Introduction
Organ transplantation is a highly effective treatment for advanced organ failure that relies on the donation of organs from living or deceased persons. The focus of this document is on the transplantation of solid organs donated from deceased persons.
Currently, the number of patients who might potentially benefit from transplantation is far greater than the number of organs donated. For this reason, organ transplantation is offered primarily to patients who have end-stage organ disease and—with the exception of kidney transplantation—who have exhausted all alternative treatment options. Furthermore, transplantation is offered only to patients who have a reasonable prospect of achieving an acceptably good quality and duration of life after transplantation. Decision-making regarding the allocation and transplantation of donated organs seeks to balance the needs of individual patients against the need to maximise the overall benefit to the community from this scarce and valuable resource.
The Transplantation Society of Australia and New Zealand (TSANZ) is the body responsible for developing eligibility criteria for organ transplantation and protocols for the allocation of deceased donor organs to wait-listed patients. Specifically, TSANZ is funded by the Australian Government’s Organ and Tissue Authority to maintain:
Current, nationally uniform eligibility criteria to ensure that there are equitable and transparent criteria by which patients are listed for organ transplantation, and
Current, nationally uniform allocation protocols to ensure consistency in the criteria by which donated organs are allocated.
The TSANZ document Organ Transplantation from Deceased Donors: Consensus Statement on Eligibility Criteria and Allocation Protocols was released in version 1.1 in June 2011. The current document (Clinical Guidelines for Organ Transplantation from Deceased Donors) replaces the previous Consensus Statement and was developed by the TSANZ Advisory Committees with written feedback sought through a targeted consultation process (see Appendix B). Version 1.0 of the Clinical Guidelines was released in April 2016. The current document, Version 1.12, updates and replaces all prior versions of the Clinical Guidelines.
Central to the eligibility criteria and allocation protocols described in this document are the following ethical principles, which are embodied in the National Health and Medical Research Council (NHMRC) publication Ethical Guidelines for Organ Transplantation from Deceased Donors (the Ethical Guidelines):11 Ethical Guidelines for Organ Transplantation from Deceased Donors. Australian Government National Health and Medical Research Council, Canberra, 2016. ×
To be eligible to be wait-listed for organ transplantation, patients must be referred for assessment and meet the relevant eligibility criteria as specified in this document. The transplant assessment process requires referred patients to be evaluated by a transplant unit; this evaluation process takes into consideration patients’ medical history and other relevant factors. Once listed, patients are regularly reviewed to ensure that they remain eligible to receive a transplant.
Organ allocation processes vary according to the organ that is to be transplanted. Allocation of hearts, lungs, livers, and intestines involves transplant units making a clinical judgement when an organ becomes available as to which patient on the waiting list has the greatest need of that particular organ, at that particular time, based on a range of factors. Patients who require kidney or pancreas transplantation are generally stable over a prolonged period of time, and the allocation of these organs is currently based primarily on the closeness of tissue matching and the time spent on dialysis or on the transplant waiting list.
The criteria used to decide which patients are placed on a transplant waiting list and how deceased donor organs are allocated do not determine how many patients will be transplanted, but rather which patients are eligible to receive which donor organs. It is recognised that whatever process is used, there will still be many patients who might benefit from an organ transplant but will not be able to receive one because of the limited supply of organs.
The criteria and processes outlined in this document seek to achieve an appropriate balance between the needs of individuals with end-stage organ failure and the obligation of transplant teams to exercise responsible stewardship of the community’s healthcare resources, including donated organs.