Executive Summary

In December 1997, the Institute of Medicine (IOM) published a report, Non-Heart-Beating Organ Transplantation: Medical and Ethical Issues in Procurement. This report presented the findings and recommendations from a study conducted by Dr. John Potts, principal investigator on the “medical and ethical issues in recovering organs from non-heart-beating donors (NHBDs) who do not meet the standard of brain death” (IOM, 1997b, p. 1).

The recommendations of the report were based on extensive information about organ supply and demand in the United States and about the policies and practices of non-heart-beating organ procurement and transplantation by organ procurement organizations (OPOs), transplant centers, and hospitals.

The study found considerable variation among OPOs and hospitals in such significant areas as criteria for the declaration of death, premortem medical interventions to preserve organs, and attention to family options (e.g., bedside attendance at the time of death). The study concluded that although considerable local variation in details was to be expected, policies and practices consistent with fundamental ethical and scientific principles ought to resemble each other in certain key areas directly related to the care of donor patients (IOM, 1997b, p. 48). Consistent approaches to non-heart-beating organ procurement support patients and their families, sustain the integrity of organ procurement efforts, and maintain public confidence in the organ transplantation system.

The IOM report made seven specific recommendations for non-heartbeating organ procurement policy (IOM, 1997b, p. 4):

  1. written, locally approved non-heart-beating donor protocols;

  2. public openness of non-heart-beating donor protocols;

  3. case-by-case decisions about the premortem administration of medications;



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Non-Heart-Beating Organ Transplantation: Practice and Protocols Executive Summary In December 1997, the Institute of Medicine (IOM) published a report, Non-Heart-Beating Organ Transplantation: Medical and Ethical Issues in Procurement. This report presented the findings and recommendations from a study conducted by Dr. John Potts, principal investigator on the “medical and ethical issues in recovering organs from non-heart-beating donors (NHBDs) who do not meet the standard of brain death” (IOM, 1997b, p. 1). The recommendations of the report were based on extensive information about organ supply and demand in the United States and about the policies and practices of non-heart-beating organ procurement and transplantation by organ procurement organizations (OPOs), transplant centers, and hospitals. The study found considerable variation among OPOs and hospitals in such significant areas as criteria for the declaration of death, premortem medical interventions to preserve organs, and attention to family options (e.g., bedside attendance at the time of death). The study concluded that although considerable local variation in details was to be expected, policies and practices consistent with fundamental ethical and scientific principles ought to resemble each other in certain key areas directly related to the care of donor patients (IOM, 1997b, p. 48). Consistent approaches to non-heart-beating organ procurement support patients and their families, sustain the integrity of organ procurement efforts, and maintain public confidence in the organ transplantation system. The IOM report made seven specific recommendations for non-heartbeating organ procurement policy (IOM, 1997b, p. 4): written, locally approved non-heart-beating donor protocols; public openness of non-heart-beating donor protocols; case-by-case decisions about the premortem administration of medications;

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Non-Heart-Beating Organ Transplantation: Practice and Protocols family consent for premortem cannulation; conflict-of-interest safeguards; determination of death (in controlled non-heart-beating donations) by cessation of cardiopulmonary function for at least five minutes by electrocardiographic and arterial pressure monitoring; and family options (e.g., attendance at life support withdrawal) and financial protection. Following the publication of this report, the Department of Health and Human Services (DHHS) contacted the Institute of Medicine with a request for an effort designed to facilitate the adoption by all OPOs of protocols regarding non-heart-beating organ donation. In response to this request, the IOM designed a dissemination, communication, and consensus effort, sponsored by the Division of Transplantation at the Health Resources and Services Administration (HRSA). The goals of this study were defined as follows (Statement of Task, Appendix A): To familiarize all relevant parties with the 1997 IOM report. To identify obstacles to implementing its recommendations. To facilitate the development of organ procurement practices consistent with the principles and recommendations articulated in the 1997 IOM report. These tasks were defined as necessary steps towards the ultimate goal of the voluntary adoption of non-heart-beating donor protocols. The need for further efforts towards this goal was identified during the study. The study was guided by a committee of experts in ethics and law, organ procurement and transplantation, and patient care. The central activity for the study was a national workshop on non-heart-beating-donor protocols held in Washington, D.C., on May 24 and May 25, 1999 (Appendix B). Participants in the workshop included care providers, organ procurement professionals, and families who supported non-heart-beating donation. In three roundtable discussions, workshop participants compared protocol content from six active non-heart-beating-donor programs, described the process of protocol development, and identified challenges encountered in implementing these protocols. Participants also reviewed and discussed work commissioned by the committee in preparation for the workshop and the report. This commissioned work included an expert paper on the determination of death (Youngner et al., 1999), a model for evaluating the outcome of non-heart-beating organ donation (Chapter 6), and a model for a family information brochure on non-heart-beating donation (Appendix E). Following the workshop, the committee formulated seven recommendations for developing and implementing non-heart-beating-donor protocols. These recommendations were based on the findings and recommendations from the 1997 IOM report and consensus achieved among participants at the national work-

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Non-Heart-Beating Organ Transplantation: Practice and Protocols shop. The committee developed these recommendations as steps towards an approach to non-heart-beating-donor organ donation and procurement consistent with underlying scientific and ethical guidelines, patient and family options and choices, and public trust in organ donation. Recommendation 1: All OPOs should explore the option of non-heart-beating organ transplantation, in cooperation with local hospitals, health care professionals, and communities. A protocol must be in place in order for non-heart-beating organ and tissue donation to proceed. Protocols to cover non-heart-beating donation are needed in order to: make this option available to patients and families who wish to donate organs and tissues; respond to increased donation referrals generated by Health Care Financing Administration (HCFA) regulations; and contribute to the supply of organs for transplantation. Recommendation 2: The decision to withdraw life-sustaining treatment should be made independently of and prior to any staff-initiated discussion of organ and tissue donation. The decision should be based on the gravity of the patient’s condition and on his or her wishes to withdraw burdensome treatment (or on guidance from a surrogate decision maker who represents or affirms the patient’s wishes). It should follow established hospital protocols for withdrawing support and providing terminal care. Recommendation 3: As recommended in the 1997 IOM report, statistically valid observational studies of patients after the cessation of cardiopulmonary function need to be undertaken by appropriate experts. These studies should address the following: conditions under which cardiac autoresuscitation might occur and at what time intervals; signs, symptoms, and testing technologies that could guide the determination of death by irreversible cessation of cardiopulmonary function; and assessment by various technological and clinical observations of the degree and permanence of loss of brain function in whole or in part following the cessation of cardiopulmonary function; Such studies are needed in order to develop further empirical and conceptual clarity on the appropriate interval between the cessation of car-

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Non-Heart-Beating Organ Transplantation: Practice and Protocols diopulmonary function and the declaration of death. The 1997 IOM report suggested parameters for determining death by cardiopulmonary criteria, based on current expert clinical and legal opinion. However, concerns about this have not yet been resolved fully. Recommendation 4: Like all care at the end of life, non-heart-beating organ and tissue donation should focus on the patient and the family. As an option for patients and families at the end of life, non-heart-beating donation should: follow patient and family wishes as closely as possible meet family needs for information, support and follow-up; recognize and respect patient and family social, economic and ethnic diversity; and follow clear mechanisms for identifying and covering all organ donation costs. Recommendation 5: Efforts to develop voluntary consensus on non-heart-beating donation practices and protocols should be continued. The 1997 IOM report recommended specific protocol provisions based on underlying clinical and ethical standards. Substantial agreement on these provisions was achieved during this study (Chapter 4). However, some variations persist, and ongoing efforts towards consensus are needed. Recommendation 6: Adequate resources must be provided to sustain non-heart-beating organ and tissue donation. Adequate resources are required to cover (1) the costs of outreach, education and support for OPOs, providers, and the public, and (2) any increased costs associated with non-heart-beating organ and tissue recovery. Financial barriers to the development and implementation of non-heart-beating protocols and practice must be removed. A thorough examination of costs and a commitment of adequate resources are critical to making non-heart-beating organ donation an option available to all patients and families. Adequate funding for education and outreach is needed to develop professional and public understanding of non-heart-beating donation, and to prepare patient care providers and organ donation personnel to participate in non-heart-beating donation. Adequate reimbursement mechanisms are needed to cover the costs associated with recovering and transplanting organs from non-heart-beating donors. A high priority should be placed on ascertaining the magnitude of these costs and identifying appropriate mechanisms to overcome these barriers.

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Non-Heart-Beating Organ Transplantation: Practice and Protocols Recommendation 7: Data collection and research should be undertaken to evaluate the impact of non-heart-beating donation on families, care providers, and the public. Further information on the burdens and benefits of this approach to donation has to be gathered in a systematic, coordinated way. Further data is needed on: patient, family, provider, and public attitudes and concerns; the costs of non-heart-beating donation; the outcomes from non-heart-beating organ transplantation, and their effect on the willingness of transplant centers to accept organs from non-heart-beating donors.