RIS Business Case Presented to IT Strategy Group on 2008 Purpose of this Document This business case demonstrates the urgent requirement for the replacement of the Radiology Information System (RIS) Key issues A RIS is a computer system designed to support the operational and business analysis within a Radiology Department The current contract will end March 2010. The Trust can either extend the contract, at an unknown cost, for a maximum of 2 years or procure a new one. The RIS is a repository for all imaging appointments, reports and results, to not have one would affect the whole Trust. Summary of Recommendations To purchase a new RIS before the end of the contract and undertake full data migration of all Radiology information. Author and Contact Person Sponsor Date to be approved by Trust Board Version Number Issue Date 2.3 19/11/08 Review Date Radiology RIS Business Case 5.11.08 Executive Summary Introduction The purpose of this document is to set out the Business Case for the procurement of a Radiology Information System (RIS) at. A RIS is a computer system designed to support the operational and business analysis within a Radiology Department. It is also a repository of all imaging reports and results, and in the future will contribute to the Electronic Patient Record. The RIS includes data on all Radiology imaging specialities. It is an essential component of the modern imaging workflow and integrates closely with existing systems such as Picture Archiving and Communications System (PACS) and Patient Administration System (PAS). The business case for the implementation of the PACS identified and included rationale for the replacement of the incumbent RIS. The benefits realisation and strategic plan for the PACS project recognised that the two systems were critically linked. A future upgrade or replacement of the RIS was essential to realise both the expected quality and financial benefits that the implementation of PACS would deliver. The replacement of the existing RIS system within Radiology is highly important and has a key deadline date. This is due to notice being given to the Trust by the current vendor, that the product currently used will no longer be supported by them from March 2012. Current vendor are also ‘sun setting’ their resources on this product so any technical or developmental support that is required up to this period will be difficult to source. An original date of March 2010 has been extended to 2012 by negotiations with Connecting for Health (CfH). The programme manager from CfH has stated to still aim for March 2010 as being the deadline date. This gives a limited window to procure and install a new system. Without a RIS system the Radiology department would find it impossible to function and so would have a major impact throughout the rest of the Trust. The procurement of a new RIS would facilitate: Unification of the Trust-wide Radiology imaging information workflow (include MRI reports and patients appointments on the system), and increase the stability and robustness of these products The Trust in the provision of a seamless Radiology service throughout the organisation Standardisation of the Trust wide Radiology datasets to facilitate improved quality of data Management and financial reporting Customisation of RIS functionality to meet Specialist requirements Workflow optimisation within Radiology through RIS/PACS Desktop integration and the adoption of Voice Recognition technologies in Radiology as well as continuation of digital dictation which is being used fully. This in tern would improve report turn around time and diagnostic wait time The realisation of the full benefits of PACS in terms of efficiency Page 2 of 78 Radiology RIS Business Case 5.11.08 The provision of a reliable RIS/PACS Business contingency and Disaster recovery plan Seamless integration with existing trust System Technologies including, PAS, eventual EPR, order comms and the Trust’s Contract and Financial Systems Developments in telemedicine and teleradiology inside and outside the Hospital. This process could be used for the delivery of oncology diagnostics, but also strategically in development of future business opportunities Clinical Governance by supporting clinical decision making The continued guarantee that both diagnostic images and reports are available as required, throughout the organisation, and externally at the point of need Radiology to meet ever increasing activity levels, with reference to imaging access and report turn around times and meeting 18 week pathway targets Radiology in achieving a 4 week diagnostic wait target as stipulated by the Trust The further development of a business model for Radiology, facilitating competitive delivery of services for internal and external market forces. Continuity of service by migrating historic Radiological data from the existing RIS database, thereby facilitating complete Radiological diagnostic record Performance monitoring of Radiology services with a robust performance framework to deliver services in a sustainable and competitive manner The document sets out the Business Case for the proposed investment and is based on a five point business case model. 1. 2. 3. 4. 5. Business Requirements Strategic Case Economic Case Financial Case Management Case 1. Business Requirements This section details the business requirements including the expected benefits, business and user objectives, that will be realised following the successful implementation of a new RIS. 2. Strategic Case The procurement of a new RIS will equip the Trust with the software required to achieve sustained improvements not only within Radiology but every other area that uses Radiology’s services. The key strategic rationale for the procurement of a new RIS is to: Page 3 of 78 Radiology RIS Business Case 5.11.08 Improve quality of care Improve Radiology’s performance Increase efficiency, productivity and eliminating waste Improve patient experience Improve patient safety and reduce clinical risk Provide accurate and up to date management information quickly Support decision making and management forecasts There are also external strategic drivers which will impact upon business of both Radiology and the Trust: 3. 18 Week Wait Patient Choice Economic Case It is well established that the current legacy RIS has a limited future within the market place. Its sustainability and resilience are under question. If there is no RIS system available to Radiology then this will have disastrous effects on the whole Trust. No Radiology examinations would be able to be booked, no reports would be available and no imaging would be available as the PACS system would not continue to function. The current functionality, although working well for Radiology, does have some severe limitations which impact heavily on the clinical and business objectives of Radiology. After evaluation of the current RIS market place, an option appraisal was conducted which resulted in three clear potential routes: Option 1: Option 2: Option 3: Do nothing Find a third party company to take on the product. Procure a new RIS from the market place by going out to tender Procurement of a new RIS was deemed to be the most appropriate economic decision. Whilst the initial investment is greater and short term disruption of services is inevitable, the quality and operational benefits will be far greater with procurement of a new system. Any new and current business developments introduced will not be supported with the current RIS infrastructure. The product will no longer be available from 2012 and there has been no indication of the financial cost of the two year extension from 2010. These facts strongly indicate that failure to carry out a full replacement of RIS before 2010 is not a realistic economic option. A new RIS is a sustainable investment and is therefore deemed to be the most appropriate way forward. 4. Financial Case The purpose of this section is to provide an evaluation of the affordability of the preferred option. Page 4 of 78 Radiology RIS Business Case 5.11.08 The original PACS business case (2006) recognised that a replacement RIS was essential to realise the financial and operational benefits of PACS and within that case the RIS replacement was scheduled for 12 – 18 months post deployment of PACS. Within the financial analysis for PACS the funding allocation required for RIS was included, and at that time was estimated at £. This was to provide a fully functioning and integrated RIS. Unfortunately this amount now seems unrealistically low in today’s climate. Key items such as data migration, voice recognition and business functionality must be purchased which will add to the over all cost substantially. An estimated cost would be £for this project to be successful. * A new RIS represents the most appropriate financial investment, both tactically and strategically. Whilst there is an appreciation that the initial capital outlay is greater, the option provides greater long term stability not only to Radiology but the Trust. 5. Management Case This final part of the business case explains how the implementation will be handled so as to ensure successful delivery of the RIS implementation. With an investment of the size and complexity of that proposed under this business case, sound project management is recognised as being of paramount importance. The project will therefore follow the PRINCE 2 project management pathway. The lead will have previously gained experience in implementing a large scale radiology project. A formal project team and organisational structure comprising staff from various parts of the Trust and beyond will be established prior to the implementation phase of the project. The project will need the support of Trust, senior executives and clinicians, and the key decision-making and consultative bodies within the Trust. Conclusion It can be concluded from the Business Case that the procurement of a new Radiology Information System is essential to support the Trust’s strategic objective of being a modern paediatric healthcare provider of choice. This business case seeks approval to proceed with purchase and implementation of a resilient, modern, high functionality RIS. This will deliver all the required performance, qualitative and financial benefits, expected in an efficient Radiology department. * Cost worked out by previous information provided during PACS implementation and discussions with TRUSTIT department Page 5 of 78 Radiology RIS Business Case 5.11.08 Table of Contents Executive Summary 1. Introduction 2. Background 2.1 The Hospital 2.2 Clinical Service Unit of Radiology 2.2.1 Overview 2.2.2 Workload 2.2.3 Image Reporting 2.3 Information Systems 2.4 PACS 2.5 Connecting for Health (CfH) and Central Data Store (CDS) 2.6 Scope of Procurement 2.7 Current Practice 2.8 IM&T Environment 3. Business Requirements 3.1 Business Objectives 3.2 Expected Benefits 3.3 User Objectives 4. Strategic Case 4.1 Key Performance Areas 4.2 Key Performance Indicators 5. Economic Case 5.1 Option Appraisal 6. Financial Case 6.1 PACS Business Case 6.2 Cash Releasing Benefits 6.3 Financial Option Appraisal 6.4 Financial Conclusion 7. Management Case 7.1 Project Management Structure and Methodology 7.2 Project Board 7.3 Project Team 7.4 Implementation Team 7.5 Team Members 7.6 Project Assurance 7.7 Audit 7.8 RSI Clinical Groups 7.9 Governance Procedures 7.10 Pre Implementation Planning 7.11 Implementation Plan 7.12 Benefits Management 7.13 Financial Cash Releasing Benefits 7.14 Financial Non-Cash Releasing Benefits Analysis 7.15 Appraisal of Qualitative Benefits 7.16 Modernisation Agenda 7.17 Training 7.18 Communications Management Strategy 7.19 Operational Staffing 7.20 Project Reviews 7.21 Post Implementation Reviews 2 8 9 9 10 10 10 11 11 12 12 13 14 14 15 15 15 16 16 17 17 19 20 22 22 23 24 24 25 25 25 25 25 26 26 26 26 26 26 27 27 27 28 28 28 28 28 28 29 29 Page 6 of 78 Radiology 7.22 7.23 7.23 RIS Business Case Project Evaluation Reviews Risk Management Security and Confidentiality 5.11.08 29 29 29 8. Risk Register 30 9. Functional Specification 30 Appendices 31 Appendix 1 Risk Register 31 Appendix 2 Functional Specification 35 Appendix 3 Issues with Current RIS 77 Page 7 of 78 Radiology RIS Business Case 5.11.08 Full Business Case Replacement of Current vendor Radiology Information System (RIS) 1. Introduction has embarked on a major upgrade to its Information Technology (IT) infrastructure in Radiology. The project includes the procurement and implementation of a Radiology Information System (RIS) and its integration with the Trust’s existing Picture Archiving and Communications System (PACS). The replacement of the existing RIS system within Radiology is highly important and has a key deadline date. The replacement of the RIS is a high priority in the Trusts IT Strategy. This is due to notice being given to the trust by the current vendor, that the product we use will no longer be supported by them from March 2012. Current vendor are also ‘sun setting’ their resources on this product so any technical support that is required up to this period will be difficult to source. This gives a limited window to procure and install a new system especially with the data migration which is required of all old RIS attendances and reports that are on the current system. RIS and PACS must be highly integrated to ensure the continuation and improvement of the radiology departments work flow. This business case supports the rationale and the benefits of replacing the RIS on a trust wide basis. The aims and objectives of replacing the existing RIS are: Unification of the Trust-wide Radiology imaging information workflow (include MRI reports and patients appointments on the system), and increase the stability and robustness of these products To enable the Trust to provide a seamless Radiology service throughout the organisation Standardisation of the Trust wide Radiology datasets to facilitate improved quality of data management and financial reporting Customisation of RIS functionality to meet Specialist requirements Workflow optimisation within Radiology through RIS/PACS Desktop integration and the adoption of Voice Recognition technologies in Radiology as well as continuation of digital dictation which is being used fully To act as a catalyst to realise the full benefits of PACS in terms of efficiency To provide a reliable RIS/PACS Business contingency and Disaster recovery plan Page 8 of 78 Radiology RIS Business Case 5.11.08 To ensure a seamless integration with existing trust IT System Technologies including, PAS, eventual EPR, order comms and the Trust’s Contract and Financial Systems To support developments in telemedicine and teleradiology inside and outside the Hospital. This process could be used for the delivery of oncology diagnostics, but also strategically in development of future business opportunities To support Clinical Governance by supporting clinical decision making To continue to ensure that both diagnostic images and reports are available as required, throughout the organisation, and externally at the point of need To enable Radiology to meet ever increasing activity levels, with reference to imaging access and report turn around times and meeting 18 week pathway targets To assist in the further development of a business model for Radiology, facilitating competitive delivery of services for internal and external market forces To ensure continuity of service by migrating historic Radiological data from the existing RIS database, thereby facilitating complete Radiological diagnostic record To monitor performance of Radiology services within a robust performance framework to deliver services in a sustainable and competitive manner 2. Background 2.1 The Hospital Trust has earned its reputation as a first class provider of healthcare. The Trust provides a wide range of high quality services, delivered by skilled professionals who are experts in the care of children, and young people. The Trust also has an excellent track record in its overall performance and making strides towards delivering improvements in line with the NHS targets. The Trust aims to provide top quality and accessible services. It provides care and treatment of the highest quality, which is accessible, evidence-based, effective, and safe exclusively for children and young people. A further aim is to develop the range of specialist services, strengthening our role as a national leader in the care of people with complex health problems. is at the leading edge within the NHS in the investigation, treatment and care of a local population within and the surrounding areas. As a tertiary centre the Trust also treats patients from elsewhere within the United Kingdom and abroad. has approximately 1800 staff and 128 inpatient beds. The Trust successfully deployed the Local Service Provider (LSP) procured AGFA Impax v6.2 PACS in February 2007. This is currently linked to Current vendor which is a legacy RIS. Page 9 of 78 Radiology RIS Business Case 5.11.08 2.2 Clinical Service Unit of Radiology: 2.2.1 Overview The Project Manager for the replacement of RIS and the Operational Manager for PACS is Mrs Sara Elliott. The General Manager of Clinical Radiology is Mr Stephen Howe The lead clinician in Radiology is Dr Iwan Roberts, the Lead Clinician involved in PACS and RIS is Dr Penny Broadley. The Operational RIS Manager is Mrs Gillian Simpson The Radiology imaging modalities available across the hospital includes Computed Radiography (CR), Fluoroscopy (RF), Ultrasound (US), Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Nuclear Medicine (NM) and Theatre work (XA), Dental imaging (DX), Dexa scanning (OT). Currently the Trust clinicians require access to all imaging and diagnostic reports produced by the modalities listed above. As of February 2007, following the implementation of the TRUST wide PACS, extensive work was conducted to ensure that all modalities archive to PACS, following registration on the local RIS. There is no routine printing to film in Radiology at TRUST albeit the facility remains in the department as an emergency back up. Where patients are transferred out from the Trust to other organisations compact discs are, where necessary, created containing the patient’s radiological history. Direct PACS to PACS electronic data transfer is also possible with some local Trusts, using the N3 network. 2.2.2 Workload In 2007/8 approximately 40,000 radiological examinations were undertaken by the Trust. A detailed analysis of the workload is given in the table below. The workload in the department is shown as being consistent in recent years, although there are significant increases in more complex imaging technologies such as Multi Slice CT and MRI and a reduction in plain film imaging. For that reason we would need to allow an annual growth of 5 % over the next 5 years. Page 10 of 78 Radiology RIS Business Case 5.11.08 Department 2007/2008 Radiographs including DEXA Fluoroscopy CT Scanning Ultrasound PET/CT Nuclear Medicine MRI 28915 1570 1983 6222 3 627 1432 Table 1.1 2.2.3 Image Reporting Most clinicians require a report to accompany a diagnostic image, relying on the expertise of a reporting radiologist to interpret the image and give a diagnosis. The replacement of RIS will continue to ensure that once an examination has been reported, it will be available for viewing, with its associated report, outside radiology without the delay of manually transporting the report to the requesting clinician. Current practise within radiology for an acute examination is for a hand written provisional report to accompany the patient back to the ward. With a new RIS there is the opportunity for an authorised report to be produced within the same time frame as the hand written report by using voice recognition technologies. This would speed up the department’s report turn around time as a second visit to the examination would not be required. The technology would be especially useful for part time radiologists who, due to the days they work, are currently not able to authorise all reports within the time available to them on the day of dictation. In the event that an examination could not be reported within the standard timescale, for example when images are taken out-of-hours, PACS will continue to ensure that the images are released for viewing outside Radiology in the knowledge that they will still be accessible for subsequent reporting. 2.3 Information Systems The Trust currently has a Radiology Information System (RIS) in operation. The Radiology Department uses the radiology module of the Patient Administrative System (PAS), licensed and supported by Current vendor Information Solutions of Warwick. The Current vendor radiology information system was installed in 1998 and is a non-windows character based application. As an application it does not support Order Communications Systems, comprehensive workflow data analysis, single user sign on for reporting or any of the more recent IHE RIS workflow tools without further investment by the Trust. The current RIS system used by Radiology only has a further two upgrades available and this product will be not supported by Current vendor from March 2012. Connecting for Health, (CfH), after consultation with Current vendor will extend the life of this product from 2010 to Page 11 of 78 Radiology RIS Business Case 5.11.08 2012. Currently there has been no indication of the financial cost to the Trust and they would have to enter an extension of contract with the supplier. This current situation has been raised and is monitored on the Diagnostic directorate’s risk register. The new RIS will be required to interface with PAS through an interface engine, to enable the transfer of patient demographic information, reports and where necessary to facilitate PAS/RIS event triggered pre-fetching. Data inputted into the RIS must then be available back on an interface engine to help both the coding and finance departments. Soon after go live it is envisaged there will be a procurement and replacement of our current PAS system. Any new provider of RIS must enable the Trust to use a new PAS provider without great financial costs being incurred. The historic RIS data from the Current vendor RIS will need to be migrated onto any new RIS. This is the medico-legal repository for all patient result/report information, prior to PACS. It was highlighted in a recent Current vendor user group meeting that if all Trust’s stayed with the software product until the end it would take two and a half years for Current vendor to undertake all of the data migration required. This is a further indication why this project must start now. The new RIS must have the potential to interface with any proposed Clinical Requesting/Order Communication System. It should also be possible to link to other systems such as the clinical coding or financial systems to facilitate the transfer of activity information from RIS for billing purposes. The interface between the new RIS and the PACS software will enable modality work lists and fully integrated RIS driven reporting, using a combination of voice recognition and digital dictation software. The RIS will capture information generated by Imaging modalities, such as dose and images taken, and will allow detailed data retrieval and statistical reports to be created. These will be used to optimise workflow, support mandatory data returns/reports and facilitate more efficient income recovery. 2.4 PACS was the first hospital in the country to have a fully functioning PACS (film less radiology) in the form of the AGFA Impax product using smart card technology. Both Connecting for Health (CfH) and Accenture (the Local Service Provider), will support the system as the NPfIT solution until 2013. The proposed new RIS must integrate closely with the existing IMPAX product, provide bidirectional desktop integration and facilitate a RIS driven workflow with PACS. 2.5 Connecting For Health (CfH) and Central Data Store (CDS) TRUSThas largely been included in the NHS’s CfH RIS/ PACS programme. In RIS terms the Trust is described as a legacy site (because it has an existing RIS installation). No funding has been made available under the CfH Programme for the upgrade or replacement of the RIS. It was recommended at the time of PACS implementation that workflow optimisation could only be achieved with upgrade of the existing RIS or a replacement with a modern alternative. It was proposed at the time to upgrade the current RIS to include HL7 messaging, which would enable Page 12 of 78 Radiology RIS Business Case 5.11.08 digital dictation, working from work lists, and that the Trust would revisit the topic 12-18 months post PACS deployment. Image storage is done through local storage (SAN) and centrally on the central data store (CDS). Within the PACS programme, legacy sites are entitled to store data in the centralised CfH LSP CDS, following the essential upgrade of RIS. We have undertaken the relevant up grades to our RIS and are now able to send our images to the CDS. Local storage capacity has been recently increased from 12 to 36 months with funding from the Strategic Health Authority (SHA) although the revenue costs for this fall to the Trust. After 36 months data will only be available from the CDS and forms our long term archive and backup. It is essential that any replacement RIS is compatible with the CDS as expansion of the local SAN is expensive whereas the CDS is currently free. It is also envisaged that CDS in the future will allow Trusts to share images. There will be no charge to retrieve other Trusts images where legitimate relationships have been created. Any RIS replacement therefore, must be compatible with CDS use. Strategically report sharing and image sharing will prove vital in the future provision of Radiology services. 2.6 Scope of the Procurement The proposed Contract is for the purchase, installation, implementation, maintenance & support of software (including interfaces) and associated hardware, for a fully resilient RIS solution. The solution must also incorporate comprehensive Disaster Recovery architecture. The proposed contract will also include migration of existing RIS data. The provision of an integrated desktop, including both RIS and PACS functionality, is a key requirement of the Contract. It should also include staff training, long-term technical support and maintenance of the System. The System will have the following outline functionality: Radiology Information System Record and store radiology appointments and attendances including relevant clinical information, the proposed examinations and the professional vetting process Capture and store examination details including dose levels as per legislative requirements Capture and store reports on examinations; the system should enable reports to be entered by keyboard or voice, and include speech recognition facilities Facilities to analyse and report on the workload of the Radiology Imaging department, including easy access to mandatory data returns, reports and financial management Provide accurate data on patient and report tracking, performance monitoring to support and develop business strategy Interfacing with other essential systems such as PAS, Order Communications, EPR Page 13 of 78 Radiology RIS Business Case 5.11.08 Delivery of timely reports in alternative formats to improve service to commissioners 2.7 Current Practice Currently requests for radiology examinations are received on paper forms and the radiology staff enter the details into the TRUSTRIS/PAS radiology module. The creation of a Radiology attendance on RIS facilitates a PACS connectivity manager generated work list, which is available at discrete DICOM imaging modalities. The operator selects the patient demographics from the modality work list to link the patient’s details with the newly acquired images. When the examination is complete the radiographic staff send the resultant images to the PACS archive directly from the imaging modality. Once the images are on PACS they can then be viewed throughout the Trust by any clinician that has a smart card. The images are also available for radiologists to review and report. When they have been reported they are then typed and returned to the radiologist for authorisation. At this point both images and reports are available to the wider clinical community on a single interface. Presently digital dictation is used to create a paper report via the RIS work list. The report is also available to all users of RIS when they look in the text area of the examination in PACS. 2.8 IM&T Environment The Trust runs version v20 of the Current vendor Total Care Patient Administrative System(PAS). A new PAS system will be procured and installed before 2012. The Trust has approximately 190 PCs connected to the Trust PACS network. The PC environment is predominantly Windows XP and 2000 based New PCs are specified at Intel Core 2 Duo, 2 Gb memory, 160 Gb sata hard drive and all PC’s meet CfH minimum standards. The LAN is based on a 1 Gigabit core network with 1 gigabit onboard card with defined resilience. The main networking components (core switches) have a high degree of reliability and redundancy built in, with dual management cards, and multiple power supplies There are 5 diagnostic work stations where radiologists and reporting ultrasonographers use digital dictation to record their reports There are approximately 25 PC’s within Radiology where RIS can be accessed. 3. Business Requirements Page 14 of 78 Radiology RIS Business Case 5.11.08 3.1 Business Objectives The business objectives of this Contract are: To continue to improve the delivery of care to patients by making radiological reports and images available to clinical staff in a timely fashion. Relevant patient data will then continue to be available throughout the Trust To unify the processes supporting the delivery of Radiology Imaging across the Trust by the deployment of a single Trust wide integrated RIS/PACS To replace the end-of-life hardware of the existing RIS System and to migrate the existing stored data onto an industry standard platform To procure and deploy RIS architecture that will minimise disruption, and resultant impact on service To implement a robust RIS Disaster Recovery solution and contingency plan To contribute in the future to the development of the Electronic Patient Record (EPR) as a repository for all information collected during the process of patient care To support developments in telemedicine and teleradiology within the local, national and international Clinical communities To provide upgrades and refresh over the life of the Contract to ensure that the system remains leading edge and fit for purpose To provide robust and sustainable data extraction business tools, for clinical coding and financial returns To facilitate a reduction in Radiology result/report turnaround times To provide quality assurance mechanisms and performance monitoring of Radiology services 3.2 Expected benefits TRUSTalready benefits from the advantages of operating a trust wide film-less Radiology service. However the Trust expects to gain the following benefits from the implementation of RIS: Improved quality of RIS data, supporting business processes and financial recovery Improved accuracy of management reporting Continuation of a film-less service Improved access to images and reports through consolidation of the digital archive and viewing application Page 15 of 78 Radiology RIS Business Case 5.11.08 Improved resilience from new a hardware platform, which manages the risks associated with end-of-life kit, currently in situ Improved data security with the implementation of a resilient Disaster Recovery solution Contribution towards the achievement of the 18-week pathway and a 4 week diagnostic wait target set by the Trust Risk management benefits from bi-directional desktop integration Enable the service to re-design working environment through use of improved technology Enhance teaching and research through greater access to information (i.e. Images and reports available together) 3.3 User objectives The users of the System include clinical staff from radiologists, radiographers and clerical staff within Radiology. Although outside of Radiology, staff do not have direct access to RIS, reports are still sought by medical, nursing and support staff across the whole of the organisation. Other non clinical areas within the Trust also require some level of access to help with financial coding and mapping. From the user point of view the System must be easy to use, intuitive, highly responsive, robust and resilient. The successful Supplier will be expected to assist the Trust in its work on clinical process mapping, so that the full benefits for users and the organisation can be realised. The system should support single sign-on, simple user interface and maximise clinical flexibility. The system should assist the Trust in its use of the CFH smartcard access model as part of the National Programme for IT (NPfIT). Data of old RIS reports and attendances must be transferred onto the new RIS system to reduce any risk caused by them not being available in a live system. 4. Strategic Case The procurement of a new RIS will increase the capability and confidence of Radiology to compete in a market driven environment, where patients and commissioners have freedom of choice. The aim is to equip the Trust with a system that will improve the delivery of high quality, patient focused service. 4.1 Key Performance Areas The key strategic rationale for procurement of RIS is to: Page 16 of 78 Radiology RIS Business Case 5.11.08 Improve performance Improve access times Improve quality of care Increased efficiency, productivity and eliminating waste Improve patient experience Improve patient safety, reduction of clinical risk Provide accurate and up to date management information to maximise income Support decision making and management forecasting Integrate into the Trust’s IT Strategic plans 4.2 Key Performance Indicators Increase the percentage of authorised reports available within 24 hours of appointment. A bench marking exercise has been carried out to determine the percentage of authorised reports available after 24 hours of the appointed examination being carried out. With new technologies being implemented such as voice recognition it is felt that an improvement on this report turn around time can be achieved. Therefore new targets have been set for 2010, post implementation of the RIS system. 24 hours October 2010 45% Increase the percentage of authorised reports available within 2 weeks of the appointment 14 days October 2008 27 % October 2008 October 2010 95% 100% 100 % of all patient radiology examinations completed within 4 weeks from time of request A significant proportion of waste can be eliminated by implementing new systems of work and using modern technology to our advantage. Currently the time from a request card being written to it arriving in the department often takes 2 or 3 days and in some extreme examples this can be extended to several weeks. By ensuring that a new RIS is able to integrate with an Order Comms system, requests could be accepted electronically and any delays abolished. Introduction of a RIS which incorporates greater functionality than the present software will allow radiology to redesign it’s internal workflows and streamline it’s processes to further reduce delays and improve patient access times. Incorporating a business statistic package with the RIS will allow near real time monitoring for diagnostic breaches and improve the management of waiting lists. Currently this is a time consuming manual process. There is limited information available to us about patients 18 week status and we are unable to track where they are in the process. An improved statistics package would also be essential in the management of other areas within Radiology such as room utilisation. Page 17 of 78 Radiology RIS Business Case 5.11.08 95 % of all patient MRI examinations completed within 2 weeks from time of request. All completed within 4 weeks Reduce the number of did not attend (DNA) examinations from 10% to 5% Currently the departments DNA rate is around 10%. By using text message technology to remind parents to bring their child for an examination it is hoped that this will reduce substantially. The Radiology department also needs to look at the work flow of creating an appointment could it be done differently and if so does it make an impact on the DNA rate. Reduce overall cost of each examination Every time someone within Radiology makes a change to the patient’s RIS entry, alteration to an appointment, look at images or types a report, this adds to the overall cost of the examination. By reducing the number of times something is done will reduce the cost of the examination and consequently increase efficiency. By using voice recognition and authorising as soon as the report has been compiled efficiency savings can be made. The voice file no longer has to go to a secretary for typing and then return to the Radiologist for authorisation. 100% of examinations booked in using national examination codes Using the national examination codes will enable correct clinical coding and therefore financial billing will be easier to facilitate. Radiology should also be able to use the patient 18 week pathway identification number to inform finance where the funding for the examination is coming from. Page 18 of 78 Radiology RIS Business Case 5.11.08 5. Economic Case It is a well established fact that the current legacy RIS, provided by Current vendor Information Solutions, has an extremely short lift span remaining. It was installed into the Trust in 1998 and has continued to be upgraded to keep up with technology advancements. Due to a contract end date being issued to the Trust with regards to this product it would be a false economy to invest in new technologies offered such as voice recognition, business objects and single smart card sign on. These alone would create significant improvements within the Radiology departments work flow but as the sustainability of this product is in question there seems to be little reason to invest. The current functionality, although working reasonably well for Radiology, does have severe limitations which impact heavily on the clinical and business objectives of Radiology and without further financial investment would not be resolved. (See Appendix 3) There are three clear options: Option 1: Option 2: Option 3: Do nothing Find a third party company to take the product on Procure a new RIS from the market place by going out to tender Page 19 of 78 Radiology RIS Business Case 5.11.08 5.1 Option Appraisal The option appraisal for the above three options are tabled below: Option Option 1: Do nothing Cost Advantages 1. No additional cost 2. No training requirements for staff 3. No data migration 4. Continued stability of existing services Disadvantages 1. No technical support from April 2012 2. An extension to the current contract must be agreed 3. Sun setting of current product 4. Digital dictation integration is unreliable 5. Request cards and voice files not stored within RIS 6. Software intermittently ‘hangs’ for all end users 7. Reliant on PAS functioning so RIS is accessible 8. Unable to record all of radiology’s activity 9. MRI use a different appointment system 10. Statistics are very difficult and time consuming to pull off RIS 11. Unable to raise bills directly from RIS 12. Not 24 hour support 13 Multiple log ins for radiologists to start reporting 14.Not 100% integration between RIS and scanned request card being viewed 15. No voice recognition technology available Option 2: Find a third party company to take the product on Estimated 1. Known product so no unknown additional training requirements 2. No data migration 1. Cost of contract unknown factor 2. No company may be interested in taking on this product due to market forces 3. Unknown service and support mechanism 4. Extremely risky 5.Current vendor may not want to sell product licence 6. Limited time scale will make this extremely difficult 7. Current financial market may mean that companies do not want to expand into an unknown area 8. Unknown if other Trusts in the same situation would want to go ahead with this option. Page 20 of 78 Radiology RIS Business Case Option 3: Procure Estimated 1. New system tailored to our and install a new £ way of working RIS evaluating all 2. Able to pull statistics quickly RIS products by and easily off RIS going out to 3. Able to use voice recognition tender and digital dictation in a fully integrated system 4. Will enable national examination codes to be used 5. Can create billing accounts and records 6. Can track CD’s that have been sent to other trusts 7. Keep a full record of radiology’s activity 8. Dictation could be fully integral reducing the number of vendors having to contact when there is a problem 9. 24 hours support can be provided making PACS reliability greater 10. Request cards can be stored against the attendance and in the RIS data 11. Not reliant on PAS function to create work lists for modalities and for reporting to be carried out 12. Uni-directional link with PAS, but all data sent to an Interface Engine so radiology information accessible to coding department 13. Whilst PAS system is being altered old patients information can be accessed on RIS 14. Efficient collection of radiology data for government statistic reports 15. Able to assess the market and look at a wide range of systems to make an informed choice 16. Potentially a new generation system with additional benefits 17. All of Radiology’s information will be on one system i.e. MRI information included in RIS 18. Bi directional link between RIS and PACS 5.11.08 1. Increased disruption and training needs 2. Cost 3. All old data must be migrated onto the new system 4. Time taken to procure and install a new system 5. Needs IT department resources and commitment from the Trust to implement Page 21 of 78 Radiology RIS Business Case 5.11.08 Option 1 – Do Nothing – Not Recommended This option entails taking no action with respect to the existing RIS. Our position would depend on discussions taking place between CfH and Current vendor, paying an unknown amount for the extension of the contract. There is no guarantee that the software provider wants to continue in the current market place. It does have the benefit of not requiring any additional training requirements or disruption to the current service offered. However, this option exposes the Trust to continued significant business risk. It is therefore deemed to be an untenable option. Option 2 – Find a third party company to take the product on – Not Recommended This should only be considered with extreme caution. There is no guarantee that Current vendor will want to sell the software licence and it is completely unknown if any other company wants to invest in this solution especially in today’s market place. All major factors such as cost, support and service are completely unknown variables. Option 3 - Procure and install a new RIS evaluating all RIS products by going out to tender - This is the recommended option It allows the department to look and consider all radiology information systems in the market place. Even though time is limited we must take this opportunity to evaluate all the different RIS products available to this Trust so an informed decision can be made. Whilst the initial investment is great, and the short term disruption of services inevitable, the quality and operational benefits will be far greater with procurement of a new system. 6. Financial Case The purpose of this section is to provide an evaluation of the affordability of the preferred option (option 3) 6.1 PACS Business Case In the original PACS Business Case which was produced in 2006 it was recognised that a replacement RIS was essential to realise both the financial and operational benefits of PACS. The RIS replacement was scheduled for 12 – 18 months post deployment of PACS. Within the financial analysis for PACS the funding allocations required for RIS were included, and at the time was estimated at £. This was to provide a fully functional and integrated RIS. Unfortunately this amount now seems unrealistic in today’s climate. Key items such as data migration, voice recognition and business objectives must be purchased which all will add to the over all cost substantially. An estimated cost would be £for this project to be successful. Please see the table below for a break down of this. Page 22 of 78 Radiology RIS Business Case 5.11.08 Description Cost in £000 Capital Cost, hardware and software Digital Dictation, voice recognition software, hardware and licences Data migration and cleaning Interface engine to link PAS to RIS Upgrade to Trust’s network Total These costs have been worked out using previous information supplied during the PACS implementation and discussions with IT. Annual revenue costs for maintenance and refreshment will be approximately £or 10 percent of the total implementation cost. During implementation it is envisaged that there will be a requirement to backfill both a radiographer and also a radiographic aide. This is so staff can be released to undertake project management, training of Radiology staff and the configuration of the new system. Additional resource costs Total Cost £000 Revenue cost Explanation 1 WTE Band 6 Radiographer for a 16 week period 1 WTE Band 3 Radiographic Aide for an 12 week period 6.2 Cash Releasing Benefits The expected financial returns, from the PACS Business Case have been successfully delivered and some places exceeded. With the inclusion of a successful deployment of a new RIS (Option 3) the estimated and agreed financial returns can be more than realised. It is felt there are limited cash releasing benefits for a new RIS. This project needs to be done out of necessity rather than the requirement to improve. If a new RIS was not procured and installed then all of the benefits we have already realised through the PACS project would not be fully retained. There are non cash releasing benefits to this project. For radiologists using voice recognition technology aid in quicker report turn around times. By doing so this would have a direct effect on the 18 week patient pathway and the 2 week diagnostic goal set by the Trust Have the opportunity to link RIS with an interface engine to aid clinical coding and finance departments have a full understanding of the patient’s route through the Trust ** IT do expect some cost but this is unknown as the product is unknown and so the amount to improve is also unknown Page 23 of 78 Radiology RIS Business Case 5.11.08 National examination codes can be adopted so exact financial payments can be compiled Statistic reports can be easily compiled reducing the requirements for management to do this manually. 6.3 Financial Option Appraisal Option Description Capital OPTION 1 – - Nil - now 1. Software unsupported from March 2012. Do nothing Future capital costs when SAN expires 2. Increase revenue costs for support of local archive OPTION 2 – Completely unknown cost 1. Failure that a company will take on the RIS product leaving the Trust in a vulnerable position. Find another software company to take on the product OPTION 3 – 1. £K Procure and deploy capital cost new RIS 2.£K data migration and cleaning Revenue Comments 1. If RIS system is not delivered than PACS benefits that have already been realise will be lost to the Trust 2. One off cost during the implementation of the RIS project. 3. £K VR and DD software licences 4. £K on interface engine connection 6.4 Financial Conclusion Option 3 represents the highest financial investment. It is the only realistic option both tactically and strategically. Whilst there is an appreciation that the initial capital outlay is greater, the option provides greater long term financial return and fulfils the objectives of Radiology and the Trust. Page 24 of 78 Radiology RIS Business Case 5.11.08 7. Management Case This final part of the business case explains how the implementation will be handled so as to ensure successful delivery of the RIS implementation. 7.1 Project Management Structure and Methodology With an investment of the size and complexity of that proposed under this business case, sound project management is recognised as being of paramount importance. The project will therefore be managed in accordance with PRINCE 2 project management technology. A formal project organisational structure comprising staff from within radiology and also various parts of the Trust has been established prior to the implementation phase of the project. The project will need the support of Trust, senior executives and clinicians, and the key decision-making and consultative bodies within the Trust. 7.2 Project Board The Project Board will consist of:- 7.3 Project Team The Project Team currently consists of:- 7.4 Implementation Team The implementation team will be made up of the project team plus other key members within radiology. These include The following specialist areas have been identified: Organisational development lead, Interface Specialist, Communications, IT Technical and Network, Benefit Assessment both pre and post implementation, Project Management, Change Management, Data cleansing and migration. 7.5 Team Members In addition to the resources defined above, representation on the project team will be required from other specialist areas within Radiology – for example, Ultrasound, CT and MRI – to work on the project at specified times during the implementation. These will be defined and specified during the planning phase. 7.6 Project Assurance The Project Assurance function will be the ultimate responsibility of the Project Board. Work associated with Project Assurance may be delegated to this team throughout the Project. Specific roles and responsibilities will be included in the stage plans. Page 25 of 78 Radiology RIS Business Case 5.11.08 7.7 Audit This project will be subject to internal audit to ensure the continued business integrity. 7.8 RIS Clinical Groups Lessons learnt from RIS implementations at other hospital Trusts have recommended that RIS clinical groups be introduced. It is important to recognise that RIS is a clinical system and during implementation will have an effect throughout the Trust, and should therefore be managed as a clinical system with IT support. Clinical commitment and support to the project from its outset is vital so there is acceptance and ownership throughout the clinical setting. RIS is solely a Radiology tool, although the reports will be utilised by many clinicians throughout the Trust. A clinical champion within Radiology, and at least one from another department should be involved in the clinical groups to maintain bi-directional communication throughout the life of the system. 7.9 Governance Procedures An established project management methodology will be utilised which, brings these requirements together into a structured process. The project management methodology used in the project is PRINCE2 (which meets the requirements outlined above and promotes arrangements to ensure both rigorous and structured planning and monitoring and the appropriate involvement of senior staff). 7.10 Pre Implementation Planning Prior to implementing RIS the following activities will be required: Installation of any local network components required to support the RIS Implementation Pre installation work within the computer server room to support software installation and back-up Data cleansing activities on the Radiology Information System (RIS). This has been happening since September 2008 and we hope to have all information up to date before April 2009. A policy for report migration needs to be defined. This will require clinical involvement and commitment – both within and outside of Radiology – to ensure that the policy for data migration currently held on the existing RIS is reflective of a clinical need. Once defined, any data migration policy must be strictly adhered to ensure accurate data reconciliation between the RIS, PACS and CDS system. NB, The migration process is very time-consuming An ongoing programme of communications with all stakeholders and interested parties will be undertaken. 7.11 Implementation Plan A detailed implementation plan will be generated as part of the initial engagement with Supplier. It will be built in accordance with the following principles: Page 26 of 78 Radiology RIS Business Case 5.11.08 The implementation project will start with site preparation, final workflow analysis and the arrival on site of the main RIS components and some workstations that can be set up for training purposes Whilst the Trust is happy to have the supplier leading the project management it also recognises that the contract should be a partnership. Both parties should act together to make the project a success. To this end each component of the implementation should be broken down into more manageable phases, with each component part leading into the next phase of the project. 7.12 Benefits Management The RIS implementations and it subsequent integration with PACS will realise benefits. The full benefits realisation plan will clearly identify the detailed arrangements for achieving the business change and driving out the benefits. A detailed benefits realisation plan will be produced within the coming weeks. This will involve detailed work to identify the scale of anticipated benefits for each of the following benefit types: Financial cash releasing benefits Financial non-cash releasing benefits Quality benefits. 7.13 Financial Cash releasing benefits These categories of benefits have already been discussed within the Financial Case, where the outputs have been used to show how they can contribute to making RIS affordable. 7.14 Financial Non–Cash Releasing Benefits Analysis Analysis must been undertaken of estimated non-cash releasing financial benefits. These represent efficiency savings that would be generated within an integrated RIS / PACS environment. This should be a working document as it will need to be refined as the Trust’s experience with RIS develops. 7.15 Appraisal of Qualitative Benefits An appraisal of the qualitative benefits will also be undertaken. 7.16 Modernisation Agenda A robust RIS/PACS infrastructure underpins and supports the migration towards full Electronic Patient Records. 7.17 Training The supplier will carry out initial training of key staff, using a ‘train the trainer’ approach. Radiology has identified key trainers to undertake cascade training these are Gillian Simpson and Melissa Bielby. The provision of a structured and adequately resources training programme will be a key element to the successful implementation of a RIS system. Page 27 of 78 Radiology RIS Business Case 5.11.08 The Trust has a RIS system manager who will allow staff to develop the necessary skills and expertise required for cascade training amongst Radiology users. The training programme will be specified in conjunction with the RIS supplier. It is envisaged that some support may have to be given outside of normal working hours during the implementation phase, and that an ‘On call’ service for RIS may need to be provided. If so, a limited overtime and Out of Hour’s budget may be required during this time. The supplier will ensure that the training plan identifies the resources required for delivery of the training (including the number of trainers; location and capacity of rooms; and infrastructure and equipment requirements). Training facilities will be required. Work has already commenced within Radiology to identify requirements for RIS training. An analysis must be completed to understand the baseline of training needs and identify training locations. 7.18 Communications Management Strategy The project team will develop Communications Strategy and Plan for the RIS Implementation Project, which reflects the requirements of the Project Team, Radiology department and the organisation as a whole. 7.19 Operational Staffing Once the system is operational, the project staffing requirements will change to reflect the switch from a project environment to an operational day-to-day service. To that end the requirement for project management will gradually disappear and the overall running of RIS be returned to the RIS manager, Gillian Simpson. The RIS Project manager will return to managing the PACS system and undertaking clinical work but will be available to back up the RIS manager when required. 7.20 Project Reviews In accordance with good practice, the project has the following outline arrangements in place for project reviews: 7.21 Post Implementation Reviews Radiology will be keen to ensure the lessons learnt are fed back to improve the effectiveness of those projects that follow within the Trust. This is especially important as the replacement of other key IT systems will be occurring quickly afterwards. 7.22 Project Evaluation Reviews The Project Implementation Team intends to undertake a post-project evaluation, using the benefits detailed in this business case as the success criteria. The objectives of the evaluation will be: Identify how well the project aims and objectives have been achieved. Determine if the project timescales were met, and what corrective actions, if any, were taken. Page 28 of 78 Radiology RIS Business Case 5.11.08 Determine if the project costs were controlled and were within budget, both overall and for each of the parts of the project, and what corrective actions, if any, were taken. Against the benefits realisation plan identify what benefits have been achieved (both cash releasing, if any, and non-cash releasing) and seek the realisation of any outstanding benefits, including the implementation of any procedural and process changes. Creation of a ‘snagging’ list post implementation which will be monitored by the project team and addressed. This will be carried out for the project at a defined period post project completion. 7.23 Risk Management Strategy and Framework The project’s Risk Management Strategy will manage, mitigate and control risks. As part of its project management approach the project team will develop a comprehensive risk register to track and manage project, service and business risks. Risks will be managed at the appropriate level with escalation to the RIS/PACS Project Board when appropriate. 7. 24 Security and Confidentiality Maintaining the confidentiality and security of patient information has been paramount in the NCRS specification (see section 730 of the NCRS Output Based Specification), design and procurement of the NPfIT solutions. All known issues of security and confidentiality will follow Caldicott principles. The issues of patient confidentiality have been taken into consideration when outlining requirements for the system. This includes the requirement for system security that ensures that all those who access and change patient information can be clearly identified through an audit trail. 8. Risk Register The evaluation of risk is an important element of the business case, particularly in large-scale transactions such as this where significant degrees of uncertainty may exist. The potential risks that apply for the deployment and subsequent operation of the RIS service are grouped into the main categories of: Development/Implementation Change Management Operational management Identification and quantification of each risk The project group must determine what actions will be taken to manage each risk and who will own each risk. Page 29 of 78 Radiology RIS Business Case 5.11.08 The results are shown in appendix 1. 9. Functional Specification In order to fulfil the procurement objectives for the proposed new Radiology Information System, a detailed functional specification has been created. This incorporates information on the various modules and core functionality that will be required to deliver the required level of service and integration. The supplier must make the Trust aware of its competence, and any previous relevant experience in this area of deployment. The functional Specification is available in appendix 2. Page 30 of 78 Radiology RIS Business Case 5.11.08 Appendix 1 Risk Register RIS Project Version No 1: 1st October 2008 Risk No 1 Risk Description Explanation Mitigating Factors Risk Owner Insufficient technical, procurement, implementation or project management skills Insufficient NHS training resources Utilise experiences of other adopters. Detailed analysis of project team requirements and skills required in the planning phase. 3 Hardware inadequately sized, performance poor Detailed analysis of the radiology department requirements. Communication between Trust and supplier technical team. Functional specification clearly identifies need 4 Trust requirement for extra items underestimated Refer to others sites and evaluate if further items were required during implementation 5 Integration with existing new systems more difficult/expensive than planned Unplanned costs of getting equipment on line with RIS. Assessment of impact analysis planning programme. 6 Network infrastructure does not support RIS requirements Detailed specification from supplier. Appropriate IT Technical involvement both from the Trust and the Supplier. User involvement and acceptance testing prior to go live. Identify review 2 Utilise experiences of other adopters. Detailed analysis of training requirements and skills required in the planning phase Page 31 of 78 Radiology RIS Business Case 5.11.08 points to check progress. 7 Product companies go into administration or withdraw from the UK market Gain a long term commitment from the company for support and up dates in the product Assess company position in the market place 8 Conflicting Trust priorities means that other projects will take precedent Programme planning, dedicated resources. A realistic timescale for implementation. Flexibility. Call on additional resources and IT Trust commitment to the project 9 Planned/Expecte d funding components not realised Detailed discussions with finance 10 Physical space requirements within the trust are under estimated Find other places to house equipment. Identification of all service users. Supplier specifications for equipment obtained early in the planning phase. New equipment purchases should reflect 'need' and not 'want' 11 Supplier failure to deliver to timescales Agreement of realistic project timescales. Contingency planning. Monitoring of planned v actual. 12 Failure of the organisation to adapt to new technology and to accept changes in working practices Training resources to be in place for all end users. Good project ownership. Regular RIS meetings, disseminate information at other meetings through out the trust. Utilise experiences of early adopters 13 Disruption to radiology and IT services during Good communication to staff as to what is happening and when. Page 32 of 78 Radiology deployment RIS Business Case 5.11.08 Have a thorough training plan to minimise disruption to department and rest of Trust Weekly staff meetings with all staff within Radiology. Monthly RIS meetings. Look at new processes and procedures. Reference to Trusts Functional Specification and suppliers contact. 14 Poor communication 15 Supplier failure to deliver to Trusts Functional Specification 16 Original specification doesn't meet user requirements Reference to Trusts Functional Specification and suppliers contact. Ensure that specification is checked by all stakeholders 17 RIS requirements affected by legislation changes or other changes driven from within the NHS Communication links with appropriate groups responsible for legislative change. Early liaison with supplier 18 Unable to provide support and helpdesk services Discuss with IT to see if we can incorporate this within the IT help desk 19 Data migration costs underestimated Contact negotiation with supplier. Contingency planning 20 Generally poor service performance, including service failure Contact negotiation with supplier. Contingency planning 21 Excessive inflation increases suppliers costs Monitor inflation rate Set the price for the system once tendered Page 33 of 78 Radiology RIS Business Case 5.11.08 22 Suppliers operational service costs underestimated Requirements should be identified in the planning phase. Liaising with suppliers. Review points through out the project 23 Security compromise/virus threat Appropriate specification and monitoring of audit trail requirements. Adherence to national and local policies for anti virus software. Contingency planning. 24 Department performance affected as a result of the implementation of a system change Effective change management strategy. Specification of future processes. Communication with Technical teams - both supplier and Trust Page 34 of 78 Radiology RIS Business Case 5.11.08 Appendix 2 Functional Specification RIS Requirements The functional specification of the Radiology Information System is described in sections below. 1. General Functionality 1.1 Information about Patients The system must have the ability to acquire information about patients from PAS and/or enable it to be directly entered if the patient is not registered on PAS. This is to include: Para Requirements 1.1.1 a) b) c) d) e) f) g) h) i) j) k) l) m) n) o) p) q) r) s) t) u) v) 1.1.2 Suppliers Compliance Statement Patient details; Surname Full given names, Preferred Given Name, Title, Address, Post Code, Date of Birth, Sex, Telephone Numbers (daytime, evening and mobile), Email address, Former Name, Alias or Other Name, Ethnic Origin, Parent/guardian/next of kin Date of Death indicator GP details. GP name GP address Registered GP code Practice code Practice contact numbers PCT Hospital number. The format is a mixture of alpha-numeric and characters 1.1.3 The Trust format must be supported and displayed. NHS number including check digit. RIS should have an algorithm, as defined in NHS I.T. Standards Procurement version 5a, part 212, and section 2, to validate the new NHS number and confirm its uniqueness within the database. Page 35 of 78 Radiology 1.1.4 a) b) c) d) e) 1.1.5 1.1.6 a) b) c) d) 1.1.7 1.1.8 1.1.9 1.1.10 1.1.11 1.1.12 1.1.13 RIS Business Case 5.11.08 Patient Type: Inpatient, Outpatient, GP, A&E, Other. Flag to state that information should not be divulged to anyone Patient’s current status NHS Private, CAT II, Research etc. Current Location (e.g. Ward, Theatre) if an inpatient, or clinic or GP if an outpatient. Known allergies or medical alerts e.g. MRSA etc. It must be possible to restrict the display of sensitive information Other Relevant Clinical information e.g. aneurysm clips, pacing wires, pace maker when requesting specific examinations which should be configurable by the Hospital. Name, speciality and GMC number of Hospital Consultant. Site of referral The system should be capable of capturing the patients relevant Unique Patient Pathway Identifier, with the ability to both import directly from the PAS system (via a choice menu of the existing UPPIs for that hospital number on PAS) or to manually enter this number as necessary. The format is an alphanumeric code of 25 characters. The system must be capable of assigning multiple UPPIs to one hospital number, and to associate multiple Examinations or Attendances with each UPPI. The system must be capable of exporting the appointments and appointments history (including cancellations and appointment offers) to the interface engine linked to the UPPI. This is to allow radiology examinations to be linked to the appropriate 18 Week pathway where there may be several pathways operating concurrently, allowing appropriate booking by Radiology in order to optimise the flow of patients along their pathways. The system must be capable of capturing current (not future) Referral To Treatment Period status (RTT status) for each relevant UPPI, with the ability to both import directly from the PAS system or manually enter RTT status as necessary, with any changes made to the PAS system also being updated to the RIS system in real time. The system should be capable of importing any locally defined RTT status codes used by the PAS system, including any created or updated in the future. This is to allow identification of those patients who have an active Referral To Treatment Period ("clock"). Page 36 of 78 Radiology RIS Business Case 5.11.08 1.1.14 The system must be capable of capturing current 18 Week RTT Start Date for each relevant UPPI with the ability to both import directly from the PAS system or manually enter RTT Start Date as necessary, with any changes made to the PAS system also being updated to the RIS system in real time. This is to allow appropriate booking by Radiology in order to optimise the flow of patients along their pathways. 1.1.15 The system must be capable of displaying an 18 Week RTT End Date for each UPPI with an active clock. The End Date is on day 126 with the RTT Start Date as day zero. This is the last day of the patient's 18 Week clock. 1.2 Maintenance of the Master Patient Index (MPI) 1.2.1 1.2.2 1.2.3 1.2.4 1.2.5 The interface between PAS and RIS is to be real time and unidirectional. The RIS database will contain a full list of patient demographics irrespective of whether a patient has a Radiological History The RIS system must have the ability to prevent duplication of the primary identifier. The RIS system should accept update or merge modify messages from PMI’s and automatically update the changes to the RIS patient record and therefore up date the record on PACS. There must be a Patient Index purification administrative function to identify potential duplicates on predefined matching criteria, i.e. those that are not on PAS. A daily report should automatically be generated to contain this information. The RIS system must have a secure system to allow the manual merge of two registrations if these are found to refer to the same patient. An audit trail of changes made to a patient record either “automatically” or with manual intervention should be available for scrutiny. The RIS system must have a secure system to allow the manual unmerge of two registrations if these are found to refer to different patients. 1.2.6 The system must have the ability for suitably privileged users or System management staff to correct any field in the patient record. 1.2.7 The system must have the ability to search its patient index by at least the: a) Barcode – using barcode to find patient b) Hospital number, c) NHS number Page 37 of 78 Radiology d) e) a) b) c) d) e) f) g) h) i) 1.2.8 a) b) c) d) e) f) g) 1.2.9 1.2.10 1.2.11 1.2.12 1.2.13 RIS Business Case 5.11.08 Patient name, Date of birth. The resultant list of matches must show the patient’s full name, date of birth, 1st line of address and postcode. A “selected record” must include Hospital Number NHS Number Full Name Title Date of Birth Sex Address incl. postcode Contact Numbers If the patient still cannot be found, then the system must have the ability to interrogate the current PAS Master Patient Index to search for that patient. If a patient cannot be found, at least the following should be possible to be checked: Surname as written; Incomplete surname; Each element of a multi-element surname; Alias (e.g. maiden name); Forename and surname interchanged; Date of birth; Wild card The resultant list of matches must show the patient’s full name, date of birth, 1st line of address and postcode. If the patient is present on the current PAS Master Patient Index then the RIS system must have the ability to update its index with the patient’s demographic details and identifying number etc. from PAS’ Master Patient Index. It must be possible to register a patient on RIS separately from PAS in the event of a Medical Emergency or when the PAS, or the interface with PAS, is unavailable. The RIS must have the ability to assign a temporary identifier to a patient and subsequently transfer the data to a permanent identifier. The system must have the ability to record data items in addition to those listed in 1.2.7 above, as defined and selected by the department. It must be possible to create a list of RIS patients without a PAS number registered in a specified time period and to query PAS to find out if they exist on PAS. Page 38 of 78 Radiology RIS Business Case 5.11.08 1.3 Patient Profiles 1.3.1 1.3.2 1.3.3 The system must have the ability to maintain details of patient episodes showing date, type, location, examination, status and referring/ordering doctor, and the facility for editing these examinations. The system must have the ability to present full details of each examination by selection from the episode history area. The system must have the ability to present both current episodes and full historical attendances. 1.4 Information about Examinations An Order Communication System may be provided in the future and a new RIS must be able to integrate with this. The supplier must give full details of how this is achieved, how many sites they have this successfully running in and with which software suppliers. The vendor must also give an estimated cost of how much this work would cost now. 1.4.1 1.4.2 1.4.4 1.4.5 1.4.6 1.4.8 1.4.9 1.4.10 1.4.11 1.4.12 1.4.13 1.4.14 1.4.15 1.4.16 1.4.17 The system must have the ability to enter examination requests onto the RIS directly Date and time If the examination is required to be done as a portable Patient location & whether an inpatient, outpatient or direct referral e.g. NHS, Private, EU patient or Other Examination codes and descriptions as defined by the Radiology Department – the NHS National codes will be adopted in the new system - discrete local coding system is currently in place. Single and multiple examinations per attendance must be supported An indication of whether the examination is urgent or not or the timescale in which it is required e.g. 3 months, 6 months etc Patient LMP as appropriate Prompts regarding contradictions for specific examinations i.e. a CT abdomen scan following a very recent barium study An area to record the height and weight of patient for a nuclear medicine examination Patient Infection control alert; Barrier Nursed etc. Patient mobility (e.g. needs a wheel chair/ trolley, requires oxygen, has drains & IV’s etc.). Need for GA/ sedation. A flag to indicate research patients Free text field for additional information Name, phone number, GMC number and affiliation of referring clinician; Directorate, specialty and Bleep Number if a hospital clinician. – Bleep number would have to be in Page 39 of 78 Radiology RIS Business Case 5.11.08 a free text area. 1.4.17 1.4.18 1.4.19 1.4.21 1.4.22 1.4.23 a) b) c) d) e) f) g) h) i) j) k) l) Referral source for contractual purposes. The referral source Trust identifier and where applicable the PCT must be recorded for each attendance. The system must validate the entry, e.g. report the last time this type of examination was ordered for this patient and warn the user if it seems as though it is being ordered again too soon, or if the examinations are being ordered in the wrong sequence. This should be displayed to the user. The RIS must assign a unique identifying number to each examination. Where there is more than one examination in an attendance there must be a unique number for each examination so that PACS can function properly. This should be assigned at the time the examination is first referred to, e.g. at Appointment or Attendance, whichever is made first. This will consist of numerical and alphabetical characters. Between the appointment and attendance this number must be consistent. The system must assign a cost code to each examination using a look up table, which can be maintained by the Hospital. The system must group Examinations into Attendances for reporting purposes. Each Attendance must be assigned a unique identifying number. Each examination within an attendance needs to be uniquely identified e.g. using a combination of attendance identification number and examination identification number. The system must provide details of which stage the attendance is in. Possible status values include: request sent; request received / on waiting list; partial booking appointment made; (deferred/non deferred flag) appointment suspended patient arrived / Did Not Attend; patient prepared for examination, e.g. sedation/ anaesthetic cream; examination started; examination completed; examination prepared for reporting (e.g. postprocessing, matching with previous non-PACS images); preliminary report dictated; preliminary report transcribed; final report approved. Clinician notified Patient cancelled Clinician Cancelled Imaging Cancelled Preliminary addendum added Page 40 of 78 Radiology RIS Business Case 5.11.08 Addendum approved Status should be visible in the RIS and any interface engine that the Trust has put in place. 1.4.25 The system must have the ability to print all the patient letters, radiology forms and labels needed for the examination either immediately or later if the examination is scheduled for the future. Whilst it is not expected to produce film identification labels, the system must have the ability to produce such labels. At a minimum, for each examination, labels must be printed for the following: a) Patient examination label b) Episode label c) Packet label 1.4.26 1.4.27 1.4.28 1.4.29 1.4.30 a) b) c) d) e) 1.4.31 The patient ID (NHS Number and Hospital ID) Attendance Number must be on these labels. The format and quantity of labels produced should be user defined. The system must be capable of printing reminder letters automatically at a time determined by the Radiology Department. The system must be capable of creating email reminders or SMS texting to a patient automatically at a time determined by the Radiology Department. The system must have the ability to enter and edit records of additional examinations per attendance and apply the additional financial codes. Where an additional examination is taken the examination information must update/ create a modality work list entry. The system must have the ability to capture all data relating to an order, which are required for billing, audit, and organisation of room occupancy. The system must have the ability: to automatically amend the status of examinations from “ordered” to “done” or "cancelled" etc., to record the consumables used and to record who is cancelling the examination and for what reason. The system must have the ability to enter examinations retrospectively, e.g. for registration of films from another hospital or following system downtime. Page 41 of 78 Radiology RIS Business Case 1.4.32 The system must have the ability for suitably privileged users or System management staff to unauthorise and correct any field relating to the examination, even after examination completion. Any changes must be recorded in a log file. In the future the Electronic Patient Record (EPR) must be updated by the RIS module and reflect the status of all orders received by RIS. 1.4.33 5.11.08 The RIS system must send EPR a message when an order has been generated/ on the receipt of the request. The system must send out subsequent messages when the status of the order changes such as an appointment is made / the request is refused/ the order is cancelled/ the patient has attended/ a report is available. 1.5 Scanned Requests 1.5.1 The system must have the ability to receive images of request forms and additional information from document image scanners and associate these images with their appropriate examination requests/ order number. The system must enable these document images to be viewed through the application software. Supplier is requested to state the types and number of document scanner required and how they are interfaced in to the system. Any scanners proposed must have very short warm-up times so that the reception process is not delayed. Page 42 of 78 Radiology RIS Business Case 5.11.08 1.6 Reception Module 1.6.1 a) b) c) d) e) f) g) h) i) j) k) l) 1.6.2 a) b) c) d) e) f) 1.6.3 1.6.4 1. 2. 3. 4. 1.6.5 1.6.6 1.6.7 a) b) c) d) e) 1.6.8 Reception Module must be capable of capturing Patient Demographics with a minimum dataset as follows (see 1.2.7): Hospital/ NHS Number/Temporary number; Full Name; Date of Birth (with an option to enter age if exact date is not known); Sex; Address / Post Code; Contact numbers (day and night); Name, address and telephone number of registered General Practitioner; Source of referral; Contrast allergy, medical alerts, claustrophobia etc. Reception Module must have the ability to: Search (either by Hospital/NHS Number patient name or by date of birth) for pre-registered patients both on RIS and PAS; Register patients with a local RIS number where the link to PAS is not available. Reception Module must have the ability to receive requests via conventional x-ray request form, in which request is entered on RIS by Radiology staff preferably using a patient barcode label or through manual entry. Reception Module must have facility for examination orders to be entered: Directly (as for walk-in, general radiography patients), By linking the order with a previously-made appointment. Reception Module must produce labels for each examination. It must be possible to ‘switch off’ this feature and to make it configurable by examination. The system must have the ability to record the patient’s arrival time in the department and the time of starting the examination. For each modality, the system must be capable of generating a list on paper and on screen This list should: Indicate the appointment time, Give patient name, ward, date of birth, examination type and referrer etc. Patient’s infection control status of patients due to come to the Radiology Department. Once the patient has arrived and been booked into the Department, the order must appear on screen at the appropriate modality for the Radiographer to view and select. Page 43 of 78 Radiology 1.6.9 1.6.10 1.6.11 1.6.12 1.6.13 1.6.14 1.6.15 1.6.16 1.6.17 RIS Business Case 5.11.08 Once the patient has been booked into the Department, the relevant examination schedule and status information must be communicated to PACS and to the Clinical Requesting System/OCS if the request for the examination originated from that system. Where there are multiple studies booked into the system within a single attendance there must be a discrete work list entries on the Modality and discrete records on the PACS archive. The system must provide the ability to enter, edit, cancel and re-enter examination orders, both those that have been requested through the Clinical Requesting System/OCS and those requested by letter, telephone, or presentation without notice. If an examination is cancelled, the reason for the cancellation must be captured and stored, and an appropriate message must be sent automatically to PACS and to the Clinical Requesting System/OCS if the request for the examination originated from that system. The system must provide the facility to record failed examinations, the reason for failure and an outcome e.g. rebooking of the examination. The system must provide the ability to amend the attendance data e.g. adding an additional examination during the attendance. Once details of an examination have been sent to PACS, it should not be possible to delete the examination from the RIS irrespective of whether the examination has been completed although we must be able to amend the examination type. The system must ensure that such cancelled examinations are not included in statistics. The system must provide active Dicom Worklists to convey status tracking on all workstations. 1.7 Appointments Module 1.7.1 1.7.2 a) b) c) d) e) f) g) h) i) The system must provide the ability to quickly allocate referrals to a Waiting List prior to an appointment being assigned. It must be possible to assign the following status to referrals: Held Referred Cancelled Rearranged by hospital Rearranged by patient Arranged DNA Attended Cancelled by patient Page 44 of 78 Radiology j) k) l) 1.7.3 1.7.4 1.7.5 1.7.6 1.7.7 1.7.8 1.7.9 1.7.10 1.7.11 1.7.12 1.7.13 RIS Business Case 5.11.08 Cancelled by clinician Patient chosen to wait It must be possible to extract management reporting data about these patients. The system must have the ability to record multiple suspensions for each waiting list entry as necessary. The system must be able to categorise these as either clinical or patient based and provide a free-text or drop-down field to hold detail about the suspension reason. The system must be able to record a start and end date for each suspension period. The system must provide the ability to make appointments for patients to have radiological examinations in the future. (Referred status). The system must display the patient’s recent examination history. The system must allow an appointment to be made for specified modalities and examinations and automatically create a pending list of those appointments for vetting by an appropriately authorised member of staff. It must be possible to amend this list and, therefore, the actual appointment and to produce an appropriate letter to the patient or their carer. During the vetting process the x-ray history of the patient must be available. Appointment letters and pre-examination preparation details must be generated by the system. This includes the ability to print letters at the time of making an appointment which inform the patient about time, date and type of examination and of any preparation the patient may need to do for this examination e.g. “Nil by Mouth from midnight”. Must be able to incorporate more than one request for the same day on the same letter giving the relevant preparation details i.e. Ultrasound, DMSA and MCU Any patient letter that is generated by the system should be recorded against the examination to which it relates. This should be clearly visible to the appointments clerk. The system must have the ability to set up certain rooms for certain specific examinations and to determine the length of the examination. Examinations of variable length may need to be booked into the same room during any one session. The system must record the date and time that the appointment was booked and the person booking it. The system must have the capability of checking for the availability of staffing resources, equipment resources and stocks and supplies in addition to room time availability during the process of booking and alert user if there is a conflict. The system must have the ability to automatically select Page 45 of 78 Radiology 1.7.14 1.7.15 1.7.16 1.7.17 1.7.18 1.7.19 1.7.20 1.7.21 1.7.22 1.7.23 RIS Business Case 5.11.08 the first available date, time and appropriate room. The system must have the ability not to accept the first time/date slot offered if that is not convenient for the patient. The system must have the ability to recognise public and statutory holidays and prevent bookings being made automatically on those days, but allow bookings to be made manually on them. The system must have the ability to schedule the examination for any modality, date and x-ray room. The system must have the ability to cancel, rearrange, and delete appointments and to record a reason for cancellation, e.g. a hospital or patient cancellation. The system must have the ability to record where a patient Did Not Attend (DNA) an appointment and it must be possible to manually convert an entry of DNA to an entry of cancellation in retrospect if necessary. There must be a complete audit trail about the patients appointment history including all instances of appointment rearrangement The department must be able to enter notes with free text in an electronic note pad area which is related to the appointment. The system must be able to send all appointment information back to the interface engine to allow viewing, tracking management and analysis of diagnostic appointments/attendances as part of the entire 18 Week pathway. The system should be able to high light potential appointment requests which could lead to a patient breaching their diagnostic wait of 4 weeks The system should be able to display a full appointments history detailing all examinations offered to the patient including dates and times and why they were declined or pushed back to a later date The system must have the ability to recalculate the waiting time from date test requested to date examination occurred (and/or date authorised report available) and adjust this calculation based upon an algorithm utilising information on appointment history, offer history and suspension history. The system should be able to alert a suitably privileged user or system manager as to when an examination request / appointment is near to breach it’s 4 weeks diagnostic target, or what ever target is set by the Trust Page 46 of 78 Radiology RIS Business Case 5.11.08 1.8 Attendance Module 1.8.1 a) b) c) d) e) f) g) h) i) j) k) 1.8.2 1.8.3 1.8.4 1.8.5 1.8.6 The RIS must include an Attendance Module in order to: Collect data required by IRMER Regulations including fields: 1 st Operator, 2nd Operator (optional), Practitioner Record positive patient ID by operator Confirm LMP asked of patient where appropriate Confirm Allergies checked where appropriate flag status of requests, e.g. patient arrived, examination in progress, examination completed; assess waiting times within the Department; assess radiographer workload; assess room occupancy; facilitate stock control; document x-ray exposures and screening times; perform reject analysis. Collect data to create Environment Agency Radioisotope waste reports When the patient is booked in for their examination this must trigger a modality worklist entry There must be a discrete entry for each examination even when the patient is having multiple examinations within the same attendance. The Attendance Module must be capable of displaying a real time tracking worklist of all current patients or a single patient from the time of arrival and all stages until the time of leaving the Radiology department and each intervention between the two. The Attendance Module must be flexible enough to allow the maximum amount of data to be entered with the minimum number of key strokes, incorporating the use of intelligent barcode readers and default data, e.g. for number of exposures, time of day, an on call period etc. Where possible fields should be populated with “known” data. The Attendance Module should be capable of receiving and storing relevant data from the Modalities & PACS (number of images taken, number of images rejected, reason for rejection, kVp, mAs, screening time, radiation dose, etc.). The Attendance Module must be capable of receiving and storing information relating to Contrast and radioisotope utilisation (e.g. contrast type, amount, batch number, whom injected by, reactions, waste etc.) For Contrast administration: a) Contrast administered, b) Batch number c) Contrast concentration, Page 47 of 78 Radiology d) e) a) b) c) d) e) f) 1.8.7 1.8.8 1.8.9 1.8.10 1.8.11 1.8.12 1.8.13 RIS Business Case 5.11.08 Contrast volume, Person administering. For Radioisotope use there must be information capturing: radioactivity administered, radiopharmaceutical, time of administered, batch number vial ID, multiple injections, Person administering. We must be able to make various fields mandatory for certain examinations Post examination data in Nuclear medicine such as isotope used, quantity, who injected and batch number. The RIS should accept radiation dose information automatically from those modalities, which support MPPS and allow manual entry of radiation dose information from those, which do not support MPPS. Ability to automatically flag out of hours cases Free text field at attendance level to be accessible by reporting radiologist Radiographer completing the examination must be able to assign the completed examination to a specific radiologist or a General pool for reporting. The nuclear Medicine department should be able to keep a record of the stock and waste they use and create and be able to produce reports of this data. The system should alert Radiographers when an examination has not been completed so that the appropriate action can be taken 1.9 Media/ Film Tracking Module 1.9.1 Although the TRUSThas been film-less for almost two years, the Trust will be dealing with removable media for some time yet. There is the requirement to track information about PACS CDs and DVDs 1.9.2 1.9.3 It is essential, therefore, that the new RIS has the capability of recording information about films and CD and their locations. The system must have the ability to enter and display the location of any patient's X-ray packet or a patient’s CD with the date of movement The system must have the ability to enter and display the identity and address of the recipient of any patient's X-ray packet or CD with the date of loan and the reason for the loan (e.g. for court cases) or export. Page 48 of 78 Radiology 1.9.4 1.9.5 1.9.6 1.9.7 1.9.8 1.9.9 a) b) c) d) e) f) g) h) RIS Business Case 5.11.08 The CD Tracking Module must be capable of tracking multiple master packets and also single examinations. The system must have the ability to print reports of all signed out X-ray film packets by recipient and by location. The system must have the ability to generate overdue loan lists. The system must have the ability to generate an audit trail of loans All loan functions should be performed with a minimum of keystrokes using barcode readers wherever possible. Where a CD or DVD is generated and then tracked out to a location the following information is to be captured: Date of request Requesting source Requesting Location Reason for Request Date CD/DVD created CD/DVD Operator/Dispatcher Courier where appropriate Encryption password 1.10 Examination Reporting Module 1.10.1 1.10.2 1.10.3 1.10.4 1.10.5 1.10.6 1.10.7 The RIS system must be fully integrated with PACS software at the Reporting Workstation. The interface between the two components MUST be bidirectional whereby selecting an examination on RIS will automatically open and present the relevant images on PACS and vice versa, opening a study on PACS will open the relevant RIS information and present the reporting screen to the radiologist. Both databases must reflect the same status about an examination. A study reported either in the RIS or the PACS software should be mirrored in the other database in real-time manner. Radiologists must be able to report from worklists It must be possible to call 3rd party viewing applications from the PACS and reporting workstations. Confirmation on whether the application will support Clinical Context Object Workgroup, (CCOW) as defined by IHE, must be provided. CCOW uses "context management" so that each individual application refers to the same patient, encounter or user The system should allow the grouping of types of examination to facilitate reporting by modality for reporting purposes, but also should group Examinations into Attendances. The Brief Clinical Note / Reason for the Examination and Known Allergies or Medical Alerts should be collated and automatically presented to the reporting radiologist and Page 49 of 78 Radiology RIS Business Case 5.11.08 a) b) c) d) e) f) g) placed at the head of each report. A separate Report must be generated and sent to PACS for each Examination, including the instances where a patient has multiple examinations during one attendance. The word processor must provide, at a minimum, the ability to insert, delete, change, save and reinsert words, lines and segments of text, and to search text for words and phrases. The Reporting Module should incorporate a recognised word processor, e.g. Microsoft Word, with comprehensive word processing facilities (e.g. spell checker). If a recognised word processor is not used, Supplier must give details of the functionality of the text editor used for compiling reports. The Reporting Module must be capable of documenting the following: Reporter / radiologist ID status of reporter (e.g. radiologist or radiographer); Additional/trainee radiologist IDs; IDs of radiologists/radiographers who carried out the investigation; transcriptionist ID; ID(s) of person(s) authorising report; a) b) c) d) e) The following should be automatic date/time dictated; date/time transcribed; date/time verified and approved; date/time additional/amended report issued; Clinician alert flag/notification. 1.10.8 1.10.9 1.10.10 1.10.11 1.10.12 1.10.13 1.10.14 1.10.15 a) b) c) d) 1.10.16 1.10.17 1.10.18 If batch reporting is being carried out then it should be necessary to enter items a) – e) only once The system must enable a user with appropriate authority to change the values of the above fields (e.g. the name of the reporting radiologist) where necessary The system must have the ability to print multiple copies of reports at several locations and to maintain a “send to” file to facilitate circulation The system must have the ability to track the progress of reporting by recording the status: report dictated report transcribed report authorised report amended A voice recognition system with the appropriate medical dictionary for reporting is required. The system must display the dictated text in real time to the Reporting Radiologist. DICOM structured reporting should be available. All reports should go to a general typing pool for the transcriptionists to select from Page 50 of 78 Radiology RIS Business Case 5.11.08 1.10.19 The system must have the ability to display listings of reports by radiologist, which have yet to be approved, and the facility for the radiologist to edit and approve the report on-line at this stage. The system must have the ability for transcriptionist’s to edit and approve reports under the radiologist's direction. 1.10.20 The Reporting Module must have a facility for coding individual examinations with a recognised clinical coding system and the ability to support in-house coding structures. 1.10.21 It must be possible to code individual examinations within an attendance. 1.10.22 The ability to flag interesting cases as teaching files for both Education and Research is required. 1.10.23 1.10.24 1.10.25 1.10.26 1.10.27 1.10.28 1.10.29 1.10.30 1.10.31 1.10.32 Please describe the software features provided. The Reporting Module must have a facility for building up a database of standard phrases and standard reports. These must be easy to select and apply (e.g. by mnemonics) when required. Transcribed reports should automatically be queued for on screen editing, verification and approval on the relevant reporter's queue. Multiple approval queues may be required (e.g. a report written by a Registrar may need verification both by the Registrar and by a Consultant Radiologist). The facility to edit a report and to record the identification of the transcriptionist and radiologist or author must be provided. The facility to record a second opinion to a report including the details of both the 1st and 2nd originators. Reported examinations should be listed by default in reverse date order. It must be possible to create worklists by radiologist and also be able to divide this up into urgent and non urgent cases The system must have the ability automatically to re-direct reports, which have not been approved within a specified period to the queue of a designated member of staff for his or her attention. The system must have an auto verify function for all studies where there is a local agreement in place for no radiology report to be issued e.g. imported foreign films. This activity should be triggered when the radiographer has completed and confirmed the recording of the post examination data in RIS. Reports should be available for viewing as soon as they are transcribed for radiology only, but a clear indication must be given of the status of the report (e.g. preliminary, unauthorised). Verified reports must not be alterable; any changes must Page 51 of 78 Radiology 1.10.33 1.10.34 1.10.35 1.10.36 1.10.37 RIS Business Case 5.11.08 be noted through addenda, which in turn require checking and verifying. Any report which includes addenda must be clearly marked and the visible on the first page of the report. Both on screen and in printed reports any addenda must appear before the original report; if there is more than one addendum they must be displayed in reverse date order. This applies to all systems, which are used to display or print reports. There must be a facility for reports to be printed off in batch or individually. For batch printing the sorting order must be user defined (e.g. by Radiologist, by transcriptionist, in chronological order, by modality, by referring consultant etc.). Reports must be communicated to PACS with the status of the report. The most recent version only of the report, including any addenda, must be available to the users of PACS. Reports must be communicated to any potential EPR and/or Clinical Requesting System/OCS with the status of the report. The most recent version only of the report, including any addenda, must be available to the users of proposed EPR and the Clinical Requesting System/OCS. All unreported examinations must be listed by department, examination type and date of examination after a period determined by the type of modality. These lists should be configurable by the user. Supplier is to list available options. 1.10.38 It must be possible to employ user-defined report templates for discrete specialities including Nuclear Medicine and Ultrasound etc, including the use of pictorial report templates. The data collected in these report templates must be available for management reporting. 1.10.39 It must be possible to incorporate a selection of jpeg images and graphs into the report. 1.10.40 It should be possible to attach scanned documents generated as part of the imaging examination and associate it with the report/ examination. E.g. Observation Chart for Nuclear Medicine Graphs for MRI 1.10.41 The system must be able to flag a report as sensitive and subsequently restrict access to it as defined by the user 1.10.42 The system must allow the Reporting Radiologist ease of access to previous Radiology Reports on RIS and associated ease of display historical images on PACS 1.10.43 The system should automatically alert a suitably privileged user or system administrator as to when a report is waiting to be completed or authorised for more than a set time as Page 52 of 78 Radiology RIS Business Case 5.11.08 required by the Trust 1.11 Teaching and Research 1.11.1 1.11.2 1.11.3 1.11.4 1.11.5 The system must have the ability to identify a patient as a research patient either through the Clinical Requesting System/OCS, or directly into the RIS or PACS. The system must have the ability to assign a diagnostic code for each examination using an on-line code finder and the coding systems as appropriate.. The system must have the ability to search the records of examinations carried out using the above codes. The system must have the ability to search the text of reports using plain text keyword fields. The system should have the ability to support Multi Disciplinary Team meetings, (MDT). Both RIS client and web users should be able to add patients to these lists . 1.12 Setting up X-Ray Rooms 1.12.1 1.12.2. 1.12.3 1.12.4 1.12.5 1.12.6 1.12.7 1.12.8 The system must have the ability to define an X-ray Room by code, name, type, place, rooms used, speciality, contractual arrangement, and status. The system must have the ability to allocate rooms to defined radiologists and/or radiographers, taking account of their availability. The system must have the ability to attribute to each room the days of the week on which it will be used, and also to set up ad-hoc use. The system must have the ability to allocate to each room and session a structure of appointment slots, times, durations, numbers of patients per slot, priorities of appointments, special appointments, maximum numbers and whether overbooking is permitted with appropriately controlled access. The system must have the ability to allocate to each room a different structure of appointment slots. The system must have the ability to redefine the sequence of slots, and to transfer patients holding appointments in the old structure to the new one. The system must have the ability to close a room for all or part of a day and record the reason for the closure and the person responsible (e.g. for visits by maintenance engineers). The system must have the ability to enable suitably authorised users to edit the details of any room and to Page 53 of 78 Radiology RIS Business Case 5.11.08 restrict the rooms. 1.13 Equipment Module 1.13.1 1.13.2 a) b) c) d) e) f) g) h) i) j) k) l) Equipment data must form part of the integrated RIS database to enable reporting across the whole database. The system must have a facility for capturing and reporting on the following Capital Assets details for equipment associated with the Radiology department: Make / model / serial number/ service UID , Supplier and contract number; Generator / tube rating; Use / room; Date installed; Life expectancy; Replacement cost; Service dates / service contract details, with a link to booking / appointments; Down time; Log of problems with flag facility for recurring problems; Quality assurance test reports. Trust asset number 1.14 RIS Data Take On / Conversion/System Sizing 1.14.1 1.14.2 1.14.3 1.14.4 1.14.5 1.14.6 1.14.7 The RIS will be required to take on 19 years of historical data from SCH. The RIS must be sized to allow at least a further 20 years of data. The Supplier must provide full details of their general approach to data conversion, including their method of dealing with any partial, incomplete or duplicate records. The Trust currently uses the Radiology module of the Current vendor TcRAD. The Supplier must be prepared to take on the historical data from this system into the new RIS. The Supplier must state whether they have previous experience of converting data from the system mentioned above. The Supplier must be able to merge together data for the same patient held in the current separate systems. NB: This may be possible via the normal patient merge function. The Supplier must provide full details of their method for mapping codes (e.g. exam code, ward, consultant) held in the current radiology information systems into the new System. The Supplier must confirm that they are willing to take responsibility for the data conversion exercise, including liaison with the current Supplier and accurate transfer of data between systems. Page 54 of 78 Radiology RIS Business Case 5.11.08 Page 55 of 78 Radiology RIS Business Case 5.11.08 1.15 Query Tool 1.15.1 1.15.2 1.15.3 Supplier must describe their approach to providing query facilities on a system which holds a large amount of data and which requires consistent, high speed user response. This must specify whether queries are run against the online database or an extracted copy of the data. Supplier must describe how online response times are guaranteed while a large and complex query is run. The RIS must provide a flexible and intuitive query facility for key users. Supplier must provide full details of the query tool available within their application including all the facilities available. Supplier must specify whether their query facility involves the use of any third party product and if so the level of training required for the users. Supplier must specify if this training is included in the purchase price. 1.15.4 The query tool must provide facilities for the specification of fields to be displayed, selection conditions (including the use of NOT, AND and OR), sort parameters (ascending and descending) and fields to be used for grouping. In addition it must be possible to use functions such as count, maximum, minimum, average, sum etc. Supplier must provide full details of all the features of their query tool. 1.15.5 There must be a facility to save a query. 1.15.6 It must be possible to save the query result in a number of formats e.g. text, fixed columns etc. 1.15.7 It must be possible to rerun a saved query by calling it up by name or from a menu. 1.15.8 It must be possible to enter run time parameters to a saved query e.g. time period to run the query for. 1.15.9 It must be possible to print the result of a query and to export it into a Microsoft Office application. 1.15.10 It must be possible to schedule queries to run at certain times. Supplier should state if this is a feature of the query tool or if there is a general scheduling tool used for this purpose. 1.15.11 The query tool must have the ability to use any database field element held by the system. 1.15.12 The Trust would like the ability to create additional tables within the database, which could then be used as part of a query. This would be useful for example where there is a long list of particular patients against which a query is required. Supplier should describe how they would satisfy this requirement and whether the creation of additional tables is possible. Page 56 of 78 Radiology RIS Business Case 5.11.08 1.16 Reporting Tool 1.16.1 1.16.2 1.16.3 1.16.4 1.16.5 1.16.6 1.16.7 1.16.8 1.16.9 1.16.10 1.16.11 1.16.12 1.16.13 1.16.14 a) b) c) d) e) f) g) There must be a flexible and intuitive report writing facility available to key users. Supplier must provide full details of the report writer available in their system. The report writer must have the ability to produce formatted reports using any database field element held by the system. The report writer must provide facilities for the specification of fields to be printed, selection conditions (including the use of AND and OR), sort parameters (ascending and descending) and fields to be used for grouping, subtotalling and totalling. The report writer must allow the use of system variables such as date, time and page number. The Supplier must specify which system variables are available to the user. Any reports defined on site must be able to be run from menus or macros with the minimum amount of additional data entry. Users must be able to provide run time parameters to previously defined reports e.g. reporting period. The end user must not be able to amend a report in any way, other than supplying parameters required to execute the report. The report writer should contain a facility for the automatic scheduling of reports so that e.g. daily, weekly and monthly reports are produced without user intervention and as a background task so that users can continue with other activities. The report writer must allow the specification and use of calculated fields within reports. Both data fields and system variables must be allowed within a calculated field. The report writer must provide facilities for the formatting of reports in terms of page headings and footings, page length, control break headers and footers, sub-totals and totals. The report writer must allow the option of displaying the report to a screen rather than printing it. Supplier will be expected to maintain and supply to the Trust an up-to-date data dictionary to facilitate use of the reporting tool. It must be possible to specify the number of copies of a report to be printed. The system must be able to produce the following specific reports: Waiting list by PCT Patients unknown to PAS Duplicate patients Incomplete examinations Unverified reports Invoice activity report (who was invoiced for what, when they were invoiced, has the invoice been Page 57 of 78 Radiology RIS Business Case 5.11.08 h) i) j) k) l) settled) Inventory (stock status, utilisation history, supply reorder notification) Cumulative individual patient dose Department of Environment radio-isotope disposal report Radiologist workload activity 1.16.15 The Supplier must ensure that the system is kept up to date with all mandatory DOH reports at no additional cost to the Trust. 2. PACS Requirements 2.1 Functional Overview 2.1.1 2.1.2 2.1.3 2.1.4 2.1.5 2.1.6 2.1.7 2.1.8 In order to gain access to a PC the user must be required to enter a username, or account name, and password combination, which must be unique to each user. The password must not be displayed on the workstation screen. Access to PACS and RIS at each workplace must be facilitated through Integrated Windows Authentication and smartcard access. The Trust has adopted Smart cards for CfH applications that connect to the Spine please suggest how these could be utilized in the RIS/PACS workstation environs. We require one single log in for radiologist to be able to start reporting with a fully integrated RIS/PACS system. On workstations used for reporting images (diagnostic workstations) it must be possible to display lists of unreported examinations giving details including the patient's name, age, sex, hospital number, date and time of examination and type of examination. The fields of the reporting work lists must be fully configurable and must include department. Users must be able to access all work lists at any time. The RIS/PACS interface will operate in real time. Standard interface protocols such as HL7, will be used for the PACS interface. The particular protocols and revision levels will be agreed during negotiations with the Supplier. When patient records are merged on the RIS, the option of sending a merge message from the RIS through the interface to the PACS, and the PACS to automatically merge the patient images. While it is expected that all patient identification data will enter the PACS via the RIS, the system will allow sufficient manual entry of data to identify patients should the other system or interface become unavailable. Software facilities will exist to enable such manually entered patient details to be reconciled with data on the RIS when the RIS or interface is restored. Page 58 of 78 Radiology RIS Business Case 5.11.08 2.2 RIS System management facilities 2.2.1 2.2.2 2.2.3 2.2.4 2.2.5 2.2.6 2.2.7 2.2.8 The system must be supplied with easy to use utilities to control and manage it; this includes tasks such as starting and stopping the system, logging off users and terminating tasks or programs, which are out of control. User accounts must be created and managed centrally. There must be a single account for each user. Each discrete user account must be accessible from all RIS workplaces. The system must be supplied with easy to use facilities to enable data and programs held on the system to be backed up onto computer readable media for storage off line. Such backups must involve a minimum, if any, time when the system is unavailable for normal use, and it must be possible to schedule them to run out of normal working hours when the system will be unattended. The system must be supplied with easy to use facilities to enable data and programs to be recovered from off line storage. Facilities must be provided to check the integrity of the file systems and databases which can be run during normal system operation and report on these. Facilities must be provided to correct any inconsistencies found. Easy to use and intuitive facilities must be provided to recover data from backup storage in the event of the loss or corruption of on-line data. Facilities must be provided for monitoring the availability of disc space on the system to ensure that adequate space is always available for system operation. Should disc space become low, easy to use software facilities must be provided to enable files to be moved between discs, or to allow discs to be re-organised to release space. In the event of a system failure in one part of the system, Supplier must describe how the remainder of the system behaves. 3. IT Requirements – RIS 3.1 Database 3.1.1 3.1.2 The Trust’s preferred standard for databases are SQL 2000/2005. Supplier must state the database used by the RIS and whether it is relational and has an SQL interface. If no SQL interface is available Supplier must provide full details of the query language or tool provided. The proposed DBMS must allow “hot” backups and point in time recovery. Page 59 of 78 Radiology 3.1.3 RIS Business Case 5.11.08 All transactions which result in changes to the data on the system must be logged, and facilities must be available for displaying, storing and purging the logs. 3.2 Application Software 3.2.1 3.2.2 3.2.3 3.2.4 3.2.5 The RIS must be supplied with a maintained test system, which will be used for testing new releases of the software prior to acceptance and issue on the live system with the Trusts PACS system. The RIS will also contain a training environment, which can be used to mimic the live system for training purposes. Supplier must provide details of how new releases of software are migrated from the test system to the live or training systems. The Supplier must provide a 2 to 3 year development plan for the System. The Supplier must provide a retrospective schedule of updates and new releases implemented over the past 2 years. 3.3 RIS Back Up 3.3.1 3.3.2 3.3.3 3.3.4 3.3.5 3.3.6 3.3.7 3.3.8 An efficient means of generating backup copies of all data and programs with minimal operator intervention must be provided. The Supplier should provide a full explanation of any backup procedures including media cycles, backup scripts, backup cycles (day/time of backup and type of backup, e.g. incremental), the data backed up, and the data excluded in the backup, backup verification, error correction /reporting. It should be possible to carry out incremental backups. The Supplier should confirm whether the backup procedures proposed are integral to the application, and what restrictions the Trust would encounter if local tailoring of the backup processes is required. The Supplier must specify the time required to do a complete backup of the whole system including the operating environment (using the Supplier’s recommended procedure). The facility to carry out backups with the system on-line, in full functional and operational use, must be provided. The Supplier must state how this is done and what effect this has on the system, data integrity and performance. The proposed backup medium must be capable of backing up the entire system, including any verification processes, within the hours the system is least used. The Supplier must explain how an overnight, unattended backup of the system will be achieved, without on-site Page 60 of 78 Radiology 3.3.9 3.3.10 3.3.11 3.3.12 3.3.13 RIS Business Case 5.11.08 overnight or weekend operator intervention. The Supplier must provide details of the operational tasks associated with the recommended backup processes. If the backup requires special equipment this must be indicated and included within the proposed system configuration. The Supplier must provide full information on the recommended processes for checking and ensuring the successful completion of an unattended backup. This process must be automated, reporting exceptions to the appropriate Trust IT Support staff. The Supplier should provide details of any automated actions the proposed backup processes will employ if a fault or error in performing the backup occurs. The backup and recovery facilities must be easy to use, quick, effective and foolproof. Any system maintenance tasks including back up which require the system to be taken down (off-line) must be stated, including duration of downtime. 3.4 RIS Recovery 3.4.1 3.4.2 3.4.3 3.4.4 3.4.5 3.4.6 3.4.7 The Supplier must provide full details on the recovery procedures, appropriate to the recommended procedures for backup. An efficient means of re-constituting the on-line data and programs following system failure with data corruption must be provided. The Supplier must state how recovery up to the point of the last complete transaction is achieved, how data integrity and security are maintained, and to what extent this is independent of user intervention. The Supplier must state the time required to reload and recover fully from the backed up data once the hardware and operating system are repaired or replaced. The supplier must state the time required to repair hardware and the operating system. The Supplier must provide estimated timings for the restoration from the backup of one year’s data following system failure. The Suppler must state as to where their system will function in a virtual environment which will aid the Trust in a disaster recovery situation 3.5 Housekeeping 3.5.1 The Supplier must provide full details of all proposed and recommended housekeeping tasks required to maintain efficient operation of service. The Supplier must provide details on all housekeeping tasks identifying the following: Page 61 of 78 Radiology RIS Business Case a) b) c) d) 3.5.2 3.5.3 3.5.4 3.5.5 3.5.6 3.5.7 3.5.8 3.5.9 3.5.10 5.11.08 impact on the service error handling and reporting task duration and recommended frequency process of task initiation task dependencies This should apply to the operating system, database and application. The Supplier must state where these housekeeping tasks are not provided as part of the package. The Supplier should confirm whether the housekeeping procedures proposed are integral to the application, and what restrictions the Trust would encounter if local tailoring of these processes is required. If any housekeeping activities require special equipment this must be indicated and included within the proposed system configuration. The Supplier must provide full information on the recommended process for checking and ensuring the successful completion of all housekeeping tasks. This process should be automated, reporting exceptions to the appropriate Trust IT Support staff. The Supplier should provide details of any automated actions the proposed housekeeping processes will employ if a fault or error in performing them occurs. The housekeeping utilities must be easy to use, efficient, robust, effective and foolproof. All housekeeping tasks must be fully documented. Supplier must provide training for all housekeeping routines. The system should provide a job scheduler for performing routine tasks at predefined times and days. 3.6 RIS Printing 3.6.1 3.6.2 3.6.3 3.6.4 3.6.5 The system must provide reprint facilities, controlled by the user, for full or part reports, in the event of reports being spoiled during output. The system must provide the ability for users to redirect or select alternative printers in the event of printer failure. The Supplier must provide details on how this is achieved. The application should not require the use of pre-printed, continuous or multi-part stationery, or paper sizes other than A5. Supplier must indicate any exceptions to this rule. The Supplier must specify all special stationery requirements other than plain A5 paper (e.g. labels) in sufficient detail for stationery to be ordered. The application must be able to use industry standard A5 laser or inkjet printers for the majority of printing requirements. Supplier must clearly specify any nonstandard printers required e.g. label printers, colour printers. Page 62 of 78 Radiology RIS Business Case 5.11.08 3.6.7 Supplier must be able to propose a range of printers, which are supported by the software application to meet all output requirements. 3.6.8 The application must be able to print locally and remotely. 3.6.9 Where printouts exceed one page in length, it must be possible to print a specified range of pages. 3.6.10 The application should feature a ‘print preview’ facility, allowing the user to see clearly the number of pages that will be printed and the general appearance of each page. 3.6.11 The application must allow the user to quickly and easily cancel a printing or spooling operation after it has begun. 3.6.12 It must be possible to print any given screen displayed as it stands e.g. a screen dump (WYSIWYG). 3.6.13 The Supplier must provide options for printers some of which must be capable of printing in colour and some of which must be quiet. 3.6.14 If a colour printer is not being used, the system must distinguish abnormal results by some alternative formatting, e.g. bold type. 3.6.15 The RIS must be able to produce various printed documents including: a) Diagnostic reports (text) b) Letters c) Modality worklists Patient identification labels 3.7 Data Export 3.7.1 3.7.2 3.7.3 The system must have facilities for exporting data in a format, which allows it to be loaded into commercial software packages. The packages supported must include Microsoft Word, Excel, Powerpoint and Access versions 2000 and XP and any future releases. Supplier should describe the export facility and state whether it is possible to define exports using the ad hoc report generator. Supplier must indicate whether there are any limitations on the data items that can be exported. The Trust may also wish to export data for use by other Trust systems e.g. EPR. Suppliers should specify whether this is possible and whether Trust staff can set up the exports. Page 63 of 78 Radiology RIS Business Case 5.11.08 3.8 Error Handling and Robustness RIS 3.8.1 3.8.2 3.8.3 3.8.4 3.8.5 3.8.6 Error messages must be self-explanatory. The Supplier must be prepared to edit unclear error messages on request. Error conditions detected by the application must result in a meaningful diagnostic message, which alerts the user that there is a problem, and provides sufficient information to allow the nature of the error to be identified. The application must be designed to minimise any loss of data or functionality in the event of an error being detected. The application must notify the user if an error has resulted in loss of any data input during that transaction. The application must notify the system manager if an error has resulted in loss of any data committed to the database. The application must create a log of errors and debug messages depending on the Trusts requirements. 3.9 System Management & System Management Documentation 3.9.1 3.9.2 3.9.3 3.9.4 3.9.5 3.9.6 3.9.7 3.9.8 3.9.10 The system must be supplied with easy to use utilities to control and manage it. This includes tasks such as starting and stopping the system, logging off users and terminating tasks and programs, which are out of control. Supplier must provide full details of all system management facilities within their system. A comprehensive package of system and applications management documentation must be delivered with the system. The Supplier must confirm that their documentation covers the following for RIS: System Overview - description of the package. System Configuration - including all devices, system software and package configuration parameters. Start-up and Shutdown Procedures - including system/application start-up scripts and processes including dependencies. Network Configuration. File/Database Description - This should include a diagrammatic layout of the installed system, with descriptions of different directories/files purposes etc. The database schema must be provided. Housekeeping - All proposed, provided or recommended housekeeping tasks must be documented, to include dependencies, prerequisites, error handling, instructions, operational initiation, frequencies, failure implications, updates and output. Explanation and instructions on all housekeeping management functions that should be performed by either the system or application managers. Page 64 of 78 Radiology RIS Business Case 3.9.11 3.9.12 Backup/Recovery - As described in housekeeping above. Print Queues - All print queues and printer management issues. Upgrades - Step by step upgrade instructions, including prerequisites and recovery procedures. Performance Management - Overview of performance tuning and monitoring for maintaining optimum service. Trouble-shooting Guide - Common faults, solutions and fault analysis guide. Security - Overview on how security functions within the package. Explanation and instructions on all security management functions that should be performed by either the system or application managers. Contact Information - Support contact details. The Trust would like the ability to message all end users from a central point. The Trust would like automatic client up grades that don’t require intervention from staff. 3.9.13 3.9.14 3.9.15 3.9.16 3.9.17 3.9.18 3.9.19 3.10 5.11.08 Reference Sites 3.10.1 3.10.2 3.10.3 3.10.4 3.10.5 The Trust wishes to understand in some detail various aspects of suppliers’ experience Suppliers must provide the name of hospitals or healthcare organisations currently utilising the proposed system. Suppliers must show the length of time each organisation has been running the system. Suppliers must give details of at least 2 reference sites, which may contact/visit to see a current installation of the proposed system and configuration. Ideally the proposed site should demonstrate a configuration including interfaces similar to that being proposed in this tender. 4. Interfaces 4.1 Interfaces – General 4.1.1 4.1.2 4.1.3 The Supplier must state their general strategy with regard to interfacing to other Trust systems such as PAS for demographic data. This should include details of any “off the shelf “ interfaces already in existence, any standards imposed (e.g. HL7) and details of any APIs (Application Programming Interfaces) available. Supplier should also state their position with regard to the development of new interfaces. Supplier must list any third party products that will be employed to achieve the interfaces The RIS must be HL7 and DICOM compliant where appropriate. Page 65 of 78 Radiology 4.1.4 5.11.08 The Trust wishes to comply with the CfH and to send patient and image data to the Spine. Supplier must provide a general statement indicating their position regarding the CfH and Spine compliance. a) b) c) d) e) f) g) h) i) j) k) l) 4.1.5 RIS Business Case The system must be able to interrogate and/or receive data from the Trust’s PAS system. The data must include: Unique Patient Identifier Patient Forenames Patient Surname Title Date of Birth Sex NHS Number and status Patient address including postcode, district of residence, phone numbers (home, work, mobile), email Ethnic Group Religion Occupation Category i.e. NHS, PP Next of Kin details – name, relationship, address, postcode, phone number GP details – GP code, name, address, postcode, phone number Admitting Consultant Admitting Specialty As the Trust must alter it’s PAS system in the future the Supplier must state how much this would cost and whether there are any systems they are unable to work with 5. System Characteristics 5.1 System Performance - RIS 5.1.1 5.1.2 5.1.3 5.1.4 5.1.5 5.1.6 5.1.7 5.1.8 Supplier must provide details of the expected and guaranteed response times of their system proposals with reference to their experience in similar environments on databases containing at least 3 years data. Figures to be provided must include response times for a variety of scenarios similar to those below: Simple data entry or update Retrieve a patient record - demographics and attendances Switch between different screens for the same patient Display a report Perform a complex transaction updating multiple records e.g. patient merge Perform a simple query on patients attendances for the day Perform a complex query using 3 years of historical data Page 66 of 78 Radiology 5.1.9 5.1.10 5.1.11 5.1.12 5.1.13 5.1.14 5.1.15 RIS Business Case 5.11.08 Run a complex report Perform a complex data extract Supplier is requested to state the maximum time taken by the system to store reports that have been sent from workstations when working under full load. The time taken to retrieve the first 20 results of any query of the system database and display them on screen as a worklist, folder or selection list ready for subsequent image retrieval and viewing must not exceed two seconds. The time taken to retrieve the image examination list of any patient with a known key identifier, such as hospital number, and display the first 10 entries on screen must not exceed two second. The time taken to retrieve a modality worklist from the system and fully display the entries on the modality workstation must not exceed 1.5 seconds under full load conditions. This shall include the time taken by the interface to convert messages to DICOM format. The Supplier must give details, including calculations where appropriate, to support claims that the proposed system will meet these performance targets. The retrieval and display times for different types of reports under different levels of system loading must be tabulated. 6. System Availability 6.1.1 6.1.2 6.1.3 6.1.4 6.1.5 The system is expected to be available continuously 24 hours per day, seven days per week. The Supplier must provide evidence in their proposals that they are able to meet the availability specified above and describe the infrastructure needed to achieve target availability. The availability in a given operational period is defined as: (Length of operational time-Length of time system is unavailable) over length of operational time expressed as a percentage. During the operational time 8:00 to 18:00 seven days per week, including public holidays (i.e. 70 hours), the minimum operational system must have an availability of 99% when averaged over a calendar month period. The maximum continuous period when the minimum operational system is unavailable will not exceed one hour during the operational time. The number of incidents which cause the minimum operational system to be unavailable during the operational time over a calendar month period will not exceed three. No one item of equipment in the whole system during the operational time will have an availability of less than 95% when averaged over a calendar month period. On the basis of continuous operation 24 hours per day, seven days per week (i.e. an operational time of 168 hours), and the minimum operational system must have an Page 67 of 78 Radiology 6.1.6 6.1.7 6.1.8 6.1.9 6.1.10 6.1.11 6.1.12 6.1.13 6.1.14 6.1.15 RIS Business Case 5.11.08 availability of at least 99% when averaged over a calendar month period, including public holidays. During this operational time, the maximum continuous period when the minimum operational system is unavailable will not exceed eight hours, and the number of incidents which cause the minimum operational system to be unavailable will not exceed three. No one item of equipment in the whole system during this operational time will have an availability of less than 90% when averaged over a calendar month period. Periods of unavailability will be measured from the time the incident is detected or reported to the Supplier’s help desk until the time the system, or particular item of equipment, is restored to full operation. During the hours 8:00 to 18:00 seven days per week, including public holidays, the time to repair a priority 1 fault, must NOT exceed 4 hours from the time the maintenance organisation has been alerted to the failure. Supplier must specify the remedies that will be applied should the target availability not be achieved. Supplier should outline manual contingency arrangements such that the Trust is still able to provide care in the event of system failure. It is expected that the Supplier will use remote support via the Trust’s firewall to enable upgrades, diagnostic tests, and possibly remedial action, to be performed remotely. The Trust will need to be assured that such arrangements do not breach patient confidentiality guidelines, or its obligations under the Data Protection Act. The trust must be informed when suppliers dial into the system. When acceptance tests are performed, the availability of the system and its components will be measured and compared with the standards specified herein. Maintenance cover and technical support will be required 24 hours per day, seven days per week, including public holidays. Any maintenance that is required MUST be done outside of the Departments working day (8:00 to 18:00) if downtime is required. Supplier must specify, and cost as an option, any levels of redundancy they feel are necessary to meet availability requirements and prevent a single point of failure’s causing the entire system to fail. In the event of a failure in any interface (e.g. between an image acquisition device and the PACS, the RIS and PACS, or the RIS and PAS it must be possible to recover and re-synchronise data acquired during the downtime. The Supplier must state the degree of user intervention required for the re-synchronisation. The Supplier must provide a contingency plan to address required recovery actions in response to failures in interfacing systems, medium and long term storage systems, workstations and other major components of the Page 68 of 78 Radiology RIS Business Case 5.11.08 system. 7. System Security 7.1.1 The Supplier must indicate if they are able to conform to the Trust’s Security Policy. 7.1.2 If the application runs under Windows, then it must not be possible for a user to gain unauthorised access to any part of the database by using widely available office automation tools. Supplier is reminded that any security features built into an application might be circumvented if users are able to access database files directly. 7.1.3 Supplier must state whether the security of their application depends on denying user access to popular software, including query tools, database packages and programming languages. 7.1.4 The application must not contain any covert ‘back door’ facility that could be used to allow access to the system without the Trust’s consent. Any attempt to embed such a facility will be regarded as evidence of intent to gain illegal access and may result in prosecution of the Supplier by the Trust. 7.1.5 The application must not contain any covert facility that is designed to stop the software from working or to modify its functionality, whether this is based on elapsed time, number of connections or transactions, a coded signal or any other method. The Supplier must explicitly declare any in-built restrictions on software usage. 7.1.6 Each authorised user must be allocated with a unique name (user-id) and a personal password 7.1.7 Users must be able to maintain and change their own password. A password expiry must be in place, the expiry period to be configurable by the System Manager. 7.1.8 Supplier must give details of innovative use of technology e.g. swipe cards / smart cards to ensure unique user identification. 7.1.9 The designated system manager must have the facility to create, maintain and delete users, or groups of users and associated privileges. 7.1.10 The ability to limit the access must be provided as follows: a) specified workstations b) the access of individual and groups of users to specific system functions or procedures 7.1.11 The designated system manager must have the facility to limit the access of individual users to specific data entities and/or attributes. 7.1.12 Individual users should be able to view on their screens only those menu options or icons which they are entitled to use. 7.1.13 Access to the data must be at a level consistent with the user’s duties e.g. read/write, amend, execute. Page 69 of 78 Radiology 7.1.14 a) b) c) d) e) f) g) 7.1.15 7.1.16 7.1.17 7.1.18 7.1.19 7.1.20 7.1.21 7.1.22 7.1.23 7.1.24 7.1.25 7.1.26 RIS Business Case 5.11.08 The package must provide the facility to report the information on registered users. These must be listed with details of allocated terminals and procedures open to them. The list to be produced on request. users currently registered on the system expired users future users date created date and time of last user session group membership of each user System and application privileges The system must be able to produce a report showing creation, amendments and deletion of users. Any passwords stored by the system must be encrypted. No one, including the system manager, must have the facility to de-crypt these passwords. User IDs and passwords must be subject to controls over format and minimum length configurable by the System Manager. It should not be possible to repeat the same character more than twice within the same user id or password. User IDs and passwords must be subject to controls over format and minimum length configurable by the System Manager. It should not be possible to repeat the same character more than twice within the same user-id or password. Where the system is used as part of a network, access control must be available at the application level in addition to that of the network. It must be possible to create a generic user ID and password for use by visiting clinicians which allows read only access and limited data entry At the end of a specified period of waiting, any user logged into the application, but not active, must automatically be logged out from the system and clear the application window or screen, as appropriate, after having secured the integrity of the database. The opened patient file should be closed so other staff can enter it. Following such a log out event, the application user must be forced to log in again before being permitted to resume processing. Details of the time-out to be recorded in the audit log. The timeout period must be configurable by the System Manager. It should be possible to set a different timeout for clinical and administrative workstations. The system should allow a user to logoff with a single keystroke in emergencies, and require the user to re-login subsequently. The system must allow a secondary user to login without requiring the primary user to logoff e.g. to permit a Radiologist to authorise a report after the secretary has Page 70 of 78 Radiology 7.1.27 7.1.28 7.1.29 7.1.30 7.1.31 7.1.32 7.1.33 7.1.34 7.1.35 7.1.36 RIS Business Case 5.11.08 typed it. Users (clients) must not be allowed to exit from the application system to the operating system unless they are explicitly authorised to do so. Strong precautions must be taken to ensure that computer staff cannot manipulate data and programs. Supplier should indicate how this is achieved. Following a number of unsuccessful log in attempts (configurable by the System manager) to gain access from a workstation, the system must disable the user id for a length of time set by the System Manager concerned. Users must be able to modify their own passwords at any time, and be forced to do so, after a period determined by the system manager, if they have not already done so. Supplier should state whether the system can support the use of workstation access control technologies such as swipe cards or thumb print recognition. If the system will support such technologies, Supplier should describe how they are used and the classes of workstation on which they can be used The system must maintain audit logs of all the additions, changes and deletions to and, optionally, retrievals from, the database with a record of the username of the user who committed the transaction and the date and time of the transaction. Details of the type of transaction with appropriate data elements must also be recorded. It must be possible for the system manager to display, print, archive and purge the audit logs. The system must record all attempts to gain invalid access. If more than three consecutive attempts are made by the same user, the system must make that users profile unavailable for a period determined by the system manager. The system manager must be able to force any or all workstations to log off the system in such a way that all active processes being run through the workstation are terminated in a controlled way that closes all open files and does not corrupt the database. If a workstation, or other peripheral device connected to the system, is switched off, or fails as a result of power failure or equipment malfunction, the system must close down any active processes being run through the device or workstation in a controlled way that closes all open files and does not corrupt the database. To ensure the security of data, including images, the system must permit the copying of all data onto media which can be stored remotely from the system and the mechanisms for doing this will be specified. Page 71 of 78 Radiology RIS Business Case 5.11.08 8. General Requirements 8.1 Development 8.1.1 The Supplier will provide New Releases Leading Edge and Technology Refresh during the period of the Contract. The supplier must define how they will perform this task. 8.2 Product safety and electrical interference standards 8.2.1 8.2.2 All equipment supplied must comply with the appropriate International and European approved standards for product safety and electrical interference. Supplier must list the standards to which their equipment complies. 8.3 Quality of products and services 8.3.1 8.3.2 8.3.3 Supplier must satisfy the Trust that good software manufacturing practices were followed during the development of any program code to be delivered. Acceptance testing is not a sufficient indication of software quality. The Supplier must be ISO 9001 accredited. The project to implement the system will use a PRINCEbased methodology. The precise project management methodology will be agreed during negotiations. 9. Service Requirements 9.1 Delivery, Installation and Demonstration 9.1.1 9.1.2 9.1.3 For the computer hardware being provided as part of the proposal, the Supplier must provide details of the hardware delivery, installation and acceptance process. The Supplier must take full responsibility for these processes and must indicate the involvement required in the process from Trust staff. The Supplier must provide details of the software delivery, installation and acceptance process. The Supplier must take full responsibility for these processes and must indicate the involvement required in the process from Trust staff. The Supplier must describe the PC / client installation process including any use of applets or security certificates. The Supplier should state whether the client installation and Page 72 of 78 Radiology RIS Business Case 5.11.08 upgrade processes can be undertaken remotely and whether they can be automated as batch processes from centrally controlled servers. The supplier must give full details of the minimum specification required of any PC in order to run there RIS product. The contactor must give details of any incompatibilities of RIS with any other product. The Supplier must provide all system software, upgrades, bug fixes, etc. on fully labelled and dated media (e.g. tape, CD-ROM, DVD). On delivery of the system the Supplier must provide Release Notes with all information that is reasonably required to install, configure and tune the application in a networked environment. Following delivery and installation the Supplier must demonstrate to the Trust that the RIS application modules are fully operational. The supplier must give a fully detailed, including cost, of all hardware required and state if the Trust was to purchase the hardware what the implications for product support would be. 9.1.4 9.1.5 9.1.6 9.1.7 9.1.8 9.1.9 9.2 Implementation Services - Technical Support during Implementation 9.2.1 a) b) c) d) e) f) g) h) i) j) k) Under the conditions of this procurement short listed Supplier will be to tender for the following services: Supply and installation of all equipment; Supply of all software, including operating, database, application and interface software; Interfacing the PACS with the RIS, if the two systems are not fully integrated; Provision of a Integrated Windows authentication Interfacing the RIS with the Current vendor PAS or a new PAS purchased in the future by the trust Integration of all hardware and software into a fully functioning system which meets the requirements stated in this Specification; Transfer of data from the existing systems to the new System; Supply of all equipment, System, application software and interface documentation in both hard copy and electronic form; Training of key staff in the Hospital covering both equipment and system management and support, and operational use of the system; Project management to cover the supplier's elements of this project, and liaison with the Hospital's project manager; Continuing maintenance and support of the system, Page 73 of 78 Radiology RIS Business Case 5.11.08 including upgrades, interfaces etc. throughout its lifetime. The Trust will be responsible for the provision of the physical environment required to support the system. However, the Supplier must give full details of the physical environment, including space, electrical, water, drainage and cooling requirements for each item of equipment proposed. The Supplier must warrant that the environment provided by the Trust meets all its requirements. The Supplier must state the project management methodology it will use for the project. 9.2.2 9.2.3 The Supplier must provide details of their approach to implementation and provide an implementation plan. The Supplier must state the technical support roles, which are required for each stage of the implementation, defining the skills, abilities and experience for each role. 9.2.4 9.2.5 9.2.6 9.2.7 9.2.8 a) b) c) d) e) f) g) h) 9.2.9 a) b) c) The Supplier must state the staff that will be involved in the implementation stating the time anticipated for the project and the roles of its staff. The Supplier must indicate what levels of technical support and expertise they expect from the Trust referenced against the roles defined above. The Supplier must give the anticipated time on site for each of these roles at each stage of the project. The Supplier must provide details of the call logging process they will employ during the implementation to handle all faults and requests reported by the Trust. The Supplier must indicate whether implementation problems are handled by their standard Help Desk or by another method. The Supplier must provide details of the training provided for specific user groups including: Consultant Radiologists Radiographers; System Trainers; Radiology Managers; Operational System Manager; Quality Assurance Radiographers; Radiology Secretarial and Clerical Staff; System Administration Staff. The Supplier must provide a detailed training plan for each of the staff group noted in 9.2.8 and Ensure that all the training materials such as training manuals, instruction books, audio-visual material, and workstations be left with the Trust for continuing training by the Trust staff; Maintain a training presence during the period before and after the first day of operation of each phase of the project; supply information relating to time scales and resource implications for the Radiology Department and the Trust of the training programme; Page 74 of 78 Radiology RIS Business Case 5.11.08 d) liaise with the Radiology Department in assessing the competency of staff for training; e) indicate how they will support and update the System Trainers for the duration of the contract; f) supply training to cover all future developments of the System; g) liaise with the Trust’s PACS/RIS Project Manager regarding the appropriate venues for user training;5 days of go live support split into two blocks decided by the trust h) create, in conjunction with the Radiology Department, a dedicated training database of anonymous images, because ‘live’ images cannot be used for training purposes. 9.2.10 The Supplier must have formal quality assurance systems for the following areas: a) Software development b) Support c) Implementation d) Training e) Standards The Supplier should outline these systems in its response. 9.3 Support Services 9.3.1 9.3.2 9.3.3 9.3.4 9.3.5 9.3.6 The Supplier must provide continuing support of the system for the life of the system. Support and maintenance for the system must cover hardware and software maintenance, technical support, regular software upgrades for all types of software on the system, and updates to the system documentation to ensure that it is appropriate for the current revision level of the system throughout its lifetime which will be a minimum of seven years from acceptance. The Supplier must provide leading edge upgrades as part of the maintenance and support agreements. The Supplier must upgrade hardware in the event that a software upgrade or a leading edge upgrade adversely affects system response or availability. Maintenance and repair services will be required to cover 24 hours per day, seven days per week, including public holidays The Supplier must provide details of the maintenance and support services provided. Technical support will be required to cover 24 hours per day, seven days per week, including public holidays. Page 75 of 78 Radiology 9.3.7 RIS Business Case 5.11.08 The Supplier must guarantee the following support response and fix times: Priority Fix Time 1 Response Time 15 minutes 2 30 minutes 6 hours 3 60 minutes 7 days 4 7 days 10 days 4 hours Priority Definitions: Priority 1: This category covers any fault in the System that prevents the Trust carrying out any planned workload on the System Priority 2: This includes errors which have a major impact on the System, but which do not stop the Trust carrying out its planned workload. Priority 3: These errors are inconvenient for the users, but can be endured for a while and do not disrupt the planned workload. Priority 4: These are errors that can be worked around without too much difficulty, but must be fixed in the next release. Planned Preventative Maintenance for core components will be done outside core working hours. System Upgrades must be undertaken outside core hours and all efforts made to minimise the impact on clinical downtime 9.3.8 9.3.9 The Supplier will be required to confirm that system manager training will be available throughout the lifetime of the system. The supplier must indicate what assistance would be given at the end of the contract period to allow the transition to a new supplier service provider 10. Constraints 10.1 Strategic 10.1.1 It is essential that the System proposed in response to this document fits into the Trust’s strategic context. As a consequence it will have an architecture which permits expansion and extension and the Trust must be assured that it will be supported and developed for the foreseeable future. Page 76 of 78 Radiology 10.1.2 RIS Business Case 5.11.08 To provide this assurance the Supplier must assure the Trust that he sees PACS and RIS as long term strategic products of its company. The Supplier must also have a good record in supplying successful systems of this type. It is highly desirable that the Supplier has a support organisation located in the United Kingdom. 10.2 Physical 10.2.1 10.2.2 The System will be located in various areas around the Trust though it is expected that the servers will located in the Trust’s existing computer rooms. The Supplier must warrant that the environment provided by the Trust meets all its requirements. The Trust will install the services required to support the System but it is not envisaged that any major structural changes will be required to the buildings Page 77 of 78 Radiology RIS Business Case 5.11.08 Appendix 3 Issues with Current RIS RIS Project Version 1: 4th November 2008 Number Current Issue / Problem 1 2 No voice recognition available to radiologists without further financial investment. There are currently 4 logins required for a radiologist to start to report. This is time consuming and aggravating. Current vendor do offer a single log in using the smart card but this would have a financial cost to the Trust 3 The system frequently ‘hangs’ with either a white screen or egg timer on display. This happens in many different modes no just reporting but also when booking in patients and doing examination details 4 5 Reliant on PAS working for the RIS to be functioning and available for use It doesn’t contain all of the department’s data as there is a separate system for MRI appointment creation. This should be included within the data we have Statistics are very difficult and time consuming to pull from the system. Business object is available for the Trust but this again would require further financial investment. 6 7 Very difficult to know what has not been completed with regards to examination details or authorisation of reports. There seems to be no automatic reminders with the latter. 8 9 10 Can seem very slow sometimes There is no where to put the patients 18 week pathway identification number National examination codes are currently not used and so it becomes time consuming and difficult to map examinations across to the correct coding level for finance and mapping analysis 11 The electronic diary is very difficult to use and so paper diaries are still used through out the department 12 Data from Radiology does not flow back to PAS so it becomes time consuming for people to see in coding and finance what examinations patients have had Page 78 of 78