Non-Heart-Beating Organ Transplantation

Practice and Protocols

Committee on Non-Heart-Beating Transplantation II: The Scientific and Ethical Basis for Practice and Protocols

Division of Health Care Services

INSTITUTE OF MEDICINE

NATIONAL ACADEMY PRESS
Washington, D.C.



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Non-Heart-Beating Organ Transplantation: Practice and Protocols Non-Heart-Beating Organ Transplantation Practice and Protocols Committee on Non-Heart-Beating Transplantation II: The Scientific and Ethical Basis for Practice and Protocols Division of Health Care Services INSTITUTE OF MEDICINE NATIONAL ACADEMY PRESS Washington, D.C.

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Non-Heart-Beating Organ Transplantation: Practice and Protocols NATIONAL ACADEMY PRESS 2101 Constitution Avenue, N.W. Washington, DC 20418 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. Support for this study was provided by the U.S. Department of Health and Human Services (Contract No. 231-99-0002). The views presented are those of the Institute of Medicine Committee on Non-Heart-Beating Transplantation II and are not necessarily those of the funding organization. International Standard Book Number 0-309-06641-7 Additional copies of this report are available for sale from the National Academy Press, 2101 Constitution Avenue, N.W., Box 285, Washington, DC 20055; call (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area), or visit the NAP’s on-line bookstore at www.nap.edu. The full text of this report is available on line at www.nap.edu/readingroom. For more information about the Institute of Medicine, visit the IOM home page at www.iom.edu. Copyright 2000 by the National Academy of Sciences. All rights reserved. Printed in the United States of America The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The image adopted as a logotype by the Institute of Medicine is based on a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin.

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Non-Heart-Beating Organ Transplantation: Practice and Protocols THE NATIONAL ACADEMIES National Academy of Sciences National Academy of Engineering Institute of Medicine National Research Council The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Bruce M. Alberts is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. William A. Wulf is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce M. Alberts and Dr. William A. Wulf are chairman and vice chairman, respectively, of the National Research Council.

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Non-Heart-Beating Organ Transplantation: Practice and Protocols COMMITTEE ON NON-HEART-BEATING TRANSPLANTATION II CHRISTINE CASSEL, M.D. (Chair), Chairman, Department of Geriatrics and Adult Development, Mt. Sinai Medical Center, New York City MARGARET ALLEE, R.N., M.S., J.D., Director of Operations, Transplant Program, Oregon Health Sciences University CAROL BEASLEY, M.M.P.M., Former Director, The Partnership for Organ Donation, Boston TOM BEAUCHAMP, M.D., Kennedy Institute of Ethics, Georgetown University JAMES D. BENTLEY, Ph.D., Senior Vice President for Strategic Policy Planning, American Hospital Association, Washington, D.C. CLIVE CALLENDER, M.D., Chairman, Department of Surgery, Howard University Hospital MARGARET COOLICAN, R.N., M.S., C.D.E., Donor Family Services Coordinator, Northeast Organ Procurement Organization, Hartford, Conn. ANTHONY D’ALESSANDRO, M.D., Associate Professor of Surgery, University of Wisconsin Hospital and Clinics HOWARD NATHAN, C.P.T.C., Executive Director, Gift of Life Donor Program, Philadelphia JOHN T. POTTS, Jr., M.D., Distinguished Jackson Professor of Clinical Medicine, Harvard Medical School JOHN ROBERTSON, J.D., Professor, School of Law, University of Texas at Austin MICHAEL WILLIAMS, M.D., Division of Neurosciences and Critical Care, Johns Hopkins Medical Center, Baltimore, Md. Staff ELLEN AGARD, R.N., M.P.H., Ph.D., Study Director, Division of Health Care Services JANET CORRIGAN, Ph.D., Director, Division of Health Care Services ROGER HERDMAN, M.D., Senior Consultant, Division of Health Care Services KAY HARRIS, Financial Associate KELLY PIKE, Senior Project Assistant, Division of Health Care Services TRACY McKAY, Research Assistant, Division of Health Care Services Consultants The following expert consultants prepared background papers on selected topics: ROBERT ARNOLD, M.D., Associate Professor of Medicine, University of Pittsburgh Medical Center Montefiore

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Non-Heart-Beating Organ Transplantation: Practice and Protocols MICHAEL DEVITA, M.D., University of Pittsburgh Medical Center Presbyterian MILDRED SOLOMON, Ed.D., Director, Center for Applied Ethics and Professional Practice, Education Development Center, Inc., Newton, Mass. STUART YOUNGER, M.D., University Hospitals of Cleveland, Cleveland, Ohio

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Non-Heart-Beating Organ Transplantation: Practice and Protocols Preface In 1997, the Institute of Medicine published a report entitled Non-Heart-Beating Organ Transplantation: Medical and Ethical Issues in Procurement. The findings and recommendations of that study defined the ethical and scientific basis for non-heart-beating organ donation and transplantation, and provided specific recommendations for practices that affirm patient welfare, promote patient and family choice, and avoid conflicts of interest. This report recommended that efforts be undertaken to develop consensus and consistency in non-heart-beating donation practices and protocols. Such efforts promote the integrity of the organ transplantation system and thus sustain public support for and interest in organ donation. Following the 1997 study, the Department of Health and Human Services requested a follow up study to promote such efforts. To meet that goal, the present study was undertaken by a committee of professionals knowledgeable about organ transplantation, patient care, and patient and family concerns. The committee gathered information on the current state of non-heart-beating organ donation practices, on similarities and differences among non-heart-beating donor protocols, on the process of developing and implementing protocols, and on possible impediments to consensus on non-heart-beating organ donation practices. The central activity for this study was a workshop held in Washington, D.C., on May 24–25, 1999. The workshop provided the opportunity for extensive dialogue on non-heart-beating organ donation among hospitals and organ procurement organizations (OPOs) that are actively involved in non-heart-beating organ and tissue donation and those with concerns about whether and how to proceed. The findings and recommendations of this report are based in large measure on the discussions and insights from that workshop.

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Non-Heart-Beating Organ Transplantation: Practice and Protocols Throughout the study, the committee emphasized a patient- and family-centered approach to organ and tissue donation. The need for organs for transplantation is a major concern, and organs from non-heart-beating donors have the potential for making a substantial contribution to meeting this need. However, the donation of organs and tissues is an intensely personal decision made by patients and families at times of great personal distress. Meeting the needs of patients and families is the primary goal of end-of-life care, and organ donation is part of the range of options that families may wish to consider at the end of life. Focusing on the needs and concerns of donor patients and donor families is an ethical and practical imperative that sustains support for organ donation and enhances care at the end of life. Ellen Agard Study Director

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Non-Heart-Beating Organ Transplantation: Practice and Protocols Acknowledgments Many groups and individuals assisted in this study. The Department of Health and Human Services provided early guidance in planning the study. The Health Resources and Services Administration provided the funding; Lynn Rothberg-Wegman, deputy director of the Division of Transplantation, provided valuable input and support. Several staff members at the United Network for Organ Sharing assisted study staff with gathering information and becoming familiar with the world of transplantation. Professional services coordinators Gloria Taylor, Debbie Seem, Lin McGaw, and Franki Chabalewski were especially generous with their time and information. Stuart Youngner, M.D., Michael DeVita, M.D., and Robert Arnold, M.D. provided a valuable background paper and input into the workshop activities and discussions. Mildred Solomon, Ed.D., of the Education Development Center, provided the research strategy included in the last chapter of this report. Numerous individuals involved in patient care, organ procurement, research on the care of the dying, and ethics gave freely of their time and expertise. Several staff at the Institute of Medicine (IOM) contributed to the success of this effort: Tracy McKay, Kelly Pike, Kathleen Nolan, and Ingrid Berger. Special thanks are due to Roger Herdman, M.D., senior scholar at the IOM and director of the 1997 study. He shared his expertise generously throughout the study and committed valuable time to coordinating the workshop discussions. Most importantly, three family members came to the workshop to share their concerns about donation. Bob and Nancy Curran and Peggy Schaeffer pro-

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Non-Heart-Beating Organ Transplantation: Practice and Protocols vided insights from their experiences as bereaved families that helped the committee to keep the patient and family focus of this study clearly in mind. REVIEWERS This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the Institute of Medicine in making the published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and the draft manuscript remain confidential to protect the integrity of the deliberative process. The committee wishes to thank the following individuals for their participation in the review of this report: James L. Bernat, M.D., Professor of Medicine, Dartmouth Medical School and Department of Neurology, Dartmouth-Hitchcock Medical Center Vicki Crosier, Chair, National Donor Family Council, New York City William H. Danforth, M.D., Chairman of the Board of Trustees, Washington University Norman Fost, M.D., Director, Program in Medical Ethics, University of Wisconsin Medical School Donald M. Nielsen, M.D., Senior Vice President for Quality Leadership, American Hospital Association, Washington, D.C. Paul Schwab, President, Association of Organ Procurement Organizations, Falls Church, Va. Susan Tolle, M.D., Director, Center for Ethics in Health Care, Oregon Health Sciences University Although the individuals acknowledged have provided valuable comments and suggestions, responsibility for the final contents of the report rests solely with the authoring committee and the Institute of Medicine.

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Non-Heart-Beating Organ Transplantation: Practice and Protocols Contents     ACRONYMS   xiii     GLOSSARY   xv     EXECUTIVE SUMMARY   1 1   NON-HEART-BEATING TRANSPLANTATION: BACKGROUND AND CURRENT PRACTICES   6      Non-Heart-Beating Transplantation: Background,   7      Non-Heart-Beating Donor Protocols: 1997–1999,   10 2   NON-HEART-BEATING DONATION AND END-OF-LIFE CARE   16      Terms and Concepts,   17      Withdrawing Life-Sustaining Treatment,   18      Determining Death,   21 3   PATIENT- AND FAMILY-CENTERED DONATION   27      Patient and Family Wishes,   27 4   NON-HEART-BEATING DONATION PROTOCOLS: CONTENT   38      Protocol Content,   39      Decision Points,   42

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Non-Heart-Beating Organ Transplantation: Practice and Protocols 5   PROTOCOL DEVELOPMENT AND IMPLEMENTATION   56      Constituents,   57      Protocol Approval,   58      Education, Training and Support,   59      Public Outreach,   61      Oversight and Review,   62      Resources,   63 6   A RESEARCH AGENDA FOR NON-HEART-BEATING ORGAN AND TISSUE DONATION   65      Research Priorities,   65      Maximizing Benefits, Minimizing Harms: A National Research Agenda to Assess the Impact of Non-Heart-Beating Organ Donation,   67     REFERENCES   87     APPENDIXES     A   Statement of Task,   93 B   Workshop Agenda,   95 C   Workshop Participants,   98 D   Bill of Rights for Donor Families, National Kidney Foundation,   102 E   Sample Family Information Brochure,   107 F   Non-Heart-Beating Donation Protocols,   112      LifeCenter,   113      Gift of Life Donor Program,   116      Shands Hospital, University of Florida,   119      New England Organ Bank,   122      University of Pittsburgh Medical Center,   133      Washington Hospital Center,   147

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Non-Heart-Beating Organ Transplantation: Practice and Protocols Acronyms DHHS Department of Health and Human Services HCFA Health Care Financing Administration HRSA Health Resources and Services Administration OPO organ procurement organization UNOS United Network for Organ Sharing

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Non-Heart-Beating Organ Transplantation: Practice and Protocols Glossary Autoresuscitation Spontaneous restoration of heart function after the heart has stopped beating. Cannula, cannulae Silastic (plastic) tubes inserted into large blood vessels (e.g. in the groin) for the administration of fluids or the withdrawal of blood. Cannulation Placement of cannulae. The blood vessel is entered with a large needle; the needle is used as a guide for the insertion of the silastic tubing and then withdrawn. The cannula is taped or sutured in place. Cold perfusion A method for preserving organs in the body (in situ) before they are removed but after death has occurred. Cold preservative solution is infused into the large vessels and blood is drained out. Heparin A medication that prevents the blood from clotting. Heparin is used in organ donation to keep the large vessels open and to maximize blood flow to the organs. Ischemia Lack of oxygen to the organs and tissues. Warm ischemia occurs when the heart and lungs are functioning but are not adequate to oxygenate blood and deliver it to the organs and tissues. It continues after cardiopulmonary function ceases, until the organs are removed or preserved in situ. At this point, cold ischemia occurs until the organs are transplanted and circulation is restored.

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Non-Heart-Beating Organ Transplantation: Practice and Protocols Maastricht categories A classification system for non-heart-beating organ donation: Category I Dead on arrival at the hospital Category II Unsuccessful resuscitation Category III Awaiting death by cardiopulmonary criteria Category IV Death by cardiopulmonary criteria following death by neurological criteria Categories I, II, and IV are uncontrolled; category III is controlled. Phentolamine A medication that dilates blood vessels. It is used in organ donation to increase blood flow to the organs and tissues. Pumping (kidneys) A method for preserving kidneys after they have been removed. The kidneys are attached to a pumping device that circulates cold preservative solution through them during storage and transport.