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Blood and Blood Produce: Salt and Risk ForoTn OD B Cod SaIbty and Blood /~v~1ab1~ty Division of Healfb Sciences Policy INSTITUTE OF MEDICINE Ncn1ik Bendixen, Frededck Wagoning and Linehe Spalacino, _ J? )~41IC~ AL ACADER4Y PRESS Washington, D.C. 1996

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National Academy Press 2101 Constitution Avenue, NW Washington, DC 20418 NOTICE: The project that oversees 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 Science, the National Academy of Engineering, and the Institute of Medicine. The members of the forum responsible for this report were chosen for their special competencies and with regard for appropriate balance. This report has been reviewed by a group other than the authors according to the procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under both the Academy's 1863 congressional charter responsibility to be an adviser to the federal government and its own initiative in identifying issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine. Support for this project was provided by the Food and Drug Administration (Contract No. 223-93- 1025), Abbott Laboratories, Baxter Health Care Corporation, Ortho Diagnostic Systems, the American Association of Blood Banks, the American Red Cross, the American Blood Resources Association, and the Council of Community Blood Centers. This support does not constitute an endorsement of the views expressed in the report. Library of Congress Catalog Card No. 96-70494 International Standard Book Number 0-309-05583-0 Additional copies ofthis report are available from: National Academy Press, Lock Box 285, 2101 Constitution Avenue, N.W., Washington, D.C. 20055. Call (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area), or visit the NAP on-line bookstore at http:/lwww.nap.edu. Call (202) 334-2352 for more information on the other activities of the Institute of Medicine, or visit the IOM home page at http://www.nas.edu/iom. Copyright 1996 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 Staatlichemuseen in Berlin.

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FORUM ON BLOOD SAFETY AND BLOOD AVAILABILITY HENRIK H. BENDIXEN, Chair, Professor Emeritus, Department of Anesthesiology, Columbia University, New York, New York. THOMAS F. ZUCK, Vice Chair, Professor of Transfi~sion Medicine, University of Cincinnati, Director, Hoxworth Blood Center, Cincinnati, Ohio JOHN W. ADAMSON, President, New York Blood Center, New York, New York ARTHUR L. CAPLAN, Director, Center for Bioethics, University of Pennsylvania, Philadelphia, Pennsylvania WILLIAM COENEN, Administrator, Community Blood Center of Greater Kansas City, Kansas City, Missouri P1NYA COHEN, Vice President of Quality Assurance and Regulatory Affairs, NABI, Boca Raton, Florida EDWARD A. DAUER, Dean Emeritus, College of Law, University of Denver, Denver, Colorado M. ELAINE EYSTER, Distinguished Professor of Medicine, Division of Hematology, The Milton Hershey Medical Center, Hershey, Pennsylvania JOSEPH C. FRATANTONI, Director, Division of Hematology, Office of Blood Research and Review, Food and Drug Administration, Rockville, Maryland HARVEY G. KLEIN, Chief, Department of Transfusion Medicine, Warren Grant Magnuson Clinical Center, National Institutes of Health, Bethesda, Maryland EVE M. LACKRITZ, Medical Epidemiologist, HIV Seroepidemiology Branch, Division of HIV/AIDS, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia PAUL R. McCURDY, Director, Blood Resources Program, National Heart, Lung, and Blood Institute, Bethesda, Maryland PAUL S. RUSSELL, John Homans Professor of Surgery, Massachusetts General Hospital, Boston, Massachusetts CAPT BRUCE D. RUTHERFORD, MSC, USN, Director, Armed Services Blood Program, Falls Church, Virginia Served from January 1995 until December 1995. . . .

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WILLIAM C. SHERWOOD, Director,-Transfusion Services, American Red Cross Blood Services, Philadelphia, Pennsylvania LINDA STEHLING, Director of Medical Affairs, Blood Systems, Inc., Scottsdale, Arizona EUGENE TIMM, Member, Board of Directors, American Blood Resources Association, Rochester Hill, Michigan ROBERT M. WINSLOW, Adjunct Professor of Medicine, University of California-San Diego, and Hematology-Oncology Section, Veterans Affairs Medical Center, San Diego, California Project Staff VALERIE P. SETLOW, Director, Health Sciences Policy Division FREDERICK J. MANNING, Project Director KIMBERLY KASBERG MARAVIGLIA, Research Associate MARY JANE BALL Senior Project Assistant ** Served from January 1994 until December 1994. 1V

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PRESENTERS JAMES R. ALLEN, Vice-President, Science, Technology and Public Health Standards, American Medical Association, Chicago, Illinois HENRIK H. BENDIXEN, Professor Emeritus, Department of Anesthesiology, Columbia University, New York, New York CARON CHESS, Director, Center for Environmental Communication Cook College, Rutgers University, New Brunswick, New Jersey DONALD COLBURN, President and CEO, American Home Care Federation, Enfield, Connecticut, and Member, Blood Products Monitoring Committee, National Hemophilia Foundation EDWARD A. DAUER, Dean Emeritus, College of Law, University of Denver, Denver, Colorado BRUCE EVATT, Chief, Hematologic Diseases Branch, Centers for Disease Control and Prevention, Atlanta, Georgia M. ELAINE EYSTER, Distinguished Professor of Medicine, Division of Hematology, The Milton Hershey Medical Center, Hershey, Pennsylvania J. MICHAEL FITZ!LAURICE, Director, Center for Infonnation Technology, Agency for Health Care and Prevention Research, Rockville, Maryland BERNARD HOROWITZ, Executive Vice-President, Melville Biologics, New York, New York MASON HOWARD, Chairman of the Board, Colorado Physicians Insurance Company, Greenwood Village, Colorado HARVEY G. KLEIN, Chief, Department of Transfusion Medicine, Warren Grant Magnuson Clinical Center, National Institutes of Health, Bethesda, Maryland JAMES J. KORELITZ, Westat, Inc., Rockville, Maryland EVE M. LACKRITZ, Medical Epidemiologist, HIV Seroepidemiology Branch, Division of HIV/AIDS, National Center for Infectious Diseases, Centers for Disease Control and,Prevention, Atlanta, Georgia JONATHAN D. MORENO, Professor of Pediatrics and Director, Division of Humanities in Medicine, Health Science Center, State University of New York, Brooklyn, New York M. GRANGER MORGAN, Professor and Department Head, Engineering and Public Policy, Carnegie Mellon University, Pittsburgh, Pennsylvania KENRAD E. NELSON, Professor and Director, Infectious Diseases Program, School of Hygiene and Public Health, Johns Hopkins University, Baltimore, Maryland DAVID J. ROTHMAN, Professor of Social Medicine and Director, Center for the Study of Society and Medicine, College of Physicians and Surgeons of Columbia University, New York, New York v

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ERNEST R. SIMON, Formerly Executive Vice President of Scientific, Medical and Technical Affairs, Blood Systems, Inc., Scottsdale, Arizona RICHARD K. SPENCE, Director of Surgery, Staten Island University Hospital, Staten Island, New York SCOTT WETTERHALL, Acting Director for Surveillance & Epidemiology, Epidemiology Program Office, Centers for Disease Control and Prevention, Atlanta, Georgia THOMAS F. ZUCK, Professor of Transfusion Medicine, University of Cincinnati, Director, Hoxworth Blood Center, Cincinnati, Ohio V1

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Foreword This is the third in a series of three monographs by the Forum on Blood Safety and Blood Availability. Each monograph provides a review and summary of selected topical presentations at four separate workshops sponsored by the Forum from January 1994 through September 1995. The first volume in the series dealt with the Forum's discussions of governmental regulation of blood banking and was entitled Blood Banking and Regulation: Procedures, Problems, and Alternatives. The second volume focused on discussions of availability and was entitled Blood Donors and the Supply of Blood and Blood Products. The talks summarized in this document were originally given at workshops on Current Risks of Disease Transmission (July, 1994~; Risk and Regulation (January, 1995~; and Managing Threats to the Blood Supply (September, 1995~. The views expressed, unless otherwise noted, are those of the individual presenters, and do not reflect the views of the individual's employer or the Institute of Medicine. This document is neither a summary of any one workshop nor a comprehensive summary of all of the Forum's workshops. It is a compilation of talks that were specifically selected for their relevance to the issues of safety and risk. To promote hill participation by Forum members, presenters, and invited guests, the Forum does not draw conclusions or make recommendations. The Forum on Blood Safety and Blood Availability was convened by the Institute of Medicine to provide a nonadversarial environment where leaders from the private blood community, the Food and Drug Administration (FDA), academia, and other interested parties could exchange information about blood safety and blood availability, to identify high-priority issues in these areas, and promote problem solving activities such as workshops. Although the inclusion of FDA officials among its members precluded the Forum from offering advice or making recommendations, during its two years of existence, the Forum identified opportunities and problems that are ongoing or expected to arise within the next five years, and has developed approaches to exploiting opportunities or solving problems. During the final meeting, in September 1995, members of the Forum reviewed its work and addressed the question of how the dialogue that it had fostered might best be continued or improved. One of the questions the group vii

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. . ~ V111 FOREWORD considered was what the criteria should be for any such future venture. Not everyone agreed with everything mentioned, and no votes were taken; consistent with its charter, the Forum reached no specific conclusions or recommendations. The group did however, request that the collected list of criteria be recorded as a possible starting point for any subsequent initiative. The suggestions on that list included the following "Criteria for a Process of Dialogue:" 1. A consensus oriented procedure capable of reaching closure on the issues being discussed. 2. Participation of diverse constituencies, such as designated represen- tatives of the public. 3. Continuity of people and process, so that issues may be addressed as they arise without the need to fashion a structure and process ad hoc. 4. Conditions supporting openness and candor. 5. Opportunities for discussion in a variety of venues, both public and-where permitted by law- private. 6. Prestigious and neutral, a forum that lends dignity and credibility to the . . alscusslons. 7. Expert facilitation, though not necessarily subject-matter expertise, by those who run or manage the process. 8. Less time devoted to education about the issues, allowing more direct engagement with decision-making. 9. Available and ready to be utilized whenever an appropriate issue is identified. 10. Fashioned to be persuasive to Congress and others.

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Preface In its deliberations the Forum has been reminded more than once of the contrast between the remarkable advances in blood safety, a noteworthy achievement by the blood community, and the lack of trust, indeed suspicion, with which that community is viewed, by the public, the media, and those at special risk, all of whom demand further advances in safety. The advances in blood safety to which I refer were reported by several speakers and, subsequently published. 2 For example, the risk of HIV, expressed as incidence rates of positive HIV tests in units of donated blood was found by Lackritz to be 1:450,000 to 1:660,000. These ratios reflect the safety of the blood supply, not the risk to the individual recipient, who, after all, is not likely to receive one unit of blood. Data on HIV seroconversion in actual recipients has been reported to be as high as 2:10,000,3 but unfortunately the data are far too few to have statistical significance. All we know is that the recipient of multiple units of transfusion, such as in open heart or trauma surgery, is at greater risk than is reflected by the per unit blood safety data. Other areas of medical practice have seen greatly increased safety, e.g., in undergoing surgery and anesthesia. In 1954, a multi-institutional study reported the following death rates caused by surgery 1:42O, and death related to anesthesia 1:1,560. About 40 years later one group with a large database reported an anesthesia related mortality among fairly healthy patients having fairly simple surgery as between 1 :100,000 and 1: 1,000,000, closer to ~Lackritz EM, GA Satten, J Aberle-Grasse, et al (1995). Estimated risk transmission of He human immunodeficiency virus by screened blood in the United States. New England Journal of Medicine, 333: 1721-1725. 2Schreiber GB, MP Busch, SH Kleinman, et al (1996). The risk of transfusion-transmitted viral infections. New England Journal of Medicine, 334: 1685-1690. 3Nelson KE, JG Donahue, A Nunoz, et al (1992). Transmission of retroviruses from seronegative donors by transfusion during cardiac surgery: A multicenter study of HIV 1 and HTLV IIII infections. Annals of Internal Medicine, Il 7: 55~559. 1X

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x PREFACE 1:1,000,000. An improvement in safety of three orders of magnitude is less than half a decade.4 If these advances in safety have not made blood or blood-component transfusion an acceptable risk, we must ask, what is, at any given time, and in any given situation an acceptable risk? Or to ask the often asked question: How safe is safe enough? To begin to answer this question, a reasonable starting point is a paper of seminal importance, published in 1969 by Starr.5 His several important contributions began with an explicit differentiation between risks involving voluntary activities, versus risks involving involuntary activities. Starr estimated that individuals will accept voluntary risks, which are three orders of magnitude greater than involuntary risks, not known and agreed to by the individual. Flying a hang glider is highly dangerous, but individuals accept the risk voluntarily, knowingly, feeling in control of their destinies. Involuntary activities involving risks are often determined by a controlling body, be it a government agency or a leadership group. The persons at risk are not informed, or not fully infonned, and they are not part of the decision process. Stan also offered a baseline for reference; the national death rate from disease, which he calculated to be 1 :1,000,000 per person per hour of exposure. He observed that the passenger death rate in commercial aviation was close to this baseline. Today commercial aviation is even safer and is often used as a psychological yardstick to help detennine a level of risk acceptability (note that using commercial aviation is in part a voluntary activity, in part the use of a public utility). Starr further pointed to the effect of potential benefits in making a risk more acceptable; and also the effect of education about risks. Others6 have pointed out that risk perception is selective and changing, i.e., situational. The transfusion of one unit of blood in a non-life-threatening situation may not be acceptable to the fully informed patient; while multiple transfusions given to the patient undergoing open heart surgery for a life-threatening illness may be readily acceptable to the fully informed patient, who finds the risk of the transfusions small in relation to the risks of surgery and anesthesia. and in relation to what he stands to gain from a cure or amelioration of his heart disease. 4Eichorn, JH (1989). Prevention of intraoperative accidents and related severe injury through safety monitoring. Anesthesiology, 70: 572-577. sstarr C (1969). Social benefit versus technological Isle what is society willing to pay for safety? Science, 165: 1232-1238. 6Teuber A (1990). Justifying risk. Journal of the American Academy of Arts and Sciences, 119: 23~254.

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PREFACE X1 Starr's paper on risk followed by only a few years the paper by Beecher,78' introducing the concept of informed consent. This led to further deliberations in courts of law, in Congress, among ethicists and philosophers, and within the medical professions. In 1982 the first report by the President's Commission, chaired by Morris Abram,9 concluded that adults are entitled to accept or reject health care interventions on the basis of their personal values and in furtherance of their own personal goals. Also: ". . . ethically valid consent is a process of shared decision making based on mutual respect and participation . . .", and " . . . although the informed consent doctrine has substantial foundation in law, it is essentially an ethical imperative." Several Forum participants have made reference to both the informed consent doctrine and to the observation that the risk that is known to the risk taker and evaluated in teens of potential gains from taking that risk is often acceptable to the risk taker, making a powerful argument for a public policy of fully informing those at risk, above all those at extra high risk; and involving them in the decision process. There is not always equity in the distribution at risk, and those at special risk must receive special attention. The Form has heard repeated references to the need for cost-benefit analysis, and for public policy rationally based on such analysis. To counter the desire for public policy based on cost-benefit analysis stands Teuber,' who states that public choices involving risk raise questions of equity to which cost-benefit analysis is blind and about which it has nothing to say. He stresses that potential risk bearers will have to be involved in every stage of the process, in formulating, implementing and adopting public policy. Speakers and discussants have repeatedly addressed the real and potential problems of so-called look-back, which is a response to the demand that any blood product recipient who received a blood product Mom a donor subsequently found to be carrying HIV (or other serious pathogens) must be informed of the potential risk. The patient's right to know is recognized, yet the look-back, as conducted in the past, is burdensome and not very 7Beecher HK, DP Todd (1954). A study of deaths associated with anesthesia and surgery. Annals of Surgery, 140: 2-34. Scotsman RJ (1987). Ethics and clinical research: Henry Beecher revisited. New England JournalofMedicine, 317: 1195-1199. 9President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (Chair: MB Abram) (1982). Making Health Care Decisions. Washington, D.C.: U.S. Government Printing Office. ~Teuber A (1990), op cit.

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X11 PREFACE effective. In the context of the look-back we also recognize the disparity in technology use between different parts of the blood system. On the one hand, driven by demands for manufacturing safety standards as high as those the pharmaceutical industry is expected to meet, the modern blood center is high technology-dependent, highly computerized and automated. As a result, a look-back is a modest burden for the blood center (i.e., on the donor side). On the other hand, for all but a few medical centers and hospitals, driven less hard by safety standards, a look-back on the patient or recipient side of the system almost invariably has to be done manually, which means that it is labor intensive, expensive and a major burden. This disparity was noted by Simon'2 (see also this volume), who proposes pre-transfusion testing for immature transfusion recipients as well as post-transfusion testing, i.e., an ongoing look-back. While ethical issues need resolution, the proposal would fit well in hospital quality improvement programs, which in turn are well suited to automation. Quality improvement programs in most hospitals today are still labor intensive, paper-based and very expensive, however important. Patient care information systems are highly developed in a few hospitals, including quality improvement programs with data being collected automatically and in real time. And the medical record, increasingly, is becoming computer-based, complete with reminders and decision support. Add also that the computer- based medical record is not only readable, but can be read by more than one person at a time. While the development phase of academic and clinical infonnation system owes much to government support, above all the National Library of Medicine, the growing role of the private sector in health care may farther accelerate the development of information systems, as managed care takes hold, with its emphasis on patient education, prevention, and early intervention. The providers will need to know the quality of their product; and the potential for . . savmgs IS enormous. Historically, the patient record started as notes scribbled by physicians, strictly for their own use, even today not often shared with a hospital. The hospital record is rarely easy to read, except for the nurses' notes. This record is shared among care providers, but rarely shared with the patient. This exclusion of the patient is changing, as the profession is beginning to recognize that patients are about to become partners in decision making, which ~ iBusch MP (1991). Let's look at human immunodeficiency virus look-back before leaping into hepatitis C virus look-back. Transfusion, 31: 655-661. Kessler, D and C Bianco (1994). Decreasing efficiency of look-back: implications for HCV. Transfusion, 34 (suppl): 54S. ~2Simon ER (1991). Identification of recipients with hepatitis C and other transfusion transmitted infections: We can do better than look-back. Transfusion, 31: 87.

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PREFACE . . . X111 argues that both providers and patients should work from the same database, as suggested as early as 1969 by Weed.'3 Physicians and hospitals may argue about, who owns the medical record. Legal consideration aside, the medical record should contain little or nothing that is note appropriate for the patient to know. Already physicians are reviewing the patient's record with the patient: on the screen or on a printout. Patients are mostly very appreciative, and this kind of sharing is a road to the building of trust to replace the awe of the old days, and the distrust of more modern times. The Forum was also reminded that we live in times of assessment and accountability, what Relman'4 called the third revolution in medical care. Prior to about 1965 the physician enjoyed autonomy and independence, alone with God and the patient, and alone with God, when deciding, in loco parentis, how little or how much to tell the patient. In the profession, we are now party to a social contract, within which we accept responsibility to and for each other, and we live with only a modest amount of grumbling about quality assurance, utilization reviews, accreditations and regulations, Congressional hearings, and many other forms of accountability. Paternalism is dead, and we are told that we still pay a price for not having involved the risk bearers more fully in the decision process in the 1980s, when the HIV problems first arose. Henrik H. Bendixen Chair, Forum on Blood Safety and Blood Availability Tweed LL (1969). Medical Records, Medical Education and Patient Care. Chicago: Year Book Medical Publishers, Inc. ~4RelmanAS(1988). Assessment and accountability the third revolutioninmedicalcare. New England Journal of Medicine, 319: 1220-1222.

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Contents I Current Risks of Disease Transmission ................ Blood and Blood Components: How Safe Are They Today?, Kenrad E. Nelson, 3 Viral Inactivation of Blood Products: A General Overview, Bernard Horowitz, 17 II Guarding the Blood Supply ...... The Retrovirus Epidemiology Donor Study: Rationale and Methods, Thomas F. Zuck, 27 Demographic and Serologic Characteristics of Volunteer Blood Donors, James J. Korelitz, 31 CDC Surveillance of Donors, Eve M. Lackritz, 39 Surveillance of Recipients, James R. Allen, 45 CDC Surveillance of High-Risk Recipients, Bruce Evatt, 53 CDC Surveillance for Unknown Pathogens, Scott Wetterhall, 59 ....... 25 III New Ideas for Safety and Monitoring 67 Information Technology and Blood Safety, J. Michael Fitzmaurice, 69 Strategies for Dealing with Potentially Infected Recipients, Ernest R. Simon, 77 IV Risk Tolerance..................................... Beneficial Aspects of Surgical Transfusion, Richard K. Spence, 83 Trade-off of the Risk of Hepatitis and the Benefit of Clotting Factor Concentrates in the 1970s and 1980s, M. Elaine Eyster, 93 Examples of Risks That We Tolerate, Harvey G. Klein, 101 xv 81

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XVI V Risk Communication .................... A Mental Model Approach to Risk Communication, M. Granger Morgan, 111 Risk Communication: Building Credibility, Caron Chess, 117 Attitudes Toward Risk: The Right to Know and the Right to Give Informed Consent, Jonathan D. Moreno, 127 Patients, Informed Consent, and the Health Care Team, David J. Rothman, 143 Communication of Risk and Uncertainty to Patients, Donald Colburn, 149 CONTENTS 109 VI No-FaultInsurance 155 Administrative and "No-Fault" Systems for Compensating Medically Related Injuries, Edward A. Dauer, 157 The Colorado and Utah Models of Compensating Patient Injury, Mason Howard, 165 VII Concluding Remarks .... Henrik H. Bendixen, 177 Appendixes A Acronyms and Abbreviations, 181 B Workshop Participants, 183 - . 175 .. 179

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Blood and Blood Products: Safely and Risk

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