Content
Recommendations for
the donation of cadaveric
organs and tissues for transplantation
PLEASE NOTE: THIS PUBLICATION WAS REVOKED ON 13-04-2007
Contents
8 Treatment before death
9 Diagnosis and confirmation of death
10 Identification and suitability of potential donors
11 Management after death
12 Removal of organs
13 Removal of tissues
14 Autopsy
Part 2: Clinical aspects (footnote)
Hospitals should include all aspects covered in Part 2 in their peer review and internal medical audit activities as part of the routine quality review processes of the institution. Hospital policies and procedures relating to organ and tissue donation should specify. the responsibilities of different categories of staff in relation to this part of the Recommendations and to accountability mechanisms.
Section 8 Treatment before death
8.1 Any tests or treatment carried out on a patient before death must be for the benefit of the patient and not solely to preserve organs and tissues for transplantation.
8.2 Extra blood for tests, such as tissue typing, screening for infections or other procedures may be taken when blood is required for tests directly concerned with the care of the patient. Costs for these extra tests should not be charged to the patient or their family (see Paragraph 10.4).
Section 9 Diagnosis and confirmation of death
9.1 The statutory definition of death in the States and Territories of Australia, with the exception of Western Australia which has not adopted a statutory definition of death, is that a person is dead when;
- there is irreversible cessation of circulation of blood in the
body of the person,
or - when there is irreversible cessation of all function of the brain of the person.
The term 'brain death' denotes irreversible cessation of all function of the brain - that is, when there is irreversible loss of consciousness and irreversible loss of brain-stem reflex responses and respiratory centre function, or irreversible cessation of intracranial blood flow.
9.2 In all States and Territories transplant legislation provides that organs and tissues may be removed for transplantation if two appropriately qualified medical practitioners certify or declare that irreversible cessation of all function of the brain has occurred. Neither practitioner should be:
- a member of the transplant team; or
- the practitioner attending the recipient of the organ or tissue to be removed; or
- the Designated Officer authorising the removal of the organ or tissue.
9.3 The diagnosis of death by reference to irreversible cessation of all function of the brain must be made in accordance with current and accepted medical standards. The Statement issued by the honorary secretary of the Conference of Medical Royal Colleges and their Faculties in the United Kingdom on 11 October 1976 established the conditions under which a diagnosis of death may be made by. reference to the irreversible cessation of brain function, and the diagnostic tests for confirming this diagnosis. This statement was endorsed by the Conjoint Conference between the Australian Medical Association and Joint Advisory Committee of the Royal Australasian College of Physicians, Royal Australasian College of Surgeons, Royal Australian College of Obstetricians and Gynaecologists and the Royal Australian College of General Practitioners on June 30 1979. In 1993, the Australian and New Zealand Intensive Care Society published a Statement on Certification of Brain Death which supports the Medical Royal Colleges' Statement and clarifies its current application.
Clinical confirmation of the diagnosis of brain death requires that irreversibility of all function of the brain be established through an appropriate period of observation. Two separate examinations should be performed during the period of observation to confirm cessation of function and demonstrate irreversibility.
Further details on the diagnosis and confirmation of death can be found in the Australian and New Zealand Intensive Care Society Statement on the Certification of Brain Death (1993).
9.4 The time of death should be recorded as the time when certification of brain death has been completed, that is following the second confirmatory examination. The family should be advised immediately.
9.5 Whether death is determined by reference to cessation of all function of the brain or by cessation of circulation of the blood, in each case the deceased may be a potential donor.
Section 10 Identification and suitability of potential donors
10.1 Medical or other appropriately qualified staff. depending on the circumstances, should initiate the process which may result in determination of suitability for organ and tissue donation, and in authority to remove organs and tissues. This process includes consulting the next of kin. The process can be initiated by contacting a donor transplant co-ordinator.
10.2 When death has been determined by reference to cessation of all function of the brain, the deceased may be suitable for the donation of vascularised organs (kidneys, liver, heart, lungs, pancreas) and tissues (corneas, heart valves, bone, musculo-skeletal tissue). When death has been determined by reference to cessation of the circulation of blood, the deceased may be suitable for the donation of tissues and possibly kidneys, but not of other vascularised organs.
10.3 The criteria used to determine suitability for donation of organs and tissues, include the following:
- Individual evaluation of each potential donor with a careful review of the history and a thorough clinical examination;
- A rigorous donor screening routine designed to discover the existence of relevant malignancy and significant transmissible and other diseases.
10.4 There are contraindications which generally render the potential donor ineligible to donate. These include malignant disease, other than some primary brain tumours and successfully treated low grade localised skin tumours; any known disease of the donor organ or tissue, relevant chronic disease or systemic or severe localised infection; infection with blood borne viruses such as human immunodeficiency virus (FEV), hepatitis B or hepatitis C virus; persons who die with any obscure undiagnosed neurological disorder, and recipients of dura mater grafts between 1972 and 1989 and treatment with human pituitary hormones (risk of CJD transmission - NHMRC 1995b).
10.5 The specific requirements and constraints in relation to the suitability of potential donors for different categories of transplantation should be clarified by consultation with the relevant transplant team through the donor coordinator. Refer to the Australasian Transplant Coordinators Association publication, National organ and tissue donation manual, for organ specific criteria.
10.6 The inquiries and procedures described in the preceding paragraphs have as their objective the potential recipients' interests and health. It is the duty of medical practitioners to disclose to patients 'material risks' of proposed treatments and procedures. The High Court of Australia enunciated legal principles in November 1992 in Rogers v Whitaker, and the NFDARC in June 1993 published General Guidelines for Medical Practitioners on Providing Information to Patients. Both reaffirmed a doctor's duty to inform and advise patients of the material risks of medical procedures so as to enable patients to make sound decisions about their own health care. A potential organ recipient may have little practical choice in relation to transplantation because of the scarcity of organs, the characteristics of transplant procedures and the gravity of diseases for which organ transplantation may be the only practical means of survival. Even so, the duty to warn and disclose risks must be discharged and patients who are potential recipients given enough advice and information to enable them to make a decision as to whether or not to proceed with transplantation.
Section 11 Management after death
11.1 After a patient's death has been diagnosed by reference to irreversible cessation of all function of the brain, additional management may be initiated to monitor and maintain the condition of the organs and tissues until the time of retrieval. Such management would be directed towards the maintenance of an adequate and stable circulation, satisfactory oxygenation, and normal function of the relevant organs and tissues. The optimal time for radiographs (X-rays) for screening purposes is after the diagnosis of death and prior to organ and tissue donation.
11.2 When death has been certified, hospital procedures should ensure that the donating family will not incur any financial costs for management relating directly to organ and tissue donation.
11.3 People needing information and advice about additional management after death should seek it from members of the relevant transplant team through the donor transplant co-ordinator.
11.4 It is neither desirable nor necessary to move a brain dead potential donor to another hospital for organ and tissue retrieval.
11.5 Materials necessary for organ and tissue preservation and the safe dispatch of organs and tissues are the transplant team's responsibility.
12.1 Once death has been established, artificial ventilation and circulatory support of the body are maintained until just before the removal of the organs.
12.2 Removal of organs should always be carried out under normal operating theatre conditions and in accordance with procedures recommended by the transplant team. Removal should be carried out by a medical practitioner with appropriate training and experience. The surgeon or medical practitioner must ascertain that certification of death has occurred and that the necessary non-objection or consent for the removal of organs has been obtained.
12.3 Only those organs for which consent has been obtained may be removed.
12.4 A high level of cooperation between surgical teams involved in the removal of different organs and tissues is essential. Where possible, the use of multiple teams should be avoided.
12.5 Sufficient records should be made to enable donated organs to be traced to recipients in the event that it becomes medically desirable to do so. Such records should be maintained by the donor transplant coordinator.
13.1 Tissues are collected, processed and stored in licensed tissue banks, in accordance with the relevant code of good manufacturing practice. These procedures should be developed in consultation with the specialist surgeons who will be transplanting the tissue. Documentation should be made to enable donated tissues to be traced to the recipients in the event that it becomes medically desirable to do so.
13.2 In circumstances where there are appropriate facilities and medical supervision, trained technical staff may remove such tissue. The procedure must be well documented with the appropriate quality control and assurance mechanisms in place.
13.3 Only the tissues for which consent has been obtained may be removed.
14.1 In coronial cases the coroner normally requires an autopsy, whether or not organ and tissue donation occurs.
14.2 Non-coronial autopsy in all States and Territories except Tasmania and the Northern Territory is covered by the same legislation as organ and tissue removal, and requires similar consent and non-objection procedures to organ and tissue donation (see Part 1, especially paragraphs 1.4 and 1.5). The next of kin should be informed that the legislation provides that authorisation of autopsy includes authority for the therapeutic, medical and scientific use of tissue removed for autopsy purposes.
14.3 In all non-coronial cases where organ and tissue donations is to occur and the deceased has not expressed a wish for, or consent to, autopsy, the next of kin should be approached to indicate whether or not the deceased had expressed an objection to autopsy and whether or not the next of kin consents to autopsy. Autopsy in all such cases is desirable because information which can be obtained only at autopsy (for example, the presence of unsuspected malignancy) may be of great importance to potential or actual organ and tissue recipients. Even though the results of autopsy may be too late to affect the actual transplanting of solid organs, the results may be important in determining the post-transplant management of recipients, and may influence whether or not to transplant other tissues.
Autopsy
An examination of the body after death to determine the cause of
death and/or to discover and describe pathological processes present
in the body at the time of death.
Brain death
Death diagnosed by reference to irreversible cessation of all function
of the brain.
Cadaver
A dead body, a corpse.
Cadaveric donor
A person who gives organs and/or tissues after death for the purpose
of transplantation into another person.
Designated officer
A member of hospital staff who is officially appointed to be responsible
and accountable under State legislation for the process of organ
and tissue donation in that hospital. Responsibilities of a Designated
Officer are referred to in Part 1, Sections 1 and 2.
Donor transplant co-ordinator
A person whose role is to facilitate the organ and tissue donation
process by acting as the liaison between the donor hospital, donor
family and transplant centre(s).
Organ
A part of the body that performs vital function(s) to maintain life.
These include the kidney, heart, lung, liver and pancreas. These
organs can be donated from a donor whose death is certified by reference
to irreversible cessation of brain function and who is in an Acute
Care Unit.
Recipient
A person who receives organs and/or tissues from another person
(the donor).
Tissue
A group of specialised cells (eg cornea, heart valves, bone, skin)
that perform defined functions. These tissues can be donated several
hours after the heart has stopped beating.
Tissue typing
The processof laboratory testing to determine
the tissue groups of a potential donor, and to perform a cross-match
between the donor and matched recipients to confirm the absence
of reactivity between them. It is similar to blood grouping and
cross-matching. The cells used for tissue typing are obtained from
the blood or from the lymph glands and spleen removed at the time
of organ and tissue retrieval.
Footnote: Refer to the Australasian Transplant Co-ordinators Association 1993