Appendix 8 The process for tissue donation
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Appendix 8 The process for tissue donation Appendix 8 The process for tissue donation Document Transcript

  • DRAFT FOR CONSULTATION – 14.05.06 SECTION 2 GUIDELINES FOR THE MANAGEMENT OF POTENTIAL ORGAN AND TISSUE DONORS CONTENTS 8. Introduction 9. Potential Organ and Tissue Donors 9.1 Heartbeating and Non-heartbeating Donors 10. The Donation Process 10.1The Role of the Donor/Tissue Transplant Co-ordinator 10.2The request for donation of organs and/or tissues for transplantation 10.3The Process 11. Summary Appendix 6 The process for organ donation in patients certified dead by neurological testing of brain stem reflexes (TBSR) Appendix 7 The process for controlled non-heart beating donation (NHBD) in the ICU Appendix 8 The process for tissue donation Appendix 9 1988 Report of a Working Party on Organ Transplantation in Neonates 8. Introduction The purpose of this section is to give medical and nursing staff caring for dying or deceased patients, basic information on the process of organ and tissue donation. These guidelines are designed to be read in conjunction with the comprehensive Intensive Care Society Guidelines for Adult Organ and Tissue Donation, where more detailed information is provided. The Intensive Care Society’s guidelines were prepared by the Society’s Working Group on Organ Donation and are available via www.ics.ac.uk DRAFT FOR CONSULTATION SECTION 2 – 14.05.06 1
  • Organ and tissue transplantation is one of the major medical success stories of our time with approximately 90% of transplant recipients alive and well after 1 year. This success has led to a situation worldwide where demand outstrips supply particularly with regard to organ donation. 9. Potential Organ and Tissue Donors Almost anyone dying in hospital is a potential organ or tissue donor. Kidneys and livers from donors over 80 years old have been successfully transplanted and there is no upper age limit for the donation of eyes, bone and skin. Due to the fact that organ transplantation is life saving there are very few absolute contraindications to organ donation. Patients with certain cancers, a confirmed diagnosis of Human Immunodeficiency Virus (HIV) or known or suspected classical or variant Creutzfeldt- Jakob Disease will not be able to donate organs. As tissue transplantation is usually life enhancing rather than life saving there are additional contraindications to tissue donation. The Advisory Committee on the Microbiological Safety of Blood, Tissues and Organs for Transplantation (MSBTO) provides national guidance on donor evaluation. This guidance can be found at www.doh.gov.uk/msbt 9.1 Heartbeating and Non-heartbeating Donors Potential heartbeating donors (HBD) are patients in an unresponsive apnoeic coma resulting from an irreversible cause. This may occur under a variety of circumstances but is often associated with a traumatic brain injury or intracranial haemorrhage. Before organ or tissue donation can take place the patient must have been declared dead following neurological testing of brain stem reflexes. Potential “controlled” non-heartbeating donors (NHBD) are principally those patients in intensive care units, who are clinically stable, but for whom continued treatment is judged not to be in the patient’s best interest and it has been agreed that active medical treatment should be withdrawn. Organ and/or tissue donation can proceed once death has been certified following cardiorespiratory arrest. DRAFT FOR CONSULTATION SECTION 2 – 14.05.06 2
  • 10. The Donation Process 10.1 The Role of the Donor/Tissue Transplant Co-ordinator The donor transplant co-ordinator will provide support for health care professionals and families of potential organ and tissue donors and will facilitate the donation process. It is essential that the donor transplant co-ordinator is informed of all potential donors as early as possible so that any retrieval can be conducted in a timely manner. The co-ordinators are best placed to ascertain suitability of potential donors, provide advice to staff on donor identification and clinical management and to discuss the option of organ and/or tissue donation with those closest to the potential donor. 10.2 The request for donation of organs and/or tissues for transplantation Before approaching those closest to the patient to discuss the option for donation it is important to confirm whether, during their lifetime, the patient had expressed their wish to be a donor by registering on the Organ Donor Register (ODR). If the patient is not registered this does not mean that they did not want to donate and the option for donation should still be discussed with those closest to them. The ODR can be checked by ringing the UK Transplant 24 hour Duty Office on 0117 9757575. As with the ICS Code, it is important to note that under the Human Tissue Act 2004, the prior wishes of the deceased take precedence in law over those of the family. Thus the family cannot agree to donate if the deceased had previously refused, and the deceased’s prior consent cannot be vetoed by the family (though if there are strong objections from relatives it might not be appropriate to proceed). More guidance will be available through the Codes of Practice of the Human Tissue Authority which are due to come into effect in September 2006 The request for donation may be made by either medical or nursing staff or by the donor transplant or tissue co-ordinator. However, evidence from the USA and some areas of the UK has demonstrated that when a collaborative approach is made to the family by the patient’s clinician and the donor transplant co-ordinator higher consent rates are achieved. DRAFT FOR CONSULTATION SECTION 2 – 14.05.06 3
  • 10.3 The Process Once agreement for organ and tissue donation has been obtained the donor transplant co-ordinator will liaise with the health care professionals in the donor hospital and the transplant units to arrange a suitable time for the retrieval operation. 11. Summary The non-clinical management of patients prior to organ or tissue donation is shown below as flow diagrams. As previously mentioned this section should be read in conjunction with the Human Tissue Authority’s Codes of Practice (www.hta.gov.uk) and the Intensive Care Society Guidelines for Adult Organ and Tissue Donation, which provide detailed information relating to the process for heartbeating and non-heartbeating organ and tissue donation (www.ics.ac.uk). DRAFT FOR CONSULTATION SECTION 2 – 14.05.06 4
  • The process for organ donation in patients certified dead by neurological testing of brain stem reflexes (TBSR) Donor Identification Up to 85 years of age Planned for brain stem testing Absolute contraindications include: HIV infection, known or suspected CJD Discuss all potential donors with the donor transplant co-ordinator Present Absent Donation is not possible if Telephone your donor transplant co-ordinators there are absolute • Option of organ donation can be discussed contraindications or no with the family, usually after first set of TBSR. Coroner’s agreement to • Once contacted the donor transplant co- proceed ordinator will attend to discuss the options with the family alongside the critical care No staff. Contact the Coroner or Permission his Officer to obtain Is the patient to be granted? permission for retrieval to referred to Coroner? Yes proceed Yes No • Legal time of death is the first set of tests demonstrating absence of brain stem reflexes • The donor transplant co-ordinators will document consent to donation from the deceased or the family • Donor assessment undertaken by donor transplant co-ordinator • The family is supported throughout this process, by the donor Organ retrieval takes place in the transplant co-ordinator and the theatre. The family may see their critical care staff. loved one following donation and • An appointment will be made by the are offered follow-up by the donor hospital for the family to see the transplant co-ordinator. hospital bereavement service. Remember the donor transplant co-ordinator is always available for advice at any time during this process DRAFT FOR CONSULTATION SECTION 2 – 14.05.06 5
  • The process for “controlled” non-heart beating donation (NHBD) in the ICU Donor Identification Discuss possible age restrictions with donor transplant co-ordinator Planned withdrawal of treatment Absolute Contraindications include: HIV infection, known or suspected CJD Discuss all potential donors with the donor transplant co-ordinator Present Absent Donation is not Telephone your donor transplant co-ordinators possible if there are • Discuss the option of non-heart beating contraindications or no organ donation with the family Coroner’s agreement to • Once contacted the donor transplant co- proceed ordinator will attend to discuss the options with the family and critical care staff No Permission Contact the Coroner or Is the patient to be granted? his Officer to obtain permission for retrieval to Yes referred to Coroner? Yes proceed No • The families are informed of the procedure for NHBD, consent documented by the donor transplant co-ordinator • Donor assessment undertaken by donor transplant co-ordinator • Arrangements made for the withdrawal of treatment with the family and critical care staff • Organ retrieval teams on-site and prepared in the operating theatre • Treatment is withdrawn and the families are supported throughout Organ retrieval takes place in the this process theatre. The family may see their loved one following donation and • After five minutes observation of are offered follow-up by the donor cessation of cardiorespiratory transplant co-ordinator function, death is certified by the critical care medical staff and documented in the medical notes Remember the donor transplant co-ordinator is always available for advice at any time during this process DRAFT FOR CONSULTATION SECTION 2 – 14.05.06 6 Remember the donor transplant co-ordinator is always available for advice at any time during this process
  • The process for tissue donation Donor Identification Age restrictions do apply (Discuss with tissue or donor transplant co-ordinator) Absolute contraindications: HIV, Hepatitis C or B, Human T cell lymphocytotrophic virus, Syphilis, known or suspected CJD or at risk of having any of the above. Have a central nervous disease of unknown aetiology. Diagnosis of leukaemia, lymphoma or myeloma. Have Alzheimer’s or an unexplained confusional state. Present Absent Discuss tissue donation options: Corneas, Heart Valves, Skin, Bone. Donation is not Almost anyone can donate one of the above possible under these circumstances Contact your local donor or tissue transplant co- ordinator to ascertain what options are available. No It is important to document the deceased’s or relative’s consent to donation. Specify what the deceased or family have agreed to donate. It is preferable to have a relative’s signature with the consent statement. Photocopy consent details, which should accompany the body of the deceased to the mortuary Contact the Coroner or Permission Is the patient to be his Officer to obtain granted? referred to Coroner permission for retrieval to Yes Yes proceed No Contact the donor or tissue transplant co-ordinator You will need to have the following information ready. For the deceased: Their name, date of birth, the time and date of death, the cause of death, details of past medical history and any medications taken and GP details. For the next of kin: Their name, address and a phone number where they can be contacted. The relative should be informed that the donor or tissue transplant co- ordinator will call them before the donation can proceed. They will be asked a few simple questions about past medical and social history. The family will have the opportunity to ask any questions and decide if they would like to know the outcome of the donation. Remember the donor or tissue transplant co-ordinator is always available for advice at any time during this process. DRAFT FOR CONSULTATION SECTION 2 – 14.05.06 7
  • Appendix 9 1988 Report of a Working Party on Organ Transplantation in Neonates The 2005 Working party endorse the 1988 working party report. This is reproduced below without any modification of the original text. The concepts of ‘brain death’ and ‘brain stem death’ are not employed in the 2005 report. The terminology that has been adopted in the 2005 report rests on the concept of a unitary state of death, as defined in the introduction of the working party report. This 2005 terminology can be substituted for the form of words selected within the 1988 report. In particular, 1988 usage 2005 usage brain stem death(d) death(d) following cessation of brain stem function brain stem death criteria criteria for certification of death resulting from cessation of brain stem function the brain is dead death has occurred as demonstrated by cessation of brain stem function The American party report referred to in the 1988 document was published after the latter was written (but before it was published). The published report can now be referenced as: ‘Taskforce on brain death in children. Guideline for the determination of brain death in children. Pediatrics 1987 80: 298-300.’ DRAFT FOR CONSULTATION SECTION 2 – 14.05.06 8
  • Conference of Medical Royal Colleges And their Faculties in the UK REPORT OF A WORKING PARTY ON ORGAN TRANSPLANTATION IN NEONATES Prepared for the Department of Health and Social Security Crown copyright 1988 DRAFT FOR CONSULTATION SECTION 2 – 14.05.06 9
  • Membership Sir Raymond Hoffenberg PRCP Chairman Dr T L Chambers FRCP Honorary Secretary Sir Douglas Black MD FRCP Mr E R Howard MS FRCS Dr D Hull FRCP Dr K M Laurence FRCPE FRCPath Dr F J Mccartney FRCP Mr C H Rodeck FRCOG Dr N P Halliday (Observer) Senior Principal Medical Officer DHSS Oral evidence received from:- Dr J D K Burton The Rev G R Dunstan Mr I M C Kennedy Dr R H Nicholson Written comments received from:- Dr M J Dillon (on behalf of the British Association for Paediatric Nephrology) Dr R G Gosling Dr B G R Neville Meetings held on 3rd, 17th March, 30th April and 26th November 1987 + Hereafter referred to as Conference *A Neonate is an infant aged up to and including 28 days after birth. Terms of Reference: To report on the diagnosis of brain death in neonates and all relevant aspects of organ transplantation from, and into, neonates. (Letter from Dr N P Halliday to the Chairman of Conference 26.11.86) DRAFT FOR CONSULTATION SECTION 2 – 14.05.06 10
  • REPORT 1. Introduction and background The working party was established by Conference at the request of the DHSS. Publicity and controversy had followed a recent heart transplant operation where the donor was anencephalic infant and the recipient a neonate with congenital heart disease. Questions had been raised about the validity of the diagnosis of brain death in newborn infants, the use of newborn infants with major malformations as a source of donor organs and the indications for organ transplantation at this age. 2. The need for organ transplantation 2.1 The working party was advised that at present, and for the foreseeable future, organ replacement is not considered appropriate for neonates with terminal liver or kidney failure and that technical considerations limit the transplantation of small livers and kidneys into older and larger recipients. There are few ocular conditions which would be treated by corneal transplantation into a recipient at this age. Corneas are removed from recently deceased infants (subject to parental permission) just as in older children and adults: this is ethical and acceptable practice. 2.2 Congenital cardiac malformation unamenable to surgical correction appears to be the only condition for which organ replacement would be required in neonates: the procedure is technically feasible but it is currently at an early stage of development. Figures presented to the working party suggest that in England and Wales approximately 150 babies per annum might be born with such cardiac malformations (Appendix I). 3. Supply of donor organs 3.1 Since the only requirement for organs from neonates is for hearts (or, possibly Heart and lung) then the donor must have a beating heart at the time of retrieval: up to 6 hours may then elapse before the removed heart is place in the recipient. The practice of organ removal in older children and adults requires that the donor circulation should be maintained in as near normal a state as possible to limit DRAFT FOR CONSULTATION SECTION 2 – 14.05.06 11
  • ischaemic damage to the donor organ which might prejudice the success of the transplant. Anatomical and surgical considerations limit the size of the donor organs to those which can be accommodated within the neonatal thoracic cavity. 3.2 In these circumstances there are two possible sources of donor organs: a) from newborn infants with non-cardiac congenital malformations which inevitably and rapidly lead to death. The best known is anencephaly. b) from otherwise normal donors who sustain major brain injury and to whom well-established criteria of brain stem death might be applied. 3.3 The number of potential donors appears to be limited and the number who might be used to supply such organs is probably much lower. For instance, it is not known how many infants and children survive a major accident to arrival at hospital, be resuscitated and subsequently be diagnosed brain stem dead, which would allow their organs to be removed. Such information could probably be acquired through the reporting system of the British Paediatric Surveillance Unit, but the numbers are likely to be very small. 3.4 Similarly, it is not known how many of the patients with lethal neurological disorders would die in circumstances which would allow their organs to be removed and used. 3.5 The most important points concerning organ removal from infants are:- a) the legal and ethical considerations in retrieving organs for donation from infants with lethal malformations but who are not pronounced dead. b) whether brain stem death criteria can be applied to the neonate and, if so whether the gestational age at birth should be taken into consideration. 4. Use of infants with lethal malformations DRAFT FOR CONSULTATION SECTION 2 – 14.05.06 12
  • 4.1 Still-born infants would not be suitable as organ donors for heart transplantation which requires a beating heart. 4.2 There are a few congenital malformations that inevitably and rapidly lead to death: anencephaly and renal agenesis are the most common. 4.3 Such infants (and particularly those with renal agenesis) may have other abnormalities such a pulmonary hypoplasia which would not make them suitable organ donors. 4.4 The working party considered in more detail the use of anencephalic infants as organ donors. Anencephaly is the most severe neural tube defect and, being almost always self-evident, is easily diagnosable. The cerebral hemispheres are usually absent and there is a major defect in the cranium with exposed tissue consisting of meningeal remnant, disorganised central nervous tissue, blood vessels and ependyma: the brain stem and sometimes the cerebellum are present but abnormal. Those anencephalic infants born alive usually only live for a few minutes or perhaps hours, and exceptionally, up to 48 hours. In these circumstances some brain stem function may be present despite the absence of higher centres. 4.5 Current antenatal surveillance programmes and natural wastage mean that in the UK few anencephalic fetuses survive to a gestational age when organ retrieval would be feasible: the working party estimated that in the United Kingdom about 20 such donors per annum might be available for heart transplantation. (Office of Population Censuses and Surveys data show that in 1985 there were 59 anencephalic live and stillbirths in England and Wales). 4.6 Current obstetric and paediatric practice in the UK is not to manage the pregnancy, labour or neonatal period with the sole aim of prolonging the survival of an anencephalic fetus or infant. This practice is likely to command public understanding and support and the working party supports it. DRAFT FOR CONSULTATION SECTION 2 – 14.05.06 13
  • 4.7.1 In the case of live-born anencephalics, current legal and ethical considerations would not allow removal of organs before the subject was pronounced dead. No third party such as a parent could consent to this. 4.7.2 This means that, subject to parental consent, such an infant would have to be maintained in an optimal condition until death occurred when the organs could be removed. 4.7.3. The working party found itself in a dilemma when it considered at what point organs could be removed from an anencephalic infant. Tests of brain stem function are applied in adults because the absence of such function establishes that the brain is dead; they are clearly inapplicable when the forebrain itself is missing. Such infants clearly have a major neurological deficiency incompatible with life for longer than a few hours. A view which commended itself to the working party was that organs could be removed from an anencephalic infant when two doctors (who are not members of the transplant team) agreed that spontaneous respiration had ceased. In the adult the diagnosis of brain death plus apnoea is recognised as death. The working party felt by analogy that the absence of the forebrain in these infants plus apnoea would similarly be recognised as death*. 4.7.4 In making these recommendations in 4.7.3 the working party is aware of public support for transplantation and is anticipating that such support would extend to neonatal heart transplantation for those infants with major cardiac malformations incompatible with life. It also recognises that some parents will wish to offer organs from their live-born anencephalic infants and that they will wish this to be carried out in an ethical and dignified way acceptable to the medical, nursing and other staff involved in the care of their dying infant. It is hoped that society recognises this generous impulse and will find the suggested basis for organ removal an acceptable means or reconciling the interests of both infants – the anencephalic donor and the recipient with a cardiac malformation. 4.7.5 The working party would condemn pressure from any source being put upon parents to continue with a pregnancy solely with the intention of organ retrieval. DRAFT FOR CONSULTATION SECTION 2 – 14.05.06 14
  • * We are aware that the Conference of Medical Royal Colleges and their Faculties in the UK is reconsidering the diagnosis of apnoea with a view to strengthening the criteria. 5. Brain stem death in the neonate 5.1 It is understood that, providing there was professional confidence that brain stem death criteria could be applied to the neonate of a certain gestational age, then there could be no legal or ethical objection to the parents agreeing to, and a surgeon undertaking, organ retrieval. 5.2 There is little firm evidence that the well established criteria used for diagnosing brain stem death in older children and adults can be applied to neonates with beating hearts in the first seven days of life for the purpose of organ removal. The ethics committee of the Child Neurology Society in the United States has concluded that there is insufficient information to diagnose brain death at this age and in that country a joint task force is investigating the matter further and will report soon.* 5.3 Until acceptable criteria for brain stem death in the first seven days of life are agreed it is the view of the working party that the brain stem death criteria used in older children and adults cannot be used to justify the removal of organs from such neonates with beating hearts for transplantation. 6. Other considerations in neonatal organ transplantation 6.1 It would not be acceptable to transplant organs retrieved from outside the UK under circumstances which do not meet our own strict conditions. 6.2 Since such procedures are at an early stage of development they should be limited to a few centres so that care is standardised and sufficient experience acquired: this will help in research and interpretation of the results. Conference wished to receive the results of these transplantation programmes: such results should include DRAFT FOR CONSULTATION SECTION 2 – 14.05.06 15
  • data about the (unidentified) source of the donor organs and the manner of their retrieval. * Since the report was written this task force has now submitted its recommendations which were published in Paediatrics (1987) Vol 80, no 2 p 298. These do not cover anencephalics, premature infants or children within the first seven days of life. 6.3 Such centres should be able to offer the full range of medical, surgical and other care for infants which would normally be available in a children’s department of a general hospital or a children’s hospital. 6.4 Longer term study is required to provide information about the prospects for growth of donor organs, e.g. the heart transplanted into a neonate and the effects of immunosuppression upon the health of the child. A register of such patients would aid follow-up. 6.5 If a substantial number of neonates are going to become organ donors then a programme of public and professional education will be required. 6.6 Future developments may enable organs other than the heart to be replaced and might allow use of other sources of organs or tissues such as stillbirths or fetuses. Conference should therefore keep the subject of neonatal organ transplantation under review. DRAFT FOR CONSULTATION SECTION 2 – 14.05.06 16
  • RECOMMENDATIONS 1. Organs for transplantation may be removed from anencephalic infants when two doctors who are not members of a transplant team agree that spontaneous respiration has ceased. In the adult the diagnosis of brain death plus apnoea is recognised as death. The working party felt by analogy that the absence of the forebrain in these infants plus apnoea would similarly be recognised as death. (para 4.7.4) 2. No pressure should be put upon parents to continue with a pregnancy solely in the interest of organ retrieval. (para 4.7.5) 3. In view of current uncertainties, organs for transplantation should not be removed within the first seven days of life from neonates with beating hearts even if they satisfy the brain stem death criteria which are used in older children and adults. This does not apply to anencephalic infants. (para 5.3) 4. It is unacceptable to transplant organs retrieved outside the UK unless the circumstances met our own strict criteria. (para 6.1) 5. Neonatal organ transplantation should only be undertaken in a limited number of centres offering a full range of paediatric care. The results of these programmes should be reported to Conference. (Para 6.2 and 6.3) 6. Long term follow-up of recipients will be required and a register of such patients is suggested. (para 6.4) 7. Further public and professional education concerning transplantation may be required. (para 6.5) 8. Conference should keep the subject of neonatal organ transplantation under review. (para 6.6) DRAFT FOR CONSULTATION SECTION 2 – 14.05.06 17
  • APPENDIX I NEONATAL ORGAN TRANSPLANTS Demand for hearts Cardiac malformation Deaths/1000 Expected Live Births per year Hypoplastic Left Heart 0.163 104 Heterotaxy 0.088 56 Pulmonary atresia with ventricular 0.002 1 septal defect _____ ___ 0.253 161 _____ ___ Based on Office of Population Censuses and Surveys (England & Wales 1984) and the New England Regional Infant Cardiac Program Report. DRAFT FOR CONSULTATION SECTION 2 – 14.05.06 18