Blood Donors and the Supply of Blood and Blood Products

Forum on Blood Safety and Blood Availability

Division of Health Sciences Policy

INSTITUTE OF MEDICINE

Frederick J. Manning and Linette Sparacino, Editors

NATIONAL ACADEMY PRESS
Washington, D.C. 1996



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--> Blood Donors and the Supply of Blood and Blood Products Forum on Blood Safety and Blood Availability Division of Health Sciences Policy INSTITUTE OF MEDICINE Frederick J. Manning and Linette Sparacino, Editors NATIONAL ACADEMY PRESS Washington, D.C. 1996

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--> National Academy Press 2101 Constitution Avenue, NW 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 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. 96-69896 International Standard Book Number 0-309-05577-6 Additional copies of this report are available from: National Academy Press, Lock Box 285, 2101 Constitution Avenue, N.W., Washington, DC 20055. Call (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area), or visit the NAP on-line bookstore at http://www.nap.edu/nap/bookstore. 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. Cover design by Francesca Moghari.

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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 Transfusion Medicine, University of Cincinnati, and 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 PINYA 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 WILLIAM C. SHERWOOD, Director, Transfusion Services, American Red Cross Blood Services, Philadelphia, Pennsylvania LINDA STEHLING, Director of Medical Affairs, Blood Systems, Inc., Scottsdale, Arizona *   Served from January 1995 until December 1995.

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--> 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 NANCY DIENER, Financial Associate (until March 1996) JAMAINE TINKER, Financial Associate (after March 1996) **   Served from January 1994 until December 1994.

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--> PRESENTERS DAVID V. BONK, Director of Membership, Marketing, and Public Relations, Blood Bank of Delaware, Newark, Delaware ARTHUR BRACEY, Transfusion Services, St. Luke's Episcopal Hospital, Houston, Texas JEFFREY L. CARSON, Professor and Chief, Division of General Internal Medicine, Robert Wood Johnson School of Medicine, University of Medicine and Dentistry of New Jersey, New Brunswick, New Jersey LLOYD COHEN, George Mason University School of Law, Arlington, Virginia ALVIN DRAKE, Ford Professor of Engineering, Massachusetts Institute of Technology, Cambridge, Massachusetts ROBERT FIELDS, Manager, Meat Merchandising and Procurement, Kroger Company, Cincinnati, Ohio JOSEPH C. FRATANTONI, Director, Division of Hematology, Office of Blood Research and Review, Food and Drug Administration, Rockville, Maryland RONALD GILCHER, Oklahoma Blood Institute, Oklahoma City, Oklahoma COLONEL JOHN HESS, MC, USA, Blood Research Detachment, Walter Reed Army Institute of Research, Washington, D.C. JEANY MARK, Director, Strategy, Policy and Analysis, Biomedical Services, American Red Cross, Arlington, Virginia JEFFREY McCULLOUGH, Director, Clinical Labs, University of Minnesota Hospital, Minneapolis, Minnesota TOBY SIMON, President, Blood Systems Foundation, Scottsdale, Arizona DOUGLAS SURGENOR, Senior Investigator, Center for Blood Research, Boston, Massachusetts C. ROBERT VALERI, Naval Blood Research Laboratory, Boston, Massachusetts COLONEL MICHAEL J. WARD, BSC, USAF, Industrial College of the Armed Forces, National Defense University, Washington, D.C. ROBERT G. WESTPHAL, Blood Services, Northeast Region, American Red Cross, Dedham, Massachusetts

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--> FOREWORD This is the second 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 previous volume dealt with the Forum's discussions of governmental regulation of blood banking and was entitled Blood Banking and Regulation: Procedures, Problems and Alternatives. A future volume on safety and risk collects the Forum's discussions of transfusion-related disease transmission and related topics. The talks summarized in this document were originally given at a workshop on blood availability held in Washington, D.C., on June 8 and 9, 1995. The views expressed in this document, unless otherwise noted, are those of the individual presenters and do not reflect the views of the individual's employing agency or the Institute of Medicine. To promote full 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, 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 giving 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 explored 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 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

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--> 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:" A consensus oriented procedure capable of reaching closure on the issues being discussed. Participation of diverse constituencies, such as designated representatives the public. 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. Conditions supporting openness and candor. Opportunities for discussion in a variety of venues, both public and—where permitted by law—private. Prestigious and neutral, a forum that lends dignity and credibility to the discussions. Expert facilitation, though not necessarily subject-matter expertise, by those who run or manage the process. Less time devoted to education about the issues, allowing more direct engagement with decision-making. Available and ready to be utilized whenever an appropriate issue is identified. Fashioned to be persuasive to Congress and others.

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--> PREFACE For a decade after the emergence of transfusion-associated AIDS, the overriding concerns with the American blood supply have centered on risk. Blood centers and hospital blood banks have been viewed less as guardians of the blood supply than as guarantors of its safety. Few members of the general public, or of the medical profession for that matter, worry much about the availability of blood. Surgeons and patients alike expect compatible blood to be available when they want it and in an amount sufficient to meet the immediate need. For the most part, these expectations have been met. Adequacy of supply and availability of blood for all Americans are, after all, two of the four goals of our National Blood Policy of 1973. Supply and access hold equal status with the principles of blood safety and system efficiency. Why then has the country experienced serious blood shortages during the past two years, and is this situation likely to worsen during the next decade? Supplying blood to patients throughout the United States turns out to be a more complicated issue than most people realize. Blood is collected by a patchwork system of large and small blood centers and hospitals and distributed by a variety of local and national mechanisms. Collections have been further subdivided into those from anonymous community donors, (allogeneic blood), donations from patients for their own use (autologous blood,) and allogeneic blood collected from friends and relatives for a specific patient (directed donations). There is also a parallel system of paid plasma donation which is used for manufacturing a variety of blood derivatives. Surprisingly few hard data are available concerning the supply of blood components from year to year, let alone from month to month and day to day. Even less is known about how blood is used. We have preconceived notions about when to expect blood shortages, but there are regional differences as well as differences in the blood type in short supply. None of these is as well understood as many believe. Are we barely able to collect all the blood that we need, or do collectors intentionally limit the amount of blood they collect—and occasionally fail to estimate accurately? Are we really running short of blood donors because of changing donor demographics and attitudes

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--> and increased deferral of donors during the screening process? Some argue that there are plenty of donors and opportunity to increase the number of donations, but that the system, despite years of study, still fails to attract and retain these donors. Others believe that we have learned little about distributing blood in an effective and efficient manner and that better management of our current collections could easily eliminate shortages. Still others look to science to provide longer blood storage intervals, less expensive cryopreservation, or blood substitutes as answers to the fluctuating supply problem. Furthermore, the system is changing. We are experiencing a rising competition for donors and blood that has not been seen for a quarter of a century. Regional suppliers have become national suppliers. Hospitals and HMOs exert substantial financial pressures as they seek the best price for their blood services. Would the American public be better served by a monolithic system of collection and distribution like that which many European countries have established? Could we improve supply and cost without sacrificing safety by replacing a system based on altruistic blood donation with one based on paid donation? Is blood a "national resource," or is that just a euphemism for a not-so-special perishable commodity, much like vegetables or seafood? How would this perception affect the public's willingness to donate blood? With these questions and many more in mind, the Forum on Blood Safety and Blood Availability convened several panels to explore several of the issues involved in blood supply. Among the participants were well-known students of the American system of supply and distribution, custodians of the blood inventory at the hospital, regional and national levels, and individuals with expertise in recruitment and inventory management from outside the discipline of blood transfusion. The presentations and discussions proved illuminating. This monograph represents the deliberations of a one-day workshop on blood availability. It seemed obvious a priori that not all of the questions, let alone the answers, could emerge from one such gathering. In fact, our meeting focused almost exclusively on whole blood and red blood cells, although platelets and white blood cells are major aspects of transfusion medicine as well. If a few additional insights into these issues of national importance have resulted from this workshop, however, it will have served its purpose. HARVEY G. KLEIN WORKSHOP MODERATOR

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--> CONTENTS I Current State of the Blood Supply   1     Longitudinal Studies of Blood Availability, Douglas M. Surgenor,   3     Blood Supply Fluctuations, Jeffrey McCullough,   9     When Should Physicians Transfuse? Jeffrey L. Carson   19     International Perspectives on Blood Availability, Robert G. Westphal,   25 II Enhancing Collections   31     The Delaware Plan, David Bonk,   33     Markets and the Blood Supply, Lloyd Cohen,   41     Blood Donor Attitudes and Behavior, Alvin Drake,   45 III Enhancing Distribution   51     American Red Cross Blood Distribution System, Jeany Mark,   53     Blood Resource Sharing Programs, Toby Simon,   59     Exporting Blood from a Regional Blood Center, Ronald Gilcher,   65     Supply and Demand in Transfusion Services, Arthur Bracey,   71     Logistic Problems and Perishables: The Kroger Company and Supermarket Seafood, Robert Fields,   77 IV Expanding the Alternatives   81     Frozen Red Cell Technology, C. Robert Valeri,   83     Logistical Concerns in Prepositioning Frozen Blood, Michael J. Ward,   91     Extended Liquid Storage of Red Blood Cells, John Hess,   99     Overview of Blood Substitutes, Joseph Fratantoni,   103

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--> V Closing Remarks   107     Henrik H. Bendixen,   109     Harvey Klein,   111 Appendixes   115 A   Acronyms,   117 B   Workshop Participants,   119