Content
Recommendations for the
donation of cadaveric
organs and tissues for transplantation
PLEASE NOTE: THIS PUBLICATION WAS REVOKED ON 13-04-2007
Contents
Organ and tissue donation-principles
Part 1: Legislative and social aspects
1 Authority to remove organs and tissues
2 Consent to donation
3 Consulting families
4 Approach to the Coroner
5 Care of the donor family
6 Care of Staff
7 Confidentiality
Organ transplantation has advanced swiftly in recent years, from experimental surgery, to accepted treatment for patients facing severe debility or premature death. Heart, lung, liver, kidney and pancreas transplants are now well established procedures in Australia.
Tissue transplantation has also developed rapidly, and the transplantation of corneas, heart valves, and bone are well established and effective therapies.
The full benefit of these therapies to Australians is limited by the availability of organs and tissues.
Australia has one of the lowest rates of organ donation in the developed world. For several years, the national rate of organ donation has ranged between 11 and 14 donations per million Australians, too few to meet the needs of all potential recipients (ACCORD 1991 - 1995). The number could be greater some Australian States have considerably higher donor rates than others. The potential clearly exists to meet more of the present need.
Australian laws prohibit commerce in human tissues, but offer opportunities for a person during life to choose voluntarily to donate organs and tissues at the time of death. In some countries, the law, assumes that organs and tissues of all dead persons are available for therapeutic purposes unless a person has recorded an objection. In practice, the rate of donation depends less on these legal arrangements than on public awareness and education, since the shortage of organs for transplant is not because potential donors are lacking, but because donations are not obtained from the many potential donors (Australian Law Reform Commission 1977).
Recent audits suggest that, of patients who could reasonably be identified medically as potential donors, only a quarter become donors; relatives withhold permission for another quarter., and consent is not sought in about half of all these cases. Relatively small changes in identifying possible donors and gaining acceptance will increase the supply of organs for transplant towards the current need of Australian patients (Hibberd & Pearson 1992).
Beneficial use of such organ and tissue donation requires effective identification of potential donors; effective liaison among donor transplant co-ordinators, transplant teams, and other clinical units for safe and timely retrieval and allocation of donor organs and tissues; compassionate, ethical and sensitive treatment of a donor's family; and recognition of the importance of the benefit, safety and health of the recipient patient.
Contribution by donor families must always be recognised, as the decision to donate occurs at a time of acute distress and grief, often following a sudden death. Sensitivity to cultural and religious issues, and attention to psychological needs and grief counselling both at the time of death and later, offer important benefits for the family in coping with the death.
Kidney transplants have been available in Australia since the early 1960's. At present, about 400 patients with renal failure receive donor kidneys in Australia each year. The one year graft survival rate for kidney transplants currently is approximately 85% (The Australian and New Zealand Dialysis and Transplant Registry 1995). Some patients also receive pancreas transplants because of associated diabetes.
Since 1984, heart, lung and heart-lung transplants have been performed in several Australian hospitals. Heart transplantation currently has a five-year actuarial patient survival rate of 78% and heart-lung transplantation a five-year actuarial survival of 40%. Single lung transplantation has a three-year actuarial survival of 62% and bilateral lung transplantation has a one-year actuarial survival of 83% (Keogh and Kaan 1992).
Liver transplantation began in Australia in 1985 and is now well established with an actuarial one-year patient survival of 90% (Australian Liver Transplant Registry 1994). A procedure for reducing adult livers to a size suitable for children has meant that many children survive who earlier would have died waiting for a suitable donor.
Use of donated tissues for transplantation has a longer history. The first corneal transplant was performed in Australia in 1941, and several thousand grafts have been performed. Recent improvements in surgical technique have increased the demand for donor corneas.
Transplantation of heart valves has become a preferred procedure for some major valve disorders of the heart where anticoagulation is not desirable.
Bone grafts from deceased donors are transplanted for a number of purposes, in some circumstances as an alternative to amputation. These procedures have been available in Australia since 1986.
Tissue banks for processing, storing and distributing corneas, skin, heart valves, bone and related tissues have been established to serve the growing need for donated tissues.
Successive versions of this document reflect the speed of change in the number and variety of transplantation treatments, and the parallel evolution of consistent legislation in the States of Australia.
Hospitals and intensive care units [ICU] should produce policy and procedure guidelines to be followed by all hospital staff based on the principles in this document.
These Recommendations apply to the donation of cadaveric organs and tissues for the purposes of transplantation, research and teaching. The Recommendations do not deal with the additional ethical issues involved in the donation of organs and tissues by living donors, or with mechanisms for encouraging organ and tissue donation. The Australian Health Ethics Committee, a principal committee of the National Health and Medical Research Council, has established a working party to inform and deepen the public's understanding of the ethical aspects of transplantation. Similarly, the removal of foetal or generative tissue is covered by the NHMRC Statement on Human Experimentation and Supplementary Notes 1992.
The Australian Co-ordinating Committee on Organ Registries and Donation (ACCORD) has responsibility for encouraging organ and tissue donation and has contributed to these Recommendations. ACCORD was established in October 1989 by the Australian Health Ministers Advisory Council (AHMAC) to deal with problems in organ donation, acquisition and transplantation and matters of national interest. ACCORD provides a forum for discussion and resolution of problems in organ donation and advises Governments on legislative and resource requirements for organ donation and transplantation.
The Australian and New Zealand Intensive Care Society and the Australasian Transplant Coordinators Association, which have participated in the preparation of these Recommendations, have both published (1993) detailed documents covering specific aspects of the diagnosis of death and organ donation after death. Reference should be made to these documents where appropriate.
Organ and tissue donation-principles
Donation of cadaveric organs and tissues is possible only because of the death of an individual, usually in a sudden and unexpected manner. Affected families are exposed to extraordinary stress at such a time. Much information must be passed on to the family members and be understood in a short period of time. Prior discussion and a decision by the deceased about donation of organs and tissues is of major assistance. While family discussion and knowledge is increasing, in many cases it has not taken place.
The arrangements for donation of organs and tissues must be handled with great care and sensitivity. Everyone involved must realise the difficulties of decision making for families who do not know the wishes of the deceased. Even if the wishes are known, it is a difficult time for the family. Good practice often goes beyond whatever would satisfy, the basic requirements of relevant legislation. In this way, a satisfactory outcome can be achieved in a difficult ethical environment.
The fundamental principles embodied in this document are these:
- The fundamental principle upon which these Recommendations are based is respect for human dignity. This includes the dignity of the prospective donor, the dignity of the prospective donor's family, and the dignity of the prospective recipient. The professional's ethical and legal duty of care is derived from this principle.
- Provision of care to the patient takes precedence over the interests of organ and tissue donation.
- The decision of a person about whether or not to donate organs and tissues must be respected.
- The goal of organ and tissue donation is to benefit a recipient and the duty of all those involved is to protect the recipient, as far as is reasonably possible, from harm.
- Recognition of the needs of health professionals involved in organ and tissue donation is also an application of the fundamental principle of respect for human dignity.
Part 1: Legislative and social aspects
Section 1 Authority to remove organs and tissues
1.1 Model legislation on removal of human tissues, published by the Australian Law Reform Commission in 1977, has been enacted with some variations by all States and Territories in Australia and is reasonably uniform throughout the country.
1.2 If a person who dies in a hospital expressed, while alive, a wish or consent to donate organs or tissues after death, and did not express a change of mind, those facts provide sufficient authority., for the donation to take place. The Designated Officer (or in Qld and NT, the equivalent officer) of the hospital may lawfully authorise the removal of the organs and tissues for therapy. In practice (although not always legally required) the next of kin, if available, should be consulted about their knowledge of the deceased person's wishes at the time of death in case there was a change of mind (Australian legislation contains corresponding provisions relating to persons who die elsewhere than in a hospital).
1.3 If the deceased's wishes are not apparent, enquiries are to be made of the 'senior available next of kin' to ascertain if the deceased had expressed any wish to donate organs and tissues or objection to donation. In many cases, the deceased's wishes will be known to the next of kin, even though they may not have been recorded in a formal manner. Information from the next of kin about the deceased's wishes will allow the Designated Officer to authorise or refuse the removal of organs and tissues accordingly.
1.4 If the deceased's wishes are not known at all, even to the next of kin, there is a legal responsibility on them Designated Officer to make enquiries that are reasonable in the circumstances to learn whether the 'senior available next of kin' consents (Qld, Vic, Tas and WA) or does not object (NSW, SA, ACT and NT) to organ or tissue removal. If the senior available next of kin consents to organ or tissue removal (Qld, Vic, Tas and WA) or does not object (NSW, SA, ACT and NT), the Designated Officer may authorise removal.
1.5 Legislation requires enquiries to be made, and permits choices and individual decisions about donation of organs and tissues. Later sections of the Recommendations deal with the application of these legislative provisions.
1.6 If no next of kin are available after reasonable enquiries have been made, or if the deceased has no next of kin, the Designated Officer may authorise removal of organs and tissues for transplantation and for other medical and scientific purposes.
2.1 If it is known at the time of death that the deceased had decided to be a donor for transplantation and/or research purposes (eg through discussion, a signed donor card, a donor registry, indication on a driver's licence, or letter or other document), and has not withdrawn this decision, there is no legal requirement many State or Territory to establish consent or objection on the part of the next of kin. The donor's decision legally overrides any objection the next of kin may make. Legislation permits the Designated Officer to authorise action on the basis of that decision. In practice, respecting the deceased's autonomy, involves being satisfied about his or her wishes. Therefore, what is known about the wishes of the deceased may be more important than the manner in which those wishes were recorded. Consequently, discussion with the senior available next of kin is always desirable, even if the deceased's wishes are known. It may help confirm or establish the deceased's wishes about organ and tissue donation, and could help the family to come to terms with the fact that their relative's organs and tissues are to be used for transplantation. Experience shows that the next of kin rarely disagree with the known decision of the deceased.
2.2 If it is not known at death whether the deceased consented or objected to act as a donor for transplantation and/or research purposes, legislation and good practice both require that enquiries should be made to discover the wishes of the deceased or. if these are unknown, the wishes of the next of kin. The Designated Officer of the hospital is legally required to make such enquiries as are reasonable 'm the circumstances to:
- ascertain the existence and whereabouts of the next of kin,
- ascertain if they know whether the deceased had expressed a consent or objection to being a donor, and
- if no wish had been expressed by the deceased, ascertain from
the senior available next of
kin whether he or she consents or does not object to removal of organs and tissues.
2.3 Legislation directs that the order of seniority for identifying the senior next of kin of an adult is:
i) Spouse (in ACT, NT & NSW, de facto spouse takes priority over the legal spouse for donations of tissue and organs after death)
ii) Adult offspring
iii) Parents
iv) Adult brothers and sisters
Legally, the wishes of the senior available next of kin will take effect and prevail over the wishes of those in the other categories. When there is more than one person in the category, of senior available next of kin, they must make a unanimous decision. An objection by one member of that category will prevail.
However, this order of priority in decision-making may cause difficulties with some cultural practices. Therefore, though legislation permits organ and tissue retrieval in the absence of an objection by the senior next of kin, respect for cultural differences may require a wider consultation. The eventual decision may then be conveyed or confirmed by the senior next of kin.
2.4 If the next of kin cannot be traced or if there are no next of kin and the wishes of the deceased are not known, the Designated Officer is empowered by legislation to authorise the removal of organs and tissues for transplantation or for other medical or scientific purposes, including research.
2.5 When the next of kin disagree with the known decision of the deceased, adequate time should be allowed for the family to consider and discuss their views/differences. If the family still believe that their wishes should take precedence over the wishes of the deceased and it appears that to proceed with the donation would cause extreme distress, then the Designated Officer may choose not to authorise the removal of organs and tissues. Discussions in these situations must be handled with extreme care and sensitivity.
2.6 Next of kin should be contacted in person wherever possible. There may, be occasions when the only practical means of beginning communication is by telephone, for instance, when the next of kin is not at the same place as the deceased when the question of donation arises. Provided that a reasonable interval has passed since the next of kin was informed of death, it is acceptable that an experienced person make telephone contact to raise the possibility of donation. Whether or not a personal visit to the next of kin is then made will depend upon their wishes. The details of the telephone call should be fully documented.
2.7 Though designed for informing patients themselves, the principles set out in the NHMRC General guidelines for medical practitioners on providing information to patients should also be followed in providing information about the death of the patient.
Relevant information should include:
- how, and by what criteria the patient's death has been determined (especially, important when death has been diagnosed by reference to irreversible cessation of brain function); and
- the appearance of the body after death has occurred and support mechanisms are still in place.
The same Guidelines should also be followed in obtaining consent or an indication of non-objection from next of kin to donate organs and tissues. Relevant information should include.
- details of the clinical actions and procedures which will follow (eg confirmation of the diagnosis after further observation; additional management to maintain and monitor the organs for retrieval; tests to exclude transmissible disease; need for autopsy; possible involvement of the Coroner.' retrieval of specific organs and tissues being donated);
- the opportunity to view the body after organ retrieval;
- the availability of support for the family members;
- lack of charges for any tests or management associated with organ donation and retrieval;
- the possibility that the organs may be found to be unsuitable for donation and/or research purposes;
- the benefits of donation both to the donor family and the recipients; and the general results of transplantation.
All relevant information should be given - it is not appropriate to withhold information because of its potential to cause distress for the relatives of the deceased. Further details are provided in Sections 3, 4 and 5, and in Part 2 of the Recommendations.
2.8 The next of kin should be given adequate time, information and privacy to make a free and comprehending response to the request for donation, including the opportunity to consult with people outside the hospital. Independent interpreters, translated information and consent forms should be used for non-English speaking persons. What is said must be comprehensive enough to inform the family fully and in detail of the procedures which will follow in relation to each of the organs or tissues for which their consent is sought.
2.9 Consent or non objection should relate to the specific organs and tissues to be donated and the intended use, whether for transplantation, other medical or scientific purposes, or both. This may, include research in projects approved by the relevant Institutional Ethics Committee. The removal of lymph nodes and spleen for tissue typing purposes should be specified. If blood is being taken for transfusion into therecipient of an organ, this should also be specified. The document recording consent or non objection should specify the organs and tissues that are donated; blanket words such as 'all' should not be used.
There may be next of kin who wish to consent to organ and tissue donation, but do not wish to discuss the matter in detail. The next of kin should still be informed of the precise nature and extent of the donation.
Section 3 Consulting families *
3.1 All discussions with the next of kin occur at a time of acute grief and distress and must be handled with appropriate attention to cultural and religious issues. The psychological and emotional needs of the next of kin should be addressed as required during these discussions.
3.2 Organ and tissue donation should not be proposed until death has been diagnosed and the family informed. The diagnosis that death has occurred is different from a prognosis that death is likely or imminent, and discussions with the relatives should make this distinction clear. The family needs to understand and acknowledge that the patient is dead because brain function has ceased irreversibly, and understand the consequences of this fact. Efforts should be made to ensure that all family members understand the concept of death by irreversible cessation of all function of the brain.
There may, however, be times, before death, when the next of kin may, wish to discuss organ and tissue donation. In these circumstances, the approach should be acknowledged, responded to with discussion, and documented in the medical record.
3.3 If the deceased's wishes about organ and tissue donation are not clearly known at the time of death, the subject should be discussed with the senior available next of kin to find out if the deceased had expressed an opinion about organ and tissue donation. If no opinion is known to have been expressed, consent or lack of objection by the next of kin should be ascertained.
If the unusual situation should arise where the views of the next of kin conflict with the wishes or consent of the deceased, the discussions must be handled with extreme care and sensitivity. This difficult situation can be resolved satisfactorily in most cases as experience has shown that the next of kin will rarely insist on overriding the known decision of the deceased.
3.4 The person consulting the relatives must show sensitivity, a feeling for their distress, and a clear understanding of the transplant process. The person best qualified for this consultation may be the senior doctor caring for the potential donor or the donor transplant co-ordinator. The assistance of a social worker, senior nurse, chaplain, family doctor, psychiatrist, or a combination of people with separate special skills, should be available.
3.5 The next of kin should feel no coercion about donation. Where a decision to donate organs and tissues has not been made by the deceased, the decision made by the next of kin must be respected.
3.6 If the person consulting the next of kin is directly associated with a potential transplant recipient, the relatives should be told of this association.
3.7 The next of kin should be given privacy, support and adequate time to consider their decision, including time to leave the hospital to consult with others if they wish to do so. The person who has approached them should offer to withdraw at this time, but remain available for discussion and advice.
3.8 During the discussions, relatives should be advised that there may be some delay before organ and tissue donation andtold about the nature of any additional tests and management of the donor's body which will be necessary before organ and tissue removal.
3.9 Effective liaison within and between hospitals and other institutions is essential if the needs of different potential recipients are to be met. The person who approaches the next of kin should cover post mortem and all the options for organ and tissue donation, removing the need for any further approach for consent. This does not preclude support provided by other hospital staff such as chaplains, social workers and liaison psychiatrists.
3.10 A record should be made in the patient's medical chart of all approaches made to the next of kin, regardless of whether consent is ultimately granted.
3.11 If the next of kin is approached and the deceased is later found to be unsuitable for donation, the next of kin should be sensitively informed by the person who approached them. The possibility that the donor may be unsuitable should be mentionedto the next of kin at the earliest possible time. Any questions about the unsuitability of a donor should be answered openly, honestly and with sensitivity.
Section 4 Approach to the Coroner
4.1 If the Coroner has jurisdiction to investigate a death or hold an inquest, removal of organs and tissues may not proceed unless the Coroner has first given consent.
4.2 The procedures for obtaining Coroner's consent vary from State to State and, in some States, from area to area and should be ascertained in advance.
4.3 The Coroner should be informed precisely what organs and tissues (including subsidiary, tissues for tissue typing) it is proposed to remove from. the donor. Consent will relate to these specific tissues.
4.4 Depositions for the coroner stating the condition of the organs and tissues donated will be required in most instances from those responsible for their removal. These will be forwarded to the Coroner to become part of the coronial file.
4.5 There may be times when the Coroner is concerned that an organ or tissue to be donated has contributed to the cause of death. In such a case it may be decided that a pathologist be present at the time of organ and tissue removal.
Section 5 Care of the donor family *
5.1 Every hospital or institution dealing with organ or tissue donation should determine and evaluate procedures for consulting the next of kin of deceased patients.
5.2 Attention should be given to any special needs of donor families.
5.3 It is essential to recognise that families experience extraordinary stress on the sudden death of a relative. They sometimes find it very hard to believe that their relative (whose appearance seems normal) is actually dead. The concept of death by cessation of all function of the brain must be understood in a short time by people who are unfamiliar with it., even if they accept it intellectually, emotional acceptance may be very difficult 'm these circumstances. The duty of care of the medical practitioner caring for the patient includes a major responsibility for explaining it in a way which can be understood and accepted by the relatives. An important part of this explanation is the distinction between the features which indicate a prognosis of death and the techniques which establish the diagnosis that death has occurred.
5.4 Subsequent discussions about donation of organs and tissues must be handled with great care and sensitivity. All involved must realise the difficulties of decision making for families who do not know the wishes of their deceased relative. Good practice will often require more action than the basic requirements of the relevant legislation.
5.5 During discussions with the family, information should be given about the procedure of organ and tissue donation and retrieval (including the treatment of the body with the full respect due to all deceased persons), the possible benefits of donation to the donor family and the benefits to recipients, the general results of transplantation, and the availability of counselling services. Legislation prohibits the release of information which would identify, either donor or recipient. This should be explained to the family.
5.6 Relatives should be offered the opportunity to view the body after organ and tissue donation. The donor transplant co-ordinator or another appropriately trained health care professional should offer to accompany the family.
5.7 Care should be taken to ensure that the donor's appearance will be suitable for viewing by the family.
5.8 Bereavement counselling and follow-up services by qualified staff should always be offered to families approached for organ and tissue donation, to assist them in their grief and to address any concerns or questions that may arise as time goes on. These services, offered at the time of the patient's death and immediately afterwards, should continue to be available to meet their long term needs as well as their short term needs. It is established practice for the donor transplant co-ordinator to send a letter of thanks to the donor's family, offering follow-up support.
5.9 The family should be offered the opportunity for further discussion with the consultant doctor and other members of the intensive care team at a later date. This maintains the continuity of communication and enables the family to discuss the event at a later time.
6.1 The process of diagnosis of death, organ and tissue donation, and care of the donor's family can cause personal stress to staff. Training, supervision and counselling and other suitable assistance must be available for stag. Hospitals should establish policies and protocols to ensure this occurs and is utilised. Inclusion of the operating room staff is particularly important. Organised debriefing sessions may also be helpful in providing an opportunity for formal peer support.
6.2 The transplant team should always be mindful of the impact of organ and tissue donation and removal of organs and tissues on the staff and resources of the hospital which had been caring for the deceased patient, and seek to minimise any disruption and inconvenience to them.
6.3 Following retrieval and transplantation of organs and tissues, it is important for the transplanting teams to communicate with relevant staff in the donor hospital, thanking them for their care of the donor and informing them of the outcome of the transplantation to their recipients.
7.1 Confidentiality of information is essential. Transplantation often attracts media attention and it is essential that the anonymity of the donor and the recipient and their families is preserved.
7.2 Disclosure of identifying information about a donor and recipient by any medical practitioner or member of hospital staff or members of the transplant team is prohibited by respective State and Territory laws.
7.3 Any disclosure of information which could link the donor and recipient may result in a breach of these laws. Identifying information may include the date of death of the donor or the date a recipient has received a transplant.
7.4 Difficulties with confidentiality may arise in clinical units whichcare for both the donor and recipient, and in smaller regions. All staff must be aware of the need for confidentiality, and the importance of their individual sensitivity and vigilance in this regard. Media coverage must be handled with great care to avoid loss of anonymity in this situation.
7.5 In some situations, the next of kin wish to know when the organ or tissue is transplanted and some basic information about the recipients. Similarly, the recipient may wish to write an anonymous letter to the donor family. Such letters may be forwarded via the donor transplant co-ordinator or the person who sought consent for the donation. Thanksgiving Services provide a common venue for donor families and recipients, but caution may be necessary to avoid the risk of breaching confidentiality. A reminder should be given that legislation does not permit the release of identifying information, although disclosure may be possible with the consent of the person to whom the information relates, and for bona fide research purposes.
* refer the Australasian Transplant Co-ordinators Association 1993