Endoscopy Equipment Evaluation and Procurement Draft 5 Full Gastrointestinal Endoscopy Equipment Evaluation and Procurement A Guide to the Process British Society of Gastroenterology 3 St Andrews Place Regent’s Park London NW1 4LB Introduction Outline of Process Process Specific instructions to participants Evaluation Form Evaluation Process Conduct of parties during the evaluation Evaluation adjudication meeting Evaluation proforma Equipment procurement process best practice NHS PaSA Legal Advice 2 3 4 5 6 6 6 7 9 11 12 1 Endoscopy Equipment Evaluation and Procurement Draft 5 Full Introduction It is the role of the endoscopy unit lead clinician to discuss with colleagues including the unit manager, what is needed and when. The procurement team should also be involved at this stage. The group should plan ahead for replacement of equipment and endeavour to take account of procurement implications in their strategic planning processes. When specifying what is needed, you must avoid insisting on compatibility of equipment at any price, requiring a higher specification than really needed, or specifying so narrowly that true competition is inhibited. You must consider every feasible alternative. Give thought to co-ordinated purchases. For example, enquire of colleagues in other specialities whether other types of endoscopes may also be required, such as brochoscopes and cystoscopes. Aggregation of similar equipment needs can bring substantial savings in the item cost, maintenance charges, delivery and in ordering and processing costs. Alternative forms of funding should be considered, such as a leasing agreement or a private purchase initiative. It is important to perform some form of supplier appraisal. Supplier information can be found on the NHS Supplier Information Database (NHS Sid). The potential suppliers should be researched and assessed in collaboration with the purchasing and supplies department who will have access to NHS Sid on PASA’s website. Competitive tendering is a legal requirement if value exceeds the EC threshold, it is essential to comply with local standing financial instructions (SFIs) if less. The introduction of competitive tendering significantly increases an institution’s purchasing power and negotiating position. Cases where there is a sole source of supply are very rare. Procurement specialists should be involved in all aspects of the tender, including the requirements of the European Community procurement directives. Post tender negotiations cannot take place to obtain an improvement in the content of the tender as they are are illegal under EU procurement regulations. The selection of the best value tender should be evidenced and records kept on how the decision was reached and justified. Costs must take full account of all whole life costing considerations. The effective management of equipment involves formally monitoring usage, seeking to minimise running and maintenance costs and negotiating maintenance agreements at keen prices. Yearly maintenance costs (up to year seven) are requested from suppliers in the tender. 2 Endoscopy Equipment Evaluation and Procurement Draft 5 Full Outline of Endoscopy Equipment Evaluation and Procurement Assessment of Need what is needed and when Specification Specification must be unbiased and generic Compatibility with existing equipment cannot be used in the spec for this equipment and cannot be used as an argument for purchasing from your existing supplier Value analysis alternatives considered Co-ordinated purchases Other ‘scopes eg Bronchoscopes and cystoscopes Funding Reliable cost estimates leasing or PPI Supplier appraisal researched and assessed supplies departments can obtain information from NHS Sid Competitive tendering Is mandatory increases purchasing and negotiating involve procurement specialists Be aware of European Community procurement directives Negotiations Post tender negotiations to improve content is not allowed Selecting best value Must be evidenced and records kept on how the decision was reached and justified. Costs must be whole life costings Equipment management formally monitoring usage, minimise running and maintenance costs negotiating maintenance agreements 3 Endoscopy Equipment Evaluation and Procurement Draft 5 Full Process You are about to embark upon a process of evaluation which is intended to provide your unit with new endoscopy equipment. This process and its conduct should be enacted following these guidelines which have been approved by the British Society of Gastroenterology. You must also take into account NHS PASA’s procurement guide and EU procurement regulations. In the past clinicians had considerable freedom to decide the type and make of equipment that they wished to use. With the advent of new procedures enforced under EU legislation, the purchase of equipment valued over £99,695 requires the choice to be justified in the context of a fair tendering and evaluation process. If under this amount must comply with local SFI’s which will still require you to go out to tender. The ultimate goal is to purchase equipment that you choose for sound clinical, technical and financial reasons, but you must take the following points into consideration: 1. European law dictates that a tendering process must occur that is intended ultimately to provide best value for money in the use of public funds. 2. It is extremely important to approach the process of equipment evaluation with a completely open mind in order to ensure an objective and unbiased evaluation. 3. Clinical aspects of the technical qualities of the equipment under evaluation are often poorly understood by the non-clinical members of the evaluation committee and managers that authorise the purchase. This is not always the case as many trusts have purchasing staff specialising in certain medical areas. You need to be prepared to spend sufficient time to explain the clinical aspects to other members of the purchasing team. 4. The process of evaluation must be robust such that it is possible both within your organisation and to external bodies, e.g. a court of law, that the choice of equipment was justified on clinical grounds and was also value for money must be justified against the award criteria given in the tender documents. 5. You must conduct the evaluations of the equipment fairly but rigorously, applying firm conditions to all participants and score the equipment as you find it on the day of use. Only those clinicians who have evaluated equipment from each supplier can have their scoring taken into account and in turn be involved in the decision making process. 6. During this evaluation process you should remember that you are the nominal buyer while the equipment manufacturers or their agents are sellers. In this context, it is the responsibility of the equipment manufacturers to attend and participate in the process. They are responsible for arranging the times of evaluation subject to your unit’s clinical commitments. Since this has been the subject of controversy it is highly advisable to ensure that your unit administrator keeps reliable documentation of all contacts with every manufacturer. It is also important to log (date, time subject, and action) of every telephone call with the manufacturers. If there is an anomaly, try and determine the facts in writing. 4 Endoscopy Equipment Evaluation and Procurement Draft 5 Full 7. Do not allow the process to be rushed by your local NHS supplies or purchasing office. The evaluation must be completed in a fair and equitable way as given in this document; otherwise it may be challenged in the courts. 8. When the time comes for the evaluation adjudication meeting; plan this carefully with a full agenda. Only those clinicians who have taken part in the product evaluations of all suppliers’ equipment should be represented. Ensure all participants attend; there should be no proxy votes or telephone discussions. It would be wise to elect a lead person to head up the evaluation process with responsibility to feedback to the committee. 5 Endoscopy Equipment Evaluation and Procurement Draft 5 Full Specific Introductions to Participants 1. You have been requested to participate in the evaluation of gastrointestinal endoscopes. 2. This is an important process in the objective determination of the type of endoscope that is best suited for your use and of your department. 3. This process is designed to evaluate gastrointestinal endoscopes against a range of criteria that have been found to affect the performance of these endoscopes. 4. It is important that you participate fully in this process to optimise the purchase of endoscopes and make the best use of public funds. The Evaluation Form 1. The evaluation criteria have been divided into three main categories. Within each category, specific criteria are given. The scoring system is also displayed. 2. Please tick only one cell in each row. 3. Comments are optional. Please keep these objective and factual. Bias is not acceptable. 4. Do not write down comments of a personal or pejorative nature. 5. In the final section you may make additional comments. Again keep these factual. 6. Complete the evaluation form immediately after evaluating an endoscope. 7. After completion, please give the form to the person organising the evaluation (Endoscopy Lead Clinician or Unit Manager). Keep a copy. The Process 1. The individual evaluation forms will be kept for at least 3 years and may form part of the legal record of the process of spending public funds. 2. The results of evaluations performed by different individuals will be collated by the Endoscopy Lead Clinician or his or her nominated deputy. 3. They will compute the scores for each evaluation by type and make of endoscope and produce a global (mean or median) score for each make (manufacturer) and type of endoscope. 4. These scores and supporting documentation showing the computation of the scores will be submitted to the purchasing/finance departments to guide management in the purchase of the appropriate endoscopes for the unit. Conduct of parties during the evaluation 1. Organise the evaluations to suit your own timetables with routine lists but make it clear who and when will evaluate and try to arrange consecutive days so that the Companies can optimise their effort and provision of equipment. 2. Log all activities related to organisation thus minimising organisational disagreements later. 6 Endoscopy Equipment Evaluation and Procurement Draft 5 Full 3. Once the equipment has been delivered be sure that all aspects of operation are understood. Also ensure that the technicians washing the scopes are aware of any differences from the in house scopes. 4. After an initial support period do not permit representatives into the endoscopy rooms during lists or to help wash the endoscopes. Suppliers often support staff in cleaning of the scopes at the beginning of the trial to ensure smooth running of the lists, once they have become accustomed to the differences in reprocessing regimes then suppliers should hand over this responsibility to the unit team. The whole point of the exercise is to evaluate not to be shown. If you get stuck then call in the representatives to explain and log this intervention. However some units may find it useful having the supplier in the room during evaluations. Whether a unit decides to let suppliers in the room or not, all suppliers must be treated the same during the tendering process. 5. Representatives should remain in the hospital available for any help when needed. 6. Do not have any conversations with the representatives that involve making ANY comments about the equipment under test OR make comparison with in house or other recently tested scopes. Representatives could use these comments in disputes. 7. Complete the evaluation form at the end of the test list and be completely rigorous. If you think the endoscope was the worst ever then mark it accordingly and add non comparative comments if you wish. For example it is NOT acceptable to state: "This colour is much less detailed than Y company’s endoscope." It may also NOT be desirable to be purely subjective: "This is probably the worst colour enhancement I have seen". Instead try and express your impressions as objectively as possible: “With this endoscope I found it difficult to differentiate red based colours” The evaluation adjudication meeting Everyone must attend. The result of this committee work guides the purchasing executive to sign the order. This is where scores for the clinical and technical aspects of the scopes are presented and debated. The scores cannot be altered. It must be chaired and have a formal agenda and with ratification of the minutes by all. This is where the small print needs to be read carefully and by someone who understands endoscopes and warranties etc. Look for in particular: Warranty conditions e.g. (this is all information that the supplies team will be able to gather from the tender documents) unconditional, escalating cost with time/age of scope, replacements, turn around time , 7 Endoscopy Equipment Evaluation and Procurement Draft 5 Full use with washer disinfectors, processors, service visits, any unusual clauses or statements, clear up any ambiguity. Add-on costs cost of single use items cost of spares, cleaning equipment-extra brushes/cleaning rods of different sizes, lamp replacements availability and cost of connectors for washer disinfectors Scope life costs An assessment of all costs that might reasonably be incurred over 7 years, estimated durability, add-ons, position of equipment in overall inventory of the Unit. Include a risk analysis of trading off second choice against a more expensive 1st choice (for example poor picture quality might lead to litigation in the future if mistakes in interpretation were made as a result of bad colour, cancelled list from absence of replacement scopes). 8 Endoscopy Equipment Evaluation and Procurement Draft 5 Full Evaluation Form NB: Use a different form for each type and make of endoscope Product Evaluated: Gastroscope/Colonoscope/Duodenoscope/Sigmoidoscope/Other ………………………………………………………………………………………………… Model…………….…………………………………………………………………………… Supplier/Maker………………………..……………………………………………………… Evaluation performed by: Name:…………………………..…………………………………… Position: Consultant/SpR/Other……………………………….. Start Date………………… Duration………………… No. of patients ..…………………… Type of procedure…………………………………… Number of procedures………………. Please put a tick in one cell only in each row (the numbers in each cell indicate the score or weighting for that cell). These weightings are given as a guide only; individual trusts may give different levels of importance to categories. Make your comments as objective and factual as possible: Excellent Very Good Average Poor 10 8 6 4 Very Poor 2 5 4 3 2 1 10 8 6 4 2 5 4 3 2 1 10 8 6 4 2 5 4 3 2 1 5 4 3 2 1 With an accessory in Suction – place rate the suction Without performance accessory in place Working Channel Size – is the channel size adequate for therapy being delivered? Accessory Passage – rate the passage of accessory through working channel to distal end? 5 4 3 2 1 5 4 3 2 1 5 4 3 2 1 5 4 3 2 1 Torque – rate the transfer of movement from the scope control body to the distal end 10 8 6 4 2 Flexibility of insertion tube – rate the drivability of the scope in the lumen 5 4 3 2 1 Comments Image Size Colour Reproduction – is the colour reproduced true to life? Close up View Focus Distant View Fit to Hand Control Body Weight Air Delivery – rate the delivery of air 9 Endoscopy Equipment Evaluation and Procurement Draft 5 Full Distal tip deflection – rate the range of distal end angulation / deflection Cleaning and Washing – rate the ease of cleaning and include the additional costs of using some disposable parts 5 4 3 2 1 10 8 6 4 2 Would you find it acceptable to use this type of endoscope on a routine daily basis for your type of work: Yes / No Any other comments (Please be as objective and factual as possible): ………………………………………………………………………………………………… ………………………………………………………………………………………………… ………………………………………………………………………………………………… ……………………………………………………………………………………… ……………………………………………………………………………………………… ……………………………………………………………………………………………… Signed……………………………………… Please return immediately to Endoscopy Lead Clinician or Unit Manager for collation. 10 Endoscopy Equipment Evaluation and Procurement Draft 5 Full Equipment Procurement Process - Best practice from National Audit Office (2000) Need The users decide what is needed and when. They should plan ahead for replacement of new equipment and endeavour to take account of procurement implications in their strategic planning processes. Specification Avoid insisting on compatibility of equipment at any price, requiring a higher specification than really needed, or specifying so narrowly that true competition is inhibited. Value analysis Every feasible alternative should be considered. This can include upgrading existing equipment or purchasing a second hand or ex-demonstration model. Co-ordinated purchases Aggregation of similar equipment needs can bring substantial savings in the item cost, maintenance charges, delivery and in ordering and processing costs. Funding Reliable estimates of the cost of the equipment should be sought. Alternative forms of funding should also be considered, such as a leasing agreement or a private purchase initiative. Supplier appraisal The potential suppliers should be researched and assessed and competitive tendering used refer to NHS Sid. Competitive tendering competitive tendering is mandatory and significantly increases an institutions purchasing power and negotiating position. Cases where there is a sole source of supply are very rare. Procurement specialists should be involved in every stage of the process , including the requirements of the European Community procurement directives. Negotiations Post tender negotiations to obtain an improvement in the content of the tender are illegal. Procurement officers, with appropriate purchasing negotiating skills, should be involved with the evaluation lead. Selecting best value The selection of the best value tender should be evidenced and records kept on how the decision was reached and justified. Costs must take full account of all whole life costing. Equipment management The effective management of equipment involves formally monitoring usage, seeking to minimise running and maintenance costs and negotiating maintenance agreements at keen prices. Maintenance costs up to year seven are requested in the tender documents. 11 Endoscopy Equipment Evaluation and Procurement Draft 5 Full NHS Purchasing and Supply Agency LEGAL ADVICE ON THE LESSONS ARISING FROM PROBLEMS ENCOUNTERED WITH PURCHASING FLEXIBLE ENDOSCOPY EQUIPMENT Recently suppliers of endoscopy equipment have challenged several NHS Trusts over their compliance with competition legislation (EU directives). It is important that Trusts understand that the suppliers of endoscopy equipment have an extensive knowledge of the EU directives and the roles and responsibilities of Trusts embodied within these regulations. Set out below are the reasons for a recent legal challenge brought against one Trust and for it having repeatedly to recommence its tender processes for flexible endoscopy equipment. These comments are based on Pinsent Curtis Biddle’s (legal advisors to the NHS Purchasing and Supply Agency) understanding of what went wrong, which is largely drawn from a complaint brought by an aggrieved supplier and from the external audit procedure commissioned by the Trust itself. It may be that the Trust could dispute that some of the facts are as set out below, but whatever the strict factual position is, the lessons that can be learned will be applicable nonetheless. 1. Extension of Tender Return Period There are essentially three possible providers of flexible endoscopy equipment, namely Keymed UK Limited, Endoscopy UK Limited and Pentax UK Limited. In one tender process two potential suppliers returned their bids by the due tender return date. However, the incumbent did not bid. The Trust then extended the tender return date, after the other two bidders had already submitted their tenders, seemingly in order to allow the incumbent time to submit a bid. Two lessons can be learned here. Firstly, a tender period should never be extended at a late stage in the proceedings when all other bidders are likely to have prepared their bids already. The deadline was extended four hours 12 Endoscopy Equipment Evaluation and Procurement Draft 5 Full after the initial deadline had passed and bidders had therefore already submitted their tenders when they were informed of the time extension. A second lesson is that whilst a contracting authority has some discretion to accept a late tender, it should always ensure that if it exercises that discretion, it does not do so in a way that means that bidders are not treated equally. Any length of an extension should only be very short. For example, if a courier bringing a bid envelope is held up in traffic, it may be considered "de minimis" to allow that bidder to submit its bid an hour or two late. Any such extension hasn't given that tenderer any longer than any other tenderer to prepare its bid. However, granting the incumbent an extra week to produce a tender when all suppliers could have seen the advert placed from the outset, certainly gives the incumbent a theoretical, if not an actual, advantage of having had extra time to prepare its bid. Where any extension to a tender return period would only really have one beneficiary, it should not be granted. An extension to a tender return period should therefore only ever be contemplated in exceptional circumstances. A further problem flowed from having extended the time for preparation of bids in order to let the incumbent submit a tender, since communication between the procurement section of the Trust and the Chief Executive's office was not as good as it should have been. Whilst the procurement section of the Trust requested by letter that the Chief Executive's secretary did not open the two bids already submitted, these were opened five days after the original tender date by mistake, vitiating the whole award process. 2. Technical Specification The aggrieved supplier also alleged that in relation to one award process, the Trust had simply lifted its product specification from a supplier’s product literature. This meant that the specification was inherently biased in favour of their products. The lesson to learn from this is that a specification has to be generic and cannot be based on a specification for an existing product. A specification has to be a genuine assessment of the requirements of the Trust. It must not contain inherent bias towards the product that the Trust is accustomed to using. If the Trust particularly likes the qualities of the product that it is using, 13 Endoscopy Equipment Evaluation and Procurement Draft 5 Full then it must work up a specification that puts into objective terms why the existing product is so good. If this cannot be done without creating bias towards the existing product it should omit these features from the specification but build into the evaluation matrix the possibility of scoring these features highly (ie. so that all tenderers bid against an objective specification but the incumbent's bid will attract extra marks). Again, though care should be taken to ensure that the award criteria are sufficiently broad that all tenderers could score under them (eg. use a general heading "quality" rather than identifying a specific quality feature of the incumbent's product that the other bidders are unlikely to match). 3. Equipment Compatibility The core equipment used for endoscopy is the scope, a processor, and a visual display unit. A single manufacturers monitor is used currently and can be used with any supplier's kit (ie. scopes and processors). The aggrieved supplier alleged that a consultant, claimed that there was "not enough space in the treatment rooms as it is" and therefore, he could not contemplate the possibility of accommodating another manufacturer's processor. However, it is actually perfectly possible to have two sets of kit side by side on a trolley, connecting up to the same monitor on the top shelf of the trolley. This was therefore evidence of bias on the part of clinicians carrying out technical trials. There were also concerns that there was difficulty in operating 2 or 3 manufacturers' kit, because this means that staff have to be trained to operate 2 or 3 sets of kit and thus they could be more likely to make mistakes with dire consequences. If the Trust really is concerned that its staff were more likely to make mistakes when operating 2 or 3 pieces of kit than just one, it could legitimately decide that it will only ever have one piece of kit that it is to be operated. However, what the Trust cannot decide is that because staff are already trained to use the kit of the incumbent supplier, they will never procure from any other supplier than the incumbent. Equally, if it really is the case that a treatment room is too small to accommodate more than one piece of kit at the same time and there is no room to store kits when not in use then it would be a legitimate reason for 14 Endoscopy Equipment Evaluation and Procurement Draft 5 Full never purchasing from more than one supplier. Again though, the trust is not at liberty to decide that this supplier must always be the incumbent. 4. Award Criteria The Trust chose to state the award criteria it would apply in relation to at least one of its tender procedures in the OJEC notice of that procedure. However, it did not then go on to apply these award criteria as the actual criteria by which it assessed the bids it received. A Trust must stick rigidly to whatever it says in the OJEC notice it will use as criteria for assessing its bids. Moreover, if it states that the award criteria are e.g. in descending order of importance, it must then create an award matrix that honours that order of importance so that the highest weightings are attached to the criteria featured at the top of the list and so on. The results of equipment trials must also be fed into the award matrix. It therefore makes sense to devise the criteria by which equipment will be assessed during the equipment trials early in the day alongside the overall award matrix, so that criteria such as "quality" and "technical merit" are appropriately weighted to reflect the importance of the equipment trials and also so that any other aspects of the products that are assessed by the equipment trials are reflected in the list of award criteria published to tenderers. 5. Clinical Trials Several other issues came up specifically in relation to clinical trials. These are as follows. 5.1 Evaluation Methodology The aggrieved supplier noted in its complaint that there was inconsistency in clinical evaluation methodology applied by the various consultants. The Trust's audit report also reported that it seemed that clinical evaluations carried out on this supplier’s equipment were conducted using the incumbent supplier’s equipment as the baseline for scoring. Therefore, any equipment tested could only be graded as the same as or worse than the incumbent therefore no equipment could be graded as better than the incumbent’s. However, the audit report also said that a consultant had said that the 15 Endoscopy Equipment Evaluation and Procurement Draft 5 Full aggrieved supplier’s products were "at least equal" to the current supplier’s. However, he did not score any scopes as high as 10. Therefore, he cannot have been using the incumbent supplier as the baseline for the scoring. Therefore, the different consultants were using different evaluation methodologies. It also appeared that the endoscopy trials carried out in April 2001 on another supplier’s equipment were carried out using no scoring method at all. The lesson to be learned here is that trials of equipment must be carried out in such circumstances as to allow an unbiased comparison of like with like. Rather than simply comparing the bidders' equipment with the equipment of the incumbent supplier, they should set up a matrix of objective criteria, reflecting what their requirements really are. 5.2 Trial Conditions There were various complaints about the way that the clinicians carried out the trials of endoscopy equipment. Testing appears to have occurred in different months, one supplier’s equipment being tested in February 2001, another supplier’s equipment being tested in April 2001 and the incumbent supplier’s equipment not being tested at all: there seems to have been some resistance by clinicians to test the full range of equipment, due to a preference for the products already in use. Consultants need to made aware of their duties under the public procurement rules to carry out tests of new suppliers' equipment against objective criteria whether they want to or not. They must also be aware that they have a duty to apply those objective criteria fairly. Whilst it is true that there is always an element of subjectivity in any scoring process, there should always be an auditable process of objective criteria being applied fairly in order that this could be held up in the face of any challenge, as it is very hard to challenge a process that appears to have involved an evenhanded application of objective criteria. For example, it is very hard to prove that a clinician has given a high score to an aspect of quality, eg. picture quality on the monitor, due to the clinician knowing and trusting the picture quality of the equipment they are used to. It goes without saying that it is not a good idea to admit in de-briefing meetings to suppliers that are 16 Endoscopy Equipment Evaluation and Procurement Draft 5 Full unsuccessful that surgeons have a clinical preference for the products that they are used to. It is also important that all consultants involved test the whole range of equipment on offer and that the task of carrying out the clinical trial is not divided up between different consultants so that eg. one consultant carries out trials on one supplier’s equipment while another consultant carries out trials on another supplier’s equipment, whilst a third carries out trials on a different supplier’s equipment. This would allow the results to be biased. Moreover conditions must essentially be as tightly controlled as with a scientific experiment. Therefore it would also be wrong for example to carry out seven tests on one supplier’s equipment and only three tests on another’s equipment. However many tests and in whatever manner they are carried out in relation to one supplier should also be applied across the board in relation to the other suppliers. Pinsent Curtis Biddle 18 April 2002 17 Endoscopy Equipment Evaluation and Procurement Draft 5 Full Procurement guide Flexible video endoscopy equipment Medical and surgical NHS Purchasing and Supply Agency Document revision control For further information please click here for contact details: Kerry Bailey Introduction Section A Section B Market overview Market Current procurement practice Products and services Profile of suppliers Products and services Websites 2 OJEC advice (see separate document) 3 Product evaluation form (see separate document) 4 Specification / operational requirement 5 Summary spreadsheet (see separate document) 6 Feedback questionnaire EU legislation Introduction Procedure CPV codes Section C Appendicies 1 Supplier profiles Procurement Process Introduction Project plan Specification/operational requirement Purchase specification OJEC advertisement Product trials and evaluations Offer documents Pre offer meetings Issuing and the return of tender documents Summary of offers Award recommendations Award and rejection letters Debriefing unsuccessful suppliers OJEC award notice Feedback Workbook Full tender documents 1-5 (see separate document) Award criteria (see separate document) 18 Endoscopy Equipment Evaluation and Procurement Draft 5 Full Introduction The NHS Purchasing and Supply Agency has produced this guide to enable NHS trusts undertake an effective procurement exercise for flexible video endoscopy equipment. The guide falls into two primary sections. Firstly, we provide a market overview, giving details of market conditions, products, suppliers, and useful contacts and links. Secondly, it provides step-by-step guidance through the procurement process with links to the relevant section of the NHS PASA website for more detailed advice and guidance if needed. This section provides template documents for the commercial purchase specification and pricing options. The guide is an evolving document and will be updated in the light of new experience and knowledge gained from contacts between NHS PASA, trusts and the marketplace. You are advised to contact Kerry Bailey, by email to kerry.bailey@doh.gsi.gov.uk or by telephone on 01924 328861 to access the latest information and guidance for this product area. If required, Kerry will visit your trust to provide direct advice on the procurement of flexible video endoscopy equipment and will provide ongoing telephone support during your procurement process. To ensure that the whole NHS can benefit from the experience of individual trusts, NHS PASA invites you to provide feedback to Kerry after the completion of your procurement process. This feedback will be used to provide anonymous benchmarking data to other trusts and to support development of the procurement guide. If you have difficulties or comments, please contact Ian Parker, by email ian.parker@doh.gsi.gov.uk, or by telephone on 01924 328826, or Kerry Bailey, contact details as above. 19 Endoscopy Equipment Evaluation and Procurement Draft 5 Full Section A - Market overview Market The current UK market value is estimated at £30 million for endoscopy equipment, in addition to this, endoscopy consumables / instruments are estimated at £15 million and endoscopy maintenance £5 million. It is difficult to clearly show market share for capital equipment. Purchases are not made on a regular basis and for the trust to change their supplier usually means a large capital investment. Therefore, well established suppliers, which have been situated in trusts for a number of years, appear to have a greater dominance in the marketplace. This situation is hard to avoid as it is more likely that trusts will purchase ad hoc than undertaken a large capital investment programme. Profile of suppliers There are three suppliers who can provide a full flexible video endoscopy system. Video monitors and printers can be sourced from suppliers of generic electrical equipment, but for the purpose of this document information will be given on the main three. A summary of each company is available at appendix 1. By loading the appendix onto your computer by disk the internet links will be activated. Simply click on the e-mail or the web site address and you will be taken to the correlating software (access to web sites will be dependant on whether you have access to the Internet). Products and services Technical detail and use A flexible endoscope is used by clinicians for internal examination of a patient. This minimally invasive procedure is used for both diagnosis and therapy. Endoscopes can produce images either through video or fibre technology. The manufacturers have moved towards developing video systems as these give image storage facilities and diagnosis is aided due to advanced picture technology. The images obtained by a video endoscope are transmitted to a monitor through a video processor, these images can then be viewed by a number of people in the room. One suppliers endoscope will not connect with another suppliers processor. This is not a great obstacle as two systems can run simultaneously. System requirements The basic equipment requirement to undertake an endoscopic procedure would be endoscopes, a videoprocessor and a lightsource. The variety of different endoscopes within the trusts inventory would be dependant on the volume and type of procedures undertaken. The British Society of Gastroenterology (BSG) have published a working party report titled “Provision of endoscopy related services in District General Hospitals”. This contains useful information on endoscopy services including sterilisation and the required equipment levels to carry out procedures. Light transmission Fibre optics are used to transmit light to the end of the endoscope. The endoscope is connected to a light source, light then travels through a fibre optic bundle which consists of thousands of glass rods (approx 40,000) which have been stretched in a process which enables the rods diameter to reduce giving the fibres flexibility. To ensure no light is lost the bundle needs ‘total internal reflection’, it is therefore coated with a sheath of glass which has a different refractive index than the glass rods. 20 Endoscopy Equipment Evaluation and Procurement Draft 5 Full Image transmission – Fiberoptic A fiber bundle where the fibers are stacked precisely throughout the cable can transmit an image as the individual fiber. Image transmission - Video A video endoscope will use a charge coupling device (CCD chip) to transmit images, each endoscope has two light transmission and one image transmission bundle. A CCD chip is made up of light sensitive cells called pixels. These are a photosensitive material which turns light into electrical energy. The amount of electrical energy generated is dependant on the amount of light which is falling on the pixel. The clarity and resolution of an image is dependant on a number of factors, including the number of pixels a chip has, the processing and display of the image. A video CCD chip can be manufactured as monochrome or colour. In a monochrome CCD just one pixel can give a full colour image as the three primary colours (red, blue & green) are passed through the chip it collects a full picture. The three colours are kept separate and transmitted independently until they appear on the video monitor. A colour CCD is a monochrome chip with a filter and has three chips to identify each primary colour. Each pixel picks up a single primary colour, it takes 4 pixels to reproduce a full colour picture. These are then collated by the videoprocessor and transmitted to a monitor. In the UK there have been no independent tests of these two types of CCD to determine which gives the clearer image. Each supplier will profess that their technology is superior. Mechanical construction At the head of a video endoscope is the control body. On this are the controls to move the endoscope tip, they are similar to dials and overlay each other, one for left and right the other up and down. Also on the head is the button for the application of air and water, these are used for removal of debris from the view of the endoscope. Also on the control body is the suction button for suction of air and debris and the channel is used for the insertion of instruments. These buttons can be moved for autoclaving. The internal composition of a flexible endoscope is made up of the following elements: two light guide fibre bundles four control wires a CCD chip air, water and suction channels inner metal helix ribbon for flexibility knitted braded weave therma plastic coating for protection of inner mechanics Imaging System A video endoscope is only operational with the use of equipment such as a video processor and a lightsource. These can be bought as two separate units or they can be integrated into one, this will depend on the supplier and system purchased. Ancillary Equipment Other equipment may include suction and diathermy units, video recorders, printers, monitors and mobile workstations. Leakage testers are also needed when cleaning the scope prior to disinfection. Endoscopy consumables / instruments The market for endoscopy consumables is very different to that for equipment. There are numerous suppliers available for both re-useable and disposable products. Details of these can be obtained from NHS Purchasing and Supply Agency along with draft tender documents. 21 Endoscopy Equipment Evaluation and Procurement Draft 5 Full Maintenance The importance of maintenance and traceability of medical equipment is becoming more apparent. Each supplier is able to offer a choice of maintenance contracts to cover each item of equipment they tender for. All suppliers offer an inclusive maintenance contract, (or extended warranty), when purchasing gastrointestinal endoscopes, this offer covers up to the first 3 years of the equipments life Third party maintenance companies There are third party maintenance companies available to service this equipment. Further details of this option can be obtained through NHS Purchasing and Supply Agency. Although it must be stressed that information supplied is not of a definitive or approved nature. Sterilisation Flexible endoscopes can not be autoclaved, therefore a cold sterilant must be used in the endoscope reprocessing machine. Not all reprocessing equipment and solutions are compatible with the composition of endoscopes, each manufacturers ‘scopes are different and they will have their own list of compatible products. Include details of the trusts sterilisation process in the tender documents and request a statement confirming approval of this process by the supplier. Another important issue to remember with sterilisation is the time taken to reprocess the endoscope before it is ready to be used on the next patient. A quick sterilisation turnaround time will ensure the scope is ready for the next patient and delays are not incurred. A combination of an effective and efficient sterilisation process, and the appropriate inventory of endoscopes, will enable the unit to perform the list, reducing the pressure on endoscopy nurses to reprocess instruments in the shortest possible time. Such pressures could result in scopes being used before being fully decontaminated. 22 Endoscopy Equipment Evaluation and Procurement Draft 5 Full Web pages British Society of Gastroenterlogy http://www.bsg.org.uk/index.html Department of health web site http://www.doh.gov.uk/ Medical Devices Agency http://www.medical-devices.gov.uk Medical search engine http://www.medisearch.co.uk/ National Institute of Clinical Excellence http://www.nice.org.uk/ NHS Purchasing & Supply Agency http://www.pasa.doh.gov.uk/ OJEC web site op.eu.int/ojs/html/index2.htm http://ted.eur- Keymed web site http://www.keymed.co.uk Olympus web site http://www.olympus.co.uk/endoscopy/ Pentax web site for product information http://www.pentax.co.uk Endoscopy UK web site http://www.fujinonendoscopy.co.uk 23 Endoscopy Equipment Evaluation and Procurement Draft 5 Full Section B – EU legislation Introduction Any procurement utilising public sector funding for goods or services above a threshold financial value must be carried out in accordance with EU procurement legislation. Procurements below the EU threshold will be subject to the trust’s Standing Orders and Standing Financial Instructions. For the practical application of the EU procurement legislation see Section C below. For up to date information on legislation and threshold values visit the NHS PASA website http://home.pasa.doh.gov.uk/purchasing/shared/oppm/ . Procedure NHS PASA advises the use of the open procedure as opposed to the restricted or negotiated procedures. This is because currently there are a small number of suppliers all with acceptable equipment and the financial and administrative structures to meet the qualification criteria. Use of the accelerated restricted procedure cannot be justified if the reason for its use is due to internal failings within the purchasers organisation e.g. inadequate equipment replace programmes. Breaking up a purchase to avoid the OJEC regulations is illegal. Trusts should be aware that suppliers in this product area have already shown a willingness to challenge Trusts on their compliance with the regulations. These currently cover compliance with OJEC time scales, specifications, use of the accelerated restricted procedure tender evaluations and awards. At least one Trust currently faces the possibility of legal action from 2 suppliers in the European Court of Justice in respect of an advertised purchase of endoscopy equipment. CPV codes EU directives are supported by a common coding system (CPV codes) to describe supplies and services. Their use is mandatory in completion of all OJEC notices. The relevant codes for endoscopy equipment are: endoscopy, endosurgery devices 5 endoscopes 6 repair and maintenance services of medical and surgical equipment 5 repair and maintenance services of medial equipment 2 33168000331681005042000050421000- 24 Endoscopy Equipment Evaluation and Procurement Draft 5 Full Section C – Procurement process OJEC advertisement The time allowed for the return of the tender is 52 days from the date the advertisement is sent to OJEC. However tenders should be sent out 6 days after a company requests the documents and applications should close 6 days before the return date. Therefore it is important to have the tender documentation available shortly after sending the OJEC advertisement. A draft OJEC notice can be found at appendix 2. If tendering for additional products it is important not to state in the OJEC ad that they must be compatible with the existing equipment. In the endoscopy market compatibility is not a valid reason to bypass European legislation. Equipment trials and evaluation Given the value of equipment the Trust is looking to purchase it is imperative that trials take place. Once purchased, the equipment will be in use for at least the next 5 years, it is therefore essential that products are assessed fairly. Suppliers will be able to offer a package which will be able to replace existing products or one which will run in conjunction to your existing equipment, therefore compatibility is not an issue. Prior to setting up trials it is important to know who the clinical decision makers will be. A reasonable time allowance for trials would be one to two weeks for each supplier, during this time the key decision makers should have the opportunity to use each manufacturers products. Evaluation sheets It is recommended that the evaluation sheet at appendix 3 be completed. This will offer feedback to each supplier and record the clinical view of each item of equipment. Some suppliers may have their own evaluation sheet, although there is nothing wrong in using these, the use of the NHS PASA sheet will give an impartial record of the evaluation, and an equal assessment of each supplier based on the same criteria. Information completed on the sheet can be used when considering and preparing the business award at the end of the process. This sheet has been assessed by the British Society of Gastroenterology and as such covers aspects which are important to clinical staff. Evaluation sheets should be shared with the relevant supplier in order for them to address any queries the trust may have. The preoffer meeting is the ideal opportunity to do this. Visits to reference sites If the trust prefers, clinical staff may be able to visit a suppliers reference site to view the equipment. Suppliers will be able to list the nearest hospitals which currently use the equipment which the trust requires. Trust’s may also find it beneficial to visit suppliers premises. Specification / operational requirement 25 Endoscopy Equipment Evaluation and Procurement Draft 5 Full The specification / operational requirement at Document No 5 contains the information needed by suppliers to offer a package which meets the trusts needs. The Document has been developed with each of the suppliers, and their input has been invaluable. A number of trusts were also consulted on the content to ensure both view points of the process were covered. This document can be found at appendix 4. The Document does not cover the technical capabilities of products as these specifications contain many variables across the supplier base. The trust will have an idea of the basic requirement needed by the endoscopy unit. This could have been established from a number of situations i.e. current equipment failure, the allocation of capital funding, increase in patient throughput. This requirement should be listed under ‘essential equipment’ in the specification / operational requirement along with the quantities needed. There is a price differential on endoscopes between suppliers, therefore the quantity of endoscopes you are able to purchase from one supplier for the same budget may vary. Although these differences exist it is important to look at the life cost of these products and services not just the basic price per instrument. In addition to the trusts basic requirement there may be equipment which is desirable if the funds are available. This can be listed in the Document as additional products or you could ask the supplier to provide details of equipment which they feel would enhance the productivity of the unit and existing / requested equipment base. By including this possible requirement in the tender the trust has the option to purchase whilst still covering annual equipment expenditure under EU legislation. Existing equipment If the equipment currently in use at the trust is nearing the end of it functional life you may consider trading this in for new. Suppliers will need certain information about this equipment, the form in “Offer schedule – Sale of existing equipment” should be completed with this information. Suppliers should be allowed to view and assess the equipment prior to returning their tender submission. The sale of this equipment, to a supplier, will be subject to NHS terms and conditions of contract for the sale of goods. Alternative purchase options The specification / operational requirement for insertion in the tender documents has been developed to incorporate various purchasing options. Predominately it is for the outright purchase of endoscopy equipment using capital money. There are variations on this and suppliers can offer different supply packages to benefit and meet the flexibility of the trusts needs. Some of these are briefly detailed below although there may also be others which can be developed solely for your trust. It is important to realise these deals prior to starting the tender so that the trust is fully aware of its options in the provision of this equipment. The NHS Purchasing and Supply Agency is keen to develop alternative purchasing options to maximise the funding available within the NHS. Some of these deals are: Outright purchase - with inclusive maintenance for a set period Outright purchase - with just equipment warranties. Post warranty service contracts agreed and paid within relevant year. Lease – with inclusive maintenance throughout period Lease – with just equipment warranties. Post warranty service contracts agreed and paid within relevant year. Cost per procedure 26 Endoscopy Equipment Evaluation and Procurement Draft 5 Full Rolling replacement programme Offer documents It is recommended that the procurement of endoscopy equipment is in accordance with NHS PASA Operational Purchasing Procedures manual, procedure 9-02D. This is for establishing one-off purchases with the trust undertaking purchase on its own behalf. This documentation can be found on the NHS PASA website http://home.pasa.doh.gov.uk/purchasing/shared/oppm/9-02d1.doc Document No 1 - Invitation to offer Insert: offer reference number, OJEC notice reference (if applicable), final date and time for receipt of offers. Document No 2 - Terms of offer Para. Samples. Delete paragraph, although you may wish to include the following instead. Evaluation of equipment 2.1 For the purpose of evaluating equipment your company should be registered on the Master Indemnity Agreement (MIA) list. If this is not the case please contact Andrea Dexter, NHS Purchasing and Supply Agency, Reading Tel: 0118 980 8841 for the appropriate paperwork to be forwarded to you. 2.2 If you would prefer to use your own indemnity agreement please ensure this is agreed by the trust prior to any equipment evaluations. 2.3 If your equipment has not been evaluated and you would like to discuss the opportunity please contact: (Name) ********* (Title) ********* (Telephone number) ********* (Fax number) ********* Alternatively, if the Trust prefers or does not have their own, standard indemnity forms can be found on the NHS PASA web site, http://home.pasa.doh.gov.uk/purchasing/shared/mia/. These can be issued with the tender documents or made available on request. To check if a supplier has already completed a Master Indemnity Agreement, please refer to the list on the NHS PASA website using the link above. Para. Offer documentation and submission Delete Include EDI trading – not applicable a completed copy of the Pre-Purchase Questionnaire (PPQ) (if the trust requires) this form can be downloaded from the NHS PASA website http://home.pasa.doh.gov.uk/purchasing/shared/standardforms/ Para. Rebates / commissions to be received by …. Delete paragraph – not applicable 27 Endoscopy Equipment Evaluation and Procurement Draft 5 Full Para. TUPE and specification Delete paragraph – not applicable Document No 3 – NHS terms and conditions of contract Conditions of contract applicable to this purchase are: Purchase of goods Supply and installation of equipment Maintenance of goods Sale of goods – this is applicable if the trust is selling equipment back to the supplier Document No 4 - Supplementary conditions of contract Supplementary conditions are not needed. Pre-offer meetings It is recommended that you invite suppliers for discussions and to take this opportunity to convey a clear message of the trusts’ requirements and key objectives. The suppliers may have questions which have arisen from the trials of equipment. It is recommended to have the completed evaluation sheets available in the meetings so as to address any concerns raised by the clinical staff. All members of the decision making unit should ideally attend pre-offer meetings. If they are unable to attend, the evaluation sheet should be used to represent any of their issues. For an agenda and the recommended meeting protocol visit the NHS PASA website http://home.pasa.doh.gov.uk/purchasing/shared/oppm/9-01.doc . In addition to the points mentioned in this link you may also like to include: a) b) c) d) e) f) Understanding of the offer process / timescales Proposed purchase date / month Proposed operational date / month Possible removal of existing equipment, to include trade in discount Training and maintenance available Reliability of service support e.g. turnaround times, provision of loan scopes. Issuing and the return of tender documents Tender documents should be issued and returned in accordance with EU legislation (if applicable) and the trusts Standing Orders and Standing Financial Instructions. The return date when using the restricted procedure should be set a minimum of 40 days from the despatch of invitations to offer. Summary of offers A suggestion of an offer summary spreadsheet has been included at appendix 5. Equipment The equipment figures that you will include in your summary are taken directly from Document No 6 in the tender and cover the essential items requested. All suppliers offer different lengths and levels of warranty with the purchase of their endoscopes. It is therefore important to be aware of this when comparing prices. Whole life costs should be calculated for each scope (6-7 yrs). It is also important for the purchaser to consider any conditions or exclusions relating to the service contract. 28 Endoscopy Equipment Evaluation and Procurement Draft 5 Full Maintenance A summary will also need to be made of the projected maintenance costs. A recommended life span to cost against is 6 years. Although your own trust may have its own procedures for this dependant on the management of the asset register. Group the same contract types together i.e. all comprehensive in same spreadsheet. Suppliers may hold maintenance prices firm for a number of years, for subsequent years estimate prices using the management formula given in the tender documents. If the company has not offered a formula you can use RPI at approximately four percent, this will cover a worst case scenario. 29 Endoscopy Equipment Evaluation and Procurement Draft 5 Full Semi-disposable components This schedule covers semi disposable items used with endoscopy equipment to ensure they operate correctly. The products and prices submitted in this schedule should be inserted into the spreadsheet for each company. Such items will include caps, valves, bulbs and cleaning brushes. These should be costed annually based on the procedure volumes stated in the specification. Projected life costs should be calculated over 6 years for each suppliers products. Adjudication meeting The decision making team identified at the beginning of the process should attend the adjudication meeting. The trust may have weighted certain award criteria on its importance. The service support element may be imperative to the trust or you may be looking to maximise the budget allocation by opting for the most cost beneficial offer. The summary analysis will clearly identify the package cost per supplier, the evaluation sheets will have recorded the clinical opinion of the suppliers equipment and through weighting of the awarding criteria a decision can be made. Particular attention should be paid to: a) b) c) d) e) f) g) h) i) comparison of costs opportunity costs – remaining funds 6/7 year projected costs – to include maintenance and consumables training required on new products – time / costs to be incurred the evaluation sheets / clinical opinion from the equipment trial references / clinical history reliability of supplier is this the latest technology? Likelihood of new innovations from supplier Award and rejection letters The successful supplier can be issued with an award letter and a purchase order for the equipment. An example of an award letter is with the OPPM procedure 9-02d. Allow approximately 7 days before issuing rejection letters to unsuccessful suppliers, this gives time for the successful supplier to except the award or contact you with any queries. There is also an example of a rejection letter with the OPPM procedure 9-02d. Debriefing unsuccessful suppliers Unsuccessful suppliers may request a reason why they were not awarded business. The evaluation and analysis of offers should be made clear to the supplier so they are aware of how the decision to award was made. The meeting should be constructive and the supplier should be offered ways in which they will be able to improve their submission for future business. OJEC award notice The OJEC award notice must be placed no later than 48 days after the award of contract to the successful supplier. A contract award notice can be found on the NHS PASA web site. 30 Endoscopy Equipment Evaluation and Procurement Draft 5 Full Feedback The importance of requesting feedback is to establish ongoing communication between yourselves, the user, and the NHS Purchasing and Supply Agency. Without this communication the package will not progress to encapsulate a trusts requirements. An essential element of using the purchasing guide is the requirement to complete the enclosed questionnaire. Your views and suggestions will be considered, along with the supplier offers you receive. This will be used in the development of a purchasing strategy to be used by the NHS Purchasing and Supply Agency. Feedback questionnaire The requirement of the guide is to complete the “Feedback questionnaire” at appendix 6. It requests your views on the guides ease of use, the relevance of questions asked, and details of the offers received from each supplier. The future strategy The information submitted will be used to further determine the approach and level of involvement the NHS Purchasing and Supply Agency takes in this market. This may lead to a national contract for equipment and/or maintenance, further involvement in bespoke contracts or increased use of the purchasing guide. 31 Endoscopy Equipment Evaluation and Procurement Draft 5 Full Company profile Pentax UK Limited Mailing address Telephone number Fax number Company e-mail address Web site Equipment brand MIA number Expiry date Country of manufacturer Quality assurance Pentax House Heron Drive Langley Slough SL3 8PN 01753 792792 01753 792723 Medical Division Direct 01753 792794 01753 798179 Medical Division Direct info@medical.pentax.co.uk http://www.pentax-endoscopy.com/ http://www.pentax.co.uk Pentax Not listed Not applicable Japan ISO 9000 Company structure and contacts Director & General Manager – Medical Division Product & Administration Manager – Medical Division Field Sales Manager – Medical Division Technical Service Manager – Medical Division Secretary – Medical Division Tender Administrator – Medical Division Service Administrator – Medical Division Brian Taylor Andy Thomas Garrie Tillett Nigel Spring Christine Regragui Paul O’Connor Emma Davis 32 Endoscopy Equipment Evaluation and Procurement Draft 5 Full KeyMed (Medical & Industrial Equipment) Limited Mailing address Telephone number Fax number Company e-mail address Web site Equipment brand MIA number Expiry date Country of manufacturer Quality assurance Keymed House Stock Road Southend-on-Sea Essex SS2 5QH 01702 616333 01702 465677 keymed@keymed.co.uk Olympus MIA007 31 July 2001 Japan BS EN ISO 9001 BS EN 46001 CE certificate as manufacturers of suction pumps Company structure and contacts Managing Director Corporate Director Divisional Manager – Medical Contracts Manager Michael Woodford Paul Hillman Nick Williams Mrs Kate Robb Keymed’s medical business is made up of five divisions Theatre products Urological, gynaecological, surgical and related products Division Head Peter Hawkins National Sales Manager Richard Reynolds Gastroenterology and respiratory Video and fibre endoscopes for gastroenterology and chest medicine. Also cleaning and disinfection equipment Division Head Nick Copeland National Sales Manager Connie Nall Endotherapy Flexible endoscope accessories Division Head Nick Copeland National Sales Manager Piers Metcalfe Surgical & ultrasound Diagnostic ultrasound systems Division Head Peter Hawkins National sales manager ultrasound Gareth Walsh Specialist products ENT endoscopy, fibre optic intubation and endoscopic ultrasound Division Head Peter Hawkins National Sales Manager Jeremy Taylor 33 Endoscopy Equipment Evaluation and Procurement Draft 5 Full Endoscopy UK Limited Mailing address Telephone number Fax number Company e-mail address Equipment brand MIA number Expiry date Country of manufacturer Quality assurance Unit 1 Ward Industrial Estate Mead Lane Lydney Gloucestershire GL15 5AA 01594 844770 01594 844863 endoscopy.uk@virgin.net Fujinon Not listed Not applicable Japan BS EN ISO 9002 EN ISO 9001 EN 46001 CE certificate for Fujinon endoscopes, ultrasound systems and accessories CE certificate for Medwork endoscopy accessories Endoscopy UK Limited is happy to receive Trust staff at its premises to carry out quality checks. To arrange such visits, interested parties should contact Keith Davis on 01594 844770. Company structure and contacts Managing Director Ray Puttock ray.puttock@virgin.net Group General Manager Matt Puttock eukmatt@btinternet.com Divisional Technical Director Colin Sutton colin.sutton.euk@virgin.net Project Manager (Endoscopic consumables) Finance and Administration Manager Luke Puttock eukluke@btinternet.com UK Product Specialist Russell Palmer DCR (D) Service Manager Mike Woodward Keith Davis keithmd@virgin.net 34 Endoscopy Equipment Evaluation and Procurement Draft 5 Full Draft OJEC Notice 1 Name, address, telephone and fax numbers of the contracting authority [Full Name and address of Trust] 2(a) Award Procedure Chosen Open. (b) Form of contract for which offers are invited [Framework agreement] or [Purchase contract] or [Lease] 3(a) Place of Delivery [Delivery Location (s)] (b) Nature and Quantity of Goods to be supplied: CPA reference number [Insert product description as generally as possible and refer to widest CPA number covering the product]. endoscopy, endosurgery devices 5 endoscopes 33168000- repair and maintenance services of medical and surgical equipment 50420000- repair and maintenance services of medial equipment 50421000- 33168100- 6 5 2 (c) Indication of whether the supplier can tender for some and/or all of the goods required Tenders for part of the overall requirement will be acceptable. (d) Derogation from the use of European Specifications Not applicable 4 Time limit on delivery, if any [Delivery Deadline, include here or ] To be stated in tender documents. 35 Endoscopy Equipment Evaluation and Procurement Draft 5 Full 5(a) Name and address from which the contract documents and additional documents may be requested Contact: [insert name and address] (b) Final date for making such requests [To be inserted must be not less than 6 days before the closing date] (c) Where applicable, the amount and terms of payment of any sum payable for such documents Not applicable 6(a) Final date for receipt of tenders [To be inserted-not less than 52 days from date of dispatch of advert ] (b) Address to which they must be sent [Return address for tenders] (c) Language(s) in which they must be drawn up English. 7(a) Person authorised to be present at the opening of tenders Authorised personnel. (b) Date, time and place of opening [To be inserted] 8 Where applicable, any deposits and guarantees required Parent company or other guarantees may be required in certain circumstances. See the invitation to offer for further details. 36 Endoscopy Equipment Evaluation and Procurement Draft 5 Full 9 The main terms concerning financing and payment and/or references to the relevant provisions See the invitation to offer. 10 Where applicable, the legal form to be taken by a grouping of suppliers winning the contract [Not applicable] or [Joint and several liability] or [We will wish to contract with a single legal entity]. 11 The information and formalities necessary for an appraisal of the minimum standards of economic and financial standing and technical capacity required of the supplier (i) A statement from the candidate that none of the grounds in Article 20(1) of Directive 93/36/EEC is applicable or if any are applicable, a full explanation of the circumstances. Confirmatory evidence may subsequently be required. (ii) Annual report and accounts of the candidate (where publication required by law) in its three [or substitute other appropriate period] financial years most recently ended. (iii) The turnover of the candidate in respect of goods of the type required under this contract in its three financial years most recently ended. (iv) A description of the candidate's technical facilities, research facilities and measures for ensuring quality. (v) [Any other information required to assess whether candidate meets minimum standards provided, in the case of technical capacity, that it falls within Regulation 16 of the Supplies Regulations] 12 Period during which the tenderer is bound to keep open his tender [To be inserted] 13 Criteria for the award of the contract Most economically advantageous tender in terms of price, delivery, whole life costs, quality and after sales service. 37 Endoscopy Equipment Evaluation and Procurement Draft 5 Full 14 Where applicable, prohibition on variants Variants will be permitted. Details will be provided in the invitation to offer. 15 Other information [ Include here details of compatibility with , light sources, washers etc] 16 Date of publication of the prior information notice in the OJ or reference to its non publication [To be inserted] 17 Date of despatch of this Notice [To be inserted] 38 Endoscopy Equipment Evaluation and Procurement Draft 5 Full Document revision control File ref: /publications/procguides/medsurg/endoscopy/pg_endoscopy.doc Version 1.10-01.1 Author/editor Kerry Bailey 2.04-2003.1 Kerry Bailey Notes First release (draft); appx 2-6 appear to be missing; also need confirmation that workbook is tender word doc New version, completely revised Date published 3 October 2001 8 April 2003 39 Endoscopy Equipment Evaluation and Procurement Draft 5 Full 40 Endoscopy Equipment Evaluation and Procurement Draft 5 Full Document No 1 Date To Dear Sirs Invitation to offer for the supply of flexible endoscopes and ancillary equipment Offer reference: ********* Official Journal of the European Communities reference: /S / /EN Offers are invited, subject to the terms of this letter and also to the Terms of offer (Document No 2), for the supply, in accordance with the NHS terms and conditions of contract (Document No 3) and Supplementary conditions of contract (Document No 4), of the goods/services detailed in the Specification/operational requirement (Document No 5). The Trust does not bind itself to accept the lowest or any Offer and reserves the right to accept an Offer either in whole or in part, each item being for this purpose treated as offered separately. The Trust reserves the right to award contracts for the supply of the product described above and arising out of this procurement process, to more than one supplier. Offers must be written in English and must be submitted in a plain sealed envelope which does not identify the name of the company, bearing the address label enclosed herewith, to arrive at that address no later than [time] on [date]. This invitation comprises the following documents: Document No 1 Document No 2 Document No 3 Document No 4 Document No 5 Document No 6 Document No 7 This covering letter Terms of offer Terms and conditions of contract (available on request) Supplementary conditions of contract Specification/operational requirement Offer schedules – Equipment Offer schedules - Maintenance Offer schedule - Questionnaire Form of offer Should any documents be missing or you require this information on disk, please contact the undersigned immediately. Yours faithfully (Name) *********** (Designation) ************** 41 Endoscopy Equipment Evaluation and Procurement Draft 5 Full Document No 2 Terms of offer Information 1.1 Information supplied to Offerors as part of the procedure is supplied in good faith. However, Offerors must satisfy themselves as to the accuracy of such information and no responsibility is accepted for any loss or damage of whatever kind or howsoever caused, arising from the use by Offerors of such information, unless such information has been supplied fraudulently by the Trust. 1.2 All information supplied in connection with this Invitation shall be regarded as confidential and by submitting an offer the Offeror agrees to be bound by the obligation to preserve the confidentiality of all such information. Information will only be used by the trust and NHS Purchasing and Supply Agency. 1.3 This invitation and its accompanying documents shall remain the property of *********** NHS Trust and must be returned on demand. Evaluation of equipment 2.1 For the purpose of evaluating equipment your company should be registered on the Master Indemnity Agreement (MIA) list. If this is not the case please contact Andrea Dexter, NHS Purchasing and Supply Agency, Reading Tel: 0118 980 8841 for the appropriate paperwork to be forwarded to you. 2.2 If you would prefer to use your own indemnity agreement please ensure this is agreed by the trust prior to any equipment evaluations. 2.3 In view of the value of this equipment and the importance of quality in the award criteria, the trust deems it necessary to conduct evaluations of manufacturers equipment. It is anticipated that evaluations will last a week. To arrange for your equipment to be evaluated please contact: (Name) ********* (Title) ********* (Telephone number) ********* (Fax number) ********* Prices 3.1 Prices must be stated in the Offer schedule (Document No 6) and must remain open for acceptance until 90 days from the closing date for receipt of offers. 3.2 Prices must be submitted in the format specified in Document No 5. Offer documentation and submission 4.1 Offers may be submitted for all products/services or for selected items. 4.2 Products/services offered should be strictly in accordance with the Specification/operational requirement (Document No 5). Alternative products/services may be offered but all differences between such items and the Specification/operational requirement must be indicated in detail in the Offer schedule (Document No 6) 42 Endoscopy Equipment Evaluation and Procurement Draft 5 Full 4.3 Offers must comprise: 4.3.1 the Offer schedules (Document No 6); 4.3.2 the Form of offer (Document No 7); 4.3.3 a statement of prompt settlement discounts, if available; 4.3.4 completed PPQ forms; 4.3.5 confirmation that any information previously supplied to the Trust in connection with the offer is still accurate and is incorporated by reference into the Offeror’s offer. 4.4 The Form of offer must be signed by an authorised signatory. In the case of a partnership by a partner for and on behalf of the firm, and in the case of a limited company by an officer duly authorised, the designation of the officer being stated. 4.5 The Form of offer and accompanying documents must be fully completed. Any offer which: 4.5.1 contains gaps, omissions or obvious errors; or 4.5.2 contains amendments which have not been initialled by the authorised signatory; or 4.5.3 is received after the closing time may be rejected. Therefore if you have any queries please contact the following for: 4.6 commercial enquiries (Name) ********* (Title) ********* (Telephone number) ********* (Fax number) ********* technical enquires (Name) ********* (Title) ********* (Telephone number) ********* (Fax number) ********* Offers must be written in English and must be submitted in a plain sealed envelope which does not identify the name of the company, bearing the address label enclosed herewith, to arrive at that address no later than [time] on [date]. Contract award criteria 5.1 The contract will be awarded on the basis of the most economically advantageous offer judged on price, quality, after sales service, delivery and whole life costs. These factors are not listed in any particular order of importance. 43 Endoscopy Equipment Evaluation and Procurement Draft 5 Full Document No 3 NHS terms and conditions of contract (Available on request) For the purchase of goods For the maintenance of equipment For the supply and installation of equipment For the sale of goods* if applicable 44 Endoscopy Equipment Evaluation and Procurement Draft 5 Full Document No 4 Supplementary conditions of contract There are no supplementary conditions of contract applicable to this tender. 45 Endoscopy Equipment Evaluation and Procurement Draft 5 Full Document No 5 Specification/operational requirement NHS contract for the supply of flexible endoscopy equipment Offer reference: ******** Introduction 1.1 You are invited to offer for the supply, installation and maintenance of equipment to meet the trusts specification. In terms of maintenance, information is required concerning the cost of repairs in the years subsequent to any warranty period, up to a maximum of six years. 1.2 The requirement is to equip *********** room(s) within ********* NHS Trust. 1.3 In addition to the offer made for the outright purchase of the equipment requirement, the Offeror is invited to provide a statement outlining any innovative pricing schedules for the acquirement of the equipment package, including alternative purchasing options. Trust profile and strategy 2.1 Add details of the Trusts development or strategy that may have a bearing upon the contract such as the development of the trust into a clinical centre of excellence, merging with another trust , expanding/changing the nature of it’s service, etc. Procedural information and current situation 3.1 The estimated annual number of endoscopy procedures performed by the trust is listed below, this also details the potential estimated growth of procedures: Example: Gastroscopy Procedures per annum 2,000 Potential estimated growth over a 3 year period 20% It is felt that the above information will assist in the structure of the package offered by your company, and any additional equipment suggested for its operational benefit. 3.2 The endoscopes currently situated in the trust are sterilised using (state disinfectant) in (state machine model/manufacturer) washer disinfectors. The Offeror will provide a statement confirming their compatibility with the trusts sterilisation methods. Should these methods be incompatible with the Offerors equipment, please provide a detailed statement, to include any additional cost, which will provide the trust with a viable solution. Equipment requirement 5.1 It is the responsibility of offerors to establish via the contact point for technical queries appropriate levels of compatitable equipment required for an effective service to be delivered by the trust. Offerors should detail any products which are needed to ensure 46 Endoscopy Equipment Evaluation and Procurement Draft 5 Full compatibility. These products should be added to the equipment list. A list of the hospitals existing equipment is available at appendix 1. 5.3 If you wish to expand on the equipment specification or offer products which will enhance the units endoscopy service these should be included in the “Additional equipment” section of the table. 5.4 A document should also be enclosed which details the technical specification of each product. 5.5 Any deviations from the specification must be stated on the applicable offer schedule. 5.6 * You are invited to submit an offer for the purchase / or removal of the trusts existing equipment which is detailed in the Offer schedule – Sale of existing equipment. Purchase offers will be in accordance with NHS terms and conditions of contract for the sale of goods. Offerors should make necessary arrangements to satisfy themselves as to the condition of the equipment. Arrangements for decommissioning and removal of equipment should be stated on a separate sheet in your offer. Disposable / Semi-disposable components 6.1 Utilising the appropriate schedule suppliers are required to detail disposable / semidisposable components such as buttons, caps, valves, bulbs, cleaning brushes, etc. needed for the continuous effective use of this equipment. 6.2 A suggested / recommended life in procedures for each item is required in order for the trust to forecast potential usage and life costs. Maintenance and service element 7.1 Costs for maintenance are required for all items of equipment tendered. 7.2 Offer schedules are split into two categories recognising the differences between the maintenance of endoscopes and electro-medical equipment. 7.3 The Offeror should list within the tables the differing types of maintenance contract available and cost per annum per item of equipment, excluding VAT. 7.4 Equipment purchase costs should include a three year fully comprehensive maintenance contract/ warranty. Maintenance contract pricing is required from the fourth to the sixth year. 7.5 Should a national contract for maintenance be established with the successful supplier, and the negotiated prices provide financial benefit to the trust, they will supersede any offer made in this tender. 47 Endoscopy Equipment Evaluation and Procurement Draft 5 Full Document No 6 Offer schedule - Equipment NHS contract for the supply of flexible endoscopy equipment Offer reference: ********* Item no. Description Qty Part/model No Package price for items Unit price Total price (exc. VAT) £ Additional compatitble equipment Package price for additional items Prices firm for Settlement discount of £ days from _____________________ % for payment made within days State the anticipated working life of the equipment offered. Is the equipment you have tendered for your latest technology? 48 Endoscopy Equipment Evaluation and Procurement Draft 5 Full Offer schedule - Deviations from requested specification Offer reference: ********* Item no. Details of deviation 49 Endoscopy Equipment Evaluation and Procurement Draft 5 Full Offer schedule – Disposable / Semi-disposable components Offer reference: ********* Product description and purpose Product code Anticipated procedure life Price each £ (exc. VAT) Endoscopes Electro-medical equipment Other Offer schedule – Sale of existing equipment NHS contract for the supply of flexible endoscopy equipment 50 Endoscopy Equipment Evaluation and Procurement Draft 5 Full Offer reference: ********* *Include if offers are to be invited to replace existing endoscopy equipment You are invited to submit an offer for the purchase of the existing endoscopy equipment at ********** NHS Trust in accordance with NHS Conditions of contract for the sale of goods. Offerors should make necessary arrangements to inspect this equipment. Please provide an additional statement which details all arrangements for decommissioning and removal of equipment. Existing endoscopy equipment Description & quantity Offer price (exc. VAT ) Part no. Serial no. Year of manufacturer Service records YES/NO £ Undertaking The attention of purchasers is directed to the requirements of Section 6 of the Health and Safety at Work Act 1974 and the duties it imposes in relation to the sale of goods for use at work. Any Purchaser is accordingly required to sign the undertaking below. The Purchaser undertakes that where goods purchased as a result of this tender may be used again to their original purpose after appropriate steps have been taken with regard to safety, the Purchaser undertakes to have the goods properly checked before use, to have them regularly surveyed and maintained and to take such other steps as are necessary to ensure, so far as is reasonably practicable, that they will be safe and without risks to health when properly used. Signed: _____________________________________________ Date: For and on behalf of: 51 Endoscopy Equipment Evaluation and Procurement Draft 5 Full Offer schedule – Maintenance of flexible endoscopes NHS contract for the supply of flexible endoscopy equipment Offer reference: ******** Package summary Item no. Description & part no. Contract type Months warranty Year 1 Year 2 Gastroscope Standard 12 Warrant 300 ETC34 Comp Year 3 Year 4 Year 5 Year 6 Year 7 300 600 800 1,000 1,200 500y 800 1,000 1,200 1,400 Endoscopes Example: 1 500 Warranty NB The manufacturers warranty will take effect from the date of installation and commissioned acceptance. 52 Endoscopy Equipment Evaluation and Procurement Draft 5 Full 1.1 Please state whether any exclusions apply to the manufacturers warranty: 1.2 Up to which year are your prices fixed? 1.3 Please detail the price management formula which your company uses to set maintenance costs 1.4 What measures can the hospital take to minimise the potential cost? and what measures will the supplier provide in monitoring contract usage which could lead to increased costs? 1.5 For prices which are not held firm, please provide details of how price increases will be determined / managed. Contract details 2.1 Please state location of repair facility for endoscopes. 2.2 The repairs listed on the following page are those which can be carried out on a flexible endoscope. Please add to the list any repairs not covered. Please answer yes or no to whether each repair would be covered under the maintenance contract(s) detailed on the previous page. If a repair is not covered please give an indication of the potential cost in the additional comments column. Please answer yes or no as to whether a loan scope is provided for each repair. Indicate the target delivery time for providing a loan scope and your performance rate against this target Indicate the turnaround time from the collection, repair and then return of the scope to the hospital, and your performance rate against this target. 53 Endoscopy Equipment Evaluation and Procurement Draft 5 Full Type of maintenance contract Repair Loan scope provided Yes/No Target delivery time Target Current Current turnaround performance performance time of rate rate repair Additional comments Blockage removal Replacement of bending section rubber Angulation adjustment Raiser wire adjustment Moisture/condensation removal from optical system Video switch head rebuild or replacement No.1 switch cover replacement ETO value overhaul Elevator wire operating rod replacement Lightguide cover glass replacement C-cover replacement All of the above where major fluid ingress has occurred Raiser wire replacement Biopsy channel replacement Aspiration channel replacement Air/water channel replacement Raiser sus-pipe replacement Major fluid invation correction 54 Endoscopy Equipment Evaluation and Procurement Draft 5 Full Raiser operating cam replacement Coherent fibre bundle Insertation tube Accidental damage Video chip replacement Complete rebuild where required Misuse/abuse 55 Gastrointestinal Endoscopy Equipment Evaluation DRAFT No 5 2.3 Do any further exclusions apply to the maintenance contract(s) offered? 2.4 Is the cost of carriage to and from the customers site included in the maintenance contract? 2.5 Is routine preventative maintenance included in the warranty and maintenance contracts available? 2.6 What is your recommended frequency for routine preventive maintenance of endoscopes? Response times 3.1 What is your response time to the following scenarios? Telephone response within hours of receiving notification from the hospital Scope collected within hours of receiving notification from the hospital Loan scope at trust within hours of identifying fault 3.2 What compensation is offered in the event that this target time is not achieved? Loan scopes 4.1 What ratio of loan instruments do you have in relation to instruments in use? (Please also provide ratios for each individual instrument on tender) 4.2 Is the cost for delivery of loan instruments covered by the supplier? 4.3 Is the cost of repairs to loan instruments covered by the supplier? Additional discounts for maintenance 56 Gastrointestinal Endoscopy Equipment Evaluation DRAFT No 5 5.1 The above maintenance costs are per endoscope. If the trust were to take out a number of maintenance contracts please detail the number required to qualify for a quantity discount and the discount which will be applied. 5.2 Please quote additional discounts offered in respect of maintenance contract as follows: 5.3 5.2.1 Payment made annually in advance (post warranty): ______________ % discount 5.2.2 A single order placed post warranty to cover a total maintenance term of 7 years, paid annually in advance: % discount 5.2.3 A single order placed post warranty to cover a total maintenance term of 7 years, paid in full in advance: % discount Please quote any further discounts offered in respect of maintenance: 57 Gastrointestinal Endoscopy Equipment Evaluation DRAFT No 5 Non-contract maintenance Non-contract maintenance costs should be stated for endoscopes in the occurrence that the trust decides to receive maintenance ad hoc. 6.1 Hourly rate £ /hour 6.2 Is carriage chargeable? YES/NO If YES, please state cost £ 6.3 The repairs detailed below have been identified as covering 80% of all repairs undertaken on endoscopes, please detail the costs attributed to the repair of these faults. ?? 6.4 Is a loan scope facility available for non contract items? (please give details) 58 Gastrointestinal Endoscopy Equipment Evaluation DRAFT No 5 Offer schedule – Maintenance of electro-medical equipment NHS contract for the supply of flexible endoscopy equipment Offer reference: ******** Package summary 1.1 The Offeror should list within the table the differing types of maintenance contract available and cost per annum per machine, excluding VAT. 1.2 All prices will be fixed for a minimum of three years. Subsequent pricing is required up to the equipments sixth year. 1.3 Should a national contract for maintenance be established with the successful supplier, and the negotiated prices provide financial benefit to the trust, they will supersede any offer made in this tender. Item no. Description & part no. Contract type Months warranty Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Electro medical equipment 1 NB The manufacturers warranty will take effect from the date of installation and commissioned acceptance. 1.4 Please state whether any exclusions apply to the manufacturers warranty: 1.5 Up to which year will your prices be fixed? 59 Gastrointestinal Endoscopy Equipment Evaluation DRAFT No 5 Contract details 2.1 Do any further exclusions apply to the maintenance contract(s) offered? 2.2 For each maintenance contract offered please indicate either YES or NO (and include cost, where applicable), to the following: Number of preventative service visits per annum Duration of preventative service visits in hours Are all emergency call outs included Is out of hours working included If NO, state price, if any, for: Saturday working (per hour) Sunday working (per hour) evening working (per hour) bank holiday working (per hour) Are all spare parts included If NO, please list any parts that are not included in the maintenance contract. Product description and purpose 2.3 Part No. Price (exc. VAT) Lead time If not already offered, for a contract involving first line in-house maintenance, please state: Cost of training (if any) Location of training course Duration of course Number of people Cost for equipment manuals Response times 3.1 What is your target repair time for electro medical equipment? 60 Gastrointestinal Endoscopy Equipment Evaluation DRAFT No 5 3.2 What is your performance rate against this target? 3.3 What is your response time to the following scenarios? Telephone technical response within hours of receiving notification from the hospital Engineer on site within hours of receiving notification from the hospital Breakdown rectified or loan equipment supplied within hours of receiving notification from the hospital 3.4 Please state the latest time on any working day to guarantee same day response to a breakdown call: hours 3.5 What compensation is offered in the event that this target response time is not achieved? Spare parts 4.1 Whether a maintenance contract is held or not, please confirm that spare parts will be available to: The Trust Any agent nominated by the above YES/NO YES/NO Please state if any conditions apply 4.2 State location of spares: 4.3 State availability of spares: 4.4 State lead time in respect of supply of spares: 4.5 Is it recommended that the Trust should hold spare parts? If YES, please give details: YES/NO 61 Gastrointestinal Endoscopy Equipment Evaluation DRAFT No 5 62 Gastrointestinal Endoscopy Equipment Evaluation DRAFT No 5 Additional discounts for maintenance 6.1 The above maintenance costs are per item of electro-medical equipment. If the trust were to take out a number of maintenance contracts please detail the number required to qualify for a quantity discount and the discount which will be applied. 6.2 Please quote additional discounts offered in respect of maintenance contract as follows: 6.3 6.2.1 Payment made annually in advance (post warranty): ______________ % discount 6.2.2 A single order placed post warranty to cover a total maintenance term of 7 years, paid annually in advance: % discount 6.2.3 A single order placed post warranty to cover a total maintenance term of 7 years, paid in full in advance: % discount Please quote any further discounts offered in respect of maintenance: Non-contract maintenance 7.1 Non-contract maintenance costs should be stated: Hourly rate £ /hour normal work hours 0830-1730 (Monday to Friday) Please state if normal working hours differ from above Is travelling time charged for? YES/NO (delete as applicable) If YES, please state cost per hour £ /hour Minimum call-out charge (if applicable) £ List potential faults????? Hourly rate outside normal working hours hour £ per Please specify hours of availability 63 Gastrointestinal Endoscopy Equipment Evaluation DRAFT No 5 Offer schedule - Questionnaire NHS contract for the supply of flexible endoscopy equipment Offer reference: ******** General 1.1 State name and nationality of parent company 1.2 Please state the number of systems in use similar to those offered on this tender: In the UK World-wide Maintenance 3.1 State location of your nearest engineer(s) for the equipment offered to this hospital: 3.2 How many engineers are available to service this hospital 3.3 How many other hospitals do they service 3.4 State the total number of engineers which you employ in respect of the equipment tendered: 64 Gastrointestinal Endoscopy Equipment Evaluation DRAFT No 5 Training 4.1 User training should be included in your offer. Please give details of the training or familiarisation to be given within the trust, in respect of the equipment tendered. 4.2 Is this training available free of charge throughout the equipments life at the trust , this should included any training needed for new staff YES/NO If NO, please give further details including potential costs. 4.3 Please state details of any other external user training or support facilities which are available to the Trust. Delivery 5.1 State time taken from notification of order to delivery 5.2 State time taken from delivery to full installation 5.3 State time taken from installation to commissioning 5.4 State method of delivery 65 Gastrointestinal Endoscopy Equipment Evaluation DRAFT No 5 Document No 7 Form of offer NHS contract for the supply of flexible endoscopy equip Offer reference: ********* ...................................................................................................................... (the Offeror) of ...................................................................................................................................... ........................................................................................................................................... ........................................................................................................................................... AGREES 1. that this Offer and any contract arising from it shall be subject to the Terms of offer, NHS conditions of contract and supplementary conditions of contract and all other terms (if any) issued with the invitation to offer; and 2. to supply goods/services in respect of which its offer is accepted (if any) to the exact quality, sort and price specified in the Offer schedule in such quantities to such extent and at such times and locations as ordered 3. that this offer is made in good faith and that the Offeror has not fixed or adjusted the amount of the offer by or in accordance with any agreement or arrangement with any other person. The Offeror certifies that it has not, and undertakes that it will not: 3.1 communicate to any person other than the person inviting these offers the amount or approximate amount of the offer, except where the disclosure, in confidence, of the approximate amount of the offer was necessary to obtain quotations required for the preparation of the offer, for insurance purposes or for a contract guarantee bond; 3.2 enter into any arrangement or agreement with any other person that he or the other person(s) shall refrain from making an offer or as to the amount of any offer to be submitted; Dated this .................................. day of ..............................…................. 20................ Name (print): ......................................................................................….…....................... Signature: ...................................................................................................................... Title: ...................................................................................................................... The Form of offer must be signed by an authorised signatory. In the case of a partnership by a partner for and on behalf of the firm, and in the case of a limited company by an officer duly authorised, the designation of the officer being stated. 66