OPO's philosophy of the donation process, principles, and a detailed protocol. Others are more general, with little reference to important aspects of the process. One protocol is constructed as a framework within which hospitals may tailor their own NHBD protocols. This protocol allows considerable freedom within some areas while setting minimum standards in others. In general, the NHBD protocols received and reviewed by the IOM have been written or approved within the last 4 years. The oldest was revised and approved in 1993, and the most recent was approved in July 1997. With respect to OPOs that have approved protocols in place, it is important to bear in mind that organs are procured from very few NHBDs (only one or two) by most OPOs each year. The fact that there are 25 OPOs with approved NHBD protocols and that UNOS reports 65 NHBDs in 1996 provides confirmation of the low rate of procurement of organs from NHBDs by most OPOs. Currently, OPOs located at hospitals tend to procure more organs from NHBDs.

Review of the NHBD protocols submitted to the IOM reveals a consensus among OPOs in two areas: (1) discussion of organ donation with families and informed consent should take place only after an independent decision to withdraw life support has been made; and (2) the physician who declares death after withdrawal of support shall not be affiliated in any way with the OPO, procurement team, or transplant team. Outside of these two areas, OPO protocols for NHBDs differ greatly. Some variations are merely procedural whereas others imply ethical differences. The criteria for determining death; medical interventions, including the use of heparin and phentolamine, which are directed toward preparation for transplantation rather than donor patient care; intervention by the OPO to assess and prepare the donor before consent for donation and declaration of death; and the timing, approach, and detail of obtaining family consent—all are problematic issues discussed next in this report. A consensus on these issues, expressed in more standardized and detailed protocols would help to avoid conflicts of interest, safeguard quality care for donors and promote procurement of viable organs. The great variation found in OPO protocols and the increasingly urgent demand for more organs suggest the value of a discussion of NHBD programs in the United States with the objective of a more effective use of the costly Organ Procurement and Transplantation Network.



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