.2.7 M View possible donors list change history R2.5.2.8 M View potential donors list change history R2.5.2.9 M View actual donors list change history R2.5.2.10 M View voluntary donors list change history R2.5.2.11 M Manage daily report data according to Appendix 6 to the present technical specification R2.5.2.12 M Setting summary reporting forms for registered donors (possible, potential, actual) over certain time period R2.5.2.13 M Setting summary reporting forms for registered voluntary donors over certain time period R2.5.2.14 M Option of printing summary reporting forms for registered donors (possible, potential, actual). R2.5.2.15 M Option of printing summary reporting forms for registered voluntary donors. R2.5.2.16 M Option to export summary reporting forms by registered donors (possible, potential, actual) into at least pdf, xls, doc format documents R2.5.2.17 M Option to export summary reporting forms by registered voluntary donors into at least pdf, xls, doc format documents 351 352 Section VI. Technical Requirements R2.5.2.18 M Option to print summary reporting forms by registered donors (possible, potential, actual, voluntary). R2.5.2.19 M Option to export information about registered donors (possible, potential, actual, voluntary) into at least pdf, xls, doc format documents М Registration of voluntary lifetime donors (individuals who had agreed to extract one of their pair organs or part of organ/tissue) with possibility to check availability of notary certified consent/denial through interacting with state information system “Unified notary information system” via health informatization and interoperability platform according to Appendix 2-1 to the present technical specification. This process includes as minimum the following: R2.5.3 R2.5.3.1 M Manage information on voluntary lifetime donor R2.5.3.2 M Selecting concrete recipient as a voluntary lifetime donor (according to donor’s perception) R2.5.3.3 M Checking the availability of notary certified consent to be a donor through interacting with state information system “Unified notary information system” via health informatization and interoperability platform R2.5.3.4 M Manage information on denial to be a donor R2.5.3.5 M Checking the availability of notary certified denial to be a donor through interacting with state information system “Unified notary information system” via health informatization and interoperability platform R2.5.3.6 M Option to print information on voluntary lifetime donor. R2.5.3.7 M Generating summary reporting forms on registered voluntary donors over specific period of time R2.5.3.8 M Option to print summary reporting forms on registered voluntary donors R2.5.3.9 M Option to export summary reporting forms on registered voluntary donors into at least pdf, xls, doc format documents. R2.5.3.10 M generating summary reporting forms on registered denials to be donors over specific period of time Section VI. Technical Requirements 353 R2.5.3.11 M Option to print summary reporting forms on registered denial to be donors over specific period of time R2.5.3.12 M Option to export summary reporting forms on registered denial to be donors into at least pdf, xls, doc format documents. R2.5.3.13 M Option to export summary reporting forms on registered voluntary lifetime donors into at least pdf, xls, doc format documents. М Registration of voluntary postmortal donors (individuals who had agreed with retrieval of their organ/part of organ and/or tissue after their death) with possibility to attach a scanned copy of notary certified consent/denial according to Appendix 2-1 to the present technical specification. This process includes as minimum the following: R2.5.4 R2.5.4.1 M Manage information about voluntary postmortal donor R2.5.4.2 M Selection of concrete recipient as voluntary postmortal donor (according to donor perception) R2.5.4.3 M Attachment of scanned notary certified copy of consent R2.5.4.4 M Manage information about denial to be donor R2.5.4.5 M Attachment of scanned notary certified copy of denial R2.5.4.6 M Option to print information about voluntary post mortal donor. R2.5.4.7 M Option to export information on voluntary postmortal donor into at least pdf, xls, doc format documents. R2.5.4.8 M generating summary reporting forms on registered voluntary donors over specific period of time R2.5.4.9 M Option to print summary reporting forms on registered voluntary donors R2.5.4.10 M Option to export summary reporting forms on registered voluntary donors to at least pdf, xls, doc format documents. R2.5.4.11 M Generating summary reporting forms on registered denials to be donors over specific period of time 353 354 Section VI. Technical Requirements R2.5.4.12 M Option to print summary reporting forms on registered denial to be donors over specific period of time R2.5.4.13 M Option to export summary reporting forms on registered denial to be donors into at least pdf, xls, doc. format documents R2.6 R2.6.1 module Republican transplantation coordinator М Manage register of donors of organs/part of organ and/or tissue (create, edit, delete, view) This process includes as minimum the following: R2.6.1.1 M Manage information on donors of organs/part of organ and/or tissue R2.6.1.2 M Dropping a donor from the register with reason indication R2.6.1.3 M Searching patient by family name, IIN, organ/part of organ and/or tissue, blood group, Rh etc. R2.6.1.4 M Option to print information on donors of organs/part of organ and/or tissue. R2.6.1.5 M Option to export information on donors of organs/part of organ and/or tissue into at least pdf, xls, doc format documents R2.6.1.6 M Generating summary reporting forms on registered donors of organs/part of organ and/or tissue R2.6.1.7 M Option to print summary reporting forms on registered donors of organs/part of organ and/or tissue R2.6.1.8 M Option to export summary reporting forms on registered donors of organs/part of organ and/or tissue into at least pdf, xls, doc format documents R2.6.1.9 M generating summary reporting forms on donors of organs/part of organ and/or tissue dropped from the register R2.6.1.10 M Option to print summary reporting forms on donors of organs/part of organ and/or tissue dropped from the register R2.6.1.11 M Option to export summary reporting forms on donors of organs/part of organ and/or tissue dropped from the register to at least pdf, xls, doc format documents. Section VI. Technical Requirements R2.6.2 М 355 Manage waiting list (create, edit, delete, view options). This process includes as minimum the following: R2.6.2.1 M Manage the waiting list R2.6.2.2 M Reviewing request to be dropped from the waiting list of regional transplantation coordinator R2.6.2.3 M Dropping the patient from the waiting list with reason indication R2.6.2.4 M Option to print information about individuals needed transplantation R2.6.2.5 M Option to export information about individuals needed transplantation into at least pdf, xls, doc format documents R2.6.2.6 M Generating summary reporting forms on registered individuals needed transplantation over specific period of time R2.6.2.7 M Option to print summary reporting forms on registered individuals needed transplantation R2.6.2.8 M Option to export summary reporting forms on registered individuals needed organ/tissue transplantation over specific period of time into at least pdf, xls, doc format documents. R2.6.2.9 M generating summary reporting forms on patients dropped from the waiting list over specific period of time R2.6.2.10 M Option to print summary reporting forms on patients dropped from the waiting list R2.6.2.11 M Option to export summary reporting forms on patients dropped from the waiting list into at least pdf, xls, doc format documents. М Automated sending by e-mail of reminder to carry out scheduled quarterly testing. This process includes as minimum the following: R2.6.3.1 M Automated generation of a list of patients for scheduled quarterly leucocytal antibodies testing, 10 days prior to the planned test date. R2.6.3 355 356 Section VI. Technical Requirements R2.6.3.2 M Automated sending by e-mail to a candidate for transplantation of a reminder to carry out scheduled quarterly testing upon 10 days prior to the planned test date. R2.6.3.3 M Automated sending by e-mail of a reminder to the regional and republican transplantation coordinator of lists of patients to carry out leucocytal antibodies testing 10 days prior to planned test date М Automated calculation of score points to define a position in the waiting list based on criteria table according to Appendix 3 to the present technical specification. This process includes as minimum the following: R2.6.4.1 M Automated calculation of score points to define a position in the waiting list based on criteria table according to Appendix 3 to the present technical specification R2.6.4.2 M Regular (at least once a day and if actual donor is found) automated recalculation of score points to define position in the waiting list based on criteria table according to Appendix 3 to the present technical specification М Automated selection of the group of potential recipients against donor. This process includes as minimum: R2.6.5.1 M Searching donor by family name, IIN, organ/part of organ and/or tissue, blood group, Rh etc. R2.6.5.2 M Automated selection of the group of potential recipients against donor. R2.6.5.3 M Option to print information about individuals selected as potential recipients against donor. R2.6.5.4 M Option to export information about individuals selected as potential recipients against donor into at least pdf, xls, doc format documents. М Automated selection of the group of potential recipients against donor with regard to several organs/tissues. This process includes as minimum: R2.6.6.1 M Searching donor by family name, IIN, organ/part of organ and/or tissue, blood group, Rh etc. R2.6.4. R2.6.5 R2.6.6 Section VI. Technical Requirements 357 R2.6.6.2 M Automated selection of the group of potential recipients against donor with regard to several organs/tissues. R2.6.6.3 M Option to print information about individuals selected as potential recipients against donor with regard to several organs/tissues R2.6.6.4 M Option to export information about individuals selected as potential recipients against donor with regard to several organs/tissues into at least pdf, xls, doc format documents. М Automated selection of the group of donors against patient needed transplantation. This process includes as minimum: R2.6.7.1 M Searching patient by family name, IIN, organ/part of organ and/or tissue, blood group, Rh and other or selection of a patient from the waiting list. R2.6.7.2 M Automated selection of the group of donors against patient needed transplantation. R2.6.7.3 M Option to print information on individuals selected as potential donors against the patient. R2.6.7.4 M Option to export information about individuals selected as potential donors against the patient into at least pdf, xls, doc format documents. М Automated selection of the group of donors against the patient needed transplantation with regard to several organs/tissues. This process includes as minimum: R2.6.8.1 M Searching patient by family name, IIN, organ/part of organ and/or tissue, blood group, Rh and other or selection of a patient from the waiting list. R2.6.8.2 M Automated selection of the group of donors against patient needed transplantation with regard to several organs/tissues. R2.6.8.3 M Option to print information about individuals selected as potential donors against patient with regard to several organs/tissues. R2.6.8.4 M Option to export information about individuals as potential donors against patient with regard to several organs/tissues into at least pdf, xls, doc format documents. R2.6.7 R2.6.8 357 358 Section VI. Technical Requirements М Manage information about council of physicians’ decision about transplantation. This process includes as minimum: R2.6.9.1 M Manage information about council of physicians (participants, venue, date etc) R2.6.9.2 M Manage council of physicians’ decision about transplantation R2.6.9.3 M Option to print information about council of physicians and decision taken. R2.6.9.4 M Option to export information about council of physicians and decision taken into at least pdf, xls, doc format documents. R2.6.9 R2.7 R2.7.1. module Transplantation brigade М Manage information on donor organs and tissues withdrawn. This process includes as minimum: R2.7.1.1 M Manage information on donor organs withdrawn R2.7.1.2 M Manage information on donor tissues withdrawn R2.7.1.3 M Manage information on surgery for organ withdrawal (health facility name, where the surgery was carried out, ICD-9 code, information about anesthesia etc) R2.7.1.4 M Option to print information about donor organs and tissues withdrawn. R2.7.1.5 M Option to print information about surgery on organ withdrawn R2.7.1.6 M Option to export information about donor organs and tissues withdrawn into at least pdf, xls, doc format documents. R2.7.1.7 M Option to export information about surgery on organs withdrawn into at least pdf, xls, doc format documents. R2.7.1.8 M generating summary reporting forms on organs and tissues withdrawn over specific period of time R2.7.1.9 M Option to print summary reporting forms on organs and tissues withdrawn Section VI. Technical Requirements 359 R2.7.1.10 M Option to export summary reporting forms on organs and tissues withdrawn into at least pdf, xls, doc format documents. R2.7.1.11 M Generating summary reporting forms on carried out surgery operations for organs/tissues withdrawn over specific time period R2.7.1.12 M Option to print summary reporting forms on carried out surgery operations for organs/tissues withdrawn R2.7.1.13 M Option to export summary reporting forms on carried out surgery operations for donor organs/tissues withdrawn into at least pdf, xls, doc format documents. М Manage information on carried out organ and tissue transplantation. This process includes as minimum: R2.7.2.1 M Manage information on donor organs/tissues transplanted to the recipient R2.7.2.2 M Manage information on surgery on organ transplantation (health facility name, where surgery operation was carried out, ICD-9 code, information about anesthesia etc) R2.7.2.3 M Manage information about pre and post surgery operation period, immunosuppressive therapy, post surgery complications. R2.7.2.4 M Option to print information about donor tissue/organ transplanted to the recipient. R2.7.2.5 M Option to print information about surgery operation on organ transplantation R2.7.2.6 M Option to export information about donor organ/tissue transplanted to the recipient into at least pdf, xls, doc format documents R2.7.2.7 M Option to export information about surgery operation on organ transplantation to at least pdf, xls, doc format documents R2.7.2.8 M Generating summary reporting forms on donor organs and tissues transplanted over specific time period R2.7.2.9 M Option to print summary reporting forms on donor organs and tissues transplanted over specific time period R2.7.2 359 360 Section VI. Technical Requirements R2.7.2.10 M Option to export summary reporting forms on donor organs and tissues transplanted over specific time period into at least pdf, xls, doc format documents R2.7.2.11 M generating summary reporting forms on carried out operations for organ/tissue transplantation to the recipient over specific time period R2.7.2.12 M Option to print summary reporting forms on carried out operations for organ/tissue transplantation to the recipient over specific time period Option to export information on transplanted donor organ/tissue to the recipient into at least pdf, xls, doc format documents R2.8 М module “monitoring of the condition of individuals whom transplantation was carried out R2.8.1.1 M Manage register of individuals who were carried out with transplantation (create, edit, view). This process includes as minimum: R2.8.1.2 M Manage information about individuals who were carried out with transplantation R2.8.1.3 M Monitoring of the condition of the donor from whom transplantation was performed. R2.8.1.4 M Searching a patient by full name, IIN, organ/part of organ and/or tissue transplanted, blood group, Rh and other. R2.8.1.5 M Option to print information about patients who were carried out with transplantation М Option to export information about patients who were carried out with transplantation into at least pdf, xls, doc format documents. R2.8.2.1 M Monitoring of patients who were carried out with transplantation. This process includes as minimum: R2.8.2.2 M Manage information about patients who were carried out with transplantation R2.8.2.3 M Manage the history of change in the health status of the patients who were carried out with transplantation R2.8.1 R2.8.2 Section VI. Technical Requirements 361 R2.8.2.4 M Monitoring of the condition of the individuals who were carried out transplantation from the same donor. R2.8.2.5 M Viewing the history of change in the health status of the patients who were carried out with transplantation with option to sort and filtrate by patient age, sex, registration date, organ which was transplanted and other criteria. R2.8.2.6 M Searching patient by full name, IIN, transplanted organ/part of organ and/or tissue, blood group, Rh and other criteria. R2.8.2.7 M Option to print information on health status of the patients who were carried out with transplantation R2.8.2.8 M Option to print history of change in the health status of the patients who were carried out with transplantation R2.8.2.9 M Option to export information about patients who were carried out with transplantation into at least pdf, xls, doc format documents R2.9 module Generating analytical and statistical tables R2.9.1 М Report on carried out allogenic relative transplantations (recipient, donor, and outcome family name list) R2.9.2 М Report on carried out allogenic non relative transplantations (recipient, donor, and outcome family name list) R2.9.3 М Report on lethal outcomes of patients included in the waiting list (by age, death reason, death date) R2.9.4 М Report on carried out transplantation: information on retrieved organs, reasons for not performed selection, health facility where retrieval was carried out R2.9.5 М Report on cases of statement of potential donor brain circulation death/arrest (family name list, death date) R2.9.6 М Monthly reports according to Appendix 4-5 to the present technical specification R2.9.7 М Daily report of regional transplantation coordinator according to Appendix 6 to the present technical specification 361 362 Section VI. Technical Requirements R2.9.8 М All output forms shall have an option to print out and save in at least xls, pdf, doc format. 1.1.4. Legal documents Minimum set of regulations to be observed: 1) "law of the RK «on national security of the RK» № 527-IV dated 6 January 2012 (http://online.zakon.kz/Document/?doc_id=31106860); 2) President decree dated 14 November 2011 № 174 " On 2016 Kazakhstan information security concept » (http://ru.government.kz/docs/u110000017420111114.htm); 3) Code of the RK N 193-IV dated 18 September 2009 “On people’s health health system”; 4) Law “on personal data and their protection” N 94-V dated 21 May 2013 (http://online.zakon.kz/Document/?doc_id=31396226); 5) Order of acting minister of health of the RK dated 23 November 2010 № 907 «On approval of health facility primary medical document forms» 6) Order of acting minister of health of the RK №75 dated 10.02.2014 “on approval of technical documents on e-health issues». (http://www.mz.gov.kz/index.php?option=com_content&view=article&id=662&Item id=1001&lang=ru) 7) Order of minister of health of the RK dated 29 March 2013 № 199 «on measures of organ and tissue transplantation service development in Kazakhstan»; 8) National regulatory framework defining requirements to EHR, EMR, e-health processes and technical requirements on interacting with central components and Kazakhstan е-health IS. 9) National regulatory framework defining requirements to processes of donation and transplantation of tissue and (or) organs (parts of organs). 1.2. Requirements to system configuration # Ty pe requirement R 3 Requirements to system configuration R 3.1 Configuration to health facility needs R 3.1.1 М The System shall provide an option to manage access to functionality based on roles. System shall enable add/delete/edit roles and designate/cancel access right to the system functionality. R 3.1.2 М System shall have preinstalled roles according to 1.2.1. of the present technical specification with option of further adjustment (add, edit or delete new roles). Section VI. Technical Requirements 363 R 3.1.3 М Access rights to different system modules and functions must be preinstalled according to Table 1 with option to change access rights (add, delete) R 3.1.4 М Access right must be at least configurable on the following aspects: all rights, create, change, delete, view. R 3.1.5 M System shall include master of reporting forms, enabling to create and edit reports using fields from the system database 1.2.1. Role description 1. Registering staff of an individual needed transplantation is a profile specialist who constantly monitors the patient with regard to certain disease who has been included into the waiting list. Positions: head of department, profile specialist, physician, freelance specialist of health department, inpatient transplantation coordinator, regional transplantation coordinator, republican transplantation coordinator 2. Inpatient transplantation coordinator – controller and initiator of donorship of tissues and (or) organs (part of organs) in health facilities, who is full time inpatient staff member. Position: inpatient transplantation coordinator. 3. Lab technician is lab staff member, who is in charge of entering into the System of lab testing data of donors, recipients, and individuals needed transplantation. Position: lab technician, lab physician, lab specialist. 4. Regional transplantation coordinator is a physician, organizer of interhospital cooperation of health facilities in the area of tissue and (or) organs (part of organs) transplantation in oblast centers of the RK. Position: Regional transplantation coordinator. 5. Republican transplantation coordinator is health facility staff member who coordinates activity of health facilities in the area of tissue and/or organ (parts of organs) transplantation. Position: physician coordinator, RCCT staff member. 6. Physician is health specialist, who carries out constant monitoring the patient’s certain disease which is the reason of putting this patient into the waiting list and also he provides medical care to the patient after transplantation. Positions: head of department, profile specialist, physician, freelance specialist of health department. 7. Administrator is specialist administering the System (account setting, access right distribution etc). Positions: TCCT staff member. Table 1 – roles access right to module functions № 1. 1.1. Requirement Roles module “Registration of an individual needed transplantation” Registration in the waiting list of an individual needed Registering staff member transplantation according to the form stated in of an individual needed Appendix 1-1, 1-2, 1-3 to the present technical transplantation specification. Option to register one patient in several 363 364 Section VI. Technical Requirements waiting lists. 1.2. Automated receipt of information about necessity to Registering staff member be registered in the waiting list of an individual needed of an individual needed transplantation based on the information received from transplantation IS of the MHSD of the RK (this functionality shall be implemented as soon as required functionality of the stated above IS will be available for interaction). 1.3. Entry of information about current state of individual Registering staff member needed transplantation (improving or worsening of the of an individual needed course of the disease with regard to progress, transplantation development of complications, concomitant disease and other). 1.4. Waiting list monitoring. 2. Registering staff member of an individual needed transplantation module Inpatient transplantation coordinator 2.1. Registration of possible donor under the form Inpatient transplantation according to Appendix 2 to the present technical coordinator specification. 2.2. Registration of potential donor under the form Inpatient transplantation according to Appendix 2 to the present technical coordinator specification. 2.3. Registration of actual donor under the form according Inpatient transplantation to Appendix 2 to the present technical specification. coordinator 2.4. Entry of information about current donor objective Inpatient transplantation status (possible, potential, actual), coordinator 3. 3.1. 4. module Lab testing Entry of performed lab testing results including but not Lab technician limited to the information about high, medium, low performance immunological tissue typing testing results of individuals recommended for transplantation and potential donors (form №410-10/у), information about individual cross match results of potential donors and individuals recommended for transplantation (form №410-11/у), leucocyte antibodies testing results of candidates for transplantation (form №410-9/у). module Regional transplantation coordinator Section VI. Technical Requirements 365 4.1. Generating request to be dropped from the waiting list Regional transplantation with a reason indication (death, change of place of coordinator living, no need in transplantation, contradictions to transplantation etc). 4.2. Monitoring of donors (possible, potential, actual, Regional transplantation voluntary). coordinator 4.3. Registration of voluntary lifetime donors (individuals Regional transplantation who had agreed to extract one of their pair organs or coordinator part of organ/tissue) with possibility to check availability of notary certified consent/denial through interacting with state information system “Unified notary information system” via health informatization and interoperability platform according to Appendix 21 to the present technical specification. 4.4. Registration of voluntary postmortal donors Regional transplantation (individuals who had agreed with retrieval of their coordinator organ/part of organ and/or tissue after their death) with possibility to attach a scanned copy of notary certified consent/denial according to Appendix 2-1 to the present technical specification. 5. module Republican transplantation coordinator 5.1. Manage register of organ/part of organ and/or tissue Republican transplantation donors (create, edit, delete, view). coordinator 5.2. Manage waiting list (create, edit, delete, view). 5.3. Automated sending by e-mail of reminder to carry out scheduled quarterly testing. 5.4. Automated calculation of score points to define a position in the waiting list based on criteria table according to Appendix 3 to the present technical specification 5.5. Automated selection of the group of potential Republican transplantation recipients against donor. coordinator 5.6. Automated selection of the group of potential Republican transplantation recipients against donor with regard to the need in coordinator several organs/tissues. Republican transplantation coordinator 365 366 Section VI. Technical Requirements 5.7. Automated selection of the group of donors against a Republican transplantation patient needed transplantation. coordinator 5.8. Automated selection of the group of donors against a Republican transplantation patient needed transplantation with regard to the need coordinator in several organs/tissues. 5.9. Manage council transplantation. 6. of physicians’ decision about Republican transplantation coordinator module Transplantation brigade 6.1. Manage information about donor organs and tissues Transplantation brigade retrieved. 6.2. Manage information about performed organ/tissue Transplantation brigade transplantation. 7. module Monitoring transplantation of individuals received 7.1. Manage register of individuals, transplantation (create, edit, delete, view). 7.2. Monitoring of health status of individuals received Republican transplantation transplantation. coordinator Regional transplantation coordinator 8. received Republican transplantation coordinator module Generating analytical and statistical tables 8.1. Report on cases of statement of potential donor brain Republican transplantation circulation death/arrest (family name list, death date) coordinator Regional transplantation coordinator 8.2. Monthly reports according to Appendix 4-5 to current Republican transplantation technical specification coordinator Regional transplantation coordinator 8.3. Monthly report of regional transplantation coordinator Republican transplantation according to Appendix 6 to present technical coordinator specification Regional transplantation coordinator 8.4. All output forms must have option to print and save in Republican transplantation at least xls, pdf, doc format. coordinator Regional transplantation coordinator 9. module Administration Section VI. Technical Requirements 367 9.1. Setting System user account. 9.2. Setting system user rights and strict designation of administrator responsibilities based on regional and administrative criteria. 9.3. Configuration of criteria for automatic selection of administrator appropriate recipient from the waiting list.. 9.4. Configuration of registration forms of recipients/ administrator donors. 9.5. Data import to system from at least xls, xml file administrator formats. 9.6. Manage system journals. 1.3. administrator administrator Requirements to system response time # type requirement Requirements to system response time M Search of patient by full name or IIN and patient related data (examination results, lab test results etc) shall not be more than 5 seconds for 80% of cases R 4.2 М Supplier during guaranteed period of service shall ensure the following system performance parameters: R 4.3 М Total system shutdown time for the reason related to its operability shall not be more than 24 hours per year. R 4.4 М One time system shutdown for the reason related to its operability shall not be more than 2 hours. 1.2.3 Requirements to the system information security Тyp e R 5 requirement Requirement to information security R 5.1 M Requirement of security are defined by existing law of the RK. System shall comply with information security requirements in terms of providing threshold access, protection from unsanctioned access etc. R 5.2 M Information protection from unsanctioned access means shall be provided in the system namely: 367 368 Section VI. Technical Requirements R 5.2.1 M User identification based on user name (login) and password validation R 5.2.2 M Option to identify user based on public key infrastructure digital certificates R 5.2.3 M User authorization for access to system information resources, that require appropriate authorizations R 5.2.4 M Personified user right determination for data management, fine-tuning, view R 5.2.5 M Personified user right determination for system resource access R 5.2.6 M Designation of system user rights by roles, groups and access level with regard to object hierarchy and organizational structure ownership. R 5.2.7 M User work protocol maintenance with System critical functions and applications R 5.2.8 M System file protection from change/damage by unauthorized users and program processes R 5.2.9 M Control journal of all updates in system program libraries shall be maintained R 5.3 M The following minimum backup means shall be realized in the system: - automated backup with option of planning - remote control of backup creation - full and partial backup R 5.4 M System shall provide data integrity. R 5.5 M System shall provide tools for data confidentiality coding during storage and in the process of transfer to other systems. R 5.6 M Electronic digital signature (hereinafter registration certificate of user by National Authorization Center of the Republic of Kazakhstan, EDS) shall be issued by NAC RK. The system shall provide the tools for digital signature of documents (objects) or portions of documents, when / if it is needed, and tools for signature authentication. This option shall be implemented in the system services (if necessary). To ensure EDS authenticity and public key validity, the System shall provide check for EDS authenticity using services of NAC RK (http://pki.gov.kz/index.php/ru/). R 5.7 M System shall conform to the “single access point” principle information structure architecture enabling to have single access point (Single Sign On) to all its components and resources, enabling to enter login and password once and get access to all system components Section VI. Technical Requirements 369 without entering password once again. R 5.8 M System shall provide user authorization in the System, designation of system user rights by roles, groups, access level with regard to object hierarchy and organizational structure ownership. R 5.9 M According to regulatory documents on information security approved by the MHSD of the RK, the following shall be realized: − Password length shall not be less than 8 symbols, letters and numbers must be in upper and lower case; − Forced password change function; − Empty password lockout function; − User password self-change; − CAPTCHA be realized for incorrect password entry for 3 times; − All user actions log in journal for viewing history of all system main events changed; − functionality of session interruption if inactive in N time period. 1.2.4 Requirements to system quality attributes N type Requirement R 6 Requirements to system quality attributes R 6.1. M System must support entry, receipt and transfer of data required for work of IS of the MHSD of the RK used by health facility and avoid double data entry. R 6.2. M System shall ensure saving of all accumulated information at the moment of shutdown or failure of any system component regardless its assignment, with follow-up recovery after repair and recovery work R 6.3 M System shall have option of soft fine-tuning in changing environment and user specific tasks without replacing the modules. R 6.4 M System shall be highly scalable and enabling operation of unlimited number of users. Restrictions can be conditioned only by hardware technical characteristics and not by the System characteristics R 6.5 M All system functional features must be developed as services. R 6.6 M System web services must be developed according to SOA architecture. R 6.7 М In realization of interoperability services it is required to follow 369 370 Section VI. Technical Requirements the standard of the MHSD of the RK concerning interoperability of IS R 6.8 M System shall provide possibility of designing of approved medical form templates available within the solution itself which could be automated without programming or incorporating modifications to the program code. R 6.9 M System shall provide conflict resolution under parallel system object processing. 1.2.5 Requirements to user interface N type R 7 requirement Requirement to user interface R 7.1 M Interface shall be provided for prevailing use of mouse manipulator meaning that system control shall be using screen menu, buttons, icons and similar elements R 7.2 M Keyboard mode must be used mainly in filling in and/or editing text and numeric fields of screen forms. Also hot buttons must be provided for moving between fields to be filled in. R 7.3 M Ergonomic solutions and interface design must be uniform for all system components and modules as possible R 7.4 M System user interface must be multilingual ad organized with support of at least state (Kazakh) and Russian languages. Exclusions could be system messages which are not subject to localization or standard administrative applications included into system software R 7.5 M Access to electronic package of maintenance documentation must be available R 7.6 M Context sensitive reference system must be realized in the system, accessible from different web application pages where references to information must be provided (user guidebook, manual etc.), for work with possibility of configuration without engagement of potential supplier at the level of purchaser; R 7.7 M In the system user interface screen visual highlight of attributes must be provided for operator only for reading R 7.8 M In the system user interface screen visual highlight of attributes required for filling in must be provided R 7.9 M System shall provide correct processing of emergency situations caused by incorrect user actions, incorrect format or invalid entry Section VI. Technical Requirements 371 data. In the above mentioned cases the system must deliver corresponding messages to the user, then go back to operation mode, that preceded incorrect (inadmissible) command or incorrect data entry R 7.10 M System shall not allow for backup and reentry (incorrect entry) of uniform information. System shall ensure exclusion of backup and reentry of information contained in state database and information systems of state bodies R 7.11 M System shall provide format-logic control of data entry. Format logical control of entered data means control of format and content of entered data. During operation the system shall provide for protection from mis-actions: - selection of only user accessible functions according to access rights; - entry only user accessible values (according to access rights); - certain format data entry (for example, impossibility to enter symbol data into the date or number format fields). 1.3 Requirement to system interoperability № type requirement R 8 Requirement to system interoperability R 8.1 General requirements to system interoperability R 8.1.1 M System solutions and applications must comply with interoperability standards including to national standards and adopted international standards listed in this chapter (and in this document). R 8.1.2 M System components must comply with national semantic tools: o Reference books and classifiers o Requirements to reference book services o Requirements to registers and register services Details on requirements for these tools are given in this section below (R8.3) R 8.1.3 I Some of compatibility tools described below are in the process of development and last versions are provided to potential suppliers as requested. Main standards are given in website of the MHSD of the RK (Order №75 dated 10.02.2014 https://www.mzsr.gov.kz/node/319759 R 8.2 R 8.2.1 Compatibility with standards M System components must be compatible at least with the following standards of the MHSD of the RK: 371 372 Section VI. Technical Requirements 1) standards requirements to e-health record (requiring compliance with EN 13940) 2) standard requirements to e-medical record (requiring compliance with EN 13940) 3) standard requirements to identification of existing health parties, used in e-health systems 4) technical requirements to interoperability (message transfer) with e-health information systems 5) regulations for ensuring information security 6) Standard requirement’s to single classifier of drugs, medical supplies and medical equipment 7) Standard requirement’s to realization and regulation of edirections 8) Regulation for interaction of stakeholders to ensure interoperability of information systems and information flow management 9) Standard for regulation of e-receipts management 10) Standard for management of e-processes of diagnostic studies and cure procedures 11) Standard for regulation of e-preventing of diseases The mentioned standards and regulatory documents are available at https://www.mzsr.gov.kz/taxonomy/term/619 R 8.2.2 M System components must be compatible with the following international standards: a. EN 13940 (on the part of compliance with standards of EHR and EMR) b. HL7 v3 (ISO/HL7 27831) HL7 (v2 orV3 or FHIR); c. HL7 CDA (ISO/ HL7 27932) d. DICOM 8.2.3 M System shall comply with requirements of standards on information security: ST RK ISO/IEC 27001-2008 «methods and tools of ensuring safety of information security management system. Requirements»; ST RK ISO/IEC 27002-2009 «Information technology. Tools of assurance. Guidebook on information protection management». R 8.3 R 8.3.1 Requirements to compatibility with national identifiers and standard classifiers/reference books M System components must support and comply with requirements to national identifiers: - patient identifier Section VI. Technical Requirements 373 - health facility identifier - medical staff identifier - medical equipment identifier R 8.3.2 M System components must support and comply with requirements for at least under the following national classifiers and reference books: 1) national classifier of drugs and supplies (mapped to АТСDDD ) 2) medical service classifier (based on ICD-9, section on services etc) 3) lad testing results classifier 4) service and their cost classifier 5) diagnosis classifier (ICD-10) 6) PHC classifier (ICPC-2) 7) mapping ICPC-2 and ICD-10 8) SNOMED, only for coding of communication between System and EHR repository) 9) to manage diagnostic services enhanced classification system shall be defined at the later stage; 10) national DRG system for patient classification implemented by the MHSD of the RK (in providing specialized care); 11) classifier of target patient group registers (dispensary groups). 12) rater of medical services; 13) list of health specialties; 14) list of positions R 8.4 R 8.4.1 M System components must provide communication between the system and platform containing EHR repository based on the following data: - minimum set of data for EHR (given in Appendix to National EHR standard and national EMR standard) - other data, not covered by semantic standards, but required according to regulatory acts of the MHSD of the RK such as attached special records (documents based on CDA) R 8.4.2 M System must provide access to data stored in EHR repository according to 2 EHR types: full EHR, short EHR. Details are described in national EHR standard R 8.4.3 M Data are transferred between the system and EHR repository in CDA format R 8.4.4 M System shall provide data transfer to EHR repository based on ICPC-2 codes, which are used in visits (and in contacts in Requirements to compatibility/data conformity 373 374 Section VI. Technical Requirements general) and mapped to ICD-10 for the purpose of statistics collection. In information systems of EMR (except for EHR /PHC systems) specialists use ICD-10 for diagnosis coding, and mapping in reverse order is not mandatory but desirable. R 8.4.5 I Systems could have additional database and repositories required for full functionality (so called EMR in the context of MHSD of the RK, but they are stored separately from EHR repository database. EHR repository content is strictly regulated by the national EMR standard. R 8.4.6 M System shall be sufficiently public to provide interoperability with existing IS of the MHSD of the RK, applications and services R 8.5 R 8.5.1 M System shall interact with national HER system according to National standards of EHR and EMR R 8.5.2 M System shall support as minimum interoperability with the following e-health service sets: - EHR repository service; - reference information services; -registration and register services; -clinical nomenclature and data classification services; - Secure information exchange and message exchange services; - Identification and authentication services; - monitoring and audit for information exchange services R 8.5.3 M The system shall comply with at least the following IHE profiles: a) IHE infrastructure profiles: ATNA; Requirements to information exchange XDS.b; PDQ; PIX; R 8.5.4 M System shall ensure option of interaction/integration using at least the following protocols and specifications: a. Communication through SOAP (and message SOAP with application), REST, Message Transmission Optimization Mechanism; b. Support of standards and specifications of web services (WS-Security, WS-Addressing, WS-Reliable Messaging, WS-coordination, WS-Transaction, WS-Secure Conversation); Section VI. Technical Requirements 375 c. Compliance with XML (XML, XSL, ebXML, и др.); d. Support SSO and control of access through SAML v2, JWT; e. Support general standards such as HTTP, HTTPS, TCP/IP, (SSL v3) and TLS; f. Enable using WSDL, WADL; g. X.509; Digital signatures (EDS NAC RK). R 8.5.5 System shall support coding of at least UTF8. R 8.5.6 M System shall interact with platform services under speed of channel 1 Мb/s and response time not more than 100 ms R 8.6 M Intersystem communication R 8.6.1 M Interaction with IS of MHSD of the RK in receipt of date of health facilities, functional departments and health facility staff, as well as general reference information used in the IS MHSD of the RK РК R 8.6.2 M Interaction with IS of MHSD of the RK on receiving data about individuals who are dispensary registered R 8.6.3 Interaction with IS of MHSD of the RK on receiving data about individuals and their attachment, death (reason of death, date of death) R 8.6.4 Interaction with IS of MHSD of the RK on receiving information about patient staying in hospital (form № 066/у) R 8.6.5 System shall interact with platform services on the part of: transfer/receipt of notifications and other information to e-government service; sending SMS-notification and other messages through SMS service of mobile government system; sending e-letters to patients though single e-mail system; receiving information about power of attorney from state information system Unified notary information system; receiving information from information about registered visit at doctor; receiving minimum information about staff member. 375 376 Section VI. Technical Requirements 1.3.3 Accompanying information about technology of some issues 1.3.4 Use of national e-health resources and platform tools System shall be able to use national resources and published Kazakhstan e-health services. N Тype Requirement R 9 Use of national e-health resources and platform tools R 9.1 M System shall be able to function according to general e-health architecture (Fig 2) R 9.2 M System shall be able to use functionality and web services, published on national level for interaction with e-health resources. R 9.3 M System shall be able to use EHR repository national classifiers and indexes (as minimum main patient index, health facility department index, staff index, building index, address index, vehicle index, medical technique index), analytical storage and other national resources required for turnkey integration according to national standards (listed in MOH of the RK order №75 dated 10.02.2014) R 9.4 M System shall support local copies of national resources and be able synchronize them on a regular basis (according to adjustable schedule) or online. System shall contain only information concerning health facility operation. For example, main patient index must be contained locally only for the list of patients who receive care in that facility. 1.3.5 Interaction with parties involved into certification process № R 10 R 10.1 Тype I R 10.2 M R 10.3 M requirement Interaction with parties involved into certification process Contract related to supply of platform and national e-health resources is carried out with present contract in parallel. Supplier of platform will be provided with access to national e-health resources only after parallel contract will be implemented successfully. To ease parallel implementation it is necessary to synchronize/coordinate joint activities. Interaction of involved parties is described in Fig 3. Activities undertaken by supplier are described in 4th column “Private IT companies” System supplier must interact with supplier of platform, health facility and MHSD of the RK to test and certify interoperability with national resources and services. Supplier must coordinate interaction of involved parties according to Fig 3. Certification based on evaluation of implemented System compliance with requirements of R8.2. The Purchaser shall establish special Committee that jointly with the Platform Supplier and Supplier of this system shall make tests in line with Rule Book for compliance to Section VI. Technical Requirements R 10.4 M R 10.5 M R 10.6 M R 10.7 M 377 M interoperability requirements according to national standards including possibility for correct interaction of delivered system with national resources delivered within the Platform. At the stage of system design (activity 4.4) Supplier must comply with requirements of regulations for web service development” and requirements to interoperability with EHR repository provided by platform supplier. System supplier may request additional information if needed for development of interaction with e-health resources. At the stage of testing/certification (activity 4.6) system Supplier must comply with requirements of guidebook published by MOH of the RK e-health standardization unit The Supplier shall certify the System before its acceptance into operation In case of circumstances that hinder fulfillment of R10.6 occurred by no fault on the side of the Supplier, Acts of System acceptance shall be signed without certification. With it, System Supplier is bounded to certify the System when conditions for certifications have appeared, without any additional costs on the side of the Purchaser System shall provide option of functioning on remote infrastructure and in cloud (virtualized) operating environment I Contract related with supply of platform of health informatization and interoperability (hereinafter platform) is carried out in parallel with the present contract. R 10.8 R 10.9 R 10.10 M The system supplier shall be granted with access to national e-health resources only after parallel contract will be successfully realized. To ease parallel implementation it is necessary to synchronize/coordinate joint activities with platform supplier. In case of circumstances arisen that impede performance of requirements on interaction with the platform due to delay in Platform supply contract performance, system supplier is obliged to implement interaction when conditions will appear without additional costs on the side of the Purchaser. 377 378 Section VI. Technical Requirements Fig. 3. Interoperability of involved parties during the System implementation and certification. 1.4 Requirements to suppliers N Тype requirement R 11 Requirements to suppliers R 11.1 M Supplier will supply his own system (components or products constituting it) or he will be authorized by developer/owner of this Section VI. Technical Requirements R 11.2 M R 11.3 M R 11.4 M 379 system (components or products of its) for supply, development, installation, support of products according to this Contract. Supplier will train in the country of Client which is related to System use and administration, and also of all developed and installed products. Training languages will be Russian and Kazakh. Training details are given in R13.2. Supplier shall have office in Purchaser country or have a partner registered as a legal entity in the Purchaser country having an official status of a partner developer/supplier or having agreement about consortium in relation with this specific contract. It is required during realization, deployment, training and guaranteed period for smooth and reliable contract implementation. Supplier shall have his own project implementation team comprising at least the following specialists (if needed two positions may be taken by one specialist provided his skills will be proved but not more than 2 positions for a specialist): 1) business analyst, having work experience of at least 3 years in IT e-health projects and work experience in at least one similar project; 2) project management specialist (team leader), having at least 3 years of experience in project management and 1 year in the project when supplied solution was implemented and he should have project management certificate (for example, PMP or IPMI at least); 3) DBMS specialist with at least 3 years of work experience with DBMS; 4) specialists with work experience of at least 2 years with standards: HL7, DICOM, CDA (R2), IHE; 5) user interface designer, with at least 3 years of work experience; 6) technical writer, with work experience of at least 2 years; 7) specialist on communications, with work experience in this area of at least 3 years of general IT experience with excellent knowledge of English, Russian and Kazakh; 8) Specialist on testing, having at least 3 years of experience in software testing; 9) Specialist on training, having at least 3 years’ experience in carrying out training; All supposed specialists shall have higher education in IT or related areas, Master’s degree is preferred. Supplier shall provide a list of specialists with CV attached, certificates to provide work experience and qualification. R 11.5 M Supplier shall submit all documents (patents, licenses, certificates of state registration of rights to copyright, etc.) for System (for all components and products), demonstrating authorization of owners to 379 380 Section VI. Technical Requirements use products for this contract or demonstrating ownership rights. R 11.6 M Plan schedule of services provided must be agreed with authorized organization of the purchaser and signed by Purchaser within 20 (twenty) working days after signing the contract. Supplier must provide service in time according to approved plan schedule. R 11.7 I R 11.8 M R 11.9 M In case of participation of foreign companies consortium is the most appropriate form of participation in the tender (while it is not mandatory), since some requirements assume knowledge and skills which are not possessed by international suppliers like work experience in the country. Software manufacturers shall have certificates of Capability Maturity Model Integration (CMMI), ISO 9000 series, ST RK ISO 9001:2009 or equivalent for quality management processes (the Bidder shall submit copies of certificates for compliance issued by authorized body) Supplier shall ensure service and technical and guarantee support including provision of new product versions according to R13.3 and R13.4. R 11.10 M Supplier shall prepare corresponding guidelines for all system components in English, Kazakh and Russian. R 11.11 M Supplier shall have proven experience with standards used in the present document: HL7 (v2, V3, FHIR), CDA (R2), IHE. Section VI. Technical Requirements 381 C. Technical specifications 2.1. General technical requirements to the system N type Requirement R 12 General technical requirements to the system R 12.1 М System shall have centralized architecture and be developed in the form of web application where the client is browser and server is web-server. R 12.2 М Access to client application must be done though any of the following internet browsers: MS Internet Explorer, Google Chrome, Opera, Safari, Mozilla Firefox R 12.3 M System server part must support work of at least in operational systems of Windows family. R 12.4 M System client part must support work of at least in operational systems Windows (2008/VISTA/7/8) (x86/x64) R 12.5 M To store information in the system relational database shall be used. R 12.6 M System database must support standard SQL, compatible with ANSI/ISO/IEC 9075-1992 standard R 12.7 M Supplier shall provide maintenance and technical support including provision of new product versions until guaranteed period expiration R 12.8 System shall provide option of authentication using Single Sign On 2.2 service specification N Тype R 13 R 13.1 R 13.1.1 M R 13.1.2 M R R 13.2 13.2.1 M requirement Service Specification Requirement to inheritance of data and functionality. In case of system supply and implementation different from exploited by the client the performer carries out full complex of required works related to inheritance of data and functionality used IS modules by the client with connection to the system of software and automated technical means, medical and lab equipment used by the client. All costs related to data and functionality migration is incurred by the performer. Training and training materials Supplier shall prepare curriculum for training of the following: System users; System administrators; Developers; 381 382 Section VI. Technical Requirements Database administrators. Curriculum and training materials on each group shall be agreed with Purchaser before the training starts. Supplier shall provide equipment, presentation materials and textbooks for the training. System supplier shall provide training materials as guidelines, textbooks and presentations, knowledge bases in state language and Russian. Supplier shall carry out training for at least 80 hours for each group of system administrators, developers, database administrators and 20 hours for the users of each health facility, where system implementation takes place. Number of hours could be increased and must be sufficient for knowledge and skills transfer. Supplier shall carry out separate training for system users and administrators, developers, database administrators. Indicative number of trainees is defined by multiplication by 2 of total number of automated work places from Appendix 7. Place of training is legal address of health facility-beneficiary. Groups of trainees shall include not more than 10 specialists. For all carried out trainings, Supplier must carry out testing and issue certificates correspondingly. Training plan for group (а) – system users – shall contain detailed explanation of automated business processes, sue of all system components, detailed description of function and interactions between different users and roles; reporting and other required information. Training also will contain practice trainings for material understanding R 13.2.2 M R 13.2.3 M R 13.2.4 M R 13.2.5 M R 13.2.6 M R 13.2.7 M R 13.2.8 M Training plan for group (b) – system administrators - shall contain description of system components administration tools including important system maintenance issues and technical support aspects. R 13.2.9 M Supplier shall carry out one introductory course and one inservice training for group (c) developers on supplied development tools and components provided within this contract. R 13.2.10 M Supplier shall carry out for group (d) database administrators one introductory course and in-service training course on supplied DBMS. R 13.2.11 M Training for groups (a) - (d) shall be carried out in Russian or Kazakh at the Purchaser’s request. R 13.2.12 M For all carried out trainings, Supplier shall carry out corresponding testing and issue certificates. R 13.2.13 I The number stated above and duration of training are minimum requirements. Supplier at the Purchaser’s request can increase these figures (in hours) to reach adequate skills level for the staff Section VI. Technical Requirements R R 13.3 13.3.1 M R 13.3.2 M R R 13.4 13.4.1 M R 13.4.2 M R 13.4.3 M R 13.4.4 M R 13.4.5 M R 13.4.6 M R 13.4.7 M 383 without extra costs incurred by the Purchaser. During this stage of project preparation precise number of hours, groups and course content will be agreed with the Supplier. User support service Supplier shall organize user support service for consulting on issues arisen during exploitation for the whole period of guaranteed service implementation and maintenance. System technical support shall be organized by the Supplier 27/7 within 3 years upon the acceptance act agreed by the Purchaser. Guaranteed service System supplier will provide guaranteed service of the Purchaser within 3 years starting right after agreement by the Purchaser of the acceptance act. Supplier shall ensure resolution of issues: A) For critical problems related to system operation that has led to data damage, the problem shall be solved within at most 2 hours; B) For noncritical problems it is to be rectified within not more than 2 days. Guaranteed service includes but it is not limited by the following service categories: - correcting errors in the system; - help to the health facility in correct rectification of all problems with data arisen as a result of wrong application functions; - providing technical support in adjustment of applications or modifying default parameters; - providing required technical support to qualified staff and retraining if it is founded out that they could not solve their problems after received training; Forms of interference could be one of the following most appropriate from the perspective of quality and effectiveness: ○ Phone calls; ○ By e-mail; ○ Skype or other Video Messenger; ○ Remote access to user; ○ Work on site. Supplier must provide during guaranteed period a group of consultants available in Purchaser’s country including one manager and at least one technical specialist and provide all required specialists for remote assistance if needed. Total system idle time under reasons related to its operation shall be greater than 24 hours. One time system time out under reasons related to its operation shall not be greater than 2 hours. 383 384 Section VI. Technical Requirements 2.3. REQUIREMENTS TO DOCUMENTS N type requirement R 14 requirement to documents R 14.1 M Supplier is required to provide the following package of documents: ● Program and method of tests; ● formulary (main characteristics, kitting and deposit software maintenance information); ● description of most widespread mistakes and their mitigation ways; ● description of database structure; ● guideline for software installation; ● administrator guideline; ● user guideline. R 14.2 M Document languages shall be at least state and Russian languages. R 14.3 M Supplier shall provide 5 packages of documents in hard copy and electronic format in English, Kazakh and Russian. E-version shall support context search option. R 14.4 M Supplier shall prepare information system and regulatory documents to carry out attestation for compliance with requirements of information security according to article 5 of Law of the Republic of Kazakhstan of 11 January 2007 «On informatics» and Resolution of the Government of the Republic of Kazakhstan of 30 December 2009 № 2280 «On approving rules for carrying out attestation of state information systems and nongovernment information systems to be integrated with state information systems for compliance with requirements of information security and standards adopted in the territory of the Republic of Kazakhstan» and enter into force according to Article 17 of the Republic of Kazakhstan of 11 January 2007 “On informatics”. Section VI. Technical Requirements 385 D. TESTING AND REQUIREMENTS TO QUALITY GUARANTEE 3.1. SYSTEM TESTING AND REQUIREMENTS TO QUALITY GUARANTEE N type requirement 15 System testing and requirements to quality guarantee R R 15.1. Pre-starting works R 15.1.1 M System supplier shall carry out standard installation tests for testing correct system installation. R 15.1.2 M Supplier shall provide a list of tests, testing conditions, success criteria etc for system testing under technical proposal. R 15.1.3 I Quality of testing is one of criteria for technical evaluation. A list of tests will include tests for each module and tests for the whole system. R 15.1.4 M R 15.1.5 М R 15.1.6 М R 15.1.7 М R 15.1.8 M System supplier will carry out phased detailed testing including performance tests, response time test, capacity test, jointly with organization authorized by the purchaser according to tests provided by Supplier. Supplier shall demonstrate the system with participation of purchaser representatives and organization authorized by the Purchaser according to system testing scenarios. Supplier shall outline demonstration results in the minutes on demonstration under the form agreed with the Purchaser. Minutes must be signed by all demonstration participants. Venue of demonstration shall be agreed with Purchaser and organization authorized by the Purchaser. Supplier shall eliminate all remarks received during demonstrations and carry out repeated demonstrations until receiving minutes about successful demonstration. Timeframe for elimination of remarks is agreed with the Purchaser. Testing shall be carried out according to one of standards IEEE 829/1009, BS 7925, ISO/AS 9100 and developed document “testing programme and methodology» of ST RK 1089-2002. R 15.1.9 M Supplier shall test the system according to the Web Content Accessibility Guidelines 2.0. Supplier shall provide detailed information about testing results. R 15.1.10 M Supplier shall test system on safety according to Open Web Application Security Project) Top 10 vulnerability. Supplier shall provide detailed information about testing results. R 15.1.11 M Supplier shall agree with Purchaser a testing scenario and provide report on each testing result с Покупателем сценарий тестирования и предоставить отчёт по результату каждого тестирования. R R 15.2 15.2.1 M Acceptance to exploitation System acceptance act is signed based on trouble free operation 385 386 Section VI. Technical Requirements under normal conditions of exploitation for the system within 3 months. In case of the system malfunctioning in the period supplier shall incorporate all necessary modifications and carry out repeated system exploitation within 3 months. Operating errors are critical errors which do not allow to run the System R 15.2.2 M Supplier shall start all required work to eliminate defects or damages within 10 working days for non critical errors. For critical errors Supplier shall start work to eliminate damages or defects within 3 working days, ensure time record and report on progress record every hour during operation and guaranteed period. Critical errors: system does not work or it works unstable. Important functional component does not work or it is inaccessible. Data damage or interruption of main flow process. System component is inapplicable due to failure or incorrect functionality. Users could not perform any work. 3.2. Requirement to ensuring control by the Purchaser N Тype Requirement R 16 R 16.1 М Supplier shall periodically defined in the plan schedule provide regular progress report to the Purchaser. R 16.2 М Report shall contain information about work performed by the Supplier over reporting period, according to approved plan schedule including services on guaranteed support as well as on technical support service of suppliers with attachment of all approved documents over the reporting period during contract implementation including official correspondence in hard copy and electronic format (in at least pdf format). R 16.3 М Report shall be agreed with organization authorized by the purchaser. R 16.4 М Purchaser can carry out control of contract performance and quality of services under the contract by the Supplier in any time. requirement to ensuring control by the Purchaser Section VI. Technical Requirements 387 E. Implementation Schedule Implementation Schedule Table System, Subsystem, or lot number: procurement of lot 10 Line Item No. 10 Subsystem / Item Medical information system for registration of donors and recipients and individuals waiting for transplantation Configuration Table No. Site / Site Code Delivery (Bidder to specify in the Preliminary Project Plan) Installation (weeks from Effective Date) Acceptance (weeks from Effective Date) Liquidated Damages Milestone 41 54 Yes 387 388 Section VI. Technical Requirements System Inventory Table (Supply and Installation Cost Items) System, Subsystem, or lot number: Lot 10 Component No. 10 Component Medical information system for registration of donors and recipients and individuals waiting for transplantation Relevant Technical Specifications No. Additional Site Information (e.g., building, floor, department, etc.) Quantity 1 Section VI. Technical Requirements 389 Site Table(s) System, Subsystem, or lot number: Lot 10 Site Code 10 Site City / Town / Region Primary Street Address Republican coordination Center on transplantation Astana Almaty rayon, Sileti St, 30 Drawing Reference No. (if any) 389 390 Section VI. Technical Requirements Holidays and other days-off Month 2014 2015 1 2 3 1, 2, 7 1, 2, 7 8, 21, 22, 23 8, 21, 22, 23 1, 7, 9 1, 7, 9 6 30 6 30 16, 17 16, 17 4 5 6 7 8 9 10 11 12 Section VI. Technical Requirements 391 G. Technical Responsiveness Checklist Note to Bidders: The following Checklist is provided to help the Bidder organize and consistently present its Technical Bid. For each of the following Technical Requirements, the Bidder shall describe how its Technical Bid responds to each Requirement. In addition, the Bidder shall provide cross references to the relevant supporting information, if any, included in the bid. The cross reference should identify the relevant document(s), page number(s), and paragraph(s). The Technical Responsiveness Checklist does not supersede the rest of the Technical Requirements (or any other part of the Bidding Documents). If a requirement is not mentioned in the Checklist, that does not relieve the Bidder from the responsibility of including supporting evidence of compliance with that other requirement in its Technical Bid. One- or two-word responses (e.g. “Yes,” “No,” “Will comply,” etc.) are normally not sufficient to confirm technical responsiveness with Technical Requirements 391 Раздел VI. Технические требования (График реализации) Technical Responsiveness Checklist # Mandatory (M)/ Preferred (P) Description R1 General requirements business R1.1 Licensing mechanism for the M System under this contract shall provide the right to use all modules and compounds for a number of users, which allow full functioning of the Health Facility (approximate scope of Health Facilities is given in description of Appendix 17) for unlimited time, unlimited number of servers, and excluding any other possible limitations. Annual license fees are not admitted; full license cost includes all costs for system licensing. R1.2 Within this Contract an M interoperability of the System with national e-health system shall be ensured according to requirement R7. General interaction scheme with national e-health system is represented in Fig.1. R1.R1.3 Generalized comprehensive М health information system architecture the system shall Item # cross references to supportin Costs g required to informati ensure on on cost technical of compliance ensuring technical complianc e: Section VI. Technical Requirements 393 comply with is shown in Fig 2 R1.4 System shall be represented as a М web application R1.5 System shall have capability of М fine tuning to provide configuration for specific needs of concrete facility without necessity to develop new one (or including minor development) R1.6 Supplier under this Contract М shall ensure System interoperability with national EHR tools (EHR repository, national classifiers and identifiers, analytical storage, EHR web services) according to R8 R1.7 System shall ensure М confidentiality of personal data in the process of saving and sending: coding of confidentially data in database, data coding during transmission via channels, use of secure transmission protocols etc. R1.8 System shall ensure using a М digital signature for signing and authentication of e-documents, files and parts of documents. The need to use digital signature shall be configurable at the level of system administrator. R1.9 System shall be fully “turnkey” М operational according to R15.2. R1.10 The Supplier shall provide at М least, but not limited to 393 394 Section VI. Technical Requirements configuration, deployment, installation, testing of the System. The Supplier shall provide trainings for users and administrators (and other staff if needed) R1.11 Supplier shall participate in the М process of certification of the System jointly with Supplier of Platform to test and certify interoperability with national resources and EHR tools as well as participate in attestation and testing of the system R1.12 Supplier shall provide М guaranteed service of the system within 3 years from the date of the system operational acceptance by the Purchaser according to R13.4. R1.13 If additional licensed software М is required for the system turnkey operation the Supplier shall ensure availability of all licenses at the expense of Supplier and their transfer to the Purchaser’s ownership under this contract. R1.14 Minimum requirements for each М module must comply with requirements of section R2 R1.15 System shall have capabilities D of integration with development environment (IDE) at least for Java and Net framework. System shall have in a package development tools (SDK) including documents, examples of code for at least Java and Net Framework for configuration of system unction. An option of extending system functionality Section VI. Technical Requirements 395 shall be available using development tools (SDK) which are included into the system composition. R1.16 Licensing mechanism for the М system within this contract shall not restrict changes which are made using development tools (SDK) that are included into the system composition. Making changes using development tools (SDK) which are included into the system composition shall not have effect on guarantee service of the system. Making changes into the system by specialists of the Purchaser is allowed upon the system operational acceptance. R1.17 Supplier shall ensure service М and technical support including provision of new product versions (according to R13.3). R1.18 Service response tome and М system components response time shall not be more than 3-5 seconds for not least 80% of cases of data entry or inquiries for data view (under channel speed 1 Mb/s and response time not more than 100 ms). R1.19 Supplier shall document and М submit in electronic format configuration files, original code of system components developed within this contract. R1.20 System shall have thin client for М interaction with equipment it is allowed to use thick client. R2 Requirements to automated 395 396 Section VI. Technical Requirements processes R2.1 Module «Administration» R2.1.1 Adjustment of system user М accounts. This process includes as minimum: R2.1.1.1 Create user accounts M R2.1.1.2 Edit user accounts M R2.1.1.3 Delete user accounts M R2.1.2 Adjustment of system users’ М rights and strict designation of responsibilities based on regional and administrative criteria. This process includes as minimum: R2.1.2.1 Personalized designation of user M access rights R2.1.2.2 Designation of system user M rights based on roles, groups and access level with regard to hierarchy of objects and ownership to organizational structure R2.1.2.3 Edit user access rights M R2.1.2.4 Delete user access rights M R2.1.3 Configuration of criteria for М automatic selection of appropriate recipient from the waiting list. This process includes as minimum the following: R2.1.3.1 Edit (add/delete) criteria for M automatic selection of appropriate recipient from the Section VI. Technical Requirements 397 waiting list R2.1.3.2 Edit weight coefficients (score M points) of criteria for automatic selection of appropriate recipient from the waiting list R2.1.4 Configuration of М recipient/donor registration forms. This process includes as minimum the following: R2.1.4.1 Edit (add/delete fields, edit M existing fields) in the entry forms for registration of recipient/donors/individuals needed transplantation R2.1.4.2 Add/delete entry forms registration recipient/donor/individuals needed transplantation for M of R2.1.4.3 Use of the following functions M to create, edit the entry forms to register recipient/donor/individuals needed transplantation: Change in font setting (style, size, bold, underline, italic etc.) Change font color Create complicated entry forms with subsections Possibility of using any reference book in the system for filling in the field in the entry form Possibility of using any content in the database for filling in the field in the entry form Possibility of using any 397 398 Section VI. Technical Requirements sampling from the database for filling in the field in the entry form Setting rules for filling in the entry form: only from the list, from the list with possibility of add-in in a free form, from the sample etc. Create new reference books, used in filling in the entry form R2.1.5 Import data into the system М from at least xls, xml file formats. R2.1.6 System journal management. M This process includes as minimum the following: R2.1.7 Journal to create, change and M delete data in the database R2.1.8 Journal of user’s entry history R2.1.9 Journal of received reporting M forms R2.1.10 Journal of data view M M R2.1.11 Journal of data processing M (create, change, delete) R2.1.12 Journal of archive history M R2.1.13 Journal of program errors and M emergency shut down R2.1.14 Journal of synchronization with M external (national) reference books, classifiers, indexes and registers Section VI. Technical Requirements R2.1.15 Journal archiving 399 M R2.2 Module «Registration of an individual needed transplantation» R2.2.1 Registration in the «waiting М list» of an individual, needed transplantation according to Appendices 1-1, 1-2, 1-3 to the present technical specification. Possibility of registration of one patient in several waiting lists. This process includes as minimum the following: R2.2.1.1 Registration in the «waiting M list» of an individual needed transplantation according to the form of Appendix 1-1 to the present technical specification R2.2.1.2 Registration in the «waiting M list» of an individual needed liver transplantation according to the form of Appendix 1-2 to the present technical specification R2.2.1.3 Registration in the «waiting M list» of an individual needed kidney transplantation according to the form of Appendix 1-3 to the present technical specification R2.2.1.4 Registration of one patient in M several waiting lists (if necessary) R2.2.1.5 Possibility of printing patient M information according to Appendices 1-1, 1-2, 1-3 to the present technical specification. R2.2.1.6 Possibility of export patient M 399 400 Section VI. Technical Requirements information according to Appendices 1-1, 1-2, 1-3 to the present technical specification to at least pdf, xls, doc format documents. R2.2.2 Automated receipt of M information about necessity to be registered in the waiting list of an individual needed transplantation based on the information received from IS of the MHSD of the RK (this functionality shall be implemented as soon as required functionality of the stated above IS will be ready for interaction). This process includes as minimum the following: R2.2.2.1 Automated receipt of M information from IS of the MHSD of the RK about the necessity for the patient to be registered in the waiting list R2.2.2.2 Patient registration in the M waiting list according to Appendices 1-1, 1-2, 1-3 to the present technical specification based on information of IS of the MHSD of the RK R2.2.2.3 Registration of one patient in M several waiting lists (if necessary). R2.2.2.4 Possibility of printing patient M information according to Appendices 1-1, 1-2, 1-3 to the present technical specification. R2.2.2.5 Possibility of export patient M information according to Appendices 1-1, 1-2, 1-3 to the present technical specification Section VI. Technical Requirements 401 to at least pdf, xls, doc format documents. R2.2.3 Manage information about М current state of individual needed transplantation (improving or worsening of the course of the disease with regard to progress, development of complications, concomitant disease and other). This process includes as minimum the following: R2.2.3.1 Search of patient based on full M name, IIN, organ/part of organ and/or tissue, blood group, Rh and other criteria. R2.2.3.2 Manage information about M current state (improving or worsening of the course of the disease with regard to progress, development of complications, concomitant disease and other). R2.2.3.3 Store in the system of the M history of changes in the patient condition R2.2.3.4 View the history of changes in M the patient condition R2.2.3.5 Option to print information M about the patient condition. R2.2.3.6 Option to print the history of M changes in the patient condition. R2.2.3.7 Option to export information M about patient condition to at least pdf, xls, doc format documents. R2.2.3.8 Option to export the history of M changes in the patient condition 401 402 Section VI. Technical Requirements to at least pdf, xls, doc format documents. R2.2.4 Waiting list monitoring. This М process includes as minimum the following: R2.2.4.1 Search patient based on full M name, IIN, organ/part of organ and/or tissue, blood group, Rh and other criteria. R2.2.4.2 View waiting list (including M generation of daily information by regions about the number of adult and child patients, number of dropped from the waiting list with a reason indication, number of new cases). R2.2.4.3 Sort and filtrate the «waiting M list» based on patient full name, patient age, sex, date of patient entry to the waiting list, region, health facility, organ/tissue to be transplanted and another criterion. R2.2.4.4 Option to print the waiting list M (including filtrated and/or sorted). R2.2.4.5 Option to export the waiting list M (including filtrated and/or sorted) into at least pdf, xls, doc format documents. R2.3 Module «Inpatient transplantation coordinator» R2.3.1 Registration of possible donor М under a form according to Appendix 2 to the present technical specification. This process includes as minimum the following: Section VI. Technical Requirements 403 R2.3.1.1 Registration of possible donor M according to Appendix 2 to the present technical documentation R2.3.1.2 Manage possible results information about M donor examination R2.3.1.3 View of earlier registered M possible donors with possibility of sorting and filtration by patient age, sex, diagnosis, entry date and other criteria. R2.3.1.4 Possibility information donor. of about printing M possible R2.3.1.5 Possibility of export of possible M donor information into at least pdf, xls, doc format documents. R2.3.2 Registration of potential donors М under form according to Appendix 2 to present technical specification. This process includes as minimum the following: R2.3.2.1 Registration of potential donor М according to Appendix 2 to the present technical specification R2.3.2.2 Manage potential results information about М donor examination R2.3.2.3 View of earlier registered М potential donors with possibility of sorting and filtration based on patient age, sex, intensive therapy department admission date, tissue/organ to be extracted and other criteria. R2.3.2.4 Possibility of setting summary М 403 404 Section VI. Technical Requirements reporting forms of registered potential donors over a certain period of time R2.3.2.5 Possibility of printing summary M reporting forms of registered potential donors over certain period of time R2.3.2.6 Possibility of printing potential donor information R2.3.2.7 Possibility of export of М summary reporting forms of registered potential donors over a certain period of time into at least pdf, xls, doc format documents R2.3.2.8 Possibility of export of potential М donor information into at least pdf, xls, doc format documents R2.3.3 Registration of actual donor М under a form according to Appendix 2 to the present technical specification. This process includes as minimum the following: R2.3.3.1 Registration of actual donor М according to Appendix 2 to the present technical specification R2.3.3.2 Manage information about М actual donor examination results R2.3.3.3 View of earlier registered actual М donors with possibility of sorting and filtration based on patient full name, age, sex, organ/tissue, to be extracted and other criteria. R2.3.3.4 Setting summary reporting М Section VI. Technical Requirements 405 forms of registered actual donors over a certain time period R2.3.3.5 Possibility of printing summary М reporting forms of registered actual donors over certain time period R2.3.3.6 Possibility of printing М information about actual donor R2.3.3.7 Possibility of export of М summary reporting forms on registered actual donors into at least pdf, xls, doc format documents R2.3.3.8 Possibility of export of actual М donor information into at least pdf, xls, doc format documents R2.3.4 Manage information about М current objective donor status (possible, potential, actual) This process includes as minimum the following: R2.3.4.1 Manage information about M current objective donor status R2.3.4.2 View of donor objective status M change history R2.3.4.3 Possibility of information about objective status printing M donor R2.3.4.4 Possibility of printing donor M objective status change history R2.3.4.5 Possibility of exporting M information about donor objective status into at least pdf, xls, doc format documents. 405 406 Section VI. Technical Requirements R2.3.4.6 Possibility of export donor M objective status change history into at least pdf, xls, doc format documents. R2.4 Module «lab testing» R2.4.1 Managing performed lab testing М results including but not limited to the information about high, medium, low performance immunological tissue typing testing results of individuals recommended for transplantation and potential donors (form №410-10/у), information about individual cross match results of potential donors and individuals recommended for transplantation (form №41011/у), leucocyte antibodies testing results of candidates for transplantation (form №4109/у). This process includes as minimum the following: R2.4.1.1 Search of patient based on full M name, IIN, organ/part of organ and/or tissue, blood group, Rh and other criteria. R2.4.1.2 Manage performed lab testing M results including but not limited to the information about high, medium, low performance tissue immunological typing testing results of individuals recommended for transplantation and potential donors (form №410-10/у), information about individual cross match results of potential donors and individuals recommended for transplantation (form №41011/у), leucocyte antibodies Section VI. Technical Requirements 407 testing results of candidates for transplantation (form №4109/у). Entry of performed lab testing results R2.4.1.3 View earlier entered lab testing M results R2.4.1.4 Option of printing lab testing M results including but not limited to the information about high, medium, low performance tissue immunological typing molecular & serological testing results of individuals recommended for transplantation and potential donors (form №410-10/у), information about individual cross match testing results of potential donors and individuals recommended for transplantation (form №41011/у), leucocyte antibodies testing results of candidates for transplantation (form №4109/у). R2.4.1.5 Option of export lab testing M results into at least pdf, xls, doc format documents. R2.5 Module «regional transplantation coordinator» R2.5.1 Setting request to be dropped М from the waiting list with a reason indication (death, change of place of living, no need in transplantation, contradictions to transplantation etc). This process includes as minimum the following: R2.5.1.1 Entry request to be dropped M from the waiting list with a reason indication (death, change 407 408 Section VI. Technical Requirements of place of living, no need in transplantation, contradiction to transplantation, rejection to have transplantation etc.) R2.5.1.2 Edit/delete request to be M dropped from the waiting list which was not sent to the republican transplantation coordinator R2.5.1.3 Sending a request to be dropped M from the waiting list to the republican transplantation coordinator for consideration R2.5.1.4 Option of printing request to be M dropped from the waiting list. R2.5.1.5 Option of export the request to M be dropped from the waiting list into at least pdf, xls, doc format document. R2.5.2 Monitoring of donors (possible, М potential, actual, as well as voluntary). This process includes as minimum the following: R2.5.2.1 View a list of possible donors M with option of sorting and filtration based on patient age, sex, diagnosis, admission date, other criteria. R2.5.2.2 View a list of potential donors M with option of sorting and filtration based on patient age, sex, intensive therapy department admission date, tissue/organ to be extracted and other criteria. R2.5.2.3 View a list of actual donors M with possibility of sorting and Section VI. Technical Requirements 409 filtration based on patient full name, age, sex, organ/tissue to be extracted and other criteria. R2.5.2.4 View a list of voluntary donors M with option of sorting and filtration based on patient age, sex, registration date and other criteria. R2.5.2.5 Search patient based on full M name, IIN, organ/part of organ and/or tissue, blood group, Rh and other criteria. R2.5.2.6 View a list of individuals who M were dropped from the list of voluntary donors (rejection to donate, contradictions to donation, death and other reasons). R2.5.2.7 View possible change history donors list M R2.5.2.8 View potential change history donors list M R2.5.2.9 View actual donors list change M history R2.5.2.1 View voluntary donors 0 change history list M R2.5.2.1 Manage daily report data M 1 according to Appendix 6 to the present technical specification R2.5.2.1 Setting summary reporting M 2 forms for registered donors (possible, potential, actual) over certain time period R2.5.2.1 Setting summary reporting M 3 forms for registered voluntary 409 410 Section VI. Technical Requirements donors over certain time period R2.5.2.1 Option of printing summary M 4 reporting forms for registered donors (possible, potential, actual). R2.5.2.1 Option of printing summary M 5 reporting forms for registered voluntary donors. R2.5.2.1 Option to export summary M 6 reporting forms by registered donors (possible, potential, actual) into at least pdf, xls, doc format documents R2.5.2.1 Option to export summary M 7 reporting forms by registered voluntary donors into at least pdf, xls, doc format documents R2.5.2.1 Option to print summary M 8 reporting forms by registered donors (possible, potential, actual, voluntary). R2.5.2.1 Option to export information M 9 about registered donors (possible, potential, actual, voluntary) into at least pdf, xls, doc format documents R2.5.3 Registration of voluntary М lifetime donors (individuals who had agreed to extract one of their pair organs or part of organ/tissue) with possibility to check availability of notary certified consent/denial through interacting with state information system “Unified notary information system” via health informatization and interoperability platform according to Appendix 2-1 to Section VI. Technical Requirements 411 the present technical specification. This process includes as minimum the following: R2.5.3.1 Manage information voluntary lifetime donor on M R2.5.3.2 Selecting concrete recipient as a M voluntary lifetime donor (according to donor’s perception) R2.5.3.3 Checking the availability of M notary certified consent to be a donor through interacting with state information system “Unified notary information system” via health informatization and interoperability platform R2.5.3.4 Manage information on denial M to be a donor R2.5.3.5 Checking the availability of M notary certified denial to be a donor through interacting with state information system “Unified notary information system” via health informatization and interoperability platform R2.5.3.6 Option to print information on M voluntary lifetime donor. R2.5.3.7 Generating summary reporting M forms on registered voluntary donors over specific period of time R2.5.3.8 Option to print summary M reporting forms on registered voluntary donors 411 412 Section VI. Technical Requirements R2.5.3.9 Option to export summary M reporting forms on registered voluntary donors into at least pdf, xls, doc format documents. R2.5.3.1 generating summary reporting M 0 forms on registered denials to be donors over specific period of time R2.5.3.1 Option to print summary M 1 reporting forms on registered denial to be donors over specific period of time R2.5.3.1 Option to export summary M 2 reporting forms on registered denial to be donors into at least pdf, xls, doc format documents. R2.5.3.1 Option to export summary M 3 reporting forms on registered voluntary lifetime donors into at least pdf, xls, doc format documents. R2.5.4 Registration of voluntary М postmortal donors (individuals who had agreed with retrieval of their organ/part of organ and/or tissue after their death) with possibility to attach a scanned copy of notary certified consent/denial according to Appendix 2-1 to the present technical specification. This process includes as minimum the following: R2.5.4.1 Manage information about M voluntary postmortal donor R2.5.4.2 Selection of concrete recipient M as voluntary postmortal donor (according to donor perception) Section VI. Technical Requirements 413 R2.5.4.3 Attachment of scanned notary M certified copy of consent R2.5.4.4 Manage information denial to be donor about M R2.5.4.5 Attachment of scanned notary M certified copy of denial R2.5.4.6 Option to print information M about voluntary post mortal donor. R2.5.4.7 Option to export information on M voluntary postmortal donor into at least pdf, xls, doc format documents. R2.5.4.8 generating summary reporting M forms on registered voluntary donors over specific period of time R2.5.4.9 Option to print summary M reporting forms on registered voluntary donors R2.5.4.1 Option to export summary M 0 reporting forms on registered voluntary donors to at least pdf, xls, doc format documents. R2.5.4.1 Generating summary reporting M 1 forms on registered denials to be donors over specific period of time R2.5.4.1 Option to print summary M 2 reporting forms on registered denial to be donors over specific period of time R2.5.4.1 Option to export summary M 3 reporting forms on registered denial to be donors into at least 413 414 Section VI. Technical Requirements pdf, xls, doc. format documents R2.6 module Republican transplantation coordinator R2.6.1 Manage register of donors of М organs/part of organ and/or tissue (create, edit, delete, view) This process includes as minimum the following: R2.6.1.1 Manage information on donors M of organs/part of organ and/or tissue R2.6.1.2 Dropping a donor from the M register with reason indication R2.6.1.3 Searching patient by family M name, IIN, organ/part of organ and/or tissue, blood group, Rh etc. R2.6.1.4 Option to print information on M donors of organs/part of organ and/or tissue. R2.6.1.5 Option to export information on M donors of organs/part of organ and/or tissue into at least pdf, xls, doc format documents R2.6.1.6 Generating summary reporting M forms on registered donors of organs/part of organ and/or tissue R2.6.1.7 Option to print summary M reporting forms on registered donors of organs/part of organ and/or tissue R2.6.1.8 Option to export summary M reporting forms on registered donors of organs/part of organ and/or tissue into at least pdf, Section VI. Technical Requirements 415 xls, doc format documents R2.6.1.9 generating summary reporting M forms on donors of organs/part of organ and/or tissue dropped from the register R2.6.1.1 Option to print summary M 0 reporting forms on donors of organs/part of organ and/or tissue dropped from the register R2.6.1.1 Option to export summary M 1 reporting forms on donors of organs/part of organ and/or tissue dropped from the register to at least pdf, xls, doc format documents. R2.6.2 Manage waiting list (create, М edit, delete, view options). This process includes as minimum the following: R2.6.2.1 Manage the waiting list M R2.6.2.2 Reviewing request to be M dropped from the waiting list of regional transplantation coordinator R2.6.2.3 Dropping the patient from the M waiting list with reason indication R2.6.2.4 Option to print information M about individuals needed transplantation R2.6.2.5 Option to export information M about individuals needed transplantation into at least pdf, xls, doc format documents R2.6.2.6 Generating summary reporting M forms on registered individuals 415 416 Section VI. Technical Requirements needed transplantation specific period of time over R2.6.2.7 Option to print summary M reporting forms on registered individuals needed transplantation R2.6.2.8 Option to export summary M reporting forms on registered individuals needed organ/tissue transplantation over specific period of time into at least pdf, xls, doc format documents. R2.6.2.9 generating summary reporting M forms on patients dropped from the waiting list over specific period of time R2.6.2.1 Option to print summary M 0 reporting forms on patients dropped from the waiting list R2.6.2.1 Option to export summary M 1 reporting forms on patients dropped from the waiting list into at least pdf, xls, doc format documents. R2.6.3 Automated sending by e-mail of М reminder to carry out scheduled quarterly testing. This process includes as minimum the following: R2.6.3.1 Automated generation of a list M of patients for scheduled quarterly leucocytal antibodies testing, 10 days prior to the planned test date. R2.6.3.2 Automated sending by e-mail to M a candidate for transplantation of a reminder to carry out scheduled quarterly testing Section VI. Technical Requirements 417 upon 10 days prior to the planned test date. R2.6.3.3 Automated sending by e-mail of M a reminder to the regional and republican transplantation coordinator of lists of patients to carry out leucocytal antibodies testing 10 days prior to planned test date R2.6.4. Automated calculation of score М points to define a position in the waiting list based on criteria table according to Appendix 3 to the present technical specification. This process includes as minimum the following: R2.6.4.1 Automated calculation of score M points to define a position in the waiting list based on criteria table according to Appendix 3 to the present technical specification R2.6.4.2 Regular (at least once a day and M if actual donor is found) automated recalculation of score points to define position in the waiting list based on criteria table according to Appendix 3 to the present technical specification R2.6.5 Automated selection of the М group of potential recipients against donor. This process includes as minimum: R2.6.5.1 Searching donor by family M name, IIN, organ/part of organ and/or tissue, blood group, Rh etc. 417 418 Section VI. Technical Requirements R2.6.5.2 Automated selection of the M group of potential recipients against donor. R2.6.5.3 Option to print information M about individuals selected as potential recipients against donor. R2.6.5.4 Option to export information M about individuals selected as potential recipients against donor into at least pdf, xls, doc format documents. R2.6.6 Automated selection of the М group of potential recipients against donor with regard to several organs/tissues. This process includes as minimum: R2.6.6.1 Searching donor by family M name, IIN, organ/part of organ and/or tissue, blood group, Rh etc. R2.6.6.2 Automated selection of the M group of potential recipients against donor with regard to several organs/tissues. R2.6.6.3 Option to print information M about individuals selected as potential recipients against donor with regard to several organs/tissues R2.6.6.4 Option to export information M about individuals selected as potential recipients against donor with regard to several organs/tissues into at least pdf, xls, doc format documents. R2.6.7 Automated selection of the М group of donors against patient Section VI. Technical Requirements 419 needed transplantation. This process includes as minimum: R2.6.7.1 Searching patient by family M name, IIN, organ/part of organ and/or tissue, blood group, Rh and other or selection of a patient from the waiting list. R2.6.7.2 Automated selection of the M group of donors against patient needed transplantation. R2.6.7.3 Option to print information on M individuals selected as potential donors against the patient. R2.6.7.4 Option to export information M about individuals selected as potential donors against the patient into at least pdf, xls, doc format documents. R2.6.8 Automated selection of the М group of donors against the patient needed transplantation with regard to several organs/tissues. This process includes as minimum: R2.6.8.1 Searching patient by family M name, IIN, organ/part of organ and/or tissue, blood group, Rh and other or selection of a patient from the waiting list. R2.6.8.2 Automated selection of the M group of donors against patient needed transplantation with regard to several organs/tissues. R2.6.8.3 Option to print information M about individuals selected as potential donors against patient with regard to several organs/tissues. 419 420 Section VI. Technical Requirements R2.6.8.4 Option to export information M about individuals as potential donors against patient with regard to several organs/tissues into at least pdf, xls, doc format documents. R2.6.9 Manage information about М council of physicians’ decision about transplantation. This process includes as minimum: R2.6.9.1 Manage information about M council of physicians (participants, venue, date etc) R2.6.9.2 Manage council of physicians’ M decision about transplantation R2.6.9.3 Option to print information M about council of physicians and decision taken. R2.6.9.4 Option to export information M about council of physicians and decision taken into at least pdf, xls, doc format documents. R2.7 module brigade R2.7.1. Manage information on donor М organs and tissues withdrawn. This process includes as minimum: Transplantation R2.7.1.1 Manage information on donor M organs withdrawn R2.7.1.2 Manage information on donor M tissues withdrawn R2.7.1.3 Manage information on surgery M for organ withdrawal (health facility name, where the surgery was carried out, ICD-9 code, Section VI. Technical Requirements 421 information about anesthesia etc) R2.7.1.4 Option to print information M about donor organs and tissues withdrawn. R2.7.1.5 Option to print information M about surgery on organ withdrawn R2.7.1.6 Option to export information M about donor organs and tissues withdrawn into at least pdf, xls, doc format documents. R2.7.1.7 Option to export information M about surgery on organs withdrawn into at least pdf, xls, doc format documents. R2.7.1.8 generating summary reporting M forms on organs and tissues withdrawn over specific period of time R2.7.1.9 Option to print summary M reporting forms on organs and tissues withdrawn R2.7.1.1 Option to export summary M 0 reporting forms on organs and tissues withdrawn into at least pdf, xls, doc format documents. R2.7.1.1 Generating summary reporting M 1 forms on carried out surgery operations for organs/tissues withdrawn over specific time period R2.7.1.1 Option to print summary M 2 reporting forms on carried out surgery operations for organs/tissues withdrawn 421 422 Section VI. Technical Requirements R2.7.1.1 Option to export summary M 3 reporting forms on carried out surgery operations for donor organs/tissues withdrawn into at least pdf, xls, doc format documents. R2.7.2 Manage information on carried М out organ and tissue transplantation. This process includes as minimum: R2.7.2.1 Manage information on donor M organs/tissues transplanted to the recipient R2.7.2.2 Manage information on surgery M on organ transplantation (health facility name, where surgery operation was carried out, ICD9 code, information about anesthesia etc) R2.7.2.3 Manage information about pre M and post surgery operation period, immunosuppressive therapy, post surgery complications. R2.7.2.4 Option to print information M about donor tissue/organ transplanted to the recipient. R2.7.2.5 Option to print information M about surgery operation on organ transplantation R2.7.2.6 Option to export information M about donor organ/tissue transplanted to the recipient into at least pdf, xls, doc format documents R2.7.2.7 Option to export information M about surgery operation on organ transplantation to at least Section VI. Technical Requirements 423 pdf, xls, doc format documents R2.7.2.8 Generating summary reporting M forms on donor organs and tissues transplanted over specific time period R2.7.2.9 Option to print summary M reporting forms on donor organs and tissues transplanted over specific time period R2.7.2.1 Option to export summary M 0 reporting forms on donor organs and tissues transplanted over specific time period into at least pdf, xls, doc format documents R2.7.2.1 generating summary reporting M 1 forms on carried out operations for organ/tissue transplantation to the recipient over specific time period R2.7.2.1 Option to print summary M 2 reporting forms on carried out operations for organ/tissue transplantation to the recipient over specific time period R2.8 module “monitoring of the condition of individuals whom transplantation was carried out R2.8.1 Manage register of individuals М who were carried out with transplantation (create, edit, view). This process includes as minimum: R2.8.1.1 Manage information about M individuals who were carried out with transplantation R2.8.1.2 Monitoring of the condition of M 423 424 Section VI. Technical Requirements the donor from whom transplantation was performed. R2.8.1.3 Searching a patient by full M name, IIN, organ/part of organ and/or tissue transplanted, blood group, Rh and other. R2.8.1.4 Option to print information M about patients who were carried out with transplantation R2.8.1.5 Option to export information M about patients who were carried out with transplantation into at least pdf, xls, doc format documents. R2.8.2 Monitoring of patients who М were carried out with transplantation. This process includes as minimum: R2.8.2.1 Manage information about M patients who were carried out with transplantation R2.8.2.2 Manage the history of change in M the health status of the patients who were carried out with transplantation R2.8.2.3 Monitoring of the condition of M the individuals who were carried out transplantation from the same donor. R2.8.2.4 Viewing the history of change M in the health status of the patients who were carried out with transplantation with option to sort and filtrate by patient age, sex, registration date, organ which was transplanted and other criteria. Section VI. Technical Requirements 425 R2.8.2.5 Searching patient by full name, M IIN, transplanted organ/part of organ and/or tissue, blood group, Rh and other criteria. R2.8.2.6 Option to print information on M health status of the patients who were carried out with transplantation R2.8.2.7 Option to print history of M change in the health status of the patients who were carried out with transplantation R2.8.2.8 Option to export information M about patients who were carried out with transplantation into at least pdf, xls, doc format documents R2.8.2.9 Option to export history of M change in the health status of the patients who were carried out with transplantation into at least pdf, xls, doc format documents. R2.9 module Generating analytical and statistical tables R2.9.1 Report on carried out allogenic М relative transplantations (recipient, donor, and outcome family name list) R2.9.2 Report on carried out allogenic М non relative transplantations (recipient, donor, and outcome family name list) R2.9.3 Report on lethal outcomes of М patients included in the waiting list (by age, death reason, death date) 425 426 Section VI. Technical Requirements R2.9.4 Report on carried out М transplantation: information on retrieved organs, reasons for not performed selection, health facility where retrieval was carried out R2.9.5 Report on cases of statement of М potential donor brain circulation death/arrest (family name list, death date) R2.9.6 Monthly reports according to М Appendix 4-5 to the present technical specification R2.9.7 Daily report of regional М transplantation coordinator according to Appendix 6 to the present technical specification R2.9.8 All output forms shall have an М option to print out and save in at least xls, pdf, doc format. R3 Requirements to system configuration R3.1 Configuration facility needs R3.1.1 The System shall provide an М option to manage access to functionality based on roles. System shall enable add/delete/edit roles and designate/cancel access right to the system functionality. R3.1.2 System shall have preinstalled М roles according to 1.2.1. of the present technical specification with option of further adjustment (add, edit or delete new roles). to health Section VI. Technical Requirements R3.1.3 Access rights to different М system modules and functions must be preinstalled according to Table 1 with option to change access rights (add, delete) R3.1.4 Access right must be at least М configurable on the following aspects: all rights, create, change, delete, view. R3.1.5 System shall include master of M reporting forms, enabling to create and edit reports using fields from the system database R4 Requirements to system response time R4.1 Search of patient by full name M or IIN and patient related data (examination results, lab test results etc) shall not be more than 5 seconds for 80% of cases R4.2 Supplier during guaranteed М period of service shall ensure the following system performance parameters: R4.3 Total system shutdown time for М the reason related to its operability shall not be more than 24 hours per year. R4.4 One time system shutdown for М the reason related to its operability shall not be more than 2 hours. R5 Requirement to information security R5.1 Requirement of security are M 427 427 428 Section VI. Technical Requirements defined by existing law of the RK. System shall comply with information security requirements in terms of providing threshold access, protection from unsanctioned access etc. R5.2. Information protection from M unsanctioned access means shall be provided in the system namely: R5.2.1 User identification based on M user name (login) and password validation R5.2.2 Option to identify user based M on public key infrastructure digital certificates R5.2.3 User authorization for access to M system information resources, that require appropriate authorizations R5.2.4 Personified user right M determination for data management, fine-tuning, view R5.2.5 Personified user determination for resource access R5.2.6 Designation of system user M rights by roles, groups and access level with regard to object hierarchy and organizational structure ownership. R5.2.7 User work protocol M maintenance with System critical functions and applications right M system Section VI. Technical Requirements 429 R5.2.8 System file protection from M change/damage by unauthorized users and program processes R5.2.9 Control journal of all updates in M system program libraries shall be maintained R5.3 The following minimum M backup means shall be realized in the system: - automated backup with option of planning - remote control of backup creation - full and partial backup R5.4 System shall integrity. provide data M R5.5 System shall provide tools for M data confidentiality coding during storage and in the process of transfer to other systems. R5.6 Electronic digital signature M (hereinafter registration certificate of user by National Authorization Center of the Republic of Kazakhstan, EDS) shall be issued by NAC RK. The system shall provide the tools for digital signature of documents (objects) or portions of documents, when / if it is needed, and tools for signature authentication. This option shall be implemented in the system services (if necessary). To ensure EDS authenticity and public key validity, the System shall provide check for EDS authenticity using services of 429 430 Section VI. Technical Requirements NAC RK (http://pki.gov.kz/index.php/ru/ ). R5.7 System shall conform to the M “single access point” principle information structure architecture enabling to have single access point (Single Sign On) to all its components and resources, enabling to enter login and password once and get access to all system components without entering password once again. R5.8 System shall provide user M authorization in the System, designation of system user rights by roles, groups, access level with regard to object hierarchy and organizational structure ownership. R5.9 According to regulatory M documents on information security approved by the MHSD of the RK, the following shall be realized: − Password length shall not be less than 8 symbols, letters and numbers must be in upper and lower case; − Forced password change function; − Empty password lockout function; − User password self-change; − CAPTCHA be realized for incorrect password entry for 3 times; − All user actions log in journal for viewing history of all Section VI. Technical Requirements 431 system main events changed; − functionality of session interruption if inactive in N time period. R6 Requirements to quality attributes R6.1. System must support entry, M receipt and transfer of data required for work of IS of the MHSD of the RK used by health facility and avoid double data entry. R6.2 System shall ensure saving of all M accumulated information at the moment of shutdown or failure of any system component regardless its assignment, with follow-up recovery after repair and recovery work R6.3 System shall have option of soft M fine-tuning in changing environment and user specific tasks without replacing the modules. R6.4 System shall be highly scalable M and enabling operation of unlimited number of users. Restrictions can be conditioned only by hardware technical characteristics and not by the System characteristics R6.5 All system functional features M must be developed as services. R6.6 System web services must be M developed according to SOA architecture. system 431 432 Section VI. Technical Requirements R6.7 In realization of interoperability М services it is required to follow the standard of the MHSD of the RK concerning interoperability of IS R6.8 System shall provide possibility M of designing of approved medical form templates available within the solution itself which could be automated without programming or incorporating modifications to the program code. R6.9 System shall provide conflict M resolution under parallel system object processing. R7 Requirement to user interface R7.1 Interface shall be provided for M prevailing use of mouse manipulator meaning that system control shall be using screen menu, buttons, icons and similar elements R7.2 Keyboard mode must be used M mainly in filling in and/or editing text and numeric fields of screen forms. Also hot buttons must be provided for moving between fields to be filled in. R7.3 Ergonomic solutions and M interface design must be uniform for all system components and modules as possible R7.4 System user interface must be M multilingual ad organized with support of at least state (Kazakh) and Russian Section VI. Technical Requirements 433 languages. Exclusions could be system messages which are not subject to localization or standard administrative applications included into system software R7.5 Access to electronic package of M maintenance documentation must be available R7.6 Context sensitive reference M system must be realized in the system, accessible from different web application pages where references to information must be provided (user guidebook, manual etc.), for work with possibility of configuration without engagement of potential supplier at the level of purchaser; R7.7 In the system user interface M screen visual highlight of attributes must be provided for operator only for reading R7.8 In the system user interface M screen visual highlight of attributes required for filling in must be provided R7.9 System shall provide correct M processing of emergency situations caused by incorrect user actions, incorrect format or invalid entry data. In the above mentioned cases the system must deliver corresponding messages to the user, then go back to operation mode, that preceded incorrect (inadmissible) command or incorrect data entry 433 434 Section VI. Technical Requirements R7.10 System shall not allow for M backup and reentry (incorrect entry) of uniform information. System shall ensure exclusion of backup and reentry of information contained in state database and information systems of state bodies R7.11 System shall provide format- M logic control of data entry. Format logical control of entered data means control of format and content of entered data. During operation the system shall provide for protection from mis-actions: - selection of only user accessible functions according to access rights; - entry only user accessible values (according to access rights); - certain format data entry (for example, impossibility to enter symbol data into the date or number format fields). R8. Requirement to interoperability R8.1. General requirements system interoperability R8.1.1 System solutions and M applications must comply with interoperability standards including to national standards and adopted international standards listed in this chapter (and in this document). R8.1.2 System components must M comply with national semantic tools: o Reference books and classifiers system to Section VI. Technical Requirements 435 o Requirements to reference book services o Requirements to registers and register services Details on requirements for these tools are given in this section below (R8.3) R8.2 Some of compatibility tools M described below are in the process of development and last versions are provided to potential suppliers as requested. Main standards are given in website of the MHSD of the RK (Order №75 dated 10.02.2014 https://www.mzsr.gov.kz/node/ 319759 R8.2.1 Compatibility with standards M R8.2.2 System components must be M compatible at least with the following standards of the MHSD of the RK: 1) standards requirements to ehealth record (requiring compliance with EN 13940) 2) standard requirements to emedical record (requiring compliance with EN 13940) 3) standard requirements to identification of existing health parties, used in e-health systems 4) technical requirements to interoperability (message transfer) with e-health information systems 5) regulations for ensuring information security 6) Standard requirement’s to single classifier of drugs, medical supplies and medical equipment 7) Standard requirement’s to realization and regulation of e435 436 Section VI. Technical Requirements directions 8) Regulation for interaction of stakeholders to ensure interoperability of information systems and information flow management 9) Standard for regulation of ereceipts management 10) Standard for management of e-processes of diagnostic studies and cure procedures 11) Standard for regulation of epreventing of diseases The mentioned standards and regulatory documents are available at https://www.mzsr.gov.kz/taxon omy/term/619 R8.2.3 System components must be M compatible with the following international standards: e. EN 13940 (on the part of compliance with standards of EHR and EMR) f. HL7 v3 (ISO/HL7 27831) HL7 (v2 orV3 or FHIR); g. HL7 CDA (ISO/ HL7 27932) h. DICOM R8.3 System shall comply with M requirements of standards on information security: ST RK ISO/IEC 270012008 «methods and tools of ensuring safety of information security management system. Requirements»; ST RK ISO/IEC 270022009 «Information technology. Tools of assurance. Guidebook Section VI. Technical Requirements 437 on information protection management». R8.3.1 Requirements to compatibility M with national identifiers and standard classifiers/reference books R8.3.2 System components must M support and comply with requirements to national identifiers: - patient identifier - health facility identifier - medical staff identifier - medical equipment identifier R8.4 System components must M support and comply with requirements for at least under the following national classifiers and reference books: 1) national classifier of drugs and supplies (mapped to АТСDDD ) 2) medical service classifier (based on ICD-9, section on services etc) 3) lad testing results classifier 4) service and their cost classifier 5) diagnosis classifier (ICD-10) 6) PHC classifier (ICPC-2) 7) mapping ICPC-2 and ICD-10 8) SNOMED, only for coding of communication between System and EHR repository) 9) to manage diagnostic services enhanced classification system shall be defined at the later stage; 10) national DRG system for patient classification implemented by the MHSD of the RK (in providing specialized care); 11) classifier of target patient 437 438 Section VI. Technical Requirements group registers (dispensary groups). 12) rater of medical services; 13) list of health specialties; 14) list of positions R8.4.1 Requirements to M compatibility/data conformity R8.4.2 System components must M provide communication between the system and platform containing EHR repository based on the following data: - minimum set of data for EHR (given in Appendix to National EHR standard and national EMR standard) - other data, not covered by semantic standards, but required according to regulatory acts of the MHSD of the RK such as attached special records (documents based on CDA) R8.4.3 System must provide access to M data stored in EHR repository according to 2 EHR types: full EHR, short EHR. Details are described in national EHR standard R8.4.4 Data are transferred between the M system and EHR repository in CDA format R8.4.6 System shall provide data M transfer to EHR repository based on ICPC-2 codes, which are used in visits (and in contacts in general) and mapped to ICD-10 for the purpose of statistics collection. In information systems of EMR (except for EHR /PHC systems) specialists use ICD-10 for diagnosis coding, and mapping Section VI. Technical Requirements in reverse order is mandatory but desirable. 439 not R8.5 Systems could have additional M database and repositories required for full functionality (so called EMR in the context of MHSD of the RK, but they are stored separately from EHR repository database. EHR repository content is strictly regulated by the national EMR standard. R8.5.1 System shall be sufficiently M public to provide interoperability with existing IS of the MHSD of the RK, applications and services R8.5.2 Requirements to information M exchange R8.5.3 System shall interact with M national HER system according to National standards of EHR and EMR R8.5.4 System shall support as M minimum interoperability with the following e-health service sets: - EHR repository service; reference information services; -registration and register services; -clinical nomenclature and data classification services; - Secure information exchange and message exchange services; Identification and authentication services; - monitoring and audit for information exchange services R8.5.5 The system shall comply with at M least the following IHE profiles: b) IHE infrastructure 439 440 Section VI. Technical Requirements profiles: ATNA; XDS.b; PDQ; PIX; R8.5.6 System shall ensure option of М interaction/integration using at least the following protocols and specifications: h. Communication through SOAP (and message SOAP with application), REST, Message Transmission Optimization Mechanism; i. Support of standards and specifications of web services (WS-Security, WS-Addressing, WSReliable Messaging, WS-coordination, WSTransaction, WS-Secure Conversation); j. Compliance with XML (XML, XSL, ebXML, и др.); k. Support control through JWT; SSO and of access SAML v2, l. Support general standards such as HTTP, HTTPS, TCP/IP, (SSL v3) and TLS; m. Enable using WSDL, WADL; n. X.509; Digital signatures (EDS NAC RK). Section VI. Technical Requirements 441 R8.6 System shall support coding of M at least UTF8. R8.6.1 System shall interact with M platform services under speed of channel 1 Мb/s and response time not more than 100 ms R8.6.2 Intersystem communication R8.6.3 Interaction with IS of MHSD of M the RK in receipt of date of health facilities, functional departments and health facility staff, as well as general reference information used in the IS MHSD of the RK РК R8.6.4 Interaction with IS of MHSD of M the RK on receiving data about individuals who are dispensary registered R8.6.5 Interaction with IS of MHSD of M the RK on receiving data about individuals and their attachment, death (reason of death, date of death) R9 Use of national e-health resources and platform tools R9.1 System shall be able to function M according to general e-health architecture (Fig 2) R9.2 System shall be able to use M functionality and web services, published on national level for interaction with e-health resources. R9.3 System shall be able to use M EHR repository national classifiers and indexes (as minimum main patient index, health facility department index, M 441 442 Section VI. Technical Requirements staff index, building index, address index, vehicle index, medical technique index), analytical storage and other national resources required for turnkey integration according to national standards (listed in MOH of the RK order №75 dated 10.02.2014) R9.4 System shall support local M copies of national resources and be able synchronize them on a regular basis (according to adjustable schedule) or online. System shall contain only information concerning health facility operation. For example, main patient index must be contained locally only for the list of patients who receive care in that facility. R10 Interaction with parties involved into certification process R10.2 Contract related to supply of M platform and national e-health resources is carried out with present contract in parallel. Supplier of platform will be provided with access to national e-health resources only after parallel contract will be implemented successfully. To ease parallel implementation it is necessary to synchronize/coordinate joint activities. Interaction of involved parties is described in Fig 3. Activities undertaken by supplier are described in 4th column “Private IT companies” R10.3 System supplier must interact M with supplier of platform, health facility and MHSD of the RK to test and certify interoperability Section VI. Technical Requirements 443 with national resources and services. R10.4 Supplier must coordinate M interaction of involved parties according to Fig 3. Certification based on evaluation of implemented System compliance with requirements of R8.2. The Purchaser shall establish special Committee that jointly with the Platform Supplier and Supplier of this system shall make tests in line with Rule Book for compliance to interoperability requirements according to national standards including possibility for correct interaction of delivered system with national resources delivered within the Platform. R10.5 At the stage of system design M (activity 4.4) Supplier must comply with requirements of regulations for web service development” and requirements to interoperability with EHR repository provided by platform supplier. System supplier may request additional information if needed for development of interaction with e-health resources. R10.6 At the stage of M testing/certification (activity 4.6) system Supplier must comply with requirements of guidebook published by MOH of the RK e-health standardization unit R10.7 The Supplier shall certify the M System before its acceptance into operation R10.8 In case of circumstances that M hinder fulfillment of R10.6 443 444 Section VI. Technical Requirements occurred by no fault on the side of the Supplier, Acts of System acceptance shall be signed without certification. With it, System Supplier is bounded to certify the System when conditions for certifications have appeared, without any additional costs on the side of the Purchaser R10.10 System shall provide option of M functioning on remote infrastructure and in cloud (virtualized) operating environment R11 Requirements to suppliers R11.1 Supplier will supply his own M system (components or products constituting it) or he will be authorized by developer/owner of this system (components or products of its) for supply, development, installation, support of products according to this Contract. R11.2 Supplier will train in the M country of Client which is related to System use and administration, and also of all developed and installed products. Training languages will be Russian and Kazakh. Training details are given in R13.2. R11.3 Supplier shall have office in M Purchaser country or have a partner registered as a legal entity in the Purchaser country having an official status of a partner developer/supplier or having agreement about consortium in relation with this specific contract. It is required Section VI. Technical Requirements 445 during realization, deployment, training and guaranteed period for smooth and reliable contract implementation. R11.4 Supplier shall have his own M project implementation team comprising at least the following specialists (if needed two positions may be taken by one specialist provided his skills will be proved but not more than 2 positions for a specialist): 1) business analyst, having work experience of at least 3 years in IT e-health projects and work experience in at least one similar project; 2) project management specialist (team leader), having at least 3 years of experience in project management and 1 year in the project when supplied solution was implemented and he should have project management certificate (for example, PMP or IPMI at least); 3) DBMS specialist with at least 3 years of work experience with DBMS; 4) specialists with work experience of at least 2 years with standards: HL7, DICOM, CDA (R2), IHE; 5) user interface designer, with at least 3 years of work experience; 6) technical writer, with work experience of at least 2 years; 7) specialist on communications, with work experience in this area of at least 3 years of general IT experience with excellent 445 446 Section VI. Technical Requirements knowledge of English, Russian and Kazakh; 8) Specialist on testing, having at least 3 years of experience in software testing; 9) Specialist on training, having at least 3 years’ experience in carrying out training; All supposed specialists shall have higher education in IT or related areas, Master’s degree is preferred. Supplier shall provide a list of specialists with CV attached, certificates to provide work experience and qualification. R11.5 Supplier shall submit all M documents (patents, licenses, certificates of state registration of rights to copyright, etc.) for System (for all components and products), demonstrating authorization of owners to use products for this contract or demonstrating ownership rights. R11.6 Plan schedule of services M provided must be agreed with authorized organization of the purchaser and signed by Purchaser within 20 (twenty) working days after signing the contract. Supplier must provide service in time according to approved plan schedule. R11.7 In case of participation of M foreign companies consortium is the most appropriate form of participation in the tender (while it is not mandatory), since some requirements assume knowledge and skills which are not possessed by international suppliers like work Section VI. Technical Requirements 447 experience in the country. R11.8 Software manufacturers shall M have certificates of Capability Maturity Model Integration (CMMI), ISO 9000 series, ST RK ISO 9001:2009 or equivalent for quality management processes (the Bidder shall submit copies of certificates for compliance issued by authorized body) R11.9 Supplier shall ensure service M and technical and guarantee support including provision of new product versions according to R13.3 and R13.4. R11.10 Supplier shall prepare M corresponding guidelines for all system components in English, Kazakh and Russian. R11.11 Supplier shall have proven M experience with standards used in the present document: HL7 (v2, V3, FHIR), CDA (R2), IHE. R12 General technical requirements to the system R12.1 System shall have centralized М architecture and be developed in the form of web application where the client is browser and server is web-server. R12.2 Access to client application М must be done though any of the following internet browsers: MS Internet Explorer, Google Chrome, Opera, Safari, Mozilla Firefox R12.3 System server part must support M work of at least in operational 447 448 Section VI. Technical Requirements systems of Windows family. R12.4 System client part must support M work of at least in operational systems Windows (2008/VISTA/7/8) (x86/x64) R12.5 To store information in the M system relational database shall be used. R12.6 System database must support M standard SQL, compatible with ANSI/ISO/IEC 9075-1992 standard R12.7 Supplier shall provide M maintenance and technical support including provision of new product versions until guaranteed period expiration R12.8 System shall provide option of M authentication using Single Sign On R13 Service Specification R13.1 Requirement to inheritance of data and functionality. R13.1.1 In case of system supply and M implementation different from exploited by the client the performer carries out full complex of required works related to inheritance of data and functionality used IS modules by the client with connection to the system of software and automated technical means, medical and lab equipment used by the client. R13.1.2 All costs related to data and M functionality migration is incurred by the performer. Section VI. Technical Requirements R13.2 Training materials and 449 training R13.2.1 Supplier shall prepare M curriculum for training of the following: System users; System administrators; Developers; Database administrators. Curriculum and training materials on each group shall be agreed with Purchaser before the training starts. R13.2.2 Supplier shall provide M equipment, presentation materials and textbooks for the training. R13.2.3 System supplier shall provide M training materials as guidelines, textbooks and presentations, knowledge bases in state language and Russian. R13.2.4 Supplier shall carry out training M for at least 80 hours for each group of system administrators, developers, database administrators and 20 hours for the users of each health facility, where system implementation takes place. Number of hours could be increased and must be sufficient for knowledge and skills transfer. R13.2.5 Supplier shall carry out separate M training for system users and administrators, developers, database administrators. Indicative number of trainees is defined by multiplication by 2 of total number of automated work places from Appendix 7. Place of training is legal address of health facility-beneficiary. Groups of trainees shall include 449 450 Section VI. Technical Requirements not more than 10 specialists. R13.2.6 For all carried out trainings, M Supplier must carry out testing and issue certificates correspondingly. R13.2.7 Training plan for group (а) – M system users – shall contain detailed explanation of automated business processes, sue of all system components, detailed description of function and interactions between different users and roles; reporting and other required information. Training also will contain practice trainings for material understanding R13.2.8 Training plan for group (b) – M system administrators - shall contain description of system components administration tools including important system maintenance issues and technical support aspects. R13.2.9 Supplier shall carry out one M introductory course and one inservice training for group (c) developers on supplied development tools and components provided within this contract. R13.2.1 Supplier shall carry out for M 0 group (d) database administrators one introductory course and in-service training course on supplied DBMS. R13.2.1 Training for groups (a) - (d) M 1 shall be carried out in Russian or Kazakh at the Purchaser’s request. Section VI. Technical Requirements 451 R13.2.1 For all carried out trainings, M 2 Supplier shall carry out corresponding testing and issue certificates. R13.3. User support service R13.3.1 Supplier shall organize user M support service for consulting on issues arisen during exploitation for the whole period of guaranteed service implementation and maintenance. R13.3.2 System technical support shall M be organized by the Supplier 27/7 within 3 years upon the acceptance act agreed by the Purchaser. R13.4. Guaranteed service R13.4.1 System supplier will provide M guaranteed service of the Purchaser within 3 years starting right after agreement by the Purchaser of the acceptance act. R13.4.2 Supplier shall ensure resolution M of issues: C) or critical problems related to system operation that has led to data damage, the problem shall be solved within at most 2 hours; D) or noncritical problems it is to be rectified within not more than 2 days. F F R13.4.3 Guaranteed service includes but M it is not limited by the following service categories: 451 452 Section VI. Technical Requirements - correcting errors in the system; - help to the health facility in correct rectification of all problems with data arisen as a result of wrong application functions; - providing technical support in adjustment of applications or modifying default parameters; - providing required technical support to qualified staff and retraining if it is founded out that they could not solve their problems after received training; R13.4.4 Forms of interference could be M one of the following most appropriate from the perspective of quality and effectiveness: ○ Phone calls; ○ By e-mail; ○ Skype or other Video Messenger; ○ Remote access to user; ○ Work on site. R13.4.5 Supplier must provide during M guaranteed period a group of consultants available in Purchaser’s country including one manager and at least one technical specialist and provide all required specialists for remote assistance if needed. R13.4.6 Total system idle time under M reasons related to its operation shall be greater than 24 hours. R13.4.7 One time system time out under M Section VI. Technical Requirements 453 reasons related to its operation shall not be greater than 2 hours R14 requirement to documents R14.1 Supplier is required to provide M the following package of documents: ● Program and method of tests; ● formulary (main characteristics, kitting and deposit software maintenance information); ● description of most widespread mistakes and their mitigation ways; ● description of database structure; ● guideline for software installation; ● administrator guideline; ● user guideline. R14.2 Document languages shall be at M least state and Russian languages. R14.3 Supplier shall provide 5 M packages of documents in hard copy and electronic format in English, Kazakh and Russian. E-version shall support context search option. R14.4 Supplier shall prepare M information system and regulatory documents to carry out attestation for compliance with requirements of information security according to article 5 of Law of the Republic of Kazakhstan of 11 January 2007 «On informatics» and Resolution of the Government of the Republic of 453 454 Section VI. Technical Requirements Kazakhstan of 30 December 2009 № 2280 «On approving rules for carrying out attestation of state information systems and nongovernment information systems to be integrated with state information systems for compliance with requirements of information security and standards adopted in the territory of the Republic of Kazakhstan» and enter into force according to Article 17 of the Republic of Kazakhstan of 11 January 2007 “On informatics”. R15 System testing requirements to guarantee R15.1 Pre-starting works and quality R15.1.1 System supplier shall carry out M standard installation tests for testing correct system installation. R15.1.2 Supplier shall provide a list of M tests, testing conditions, success criteria etc for system testing under technical proposal. R15.1.4 Quality of testing is one of M criteria for technical evaluation. A list of tests will include tests for each module and tests for the whole system. R15.1.5 System supplier will carry out М phased detailed testing including performance tests, response time test, capacity test, jointly with organization authorized by the purchaser according to tests provided by Supplier. Section VI. Technical Requirements 455 R15.1.6 Supplier shall demonstrate the М system with participation of purchaser representatives and organization authorized by the Purchaser according to system testing scenarios. R15.1.7 Supplier shall outline М demonstration results in the minutes on demonstration under the form agreed with the Purchaser. Minutes must be signed by all demonstration participants. Venue of demonstration shall be agreed with Purchaser and organization authorized by the Purchaser. R15.1.8 Supplier shall eliminate all М remarks received during demonstrations and carry out repeated demonstrations until receiving minutes about successful demonstration. Timeframe for elimination of remarks is agreed with the Purchaser. R15.1.9 Testing shall be carried out М according to one of standards IEEE 829/1009, BS 7925, ISO/AS 9100 and developed document “testing programme and methodology» of ST RK 1089-2002. R15.1.1 Supplier shall test the system М 0 according to the Web Content Accessibility Guidelines 2.0. Supplier shall provide detailed information about testing results. R15.1.1 Supplier shall test system on М 1 safety according to Open Web Application Security Project) Top 10 vulnerability. Supplier 455 456 Section VI. Technical Requirements shall provide information about results. R15.2 detailed testing Supplier shall agree with Purchaser a testing scenario and provide report on each testing result. R15.2.1 Acceptance to exploitation M R15.2.2 System acceptance act is signed M based on trouble free operation under normal conditions of exploitation for the system within 3 months. In case of the system malfunctioning in the period supplier shall incorporate all necessary modifications and carry out repeated system exploitation within 3 months. Operating errors are critical errors which do not allow to run the System R16 requirement to ensuring control by the Purchaser R16.1 Supplier shall periodically М defined in the plan schedule provide regular progress report to the Purchaser. R16.2 Report shall contain М information about work performed by the Supplier over reporting period, according to approved plan schedule including services on guaranteed support as well as on technical support service of suppliers with attachment of all approved documents over the reporting period during contract implementation including official correspondence in hard copy and electronic format (in at least pdf format). Section VI. Technical Requirements R16.3 Report shall be agreed with М organization authorized by the purchaser. R16.4 Purchaser can carry out control М of contract performance and quality of services under the contract by the Supplier in any time. 457 457 458 Section VI. Technical Requirements H. APPENDICES Appendix 1 On republican coordination transplantation center 1. Entity «Republican transplantation coordination center” established to implement plan of activities of the state health development program “Salamatti Kazakhstan” for 2011-2015, approved by decree of government of the Republic of Kazakhstan dated 29 January 2011 № 41, to organize effective activities on predtransplantation preparation including on retrieving and distribution of tissues and (or) organs (part of organs) into state health facilities, performing activity on specialty “transplantology” according to license. 2. In present document the following main definitions are used: 1) Transplantation coordination – organization of activities on receiving and managing information about presence of potential donors and recipients as well as retrieving conservation and distribution and transportation of tissues and (or) organs (part of organs) into transplantation centers after receiving donor recipient matching results; 2) Transplantation center – health facility, performing activity on specialty “transplantology” according to licenses; 3) Donor inpatient facility – health facility, in which retrieval of tissues and (or) organs (parts of organs) from cadaveric donor is done; 4) Brigade on retrieving organs – group of specialists on retrieving tissues and (or) organs (part of organs) by surgery operation from cadaveric donor to transplant; 5) Recipient waiting list – information database about recipients needed transplantation of tissue and (or) organs (part of parts); 6) Register of donors of tissues and (or) organs (part of organs) – information database about persons expressed their lifetime consent for retrieval after their death of tissue and (or) organs (part of organs) to transplant; 7) HLA-typing – blood test to detect human leucocyte antigens; 8) Cross matching reaction – measuring the level of recipient blood antibodies and antigens located on the surface of potential donor blood cells. Corss typing of donor lymphocytes and recipient blood serum. 3. In its work RCCT is governed by Constitutions of the Republic of Kazakhstan, code of the RK “On people’s health and health system”, regulatory leal acts of the RK. Main RCCT tasks and functions 1. Main RCCT task is to provide and conduct operative activities on creating effective tissues and (or) organs (part of organs) donorship system in Kazakhstan to transplant and save lives as well as recover health of citizens, prevention of illegal trade with tissues and (or) organs (part of organs) of human being. 2. Main RCCT functions are as follows: 1) Ensuring quick and high standard tissues and (or) organs (part of organs) transplantation process form the moment of finding potential donor to organ transplantation from this donor to the recipient; 2) Coordination of activities on retrieving, conservation, distribution and of Section VI. Technical Requirements 459 tissues and transportation of (or) organs (part of organs) for transplantation to transplantation centers; 3) Organization of training of persons performing transplantation coordination as well as medical staff of donor inpatient facilities on issues of law of Kazakhstan in the area of transplantology, donor management, communication with relatives of potential donor, human death statement based on irreversible brain death; 4) Management and updating of recipient waiting list as well as register of donors of tissues and (or) organs (part of organs); 5) Monitoring of using donor tissues and (or) organs (part of organs) in transplantation centers, including registration and analysis of complications and side effects; 6) Participation in organization and implementation of information programs in mass media, interaction with representatives of religious confessions on tissues and (or) organs (part of organs) donorship advocacy among population of the RK; 7) Interaction with public bodies, NGOs and international organizations on issues of donorship and tissues and (or) organs (part of organs) transplantation in the RK; 8) Submission of proposals to the authorized body in the area of health on refining legal acts in the area of tissues and (or) organs (part of organs) transplantation; 9) Preparation and carrying out republican seminars, symposiums, conferences, as well as participation in republican and international conferences on issues of organ donorship and tissues and (or) organs (part of organs) transplantation. RCCT organization 3. RCCT organizes its activity according to layout of health facility interaction on tissues and (or) organs (part of organs) transplantation, according to annex 4 to the order № 199 dated 29.03.2013 «on activities to develop tissues and organs transplantation service in the RK» (with amendments and additions on 13.08.2013.) 4. RCCT interacts with donor inpatient facilities in part of organization of surgery extraction of tissue and (or) organs (part of organs) from cadaveric donor and transplantation bodies on carrying out tissues and (or) organs (part of organs) transplantation to the recipient, as well as provide emergency run-out of brigade on organ extraction. 5. Republican coordination center of air ambulance provides timely transportation by brigade of organ extraction as well as tissues and (or) organs (part of organs) on emergency call received by RCCT. 6. RCCT is closely interacts with health facilities performing their activity in blood service on issues of carrying out HLA-typing, cross matching of donors’ tissues and (or) organs (part of organs) and the recipients as well as with infection control lab. 7. Transplantation coordination is carried out by RCCT staff having medical education functions of which are: 1) Receiving from regional transplantation coordinator primary information about availability of potential donor in certain donor inpatient facility; 2) Making decision jointly with regional transplantation coordinator about character of tissues and (or) organs (part of organs) extraction from cadaveric donor; 3) Informing of transplantation centers about possibility and character of extraction of tissues and (or) organs (part of organs) extraction from cadaveric donor; 4) Distribution (before extraction) of tissues and (or) organs (part of organs) and selection of the recipients with regard to HLA- typing and cross matching of “donorrecipient” reaction; 5) Organization of call and sending organ extraction brigade to donor inpatient 459 460 Section VI. Technical Requirements facility; 6) Organization of recipient call for tissues and (or) organs (part of organs) transplantation if needed organization of his clinical lab diagnostics; 7) Management and updating recipient waiting list and register of tissue and (or) organs (part of organs) donors; 8) Management of time study from the moment of extraction of donor tissues and (or) organs (part of organs) up to recipient transplantation. 8. Heads of donor inpatient facilities provide 24/7 information delivery to the RCCT on available donors through regional transplantation coordinators. 9. Medical staff performing regional transplantation coordination functions, are the following: 1) Detection of potential donor of tissues and (or) organs (part of organs) under close coordination with staff of anesthesiology/resuscitation, neurology, neurosurgery department etc.; 2) Interaction with spouse, close relatives or potential donor law representatives to receive consent for extraction of tissues and (or) organs (part of organs) for follow-up transplantation to the recipients; 3) Timely delivery of information by phone to the RCCT about possibility of tissues and (or) organs (part of organs) extraction from cadaveric donor under receiving consent of his close relatives; 4) Information delivery to the donor inpatient facility or person in charge of availability of potential donor and possibility of tissues and (or) organs (part of organs) extraction for follow-up transplantation to the recipients; 5) Ensuring participation of forensic pathologist and (or) pathologist during extraction of tissues and (or) organs (part of organs) from cadaveric donor; 6) Organization of sending biological material of potential donor tissue and (or) organs (part of organs) to lab for detection of transfusion infections (HIV, HVB HVC, syphilis, cytomegalovirus), as well as for HLA-typing and cross matching; 7) Management of statistical reporting on donor for extraction of tissue and (or) organs (part of organs). 10. Transplantation centers provide monitoring of recipient condition before and after surgery intervention as well as their timely examination. 11. In transplantation centers surgery brigades for extraction of organs working around the clock are set. 12. RCCT is governed by official with professional medical education having certificate of specialist on “social hygiene and health organization”, designated for the position and resigned from the post based on agreement with health authorized body. 13. Head of RCCT performs the following functions: 1) Ensures realization of RCCT functions set by present provisions; 2) Submits quarterly report on RCCT performance to health authorized body of the RK; 3) Performs other functions provided by legislation of the RK. 14. Transplantation coordination is done around the clock. 15. Regional RCCT branches are established in oblast centers and/or republican status cities where there are more than one state health facility carrying out transplantation according to license. 16. RCCT funding is done at the expense of republican budget. Section VI. Technical Requirements 461 Recommended staffing and material technical base of RCCT 17. The following staffing is recommended: 2 deputy director, 5 republican transplantation coordinators, 16 regional transplantation coordinators, 64 inpatient transplantation coordinators, lawyer, system administrator and auxiliary services. 18. Recommended material technical base: Donor inpatient facilities National scientific surgery center of A.N.Syzganov JSC Almaty city Transplantation centers Republican scientific production center of transfusiology Republican scientific emergency care center JSC Astana city Republican scientific neurosurgery center JSC Astana city Republican scientific emergency care center JSC Astana city National scientific surgery center of A.N.Syzganov JSC Almaty city Republican coordination center on transplantation National scientific cardiosurgery center JSC Astana GBE Municipal clinical hospital #7 Almaty National scientific medical center JSC Astana National scientific medical center JSC Astana National scientific cardiosurgery center JSC Astana Health facilities of oblasts, Almaty and Astana cities providing inpatient care (as agreed) Republican coordination center on sanitary aiviation National scientific center of maternity and childhood JSC Astanа RGE Scientific center of pediatrics and child surgery, Almaty Fig. А1. Interaction of health facilities on transplantation of tissue and (or) organs (part of organs) in the RK 461 462 Section VI. Technical Requirements Appendix 1-1 INDIVIDUAL NEEDED HEART TRANSPLANTATION REGISTRATION FORM Reg. №. _______ «___»__________201__. IIN Family name Name Father’s name Health facility name Information about cardiologist of the patient attached Post Office tel. Mobile tel. e-mail General information about patient IIN nationality Date of birth (dd/mm/yyyy) Sex Age Registration date Urgency status Social status: 1 – employee, 2 - worker, 3 – agriculture worker, 4 - retired, 5 - student, 6 - housekeeper, 7 – individual self-employed, 8 – minister of religion, 9 - unemployed, 10 - other. Family name Name Father’s name Benefit category: disabled world war II veteran - 1, world war II veteran - 2, Afghanistan war soldier - 3, disabled from childhood - 4, disabled due to disease - 5, individuals imposed to radiation - 6, individuals same as world war II veteran – 7, draftee - 8, disabled from professional occupation - 9, migrants - 10, other - 99. oblast Patient contact details Mobile tel. Residence tel. Office tel. Patient address information Registration address rayon Community name street building apt oblast Residence address Community name street building apt Family name name e-mail rayon Section VI. Technical Requirements Mobile tel Residence tel 463 Office tel e-mail Patient examination information diagnosis (main) name ICD-10 code Additional diagnosis №. ICD-10 code Blood group Rh factor RW HIV Serum sampling date A B А А A* B* ELISA IgM ToxoIgM HBsAg HBcAg HBeAg HCV total EBV IgM HSV IgM Ао мах LV мах PA мах* name height weight BMI BSA Control date of the next serum sampling HLA-typing (medium resolution) Cw Dw HLA-typing by serologic method (medium resolution) В Cw HLA-typing by molecular method (medium resolution) В DRB1 HLA-typing (high resolution) DRB1* DRQB1* % sensibilization serology CMV IgG toxoplasmosis ToxoIgG Hepatitis В aHBs aHBcIgG aHBcIgM Hepatitis C aHCVIgM aHCVIgG EBV EBV IgM Simple herpes virus HSV IgG CVP sampling Ао min Ао med LV min LV EDP PA min PA med 463 464 RVмах RA мах VCI мах BP syst SatO2 PVR (Wood)* HR EDV Creatinine Total bilirubin GPT INR TSH Т4 св Hb platelet creatinine НЛА, сенсит % ДЛА мах* Section VI. Technical Requirements RV min RA min VCI min RV med RA med VCI med BP diast SatO2 RA CO* ДЗЛК cardiogram EDD LVEF Lab tests urea Direct bilirubin AST glucose Т3 св Thyroperoxidase antibodies Leucocytes ProBNP urea LVEF % PVR (W) Note Section VI. Technical Requirements 465 Appendix 1-2 INDIVIDUAL NEEDED LIVER TRANSPLANTATION REGISTRATION FORM Reg. №. _______ «___»__________201__. Physician information position Office tel Mobile tel e-mail IIN Family name Name Father’s name Health facility name General patient information IIN nationality Date of birth (dd/mm/yyyy) Age Urgency level Family name Name Father’s name sex Health facility admission Death date Death reason Health facility attached Social status: 1 – employee, 2 - worker, 3 – agriculture worker, 4 retired, 5 - student, 6 - housekeeper, 7 – individual self-employed, 8 – minister of religion, 9 - unemployed, 10 - other. Benefit category: disabled world war II veteran - 1, world war II veteran - 2, Afghanistan war soldier - 3, disabled from childhood 4, disabled due to disease - 5, individuals imposed to radiation - 6, individuals same as world war II veteran – 7, draftee - 8, disabled from professional occupation - 9, migrants - 10, other - 99. Patient contact person Mobile tel Res.tel Office tel. Patient address information Registration address Family name name e-mail oblast rayon Name of community street buil ding apt street Buil ding apt Residence address oblast rayon Name of community 465 466 Section VI. Technical Requirements Mobile tel Resid.tel Office tel e-mail Patient examination information Diagnosis a basis for transplantation Diagnosis of liver failure name ICD-10 code name ICD-10 code Additional diagnoses №. ICD-10 code Blood group Rh factor abdominal circumference RW HIV PRA level (%) by ELISA method PRA level (%) by serology method Specificity of PAG 1 class HLA by ELISA method name height weight Chest circumference Varicose veins of esophagus Virus hepatitis markers VH vaccination Date of Blood test for PRA level (%) by ELISA Date of blood test for PRA (%) level by serology method Total bilirubin (mcmol/l) HLA-typing by serology method (medium resolution) B Cw HLA-typing by molecular method (medium resolution) A B DRB1 Cross matching Cross matching Sample date Donor IIN A Transplantation center Reserve transplantation center Expected transplantation (from alive person and cadaver) supposed donor Transplantation information transplantation Donor IIN Transplantation date Health facility name, where transplantation was done Section VI. Technical Requirements 467 467 468 Section VI. Technical Requirements Appendix 1-3 INDIVIDUAL NEEDED KIDNEY TRANSPLANTATION REGISTRATION FORM Reg. №. _______ «___»__________201__. Physician name position Office tel Mobile tel e-mail IIN Family name name Father’s name Health facility name Patient general information IIN nationality Date of birth (dd/mm/yyyy) age Urgency level Family name name Father’s name sex Health facility registration date Outpatient facility Hemodialysis start date attached Death date Death reason Health facility the patient is attached Social status: 1 – employee, 2 - worker, 3 – agriculture worker, 4 retired, 5 - student, 6 - housekeeper, 7 – individual self-employed, 8 – minister of religion, 9 - unemployed, 10 - other. Benefit category: disabled world war II veteran - 1, world war II veteran - 2, Afghanistan war soldier - 3, disabled from childhood 4, disabled due to disease - 5, individuals imposed to radiation - 6, individuals same as world war II veteran – 7, draftee - 8, disabled from professional occupation - 9, migrants - 10, other - 99. Patient contact person Mobile tel Residence tel Office tel Patient address information Registration address Family name name e-mail oblast rayon Community name Residence address street buil ding apartment Section VI. Technical Requirements oblast rayon Mobile tel Residence tel 469 Community name street buil ding apartment Office tel e-mail Patient examination information diagnosis (basis for transplantation) diagnosis (main is the reason for transplantation) name ICD-10 code name ICD-10 code Additional diagnosis №. ICD-10 code Blood group Rh RW HIV PRA (%) byELISA PRA (%) by serology method name height weight Virus hepatitis marker VH vaccination Blood sample for determination of PRA (%) by ELISA Blood sample for determination of PRA (%) by serology method Specificity of PAG class HLA by ELISA HLA-typing by serology method (medium resolution) A B Cw HLA-typing by molecular method (medium resolution) A B DRB1 Cross matching Cross matching Sample date IIN of supposed donor Supposed transplantation center Reserve transplantation center Supposed transplantation (from alive and cadaver) Supposed donor Transplantation information Transplantation type IIN donor Transplantation date Health facility name, where transplantation was done 469 470 Section VI. Technical Requirements Section VI. Technical Requirements 471 Appendix 2 DONOR REGISTRATION FORM Reg. №. _______ «___»__________201__. Information about person filling in form position Office tel Mobile tel e-mail IIN Family name Name Father’s name Health facility name Possible donor sex age № disease history Birth date (dd/mm/yyyy) Admission date (dd/mm/yyyy) Diagnosis main name ICD-10 code Additional diagnosis № ICD-10 code name note (including cadaver, patient moved to department, relatives’ denial etc.) Potential donor RITU admission date Period of stay in RITU Blood group Rh Death/irreversible circulation arrest statement date Conditioning Consent of relatives for extraction of organs/lifetime consent note (including cadaver, patient moved to department, relatives’ denial etc.) List of organs/tissues to be retrieved № name note Actual donor name Father’s name IIN Family name note (including cadaver, moved to department, relatives’ denial etc.) List of organs/tissues to be retrieved № name note 471 472 Section VI. Technical Requirements Section VI. Technical Requirements 473 Appendix 2-1 VOLUNTARY DONOR REGISTRATION FORM Reg. №. _______ «___»__________201__. Information about applicant position Office tel Mobile tel e-mail IIN Family name Name Father’s name Health facility name patient general information IIN nationality Date of birth (dd/mm/yyyy) age Family name name Father’s name sex Attached health facility Social status: 1 – employee, 2 - worker, 3 – agriculture worker, 4 retired, 5 - student, 6 - housekeeper, 7 – individual self-employed, 8 – minister of religion, 9 - unemployed, 10 - other. Benefit category: disabled world war II veteran - 1, world war II veteran - 2, Afghanistan war soldier - 3, disabled from childhood 4, disabled due to disease - 5, individuals imposed to radiation - 6, individuals same as world war II veteran – 7, draftee - 8, disabled from professional occupation - 9, migrants - 10, other - 99. Document identifying person Document (passport, # Issued by identity card) Valid until Patient contact person Mobile tel Residence tel Office tel Patient address information Registration address Family name name e-mail oblast Issued when rayon Community name street buil ding apartment street buil ding apartment Residence address oblast rayon Community name 473 474 Section VI. Technical Requirements Mobile tel Residence tel Office tel e-mail Patient examination information* Blood group height Rh weight RW Virus hepatitis markers HIV VH vaccination information HLA-typing by serology method (medium resolution) A B Cw HLA-typing by molecular method (medium resolution) A B DRB1 Cross matching Cross matching Sampling date IIN of proposed recipient Registration date Death date Type of consent for using organs/part of organs and/or tissues** (consent for lifetime use for relative with indication of concrete person, consent for lifetime use to any of the patients from health facility, consent for post mortal use to any of persons from health facility) List of organs/part of organs and/or tissues Transplantation type organs/part of organs and/or IIN of proposed recipient tissues note *scanned copy of discharge to be attached, it is issued not later than 1 month from the registration date and containing the following information: − height − weight − blood group − rhesus − absence of cancer disease; − absence of active TB; − determination of blood group and rhesus крови based on ABO − total blood count test − total urine count test − total protein, Alpha and gamma globulin count Section VI. Technical Requirements − − − − − − − − − − − − − − − − − − − − − − − − − − − − − − − − − − − − − − − − − − − − − 475 albumin test bilirubin test creatinine test glucose test urea test albumin test, Ca, Mg, P determination of GGT active determination of ALP active determination of blood electrolyte concentration ( К,Na, Ca, Cl) Determination of acid base condition parameters Determination of ALT active Determination of AST Determination of alpha amylase Determination of lipid spectrum hemostasis testing: aPPT, AST, determination of activated partial tromboplastin time, protrombin time, international normalized ratio, thrombin time, determination of fibrinogen concentration and soluble fibrin monomeric complex, d-dimers, antitrombin III, protein «С» and «S», if agents available. ELISA anti CMV (IgM+G)$,if agents available. ELISA for HIV markers (antiHIV and HIV Ag); HLA typing 1 class (HLA-A,B) and II class (HLA-DR); Testing for preceding HLA antibodies ELISA for HBsAg and summary antibodies to core-antigen HBV; (PCR) for HBV-DNA (if positive HBsAg); ELISA for antibodies to HBc Ig class М and summary Ig (if positive HBsAg); ELISA for HBeAg (if positive HBsAg); ELISA for anti-HBe (if positive HBsAg); ELISA for Anti-HDV IgM,G (if positive HBsAg); PCR for HDV-DNA (if positive ELISA for anti-HDV); ELISA for anti-HCV; for HCV-RNA (if positive ELISA for anti-HCV); ELISA for EBV IgM;} ELISA for EBV IgG;} if agents available ELISA for CMV IgM;} ELISA for CMV IgG;} ELISA for HIV-Ag and ELISA for anti-HIV; ELISA for HIV-RNA if positive ELISA for anti-HIV Complex serology reactions for syphilis (anti-T/pallidum, RW) Bacteriological testing of mucous membrane of fauces, nose and vagina; urine; faeces ( for salmonella, shigella, stap.auresus , fungus), sputum if present. electrocardiograph (ECG) chest x-ray heart ultrasound (echocardiography) abdominal cavity organs ultrasound spirography (as indicated) chest cavity organs x-ray fiberoptic gastroduodenoscopy (ФГДС) retrograde or MR cholangiography (if indicated) colonoscopy (if indicated) 475 476 Section VI. Technical Requirements − multidetector computer tomography КТ-64)- three phased angiographic study of abdominal cavity organs − chest CT (if indicated) − brain CT − determination of oncomarker- alpha fetoprotein (AFP) − determination of oncomarker СА-19-9 − determination of cancer embryonal antigen (CEA) − determination of prostate specific antigen (if indicated) − Doppler of kidney and liver − Liver biopsy − Diagnostics of enzyme defect − Determination of anti mitochondrial antibodies (АМА М2) − Determination of antinuclear antibodies (ANA) − Determination of anti neutrophil antibodies (ANCA) − Determination of antibodies to liver and kidney microsomes (anti LKM-1), if agents available − Glucose tolerance test ( if indicated) − Physician consultation} − Cardiologist consultation} if these specialists are available in hospital − Gastroenterologist consultation} − otorhinolaryngologist consultation − physiotherapist consultation − consultation of infectious disease physician, if these specialists is available in hospital − immunology specialist consultation − hematology specialist consultation − endocrinologist consultation − surgeon and transplantologist consultation − anaesthesiologist consultation **scanned copy of notary certified written expression of will shall be attached Section VI. Technical Requirements 477 Appendix 3 Table of criteria for selection of potential recipient from the waiting list criterion Score points 9 points for 100% compatibility under А,В,Cw,DRB1 HLA-compatibility 7 points for 100% compatibility under В or DRB1 5 points for non-compatibility under one of antigens В or DRB1 2 points for non-compatibility under two of antigens В or DRB1 Pre-existing antibodies age 4 points for over 80% and negative cross matching sample 4 points to the patient younger than 40 years 3 points to the patient in the age of 41 to 63 According to council of physicians urgency Keeping other conditions the same priority is given to the region population living in the area of concrete transplantation center 1 point for compatible blood group of the patient with the longest waiting period Waiting time 1 extra point for every consecutive year of being in waiting list 1 extra point, if the patient was organ donor in the past 477 *PDR **DER ***TCER note Transplantation coordination efficiency ratio *** Donorship efficiency ratio ** Potential donorship ratio* Number of carried out non-relative transplantation Number of carried out relative transplantation Number of actual donors Number of potential donors Number of possible donors Total number of cadaver in RITU Number of cadaver in resuscitation and intensive therapy unit over the 1-7-th day period Health facility name 478 Section VI. Technical Requirements Appendix 4 Coordinating physician’s monthly report Potential donorship ratio (ratio of cadaver people over the 1-7th-day period to the total number of cadaver in RITU*100) Donorship efficiency ratio (ration of actual donors to the number of cadaver donors over the 1-7-th day period*100) Transplantation coordination efficiency ratio (DER to PDR ratio) total: Number of deaths Number of r allogenic pancreas transplantation, pancreatic islet Number of allogenic heart transplantation Number of non relative allogenic liver transplantation Number of relative allogenic liver transplantation Number of non relative allogenic kidney transplantation Number of relative allogenic kidney transplantation Health facility legal name region Section VI. Technical Requirements 479 Appendix 5 Report on allogenic organ transplantation 479 № List of ex planted organs Organ ex plantation date age IIN Blood group and rhesus factor Period of staying in resuscitation and intensive thrapy dpt conditioning Consent of relatives for extraction organs lifetime consent Family name sex age Diagnosis (ICD code) admission date age diagnosis (ICD code № disease history Health facility name (legal name) 480 Section VI. Technical Requirements Appendix 6 Regional transplantation coordinator daily report POSSIBLE POTENTIAL donor ACTUAL donor donor note (including the cadaver, moved to department , denial of relatives etc.) Раздел VI. Технические требования (График реализации) Appendix 7 Estimated number of system users by modules breakdown № Requirement 1 Module «Registration of an individual needed transplantation» – 133 users. 2 Module «Inpatient transplantation coordinator» – 19 users 3 Module «lab testing» – 2 users 4 Module «regional transplantation coordinator» – 16 users 5 module Republican transplantation coordinator – 6 users 6 module Transplantation brigade – 10 users 7 module “monitoring of the condition of individuals whom transplantation was carried out – 21 users 8 module Generating analytical and statistical tables – 21 users 9 Мodule «Administration» – 3 users 482 Section VI. Technical Requirements Section VII. Sample Forms 483 SECTION VII. SAMPLE FORMS Notes to Bidders on working with the Sample Forms The Purchaser has prepared the forms in this section of the Bidding Documents to suit the specific requirements of the System being procured. They are derived from the forms contained in the World Bank’s Standard Bidding Documents for the Supply and Installation of Information Systems. In its bid, the Bidder must use these forms (or forms that present in the same sequence substantially the same information). Bidders should not introduce changes without the Purchaser’s prior written consent (which may also require the clearance of the World Bank). If the Bidder has a question regarding the meaning or appropriateness of the contents or format of the forms and/or the instructions contained in them, these questions should be brought to the Purchaser’s attention as soon as possible during the bid clarification process, either at the pre-bid meeting or by addressing them to the Purchaser in writing pursuant to ITB Clause 10. The Purchaser has tried to provide explanatory text and instructions to help the Bidder prepare the forms accurately and completely. The instructions that appear directly on the forms themselves are indicated by use of typographical aides such as italicized text within square brackets as is shown in the following example taken from the Bid Submission Form: Duly authorized to sign this bid for and on behalf of [ insert: name of Bidder ] In preparing its bid, the Bidder must ensure all such information is provided and that the typographical aides are removed. The sample forms provide a standard set of documents that support the procurement process as it moves forward from the stage of bidding, through Contract formation and onto Contract performance. The first set of forms must be completed and submitted as part of the bid prior to the deadline for bid submission. These include: (i) the Bid Submission Form; (ii) the Price Schedules; (iii) the Manufacturer’s Authorizations and key Subcontractor agreements; (iv) the List of Proposed Subcontractors; (v) the form(s) for securing the bid (if and as required); and other forms as found in sub-sections 1 through 4 of this Section VII of the Bidding Documents. Bid Submission Form: In addition to being the place where official confirmation of the bid price, the currency breakdown, the completion date(s), and other important Contract details are expressed, the Bid Submission Form is also used by the Bidder to confirm - in case adjudication applies in this Contract - its acceptance of the Purchaser’s proposed Adjudicator, or to propose an alternative. If the bid is being submitted on behalf of a Joint Venture, it is essential that the Bid Submission Form be signed by the partner in charge and that it be supported by the authorizations and power of attorney required pursuant to ITB Clause 6.2. Given widespread concern about illegal use of licensed software, Bidders will be asked to certify in the Bid Submission Form that either the Software included in the bid was developed and is 483 484 Section VII. Sample Forms owned by the Bidder, or, if not, the Software is covered by valid licenses with the proprietor of the Software. Price Schedules: The prices quoted in the Price Schedules should constitute full and fair compensation for supply, installation, and achieving Operational Acceptance of the System as described in the Technical Requirements based on the Implementation Schedule, and the terms and conditions of the proposed Contract as set forth in the Bidding Documents. Prices should be given for each line item provided in the Schedules, with costs carefully aggregated first at the Subsystem level and then for the entire System. If the Price Schedules provide only a summary breakdown of items and components, or do not cover some items unique to the Bidder’s specific technical solution, the Bidder may extend the Schedules to capture those items or components. If supporting price and cost tables are needed for a full understanding of the bid, they should be included. Arithmetical errors should be avoided. If they occur, the Purchaser will correct them according to ITB Clause 26.2 (ITB Clause 38.2 in the two-stage SBD) without consulting the Bidder. Major omissions, inconsistencies, or lack of substantiating detail can lead to rejection of a bid for commercial non-responsiveness. Presenting prices according to the breakdown prescribed in the Price Schedules is also essential for another reason. If a bid does not separate prices in the prescribed way, and, as a result, the Purchaser cannot apply the domestic preference provision described in ITB Clause 29 (ITB Clause 41 in the two-stage SBD), if they are applicable in this bidding, the Bidder will lose the benefit of the preference. Once bids are opened, none of these problems can be rectified. At that stage, Bidders are not permitted to change their bid prices to overcome errors or omissions. Manufacturer’s Authorizations and written agreements by key Subcontractors: In accordance with ITB Clauses 6.1 (b) and (c), a Bidder may be required to submit, as part of its bid, Manufacturer’s Authorizations in the format provided in the Bidding Documents, and agreements by Subcontractors proposed for key services, for all items specified in the Bid Data Sheet. There is no particular format (or sample form) for Subcontractor agreements. List of Proposed Subcontractors: In accordance with ITB Clause 6.3, a Bidder must submit, as part of its bid, a list of proposed subcontracts for major items of Technologies, Goods, and/or Services. The list should also include the names and places of registration of the Subcontractors proposed for each item and a summary of their qualifications. List of Software and Materials: In accordance with ITB Clause 13.1 (e) (vi) (ITB Clauses 13.1 (c) (vi) and 25.1 (e) (vi) in the two-stage SBD), Bidders must submit, as part of their bids, lists of all the Software included in the bid assigned to one of the following categories: (A) System, General-Purpose, or Application Software; or (B) Standard or Custom Software. Bidders must also submit a list of all Custom Materials. If provided for in the Bid Data Sheet, the Purchaser may reserve the right to reassign certain key Software to a different category. Section VII. Sample Forms 485 Qualification information forms: In accordance with ITB Clause 6, the Purchaser will determine whether the Bidder is qualified to undertake the Contract. This entails financial, technical as well as performance history criteria which are specified in the BDS for ITB Clause 6. The Bidder must provide the necessary information for the Purchaser to make this assessment through the forms in this sub-section. The forms contain additional detailed instructions which the Bidder must follow. Securing the bid: If the BDS for ITB Clause 17 (ITB Clause 29 in the two-stage SBD) requires that bids be secured, the Bidder shall do so in accordance with the type and details specified in the same ITB/BDS Clause, either using the form(s) included in these Sample Forms or using another form acceptable to the Purchaser. If a Bidder wishes to use an alternative form, it should ensure that the revised format provides substantially the same protection as the standard format; failing that, the Bidder runs the risk of rejection for commercial non-responsiveness. Bidders need not provide the Performance Security and Advance Payment Security with their bids. Only the Bidder selected for award by the Purchaser will be required to provide these securities. The following forms are to be completed and submitted by the successful Bidder following notification of award: (i) Contract Agreement, with all Appendices; (ii) Performance Security; and (iii) Advance Payment Security. Contract Agreement: In addition to specifying the parties and the Contract Price, the Contract Agreement is where the: (i) Supplier Representative; (ii) if applicable, agreed Adjudicator and his/her compensation; and (iii) the List of Approved Subcontractors are specified. In addition, modifications to the successful Bidder’s Bid Price Schedules are attached to the Agreement. These contain corrections and adjustments to the Supplier’s bid prices to correct errors, adjust the Contract Price to reflect – if applicable - any extensions to bid validity beyond the last day of original bid validity plus 56 days, etc. Performance Security: Pursuant to GCC Clause 13.3, the successful Bidder is required to provide the Performance Security in the form contained in this section of these Bidding Documents and in the amount specified in accordance with the SCC. Advance Payment Security: Pursuant to GCC Clause 13.2, the successful Bidder is required to provide a bank guarantee for the full amount of the Advance Payment - if an Advance Payment is specified in the SCC for GCC 12.1 - in the form contained in this section of these Bidding Documents or another form acceptable to the Purchaser. If a Bidder wishes to propose a different Advance Payment Security form, it should submit a copy to the Purchaser promptly for review and confirmation of acceptability before the bid submission deadline. The Purchaser and Supplier will use the following additional forms during Contract implementation to formalize or certify important Contract events: (i) the Installation and Operational Acceptance Certificates; and (ii) the various Change Order forms. These and the procedures for their use during performance of the Contract are included in the Bidding Documents for the information of Bidders. 485 486 Section VII. Sample Forms Table of Sample Forms 1. Bid Submission Form (Single-Stage Bidding) ..............................................................488 2. Price Schedule Forms .....................................................................................................492 2.1 2.2 2.3 2.4 2.5 2.6 2.7 Preamble .................................................................................................................493 Grand Summary Cost Table....................................................................................495 Supply and Installation Cost Summary Table ........................................................496 Recurrent Cost Summary Table ..............................................................................498 Supply and Installation Cost Sub-Table [ insert: identifying number ]Error! Bookmark not defined. Recurrent Cost Sub-Table [ insert: identifying number ] .....................................500 Country of Origin Code Table ................................................................................500 3. Other Bid Forms and Lists.............................................................................................501 3.1 Manufacturer’s Authorization .................................................................................502 3.2 List of Proposed Subcontractors .............................................................................503 3.3 Software List ...........................................................................................................504 3.4 List of Custom Materials ........................................................................................505 3.5.1 General Information Form ......................................................................................506 3.5.2 General Information Systems Experience Record ..................................................507 3.5.2a Joint Venture Summary........................................................................................508 3.5.3 Particular Information Systems Experience Record ...............................................509 3.5.3a Details of Contracts of Similar Nature and Complexity ......................................510 3.5.4 Summary Sheet: Current Contract Commitments / Work in Progress ..................511 3.5.5 Financial Capabilities..............................................................................................512 3.5.6 Personnel Capabilities .............................................................................................514 3.5.6a Candidate Summary .............................................................................................515 3.5.7 Technical Capabilities .............................................................................................516 3.5.8 Litigation History ....................................................................................................517 4. Bid-Securing Declaration ...............................................................................................518 4A. Bid Security (Bank Guarantee) ..................................................................................519 4B. Bid Security (Bid Bond) ...............................................................................................520 5. Contract Agreement .......................................................................................................521 Appendix 1. Supplier’s Representative...........................................................................525 Appendix 2. Adjudicator .................................................................................................526 Appendix 3. List of Approved Subcontractors ...............................................................527 Appendix 4. Categories of Software ...............................................................................528 Appendix 5. Custom Materials .......................................................................................529 Appendix 6. Revised Price Schedules ............................................................................530 Appendix 7. Minutes of Contract Finalization Discussions and Agreed-to Contract Amendments ...........................................................................................................531 6. Performance and Advance Payment Security Forms..................................................532 Section VII. Sample Forms 6.1 6.2 487 Performance Security Form (Bank Guarantee).......................................................533 Advance Payment Security Form (Bank Guarantee) ..............................................535 7. Installation and Acceptance Certificates ......................................................................537 7.1 7.2 Installation Certificate .............................................................................................538 Operational Acceptance Certificate ........................................................................539 8. Change Order Procedures and Forms ..........................................................................540 8.1 8.2 8.3 8.4 8.5 8.6 Request for Change Proposal Form ........................................................................541 Change Estimate Proposal Form .............................................................................543 Estimate Acceptance Form .....................................................................................545 Change Proposal Form ............................................................................................547 Change Order Form ................................................................................................549 Application for Change Proposal Form ..................................................................551 487 488 Section VII. Sample Forms 1. BID SUBMISSION FORM (SINGLE-STAGE BIDDING) Date: Loan/Credit No.: IFB: Contract: [ Bidder insert: date of bid ] [ Purchaser insert: number ] [ Purchaser insert: IFB title and number ] [ Purchaser insert: name of Contract ] To: [ Purchaser insert: name and address of Purchaser ] Dear Sir or Madam: Having examined the Bidding Documents, including Addenda Nos. [ insert numbers ], the receipt of which is hereby acknowledged, we, the undersigned, offer to supply, install, achieve Operational Acceptance of, and support the Information System under the above-named Contract in full conformity with the said Bidding Documents for the sum of: plus [ insert: amount of local currency in words ] ([ insert: amount of local currency in figures from corresponding Grand Total entry of the Grand Summary Cost Table ]) [ insert: amount of foreign currency A in words ] ([ insert: amount of foreign currency A in figures from corresponding Grand Total entry of the Grand Summary Cost Table ]) [ as appropriate, add the following ] plus [ insert: amount of foreign currency B in words ] ([ insert: amount of foreign currency B in figures from corresponding Grand Total entry of the Grand Summary Cost Table ]) plus [ insert: amount of foreign currency C in words ] ([ insert: amount of foreign currency C in figures from corresponding Grand Total entry of the Grand Summary Cost Table ]) or such other sums as may be determined in accordance with the terms and conditions of the Contract. The above amounts are in accordance with the Price Schedules attached herewith and made part of this bid. Section VII. Sample Forms 489 We undertake, if our bid is accepted, to commence work on the Information System and to achieve Installation and Operational Acceptance within the respective times stated in the Bidding Documents. If our bid is accepted, and if these Bidding Documents so require, we undertake to provide an advance payment security and a performance security in the form, in the amounts, and within the times specified in the Bidding Documents. [ As appropriate, include or delete the following paragraph ] “We accept the appointment of [ Purchaser insert: name of proposed Adjudicator from the Bid Data Sheet ] as the Adjudicator.” [ and delete the following paragraph, or, as appropriate, delete the above and include the following, or, if no Adjudicator is stated in the Bid Data Sheet, delete both the above and the following ] “We do not accept the appointment of [ Purchaser insert: name of proposed Adjudicator from the Bid Data Sheet ] as the Adjudicator, and we propose instead that [ insert: name ] be appointed as Adjudicator, whose résumé and hourly fees are attached.” We hereby certify that the Software offered in this bid and to be supplied under the Contract (i) either is owned by us, or (ii) if not owned by us, is covered by a valid license from the proprietor of the Software. We agree to abide by this bid, which, in accordance with ITB Clauses 13 and 16, consists of this letter (Bid Submission Form) and the enclosures listed below, for a period of [ Purchaser insert: number from Bid Data Sheet ] days from the date fixed for submission of bids as stipulated in the Bidding Documents, and it shall remain binding upon us and may be accepted by you at any time before the expiration of that period. Commissions or gratuities, if any, paid or to be paid by us to agents relating to this Bid, and to Contract execution if we are awarded the Contract, are listed below: Name and Address of Agent Etc. Amount and Currency Purpose of Commission or Gratuity [if none, state: “none”] Until the formal final Contract is prepared and executed between us, this bid, together with your written acceptance of the bid and your notification of award, shall constitute a binding contract between us. We understand that you are not bound to accept the lowest or any bid you may receive. Dated this [ insert: ordinal ] day of [ insert: month ], [ insert: year ]. 489 490 Section VII. Sample Forms Signed: Date: In the capacity of [ insert: title or position ] Duly authorized to sign this bid for and on behalf of [ insert: name of Bidder ] ENCLOSURES: Price Schedules Bid-Securing Declaration or Bid-Security (if and as required) Signature Authorization [plus, in the case of a Joint Venture Bidder, list all other authorizations pursuant to ITB Clause 6.2] Attachment 1. Bidder’s Eligibility Attachment 2. Bidder’s Qualifications (including Manufacturer’s Authorizations and Subcontractor agreements if and as required) Attachment 3. Eligibility of Goods and Services Attachment 4. Conformity of the Information System to the Bidding Documents Attachment 5. Proposed Subcontractors Attachment 6. Intellectual Property (Software and Materials Lists) [if appropriate, specify further attachments or other enclosures] Section VII. Sample Forms 491 Bid Table of Contents and Checklist Note: Purchasers should expand and modify (as appropriate) the following table to reflect the required elements of the Bidder’s bid. As the following note to Bidders explains, it is in both the Purchaser’s and Bidder’s interest to provide this table and accurately fill it out. Note: Bidders should expand and (if appropriate) modify and complete the following table. The purpose of the table is to provide the Bidder with a summary checklist of items that must be included in the bid as described in ITB Clauses 13.1 and 16, in order for the bid to be considered for Contract award. The table also provides a summary page reference scheme to ease and speed the Purchaser’s bid evaluation process. Item present: y/n page no. Bid Submission Form...................................................... Price Schedules ............................................................... Bid-Securing Declaration / Bid-Security (if and as required) .......................................................................... Signature Authorization (for Joint Ventures additionally including the authorizations listed in ITB Clause 6.2).... Attachment 1 ................................................................... Attachment 2 ................................................................... Manufacturer’s Authorizations ................................. Subcontractor agreements ......................................... Attachment 3 ................................................................... Attachment 4 ................................................................... Attachment 5 ................................................................... Attachment 6 ................................................................... ......................................................................................... 491 492 Section VII. Sample Forms 2. PRICE SCHEDULE FORMS Note: in information systems procurement, the Contract Price (and payment schedule) should be linked as much as possible to achievement of operational capabilities, not just to the physical delivery of technology. Section VII. Sample Forms 493 2.1 Preamble Note: Purchasers should highlight any special requirements of the System and Contract in a Preamble to the Price Schedules. The following is an example of one such preamble. General 1. The Price Schedules are divided into separate Schedules as follows: 2.2 Grand Summary Cost Table 2.3 Supply and Installation Cost Summary Table 2.5 Supply and Installation Cost Sub-Table(s) 2.7 Country of Origin Code Table [ insert: any other Schedules as appropriate ] 2. The Schedules do not generally give a full description of the information technologies to be supplied, installed, and operationally accepted, or the Services to be performed under each item. However, it is assumed that Bidders shall have read the Technical Requirements and other sections of these Bidding Documents to ascertain the full scope of the requirements associated with each item prior to filling in the rates and prices. The quoted rates and prices shall be deemed to cover the full scope of these Technical Requirements, as well as overhead and profit. 3. If Bidders are unclear or uncertain as to the scope of any item, they shall seek clarification in accordance with the Instructions to Bidders in the Bidding Documents prior to submitting their bid. Pricing 4. Prices shall be filled in indelible ink, and any alterations necessary due to errors, etc., shall be initialed by the Bidder. As specified in the Bid Data Sheet, prices shall be fixed and firm for the duration of the Contract. 5. Bid prices shall be quoted in the manner indicated and in the currencies specified in ITB Clauses 14 and 15 (ITB Clauses 27 and 28 in the two-stage SBD). Prices must correspond to items of the scope and quality defined in the Technical Requirements or elsewhere in these Bidding Documents. 6. The Bidder must exercise great care in preparing its calculations, since there is no opportunity to correct errors once the deadline for submission of bids has passed. A single error in specifying a unit price can therefore change a Bidder’s overall total bid price substantially, make the bid noncompetitive, or subject the Bidder to possible loss. The Purchaser will correct any arithmetic error in accordance with the provisions of ITB Clause 26.2 (ITB Clause 38.2 in the two-stage SBD). 493 494 7. Section VII. Sample Forms Payments will be made to the Supplier in the currency or currencies indicated under each respective item. As specified in ITB Clause 15.1 (ITB Clause 28.1 in the twostage SBD), no more than three foreign currencies may be used. The price of an item should be unique regardless of installation site. Section VII. Sample Forms 495 2.2 Grand Summary Cost Table [ insert: Local Currency ] Price 1. Supply and Installation Costs (from Supply and Installation Cost Summary Table) 2. Grand Totals (to Bid Submission Form) [ insert: Foreign Currency A ] Price [ insert: Foreign Currency B ] Price [ insert: Foreign Currency C ] Price Name of Bidder: Authorized Signature of Bidder: 495 496 Section VII. Sample Forms 2.3 Supply and Installation Cost Summary Table System or Subsystem number: [ if a multi-lot procurement, insert: Subsystem number; otherwise state “entire System procurement” ] [ as necessary for supply, installation, and achieving Operational Acceptance of the System, specify items in the Table below, modifying, deleting, or expanding the sample line items and sample table entries as needed. ] Costs MUST reflect prices and rates quoted in accordance with ITB Clauses 14 and 15 . Supply & Installation Prices Locally supplied items Line Item No. Subsystem / Item Supply and Installation Cost SubTable No. [ insert: Local Currency ] Price Items supplied from outside the Purchaser’s Country [ insert: Local Currency ] Price [ insert: Foreign Currency A] Price [ insert: Foreign Currency B] Price [ insert: Foreign Currency C] Price 1 1.1 1.2 1.3 SUBTOTALS TOTAL (To Grand Summary Table) Note: - - indicates not applicable. “ indicates repetition of table entry above. Refer to the relevant Supply and Installation Cost Sub-Table for the specific components that constitute each Subsystem or line item in this summary table Section VII. Sample Forms 497 Name of Bidder: Authorized Signature of Bidder: 497 498 Section VII. Sample Forms 2.4 Recurrent Cost Summary Table – Not Applicable 2.5 Supply and Installation Cost Sub-Table № System or Subsystem number: entire System procurement Line item number: [ as necessary for supply, installation, and achieving Operational Acceptance of the System, specify: the detailed components and quantities in the Sub-Table below for the line item specified above, modifying the sample components and sample table entries as needed. Repeat the Sub-Table as needed to cover each and every line item in the Supply and Installation Cost Summary Table that requires elaboration. ] Prices, rates, and subtotals MUST be quoted in accordance with ITB Clauses 14 and 15. Unit prices for the same item appearing several times in the table must be identical in amount and currency. Unit Prices / Rates Supplied Locally Compo- Component Country Quannent Description of Origin tity No. Code [ insert: local currency] Supplied from outside the Purchaser’s Country [ insert: local currency] [ insert: [ insert [ insert: foreign foreign foreign currency currency currency A] B] C] Subtotals (to [ insert: line item ] of Supply and Installation Cost Summary Table) Note: - - indicates not applicable. Total Prices Supplied Supplied from outside the Purchaser’s Country Locally [ insert: [ insert: local local currency] currency] [ insert: foreign currency A] [ insert: foreign currency B] [ insert: foreign currency C] Section VII. Sample Forms 499 Name of Bidder: Authorized Signature of Bidder: 499 500 Section VII. Sample Forms 2.6 Recurrent Cost Sub-Table – Not Applicable 2.7 Country of Origin Country Code Country of Origin Code Table Country of Origin Country Code Country of Origin Country Code Section VII. Sample Forms 501 3. OTHER BID FORMS AND LISTS 501 502 Section VII. Sample Forms 3.1 Manufacturer’s Authorization Invitation for Bids Title and No.: [If applicable:] Lot, Slice, Subsystem No(s).: To: ________________________________ WHEREAS _______________________________________ who are official producers of _______________________________________________ and having production facilities at __________________________________________________________ do hereby authorize __________________________________________________________________ located at _____________________________________________________ (hereinafter, the “Bidder”) to submit a bid and subsequently negotiate and sign a Contract with you for resale of the following Products produced by us: . We hereby confirm that, in case the bidding results in a Contract between you and the Bidder, the above-listed products will come with our full standard warranty. Name In the capacity of Signed Duly authorized to sign the authorization for and on behalf of : ________________________ Dated on _______________________________ day of ______________________, ______. Note: This authorization should be written on the letterhead of the Manufacturer and be signed by a person with the proper authority to sign documents that are binding on the Manufacturer. Section VII. Sample Forms 503 3.2 Item List of Proposed Subcontractors Proposed Subcontractor Place of Registration & Qualifications 503 504 Section VII. Sample Forms 3.3 Software List (select one per item) Software Item System Software GeneralPurpose Software Application Software (select one per item) Standard Software Custom Software Section VII. Sample Forms 505 3.4 List of Custom Materials Custom Materials 505 506 Section VII. Sample Forms 3.5.1 General Information Form All individual firms and each partner of a Joint Venture that are bidding must complete the information in this form. Nationality information should be provided for all owners or Bidders that are partnerships or individually owned firms. Where the Bidder proposes to use named Subcontractors for highly specialized components of the Information System, the following information should also be supplied for the Subcontractor(s), together with the information in Forms 3.5.2, 3.5.3, 3.5.3a, 3.5.4, and 3.5.5. Joint Ventures must also fill out Form 3.5.2a. 1. Name of firm 2. Head office address 3. Telephone Contact 4. Fax Telex 5. Place of incorporation / registration Year of incorporation / registration Nationality of owners¹ Name Nationality 1. 2. 3. 4. 5. ¹/ To be completed by all owners of partnerships or individually owned firms. Section VII. Sample Forms 507 3.5.2 General Information Systems Experience Record Name of Bidder or partner of a Joint Venture All individual firms and all partners of a Joint Venture must complete the information in this form with regard to the management of Information Systems contracts generally. The information supplied should be the annual turnover of the Bidder (or each member of a Joint Venture), in terms of the amounts billed to clients for each year for work in progress or completed, converted to U.S. dollars at the rate of exchange at the end of the period reported. The annual periods should be calendar years, with partial accounting for the year up to the date of submission of applications. This form may be included for Subcontractors only if the Bid Data Sheet for ITB Clause 6.1 (a) explicitly permits experience and resources of (certain) Subcontractors to contribute to the Bidder’s qualifications. A brief note on each contract should be appended, describing the nature of the Information System, duration and amount of contract, managerial arrangements, purchaser, and other relevant details. Use a separate page for each partner of a Joint Venture, and number these pages. Bidders should not enclose testimonials, certificates, and publicity material with their applications; they will not be taken into account in the evaluation of qualifications. Annual turnover data (applicable activities only) Year¹ Turnover US$ equivalent 1. 2. 3. 4. 5. ¹/ Commencing with the partial year up to the date of submission of bids 507 508 Section VII. Sample Forms 3.5.2a Joint Venture Summary Names of all partners of a Joint Venture 1. Partner in charge 2. Partner 3. Partner 4. Partner 5. Partner 6. etc. Total value of annual turnover, in terms of Information System billed to clients, in US$ equivalent, converted at the rate of exchange at the end of the period reported: Annual turnover data (applicable activities only; US$ equivalent) Partner 1. Partner in charge 2. Partner 3. Partner 4. Partner 5. Partner 6. Etc. Totals Form Year 1 3.5.2 page no. Year 2 Year 3 Year 4 Year 5 Section VII. Sample Forms 509 3.5.3 Particular Information Systems Experience Record Name of Bidder or partner of a Joint Venture On separate pages, using the format of Form 3.5.3a, the Bidder is requested to list contracts of a similar nature, complexity, and requiring similar information technology and methodologies to the contract or contracts for which these Bidding Documents are issued, and which the Bidder has undertaken during the period, and of the number, specified in the BDS for ITB Clause 6.1 (a). Each partner of a Joint Venture should separately provide details of its own relevant contracts. The contract value should be based on the payment currencies of the contracts converted into U.S. dollars, at the date of substantial completion, or for ongoing contracts at the time of award. 509 510 Section VII. Sample Forms 3.5.3a Details of Contracts of Similar Nature and Complexity Name of Bidder or partner of a Joint Venture Use a separate sheet for each contract. 1. Number of contract Name of contract Country 2. Name of Purchaser 3. Purchaser address 4. Nature of Information Systems and special features relevant to the contract for which the Bidding Documents are issued 5. Contract role (check one) Prime Supplier Management Contractor Subcontractor Partner in a Joint Venture 6. Amount of the total contract/subcontract/partner share (in specified currencies at completion, or at date of award for current contracts) Currency 7. Currency Currency Subcontract: $_______; Partner share: $_______; Equivalent amount US$ Total contract: $_______; 8. Date of award/completion 9. Contract was completed _____ months ahead/behind original schedule (if behind, provide explanation). 10. Contract was completed US$ _________ equivalent under/over original contract amount (if over, provide explanation). 11. Special contractual/technical requirements. 12. Indicate the approximate percent of total contract value (and US$ amount) of Information System undertaken by subcontract, if any, and the nature of such Information System. Section VII. Sample Forms 511 3.5.4 Summary Sheet: Current Contract Commitments / Work in Progress Name of Bidder or partner of a Joint Venture Bidders and each partner to an Joint Venture bid should provide information on their current commitments on all contracts that have been awarded, or for which a letter of intent or acceptance has been received, or for contracts approaching completion, but for which an unqualified, full completion certificate has yet to be issued. Name of contract Purchaser, contact address/tel./fax Value of outstanding Information System (current US$ equivalent) Estimated completion date Average monthly invoicing over last six months (US$/month) 1. 2. 3. 4. 5. etc. 511 512 Section VII. Sample Forms 3.5.5 Financial Capabilities Name of Bidder or partner of a Joint Venture Bidders, including each partner of a Joint Venture, shall provide financial information to demonstrate that they meet the requirements stated in the BDS for ITB Clause 6.1 (a). Each Bidder or partner of a Joint Venture shall complete this form. If necessary, separate sheets shall be used to provide complete banker information. A copy of the audited balance sheets shall be attached. Autonomous subdivisions of parent conglomerate businesses shall submit financial information related only to the particular activities of the subdivision. Banker Name of banker Address of banker Telephone Contact name and title Fax Telex Summarize actual assets and liabilities in U.S. dollar equivalent (at the rates of exchange current at the end of each year) for the previous five calendar years. Based upon known commitments, summarize projected assets and liabilities in U.S. dollar equivalent for the next two calendar years, unless the withholding of such information by stock market listed public companies can be substantiated by the Bidder. Financial information in US$ equivalent Actual: Projected: Previous five years Next two years 5 1. Total assets 2. Current assets 3. Total liabilities 4. Current liabilities 5. Profits before taxes 6. Profits after taxes 4 3 2 1 1 2 Section VII. Sample Forms 513 Specify proposed sources of financing, such as liquid assets, unencumbered real assets, lines of credit, and other financial means, net of current commitments, available to meet the total construction cash flow demands of the subject contract or contracts as indicated in the BDS for ITB Clause 6.1 (a). Source of financing Amount (US$ equivalent) 1. 2. 3. 4. Attach audited financial statements—including, as a minimum, profit and loss account, balance sheet, and explanatory notes—for the period stated in the BDS for ITB Clause 6.1 (a) (for the individual Bidder or each partner of a Joint Venture). If audits are not required by the laws of Bidders' countries of origin, partnerships and firms owned by individuals may submit their balance sheets certified by a registered accountant, and supported by copies of tax returns, 513 514 Section VII. Sample Forms 3.5.6 Personnel Capabilities Name of Bidder For specific positions essential to contract management and implementation (and/or those specified in the Bidding Documents, if any), Bidders should provide the names of at least two candidates qualified to meet the specified requirements stated for each position. The data on their experience should be supplied on separate sheets using one Form 3.5.6a for each candidate. Bidders may propose alternative management and implementation arrangements requiring different key personnel, whose experience records should be provided. 1. Title of position Name of prime candidate Name of alternate candidate 2. Title of position Name of prime candidate Name of alternate candidate 3. Title of position Name of prime candidate Name of alternate candidate 4. Title of position Name of prime candidate Name of alternate candidate Section VII. Sample Forms 515 3.5.6a Candidate Summary Name of Bidder Position Candidate Candidate information Name of candidate Prime Alternate Date of birth Professional qualifications Present employment Name of Employer Address of Employer Telephone Contact (manager / personnel officer) Fax Telex Job title of candidate Years with present Employer Summarize professional experience over the last twenty years, in reverse chronological order. Indicate particular technical and managerial experience relevant to the project. From To Company/Project/ Position/Relevant technical and management experience 515 516 Section VII. Sample Forms 3.5.7 Technical Capabilities Name of Bidder The Bidder shall provide adequate information to demonstrate clearly that it has the technical capability to meet the requirements for the Information System. With this form, the Bidder should summarize important certifications, proprietary methodologies, and/or specialized technologies which the Bidder proposes to utilize in the execution of the Contract or Contracts. Section VII. Sample Forms 517 3.5.8 Litigation History Name of Bidder or partner of a Joint Venture Bidders, including each of the partners of a Joint Venture, shall provide information on any history of litigation or arbitration resulting from contracts executed in the last five years or currently under execution. A separate sheet should be used for each partner of a Joint Venture. Year Award FOR Name of client, cause of litigation, and matter in Disputed amount or AGAINST dispute (current value, US$ Bidder equivalent) 517 518 Section VII. Sample Forms 4. BID-SECURING DECLARATION Not Applicable Section VII. Sample Forms 519 4A. Bid Security (Bank Guarantee) [The Bank shall fill in this Bank Guarantee Form in accordance with the instructions indicated.] ________________________________ [Bank’s Name, and Address of Issuing Branch or Office] Beneficiary: ___________________ [Name and Address of Purchaser] Date: ________________ BID GUARANTEE No.: _________________ We have been informed that [name of the Bidder] (hereinafter called "the Bidder") has submitted to you its bid dated (hereinafter called "the Bid") for the execution of [name of contract] under Invitation for Bids No. [IFB number] (“the IFB”). Furthermore, we understand that, according to your conditions, bids must be supported by a bid guarantee. At the request of the Bidder, we [name of Bank] hereby irrevocably undertake to pay you any sum or sums not exceeding in total an amount of [amount in figures] ([amount in words]) upon receipt by us of your first demand in writing accompanied by a written statement stating that the Bidder is in breach of its obligation(s) under the bid conditions, because the Bidder: (a) has withdrawn its Bid during the period of bid validity specified by the Bidder in the Form of Bid; or (b) having been notified of the acceptance of its Bid by the Purchaser during the period of bid validity, (i) fails or refuses to execute the Contract Form; or (ii) fails or refuses to furnish the performance security, if required, in accordance with the Instructions to Bidders. This guarantee will expire: (a) if the Bidder is the successful bidder, upon our receipt of copies of the contract signed by the Bidder and the performance security issued to you upon the instruction of the Bidder; or (b) if the Bidder is not the successful bidder, upon the earlier of (i) our receipt of a copy of your notification to the Bidder of the name of the successful bidder; or (ii) twenty-eight days after the expiration of the Bidder’s Bid. Consequently, any demand for payment under this guarantee must be received by us at the office on or before that date. 519 520 Section VII. Sample Forms This guarantee is subject to the Uniform Rules for Demand Guarantees, ICC Publication No. 458. _____________________________ [signature(s)] 4B. BID SECURITY (BID BOND) Not Applicable Section VII. Sample Forms 521 5. CONTRACT AGREEMENT THIS CONTRACT AGREEMENT is made the [ insert: ordinal ] day of [ insert: month ], [ insert: year ]. BETWEEN (1) [ insert: Name of Purchaser ], a [ insert: description of type of legal entity, for example, an agency of the Ministry of . . . ] of the Government of [ insert: country of Purchaser ], or corporation incorporated under the laws of [ insert: country of Purchaser ] and having its principal place of business at [ insert: address of Purchaser ] (hereinafter called “the Purchaser”), and (2) [ insert: name of Supplier], a corporation incorporated under the laws of [ insert: country of Supplier] and having its principal place of business at [ insert: address of Supplier ] (hereinafter called “the Supplier”). WHEREAS the Purchaser desires to engage the Supplier to supply, install, achieve Operational Acceptance of, and support the following Information System [ insert: brief description of the Information System ] (“the System”), and the Supplier has agreed to such engagement upon and subject to the terms and conditions appearing below in this Contract Agreement. NOW IT IS HEREBY AGREED as follows: Article 1. Contract Documents 1.1 Contract Documents (Reference GCC Clause 1.1 (a) (ii)) The following documents shall constitute the Contract between the Purchaser and the Supplier, and each shall be read and construed as an integral part of the Contract: (a) This Contract Agreement and the Appendices attached to the Contract Agreement (b) Special Conditions of Contract (c) General Conditions of Contract (d) Technical Requirements (including Implementation Schedule) (e) The Supplier’s bid and original Price Schedules (f) [ Add here: any other documents ] 521 522 Section VII. Sample Forms 1.2 Order of Precedence (Reference GCC Clause 2) In the event of any ambiguity or conflict between the Contract Documents listed above, the order of precedence shall be the order in which the Contract Documents are listed in Article 1.1 (Contract Documents) above, provided that Appendix 7 shall prevail over all provisions of the Contract Agreement and the other Appendices attached to the Contract Agreement and all the other Contract Documents listed in Article 1.1 above. 1.3 Definitions (Reference GCC Clause 1) Capitalized words and phrases used in this Contract Agreement shall have the same meanings as are ascribed to them in the General Conditions of Contract. Article 2. 2.1 Contract Price and Terms of Payment Contract Price (Reference GCC Clause 1.1(a)(viii) and GCC Clause 11) The Purchaser hereby agrees to pay to the Supplier the Contract Price in consideration of the performance by the Supplier of its obligations under the Contract. The Contract Price shall be the aggregate of: [ insert: amount of foreign currency A in words ], [insert: amount in figures ], plus [ insert: amount of foreign currency B in words ], [insert: amount in figures ], plus [ insert: amount of foreign currency C in words ], [insert: amount in figures ], [ insert: amount of local currency in words ], [ insert: amount in figures ], as specified in the Grand Summary Price Schedule. The Contract Price shall be understood to reflect the terms and conditions used in the specification of prices in the detailed price schedules, including the terms and conditions of the associated Incoterms, and the taxes, duties and related levies if and as identified. Article 3. Effective Date for Determining Time for Operational Acceptance 3.1 Effective Date (Reference GCC Clause 1.1 (e) (ix)) The time allowed for supply, installation, and achieving Operational Acceptance of the System shall be determined from the date when all of the following conditions have been fulfilled: (a) This Contract Agreement has been duly executed for and on behalf of the Purchaser and the Supplier; (b) The Supplier has submitted to the Purchaser the performance security and the advance payment security, in accordance with GCC Clause 13.2 and GCC Clause 13.3; (c) The Purchaser has paid the Supplier the advance payment, in accordance with GCC Clause 12; Section VII. Sample Forms 523 (d) [ specify here: any other conditions, for example, opening/confirmation of letter of credit ]. Each party shall use its best efforts to fulfill the above conditions for which it is responsible as soon as practicable. Article 4. 3.2 If the conditions listed under 3.1 are not fulfilled within two (2) months from the date of this Contract Agreement because of reasons not attributable to the Supplier, the parties shall discuss and agree on an equitable adjustment to the Contract Price and the Time for Achieving Operational Acceptance and/or other relevant conditions of the Contract. 4.1 The Appendixes listed below shall be deemed to form an integral part of this Contract Agreement. 4.2 Reference in the Contract to any Appendix shall mean the Appendixes listed below and attached to this Contract Agreement, and the Contract shall be read and construed accordingly. Appendixes APPENDIXES Appendix 1. Appendix 2. Appendix 3. Appendix 4. Appendix 5. Appendix 6. Appendix 7. Supplier’s Representative Adjudicator [if there is no Adjudicator, state “not applicable”] List of Approved Subcontractors Categories of Software Custom Materials Revised Price Schedules (if any) Minutes of Contract Finalization Discussions and Agreed-to Contract Amendments 523 524 Section VII. Sample Forms IN WITNESS WHEREOF the Purchaser and the Supplier have caused this Agreement to be duly executed by their duly authorized representatives the day and year first above written. For and on behalf of the Purchaser Signed: in the capacity of [ insert: title or other appropriate designation ] in the presence of For and on behalf of the Supplier Signed: in the capacity of [ insert: title or other appropriate designation ] in the presence of CONTRACT AGREEMENT dated the [ insert: number ] day of [ insert: month ], [ insert: year ] BETWEEN [ insert: name of Purchaser ], “the Purchaser” and [ insert: name of Supplier ], “the Supplier” Section VII. Sample Forms 525 Appendix 1. Supplier’s Representative In accordance with GCC Clause 1.1 (b) (iv), the Supplier’s Representative is: Name: [ insert: name and provide title and address further below, or state “to be nominated within fourteen (14) days of the Effective Date” ] Title: [ if appropriate, insert: title ] In accordance with GCC Clause 4.3, the Supplier's addresses for notices under the Contract are: Address of the Supplier's Representative: [ as appropriate, insert: personal delivery, postal, cable, telegraph, telex, facsimile, electronic mail, and/or EDI addresses. ] Fallback address of the Supplier: [ as appropriate, insert: personal delivery, postal, cable, telegraph, telex, facsimile, electronic mail, and/or EDI addresses. ] 525 526 Section VII. Sample Forms Appendix 2. Adjudicator In accordance with GCC Clause 1.1 (b) (vi), the agreed-upon Adjudicator is: Name: [ insert: name ] Title: [ insert: title ] Address: [ insert: postal address ] Telephone: [ insert: telephone ] In accordance with GCC Clause 6.1.3, the agreed-upon fees and reimbursable expenses are: Hourly Fees: [ insert: hourly fees ] Reimbursable Expenses: [ list: reimbursables ] Pursuant to GCC Clause 6.1.4, if at the time of Contract signing, agreement has not been reached between the Purchaser and the Supplier, an Adjudicator will be appointed by the Appointing Authority named in the SCC. Section VII. Sample Forms 527 Appendix 3. List of Approved Subcontractors The Purchaser has approved use of the following Subcontractors nominated by the Supplier for carrying out the item or component of the System indicated. Where more than one Subcontractor is listed, the Supplier is free to choose between them, but it must notify the Purchaser of its choice sufficiently in advance of the time when the subcontracted work needs to commence to give the Purchaser reasonable time for review. In accordance with GCC Clause 20.1, the Supplier is free to submit proposals for Subcontractors for additional items from time to time. No subcontracts shall be placed with any such Subcontractors for additional items until the Subcontractors have been approved in writing by the Purchaser and their names have been added to this list of Approved Subcontractors, subject to GCC Clause 20.3. [ specify: item, approved Subcontractors, and their place of registration that the Supplier proposed in the corresponding attachment to its bid and that the Purchaser approves that the Supplier engage during the performance of the Contract. Add additional pages as necessary. ] Item Approved Subcontractors Place of Registration 527 528 Section VII. Sample Forms Appendix 4. Categories of Software The following table assigns each item of Software supplied and installed under the Contract to one of the three categories: (i) System Software, (ii) General-Purpose Software, or (iii) Application Software; and to one of the two categories: (i) Standard Software or (ii) Custom Software. (select one per item) Software Item System Software GeneralPurpose Software Application Software (select one per item) Standard Software Custom Software Section VII. Sample Forms 529 Appendix 5. Custom Materials The follow table specifies the Custom Materials the Supplier will provide under the Contract. Custom Materials 529 530 Section VII. Sample Forms Appendix 6. Revised Price Schedules The attached Revised Price Schedules (if any) shall form part of this Contract Agreement and, where differences exist, shall supersede the Price Schedules contained in the Supplier’s Bid. These Revised Price Schedules reflect any corrections or adjustments to the Supplier’s bid price, pursuant to the ITB Clauses 18.3, 26.2, and 33.1 (ITB Clauses 30.3, 38.2, and 45.1 in the two-stage SBD). Section VII. Sample Forms 531 Appendix 7. Minutes of Contract Finalization Discussions and Agreed-to Contract Amendments The attached Contract amendments (if any) shall form part of this Contract Agreement and, where differences exist, shall supersede the relevant clauses in the GCC, SCC, Technical Requirements, or other parts of this Contract as defined in GCC Clause 1.1 (a) (ii). 531 532 Section VII. Sample Forms 6. PERFORMANCE AND ADVANCE PAYMENT SECURITY FORMS Section VII. Sample Forms 533 6.1 Performance Security [The bank, as requested by the successful Bidder, shall fill in this form in accordance with the instructions indicated] Date: [insert date (as day, month, and year) of Bid Submission] ICB No. and title: [insert no. and title of bidding process] Bank’s Branch or Office: [insert complete name of Guarantor] Beneficiary: [insert complete name of Purchaser] PERFORMANCE GUARANTEE No.: [insert Performance Guarantee number] We have been informed that [insert complete name of Supplier] (hereinafter called "the Supplier") has entered into Contract No. [insert number] dated [insert day and month], [insert year] with you, for the supply of [description of Goods and related Services] (hereinafter called "the Contract"). Furthermore, we understand that, according to the conditions of the Contract, a Performance Guarantee is required. At the request of the Supplier, we hereby irrevocably undertake to pay you any sum(s) not exceeding [insert amount(s1) in figures and words] upon receipt by us of your first demand in writing declaring the Supplier to be in default under the Contract, without cavil or argument, or your needing to prove or to show grounds or reasons for your demand or the sum specified therein. This Guarantee shall expire no later than the [insert number] day of [insert month] [insert year],2 and any demand for payment under it must be received by us at this office on or before that date. 1 The Bank shall insert the amount(s) specified in the SCC and denominated, as specified in the SCC, either in the currency(ies) of the Contract or a freely convertible currency acceptable to the Purchaser. 2 Dates established in accordance with Clause 18.4 of the General Conditions of Contract (“GCC”), taking into account any warranty obligations of the Supplier under Clause 16.2 of the GCC intended to be secured by a partial Performance Guarantee. The Purchaser should note that in the event of an extension of the time to perform the Contract, the Purchaser would need to request an extension of this Guarantee from the Bank. Such request must be in writing and must be made prior to the expiration date established in the Guarantee. In preparing this Guarantee, the Purchaser might consider adding the following text to the Form, at the end of the penultimate 533 534 Section VII. Sample Forms This guarantee is subject to the Uniform Rules for Demand Guarantees, ICC Publication No. 458, except that subparagraph (ii) of Sub-article 20(a) is hereby excluded. [signatures of authorized representatives of the bank and the Supplier] paragraph: “We agree to a one-time extension of this Guarantee for a period not to exceed [six months] [one year], in response to the Purchaser’s written request for such extension, such request to be presented to us before the expiry of the Guarantee.” Section VII. Sample Forms 535 6.2 Bank Guarantee for Advance Payment [The bank, as requested by the successful Bidder, shall fill in this form in accordance with the instructions indicated.] Date: [insert date (as day, month, and year) of Bid Submission] ICB No. and title: [insert number and title of bidding process] [bank’s letterhead] Beneficiary: [insert legal name and address of Purchaser] ADVANCE PAYMENT GUARANTEE No.: [insert Advance Payment Guarantee no.] We, [insert legal name and address of bank], have been informed that [insert complete name and address of Supplier] (hereinafter called "the Supplier") has entered into Contract No. [insert number] dated [insert date of Agreement] with you, for the supply of [insert types of Goods to be delivered] (hereinafter called "the Contract"). Furthermore, we understand that, according to the conditions of the Contract, an advance is to be made against an advance payment guarantee. At the request of the Supplier, we hereby irrevocably undertake to pay you any sum or sums not exceeding in total an amount of [insert amount(s)1 in figures and words] upon receipt by us of your first demand in writing declaring that the Supplier is in breach of its obligation under the Contract because the Supplier used the advance payment for purposes other than toward delivery of the Goods. It is a condition for any claim and payment under this Guarantee to be made that the advance payment referred to above must have been received by the Supplier on its account [insert number and domicile of the account] This Guarantee shall remain valid and in full effect from the date of the advance payment received by the Supplier under the Contract until [insert date2]. 1 The bank shall insert the amount(s) specified in the SCC and denominated, as specified in the SCC, either in the currency(ies) of the Contract or a freely convertible currency acceptable to the Purchaser. 2 Insert the Delivery date stipulated in the Contract Delivery Schedule. The Purchaser should note that in the event of an extension of the time to perform the Contract, the Purchaser would need to request an extension of this Guarantee from the bank. Such request must be in writing and must be made prior to the expiration date established in the Guarantee. In preparing this Guarantee, the Purchaser might consider adding the following text to the Form, at the end of the penultimate 535 536 Section VII. Sample Forms This Guarantee is subject to the Uniform Rules for Demand Guarantees, ICC Publication No. 458. _____________________ [signature(s) of authorized representative(s) of the bank] paragraph: “We agree to a one-time extension of this Guarantee for a period not to exceed [six months][one year], in response to the Purchaser’s written request for such extension, such request to be presented to us before the expiry of the Guarantee.” Section VII. Sample Forms 537 7. INSTALLATION AND ACCEPTANCE CERTIFICATES 537 538 Section VII. Sample Forms 7.1 Installation Certificate Date: [ insert: date ] Loan/Credit Number: [ insert: loan or credit number from IFB ] IFB: [ insert: title and number of IFB ] Contract: [ insert: name and number of Contract ] To: [ insert: name and address of Supplier ] Dear Sir or Madam: Pursuant to GCC Clause 26 (Installation of the System) of the Contract entered into between yourselves and the [ insert: name of Purchaser ] (hereinafter the “Purchaser”) dated [ insert: date of Contract ], relating to the [ insert: brief description of the Information System ], we hereby notify you that the System (or a Subsystem or major component thereof) was deemed to have been correctly installed on the date specified below. 1. Description of the System (or relevant Subsystem or major component: [ insert: description ] 2. Date of Installation: [ insert: date ] Notwithstanding the above, you are required to complete the outstanding items listed in the attachment to this certificate as soon as practicable. This letter shall not relieve you of your obligation to achieve Operational Acceptance of the System in accordance with the Contract nor of your obligations during the Warranty Period. For and on behalf of the Purchaser Signed: Date: in the capacity of: [ state: “Project Manager” or state the title of a higher level authority in the Purchaser’s organization ] Section VII. Sample Forms 7.2 539 Operational Acceptance Certificate Date: [ insert: date ] Loan/Credit Number: [ insert: loan or credit number from IFB ] IFB: [ insert: title and number of IFB ] Contract: [ insert: name of System or Subsystem and number of Contract ] To: [ insert: name and address of Supplier ] Dear Sir or Madam: Pursuant to GCC Clause 27 (Commissioning and Operational Acceptance) of the Contract entered into between yourselves and the [ insert: name of Purchaser ] (hereinafter the “Purchaser”) dated [ insert: date of Contract ], relating to the [ insert: brief description of the Information System ], we hereby notify you the System (or the Subsystem or major component identified below) successfully completed the Operational Acceptance Tests specified in the Contract. In accordance with the terms of the Contract, the Purchaser hereby takes over the System (or the Subsystem or major component identified below), together with the responsibility for care and custody and the risk of loss thereof on the date mentioned below. 1. Description of the System (or Subsystem or major component): description ] 2. [ insert: Date of Operational Acceptance: [ insert: date ] This letter shall not relieve you of your remaining performance obligations under the Contract nor of your obligations during the Warranty Period. For and on behalf of the Purchaser Signed: Date: in the capacity of: [ state: “Project Manager” or higher level authority in the Purchaser’s organization ] 539 540 Section VII. Sample Forms 8. CHANGE ORDER PROCEDURES AND FORMS Date: [ insert: date ] Loan/Credit Number: [ insert: loan or credit number from IFB ] IFB: [ insert: title and number of IFB ] Contract: [ insert: name or System or Subsystem and number of Contract ] General This section provides samples of procedures and forms for carrying out changes to the System during the performance of the Contract in accordance with GCC Clause 39 (Changes to the System) of the Contract. Change Order Log The Supplier shall keep an up-to-date Change Order Log to show the current status of Requests for Change and Change Orders authorized or pending. Changes shall be entered regularly in the Change Order Log to ensure that the log is kept up-to-date. The Supplier shall attach a copy of the current Change Order Log in the monthly progress report to be submitted to the Purchaser. References to Changes (1) (2) (3) (4) (5) Request for Change Proposals (including Application for Change Proposals) shall be serially numbered CR-nnn. Change Estimate Proposals shall be numbered CN-nnn. Estimate Acceptances shall be numbered CA-nnn. Change Proposals shall be numbered CP-nnn. Change Orders shall be numbered CO-nnn. On all forms, the numbering shall be determined by the original CR-nnn. Annexes 8.1 8.2 8.3 8.4 8.5 8.6 Request for Change Proposal Form Change Estimate Proposal Form Estimate Acceptance Form Change Proposal Form Change Order Form Application for Change Proposal Form Section VII. Sample Forms 8.1 541 Request for Change Proposal Form (Purchaser’s Letterhead) Date: [ insert: date ] Loan/Credit Number: [ insert: loan or credit number from IFB ] IFB: [ insert: title and number of IFB ] Contract: [ insert: name of System or Subsystem or number of Contract ] To: [ insert: name of Supplier and address ] Attention: [ insert: name and title ] Dear Sir or Madam: With reference to the above-referenced Contract, you are requested to prepare and submit a Change Proposal for the Change noted below in accordance with the following instructions within [ insert: number ] days of the date of this letter. 1. Title of Change: [ insert: title ] 2. Request for Change No./Rev.: [ insert: number ] 3. Originator of Change: [ select Purchaser / Supplier (by Application for Change Proposal), and add: name of originator ] 4. Brief Description of Change: [ insert: description ] 5. System (or Subsystem or major component affected by requested Change): [ insert: description ] 6. Technical documents and/or drawings for the request of Change: 541 542 Section VII. Sample Forms Document or Drawing No. Description 7. Detailed conditions or special requirements of the requested Change: description ] 8. Procedures to be followed: 9. [ insert: (a) Your Change Proposal will have to show what effect the requested Change will have on the Contract Price. (b) Your Change Proposal shall explain the time it will take to complete the requested Change and the impact, if any, it will have on the date when Operational Acceptance of the entire System agreed in the Contract. (c) If you believe implementation of the requested Change will have a negative impact on the quality, operability, or integrity of the System, please provide a detailed explanation, including other approaches that might achieve the same impact as the requested Change. (d) You should also indicate what impact the Change will have on the number and mix of staff needed by the Supplier to perform the Contract. (e) You shall not proceed with the execution of work related to the requested Change until we have accepted and confirmed the impact it will have on the Contract Price and the Implementation Schedule in writing. As next step, please respond using the Change Estimate Proposal form, indicating how much it will cost you to prepare a concrete Change Proposal that will describe the proposed approach for implementing the Change, all its elements, and will also address the points in paragraph 8 above pursuant to GCC Clause 39.2.1. Your Change Estimate Proposal should contain a first approximation of the proposed approach, and implications for schedule and cost, of the Change. For and on behalf of the Purchaser Signed: Date: in the capacity of: [ state: “Project Manager” or higher level authority in the Purchaser’s organization ] Section VII. Sample Forms 8.2 543 Change Estimate Proposal Form (Supplier’s Letterhead) Date: [ insert: date ] Loan/Credit Number: [ insert: loan or credit number from IFB ] IFB: [ insert: title and number of IFB ] Contract: [ insert: name of System or Subsystem and number of Contract ] To: [ insert: name of Purchaser and address ] Attention: [ insert: name and title ] Dear Sir or Madam: With reference to your Request for Change Proposal, we are pleased to notify you of the approximate cost of preparing the below-referenced Change in accordance with GCC Clause 39.2.1 of the Contract. We acknowledge that your agreement to the cost of preparing the Change Proposal, in accordance with GCC Clause 39.2.2, is required before we proceed to prepare the actual Change Proposal including a detailed estimate of the cost of implementing the Change itself. 1. Title of Change: [ insert: title ] 2. Request for Change No./Rev.: [ insert: number ] 3. Brief Description of Change (including proposed implementation approach): [ insert: description ] 4. Schedule Impact of Change (initial estimate): [ insert: description ] 5. Initial Cost Estimate for Implementing the Change: [insert: initial cost estimate] 543 544 6. Section VII. Sample Forms Cost for Preparation of Change Proposal: [ insert: cost in the currencies of the Contract ], as detailed below in the breakdown of prices, rates, and quantities. For and on behalf of the Supplier Signed: Date: in the capacity of: [ state: “Supplier’s Representative” or other higher level authority in the Supplier’s organization ] Section VII. Sample Forms 545 8.3 Estimate Acceptance Form (Purchaser’s Letterhead) Date: [ insert: date ] Loan/Credit Number: [ insert: loan or credit number from IFB ] IFB: [ insert: title and number of IFB ] Contract: [ insert: name of System or Subsystem and number of Contract ] To: [ insert: name of Supplier and address ] Attention: [ insert: name and title ] Dear Sir or Madam: We hereby accept your Change Estimate and agree that you should proceed with the preparation of a formal Change Proposal. 1. Title of Change: [ insert: title ] 2. Request for Change No./Rev.: [ insert: request number / revision ] 3. Change Estimate Proposal No./Rev.: [ insert: proposal number / revision ] 4. Estimate Acceptance No./Rev.: [ insert: estimate number / revision ] 5. Brief Description of Change: [ insert: description ] 6. Other Terms and Conditions: In the event that we decide not to order the Change referenced above, you shall be entitled to compensation for the cost of preparing the Change Proposal up to the 545 546 Section VII. Sample Forms amount estimated for this purpose in the Change Estimate Proposal, in accordance with GCC Clause 39 of the General Conditions of Contract. For and on behalf of the Purchaser Signed: Date: in the capacity of: [ state: “Project Manager” or higher level authority in the Purchaser’s organization ] Section VII. Sample Forms 547 8.4 Change Proposal Form (Supplier’s Letterhead) Date: [ insert: date ] Loan/Credit Number: [ insert: loan or credit number from IFB ] IFB: [ insert: title and number of IFB ] Contract: [ insert: name of System or Subsystem and number of Contract ] To: [ insert: name of Purchaser and address ] Attention: [ insert: name and title ] Dear Sir or Madam: In response to your Request for Change Proposal No. [ insert: number ], we hereby submit our proposal as follows: 1. Title of Change: [ insert: name ] 2. Change Proposal No./Rev.: [ insert: proposal number/revision ] 3. Originator of Change: [ select: Purchaser / Supplier; and add: name] 4. Brief Description of Change: [ insert: description ] 5. Reasons for Change: [ insert: reason ] 6. The System Subsystem, major component, or equipment that will be affected by the requested Change: [ insert: description ] 7. Technical documents and/or drawings for the requested Change: 547 548 Section VII. Sample Forms Document or Drawing No. 8. Description Estimate of the increase/decrease to the Contract Price resulting from the proposed Change: [ insert: amount in currencies of Contract ], as detailed below in the breakdown of prices, rates, and quantities. Total lump sum cost of the Change: Cost to prepare this Change Proposal (i.e., the amount payable if the Change is not accepted, limited as provided by GCC Clause 39.2.6): 9. Additional Time for Achieving Operational Acceptance required due to the Change: [ insert: amount in days / weeks ] 10. Effect on the Functional Guarantees: [ insert: description ] 11. Effect on the other terms and conditions of the Contract: [ insert: description ] 12. Validity of this Proposal: for a period of [ insert: number ] days after receipt of this Proposal by the Purchaser 13. Procedures to be followed: (a) You are requested to notify us of your acceptance, comments, or rejection of this detailed Change Proposal within [ insert: number ] days from your receipt of this Proposal. (b) The amount of any increase and/or decrease shall be taken into account in the adjustment of the Contract Price. For and on behalf of the Supplier Signed: Date: in the capacity of: [ state: “Supplier’s Representative” or other higher level authority in the Supplier’s organization ] Section VII. Sample Forms 549 8.5 Change Order Form (Purchaser’s Letterhead) Date: [ insert: date ] Loan/Credit Number: [ insert: loan or credit number from IFB ] IFB: [ insert: title and number of IFB ] Contract: [ insert: name of System or Subsystem and number of Contract ] To: [ insert: name of Supplier and address ] Attention: [ insert: name and title ] Dear Sir or Madam: We hereby approve the Change Order for the work specified in Change Proposal No. [ insert: number ], and agree to adjust the Contract Price, Time for Completion, and/or other conditions of the Contract in accordance with GCC Clause 39 of the Contract. 1. Title of Change: [ insert: name ] 2. Request for Change No./Rev.: [ insert: request number / revision ] 3. Change Order No./Rev.: [ insert: order number / revision ] 4. Originator of Change: [ select: Purchaser / Supplier; and add: name ] 5. Authorized Price for the Change: Ref. No.: [ insert: number ] Date: [ insert: date ] 549 550 Section VII. Sample Forms [ insert: amount in foreign currency A ] plus [ insert: amount in foreign currency B ] plus [ insert: amount in foreign currency C ] plus [ insert: amount in local currency ] 6. Adjustment of Time for Achieving Operational Acceptance: [ insert: amount and description of adjustment ] 7. Other effects, if any: [ state: “none” or insert description ] For and on behalf of the Purchaser Signed: Date: in the capacity of: [ state: “Project Manager” or higher level authority in the Purchaser’s organization ] For and on behalf of the Supplier Signed: Date: in the capacity of: [ state “Supplier’s Representative” or higher level authority in the Supplier’s organization ] Section VII. Sample Forms 8.6 551 Application for Change Proposal Form (Supplier’s Letterhead) Date: [ insert: date ] Loan/Credit Number: [ insert: loan or credit number from IFB ] IFB: [ insert: title and number of IFB ] Contract: [ insert: name of System or Subsystem and number of Contract ] To: [ insert: name of Purchaser and address ] Attention: [ insert: name and title ] Dear Sir or Madam: We hereby propose that the below-mentioned work be treated as a Change to the System. 1. Title of Change: [ insert: name ] 2. Application for Change Proposal No./Rev.: [ insert: date ] 3. Brief Description of Change: [ insert: description ] 4. Reasons for Change: [ insert: description ] 5. Order of Magnitude Estimation: [ insert: amount in currencies of the Contract ] 6. Schedule Impact of Change: [ insert: description ] 7. Effect on Functional Guarantees, if any: [ insert: description ] [ insert: number / revision] dated: 551 552 8. Section VII. Sample Forms Appendix: [ insert: titles (if any); otherwise state “none” ] For and on behalf of the Supplier Signed: Date: in the capacity of: [ state: “Supplier’s Representative” or higher level authority in the Supplier’s organization ]