The Transplant Unit

Transplant Units should in general serve at least 2 million total population depending on geography, communications and population density. They should be appropriately located and preferably perform at least 50 transplants per year. Transplant Units must be adequately staffed both medically and surgically at senior and junior level, and have full support services. Specialist advisory committee recommendations and junior doctors' hours guidelines must be followed. The care of the renal transplant recipient is best carried out by a multidisciplinary team with equal input from Nephrologists and Transplant Surgeons. This element of care along with full integration with the dialysis service is essential (good practice).

7.13 Renal transplantation facilities should be located taking to account geography, population density and communications. This avoids duplication of specialised resources such as histocompatibility laboratories and organ retrieval teams and permits efficient training of medical and other staff.

7.14 The Transplant Unit should have 4 beds per million population available for new transplants one third of which should be single bed cubicles. This figure may need to be varied in the light of geography, communication networks and population density. The beds, with the facilities to provide dialysis when needed, must be within a single ward to ensure high standards of training, nursing and cross infection care although all the beds in the ward need not be devoted to transplantation.

7.15 Access to operating theatres 24 hours a day without delay to minimise the cold ischaemic time is essential (Morris et al 1999) and in addition elective operating theatre facilities are needed. Laboratory support is required for histocompatibility and HLA antibody testing, haematology, biochemistry, virology, bacteriology and pathology. Histopathological services should include a pathologist trained in interpretation of renal transplant biopsies.

7.16 Imaging services required include routine X-ray, conventional and duplex ultrasound, computed tomography, magnetic resonance imaging and radioisotope scanning. It is important to emphasise that these services will often be required at short notice and out of normal working hours.

7.17 Access to Urology services and advice is necessary and joint management of diabetic patients with a Diabetologist is desirable before and after transplantation. For post transplant surveillance close links with Cardiology, Dermatology and Gynaecology will be needed and access to other specialties such as Neurology, Gastroenterology, Thoracic Medicine and Infectious Disease will be needed on occasion for acute consultation.

7.18 Patients should be followed up in a Transplant Clinic with appropriately trained and experienced staff. Consultant led clinics will be needed for this although junior staff should participate under supervision as may Nurse Practitioners. Recipients should be reviewed at least annually at the Transplant Centre unless the facilities in the devolved Renal Unit are adequate with the ability to transfer data centrally. In addition to monitoring and optimising renal function follow up clinics should consider cardiovascular risk management including hypertension, smoking, diet, exercise and dyslipidaemia, prevention and detection of skin malignancy, osteoporosis, malignancy, post-transplantation pregnancy and other women's health issues.

Blood pressure targets for renal transplant recipients are <130mmHg systolic <80mmHg diastolic (B).

7.19 Controlled trials of different blood pressure targets in renal transplant recipients are not available and in the meantime it is recommended that blood pressure control should have the same targets as in other patients with renal disease (see page X). Treatment of hyperlipidaemia and other secondary prevention measures including aspirin for primary prevention in diabetics is recommended (Scottish Intercollegiate Guidelines 40, 1999 & 41, 2000). Controlled trials of the treatment of hypercholesterolaemia in renal transplant recipients are ongoing and in the meantime no firm recommendation for primary prevention can be made (Silkensen 2000, Kew and Curtis 1998). Prevention of osteoporosis should be aimed at by cessation of smoking, minimising corticosteroid exposure, encouraging exercise, hormone replacement therapy and adequate dietary calcium intake. Treatment of symptomatic osteoporosis should follow established guidelines (Royal College of Physicians of London 2000).

7.20 Data storage and access is essential for both clinical and service audit: both staff and equipment must be costed in to the service. The database should be interfaced with the UKTSSA which is integrated with the National Renal Registry. If patients are referred back for continuing care to local Nephrologists the local databases should be linked to the Transplant Unit.

7.21 Surgical staffing has been dealt with in detail in the review of renal services in England (Department of Health 1996). There should be at least 4 surgeons trained in transplantation per 2 million population plus appropriate support staff; Consultant rotas should not be more than one in four (Royal Surgical Colleges 1997), cross cover by Surgeons untrained in transplantation which should be avoided and the presence of only a single handed Consultant transplant Surgeon is to be condemned.

7.22 Multi-organ donation continues to increase and organ retrieval services must be designed with this in mind. Occasionally recipients will receive kidney/liver and kidney/heart transplants and the services for these patients must be sited and administered with care and joint management in Transplant Centres performing multiple transplants is desirable.

An accredited tissue typing service is an essential part of a successful kidney transplant programme. Day-to-day direction of the laboratory must be provided by a medical or scientific consultant trained in Histocompatibility & Immunogenetics (H&I). The tissue typing laboratory staff must be an integral part of the transplant team. Laboratory staff must be available 24hrs a day to type and crossmatch against donors. Living donors and recipients must be tested as required under the terms of the Human Organ Transplants Act 1989 (good practice). All renal centres should participate in the agreed UK organ allocation scheme for cadaver kidneys. All centres should document local allocation criteria. Patient registration on the national waiting list must contain sufficient HLA typing and sensitisation information to support the operation of the allocation scheme (good practice). All screening for HLA-specific antibodies should use a typed panel which allows interpretation of positive reactions. The tissue typing laboratory must be provided with patients' serum following sensitising events such as the transfusion of blood products or transplantation. Following transplantation it is essential that the tissue typing laboratory continues to regularly receive serum samples for antibody screening. Failure to provide these samples may jeopardise a patient's future chances of transplantation. All potential recipients must be screened regularly for HLA-specific antibodies. This should be at least every 3 months. The tissue type of fathers and children borne by potential recipients should be determined wherever possible (good practice). Sensitised recipients must have the HLA-specificities of circulating antibodies defined carefully. The sensitisation status of every patient registered on the national waiting list should be reviewed on at least an annual basis (B). All donor recipient pairs should be cross-matched by an appropriate technique before transplantation. Flow cytometric cross-matching may be helpful for re-transplants and highly sensitised recipients (B).

7.23 Crucial to the provision of a quality service and the introduction of new developments are the staffing structure and personnel qualifications within the Histocompatibility and Immunogenetics (H&I) laboratory. The laboratory must be directed by a medical consultant or a substantive consultant scientist (Grade C Clinical Scientist) who is in charge of the day-to-day laboratory activity and is available for contact outside normal working hours. The director of the laboratory must have experience of working in an H&I laboratory and must have Membership of the Royal College of Pathologists in H&I or evidence of at least an equivalent level of training in the subject.

Other scientific/technical staff should have successfully completed a recognised training scheme in H&I (British Society for Histocompatibility & Immunogenetics (BSHI) or Council for Professions Supplementary to Medicine (CPSM)) and should participate in relevant continuing professional development schemes. Trainees must participate in a recognised training scheme. It is therefore essential that training opportunities are provided within the laboratory for all personnel.

7.24 The laboratory must be accredited by Clinical Pathology Accreditation (UK) Ltd (CPA), must participate in the UK National External Quality Assurance scheme (UK NEQAS) for each of the services offered and demonstrate an acceptable standard of performance.

7.25 It is important that close liaison is maintained between the laboratory and the clinical team. The head of the laboratory and other appropriate laboratory staff must therefore establish good professional relationships with the medical and professional staff in the transplant unit. Laboratory representation at relevant clinical and audit meetings is essential.

7.26 Technical developments in laboratory aspects of kidney transplantation have progressed rapidly and this is likely to continue. The advent of molecular biological techniques has had a significant impact on the quality of HLA typing and serological analysis. The introduction and use of novel cross-matching techniques has allowed the safe transplantation of otherwise high risk transplant recipients. H&I laboratories will offer different repertoires of tests depending on the service(s) they provide and the transplant programme(s) they support. Descriptions of the tests that can be offered are given in the document 'Standard tests in Histocompatibility & Immunogenetics' which can be obtained from the laboratory or from BSHI. Each laboratory should provide a description of the tests offered and their clinical application.

7.27 The Human Organ Transplants (Establishment of Relationship) Regulations 1998 incorporated in the Human Organ Transplants Act 1989 state that for living donor transplantation the genetic relationship between the proposed donor and recipient is to be established by means of genetic tests based on DNA variations. The tests are to be specified and the results interpreted by an 'approved tester' appointed by the Department of Health. Where there is no claimed genetic relationship, or when such a relationship cannot be established, the case must be referred to the Unrelated Live Transplant Regulatory Authority (ULTRA) via the ULTRA Secretariat at the Department of Health. The genetic relationships recognised by the Act are given in appendix #.

Approved testers must be fully aware of their responsibilities under the regulations, including receipt of signed statements claiming a relationship, documented blood samples, completion of specified tests, recording and long term storage of test results and formal reporting. Testers must be aware of the limitations of the specified tests and should report accordingly. The penalties defined in the Act should be understood.

7.28 Identity or compatibility of ABO blood groups between donor and recipient currently is essential. The principle of matching the donor HLA type to that of the recipient to optimise transplant outcome and minimise rejection is well established and has been practised by UK units since 1970. Matching is especially important in determining longer term (5-15years) outcomes [Opelz et al 1992; Held et al 1994].

7.29 As a minimum, for solid organ transplantation, all prospective donors and recipients must be typed for HLA-A, -B, -Cw, -DR, -DQ at the level required for the organ allocation programme.

7.30 In the UK, during 1997 and early 1998 the UK Transplant Users' Kidney Advisory Group developed and presented revised protocols for the allocation of kidneys based on a 3-tier system. The system for exchange of kidneys based on HLA matching and other factors affecting outcome is currently operated on the UK transplant community's behalf through the UK Transplant. In the allocation scheme local patients have priority over other equally matched patients and certain groups of centres have formed waiting list alliances for organ allocation. The number of donor kidneys that are exported to other units and those received from elsewhere are recorded for each participating unit and openly monitored. All UK units are encouraged to join the national scheme and register their potential recipients. The registration of patients must contain sufficient HLA typing and sensitisation information to support the operation of the national allocation scheme.

We would very much like your comments on this document

Please send them to Alison MacLeod, Chairman, Standards & Audit Subcommittee of the Renal Association, at: mmd175@abdn.ac.uk