A Scottish Histocompatibility & Immunogenetics Network: SHINe

Transcription

1 A Scottish Histocompatibility & Immunogenetics Network: SHINe A collaborative bid submitted by: Professor Phil DYER PhD FRCPath correspondent: Director of Histocompatibility & Immunogenetics Services phil.dyer@nhs.net Scottish National Blood Transfusion Service Royal Infirmary of Edinburgh Dr Ann-Margaret LITTLE PhD FRCPath Director of Histocompatibility & Immunogenetics Laboratory Diagnostics Directorate, Department of Laboratory Medicine Gartnavel General Hospital Glasgow Dr David TURNER PhD FRCPath Director of Histocompatibility & Immunogenetics Laboratory Scottish National Blood Transfusion Service Royal Infirmary of Edinburgh

2 1. Introduction Histocompatibility & Immunogenetics [H&I, Tissue Typing, HLA typing, HLA specific antibody screening] is a specialised laboratory discipline which supports clinical organ, tissue and cell transplantation, transfusion medicine and disease susceptibility diagnosis. In Scotland H&I laboratories are located at: Aberdeen, SNBTS, Royal Infirmary [ABD] Dundee, SNBTS, Ninewells Hospital [DUN] Edinburgh, SNBTS, Royal Infirmary [EDI] Glasgow, SNBTS, Gartnavel General Hospital [GSNBTS] Glasgow, GGC Diagnostics Directorate, Department of Laboratory Medicine, Gartnavel General Hospital [GGGC] There are 45 staff employed in these laboratories as Medical Laboratory Assistants, Biomedical Scientists and Clinical Scientists. Direction of these laboratories is delivered by Consultant Clinical Scientists: Professor Phil DYER PhD FRCPath National Director, SNBTS Histocompatibility & Immunogenetics Services phil.dyer@nhs.net Dr David TURNER PhD FRCPath Director, SNBTS Histocompatibility & Immunogenetics Laboratory, Royal Infirmary of Edinburgh david.turner2@nhs.net Dr Ann-Margaret LITTLE PhD FRCPath Director, GGC Histocompatibility & Immunogenetics Laboratory, Gartnavel General Hospital, Glasgow alittle1@nhs.net This bid is submitted with full support and intention to achieve the stated aims by the above CCSs. The technologies used in these laboratories are rapidly developing and innovative but require considerable hands on application. A 24/7/365 service is delivered to support organ donation for transplantation from Edinburgh and Glasgow GGGC H&I Laboratories. Within SNBTS, a review has led to rationalisation of H&I services and further development will progress with the SNBTS Strategic Review of Patient Services process. There is agreement that the SNBTS H&I Laboratory at Gartnavel General Hospital will be supervised by the Consultant Clinical Scientist Directing the GGC H&I Laboratory (A-ML). H&I support for organ transplantation extends beyond Scotland since the transplant map is UK wide. Organs donated by the deceased in Scotland may be transplanted anywhere in the UK and the reciprocal occurs; the aim is to support effective organ transplantation no matter where a patient resides. Scotland also provides combined kidney and pancreas transplant services for residents in Northern Ireland at Edinburgh Royal Infirmary. The Scottish Transplant Group is acting on the UK Organ Donation Working Party document Organs for Transplants to double organ donation by 2013; the implications for H&I services in Scotland to meet this significant target are considerable and will require significant investment and development of infrastructure with immediate effect. At the STG meeting in March 2009, a paper was presented outlining the need to develop and integrate H&I Services across Scotland. The STG fully supports the aims of that paper (Appendix A). Page 1

3 Other clinical services which need H&I support are also undergoing rapid development including haempoietic stem cell transplantation and cellular therapies - in which Scotland is a world leader. Establishment of a managed clinical network, the Scottish Histocompatibility & Immunogenetics Network [SHINe], is timely and necessary and will ensure an integrated approach to support the pressing needs of important clinical services to deliver effective patient treatments. 2. The aims of a Scottish Histocompatibility & Immunogenetics Network. The Establishment of SHINe has full support from: Directors of H&I services in Scotland clinical teams using H&I services relevant NHS organisations dependent on H&I services to deliver effective patient care (NES, STG, NHSBT-ODT, SNBTS) professional bodies (RCPath, BSHI, BTS) Patient organisations. Details of this support are included in Appendix B. SHINe will: a] inspire, instigate and support improvements in H&I services to benefit patients b] facilitate effective collaboration between healthcare disciplines providing or working with Histocompatibility & Immunogenetics technical services in Scotland and beyond. c] source, review and act on evidence to change and improve patient care d] develop current and instigate new and effective protocols across all H&I laboratories to share experience and establish best practice across Scotland e] establish effective audit processes to support c] and d] and maintain an effective audit cycle to continually improve service delivery f] meet international and national standards and associated protocols to effect delivery of H&I service support for patients through liaison with clinical colleagues g] work closely and effectively with clinical colleagues no matter their location h] inform any interested party of the work plan, achievements and ambitions of SHINe through a comprehensive annual report i] develop, instigate and support research projects aimed to improve H&I services for patients and will integrate this research with that of clinical colleagues j] provide and support teaching in the field of H&I across laboratory, nursing and medical disciplines; provide information for patients to assist their understanding of their treatment k] review and revise these aims, in the light of experience, to maintain an effective Network Page 2

4 3. Network description / Proposed structure for SHINe. Incidence & prevalence of H&I Services. Currently, services are provided from the locations shown in the table: H&I centre Heart Kidney (adult Kidney and pancreas Liver HSCT (related donors) HSCT (alternative donors) Disease Association patients) ABD X X X X X DUN X X X X X EDI X X X GGGH X X X GSNBTS X X X X X X X Transfusion specific tests Activity in 2008/09 for these services was: H&I Test Patients tested ABD DUN EDI GGG C GSN BTS Organ donors & recipients Haemapoietic stem cell HLA typing donors & recipients Apheresis platelet donors Disease association Donor / recipient crossmatching Transplant recipients HLA specific antibody testing Many HPA typing Platelet recipients Platelet antibody testing Platelet recipients Immunohaematology Transfusion recipients Estimating the need for H&I services. Activity for H&I services is distinctly variable between locations. An early aim of SHINe will be to establish and report an audit of activity in all H&I Laboratories. This will inform effective and timely delivery of services irrespective of the location of the patient. In turn SHINe will review instances where services could be improved by testing and delivery at the appropriate location. Fundamental to delivery of H&I services is the ability to perform tests to the set standards and meeting time restraints, as in organ donor testing. The strength of a network will ensure: equal access to services consistent achievement of service level agreements maintenance of quality through activity. All Laboratories participate in external quality assurance schemes (UK NEQAS) appropriate to the services they deliver and performance would be reviewed through the Network. Some techniques used in H&I laboratories are highly specialised and sharing experience in such low volume testing areas through a network would maintain functionality for these infrequent but clinically important tests. An example is HLA typing at the DNA sequence level for HSCT donors and recipients. Page 3

5 It is essential to react to the major national initiative currently underway to double organ donation from the deceased, by This target impacts heavily on H&I service provision. In 2008/09 organs were donated from 72 deceased persons in Scotland, a 5% increase on previous years indicating that progress towards set targets is being made. As a matter of urgency, the Network would have to consider what investments would be essential to meet this demand. This assessment must cover accommodation, equipment, staffing, training and consumable items. The build process for all these areas must be started immediately to guarantee success in supporting donation and clinical organ transplantation in years to come. The number of haemapoietic stem cell transplants is increasing because this therapy is of benefit to an increasing range of patients due to a reduction in transplant related morbidity and the use of alternative donors, such as cord blood. The establishment of a Scottish islet cell transplant programme is in progress and funding to provide relevant H&I support has been made available. As a national service for diabetic patients, H&I laboratories must provide services for these patients. Scotland is pioneering novel stem cell technologies and therapies in several centres (Aberdeen SNBTS, Edinburgh SNBTS / Centre for Regenerative Medicine, Glasgow Cord Blood Bank). As yet the risk of immune mediated rejection in these treatments is not established but theory indicates a significant role for HLA compatibility in contributing to a successful outcome. It is inevitable that these clinical innovations using stem cells in a diverse range of treatments will require support from H&I laboratories. Further indicative evidence comes from centres transplanting islet cells to diabetic patients where outcome is influenced by sensitisation of the recipient to donor HLA types. This observation has led to UK guidelines requiring monitoring of islet recipients with H&I compatibility tests. 5. Service patterns. H&I services are provided at tertiary level because of their specialist nature. On occasion, disease association testing may be requested by primary or secondary care partners. Patients waiting for kidney transplantation may be treated at dialysis centres located in a variety of hospitals and samples for H&I testing originate from these. To summarise, H&I testing requests can originate from: General Practice District General Hospitals Teaching Hospitals And can be requested by: GPs Nurses Consultants The accompanying figure describes the relationships between H&I services and their healthcare partners (Appendix C). 6. Equality and diversity. As a laboratory service, H&I testing activity is governed by referrals from clinical colleagues. Turn-round times for reporting of test results are optimised irrespective of the location of the patient. The Consultant Clinical Scientist, as Director of the H&I Laboratory, is responsible for ensuring that reporting times and consultative advice are provided in a timely manner. For example, attendance at clinical review meetings is a priority task. Since HLA types are biologically diverse, the advice from an H&I CCS is essential in assisting clinical colleagues Page 4

6 when they are planning effective and equitable patient care. Decisions which can be significantly influenced by HLA types are: access to transplantation availability of suitable donors disease diagnosis. Some patients are denied easy access to transplantation because of biological barriers, such as ABO blood group. These are increasingly being overcome but only by careful design of conditioning protocols which are dependent on effective H&I Laboratory support. A quality H&I service will ensure access to transplant options for Scottish patients. 7. Clinical effectiveness of H&I services. The fundamental role of H&I support for clinical organ, tissue and cell transplantation is well established. A list of 14 out of 55 NSAG Nationally Funded Services which rely on H&I Laboratory support is available in Appendix D. In haemapoietic stem cell transplantation (HSCT, bone marrow transplantation) incompatibilities between donor and recipient HLA types contribute to either failure of engraftment, or graft versus host disease. To avoid these consequences and to ensure successful HSCT both recipient and donor HLA types must be established and their compatibility assessed before transplantation can proceed. Selection of a suitable matched donor is a complex process demanding input from expert H&I staff to the clinical review / MDT meeting. This role is expanded when sibling or genetically related donors are unavailable. H&I scientists are responsible for coordinating the search for an HLA matched unrelated adult donor amongst the worldwide registers, and where appropriate, the search for a suitable unrelated cord blood donation. The indicators for HSCT are usually life-threatening conditions such as leukaemia which establishes H&I support for effective transplantation as a high healthcare priority. In organ transplantation H&I testing, especially the crossmatch performed in the acute situation following donation, is essential to avoid rapid, life-threatening immune mediated failure of the transplant. In addition, since donated organs are in high demand and insufficient supply, failure of a single transplanted organ is disastrous. The role of H&I services in organ transplantation extends from patient pre-transplant workup through immediate pre-transplant compatibility testing, including donor testing, to life-long posttransplant monitoring. This demands effective storage of patient information and blood and tissue samples, which is another key role of H&I laboratories. There has to be effective collaborative working of all H&I laboratories across the UK to ensure life-long transplant patient support. The effectiveness of H&I services for organ transplantation is written into guidelines from national and international professional bodies ( and in the requirements of NHS BT ODT. In some conditions diagnostic HLA testing of a patient can guide optimal treatment. An example is HLA-B27 positivity in patients likely to have ankylosing spondylitis, a debilitating condition of stiffening of the spine which necessitates interventional physiotherapy. A developing area for H&I testing is that of predicting drug sensitivity reactions. For example the front line anti-retroviral drug, abacavir, leads to hyperresponse in about 5% of patients and these usually possess the HLA-B*5701 type. Testing patients before treatment can inform clinical treatment options and avoid dangerous side-effects. Page 5

7 Transfusion of blood is usually a safe procedure however in some infrequent instances, or in cases where multiple blood transfusions are essential, the recipient can react to non-self antigens in the donor blood. The antigens which can give rise to transfusion reactions include HLA and platelet antigens and antibodies to these antigens must also be investigated. The rare condition of transfusion related acute lung injury, TRALI, can be life-threatening. TRALI is due to antibodies in the donated blood and investigation to avoid recurrence is essential. Immunogenetic testing, including for HLA antigens and antibodies directed to them is specialised. The genetic system coding for HLA is complex and highly variable; it is the most polymorphic in the human genome. The technologies used are innovative, reliable and powerful. Currently X-map (Luminex) assays predominate and they are based on polymerase chain reaction amplification of patient DNA followed by flow-cytometric analysis of binding patterns between patient amplicons and immobilised DNA probes attached to microspheres. Interpretation of the output from the analyser is demanding requiring high level expertise to inform clinical decisions. X-map technology is also used to detect and define antibodies to HLA antigens which can lead to transplant rejection or sub-optimal transplant function. For urgent typing of organ donors, H&I laboratories can define HLA types in the donor by assessing the most variable gene complex in humans within 4 hours. The testing required to assess compatibility between a HSC transplant donor and patient is more detailed and utilises at least two different methodologies in order to obtain the high resolution HLA typing required. The evidence base on which H&I services have been established is found in peer review publications, in professional guidance and in requirements set out by bodies such as NHS BT ODT ( There have been no reviews of H&I services by NICE, because of the well-established clinical need for H&I services and because of the speciality of H&I. To be blunt without H&I services there is no clinical transplantation! 8. Why establish a Scottish H&I Network, SHINe? There are three change drivers which shape the need for an integrated Scottish H&I Service Network: Scottish Transplant Group Newsletter, Feb 2009 Meeting the Transfusion Needs of Patients, SNBTS Strategy Specialist Laboratories Medical Services (SLaMS) : Draft Proposed Implementation Plan, Aug 2008, adopted March In addition, following publication of Organs for Transplants in early 2008, BSHI, the professional body for H&I, received support from NHS BT ODT Kidney Advisory Group to plan for centralised commissioning of organ donor HLA typing. The National Commissioning Group (England & Wales) has asked the DH Chief Scientist, the Director of Pathology Modernisation and the office of the National Clinical Lead for Renal Services to propose how centralised commissioning might progress. This work is ongoing. The situation in Scotland is under discussion with the Scottish Transplant Group and with the Medical Director of NSS. One possibility would be for single commissioning of organ donor HLA typing with a concomitant review of funding mechanisms for H&I services across Scotland. The developments in service provision are in this general direction and would allow a coordinated approach through a Network. It is essential to recruit trainee Healthcare Scientists from 2009 and 2010 graduates. NHS Education Scotland has received a case and a bid for two posts commencing in September 2009 with a request to take on further trainees in 2010 followed by a review of need Page 6

8 (workforce planning exercise). The outcome of this bid is currently awaited. Implementation of training would be across all H&I laboratories in Scotland to maximise the training expertise and clinical laboratory experience available. The range of H&I services in Scotland will make these training opportunities highly attractive to the best science graduates. This training programme would be coordinated through SHINe. Information Technology support for H&I laboratories in Scotland is of prime importance but it is currently outdated with all laboratories depending on fragile non-integrated legacy systems. There is a need for a modern IT system which will support all Scottish H&I Laboratories with full connectivity to clinical systems and ODT. This would be best achieved through a Network The option to establish an H&I Network is strongly supported by clinical service leads as evidenced in Appendix B. The specific targets for service improvement following establishment of an H&I Network will be: Provision of an integrated H&I service across Scotland accessible to all patients Meeting the need to double organ donation by 2013 An integrated service level agreement process Modernisation of laboratory equipment, including an integrated IT system Review of laboratory space available for delivery of H&I services to maximise use of facilities Provision of training at the highest level and recruitment of Healthcare Scientists to ensure a robust workforce 9. Teaching and research Links with NES have been established so that intake of trainee Healthcare Scientists can commence without delay, subject to agreed funding. These, and other trainees already in post, will benefit from the BSHI training programme which can be delivered across Scotland by BSHI approved Training Managers (5 in post in Scotland). Progression through HPC Registration, study for higher degrees and ultimately Fellowship of the Royal College of Pathologists will be offered with the best trainees being expected to exit within 8 years. The Consultant Clinical Scientists now in post in Scottish H&I Laboratories have delivered training to all of these levels in previous appointments. Indeed the BSHI scheme was designed by one CCS and was first achieved successfully by another, who now advises on HPC Registration at the UK level. All three CCSs have successfully supervised several trainees to MSc and PhD levels. One CCS has served as Chairperson of the RCPath H&I Examiners Committee. This strong experience in training in H&I will be used within the Network for significant benefit of H&I training in Scotland. The Modernising Scientific Careers proposal is being monitored in the context of training and career development for H&I Healthcare Scientists in Scotland. As yet engagement with Scottish Universities for delivery of training expertise in H&I has to be achieved. This will be an aim of the Network. Initial approaches have been warmly welcomed, at under- and post-graduate levels. Since the start of 2009, post-graduate medical training in H&I has been offered with a series of seminars and tutorials having been established. These are delivered locally and informally Page 7

9 but a Network would open up opportunities to share this expertise across Scotland, whenever requested. Connections with industrial partners have been opened through the Scottish Stem Cell Network ( Several Scottish companies active in development of stem cell therapies have sought guidance and training in H&I issues. The CCSs have or will be granted honorary academic positions to recognise past and future contributions to research and development in H&I. Since H&I Laboratory Direction in Scotland has only recently been revised, R&D issues cannot be a high priority in the short term. Establishment of an H&I Network will be the ideal manner in which to progress effective and integrated clinically relevant R&D and some collaborations are already emerging. 10. SHINe specific activities. An effective audit cycle for H&I services would be catalysed by the proposed collaborative Network. Audit would review specified activities and volume, external quality assurance performance, audit of performance against national and international standards and guidelines and audit against clinical outcomes. The indications for these audits are explicit in professional guidelines. In addition, one of the three H&I CCSs has previously obtained funding for and has led effective audits elsewhere. The essence of an audit process is completion of the audit cycle leading to effective change in practices to gain improvements. H&I Laboratories have strong working relationships with clinical service users allowing access to patient outcomes in relation to H&I testing. Publication of audits is essential and this would be at local, Network and UK levels particularly in peer review journals. An early task for SHINe would be to discuss and prioritise audits which would address pressing issues within H&I services in Scotland. H&I Laboratories regularly participate in national meetings such as the British Society for Histocompatibility & Immunogenetics, the British Transplantation Society and international meetings such as the European Foundation for Immunogenetics and completed audits would be offered for presentation at these meetings. All three H&I CCSs have wide experience in presenting at these levels and also have an extensive list of publications in peer review journals. Collaboration with national and international transplant registries such as: the Scottish Renal Registry NHS BT Organ Donation and Transplant National Transplant Database The Anthony Nolan Trust (HSCT) British Bone Marrow Registry Welsh Bone Marrow Donor Registry World Marrow Donor Association Collaborative Transplant Registry (Heidelberg) is established and ongoing and will allow an identity for SHINe in these areas. One of the CCSs has recently obtained funding (c 150K), in collaboration with a transplant surgeon, to establish audit and review of kidney transplant support services in the immediate preoperative period with the explicit aim of reducing ex-vivo storage to maximise early function of transplanted kidneys. Currently, H&I staff in Scotland collaborate effectively but resources and workloads impose limits. As SHINe establishes a guiding role then opportunities for H&I staff to gain CPD and enhance their technical experience by working in the Networked Laboratories will significantly increase. From 2009 regular CPD seminars led by invited external speakers have been established; attendance has been good but not universal. These events have attracted clinical and transplant coordinator staff and so are multidisciplinary. SHINe would aim to maintain these events but to catalyse increased attendance at them. Page 8

10 11. Arrangements for SHINe. The Network will be led by one of the three H&I Consultant Clinical Scientists currently in post the Network Lead, who will be responsible for managing the Network funding. Discussions suggest a planned rotational system (every 3-4 years) based on strong cooperation and mutual support with the specific aims of the Network being central to this collaboration. The three CCSs have previously worked together successfully. It is envisaged that the Network Lead would, on average, spend 2 sessions each week on Network affairs. There would be open and fair competition for the Network Lead appointment from the outset and at the agreed times for rotation. A Network Manager (AfC B5 0.5 wte) would be recruited and appointed. This interesting opportunity might attract a science graduate seeking to use their training in an NHS management environment. Full support for career development (eg NHS management training courses, MBA) would be supported as far as possible. The Network Manager would have to be mobile to work with all H&I Laboratories in Scotland and willing to re-locate when the Network Lead position moves between Laboratories. A Network Administrator (AfC B4 1.0 wte) would be recruited and appointed. Their role would be to provide a range of administrative support to the other Network officers. They would be required to work flexibility across Network locations. A Network Stakeholders Group will be established as a priority. This Group will be a sounding board and guide to support the Network Lead and Manager in developing the effective role of the Network to achieve the stated aims. It is likely that this Group will comprise the Network Lead and Manager, the other two CCSs, representatives from H&I BMS staff, Clinical Users, a Transplant Coordinator and of importance, patient representatives. Other interested parties expressing a wish to make active contributions will be welcomed. It will be essential to ensure that clinical users and patient representatives cover all the main functional areas of H&I services. The Stakeholder Group would meet as frequently as necessary to ensure the business of the Network is completed; initially this might be monthly but as arrangements mature the frequency will decrease. The Network would hold half-yearly open meetings with the purpose of informing all interested parties of the plans, activity and achievements of the Network. It would be expected that all staff working in H&I Laboratories in Scotland would be invited to attend. There would be a significant CPD component to these meetings which would be held in a location most likely to attract good attendance. These activities will be carefully costed and delivered within budget. Any foreseen financial pressures would be agreed with the funding organisation in advance of any expenditure. Page 9

11 12. SHINe costs and cost effectiveness. The proposed costs of SHINe are: Expenditure Per Year 000 Network Lead: Consultant Clinical Scientist, 0.2 wte 32 including on-costs Network Manager: AfC B7 0.5 wte 21 including on-costs & recruitment costs Network Administrator: AfC B4 1.0 wte 22 including on-costs & recruitment costs Network Stakeholder meetings 10 Room hire & catering Members travel Teleconferencing Stationary Total 85 The aim of SHINe is to ensure that H&I Laboratories across Scotland are able to deliver effective services for patients in rapidly developing and expanding clinical services such as organ, tissue and cell transplantation. These important, high priority services cannot proceed without H&I Laboratory support. In this context, the above costs are reasonable to ensure that Scotland provides quality support for patients in need of these costly but cost effective clinical services. H&I is a key member of the clinical and R&D teams at the forefront of and potentially revolutionary clinical services in Scotland; to maintain this position an effective Network should be established. References: Scottish Transplant Group Newsletter, Feb 2009 Meeting the Transfusion Needs of Patients, SNBTS Strategy Specialist Laboratories Medical Services (SLaMS) : Draft Proposed Implementation Plan, Aug 2008, adopted March 2009 Organs for Transplants DH London Page 10

12 Appendix A Histocompatibility & Immunogenetics Services in Scotland a paper presented to and supported by the Scottish Transplant Group on 18 March The STG has invited a presentation on 18 March to summarise provision of H&I Services in Scotland. This paper notes the points to be presented by Phil Dyer, SNBTS Director of H&I Services. The support of Dr Ann-Margaret Little, Director of the GGC H&I Laboratory at Gartnavel Hospital, Glasgow and Dr David Turner, Director of the SNBTS H&I Laboratory at the Royal Infirmary of Edinburgh, both Consultant Clinical Scientists, is acknowledged. Effective H&I Laboratory services are fundamental to successful organ transplantation and are an integral component of the transplant process. Immediate and early immunologically mediated loss of transplanted organs is prevented by donor / recipient HLA typing, matching and crossmatching. In addition, H&I Laboratories support haemapoietic progenitor cell transplantation, transfusion services, and disease diagnostics. The transplant map extends to the whole UK and organs donated in Scotland may be transplanted anywhere in the UK, following NHSBT ODT allocation policies. Healthcare Scientists delivering H&I Services provide 24/7/365 availability to enable UK wide transplant provision. In Scotland there are H&I Laboratories at: a. Gartnavel Hospital Glasgow (x2 - GGC & SNBTS provided) b. Royal Infirmary Edinburgh (SNBTS Provided). c. Ninewells Hospital Dundee (SNBTS Provided). d. Aberdeen Royal Infirmary (SNBTS Provided). Recipient and donor testing for organ transplantation takes place at (a) & (b) only. In 2008 significant developments in service provision occurred. In Scotland there are three change drivers which will shape the need for an integrated H&I Service most probably a NETWORK (Scottish Histocompatibility & Immunogenetics Network, SHINe?). These are: e. Scottish Transplant Group Newsletter, Feb f. Meeting the Transfusion Needs of Patients, SNBTS Strategy g. Specialist Laboratories Medical Services (SLaMS): Draft Proposed Implementation Plan, Aug 2008, adopted March A Network would promote common standards for H&I services in Scotland. This would include a full range of pre-, peri- and post-transplant H&I testing available to all transplant patients in Scotland. In addition a Network would facilitate audit across Scotland to promote quality H&I services and meeting the requirements of accreditation bodies (CPA, EFI). Following publication of Organs for Transplants in early 2008, the professional body for H&I (British Society for Histocompatibility & Immunogenetics, received support from the ODT Kidney Advisory Group to plan for centralised commissioning of organ donor HLA typing. The National Commissioning Group (England & Wales) has asked the DH Chief Scientist and the Director of Pathology Modernisation to propose how centralised commissioning might progress. This work is ongoing. The situation in Scotland is under discussion and there has been a recent useful meeting between SNBTS staff and the Medical Director of NSS. One possibility would be for single commissioning of organ donor HLA typing with a concomitant review of funding mechanisms for H&I services across Scotland. The developments in service provision are in this general direction and would allow a coordinated approach to some of the problems mentioned hereafter. 1) Increased demand for H&I services The planned increase in transplant rates (+50% by 2013) will be accompanied by a significant increase in demand for H&I services; to build adequate infrastructure it is essential to recruit trainee Healthcare Scientists from 2009 and 2010 graduates. NHS Education Scotland has received a case and a bid for two posts commencing in September 2009 with a request to take on further trainees in 2010 followed by a review of need (workforce planning exercise). The outcome of this bid is awaited at the end of March The period of training up to Registration is 4 years and to build for the increase in demand for H&I services across Scotland, together with succession planning, there must be an adequate number of training posts available. At present there are none. The evidence for increasing demand exists within current budgeting systems which document legacy funding, raising concerns. There are significant developments of clinical transplant services which require support from H&I Laboratories: a. allocation of organs donated after cardiac death b. virtual crossmatching to reduce cold storage time c. antibody incompatible transplantation d. islet transplantation e. cytotoxic T lymphocytes to treat post-transplant lymphoproliferative disease f. cell therapies (stem cell biology). It will be essential for these developments to be integrated across Scotland to ensure equitable provision of quality services to patients. At the same time, there must be local flexibility to support delivery of specialist services when the need is small. Page 11

13 2) Staff pressures There are significant pressures on H&I laboratory staffing including retention of experienced staff, AfC pay rates for outof-hours working and development of future staffing structures through Modernising Scientific Careers. These pressures must be addressed in a sensitive and supportive manner to ensure an effective H&I workforce. 3) Equipment/IT Modern laboratory equipment has the advantage of semi-automation and IT connectivity reducing pressures on staff, but not all H&I Laboratories benefit in this way. A review would identify ways in which effective investment could result in these benefits through increased automation. Equipment needs a safe home; in particular the space available for the H&I Laboratory at the Royal Infirmary in Edinburgh is inadequate. Information Technology support for H&I laboratories in Scotland is outdated with all laboratories depending on fragile legacy systems which are not integrated. There is a need for a modern IT system which will support all Scottish H&I Laboratories with full connectivity to clinical systems and ODT. Within SNBTS an H&I IT scoping process is underway. Summary Specifically, support from the STG is sought for: a. establishment and resourcing of a Scottish H&I Network b. a review of funding mechanisms for all H&I services in Scotland and commissioning arrangements for organ donor HLA typing across Scotland c. supernumary trainee Healthcare Scientist posts (resourced through NES) d. developments of equipment and technology within H&I laboratories Page 12

14 Appendix B Letters of Support for SHINe The following letter was widely distributed to interested parties: Dear colleague, Establishment of a Scottish Histocompatibility & Immunogenetics managed network SHINe. We are compiling a bid to the National Services Advisory Group, NHS National Services Scotland, to establish and recognise a managed network for H&I Services in Scotland. The specific aim of this network will be to facilitate integrated working of all H&I laboratories in Scotland to maintain close liaison with clinical colleagues and so to effect delivery of quality patient care. The stated aims of SHINe in our bid are to: a] facilitate effective collaboration of all healthcare disciplines providing or working with Histocompatibility & Immunogenetics technical services in Scotland and beyond. b] inspire, instigate and support improvements in H&I services to benefit patients c] source, review and act on evidence to change and improve patient care d] establish effective standards for H&I laboratory work e] develop current and instigate new and effective protocols across all H&I laboratories to share experience and establish best practice across Scotland f] establish effective audit processes to support c], d] and e] and to maintain an effective audit cycle to continually improve service delivery g] meet established international and national standards and associated protocols to effect delivery across Scotland of H&I service support for patients through liaison with clinical colleagues h] work closely and effectively with clinical colleagues no matter their location i] inform any interested party of the work plan, achievements and ambitions of SHINe through a comprehensive annual report j] develop, instigate and support research projects aimed to improve H&I services for patients and will integrate this research with that of clinical colleagues k] provide and support teaching in the field of H&I across laboratory, nursing and medical disciplines and will provide information for patients to assist their understanding of their treatment l] review and revise these aims, in the light of experience, to maintain an effective Network. We are seeking your support, in writing, which will be included as an appendix to our bid. Your response need not be extensive and might simply indicate your support for the above aims of SHINe. It is a requirement that a bid to establish a network is accompanied by statements of support from a range of interested parties so we greatly appreciate the effort you may make on our behalf. Your letter will be open to view by those accessing the bid document. We will be pleased to supply a copy of the bid document once it has been submitted and hopefully accepted for instigation of SHINe. We understand that our request for your support in writing will take some of your time so we greatly appreciate your help. We have a deadline of the end of May to submit our bid so your early response would be appreciated. We would prefer you to respond on headed paper but otherwise an will suffice. We look forward to hearing from you and appreciate your support for this important development in H&I services for Scotland. Yours sincerely, Philip DYER Ann-Margaret LITTLE David TURNER Director of SNBTS H&I Services Director of H&I Laboratory Director of SNBTS H&I Laboratory Royal Infirmary of Edinburgh Gartnavel General Hospital Royal Infirmary of Edinburgh Glasgow Page 13

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34 Appendix C Relationships between H&I Healthcare Partners Organ failure physicians Organ transplant Surgeons HSCT physicians Transfusion practitioners GPs Patients HSCT physicians Organ transplant HSCT Disease diagnosis Transfusion Nurses Donor & recipient Coordinators HSCT Donor Registries Testing Interpretation Reporting Liaison Organ Donation and Transplant (NHS Blood & Transplant) Histocompatibility & Immunogenetics Laboratory Scottish Transplant Group Scottish Government Health Directorate Registration Reporting Liaison Aberdeen Dundee Edinburgh Line of management SNBTS NSS British Society for Histocompatibility & Immunogenetics Glasgow x 2 GGC Laboratory Medicine Institute of Biomedical Scientists Royal College of Pathologists Profession al affairs Training & s NES Page 33

35 Appendix D List of Nationally Funded Services H&I Laboratory services integral to delivery of clinical treatments Extracted from NSAG Applications 2008, Appendix B Service Advanced heart failure in adults (includes heart transplantation) Alternative donor stem cell (bone marrow) transplantation in adults Clinical Scientist Training Schemes Commencing Autumn 2009 Donor transplant coordination Heart, heart-lung and lung transplantation Liver transplantation Molecular genetics Disease diagnosis Drug sensitivity Paediatric bone marrow transplantation Paediatric renal transplantation Pancreas and simultaneous pancreas / renal transplantation Pancreas islet transplantation Commencing Autumn 2009 Severe combined immunodeficiency and related disorders (SCIDs) Small bowel transplantation Stem cell transplantation for juvenile idiopathic arthritis and related connective tissue disorders Location Glasgow Golden Jubilee Hospital Glasgow Beatson, West of Scotland Cancer Centre All H&I Laboratories in Scotland Based centrally in Falkirk, working in Aberdeen, Dundee, Glasgow, Edinburgh, and Inverness and elsewhere across Scotland Patients from across Scotland are referred to centres in England Edinburgh Dundee & Glasgow Yorkhill, Glasgow Yorkhill, Glasgow Edinburgh Edinburgh Patients from across Scotland are referred to centres in England Patients from across Scotland are referred to centres in England Patients from across Scotland are referred to centres in England Of the total 55 Nationally funded services, the above 14 are provided with input from Scottish H&I Laboratories. Page 34