NEFROLOGÍA. Vol. XIX. Suplemento 4. 1999 EDITORIAL COUNCIL OF EUROPE CONSENSUS DOCUMENT: «MEETING THE ORGAN SHORTAGE» «Meeting the organ shortage: an european consensus document» During the last decades the progress in transplantation has been impressive. Thanks to the advances in surgery and medicine, and the development of new immunosuppresive drugs, every day more and more patients can be transplanted successfully. Over 1 million people worldwide have received an organ and some of them have alreday survived more than 25 years. The severe shortage of cadaveric organ donors remains however the major obstacle preventing the full development of these techniques and imposes a severe limit to the number of patients who benefit from this form of therapy. The gap between the number of available organs and the waiting lists becomes higher and higher in most of the countries despite the fact that these figures do not reveal the true levels of the unmet need, because the shortage of organs means that only the patients most likely to benefit are put on the waiting list. There is now a strong international consensus that, until or unless some alternative such as xenotransplantation becomes available, the only acceptable course of action is to make every effort to maximise the procurement of cadaveric organs for transplantation. Increasingly, national health departments, international working groups and meetings of experts are seeking to develop a closer co-operation between health professionals and administrations. Furthermore, organ procurement is not just a matter for transplant teams. The whole medical community needs to be aware of the problem and become involved either indirectly or directly in the process of organ procurement. All health care staff can help identify potential donors and ensure that such patients are recognised and assessed. As in any other medical activity, the overall success of transplantation is ultimately the responsability of all health care professionals. 2 The Select Committee of Experts on the Organisational Aspects of Cooperation in Organ Transplantation of the Council of Europe defined in 1996 the solution of cadaveric organ shortage as its main priority for future actions. The first draft of the document «Meeting the Organ Shortage» was prepared and approved by this Committee after being circulated to more than 500 transplant professionals and 20 International Scientific Societies. During the last two years, this European Consensus Document has been thoroughly analysed by all the member countries and was finally approved by the Health Committee. This document provides an analysis of the steps necessary to achieve an effective process for organ procurement taking into account the available scientific evidence and describing relevant international experience. The document focuses on the technical and organisational aspects of cadaveric organ donation. Recommendations are made wherever opportunities exist for improving the process. It is clear that organ donation rate never result from fate or chance but from the work and effort of the whole Health System together with the solidarity of the population. Health professionals need support from their respective administrations in order to obtain the organizative structure that will make organ donation possible. We are sure that, if properly adapted to the characteristics of every country member, these recommendations will result in promotion of organ donation. The idea of solidarity and donation is a perfect way to contribute to the construction of Europe. Rafael Matesanz President Transplant Experts Committee Council of Europe COUNCIL OF EUROPE CONSENSUS DOCUMENT: «MEETING THE ORGAN SHORTAGE» GLOSSARY The following definitions will be used throughout this document: Transplantation - The procedure, comprising a series of technical steps which need to be followed in a defined order, that enables the organs (or tissues) obtained from dead people (donors) to be transplanted into an appropriate live donor. It starts with the identification of all potential donors and ends with the transplantation (or storage) of the organs (and/or tissues) retrieved. Brain Death - Complete and irreversible cessation of all cerebral and brain stem functions which, from the scientific, ethical and legal point of view is accepted as equivalent to the death of the individual. Strict testing according to agreed protocols is required to establish brain death beyond doubt. Potential Donor - Any person diagnosed as brain dead, by means of clinical examination, following the elimination of any medical contraindications to donation, i.e. conditions representing a potential risk for recipients. Effective Donor - A potential donor from whom at least one solid organ (or tissue) has been retrieved for transplantation. (Potential and/or effective donor rates can be expressed either by reference to the catchment population (donors per million population - pmp) or by reference to hospital parameters (e.g. donors as a percentage of overall hospital mortality; of intensive care mortality or as a rate per hundred hospital beds, etc.). Retrieval - removal of an organ or tissue intended for transplantation whether subsequently transplanted or not. Key Donation Person: A person responsible for organ donation in a specific area or hospital. He/She may or may not be the transplant co-ordinator. Organ Sharing Office (OSO)*: Bureau responsible for the collection and management of data from donors and recipients and allocation of organs according to agreed criteria. Organ Exchange Organisation (OEO)*: Organisation responsible for the organ +/- tissue allocation in a specific region/country. Organ Procurement Organisation (OPO)*: A body or organisation responsible for organ donation and procurement in a specific region/country. 1. SUMMARY 1.1 Organ transplantation is the best available established technique for the treatment of end stage failure of most essential organs (liver, heart and lungs). Corneal transplantation is similarly well established and tissue transplantation, particularly of bone but also of skin, tendons, etc., is growing very rapidly. Over 1 million people world-wide have benefited from successful organ transplantation. A number of transplant patients have survived well over 25 years and five years survival rates for most organ transplant programmes are around 70%. With modern techniques of organ preservation and advances in immuno-suppression, a significant proportion of patients can now expect to achieve long-term survival with a high quality of life. 1.2 Many more people could benefit from organ transplantation than receive transplants at present. There are currently nearly 40,000 patients waiting for a kidney in Western Europe. Mortality rates for patients waiting for a heart, liver or lung range between 15 and 30%, i.e. 400 plus die waiting for an organ each year. These figures do not represent the true position. Because of the chronic shortage of organs, some transplant clinicians are extremely selective about the patients they put on the waiting list. Currently only those patients most likely to benefit will be even considered for transplantation. 1.3 The critical factor is the supply of organs for transplantation. Only good quality organs are likely to function satisfactorily and there are strict limits on the time that can be taken to retrieve and transplant the organ. In practice this means that, for most organs, only relatively young donors are suitable who are admitted into intensive care units and subsequently declared brain dead so that organs can be retrieved while the donors heart is still beating. A typical donor has suffered either a road traffic accident or a severe cerebrovascular accident. Due to improvements in road safety in European countries, donors in the former group are in decline. Kidneys are somewhat less sensitive to ischaemia (shortage of oxygen). 1.4 In view of the potential for successful transplantation, it is considered essential that countries with an organ transplant service, take all possible measures to ensure that all potential donors are identified and as many as possible converted into effective donors. 3 * In some countries one organisation may perform more than one or all of the above functions within a region or country. COUNCIL OF EUROPE CONSENSUS DOCUMENT: «MEETING THE ORGAN SHORTAGE» 1.5 The organ donation/transplantation process is necessarily complex. There is a number of important steps each of which needs to be recognised and an effective system put in place to manage that every part of the process if potential donor organs are not to be lost. The steps are: i. Donor identification ­ all potential donors should be identified at as early a stage as possible. This will facilitate donor screening and donor management (see below). ii. Donor screening ­ donors should not be used if there is a risk of transmission of serious disease (cancer, infection) to the recipient. Guidance has been prepared by the Council of Europe and some member states on the serological and other screening methods that should be used to minimise the risk of transmission of infectious or malignant diseases to the recipient. Whenever possible, screening should include a social history taken from the relatives to exclude recent high risk behaviour, which might indicate a risk of a transmissible disease which is at too earlier stage to be detected by serological screening. iii. Donor management - it is essential that organs procured are in good condition prior to retrieval. The management of the potential donors physiological state while on intensive care and of the donor prior to and during retrieval can make a major difference to the condition of the organs. Poor donor management can make organs unusable. iv. Consent/authorisation - appropriate consent or authorisation has to be obtained before organs can be removed. Countries have different legal requirements, in some consent is presumed while in others specific consent has to be sought from either relatives or some body. Whatever the system, it is advisable to discuss donation with any relatives as part of the screening process. There is evidence that the approach to the relatives can affect their willingness to agree to donation. Staff seeking to obtain the agreement of relatives should be appropriately trained. v. Organ retrieval - the surgical technique for removing organs from the body and the way those organs are subsequently handled and preserved prior to and during transportation are critical to the successful outcome of the transplant. Each year a number of organs 4 are damaged during removal and/or transportation. Some can be repaired but a few will have to be discarded. vi. Organ allocation - for some organs, particularly kidneys, the successful long-term outcome of the transplant depends partly on appropriate matching between donor and recipient. A well-organised system for allocating and transporting donated organs to the most appropriate recipient is important. In some cases, optimum allocation will require exchange of organs or tissues between transplant organisations and countries. Co-operation between countries is increasingly important. 1.6 The purpose of this document is to provide a step-by-step guide to the most effective ways of procuring the maximum number of high quality organs for transplantation from cadaveric donors based on an analysis of the scientific data available and relevant international experience. Recommendations are made on the most effective ways of procuring organs from such donors primarily from heart beating donors (a short section on non-heart beating donors is included for reference) and for monitoring the procurement process. In making the recommendations, local and national requirements and the legal, ethical and cultural frameworks within which individual countries have to operate have been taken into account. 1.7 If at each stage of the process and level of organisation, certain key objectives can be met, countries can maximise the rate of organ transplantation. 2. SUMMARY OF RECOMMENDATIONS 2.1 Organ procurement i. The transplant process is long and complex and cannot be left to chance. Protocols should be developed for each step. A key person should be made responsible in each area/hospital for managing and monitoring the process with the power to determine where efforts and resources should be directed. Published figures cannot be extrapolated to provide local rates of potential versus effective donors (although marked differences from published rates for potential donors should be considered as suggestive of under ii. COUNCIL OF EUROPE CONSENSUS DOCUMENT: «MEETING THE ORGAN SHORTAGE» 5 COUNCIL OF EUROPE CONSENSUS DOCUMENT: «MEETING THE ORGAN SHORTAGE» detection). A donor detection gap should be established for each hospital/area and systems for monitoring the rates established. iii. A means should be developed to evaluate the size and characteristics of the potential donor pool to measure and monitor potential donor detection rates. To ensure reliability, data should be collected prospectively and analysed retrospectively as recommended in the «Donor Action Programme». iv. Proactive donor detection programmes should be instituted in every acute hospital using specially trained professionals (key donation persons) working to agreed protocols and ethical rules. v. A «key donation person», independent from transplant teams, should be appointed in every acute hospital with a clearly defined role and responsibility for establishing, managing and auditing systems for donor identification and identifying potential areas for improvement. vi. Protocols should be developed setting out the criteria for screening potential donors and their organs for the risk of disease transmission and potential viability. All appropriate steps should be taken to avoid the transmission of infectious and neoplastic diseases and primary organ failure. vii. The incidence of irreversible cardiac arrest, sepsis and other contraindications to organ donation relating to donor management of potential donors should be monitored and audited to detect and correct any problems identified. Involvement of Intensive Care Unit staff in research and/or educational programmes on donor management should help raise standards. viii. An appropriate legal framework for donation and transplantation is required which adequately defines brain stem death; the type of consent or authorisation required for retrieval (see below); the means of organ retrieval, which ensures traceability but maintains confidentiality and which bans organ trafficking. ix. Law professionals should be fully aware of the transplant process and the co-operation of those most closely involved, i.e. judges and coroners, should be sought to reduce legal refusals to a minimum. x. It is advisable to ascertain the opinion of the public and health professionals about presumed or informed consent for organ donation before considering legal changes that might be potentially detrimental. The key donation person appointed in each centre/area must be 6 xi. xii. xiii. xiv. xv. xvi. aware of all local legal criteria and should be responsible for meeting these requirements. There should be a system for the safe custody of all certificates and test results required by the law. Because both positive and negative messages can affect the public's willingness to donate organs, there is a need for a professional attitude towards, and support from experts in the field of, communications. They should help to minimise the impact of «bad news» on, and to maximise the communication of «good news» about transplantation to, health professionals, the media and the public. Special attention should be paid to both the content of the message and the best means of dealing with the most controversial topics. The preparation of specific briefing materials should be considered. The most cost effective means of increasing the publics willingness to donate seems to be improving the knowledge of health professionals (not directly involved in transplantation) and the media about transplantation issues. Continuing education should form an essential element of any communication strategy. A transplant hot line manned by appropriately trained professionals should be considered. People should be encouraged to speak about organ donation and transplantation and to communicate their wishes to their relatives. As a donor's wishes will not always be known, staff in a position to make requests for agreement to organ donation to relatives should be properly trained for the purpose. If such requests are well handled the rate of donation refusals can be reduced. Organ retrieval procedures should be well planned to minimise delay and disruption to donor hospital. Retrieval teams should be lead by experienced surgeons trained, where appropriate, in multi organ retrieval. Organ damage during retrieval should be reported and monitored and further training provided as necessary to minimise damage during retrieval or transportation. An organ sharing/allocation organisation is essential but its roles and responsibilities must be clearly defined, particularly if it is to have a role in organ donation and procurement (see below). Attention should be paid to ensuring that hospitals are properly resourced and, if necessary, reimbursed for maximising organ procurement. COUNCIL OF EUROPE CONSENSUS DOCUMENT: «MEETING THE ORGAN SHORTAGE» xvii. In order to optimise organ donation there is need for a supra hospital transplant organisation, appropriate in size and structure to the local situation with specific responsibilities for the whole process of organ procurement. xviii. The most effective organisational approach is one which balances the requirements for effective organ procurement (small, local) with those for organ allocation (large, national/multinational) (see below) and appears to be a decentralised system comprising local/regional organisations (i.e. up to 10 million population), working to protocols agreed by or under the direct supervision of a larger organisation responsible for setting/monitoring standards and for organ sharing. The aim should be to optimise organ procurement whilst ensuring the most clinically effective allocation of organs and tissues. xix. Health Administrations are responsible for ensuring that there is proper organisational support for organ donation and distribution and should guarantee the fairness, transparency and safety of the whole system. 2.2 International co-operation xx. International co-operation on the promotion of organ donation is desirable to help maximise organ donation and equalise access to transplantation between countries. Governments should actively promote such co-operation. xxi. Priority should be given to international cooperation which improves standards of training, exchange of experience, and which helps guarantee the safety of organs and the ethical standards by which they are retrieved and transplanted. 3. INTRODUCTION After four decades of experience, progress in transplantation medicine and surgery has been impressive. Advances in technique and the development of new immunosuppressive drugs have made it possible to transplant successfully several major organs, i.e. kidney, heart, heart/lung, lung and liver, into an increasingly large number of patients. Transplants of the pancreas and small bowel are also being performed. Over 1 million people world-wide have received an organ transplant and some have already survived more than 25 years. Five-year survival rates for most organs are now at least 70%. Transplantation of parts of organs or tissues including corneas, heart valves, bone, tendons, etc. are also well established and in some cases like bone, demand is growing very rapidly. However, a severe shortage of cadaveric organ donors remains a major obstacle preventing the full development of transplant services and imposes a severe limit to the number of patients who benefit from this form of therapy. Although organ transplants save thousands of lives and transform the quality of life of thousands more, many people will die or remain on renal replacement therapy because the organ supply falls drastically short of demand. Nearly 40,000 patients are at the moment waiting for a kidney in Western Europe whilst the number of cadaveric donors remains stable at around 5,000 each year.(1) This is also the case in USA where the gap between the number of available organs and patients on the waiting list is also very high. They have more than 30,000 patients on the waiting list and the number of cadaveric donors is around 5,000 each year.(2) Mortality rates while waiting for a heart, liver or lung transplant generally range between 15% and 30% but are even higher in some reports depending on the type of the organ needed 1, 2. In 1994 there were no suitable livers for some 400 European citizens and around a further 400 died while waiting for a heart 1. These figures do not reveal the true levels of unmet need for such organs. The potential need for the different organs is much higher 3. The shortage of organs means that only the patients most likely to benefit are put on the waiting list for an organ transplant. To put patients on a waiting list who have no hope of receiving an organ is both pointless and highly questionable ethically 4. The increasing demand for organs with no increase in the supply poses problems for many countries, particularly countries in which regulation of live donation is non-existent or poorly regulated, as the risk of organ trafficking increases. In some countries outside Europe, adults have voluntarily sold one of their kidneys in exchange for money or some other kind of compensation. There have been rumours of kidnapping and coercion to force the donation of a kidney although these are fortunately mostly unfounded. Organ trafficking not only poses major ethical problems, but also makes it more difficult to guarantee the quality and safety of the organ. Organ donation, properly regulated, allows the safety and quality of the organs to be properly assessed. For this reason there is now a strong international consensus that, until or unless some alternative such as xenotransplantation becomes available, the only acceptable course of action is to make every 7 COUNCIL OF EUROPE CONSENSUS DOCUMENT: «MEETING THE ORGAN SHORTAGE» effort to maximise the procurement of cadaveric organs for transplantation. Member states of the Council of Europe and the European Union and their respective transplant organisations have taken steps to eliminate the possibility of coercion or organ trafficking. Specifically, Article 21 of the Convention on Human Rights and Biomedicine states "the human body and its parts shall not, as such, give rise to financial gain". Transplantation comprises the processes of organ donation and subsequent implantation or grafting. The two parts are totally interdependent. However, historically, the techniques of organ implantation have received far more attention from the scientific community in terms of both research effort and resources than organ and tissue procurement. Until very recently, only 2-3% of papers submitted to International transplant meetings were devoted to organ donation, procurement and preservation. Most transplant professionals now recognise the severity of the organ shortage and the need to address the problems posed. Editorials in specialist journals have recently addressed the problem 5, 6. but there are still few research papers in this field. Increasingly, national health departments, international working groups and meetings of experts are seeking to develop a closer co-operation between health professionals and administrations. Private companies and foundations are also now dedicating financial resources to support the development of educational or research programmes relating to organ procurement. The programmes of all international transplant meetings now include sessions devoted to organ procurement. However, organ procurement is not just a matter for transplant teams. The whole medical community needs to be aware of the problem and become involved either indirectly or directly in the process of organ procurement. Indirectly health care professionals can educate others about the problem, allay fears and encourage a positive attitude to donation. Directly, all health care staff can help identify potential donors and ensure that such patients are recognised and assessed. As in any other medical activity, the overall success of transplantation is ultimately the responsibility of all health care professionals. This document provides an analysis of the steps necessary to achieve an effective process for organ procurement taking into account the available scientific evidence and describing relevant international experience. The document focuses on the technical and organisational aspects of cadaveric organ donation. It should however be remembered that the deceased's wishes and the sentiments of his/her family 8 have to be treated with respect. The communication established with the deceased's family and the consideration given to their wishes are essential elements in the process of procurement itself. Recommendations are made wherever opportunities exist for improving the process. This document does not discuss living donation. It does not discuss organ retrieval from non-heart beating donors (NHBDs) either, since such techniques are not currently universally accepted due to additional ethical, legal, technical and organisational problems. 4. ORGAN PROCUREMENT 4.1 The Transplantation Process 4.1.1 Overview Transplantation is a complex process involving a number of discrete but interconnected steps. Before considering the practicalities of the process, it is important to recognise the context within which it takes place. The use of substances derived from one human being for the treatment of others imposes unique ethical questions for society, particularly when, in the case of organs and most tissues, those substances are not renewable. Society now demands this type of treatment and itself benefits from the results. As Arthur Caplan testified before the US congress in 1990 «What is truly distinctive about transplantation is not technology or cost, but ethics. Transplantation is the only area in all of health care, which cannot exist without the participation of the public. It is the individual citizen who while alive, or in the case of vital organs, after death, who makes organs and tissues available for transplantation. If there were no gift of organs or tissues, transplantation would come to a grinding halt»7. Essentially, any acceptable organ transplant service depends totally on altruistic organ donation by either living or cadaveric donors. However, the Convention on Human Rights and Biomedicine states that «Removal of organs or tissue from a living person for transplantation purposes may be carried out solely for the therapeutic benefit of the recipient and when there is no suitable organ or tissue available from a deceased person and no other alternative therapeutic methods of comparable effectiveness.» When considering aspects of the transplant process, these important societal principles have to be taken into account. Health professionals are essential to transplantation, as transplants are medical procedures. Such factors as economic benefit, institutional or individuals COUNCIL OF EUROPE CONSENSUS DOCUMENT: «MEETING THE ORGAN SHORTAGE» reputations, surgical ego, municipal pride or chauvinism, however, should never be the raison d'être for a transplant programme 8. The overriding aim of any transplant programme should be to minimise the donor organ and tissue shortage by optimising the levels of altruistic donation of organs and tissue and ensuring their allocation to the most clinically appropriate recipient. The system should be based on strict adherence to widely accepted ethical rules 9. Any practice contravening such principles is to be deprecated. 4.1.2 The six steps The donation/transplant process should start with the identification (donor identification) of all individuals with potential brain death being ventilated in intensive care units (ICUs). Such potential donors should be carefully assessed to exclude contraindications to donation (donor screening) pending the necessary clinical and legal procedures required to establish and certify brain stem death. During this phase, the haemodynamic stability of the potential donor must be maintained (donor management) to preserve the viability of the organs. The legal or social requirements for authorising the removal of organs or tissues have to be met. The relatives will have to be approached and interviewed either to obtain formal consent or to obtain a social history about the potential donor. Adequate support for the family from trained staff at this time is essential. The existence of the donor has to be notified to a transplant co-ordinator or appropriate transplant organisation to ensure that an appropriately trained person takes charge of the process of organ removal. Arrangements, both within and outside the hospital, for (multiple) organ retrieval (and/or tissue) must also be made. Organ retrieval, preparation, preservation and packaging preparatory to transportation are a difficult process, which requires significant expertise if organs are not to be damaged and rendered unusable. The organs retrieved should be allocated (organ allocation) according to previously agreed criteria preferably by an organisation, which holds a common waiting list and can co-ordinate the distribution and transport of organs. Organs will normally be transplanted within a few hours of retrieval, although kidneys can be stored for up to 24 hours. Many tissues may be stored for much longer periods but may require further processing. The whole process can take many hours and involve a large number of staff with very different skills and from many backgrounds. Such a process cannot be left to chance. Protocols or operating procedures are needed for each step and the staff involved needs to be properly trained and adequately experienced in their respective roles. Even in the best centres with the most complete infrastructure, difficulties sometimes arise and there is a risk that either the donor or the organs will be lost. It is important to have a means of auditing the procedures to identify problems and modify procedures accordingly, if the continued effectiveness of the process is to be ensured. Ideally, one key (donor) person should be appointed in each area/hospital with the specific role of managing and monitoring the transplant process. Recommendation: The transplant process is long and complex and cannot be left to chance. Protocols should be developed for each step and a key person should be made responsible in each area/hospital for managing and monitoring the process with the authority to determine where efforts and resources should be directed. 4.2 Donor Detection: Potential and Identification 4.2.1 Scope of the problem Detecting potential donors is the starting point of transplantation and is possibly the most difficult to subject to standard protocols. The only way to be sure that donors are not missed is to have a means of identifying and monitoring the potential and effective donor pools within relevant hospitals or areas. To do so requires collecting information about the total number of people certified as brain stem dead and the reasons, including relatives refusal, why some did not become donors. Reasons other than strict medical contraindications need to be examined including non-admission to an ICU. This in turn depends on the physicians in charge of patients identifying potential donors. The question remains how to monitor rates of potential and effective donation in such a way as to identify hospitals or areas where rates are low because of poor organisation or reluctance on the part of health care staff or relatives. There are a number of possible indicators which depend on calculating rates of donation either in relation to the population of a specific area, or based on hospital indices such as the rate of donation compared to the hospital death rate, ICU death rate, or number of hospital beds, etc. The advantage of using indices based on large areas, e.g. a population of 10 million plus, is that rates are more reliable and stable over time. Data based on smaller populations or units may be affected by many factors. Several studies using different methods suggest that rates of over 50 potential donors per million popula9 COUNCIL OF EUROPE CONSENSUS DOCUMENT: «MEETING THE ORGAN SHORTAGE» TABLE I. POTENTIAL ORGAN DONATION RATES AND EFFECTIVENESS IN DONOR DETECTION IN DIFFERENT COUNTRIES/AREAS POTENTIAL DONOR POOL (DONORS PMP/YEAR) 50.8 DONOR DETECTION EFFECTIVENESS RATE 75% YEAR 1988 SIIMIINOF Y COLS. S M NOF ET AL. 1991-92 PENNSYLVANNIA + MINNESOTA PENNSYLVANIA + MINNESOTA (11) 1995 65.4(*) 91.5% (11) 1995 NATHAN Y COLS. NATHAN ET AL. PENNSYLVANIA (12) 1991 1987 38.3-55.2 52% PENNSYLVANIA (12) 1991 and potential rates if this first step of donor detection were to be fully effective. It is, in theory, possible that in some countries the transplant rates could be more than doubled. However, it is difficult to extrapolate from such studies to provide expected local rates as these will vary due to local factors such as road death rates, intracranial haemorrhage prevalence, population density, number of ICU beds, age structure, etc. 21, 22. It is preferable to establish the donor detection gap for each hospital/area. Steps can then be taken locally to analyse the causes of the gap and implement measures to improve performance. Recommendation: Published figures cannot be extrapolated to provide local rates of potential versus effective donors (although marked differences from published rates for potential donors should be considered as suggestive of under detection). The donor detection gap should be established for each hospital/area and systems for monitoring the rates established. 4.2.2 Improving donor detection ESPINE ET AL. CATALUÑA ESPINELLY COLS.CATALUÑA ((13)) 1999 13 1989 1987 40 92% RANZABAL ET AL. EUSKADI ARANZABAL Y COLS. EUSKADI ((14)) 1995 14 1995 1993 53 90 EVANS ET AL USA EVANS Y COLS. USA ((15)) 1992 15 1992 -- 43.7 Estimation MULTIICENTTRESPANISH T CEN RE SPANISH STUDY (16) 1994 STUDY (16) 1994 1994 65 (*) 90 * Brain dead declared people medical contra-indications including ( ) = References tion per year (pmp/yr) 10-17 can be achieved. None of the studies achieved 100% donor detection rates (table I). Studies of hospital indexes(18-20) have suggested that 2% to 3% of all people dying in a hospital and around 14% of those dying in the intensive care units, will suffer brain death. Of these, between 17% and 20% will have a medical contraindication to organ donation. Such studies suggest that rates of effective donation of well over 30 pmp/year, can be achieved. (Such rates cannot apply to all organs. Suitable donors for heart and lungs, for example, need to be younger and fitter.) In contrast the mean organ donor rate in the European Union during 1995 was 14 donors pmp/yr. The cadaveric kidney transplant rate over the same period was 27.3 pmp/yr 1. Such studies give an estimate of the possible "donor detection gap" between current donor rates 10 Knowledge of the environmental characteristics in the catchment area, e.g. health resources, infrastructure of the hospitals, location of neurosurgery teams and trauma centres, mortality rates, incidence of traffic accidents, cerebrovascular accidents, cerebral tumours, bullet wounds, etc. will help estimate the likely overall size of the donor detection pool. However, the best means of improving donor detection rates require an effective system for the early identification and follow up of all patients admitted to acute hospitals that may eventually be diagnosed as brain dead. The Donor Action Programme 23 advises that information on potential brain death patients should be recorded prospectively but analysed retrospectively by means of a review of the medical record. This type of analysis will identify localities or hospitals with both an underdetection problem 17 and failure to convert detected potential donors into effective donors. Recommendation: A means should be developed to evaluate the size and characteristics of the potential donor pool to measure and monitor the potential donor rates. To ensure reliability, data should be collected prospectively and analysed retrospectively as recommended in the «Donor Action Programme». 4.2.3 Donor Detection Programmes The best means by which potential donors are detected and rates monitored is a proactive system of COUNCIL OF EUROPE CONSENSUS DOCUMENT: «MEETING THE ORGAN SHORTAGE» donor detection every acute hospital for which a person of sufficient authority is given responsibility. Ideally a key individual (key donation person) should be given the responsibility for: i. development of a protocol for identifying potential donors which includes events to be recorded and clarifies the roles and responsibilities of hospital professionals in donor identification; ii. educational programmes for health staff about transplantation; iii. auditing donor procurement and problems on a regular basis. Recommendation: Proactive donor detection programmes should be instituted in every acute hospital using specially trained professionals (key donation persons) working to agreed protocols and ethical rules. 4.2.4 The role of the «Key Donation Person» The key donation person needs to be a member of the hospital staff, well respected and closely related with the intensive care units. He/She should work in close relation, but independent from any transplant team(s) and report directly to the medical director of the institution and the OPO/OEO, who are accountable for overall performance. The role of the key donation person is now considered by many to be fundamental to improving donor detection rates. It is he/she who will be responsible for integrating the actions noted above; for development of donor detection programmes and specific protocols, etc., and for defining local benchmark figures and targets for improvement. The appointment of such a person will make the difference between a successful and a non-successful donation programme. Recommendation: A «key donation person», independent from transplant teams, should be appointed in every acute hospital with clearly defines roles and responsibilities for establishing, managing and auditing systems for donor identification and identifying potential areas for improvement. 4.3 Donor Screening: acceptability of Organs It is important to ensure that, as far as possible, any organs retrieved from a donor are of acceptable quality and do not pose an unacceptable risk to the recipient. The major risks to the recipient are the transmission of infectious or malignant disease with the organ. Advice on microbiological screening has been prepared by the Council of Europe 24 and ot- hers and guidance on screening donors for malignancy has also been published by the Council of Europe 25. Standard protocols for screening potential donors should be developed locally. The risk factors which determine the suitability of potential donors change from time to time and include not just the risk of transmission but the quality of the organ in terms of its viability. Improvement in donor management, organ preservation and transplant experience have meant that increasingly transplant teams can use organs which were considered marginal a few years ago 26. Protocols to assess the suitability of donor and each of their organs should be developed but will need to be reviewed from time to time to maintain the balance between minimising the risk of organ transplantation for the recipient and maximising the supply of organs. Recommendation: Protocols should be developed setting out the criteria for screening potential donors and their organs for the risk of disease transmission and potential viability. All appropriate steps should be taken to avoid the transmission of infectious and neoplastic diseases and primary organ failure. 4.4 Donor Management 4.4.1 Scope of the Problem There is time further to evaluate and screen the potential donor. After completing brain death certification, obtaining appropriate consent; fulfilling legal requirements (see below) and organising the retrieval procedure (see below), it is necessary to maintain the potential donor in a medical condition which will maximise the viability of the organs. Depending on time necessary to complete the above processes, donor management may be critical over a period of 24 hours or more during which time the donor 's condition could deteriorate sufficiently to prevent the use of some or all of the organs. Prevention of severe sepsis, maintenance of haemodynamic stability and avoidance of cardiac arrest are examples of good donor management. In a five-year study performed in a hospital in Barcelona, 14% (55/399) of otherwise acceptable organ donors suffered from either a cardiac arrest or uncontrolled sepsis which were contraindications to retrieval 27. In a Madrid study 18, 9.5% (107/1137) of all brain death subjects suffered a cardiac arrest at some point in the process. Similarly, a 1993 Basque study(16) reported cardiac arrest in 11 of 131 potential donors (8.4%). In a multicentre Spanish audit performed during 1995, the figure had been reduced to 4%.(20) In another study, an aggressive approach to donor ma11