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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
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Copyright 1996 by the National Academy of Sciences. All rights reserved.
Printed in the United States of America
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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.
OCR for page R13
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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