[House Hearing, 106 Congress]
[From the U.S. Government Publishing Office]



 
                     BLOOD SAFETY AND AVAILABILITY

=======================================================================

                                HEARINGS

                               before the

                            SUBCOMMITTEE ON
                      OVERSIGHT AND INVESTIGATIONS

                                 of the

                         COMMITTEE ON COMMERCE
                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED SIXTH CONGRESS

                             FIRST SESSION

                               __________

             SEPTEMBER 23, OCTOBER 6, and OCTOBER 19, 1999

                               __________

                           Serial No. 106-79

                               __________

            Printed for the use of the Committee on Commerce



                    U.S. GOVERNMENT PRINTING OFFICE
59-993 CC                   WASHINGTON : 1999



                         COMMITTEE ON COMMERCE

                     TOM BLILEY, Virginia, Chairman

W.J. ``BILLY'' TAUZIN, Louisiana     JOHN D. DINGELL, Michigan
MICHAEL G. OXLEY, Ohio               HENRY A. WAXMAN, California
MICHAEL BILIRAKIS, Florida           EDWARD J. MARKEY, Massachusetts
JOE BARTON, Texas                    RALPH M. HALL, Texas
FRED UPTON, Michigan                 RICK BOUCHER, Virginia
CLIFF STEARNS, Florida               EDOLPHUS TOWNS, New York
PAUL E. GILLMOR, Ohio                FRANK PALLONE, Jr., New Jersey
  Vice Chairman                      SHERROD BROWN, Ohio
JAMES C. GREENWOOD, Pennsylvania     BART GORDON, Tennessee
CHRISTOPHER COX, California          PETER DEUTSCH, Florida
NATHAN DEAL, Georgia                 BOBBY L. RUSH, Illinois
STEVE LARGENT, Oklahoma              ANNA G. ESHOO, California
RICHARD BURR, North Carolina         RON KLINK, Pennsylvania
BRIAN P. BILBRAY, California         BART STUPAK, Michigan
ED WHITFIELD, Kentucky               ELIOT L. ENGEL, New York
GREG GANSKE, Iowa                    THOMAS C. SAWYER, Ohio
CHARLIE NORWOOD, Georgia             ALBERT R. WYNN, Maryland
TOM A. COBURN, Oklahoma              GENE GREEN, Texas
RICK LAZIO, New York                 KAREN McCARTHY, Missouri
BARBARA CUBIN, Wyoming               TED STRICKLAND, Ohio
JAMES E. ROGAN, California           DIANA DeGETTE, Colorado
JOHN SHIMKUS, Illinois               THOMAS M. BARRETT, Wisconsin
HEATHER WILSON, New Mexico           BILL LUTHER, Minnesota
JOHN B. SHADEGG, Arizona             LOIS CAPPS, California
CHARLES W. ``CHIP'' PICKERING, 
Mississippi
VITO FOSSELLA, New York
ROY BLUNT, Missouri
ED BRYANT, Tennessee
ROBERT L. EHRLICH, Jr., Maryland

                   James E. Derderian, Chief of Staff

                   James D. Barnette, General Counsel

      Reid P.F. Stuntz, Minority Staff Director and Chief Counsel

                                 ______

              Subcommittee on Oversight and Investigations

                     FRED UPTON, Michigan, Chairman

JOE BARTON, Texas                    RON KLINK, Pennsylvania
CHRISTOPHER COX, California          HENRY A. WAXMAN, California
RICHARD BURR, North Carolina         BART STUPAK, Michigan
  Vice Chairman                      GENE GREEN, Texas
BRIAN P. BILBRAY, California         KAREN McCARTHY, Missouri
ED WHITFIELD, Kentucky               TED STRICKLAND, Ohio
GREG GANSKE, Iowa                    DIANA DeGETTE, Colorado
ROY BLUNT, Missouri                  JOHN D. DINGELL, Michigan,
ED BRYANT, Tennessee                   (Ex Officio)
TOM BLILEY, Virginia,
  (Ex Officio)

                                  (ii)






                            C O N T E N T S

                               __________
                                                                   Page

Hearings held:
    September 23, 1999...........................................     1
    October 6, 1999..............................................    57
    October 19, 1999.............................................   107
Testimony of:
    AuBuchon, James P., Professor of Pathology and Medicine, 
      Dartmouth-Hitchcock Medical Center.........................    27
    Bianco, Celso, President, America's Blood Centers............   125
    Fredrick, Jacquelyn, Chief Operating Officer, American Red 
      Cross Biomedical Services, National Headquarters...........   119
    Heinrich, Janet, Associate Director, Health, Education and 
      Human Service Division, General Accounting Office..........    10
    Roslewicz, Thomas D., Deputy Inspector General for Audit 
      Services, accompanied by Joseph Green, Assistant Inspector 
      General for Audits, Public Health Service Audit Division, 
      Department of Health and Human Services....................    17
    Satcher, David, Assistant Secretary for Health and Surgeon 
      General, Department of Health and Human Services, 
      accompanied by Kathryn Zoon, Director, Center for Biologics 
      Evaluation and Research, Steven A. Masiello, Director, 
      Office of Compliance and Biologics Quality, Center for 
      Biologics Evaluation and Research, and Jay S. Epstein, 
      Director, Office of Blood and Research Review, Center for 
      Biologics Evaluation and Research, U.S. Food and Drug 
      Administration.............................................    62
    Sperry, Craig and Jennifer, c/o America's Blood Centers......   112
    Sullivan, Marian T., Executive Director, National Blood Data 
      Resource Center............................................    23
    Wilkinson, Susan L., Deputy Director, Clinical and Technical 
      Services, Hoxworth Blood Center............................   113
Material submitted for the record by:
    American Association of Blood Banks, material dated December 
      22, 1997, submitted for the record.........................    46
    Plaisier, Melinda, Associate Commissioner for Legislation, 
      Food and Drug Administration, letter dated November 23, 
      1999, to Hon. Fred Upton, enclosing response for the record    85
    Upton, Hon. Fred, Chairman, Subcommittee on Oversight and 
      Investigations:
        Letter dated October 21, 1999, to Hon. David Satcher, 
          enclosing question for the record and response to same.    81
        Letter dated November 1, 1999, to Hon. David Satcher, 
          enclosing questions for the record and response to same    83

                                 (iii)








                     BLOOD SAFETY AND AVAILABILITY

                              ----------                              


                      THURSDAY, SEPTEMBER 23, 1999

                  House of Representatives,
                             Committee on Commerce,
              Subcommittee on Oversight and Investigations,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 10 a.m., in 
room 2322, Rayburn House Office Building, Hon. Fred Upton 
(chairman) presiding.
    Members present: Representatives Upton, Cox, Bilbray, 
Ganske, Bryant and Strickland.
    Staff present: Alan Slobodin, majority counsel; Anthony, 
Habib, legislative clerk; Chris Knauer, minority counsel; and 
Brendan Kelsay, minority clerk.
    Mr. Upton. Good morning, everyone. I apologize in advance 
for my cold, my bad ears.
    This morning the subcommittee holds the first of three 
oversight hearings on the safety and availability of the U.S. 
blood supply. The issue of the blood supply is not a remote one 
to any of us. Every 3 seconds, a person needs blood. Michigan 
hospitals, as one example, use a pint of blood every 43 
seconds. According to one estimate, 95 percent of us will need 
a blood transfusion by the time we're 75. And we expect the 
blood to be there and for it to be safe.
    Recently, we have seen some anecdotal reports about blood 
shortages during certain times of the year in some areas of the 
country. We have heard about elective surgeries postponed 
because of blood shortages and increased risks to patients who 
may have an immediate need for a transfusion. In one example 
last year, one third of the 38 American Red Cross blood regions 
were down to only a day's supply of type O blood and nine 
regions were on emergency appeal, meaning they had less than 1 
day's supply of type O blood. In another example, this past 
winter about half of all U.S. blood banks had less than a day's 
supply.
    In looking at the long-term trend, an internal memo dated 
July 2 of this year from the NIH noted, ``A gradual decline has 
occurred in blood donation by the U.S. general population over 
the past 10 years.''
    Another internal NIH memorandum dated August 6, 1999, 
states, ``There is an immediate need to monitor the blood 
supply for adequacy. The time is approaching when supply will 
become a safety issue.''
    I ask unanimous consent that both of these memoranda be 
inserted in the record in their entirety.
    [The information referred to follows:]




TO: Ruth Kirschstein, M.D., Deputy Director, NIH
FROM: Director, NHLBI
SUBJECT: Monitoring the US Blood Supply

    In following up to Dr. Sachter's memorandum of July 22, the NHLBI 
concur with the importance assigned to monitoring the adequacy of the 
US blood supply, especially in view of the imminent deferral of 
potential donors who have spent time in the United Kingdom.
    The Institute is prepared to respond by arranging for monthly data 
collection from a sample of blood collection centers, with analysis 
focusing on trends and possible seasonal shortages. If Feasible, data 
will also be collected from transfusion services, emphasizing the 
detection of shortages, if they occur, and their adverse effects, if 
any, on patient care. The mechanisms by which this data collection will 
be supported are under review, but the cost seems unlikely to exceed 
$300,000 annually and may be somewhat less.
    Other PHS Agencies and parts of the private sector will be involved 
to ensure that the data meet the needs of the government and of the 
blood collectors and that there is a smooth transition between 
procedures used to satisfy immediate requirements and a long term 
solution to providing necessary blood data.
                                                Claud Lenfant, M.D.
cc:
Dr. Alving
Dr. McCurdy
                                 ______
                                 
              Department of Health & Human Services
                              National Institutes of Health
                          National Heart, Lung, and Blood Institute
                               Memorandum
Date: August 6, 1999

From: George J. Nemo, Ph.D.
      Paul R. McCurdy, M.D.

Subject: Blood Data

To: Director, NHLBI
   Through: Director, DBDR

    The PHS has an immediate need to monitor the nation's blood supply 
for adequacy. This action is necessary to determine the effect of 
deferring blood donors who have spent an aggregate of 6 or more months 
in the UK between 1980 and 1996. This deferral policy will be activated 
by an FDA Guidance document which is expected to be released by the end 
of August. Other safety-related initiatives such as the recent 
introduction of nucleotide amplification technology (NAT testing) are 
also likely to have an adverse effect on supply, while improving 
safety. The time is approaching when supply will become a safety issue.
    The NHLBI has long been aware of the limitations on information 
about the collection and transfusion of blood. The Institute supported 
the data system of the American Blood Commission (ABC) in the late 70s, 
but with drew that support because the ABC tried to accomplish too much 
and failed to provide useful data in a timely fashion. One of the NHLBI 
SCOR programs in Transfusion Medicine provided considerable information 
for over a decade on the collection and use of blood in the U.S. These 
data were not obtained frequently enough, however, for decision-making 
purposes. The Institute also sponsored a workshop on blood data in 
1989, but its recommendations were never implemented.
    To be most helpful, data to be collected must be carefully 
determined and examined in the light of detecting seasonal and other 
changes in supply and demand for blood and its components. Thus, 
setting up data collection and analysis is a research activity and well 
within the purview of the NHLBI. It is anticipated that in the future, 
most likely in FY2002, the data system will be established to be 
contracted for management by another agency as a service (e.g., CDC).
    Hence, it is recommended that the NHLBI support through appropriate 
mechanisms blood data collection and analysis to evaluate ways of 
accomplishing this activity and to support necessary initiatives to 
improve blood safety while maintaining an adequate supply.
    Attached is a note addressing several issues relating to blood data 
collection and analysis and a plan for the Institute to obtain blood 
data on a timely basis.

cc: Ruth Kirschstein, M.D.


                                 ______
                                 
              Department of Health & Human Services
                                      Public Health Service
                                      National Institutes of Health
August 3, 1999

TO: Assistant Secretary for Health and Surgeon General
FROM: Deputy Director, National Institutes of Health
SUBJECT: Procedures to Monitor the Blood Supply

    Dr. Varmus has asked me to respond to your memorandum of July 21. 
Following the meeting of the Blood Safety Committee on June 8, at which 
there was much discussion about the likely reductions in the number of 
blood donations in the United States, I met with Dr. Claude Lenfant, 
Director, National Heart, Lung, and Blood Institute (NHLBI) , the staff 
of its Division of Blood Diseases and Resources and Dr. Paul McCurdy, a 
consultant to Dr. Lenfant and to me. The following plan is the result 
of those discussions:
        The plan consists of six discrete activities, three of which, 
        currently supported by NHLBI, will be continued and three 
        proposed new ones which can be implemented after approval by 
        the National Advisory Council of the Institute. Descriptions of 
        the research plan are attached.
    The current expenditures for FY1999 for the ongoing projects, #1, 
2, and 6 and the total proposed for FY2000 are:

------------------------------------------------------------------------
                                         FY99              FY2000
------------------------------------------------------------------------
#1 and 2..........................      $1,137,500              $500,000
#6................................        $180,000     Not determined as
                                                                     yet
------------------------------------------------------------------------

    The new projects, #3, 4, and 5, if approved by the Council, will 
start in fiscal year 2000 and are projected to be:

FY00......................................................    $1,638,347
FY01......................................................    $1,638,347
FY02......................................................    $1,165,786


    As these studies progress, and in some cases, start, NIH will work 
with your office and the Blood Safety Committee to assess the need for, 
and types of studies, to be planned regarding blood donations.
                                          Ruth L. Kirschstein, M.D.
Attachment
                                 ______
                                 
                                                       July 2, 1999
         NHLBI Research Plan to Increase the U.S. Blood Supply
    With demand for blood increasing and supply decreasing, the AABB 
National Blood Data Resource Center estimates that overall demand will 
exceed supply in the year 2000. The recent decision of the U.S. Public 
Health Service to recommend deferral of donors who have visited and/or 
resided in the United Kingdom and the Republic of Ireland for a 
cumulative period of six months or greater between 1980 and 1996 will 
likely contribute to this problem.
    Understanding why people donate blood is paramount to insuring the 
adequacy and safety of the blood supply. The National Heart, Lung, and 
Blood Institute (NHLBI) through its Retrovirus Epidemiology Donor Study 
(REDS) plans to conduct a survey of donor motivations. Furthermore, the 
Institute plans to evaluate the use, effectiveness, and safety of blood 
donation incentives. A study is also being developed to determine the 
feasibility of increasing the frequency of donations in repeat blood 
donors by one donation per year. A longitudinal study is being planned 
on the recruitment and retention of blood donors. Another project is 
being planned to determine the feasibility and cost effectiveness of 
using double red blood cell collection by apheresis as a means of 
increase red cell donations. The Institute is also supporting a study 
that is evaluating a computer-assisted interactive video donor 
screening system. Brief descriptions of these studies follow.
1) Evaluation of the Impact of Recruitment Strategies on Blood Donation 
        Behavior
    Extensive literature exists on ways to recruit blood donors. 
However, few attempts have been made to study the real-time 
interactions of blood centers with their donors on a large scale, or to 
conduct controlled experiments to determine the positive and negative 
impact of specific recruitment programs, especially those offering 
various forms of incentives. The primary goal of this study is to 
produce measurable


improvement in donor recruitment efficiency as measured by new and 
repeat donation behaviors in those subgroups, while monitoring any 
major changes in deferrable risk.
    In Phase I of the study, REDS will interact closely with a small 
group of mobile blood collection units for approximately 6 months. The 
recruitment strategies used for donors at a sample of these mobile 
units such as telerecruiting, direct mailing, and media appeals will be 
documented and donor responses to these recruitment strategies will be 
measured. A combination of mail and on-site survey techniques will be 
used to measure prevalence of deferrable risk and, donor attitudes and 
responses to recruitment practices.
    Based upon data derived from previous REDS Donor surveys and 
available data from Phase I, four REDS blood centers will implement and 
evaluate experimental incentive programs in Phase II of the study. In 
this phase, specific incentives and promotional strategies such as 
cholesterol testing, gifts, or time off from work will be provided to 
the same mobile units, with the goal of measuring the positive and 
negative impact of these specific interventions. Prevalence of 
deferrable risk and recruitment efficiency among sites that implemented 
new incentives programs will then be measured and compared to similar 
data obtained in Phase I before implementation of the incentives. The 
survey instruments for this study are being developed. It is 
anticipated that the documents will be submitted to the office of 
Management and Budget (OMB) in October 1999 and the study initiated in 
January 2000.
2) Study of donor Motivations
    Little appears to be known about what motivates some people to 
become regular blood donors, or why only about 39 percent of first-time 
donors return. Adequate information pertaining to donor motivation in 
various ethnic groups is also lacking; data which would be valuable for 
minority recruitment efforts. With the current difficulties in 
maintaining an adequate blood supply, it is important to discern the 
reasons behind people's decisions to donate, so that better recruitment 
strategies can be formulated.
    The REDS group is in the process of developing a donor survey to 
examine motivational factors. The survey will be conducted at all five 
REDS blood centers at both fixed and mobile recruitment sites. Donors 
will be presented with a questionnaire to be completed during the 
donation process. Previous REDS donor surveys have yielded low response 
rates from certain groups of donors, such as first timers, minorities, 
and the young. It is thought that using the approach of surveying 
donors while they are still at the center will increase response rates 
for these groups and be of minimal cost.
    Approximately 37,000 donors will be surveyed over a 6-month period 
at the five REDS centers. The survey will be identity-linked to enable 
follow-up of donors in the REDS donation database. This will permit 
REDS investigators to compare actual donation behaviors to stated 
intent. Questions pertaining to motivational factors and demographic 
data will be collected. Blood centers will also track incentive use and 
recruitment techniques at both mobile and fixed sites to permit 
evaluation of the association between actual exposure to incentives and 
reported donor motivational factors. The survey document is currently 
being developed and will be submitted to the OMB in October 1999. The 
study is scheduled to begin January 2000.
3) Study to Increase Blood Donations
    A study is being planned within REDS to increase the frequency of 
blood donations in repeat blood donors by one donation per year. For 
many years, data have repeatedly shown that most blood donors give but 
once a year (50-70%, most recent REDS data). If a second blood donation 
is given within 1-2 years of the first, the individual is more likely 
to become a ``regular donor,'' defined as one who gives every 1-2 years 
for several years. It is hypothesized that arranging for donors who 
give 1-2 times yearly to donate blood once more per year is feasible 
and will increase the blood supply and eliminate shortages.
    The study would be conducted in two or more REDS blood centers. For 
a sample of a blood center's fixed and mobile sites, arrangements would 
be made for each donor, while resting in the canteen after donating, to 
make an appointment for the next donation (after 3-6 months). A 
reminder (card and/or call) will be sent before the appointment. 
Control sites will have no such appointment plans. Endpoints would be 
the number of donations at the test sites with an appointment system, 
compared with those sites who use current procedures. This study will 
be conducted at two REDS blood centers and is scheduled to be completed 
in two years.
4) Study on the Recruitment and Retention of Blood Donors
    A gradual decline has occurred in blood donation by the U.S. 
general population over the past ten years. As a result, recruitment 
and retention of donors is a top


priority for virtually all of the nation's blood collectors and each 
blood center now spends an increasingly large proportion of their 
overall resources to maintain the current supply.
    What appears to be missing from this intense recruitment activity 
is a structured approach to understanding the reasons why sub-
populations of donors appear for donation the first time, and why they 
appear for return donations with varying levels of frequency. When 
stratified by demographic subgroups, improved understanding of these 
factors should help to inform the design of experimental studies and 
demonstration projects related to recruitment and retention and allow 
rapid transfer of information to the field.
    At the five REDS centers and three additional blood centers (chosen 
to represent the overall U.S. population), a representative sample of 
approximately 25,000 active donors will be invited to participate in a 
linked study of blood donation patterns. The follow-up of each donor 
will last for two years. Two weeks following enrollment and at six 
month intervals thereafter, mail surveys will be sent to study 
participants to gather information about donation experiences, blood 
donation recruitment exposures (ads, telephone calls, sponsored 
donations, incentive offerings, etc.), reactions to these exposures, 
rationale for becoming a donor in the first place and actual or 
intended post-enrollment donation.
    A subset of this study will involve the over sampling (an 
additional 10,000) of college-age donors to participate in a similar, 
but more targeted version of this study. Surveys distributed to this 
subset of donors will include questions about donations made during 
high school, donation patterns of their parents, how they were first 
introduced to the donation experience, and what types of opportunities, 
fed back, or appeals will encourage them to become lifetime donors.
5) Feasibility of Increasing Red Cell Donations using Apheresis 
        Procedures
    This project will study the use of double red blood cell (2RBC) 
collection by apheresis as a means to increase red cell donations. The 
2 RBC procedure collects the equivalent of two whole blood derived 
packed RBC units from one donor in a single procedure. Donors who give 
typically only once or twice a year, if recruited to give 2RBC 
donations would effectively double their donations. This would be of 
particular value for Rh negative donors and those with blood types 
always needed such as group O.
    Practical limitations have existed in the length of time required 
for 2RBC donations (35-40 min.), donor size and hematrocrit 
requirements, and relative cost of the procedure. The costs of 
disposable collection equipment, however, have begun to decline. The 
purpose of this project would be to demonstrate the feasibility of 
converting whole blood donors to 2RBC donors, and that this conversion 
can be performed in an economically feasible manner. This project will 
be conducted at two blood centers and is scheduled to be completed 
within two years.
6) Computer-assisted Interactive Video Donor Screening
    The Institute is supporting a grant program to develop an 
interactive, multimedia video blood and plasma donor health history 
system; and to evaluate its acceptance and feasibility in operational 
settings. The principal aims of the program are to improve overall 
operational systems for screening donors and collecting blood and 
plasma; and to improve the safety of blood and plasma supplies. these 
aims will be evaluated in two stages. In the initial stage, the 
interactive video screening software will have no decision logic and 
the nursing staff will determine donor suitability from the printed 
output of the screening system. In the final stage, it is planned to 
integrate the interactive video donor screening system into the data 
management system of the donor center resulting in a ``paperless'' 
health history assessment.

    Mr. Upton. We have become concerned, as have the blood 
banking community and public health experts, about the apparent 
tightening of the blood supply. There seem to be several 
factors that are contributing to this trend of an apparent 
tightening of our blood supply: A growing population over 65 
that will need more operations and thus more blood 
transfusions, younger generations donating at lower rates than 
the past generations, and improved screening and testing, to 
name just a few.
    Officials in both the blood banking community and the 
government have raised concerns about these trends. In response 
to these concerns, Chairman Bliley asked the GAO to conduct an 
assessment of the availability of the U.S. blood supply. We 
look forward


to hearing the GAO's testimony on the supply and the demand 
trends.
    We're also pleased to have two experts, Marian Sullivan of 
the National Blood Data Resource Center and Dr. James AuBuchon, 
of the Dartmouth-Hitchcock Medical Center, who will also 
discuss the matter.
    At the same time concerns have been raised about the blood 
shortages and the trends in the blood supply, a new Federal 
policy will further decrease that blood supply. Last month, the 
FDA issued a new policy that requires that individuals who 
spent a total of 6 months or more in the United Kingdom between 
1980 and the end of 1996 be prohibited from donating blood 
because of concerns over theoretical risk of spreading a new 
variant of CJD, Creutzfeldt-Jakob Disease, or the human form of 
the mad cow disease.
    This new donor exclusion policy was taken as a precaution 
since little is known about this new variant of mad cow 
disease, how it is transmitted, what the incubation period is 
and whether it is transmissible through blood transfusions. 
However, the new policy has been estimated to reduce the blood 
supply by 2.2 percent.
    Chairman Bliley asked the GAO to analyze this policy and 
the expected loss to the blood supply. The GAO will be 
testifying on this new policy.
    To alleviate blood shortages and especially to offset the 
expected loss to the blood supply, the Department of HHS asked 
the FDA and HCFA to identify a strategy to increase the blood 
supply by easing restrictions on the distribution of blood 
collected from hemochromatosis patients. This is an iron 
overload disorder that is genetic and not a transmissible 
disease.
    These patients are not less safe donors because of their 
disease. However, because of their disease, these patients 
require blood removal as therapy and most patients are charged 
for the removal. A concern is that a financial incentive to 
donate at no cost, rather than having blood removed 
therapeutically, might cause the donor to be less truthful 
about acknowledging risk behaviors.
    Ways are being considered to remove financial incentives 
for these patients. Chairman Bliley again asked the GAO to 
evaluate the potential impact of a change in policy to allow 
units of blood collected from these patients to be distributed. 
The GAO's testimony before us today will cover this area as 
well.
    We're also pleased to hear the testimony from the Inspector 
General at HHS concerning error and accident reports. In May 
1995, the IG issued a report that concluded the FDA could 
improve the safety of the blood supply by doing a better job of 
collecting data on errors and accidents made by hospitals and 
blood banks.
    The audit found that the FDA was not insisting that 
hospitals and blood banks submit error reports in a timely 
fashion and that FDA does not get these reports at all from 
unlicensed facilities that handle about 10 percent of the blood 
used in the U.S. In contrast, blood centers that account for 
about 80 percent of the blood supply are covered by consent 
decrees that are required to submit error and accident reports 
within 30 days.
    The IG recommended that the FDA expedite regulations that 
would be more specific about the timeframe in which reports are


required to be submitted and that would require unlicensed 
blood establishments to submit their reports. The IG will be 
testifying on the status of the implementation of these 
recommendations.
    Today we lay a foundation for oversight efforts. In future 
hearings, we will have witnesses from the Department of HHS, as 
well as the FDA and from the blood banking community.
    I was a member of this subcommittee in the early 1990's 
when we investigated the contamination of blood supply with the 
AIDS virus. Since that time, a number of measures have been 
taken by the government and the blood banks to provide greater 
assurance of safety.
    They have also been technological advances such as nucleic 
acid testing and viral inactivation that could make the blood 
supply even safer. This subcommittee will continue to oversee 
blood safety vigorously, with a watchful eye on availability.
    I look forward to working with my colleagues on this 
subcommittee, the administration, the blood banking community, 
the public health and medical communities, and especially the 
patients who receive blood transfusions, to provide absolutely 
the strongest assurance possible for the safety and 
availability of the Nation's blood supply.
    And I yield to my friend from Ohio, Mr. Strickland, for an 
opening statement.
    Mr. Strickland. Thank you.
    I thank you, Mr. Chairman; and I want to thank you for 
holding these hearings. This is an important issue. It could 
potentially affect every American citizen. And it is proper 
that we hold these hearings to find out what we, as a Congress, 
need to do or can do to make sure that our Nation's blood 
supply is adequate and safe; and I look forward to hearing from 
the witnesses. Thank you.
    Mr. Upton. Mr. Bryant.
    Mr. Bryant. Thank you, Mr. Chairman.
    I want to welcome all of those in the audience, including 
our panel of witnesses. I have reviewed the qualifications and 
certainly we have a very distinguished panel who are competent 
to testify about the issues that are before us today, which has 
been said already twice this morning, this is a very important 
issue for this country.
    I must apologize that sometimes we have overlapping 
schedules, and I will be in and out today. We are downstairs 
marking up a bill in another subcommittee on the Commerce 
Committee, on which I serve as well, and on the floor with a 
bill that has to do with class action litigation, something 
that is very near and dear to my heart, and I will have a role 
in that.
    So all that to tell you I must leave after making the 
statement. But I will try and get back and hear some of the 
testimony. I would like to be available to ask some questions.
    I know there are issues out there, and there appears to be 
some conflict among our witnesses as to the adequacy--the state 
of our current Nation's blood supply, the effect on the new FDA 
policy regarding transfusions--or not transfusions, but 
obtaining blood from people who have been to England, and the 
reporting requirements, all important matters that I'm sure 
this panel will discuss in detail.


    But, again, I must apologize for missing this. I will have 
the opportunity to review your testimony if I should miss it. 
And I want to especially thank the chairman of the Oversight 
Subcommittee, Mr. Upton, for his foresight in having this 
hearing.
    I mentioned to someone this morning as I came up, it's 
about blood safety, but you don't think too much about that 
until you, yourself, or someone in your family needs that 
blood, and then you say I hope that blood is safe, and I trust 
that blood is safe.
    But it's good to have this hearing, and I appreciate, Mr. 
Chairman, you for calling this. And I yield back my time.
    Mr. Upton. Thank you.
    Mr. Cox.
    Mr. Cox. Thank you, Mr. Chairman.
    The FDA has told us--in fact, Commissioner Jane Henney--
that blood safety is one of FDA's top priorities; and today the 
purpose of our oversight hearing is to ensure that is and 
remains the case.
    Four years ago, the Office of Inspector General at the 
Department of Health and Human Services completed a study and 
report that recommended the FDA expand its use of error and 
accident information; and, at the same time, the Public Health 
Service, which is FDA's oversight agency, agreed with that 
recommendation and told Congress that there would be a proposed 
rule issued by February 1996. But 1\1/2\ years later, there 
still had not been a proposed rule issued.
    Finally, in September 1997, that proposed rule was issued, 
but we are told now that a rule in final form is going to be 
postponed until sometime in 2001. And because we wish this to 
be a top priority, not a secondary priority, of FDA, we are 
concerned that the reason given by FDA for delay of its final 
rule is ``because of multiple public-health-related priorities 
of the agency''. In other words, this isn't a top priority. 
That's the way I understand FDA's statement.
    I'm sure we will be told today that it is and remains a top 
priority, but we will have to look to results rather than 
rhetoric. Error and accident reports are the basis for FDA's 
oversight of the blood industry. Some 13,000 reports were filed 
last year, but there is indication that they are still not on 
an overall systemic basis being provided promptly. Furthermore, 
those establishments that do not shift blood interstate--and 
thus are not subject to the licensing regime--are not on a 
continuing basis, as was identified some 4 years ago, 
submitting reports that provide data to FDA for its oversight 
of the blood supply.
    And when 10 percent of the blood supply is missing from 
this equation, it raises obvious concerns of the establishments 
that are unlicensed. Representing about 10 percent of the 
supply, they accounted for only 1 percent of the report. So 
either the situation with these establishments is completely 
different than with all of the licensed establishments or we 
are simply not getting the information from them, which is more 
likely the case.
    So today's hearing is properly focused on what FDA is doing 
now and, even more importantly, what they're going to do 
tomorrow morning; and I think this panel of four is especially 
well-suited to address those questions.
    And I thank the chairman for scheduling the hearing.


    Mr. Upton. Thank you, Mr. Cox.
    At this point it's been noted we have a number of 
subcommittee meetings this morning, and I would ask that all 
members of this subcommittee under unanimous consent request be 
allowed to offer as part of the record any opening statement 
that they may have.
    At this point, without objection, so ordered.
    [Additional statement submitted for the record follows:]
 Prepared Statement of Hon. Tom Bliley, Chairman, Committee on Commerce
    Mr. Chairman, thank you for these hearings concerning the safety 
and availability of the Nation's blood supply. Last June, I asked the 
General Accounting Office (GAO) to conduct an assessment about the 
blood supply. I specifically asked the GAO to provide: (1) information 
on recent trends in blood supply and demand, (2) the expected impact on 
the blood supply by a new ban on donors who have traveled to the United 
Kingdom, and (3) the potential impact on the blood supply from a change 
in policy to make it easier to distribute units of blood collected from 
patients with an iron overload disorder. I appreciate the GAO's work 
and believe the GAO's findings will provide a sound foundation for this 
Subcommittee to investigate in a careful, fair, and balanced manner. In 
addition, the Office of Inspector General (IG) at HHS, will report to 
the Subcommittee on the status of FDA's implementation of the IG's 
recommendations concerning certain blood safety reports.
    However, today's hearings about blood, and the hearings to come, 
mean more to me than just facts and figures. It's about people's lives. 
It's about a young married couple, Bruce and Kristina Wenger, of 
Hanover, Virginia, who were the first unrelated partial liver 
transplant case in the United States.
    Four years ago, Bruce was diagnosed with a rare liver disease. By 
the beginning of 1998, Bruce was about to die from this disease and 
would have left his young wife and infant son. But his wife, Kristina, 
volunteered to donate part of her liver. Tests showed her liver was 
compatible. On Valentine's Day 1998, 60 percent of Kristina's liver was 
removed and transplanted into Bruce. The transplant team was led by Dr. 
Robert Fisher, director of the liver transplant program at Virginia 
Commonwealth University's Medical College of Virginia.
    During the operation Bruce received five pints of packed red cells. 
Kristina didn't receive any blood products: Her own blood was recycled. 
According to the blood bank at the Medical College of Virginia, partial 
liver recipients use an average of 40 blood products, including red 
cells, fresh frozen plasma and platelets.
    Bruce is now back at work part time as an estimator for a 
homebuilder. Kristina is a Captain in the Marine Corps Reserves and a 
full-time mom. Bruce was kept alive for his son, Bruce Jr. And I am 
delighted to report that last week the Wengers had their second child. 
The transplant, and the blood transfusion that made it possible, were 
gifts of life and love.
    Throughout the years, hundreds of thousands of people in my 
district like Bruce have needed blood during operations. The good news 
is that the blood supply has never been safer, with more advances 
coming to improve blood safety. But blood still has risks. We still 
must be vigilant on safety. However, the greater challenge now appears 
to be on the supply side. Our task is to ensure that the blood is there 
and that the blood is safe.
    As we learn more about blood, and look at ways to improve the 
quantity and quality of the blood supply, my thoughts will be with the 
people. People like Bruce and Kristina Wenger.

    Mr. Upton. At this point, we would like the witnesses to 
come forward: Janet Heinrich, Associate Director of Health 
Financing and Public Health Issues at GAO; Thomas Roslewicz, 
Deputy Inspector General for Audit Services at the Department 
of Health and Human Services; Marian Sullivan, Executive 
Director of the National Blood Data Resource Center; and James 
AuBuchon, Professor of Pathology and Medicine at Dartmouth-
Hitchcock Medical Center.
    As you all know, this is a subcommittee where we take 
testimony under oath. Do you have any objection to that?
    [Witnesses sworn.]


    Mr. Upton. You're under oath and you may have a seat. Your 
statement will be made part of the record in its entirety. We 
would like, if we can, to limit your statement or your opening 
to 5 minutes or so.
    Dr. Heinrich, we will start with you. Thank you for coming.

   TESTIMONY OF JANET HEINRICH, ASSOCIATE DIRECTOR, HEALTH, 
   EDUCATION AND HUMAN SERVICE DIVISION, GENERAL ACCOUNTING 
OFFICE; THOMAS D. ROSLEWICZ, DEPUTY INSPECTOR GENERAL FOR AUDIT 
  SERVICES, ACCOMPANIED BY JOSEPH GREEN, ASSISTANT INSPECTOR 
   GENERAL FOR AUDITS, PUBLIC HEALTH SERVICE AUDIT DIVISION, 
 DEPARTMENT OF HEALTH AND HUMAN SERVICES; MARIAN T. SULLIVAN, 
 EXECUTIVE DIRECTOR, NATIONAL BLOOD DATA RESOURCE CENTER; AND 
    JAMES P. AUBUCHON, PROFESSOR OF PATHOLOGY AND MEDICINE, 
               DARTMOUTH-HITCHCOCK MEDICAL CENTER

    Ms. Heinrich. Thank you very much.
    Mr. Chairman and members of the committee, I am pleased to 
be here today as you discuss the availability----
    Mr. Upton. If you could just move the mike just a little 
closer. Thank you.
    Ms. Heinrich. As you discuss the availability of blood to 
meet the Nation's requirements, as well as recent and proposed 
FDA policy changes regarding blood donations.
    At the committee's request, we have examined trends in the 
Nation's blood supply, the effect of a ban on donors who have 
traveled to the UK and the potential effect of policy changes 
to allow blood collected from people with hemochromatosis to be 
distributed. And we did issue a report to you earlier this 
week.
    I will focus on the trends in the blood supply and our 
analysis of the policy changes recommended by HHS. We found 
that while there is concern for shortages of certain blood 
types, seasonal patterns and occasional shortages in certain 
regions of the country, the blood supply, as a whole, is not in 
crisis. The blood supply has decreased over the last decade, 
and there is some evidence that, in recent years, the demand 
for blood has increased. However, any conclusions about the 
trend in the blood supply are hampered because information 
about the supply has not been gathered routinely. The last 
survey was conducted in 1998.
    The total decrease in units collected between 1994 and 1997 
was 5.5 percent, according to the National Blood Data Resource 
Center. Most of this decline was in donations targeted for 
specific individuals, especially autologous collections taken 
from individual patients for personal use prior to surgery, 
rather than in the allogenic or community supply of blood 
available to anyone.
    During the same period, there was a decrease in the 
community supply of about 2 percent. We believe that the NBDRC 
study overstates the decline in the blood supply. Overall, the 
blood banking system had an adequate supply to meet increasing 
demand as total units transfused increased by 3.7 percent 
during the same period.
    The supply cushion is growing smaller. Blood centers gave 
us data showing less than 1 day's supply on hand for some blood 
types, such as O & B in some regions this summer. Blood centers


have no incentives to collect more blood than can be used. In 
1997 only about 4 percent of the allogenic blood supply expired 
before being transfused.
    With 93 percent of available supply used in transfusions, 
blood centers state that they are below the comfort level in 
many regions. Blood banks can mitigate the effects of local 
blood shortages by transferring blood from regions with an 
excess supply to those with shortages. The American Association 
of Blood Banks National Blood Exchange and the American Red 
Cross together moved about 1.1 million units of blood between 
blood centers last year.
    Estimates of the future demand for blood are uncertain. 
Blood banks want to ensure that trauma patients and others who 
may require many units of blood can be promptly treated 
whenever the need arises. Persons that are 65 and older receive 
twice as much blood per capita as young individuals, so we do 
expect that the aging population may increase the demand. 
Further, the number of surgical procedures that require blood 
or blood products are increasing.
    On the other hand, some evidence indicates that the use of 
blood can be substantially reduced without effecting clinical 
outcomes. For example, the amount of blood used for hospitals 
vary widely, and at least one pilot program has shown that the 
use of blood can be substantially reduced without affecting the 
clinical outcomes.
    Improved surgical techniques and better understanding of 
the clinical thresholds that trigger blood transfusions has 
reduced the demand for blood in some instances as well.
    In response to concerns for the safety of the blood supply, 
FDA has issued a guidance recommending that collections be 
prohibited from donors who traveled or resided in the UK for a 
total of 6 months or more between 1980 and 1996 because of the 
theoretical risk of transmitting new variant CJD through blood 
transfusions.
    Transmission by blood in humans has not been documented, 
although animal research suggests that infection by blood is 
theoretically possible. The 6-month residence interval was 
selected to balance the twin goals of minimizing losses in 
blood and eliminating as much risk as possible.
    Would you like me----
    Mr. Upton. If you can.
    Ms. Heinrich. [continuing] to summarize?
    Mr. Upton. Yes, that would be great.
    Ms. Heinrich. The other policy that you asked us to 
evaluate was making hemochromatosis patients available to 
donate blood. We estimate that that might mean that we have 
300,000 units, 3 million units, it's very hard to estimate 
exactly how much. There are concerns, though, about financial 
incentives for these individuals to donate blood because of the 
issues of cost incentives that must be addressed before the 
inclusion of hemochromatosis patients blood enter the community 
supply. We are concerned about how quickly this blood would be 
available.
    This concludes my prepared statement, Mr. Chairman. I will 
be happy to answer any questions.
    [The prepared statement of Janet Heinrich follows:]


   Prepared Statement of Janet Heinrich, Associate Director, Health 
   Financing and Public Health Issues, Health, Education, and Human 
                         Services Division, GAO
    Mr. Chairman and Members of the Subcommittee: I am pleased to be 
here as you discuss the availability of blood to meet the nation's 
requirements as well as recent and proposed policy changes regarding 
blood donation that may affect the future supply.
    A recent report by the National Blood Data Resource Center (NBDRC), 
a group representing blood banks, projected that the demand for blood 
will outstrip the available supply by next year. At the same time, the 
Department of Health and Human Services (HHS), which oversees the 
nation's blood supply, has initiated a major policy change--and is 
considering another--that could further affect the blood supply. 
Specifically, the Department's Food and Drug Administration (FDA) has 
recommended prohibiting blood donations from individuals who spent a 
total of 6 months or more in the United Kingdom between 1980 and the 
end of 1996 because of concerns over the possible transmissibility of 
new variant Creutzfeldt-Jakob disease (nvCJD), the human form of ``mad 
cow'' disease. HHS has also proposed removing barriers to donation by 
individuals with hemochromatosis--an iron-overload disease that may be 
treated by drawing blood--to make up some of the loss in blood 
donations from the decreases in donations and losses that may result 
from the U.K. donor exclusion.
    In light of these developments, you asked us to discuss the results 
of our recent correspondence on the blood supply.1 In that 
report, done at the Committee's request, we provide information on (1) 
recent trends in blood donation and the demand for blood transfusions, 
(2) the expected effect of a ban on donors who have traveled to the 
United Kingdom, and (3) the potential effect of policy changes to allow 
units of blood collected from individuals with hemochromatosis to 
bedistributed. The points I will present today are discussed in more 
detail in the correspondence.
---------------------------------------------------------------------------
    \1\ Blood Supply: Availability of Blood to Meet the Nation's 
Requirements (GAO/HEHS-99-187R, Sept. 20, 1999).
---------------------------------------------------------------------------
    In summary, we found that, while there is cause for concern about 
shortages of certain blood types or in certain regions, the blood 
supply as a whole is not in crisis. We believe that the NBDRC study 
overstates the decline in the blood supply. Most of the decline found 
by NBDRC was in donations targeted for specific individuals, rather 
than in the community supply of blood available to anyone in need. 
Further, the projection of a shortage relies on data from only 2 years. 
The U.K. donor exclusion policy has been estimated to reduce the blood 
supply by approximately 2.2 percent. Blood banks fear that the actual 
loss due to this exclusion will be greater, but it is not possible to 
assess the validity of their concerns. Estimates of the potential 
increase in the blood supply from donations by individuals with 
hemochromatosis vary widely, from 300,000 to 3 million units. 
Regardless, use of such donations will require changes to current 
regulations, which may delay their availability for some time.
                               background
    About 8 million volunteers donate approximately 12 million units of 
whole blood each year. Sixty percent of the population is eligible to 
donate, and about 5 percent of the eligible population actually donate 
each year.2 There are four sources of whole blood from 
volunteer donors for transfusion. The first, allogeneic donations, is 
the most important category, accounting for roughly 90 percent of the 
blood supply. Blood from allogeneic donations is available to any 
patient in need, and efforts to increase the blood supply usually focus 
on increasing participation in blood drives or otherwise raising the 
number of allogeneic collections. Second, autologous collections 
involve blood taken from patients before a medical procedure for their 
own use. Third, directed collections involve blood donated for use by a 
particular patient. A small portion of the autologous and directed 
collections ultimately are ``crossed over'' to the general supply. 
Finally, less than 2 percent of the total blood supply is imported.
---------------------------------------------------------------------------
    \2\ To be eligible to donate, a person should be at least 17 years 
of age, weigh at least 110 pounds, be in good physical health, and pass 
a physical and medical history examination.
---------------------------------------------------------------------------
    Blood banks maintain a supply cushion to meet the uncertain demand 
for blood. Local demand for particular blood types varies over the 
course of the year, and blood banks want to ensure that trauma patients 
and others who may require many units of blood can be treated promptly 
whenever the need arises. The supply cushion


means that some blood is discarded--in 1997, for example, about 4 
percent of the allogeneic blood supply expired without being 
transfused.
    New variant CJD is a chronic, progressive neurodegenerative disease 
that is inevitably fatal. It has a long, but unknown, incubation 
period. As of August 1999, there had been 43 confirmed cases--41 in the 
United Kingdom, 1 in France, and 1 in Ireland. It is suspected that all 
of these individuals contracted nvCJD from eating contaminated tissues 
from cattle infected with bovine spongiform encephalopathy (``mad cow'' 
disease) in the United Kingdom, probably prior to 1990. Estimates of 
the number of U.K. residents who will ultimately manifest nvCJD range 
from the hundreds to more than 500,000. In the United States, there 
have been no documented cases of nvCJD.
    Hemochromatosis is the most common genetic disease in Americans of 
European descent--about 1 in 10 may carry the gene for this disease, 
and as many as 1 million Americans have evidence of 
hemochromatosis.3 The proportion of individuals, however, 
who have the mutations associated with hemochromatosis and later 
develop the disease is unknown because not all of these individuals 
become ill. Treatment of hemochromatosis has two phases: (1) iron 
depletion therapy, in which the patient receives a therapeutic 
phlebotomy, or drawing of blood, about 1 to 2 times a week for several 
months up to 3 years to remove excessive iron stores, and (2) 
maintenance therapy, in which the patient continues to undergo 
therapeutic phlebotomies but less frequently (2 to 6 times a year) to 
keep body iron stores low and iron levels normal for the remainder of 
the patient's life.
---------------------------------------------------------------------------
    \3\ There are two genetic mutations, C282Y and H63D, associated 
with hemochromatosis. C282Y is considered the major mutation; fewer 
data are available on the prevalence of hemochromatosis in other 
populations.
---------------------------------------------------------------------------
                   recent trends in supply and demand
    The blood supply has decreased over the last decade, and there is 
some evidence that in recent years the demand for blood has increased. 
However, any conclusions about the trends in the blood supply are 
hampered because information about the blood supply has not been 
gathered routinely. The last systematic survey of the blood supply was 
conducted by NBDRC in 1998, which measured units collected and 
transfused in 1997. NBDRC will release the results of a new survey of 
blood collections this November, and the National Heart, Lung, and 
Blood Institute of the National Institutes of Health (NIH) has recently 
arranged for NBDRC to collect data on blood donations on a monthly 
basis from a sample of blood centers.
    Earlier this year, NBDRC projected that the demand for blood will 
outstrip supply by next year.4 We found that current 
evidence indicates the blood supply has declined more slowly than 
assumed for that projection. NBDRC's projection rests on the overall 
5.5 percent decrease in the blood supply from 1994 to 1997, and on the 
observed 3.7 percent increase in the number of units transfused during 
those years. (See table 1.)
---------------------------------------------------------------------------
    \4\ This projection did not consider the consequences of excluding 
travelers to the United Kingdom from donating blood or of any other 
policy changes that may affect the blood supply.

                                          Table 1: Blood Supply Trends
----------------------------------------------------------------------------------------------------------------
                                                                                                       Percent
                                                     1989         1992         1994         1997        change
                                                                                                     (1994-1997)
----------------------------------------------------------------------------------------------------------------
Total units collected..........................   14,229,000   13,794,000   13,340,000   12,602,000       -5.5
Total community supply.........................   13,296,000   12,303,000   12,075,000   11,837,000       -2.0
Total units transfused.........................   12,059,000   11,307,000   11,107,000   11,517,000       +3.7
----------------------------------------------------------------------------------------------------------------

    Our analysis of the blood supply data found that the 5.5 percent 
figure suggests a more serious decline than actually occurred in the 
community supply of blood (available to anyone in need). Most of the 
5.5 percent decrease came from a drop in blood not included in the 
community supply, which decreased only about 2 percent from 1994 to 
1997. The number of units designated for particular transfusion 
patients, both autologous and directed donations, decreased by 37 
percent from 1994 to 1997, accounting for two-thirds of the overall 5.5 
percent decline. Indeed, there was an even larger decline in the number 
of such units that had been collected but not used.5
---------------------------------------------------------------------------
    \5\ The number of autologous and directed units collected but not 
transfused dropped 63 percent between 1994 and 1997.

---------------------------------------------------------------------------


    While other evidence seems to indicate that the blood supply 
cushion has narrowed, it is difficult to determine if shortages are 
worse now than in earlier years because blood banks have no incentive 
to collect more blood than can be used. The American Red Cross informed 
us that the number of days' supply decreased below the comfort level in 
many of its centers and gave us data showing less than 1 day's supply 
on hand for some blood types in some regions at one point this summer. 
America's Blood Centers reported anecdotal evidence of shortages in 
many of its affiliated blood banks this year. Shortages occur more 
frequently in some regions, as do shortages of blood types O and B. 
Furthermore, the 1998 NBDRC survey found that at least some surgeries 
and medical procedures have been postponed due to blood shortages. 
Specifically, 8.6 percent of the hospitals surveyed indicated that 
elective surgeries were cancelled on 1 or more days in 1997 due to 
blood shortages; 24.7 percent of hospitals said that they were unable 
to meet nonsurgical blood requests on 1 or more days in 
1997.6
---------------------------------------------------------------------------
    \6\ Among all hospitals responding to the survey, the mean number 
of days with surgeries cancelled was 0.44 and the mean number of days 
with unmet nonsurgical blood requests was 2.1.
---------------------------------------------------------------------------
    Blood banks can mitigate the effects of local blood shortages by 
transferring blood from regions with an excess supply to those with 
shortages. The American Association of Blood Banks' National Blood 
Exchange and the American Red Cross together moved about 1.1 million 
units of blood between blood centers last year. This blood is purchased 
by centers in shortage areas from centers with surpluses of particular 
types of blood.
    Estimates of the future demand for blood are also uncertain. On the 
one hand, persons aged 65 and older receive twice as much blood per 
capita as younger individuals, so the aging of the population may 
increase the demand for blood products. Further, some procedures 
requiring blood are being performed with increasing frequency, and the 
range of treatments requiring blood or blood products is increasing. On 
the other hand, some evidence indicates that the use of blood can be 
substantially reduced. The amount of blood used for the same procedures 
varies widely among hospitals, and at least one pilot program has shown 
that clinical outcomes would not be affected if the use of blood were 
substantially reduced. Similarly, improved surgical techniques and 
better understanding of the clinical thresholds that trigger blood 
transfusions has reduced the demand for blood in some instances.
expected effect of excluding donors who have resided or traveled in the 
                             united kingdom
    Last month, FDA issued guidance recommending that collections be 
prohibited from donors who had traveled or resided in the United 
Kingdom for a total of 6 months or more between 1980 and 1996--because 
of the theoretical risk of transmitting nvCJD through blood 
transfusions--which has raised concern among some about the effect such 
a policy would have on the blood supply. FDA will review this policy at 
6-month intervals, to consider any new scientific information and the 
policy's effect on the blood supply.
    While it has not been shown that nvCJD is transmissible by blood 
transfusion, animal research suggests that infection by blood is 
theoretically possible--in some cases, direct injection of blood from a 
contaminated animal into the brain of another has caused infection. 
However, no cases of transmission by blood in humans have been 
documented. In the United Kingdom, 4 donors subsequently diagnosed with 
nvCJD gave blood that was transfused into 10 recipients. None of these 
recipients have developed nvCJD to date, although they may later 
because of the long incubation period.
Effect on the Blood Supply
    The 6-month U.K. residence interval was selected to balance the 
twin goals of minimizing losses to the blood supply and eliminating as 
much risk as possible. A survey of blood donors by the American Red 
Cross found that 23 percent of donors had traveled to the United 
Kingdom between 1980 and 1996. Only one-fifth of the blood-donor 
travelers had been in the United Kingdom for more than 30 days, and 
just 1 in 10 of them had a cumulative stay of 5 months or more. The Red 
Cross analysis estimated that the 6-month exclusion criterion would 
result in a 2.2 percent reduction in the blood supply and eliminate 87 
percent of the risk of collecting blood from a person infected with 
nvCJD.
    Blood banks have expressed concern that this exclusion will result 
in more than a 2.2 percent loss. First, there is the possibility that 
some potential donors will fail to attend to the details of the policy 
and not donate blood even though they are eligible to do so. For 
example, donors who traveled to the United Kingdom only in


1997 may stop donating even though they remain eligible to do so. 
Second, there is concern that potential donors may become discouraged 
because their friends or neighbors are excluded, heightening the sense 
that it is difficult to pass all the screening criteria for giving 
blood. Third, there is worry that excluded U.K. travelers will not 
return to donate blood if, and when, the restriction is lifted.
    Blood banks are also concerned about other burdens imposed by this 
exclusion. For example, according to research conducted by the American 
Red Cross, donors who resided or traveled in the United Kingdom are 
disproportionately repeat donors. Without these donors, the blood banks 
will need to recruit a large number of first-time donors to replace 
them because first-time donors are roughly twice as likely to have 
disqualifying medical conditions as regular donors. Second, the effect 
will vary by blood center, as those with a larger proportion of U.K. 
travelers will lose more of their donors than other blood collection 
centers. The Red Cross survey found that the proportion of donors 
affected in some blood centers were 35 percent greater, and others 50 
percent less, than the overall average.
Risk Reduction
    Estimates of the degree of risk reduction achieved by this 
exclusion are problematic. First, the degree of potential risk to be 
mitigated is unknown. Second, because the prohibition applies only to 
future donations, some blood from donors who would now be excluded has 
entered the blood supply in the recent past. Third, because so little 
is certain about how nvCJD is acquired, estimates of the beneficial 
effect of any prohibition threshold--other than a complete ban on 
potential donors who have traveled to the United Kingdom at all--are 
uncertain. For example, the Red Cross estimate assumed that the risk of 
acquiring nvCJD increased directly with each day spent in the United 
Kingdom. Any change in this assumed relationship would lead to a 
significantly different risk reduction estimate. Indeed, HHS told us 
that the Department did not totally agree with the Red Cross risk 
formulation and that its choice of the 6-month threshold was based on 
other information. In particular, HHS told us that all of the 
individuals in the British cases (41 of the 43 known cases) were born 
in the United Kingdom and resided there for at least 10 years between 
1980 and 1996; thus, the Department reasoned that any exclusion 
threshold of 1 year or less would reduce the presumed risk tenfold or 
more.
  potential for blood donations from individuals with hemochromatosis
    In April 1999, the Public Health Service's Advisory Committee on 
Blood Safety and Availability recommended that policy changes be made 
to allow blood collected from individuals with hemochromatosis to be 
distributed for transfusion.7 Making hemochromatosis 
patients eligible to donate would essentially guarantee an increased 
number of donors because they have to periodically have blood drawn to 
treat their condition. Members of the advisory committee concluded that 
blood products from individuals with hemochromatosis carry no known 
increased risk to recipients. Therefore, they recommended that HHS 
change its policies and remove any barriers to the use of this blood. 
At the same time, the advisory committee recommended that HHS take 
steps to eliminate any financial incentive for these individuals to 
donate blood. Since individuals with hemochromatosis may have to pay to 
have their blood drawn through therapeutic phlebotomy, 8 
there would be a financial incentive to avoid this cost by donating 
blood. Unless this incentive is removed, FDA is concerned that these 
potential donors will not truthfully answer screening questions about 
risk factors that would disqualify them from donating, thereby 
compromising the safety of the blood supply.
---------------------------------------------------------------------------
    \7\ Hemochromatosis is a disease of iron regulation that results in 
excessive iron absorption and accumulation, leading to organ damage. 
The human body cannot excrete excess iron, so it remains in the body 
unless it is lost through menstruation, childbirth, hemorrhage, or 
blood donation. Iron is highly toxic when an excessive amount is 
absorbed. Some clinical chronic conditions associated with 
hemochromatosis include severe fatigue, diabetes mellitus, heart 
disease, cirrhosis of the liver, and cancer.
    \8\ Therapeutic phlebotomy is the removal of a full unit of blood 
from an individual, about 500 mls, for the purpose of treating a 
disease.
---------------------------------------------------------------------------
    According to one survey, most individuals with hemochromatosis are 
insured or partially insured for therapeutic phlebotomies. However, 
even though therapeutic phlebotomies are necessary medical treatment 
for some individuals, insurance does not always cover the costs. The 
average cost of the procedure per unit of blood ranges from $52 at 
blood centers to $69 at physician offices and $90 at hospitals, with an 
average out-of-pocket cost of $45 for all respondents to the 
survey.9 These


out-of-pocket costs are a financial incentive for persons with 
hemochromatosis to not disclose any disqualifying conditions and 
volunteer for blood donations. In one study, 37 percent of the 
hemochromatosis patients surveyed reported being voluntary donors 
before their diagnosis and 54 percent of the individuals attempted to 
donate blood after diagnosis.10 The results from the 
National Donor Research and Education Study sponsored by NIH show that 
about half of the individuals who responded that they had 
hemochromatosis (only 0.4 percent of those surveyed) were volunteer 
donors. At present, there is no routine screening for this disease.
---------------------------------------------------------------------------
    \9\ S. M. McDonnell and others, ``A Survey of Phlebotomy Among 
Persons With Hemochromatosis,'' Transfusion, Vol. 39 (1999), pp. 651-6.
    \10\ S. M. McDonnell and others, ``A Survey of Phlebotomy Among 
Persons With Hemochromatosis.''
---------------------------------------------------------------------------
    In the United States, blood obtained by therapeutic phlebotomy from 
individuals with hemochromatosis is currently discarded. Although 
hemochromatosis is inherited, not transmitted, and there is no evidence 
that the use of hemochromatosis blood for transfusion carries any risks 
to the recipients, 11 hospitals and physicians hesitate to 
use this blood. FDA permits the use of blood from individuals with 
hemochromatosis, as long as they meet the same donor suitability 
criteria as any other donor, but it requires that this blood be labeled 
as coming from a hemochromatosis donor, which effectively impedes the 
use of this blood. Some in the U.S. blood industry consider 
hemochromatosis donors to be the same as paid donors, implying a 
decreased level of safety.12 In 1996, the American 
Association of Blood Banks issued standards discouraging transfusion of 
blood from donors who had therapeutic phlebotomies. Because many blood 
centers conform to these standards, this policy effectively excludes 
most individuals with hemochromatosis from donating blood.
---------------------------------------------------------------------------
    \11\ The processing of whole blood units into packed red cells 
removes most of the iron-enriched serum.
    \12\ Data show that blood from paid donors is more likely to 
transmit disease than that from volunteer donors; R. A. Sacher, 
``Hemochromatosis and Blood Donors: A Perspective,'' Transfusion, Vol. 
39 (1999), pp. 551-4.
---------------------------------------------------------------------------
    FDA has agreed to make the necessary regulatory changes to remove 
barriers to donation once financial incentives for hemochromatosis 
patients are removed.13 There are several different 
requirements that would need to be changed. FDA currently requires an 
8-week interval between donations to prevent iron depletion of donors, 
but individuals with hemochromatosis at the initial stage of treatment 
undergo therapeutic phlebotomies 1 to 2 times a week. FDA also requires 
blood from therapeutic bleeding, including for hemochromatosis, to be 
labeled with the disease for which the bleeding was performed, which 
discourages health care providers from using this blood.
---------------------------------------------------------------------------
    \13\ The American Association of Blood Banks has also indicated 
that, if FDA changes the regulations, it would make changes to its 
standards related to the use of blood from patients with 
hemochromatosis, so that centers could remain in compliance with the 
association's requirements.
---------------------------------------------------------------------------
    As an initial step, FDA recently agreed to consider case-by-case 
exemptions to existing regulations on blood labeling and frequency of 
blood collection for blood establishments that can verify that 
therapeutic phlebotomy for hemochromatosis is performed at no expense 
to the patient. However, FDA officials have publicly stated that in 
making these exemptions, they will require a commitment from blood 
collection facilities to concurrently provide safety data, including 
viral marker rates, incidence of transmissible infections based on 
seroconversion rates, frequency of postdonation reports of undisclosed 
risks, and reports of adverse events.
    Individuals with hemochromatosis have the potential to make up some 
of the loss in blood donations due to the U.K. donor exclusion policy. 
Estimates of increases in the blood supply through donations by these 
individuals vary widely, from 300,000 to 3 million units--although the 
former is generally considered a better estimation. Regardless, changes 
to current regulations affecting blood from hemochromatosis patients 
will occur considerably later than FDA guidance to exclude donors, 
which has already gone into effect. It seems unlikely that the issue of 
coverage of therapeutic phlebotomies by insurers will be quickly 
addressed and that anything less than full reimbursement may be 
considered undue donor incentive. Therefore, unless blood centers 
absorb the costs of providing therapeutic phlebotomies to persons with 
hemochromatosis, it is also unlikely that FDA will revise current 
regulations.
                              conclusions
    On the basis of the information we reviewed, we conclude that the 
blood supply is not in crisis. However, there is cause for concern 
about the possibility of some regional shortages and shortages of some 
types of blood. These may be exacerbated somewhat by the U.K. donor 
exclusion policy, which will affect blood banks dif


ferently. Potential additions to the blood supply from hemochromatosis 
patients cannot occur for some time, since blood from these individuals 
will not be entered into the community supply until issues related to 
who pays the costs of therapeutic phlebotomies are resolved and 
regulatory changes are implemented.
    This concludes my prepared statement, Mr. Chairman. I will be happy 
to respond to any questions that you or Members of the Subcommittee may 
have.
                      contacts and acknowledgments
    For future contacts regarding this testimony, please call Janet 
Heinrich at (202) 512-7119. Key contributors to this testimony include 
Marcia Crosse, Martin T. Gahart, and Angela Choy.

    Mr. Upton. Thank you very much.
    Mr. Roslewicz.

                TESTIMONY OF THOMAS D. ROSLEWICZ

    Mr. Roslewicz. Thank you, Mr. Chairman.
    If I may, I would like to invite Mr. Joseph Green to join 
me at the table. He is the Assistant Inspector General for 
Audits at our Public Health Service Audit Division.
    Mr. Upton. That would be fine. I need to swear him in as 
well. I should have.
    Mr. Roslewicz. His staff was responsible for this audit.
    [Witness sworn.]
    Mr. Roslewicz. Thank you, Mr. Chairman.
    Mr. Upton. Thank you.
    Mr. Roslewicz. I'm pleased to discuss the results of our 
work requested by the subcommittee concerning the Food and Drug 
Administration's error and accident reporting process for 
blood.
    Errors and accidents are events occurring in blood 
establishments that may affect the safety, security or potency 
of blood and blood products. Examples include incorrectly 
labeling blood products or shipping the unit that has 
repeatedly tested reactive to a viral marker test, such as 
human immuno deficiency, HIV virus.
    According to FDA, it is important that the agency receive 
error and accident reports from blood establishments so that it 
can accurately monitor actions taken to respond to problems and 
facilitate a rapid response where the public health may be at 
risk. We issued a final report on May 31, 1995, detailing our 
findings and recommendations to the Commissioner of Food and 
Drugs.
    At that time, FDA agreed to take specific regulatory steps 
to strengthen its oversight of the blood industry. As I 
discussed below, the agency proposed regulations in 1997 to 
improve the error and accident reporting process but does not 
anticipate issuing the final regulations until February 2001.
    The FDA is the Federal agency responsible for regulating 
blood establishments, which include human blood and plasma 
donor centers, blood banks, transfusion services, and other 
blood product manufacturers. Such regulation, which is the 
responsibility of the Center for Biologics, Evaluation and 
Research--CBER--includes registering establishments, licensing 
products and issuing and enforcing safety rules. The Office of 
Regulatory Affairs directs the agency's field staff, which 
performs inspections of blood establishments, to ensure, for 
example, that they are complying with current manufacturing 
practices and implementing all the safeguards over blood and 
blood products.


    In the early 1990's, we chose to review FDA's error and 
accident reporting process because it was critical to FDA's 
oversight of the blood industry. Further, the agency planned to 
expand the use of the error and accident reports to upgrade the 
quality of the blood industry.
    Licensed blood establishments, those that ship their 
products interstate, are required by regulation to promptly 
report errors and accidents to FDA. Unlicensed establishments, 
those operating intrastate, have been requested by FDA to 
voluntarily submit reports. When errors and accidents occur, 
all blood establishments are required to investigate them, take 
appropriate corrective action and, if indicated, initiate a 
recall. The Food and Drug Administration uses the error and 
accident reports to gauge the severity of the incident, monitor 
the actions taken in response to the events reported, and to 
classify the most serious events as recalls.
    In fiscal year 1998, FDA received about 13,000 error and 
accident reports. Our reviews show that FDA's error and 
accident reporting process is a valuable management tool 
because it provides a framework to enable the agency to 
evaluate and monitor the blood establishments' actions to 
problems. However, the process would require more prompt and 
comprehensive reporting to be able to provide an effective 
early warning device for FDA field offices and the blood 
industry.
    We found two shortcomings that could hamper FDA's plan to 
expand the usefulness of error and accident reports. First, the 
blood establishments were not submitting error and accident 
reports to FDA promptly, as required by Federal regulations. 
Our sample indicates that the time between the date the error 
or accident was detected and the date it was reported to FDA 
ranged from less than 1 month to over 1 year, with an average 
of a little over 4 months. Only about 14 percent of the error 
and accident reports we reviewed were submitted by blood 
establishments within 1 month after the detection of the 
incident, while 13 percent were reported 6 months or more after 
detection.
    Second, there was no assurance that unlicensed blood 
establishments were voluntarily submitting their reports. At 
the time of our review, even though 75 percent of the 2,900 
blood establishments were involved in intrastate activity only, 
and thus were unlicensed, this group provided only 1 percent of 
the error and accident reports received by FDA.
    Overall, we concluded that, without prompt and complete 
reporting by blood establishments on the number and types of 
errors and accidents that are detected, FDA may be hampered in 
its efforts to evaluate and monitor the blood industry.
    In May 1995, we recommended that the Commissioner of Food 
and Drugs, first of all, expedite the development and issuance 
of revisions to the Federal regulation on error and accident 
reporting to be more specific concerning the timeframe in which 
error and accident reports are required to be submitted and, 
second, expedite the development and issuance of a regulation 
to require unlicensed blood establishments to submit error and 
accident reports.
    The FDA agreed with these recommendations and assured us 
that they were already taking action to implement them. The 
agen


cy estimated that the proposed regulations would be issued in 
November 1995. I'm just about finished.
    Mr. Upton. That's fine.
    Mr. Roslewicz. In August 1999, staff of the subcommittee 
requested the Office of Inspector General to determine the 
status of our 1995 recommendations. Through an August 24, 1999, 
memorandum, FDA provided the following information: A proposed 
rule was published on September 23, 1997, first of all, to 
require blood establishments to report errors and accidents as 
soon as possible but not to exceed 45 calendar days; and, 
second, required reporting of all blood establishments, 
including licensed manufacturers of blood and blood components, 
unlicensed registered blood establishments and transfusion 
services.
    CBER was in the process of making revisions to the proposed 
rule based on the comments received during the comment period. 
In an effort to make reporting requirements effective and less 
burdensome to the industry, the FDA planned not issuing the 
final regulation until--they delayed until February 2001 
because of multiple public-health-related priorities of the 
agency.
    We recently spoke with FDA officials involved in blood 
safety to pinpoint reasons for the delay in issuing the final 
regulation. According to the Director of CBER, the Food and 
Drug Administration received 97 comments on the proposed rule. 
The comments were varied and complex and required revision of 
considerable solutions in order to give a straightforward 
response. The Director stated that the final regulations were 
slated to be cleared through FDA by June 2000 and that they 
would likely be published in February 2001.
    Mr. Chairman, that concludes my statement. I will be 
available to answer questions.
    [The prepared statement of Thomas D. Roslewicz follows:]
Prepared Statement of Thomas D. Roslewicz, Deputy Inspector General for 
        Audit Services, Department of Health and Human Services
                              introduction
    Mr. Chairman and members of the Subcommittee, I am Thomas D. 
Roslewicz, Deputy Inspector General for Audit Services at the 
Department of Health and Human Services. I am pleased to discuss our 
previous work concerning the Food and Drug Administration's (FDA) error 
and accident reporting process for blood. We issued a final report on 
May 31, 1995 detailing our findings and recommendations to the 
Commissioner of Food and Drugs. At that time, FDA agreed to take 
specific regulatory steps to strengthen its oversight of the blood 
supply. As I discuss below, the agency proposed regulations in 1997 to 
improve the error and accident reporting process, but does not 
anticipate issuing the final regulations until 2001.
    For this hearing, the Subcommittee asked us to summarize the 
findings and recommendations contained in our 1995 report on the error 
and accident reporting process, and to discuss the status of FDA's 
actions with regard to our recommendations. Before providing this 
information, I will briefly describe the FDA's and the blood 
establishments' responsibilities in ensuring the safety of our blood 
supply, including a description of the error and accident reporting 
process.
                               background
Organizational and Legal Responsibilities
    The FDA regulates the blood industry by licensing products, and 
issuing and enforcing safety rules. The Center for Biologics Evaluation 
and Research (CBER) is the FDA component responsible for regulating 
products used for the prevention, treatment or cure of diseases and 
injuries, including blood products, vaccines, se


rums, and toxins. The Office of Regulatory Affairs (ORA) directs the 
agency's field force, which performs inspections of FDA-regulated 
establishments.
    The PHS Act (Title 42 U.S.C. 262) and the Federal Food, Drug and 
Cosmetic Act (Title 21 U.S.C. 331) place the responsibility for the 
oversight of blood establishments with FDA. The FDA has the authority 
to register all blood establishments and to license those 
establishments that ship blood and blood products interstate. 
Registered blood establishments that are not licensed by FDA (these 
unlicensed establishments do not engage in interstate shipments of 
blood products) fall under State licensing procedures. All registered 
blood establishments--whether licensed or not--are to be inspected by 
FDA every 2 years, and many are inspected more frequently if they are 
under scrutiny for previous quality problems. The FDA has several 
regulatory options available to it, ranging from warning letters to 
product seizures, for protecting the blood supply. These enforcement 
options apply to all registered blood establishments.
The Blood Establishments' Role in Ensuring Blood Safety
    With the emergence of the Acquired Immune Deficiency Syndrome 
(AIDS) epidemic, ensuring the safety of the blood supply has become 
extremely complex. While FDA provides guidance to blood establishments 
to help them comply with industry standards and safeguards, all blood 
establishments, including unlicensed establishments, are responsible 
for ensuring the safety of their blood products. To meet this 
responsibility, blood establishments are to comply with established 
current good manufacturing practices, which are defined as those 
standards that would be generally acceptable in a particular industry 
and would result in the manufacturing of products which would meet 
standards of the Federal Food, Drug and Cosmetic Act. They are also 
required to fully implement all safeguards over blood and blood 
products including:

 eliminating high risk donors by encouraging them to exclude 
        themselves, and by evaluating their behavioral and medical 
        history as a basis for deferral;
 updating a list of unsuitable donors and checking the donors' 
        names against this list to prevent use of their blood;
 testing the blood for such blood-borne agents as HIV, 
        hepatitis, and syphilis;
 quarantining all donated blood until tests and other control 
        procedures established its safety; and
 investigating all incidents, auditing their systems, and 
        correcting all deficiencies.
    When an error or accident occurs that may affect the safety, 
purity, or potency of blood, licensed blood establishments are required 
to self-report the incident to FDA. Unlicensed establishments are not 
required to self-report, but have been requested to do so on a 
voluntary basis. The FDA has provided guidance to the blood 
establishments as to what constitutes a reportable error or accident. 
The reportable incidents include, but are not limited to, the 
following:

 release of units repeatedly reactive to tests indicating 
        hepatitis or HIV;
 release of units in which testing was performed incorrectly or 
        misinterpreted;
 release of units from donors who are, or should have been, 
        permanently or temporarily deferred due to medical history or a 
        history of repeatedly reactive viral test results for hepatitis 
        or HIV;
 release of units prior to completion of all tests or that are 
        incorrectly labeled, e.g., incorrect expiration date; and
 release of contaminated blood components when the 
        contamination is attributed to an error in manufacturing.
    The error and accident report identifies the blood establishment, 
the donor, the blood product, and the final disposition of the blood 
product. It contains appropriate dates such as date the incident 
occurred, date it was discovered, date of the report, and type of error 
or accident involved. There are three basic types of incidents: (1) 
labeling error or accident--testing correctly performed, but incorrect 
label applied to product; (2) testing error or accident--test either 
incorrectly performed or misinterpreted, or product released 
inadvertently before tests completed; and (3) manufacturing/control 
procedure error or accident. The report also lists contributing factors 
causing the error or accident and the actions taken by the blood 
establishment.
FDA's Role in Processing Error and Accident Reports
    The FDA relies on error and accident reports, in conjunction with 
inspections and other surveillance activities, to provide a continuing 
overview of the blood industry. According to FDA, receipt of the 
reports--which numbered 13,232 in Fiscal Year 1998--helps ensure that 
the industry identifies instances where additional corrective action is 
needed, such as additional training and revisions of standard operating 
procedures.


    The error and accident reports are to be submitted ``promptly'' 
1 to CBER's Office of Compliance, which is responsible for 
analyzing the reports. If the report clearly does not require further 
evaluation of the severity of the incident, it is sent to the 
appropriate district office for follow up at the next inspection. The 
FDA's ORA is responsible for the coordination of all field office 
activities. The field offices, under the direction of ORA, are 
responsible for conducting all routine blood establishment inspections.
---------------------------------------------------------------------------
    \1\ Regulation 21 CFR 600.14(a) states that error and accident 
reports are to be submitted to CBER promptly, but does not define the 
term ``promptly''.
---------------------------------------------------------------------------
    If an error and accident report indicates that further evaluation 
of the severity of the incident is warranted, the report is forwarded 
to Case Management within the Office of Compliance. This group 
evaluates the error or accident being reported and, based on the 
severity of the incident, may recommend that it be classified as a 
blood recall. At the time of our previous review, about 8 percent of 
the error and accident reports were referred to Case Management to be 
evaluated for a recall classification.
    A recall is a blood establishment's voluntary removal or correction 
of a marketed blood product that violates laws administered by FDA. The 
FDA cannot issue a product recall but can request that a firm do so. 
The FDA recognizes that a voluntary recall is generally more 
appropriate and affords better protection for consumers than seizure, 
which is a FDA option when a firm refuses to undertake a recall. In the 
case of blood, blood establishments are responsible for voluntarily 
initiating recalls to protect the public health from any defective 
products. They are also responsible for developing a recall strategy 
and determining whether the recall is progressing satisfactorily. Blood 
recalls differ from other product recalls because blood, having a short 
shelf life, is often used before it can be retrieved. If the blood 
cannot be retrieved, the blood establishment is responsible for 
identifying all recipients of the blood subject to the recall so that 
they can take extra steps to guard their health and avoid infecting 
others.
    The FDA is responsible for classifying the blood establishment's 
recall according to the health hazard presented by the incident, and 
conducting its own audit checks to assess whether the establishment has 
notified all affected parties and taken appropriate action. The FDA 
publishes all recall actions in its weekly Enforcement Report 
regardless of when the recall was made.
    According to FDA, since blood establishments are required to 
investigate all errors and accidents, including those that are 
eventually classified as blood recalls, the corrective action is 
generally completed by the blood establishment before FDA classifies 
the recall. At the time of our review, FDA told us that compliance with 
industry standards and safeguards accounted for the relatively few 
accidents severe enough to warrant a blood recall.
FDA's 1993 Plan For Blood Quality Assurance
    Just prior to our review of 1993-1994 error and accident reporting, 
FDA proposed a plan to establish a blood quality assurance initiative 
aimed at ensuring the safety of the Nation's blood supply and upgrading 
the operational quality of the blood industry. As part of the plan, FDA 
sought to: strengthen its capability to identify blood center 
operational deficiencies; provide appropriate guidance to the blood 
industry; educate and assist blood centers in conforming to this 
guidance; provide more timely decisions on licensing applications and 
amendments; and carry out inspections that assess the industry's 
progress in bringing operations to a higher standard.
    One component of this plan focused on the blood industry's self-
reporting of errors and accidents that may affect the safety, purity, 
or potency of blood and blood products. The FDA envisioned that the 
error and accident reports submitted by blood establishments could be 
used to identify trends and develop appropriate ``early warning'' 
guidance to the field offices and the blood industry. Another component 
of this plan was the consolidation of FDA's multiple automated systems 
into a single relational data base designed to facilitate the exchange 
of information between field and headquarters staff and permit FDA to 
identify trends and problems in early stages of development and issue 
guidance to blood establishments to prevent errors and accidents.
     oig findings and recommendations on error and accident report 
                               processing
    Our review showed that while FDA's error and accident reporting 
process was a valuable management tool for evaluating and monitoring 
blood establishments's actions, it could be more useful with prompter 
and more comprehensive reporting. The


FDA processed error and accident reports in our sample in accordance 
with established procedures; however, we identified two shortcomings 
that could hamper the success of FDA's plan to expand the usefulness of 
error and accident reports:
    (1) Blood establishments were not submitting error and accident 
reports to FDA ``promptly,'' as required by the regulation (21 CFR 
600.14(a)) and as encouraged by FDA correspondence with the industry in 
1991. Based on a sample of 163 error and accident reports received in 
the first half of Fiscal Year 1993, we found that the time between the 
date the error or accident was detected and the date it was reported to 
FDA ranged from less than 1 month to over 1 year, with an average of a 
little over 4 months. Only about 14 percent of the error and accident 
reports we reviewed were submitted by the blood establishments within 1 
month after the detection of the incident, while 13 percent were 
reported 6 months or more after detection.
    We concluded that blood establishments, in light of the lack of 
specificity concerning the term ``promptly,'' were taking a liberal 
interpretation of the time frame in which they are to report incidents 
affecting blood and blood products. This concerned us given that there 
were 17 cases in our sample requiring further evaluation for a possible 
recall. These cases involved, for example, shipping blood that tested 
positive for Hepatitis C; shipping mislabeled plasma units; and 
shipping units of red blood cells that were contaminated after being 
stored at room temperature.
    (2) There was no assurance that unlicensed blood establishments 
were voluntarily, as requested by a March 1991 FDA memorandum, 
submitting the reports. Data provided by FDA during our review 
indicated that of the 10,308 error and accident reports submitted to 
the agency during Fiscal Year 1991, 99 percent were submitted by 
licensed blood establishments, with only 148 reports--about 1 percent--
submitted by unlicensed blood establishments. We found a similar split 
between the licensed and unlicensed establishments for the error and 
accident reports reviewed in our sample: Of the 163 error and accident 
reports in our sample, only 2 were from unlicensed establishments. 
Acknowledging that FDA was seeking to more effectively evaluate and 
monitor the blood industry--as outlined in its 1993 plan--we concluded 
that it should have reports from the full spectrum of establishments.
    Comparing the reporting data with the numbers of unlicensed 
establishments, we believed that the statistics provided by FDA and the 
data from our sample were more likely indicative of nonreporting, 
rather than unlicensed establishments having less problems than their 
licensed counterparts. At the time of our review, about 2,900 blood 
establishments were registered by FDA: about one-fourth of those 
registered would have been licensed by FDA, and required to submit 
error and accident reports related to blood and blood products. The 
remaining 75 percent of the registered blood establishments would not 
be shipping blood or blood products interstate and, therefore, would be 
unlicensed. Unlicensed establishments are not required to submit these 
reports to FDA except for cases involving fatalities. According to FDA 
at the time of our previous review, unlicensed establishments accounted 
for about one-tenth of the blood collected in this country.
    We concluded during our previous review that without prompt and 
complete reporting by blood establishments on the number and types of 
errors and accidents that are detected, FDA may be hampered in its 
efforts to evaluate and monitor the blood industry. The FDA pointed out 
repeatedly that delays in reporting by licensed blood establishments 
and/or failure to voluntarily report by unlicensed establishments 
should not cause corresponding delays in initiating action aimed at 
correcting the specific problems being reported. This is because all 
blood establishments are required to investigate and correct all errors 
and accidents detected, independent of the reporting process. While we 
did not evaluate the timeliness or appropriateness of the blood 
establishments' actions, we noted that all 163 error and accident 
reports in our sample contained information showing that some action 
was taken. According to FDA, the actions reported to be taken by the 
blood establishments were appropriate.
    In May 1995, we recommended that the Commissioner of Food and 
Drugs:

1. Expedite the development and issuance of revisions to the Federal 
        regulation on error and accident reporting (21 Code of Federal 
        Regulations (C.F.R.) 600.14(a)) to be more specific concerning 
        the time frame in which error and accident reports are required 
        to be submitted;
2. Expedite the development and issuance of a regulation to require 
        unlicensed blood establishments to submit error and accident 
        reports; and
3. Expand CBER's use of existing information in its current error and 
        accident data base to identify blood establishments that 
        regularly fail to submit error and accident reports in a timely 
        manner and provide additional trend analysis reports to FDA 
        field offices and blood establishments.


    In its April 28, 1995 response to our draft audit report, the 
Public Health Service (PHS), FDA's oversight agency at the time of our 
review, agreed with our recommendations and indicated that FDA was 
taking action to implement them. The PHS asked us to revise our 
recommendations to reflect its view that many ideas presented in our 
report were already being translated into action. For example, PHS 
asked the OIG to add the word ``expedite'' to recommendations 1 and 2. 
The agency also informed us in its comments that the proposed 
regulation regarding recommendations 1 and 2 would be issued in 
November 1995, with a final publishing date of February 1996.
              status of fda actions on oig recommendations
    In August 1999, staff of the Subcommittee requested the OIG to 
contact FDA to determine the status of the recommendations made in its 
May 1995 report. In response to our request, FDA's Deputy Commissioner 
for Management and Systems forwarded a written memo, dated August 24, 
1999 providing an update on our recommendations.
    Regarding our recommendations to expedite development and issuance 
of revisions to the Federal regulation on error and accident reporting, 
to be more specific about the time frame in which the reports are to be 
submitted, and to require unlicensed establishments to submit such 
reports, FDA provided the following information:

 A proposed rule was published on September 23, 1997 to: (1) 
        require blood establishments to report errors and accidents 
        ``as soon as possible but not to exceed 45 calendar days,'' and 
        (2) require the reporting of all blood establishments including 
        licensed manufacturers of blood and blood components, 
        unlicensed registered blood establishments, and transfusion 
        service. The introductory portion of the proposed rule states: 
        ``FDA regards the proposal to amend the error and accident 
        reporting regulation to be an essential tool in its directive 
        to protect public health by establishing and maintaining 
        surveillance programs that provide timely and useful 
        information.''
 CBER was in the process of making revisions to ``the proposed 
        rule based on the comments received during the comment period 
        in an effort to make reporting requirements effective and less 
        burdensome to the industry.''
 The FDA planned a delay in issuing the final regulation until 
        February 2001 ``because of multiple public health related 
        priorities of the Agency.''
    Regarding our third recommendation, focusing on FDA expanding the 
use of error and accident report information, the agency informed us 
that summary reports of errors and accidents continue to be sent to 
FDA's Office of Regulatory Affairs Regional and District Directors and 
are also available to the industry through CBER's FAX Information 
system. The FDA further stated that CBER would continue to identify 
trends for reporting times, but that it would wait until the final rule 
is published--in February 2001--before making any changes in how the 
error and accident information is used.
    The agency response provided limited detail on the status of our 
recommendations; however, in anticipation of this hearing, we recently 
spoke with FDA officials involved in the blood safety area to pinpoint 
reasons for FDA's anticipated delay in issuing the final regulation. 
According to the director of CBER, FDA received 97 comments on the 
proposed rule--comments that were varied and ``not straightforward'' to 
address. She stated that the final regulations were slated to be 
cleared through FDA by June 2000 and that they would likely be 
published in February 2001.
                               conclusion
    That concludes my testimony, Mr. Chairman. At this time, I would be 
happy to answer questions from the Subcommittee.

    Mr. Upton. Thank you very much.
    Ms. Sullivan.

                 TESTIMONY OF MARIAN T. SULLIVAN

    Ms. Sullivan. Good morning. My name is Marian Sullivan. I'm 
the Executive Director of the National Blood Data Resource 
Center in Bethesda, Maryland. I'm pleased to have the 
opportunity to speak to you about the NBDRC; and after briefly 
introducing you to our organization and our activities, I will 
summarize for you our


most recent findings regarding the U.S. blood supply and our 
plan for monitoring it in the next 16 months.
    The NBDRC is an independent, not-for-profit corporation, 
conceived and founded by the American Association of Blood 
Banks in July 1997. The mission of the NBDRC is to collect, 
analyze and distribute data on all aspects of blood banking and 
transfusion medicine. Prior to the founding of the NBDRC, there 
was no existing organization dedicated to the collection of 
blood supply monitoring data.
    The goals of the NBDRC are to assist members of the blood 
community in identifying and assessing existing and emerging 
issues, improving operations, promoting the highest standards 
of care for patients and donors, and making policy at the 
national, regional and local levels. In short, we strive to 
provide whatever information is needed by the community to 
ensure a safe and efficient blood system.
    We rely on the AABB and our own limited membership for the 
financial support of our operations. Our small staff has worked 
hard to meet our goals in the brief 25 months since we opened 
our doors. Our accomplishments include the 1998 Nationwide 
Blood Collection and Utilization Survey, a comprehensive survey 
of blood services activities completed by 2,360 blood centers 
and hospitals. Data from this project have assisted numerous 
Federal agencies and advisory committees in recent policy 
discussions and been quoted in the media by the Surgeon 
General, yet not $1 of Federal funds supported this ambitious 
NBDRC project.
    The NBDRC has also contributed directly to the safety of 
the blood supply by continuation of the long-term Creutzfeldt-
Jakob Disease Lookback Study, now funded by the Centers for 
Disease Control and Prevention, and the Survey of Donation 
Incentives, supported by a grant from the National Blood 
Foundation.
    The results of our most recent national survey indicated 
that 700,000 fewer units of whole blood were collected in the 
U.S. in 1997 than in 1994, a statistically significant decrease 
of 5.5 percent. It's important to note that 205,000 of these 
units were directed donations intended for a specific patient 
and 643,000 units were autologous donations for the donor's own 
use. Although we recognize that both directed and autologous 
donations have been on a steep downward trend since they peaked 
in popularity in 1992, we cannot disregard the fact that these 
donations combined to account for .6 million transfused units 
in 1997, units that would have otherwise come out of the 
community supply.
    On the other hand, the total number of transfused whole 
blood and red cell units increased by 4 percent in 1997, in 
comparison with 1994, to 11.45 units. If the rates of overall 
blood collection and transfusion that occurred between 1994 and 
1997 are continuing, the United States may experience a 
national blood shortage as early as next year.
    The NBDRC is committed to conducting another nationwide 
survey in 2000, even if it must be supported entirely by 
internal funds and report sales as it was last year. The 
results of the 2000 survey, which will be available to NBDRC 
members and customers approximately 12 months from now, will 
provide data for 1999 and enable us to extend the historical 
trends analysis.


    However, in the interim between surveys, there's little 
information available regarding the adequacy of the blood 
supply, other than anecdotal. Some blood centers have recently 
reported significant increases in collections, while other 
centers issue repeated appeals for blood. The impact of this on 
the national supply cannot be carefully assessed without 
current nationwide data for comparable time periods and 
donation types.
    In order to better estimate the adequacy of the recent 
supply and to enable us to more accurately project the 
available supply for next year, the NBDRC is currently 
conducting a QuiKount of the whole blood donations made at 
every U.S. blood center. The survey will capture blood 
collection data for all of 1998 and the first 6 months of 1999 
by calendar quarter. This project is supported entirely by 
internal funding, and the results will be shared with all 
interested parties in early November.
    Finally, I'm very pleased to tell you that we will begin to 
collect supply data on a monthly basis in approximately 2 
months from a representative sample of blood centers under a 
short-term financial arrangement with the National Heart, Lung 
and Blood Institute.
    Congress has rightly recognized that the safety of our 
blood supply is a national public health priority. However, 
patients cannot benefit from safe blood if it is not readily 
accessible, and long-term blood collection and usage data are 
needed to detect and avoid potential blood shortages.
    The NBDRC urges Congress to support the collection of blood 
supply monitoring data. We are proud that in our short tenure 
the NBDRC has established a reputation as the premier source of 
national blood data. We appreciate the recognition of this 
subcommittee, the NHLBI and the various advisory committees and 
agencies which relied on our data to characterize the U.S. 
blood supply. You have our commitment to continue to provide 
accurate and timely data to meet the needs of the U.S. public 
health service as long as sufficient financial support is 
available.
    Thank you for the opportunity to testify today. I will be 
pleased to answer any questions.
    [The prepared statement of Marian T. Sullivan follows:]
  Prepared Statement of Marian Sullivan, Executive Director. National 
                       Blood Data Resource Center
    Good morning, My name is Marian Sullivan. I am the Executive 
Director of the National Blood Data Resource Center (NBDRC) in 
Bethesda, Maryland. I am pleased to have the opportunity to speak to 
you about the NBDRC. After briefly introducing you to the NBDRC and our 
activities, I would like to outline for you our most recent findings 
regarding the U.S. blood supply and our plan for monitoring it in the 
next sixteen months.
    The NBDRC is an independent, not-for-profit, corporation, conceived 
and founded by the American Association of Blood Banks (AABB) in July 
of 1997. The mission of the NBDRC is to collect, analyze, and 
distribute data on all aspects of blood banking and transfusion 
medicine. Prior to the founding of the NBDRC, there was no existing 
organization dedicated to the collection of blood supply monitoring 
data.
    The goals of the NBDRC are to assist members of the blood community 
at large in identifying and assessing existing and emerging issues, 
validating new technologies, improving operations, promoting the 
highest standards of care for patients and donors, and making policy at 
the national, regional, and local levels. In short, we strive to 
provide whatever information is needed by the community to ensure a 
safe and efficient modern blood system.
    We rely on the AABB and our own limited membership for the 
financial support of our operations. Our small staff has worked hard to 
meet our goals in the brief


25 months since we opened our doors. Our accomplishments include the 
1998 Nationwide Blood Collection and Utilization Survey--a 
comprehensive survey of blood services activities completed by 2,360 
blood centers and hospitals. Data from this project have assisted 
numerous federal agencies and advisory committees in recent policy 
discussions, and been quoted in the media by the Surgeon General, yet 
not one dollar of federal funds supported this ambitious NBDRC project.
    The NBDRC has also contributed directly to the safety of the blood 
supply by continuation of the long-term Creutzfeldt-Jakob Disease 
Lookback Study, now funded by the Centers for Disease Control and 
Prevention, and the Survey of Donation Incentives, supported by a grant 
from the National Blood Foundation.
    The results of our previous Nationwide Blood Collection and 
Utilization Survey indicated that 700,000 fewer units of whole blood 
were collected in the United States in 1997 than in 1994, a 
statistically significant decrease of 5.5%. It is important to note 
that 205,000 of these units were directed donations (intended for a 
specific patient) and 643,000 units were autologous donations (for the 
donor's own use). Although we recognize that both directed and 
autologous donations have been on a steep downward trend since they 
peaked in popularity in 1992, we cannot disregard the fact that these 
donations combined to account for 0.6 million transfused units; units 
which would have otherwise come out of the community supply.
    On the other hand, the total number of transfused whole blood and 
red blood cell units increased by 4% in 1997 in comparison to 1994, to 
11.5 million units. If the rates of overall whole blood collection and 
transfusion that occurred between 1994 and 1997 are continuing, the 
United States may experience a national blood shortage as early as next 
year.
    The NBDRC is committed to conducting another Nationwide Blood 
Collection and Utilization Survey in 2000, even if it must be supported 
entirely by internal funds and report sales, as it was last year. The 
previous survey captured blood collection and transfusion data for the 
calendar year 1997. In February 2000 we will distribute the next 
nationwide survey to 3,000 hospitals and blood centers.
    The results of the 2000 survey, which will be available to NBDRC 
members and customers approximately twelve months from now, will 
provide data for 1999, and enable us to extend the historical trends 
analysis through 1999 as well. However, in the interim between surveys, 
there is little information available regarding the adequacy of the 
blood supply, other than anecdotal. Some blood centers have recently 
reported significant increases in 1998 and 1999 collections, while 
other centers have issued repeated appeals for blood, beginning well in 
advance of the anticipated summer shortages this year. The impact of 
this on the national supply cannot be carefully assessed without 
current nationwide data for comparable time periods and donation types.
    In order to better estimate the adequacy of the recent supply, and 
to enable us to more accurately project the available supply for the 
year 2000, the NBDRC is currently conducting a ``QuiKount'' of the 
whole blood donations made at every U.S. blood center. The short survey 
was mailed out last week and will capture blood collection data for all 
of 1998 and the first six months of 1999 by calendar quarter. The 
QuiKount project is supported entirely by internal funding, and the 
results will be shared with all interested parties in early November.
    Finally, I am very pleased to tell you that we will begin to 
collect supply data on a monthly basis in approximately two months, 
under a short-term financial arrangement with the National Heart, Lung 
and Blood Institute (NHLBI). Initially, we will enlist the 
participation of a representative sample of blood centers willing to 
report their monthly distribution figures very rapidly. Later on, next 
year, we hope to bring the corresponding national hospital sample on-
line in order to capture timely and detailed blood utilization data.
    Congress has rightly recognized that the safety of our blood supply 
is a national public health priority. However, patients cannot benefit 
from safe blood if it is not readily accessible. Moreover, long-term 
blood collection and usage data are needed in order to detect and avoid 
potential blood shortages. The NBDRC urges Congress to support the 
collection of blood supply monitoring data.
    We are proud that in our short tenure, the National Blood Data 
Resource Center has established a reputation as the premier source of 
reliable, national blood data, and we sincerely appreciate the 
recognition of this subcommittee, the NHLBI, and the various advisory 
committees, task groups and agencies which have relied on our data to 
characterize the U.S. blood supply. You have our commitment to continue 
to provide accurate and timely data to meet the needs of the U.S. 
Public Health Service, both routine and urgent, as long as sufficient 
financial support is available. Thank you for the opportunity to 
testify today. I would be pleased to answer any questions.




    Mr. Upton. Thank you.
    Dr. AuBuchon.

                 TESTIMONY OF JAMES P. AUBUCHON

    Mr. AuBuchon. Good morning. My name is James AuBuchon. I'm 
a physician and professor of pathology and medicine at 
Dartmouth Medical School and Medical Director of the Blood Bank 
and Transfusion Service of Mary Hitchcock Memorial Hospital in 
New Hampshire. I appreciate the opportunity to offer the 
perspective of a physician who specializes in transfusion 
medicine in considering blood safety and availability.
    Transfusion medicine specialists are pleased, and I'm sure 
our patients are grateful, that receiving a transfusion today 
has less risk than ever before. Reduction in the risk of viral 
transmission has occurred through the diligence of oversight on 
the part of regulatory bodies such as the FDA and through the 
dedication of thousands of medical, technical and 
administrative professionals in blood centers and hospitals.
    The success of these efforts has created new dilemmas, 
however. Dramatic reductions in the risk of HIV have fueled 
public anticipation of transfusion without any risk. However, 
continual focus on one type of risk, viral infection, prevents 
a rational prioritization according to where the greatest 
residual risk remains. Reducing the risks of transfusion also 
encourages transfusion in situations where the predictable 
benefit is smaller.
    The consequential increase in demand for blood comes at a 
time when the demands for increased safety and other factors 
have reduced the availability of blood. The intersecting 
interests here are clear particularly when an inadequate blood 
supply becomes a safety risk for a patient who cannot get a 
needed transfusion.
    It is commonly accepted among transfusion medicine 
specialists that many transfusions cannot be justified 
medically. For example, at least a third of plasma transfusions 
do not occur in situations where the plasma confers benefit. We 
face three major hurdles in reducing inappropriate transfusion.
    One, information. We simply do not have enough data about 
the effects of transfusing all the different kinds of blood 
components and all the different kinds of clinical situations 
where they may be applied. As a result, many transfusion 
decisions are made on guesses and personal experience. Studies 
indicate that a conservative approach to transfusion uses less 
blood in the end and is associated with better patient 
survival. Clearly, more clinical research is needed to define 
when transfusion should not be given.
    Two, patient variability. Compounding the problem of 
inadequate research in this field is the inherent variability 
of patients. What may be a safe level of anemia that does not 
require treatment for one may be lethal for another. Medical 
science does not allow us to know enough about each patient to 
make well-founded individual decisions. The consequences of not 
transfusing when needed are immediate and catastrophic, whereas 
the consequences of transfusing when not needed are distant and 
only remote possibilities; hence, physicians frequently err on 
the side of treatment.
    Three, education. In attempting to change transfusion 
behaviors, considerable trust must be developed in the 
transfusion medicine


specialist by the clinician. This must be followed by the 
investment of considerable time for prompt clinical 
interactions to redirect the clinician's practice. Many studies 
have shown that ongoing interactions with clinicians can have a 
positive impact. However, there is no support for this 
activity; and only academic medical centers have the trained 
staff and anything close to sufficient time to attempt it.
    Given the demographics of our population, the blood supply 
situation is only going to get worse. A report of the Office of 
Technology Assessment 15 years ago noted that while 12 percent 
of the population was age 65 or over, this segment accounted 
for 22 percent of all hospital admissions and 45 percent of all 
transfusions. The graying of the population will not only 
accelerate blood usage but also reduce the number of available 
donors.
    We may already be seeing the tip of the iceberg of this 
shortage. Will the periodic shortages we have been experiencing 
with increasing frequency become perpetual? Will the trends of 
increasing usage and decreasing availability soon combine to 
cause the death of a patient needing a transfusion? What can we 
do to forestall this?
    Frankly, I do not hold out the promise of significant 
reduction in usage because of the advancing age of the 
population and because of increased aggressiveness of a wide 
variety of therapies that would require transfusion support. 
Greater use of autologous blood options is attractive but 
impractical since most approaches to autologous therapy are 
more expensive than depending on the community blood supply. 
Until this blood supply is so short or undependable that 
elective surgery is frequently postponed, most will not opt for 
this approach.
    Some blood conservation mechanisms are now fairly common in 
larger hospitals, and these do decrease reliance on the 
community supply. For example, using equipment to recover red 
cells lost in surgical wounds for reinfusion back to the 
patient can decrease the transfusion of banked blood by 50 
percent or more in cases that require blood. Smaller hospitals 
find only occasional use for this equipment, however, and have 
not adopted it widely.
    Other options, such as diluting the patient's blood with a 
salt solution while collecting several units at the start of a 
surgical procedure, generally save a unit of blood or less and 
are not cost-effective. Units of blood donated by patients 
several weeks ahead of surgery do save the need to call on the 
community blood supply as often. However, not all patients are 
in sufficiently good health to donate, and unused units do not 
augment the blood supply.
    Is medical practice likely to change sufficiently to avoid 
or delay the projected shortfall in blood availability? 
Physicians and surgeons have become accustomed to a safe and 
readily available blood supply. It is difficult to make the 
argument to a physician that he or she should increase the risk 
of a heart attack in his or her patient in order to maintain 
the blood bank's inventory so that another patient might have 
blood available. Increasing the knowledge base of clinicians 
about appropriate transfusions would tend to decrease usage, 
but this will require concerted effort of the entire medical 
establishment, and there are just too few medical specialists 
in transfusion medicine to accomplish this.


    What is needed? The medical community will likely acclimate 
itself to blood shortages through increased internal audits of 
blood transfusion decisions in each hospital. This committee 
and Congress could provide assistance in a variety of ways. I 
would make a plea for funds for research and educational 
efforts, and I would ask that when the American Association of 
Blood Banks comes before Congress each year to define areas in 
which heightened research activity would be beneficial that 
Congress accept these recommendations with the knowledge that 
all in society will benefit from these advances.
    Furthermore, Congress can provide needed assistance to us 
today in our mission by serving as the voice of the people, by 
helping to define for the blood banking community what society 
expects from its blood supply.
    When the requirements of increased safety and tightening 
availability conflict, how should choices be made? The FDA, 
chastened by retrospective criticism of decisions made over 15 
years ago, always opts for increased safety, regardless of the 
costs and with scant attention on supply. Many in our field 
believe that the public still expects the impossible, a risk-
free blood supply. The public's attention to AIDS and hepatitis 
is focused on minuscule or improbable infectious risks while 
missing much larger opportunities to make transfusion safer, 
such as methods to ensure that units are transfused to the 
right patient.
    A clear statement of understanding that safety and 
availability may have opposing elements and a clear acceptance 
that a certain level of risk is unavoidable would help all 
blood bankers and transfusion specialists deal with the reality 
of our situation productively.
    In the same manner, I believe that Congress should 
recognize that blood is indeed different than other medical 
commodities. Including its provision in underfunded Medicare 
prospective payment systems and expecting that the free market 
will resolve all ills in the blood supply system is mistaken. 
Heaping additional safety requirements on the blood supply 
system by Federal fiat without providing specific financial 
resources to accomplish these tasks creates unresolvable 
conflicts in the blood collection system. In the end, that 
constrained system must choose between measures that will 
augment safety or that will augment supply, a Hobbsian choice 
that none of us wish to make.
    I will urge that the important and sacred place that this 
precious donated human research has in the medical care system 
be recognized so that the public's desire for a safe and 
adequate blood supply can be met.
    Thank you.
    [The prepared statement of James P. AuBuchon follows:]
  Prepared Statement of James P. AuBuchon, Professor of Pathology and 
              Medicine, Dartmouth-Hitchcock Medical Center
    Good morning. My name is James AuBuchon. I am a physician and a 
professor of Pathology and Medicine at Dartmouth Medical School. I am 
also the Medical Director of the Blood Bank and Transfusion Service of 
Mary Hitchcock Memorial Hospital in Lebanon, New Hampshire. I 
appreciate the opportunity to offer the perspective of a physician who 
specializes in transfusion medicine in considering blood safety and 
availability.
    Those of us in transfusion medicine are pleased--and I am sure that 
our patients are grateful--that receiving a transfusion today has less 
risk than ever before. Re


duction in the risk of viral transmission has occurred through the 
diligence of oversight on the part of regulatory bodies, such as the 
FDA, and through the dedication of thousands of medical, technical and 
administrative professionals in blood centers and hospitals. Early 
information suggests that when appropriately selected volunteer donors 
are tested with the most advanced technology, there is virtually no 
risk that their donated blood units will transmit the two most feared 
viruses, HIV and hepatitis C.
    This incredible success story has created new problems for us and 
for our patients, however. Dramatic reductions in the risk of HIV have 
fueled public anticipation of transfusion without any risk. However, 
continual focus on one type of risk--viral infections--prevents a 
rational prioritization according to where the greatest residual risk 
remains. Reducing the risks of transfusion also encourages transfusion 
in situations where the predictable benefit is smaller. The 
consequential increase in demand for blood comes at a time when the 
demands for increased safety and other factors have reduced the 
availability of blood. The intersecting interests here are clear, 
particularly when an inadequate blood supply becomes a safety risk for 
a patient who cannot get a needed transfusion.
    Transfusion medicine specialists direct much of their consultative 
efforts into ensuring that transfusions are clinically indicated. Many 
clinicians view us as the ``blood police'' because of our attempts to 
enforce protocols designed to ensure that this precious, scarce--and 
potentially dangerous--resource is used wisely. It is commonly accepted 
amongst our fraternity that many transfusions cannot be justified 
medically. For example, several studies of the use of plasma have shown 
that at least a third of plasma transfusions do not occur in situations 
where the plasma confers benefit, and approximately 10% of red cell 
transfusions fall into the same category. We face three major hurdles 
in reducing these proportions.
1. Information. We simply do not have enough data about the effects of 
        transfusing all the different kinds of blood components in all 
        the different kinds of clinical situations in which they may be 
        applied. As a result, many transfusion decisions are made based 
        on guesses, hunches and personal experience. Studies indicate 
        that a conservative approach to transfusion uses less blood in 
        the end, results in exposure to fewer donors, and is associated 
        with better patient survival. Clearly more clinical research is 
        needed to define when transfusions should--and need not--be 
        given.
2. Patient Variability. Compounding the problem of inadequate research 
        in this field is the inherent variability of patients. Not only 
        are babies different from octogenarians, but not every 80 year 
        old man is the same. What may be a safe level of anemia that 
        does not require treatment for one may be a lethal anemia for 
        another. Medical science does not allow us to know enough about 
        each patient to make well-founded individual decisions. The 
        consequences of not transfusing when needed are immediate and 
        catastrophic, whereas the consequences of transfusing when not 
        needed are distant and only ``remote possibilities''; hence, 
        physicians frequently err on the side of treatment. Indeed, 
        there are concerns that, in some circumstances, physicians are 
        undertransfusing, that is, withholding transfusion when it 
        would be beneficial, because of overstated fears about 
        infectious transmission. We must be careful to strike an 
        informed balance between risk and benefit.
3. Education. In attempting to change transfusion behaviors, 
        considerable trust must be developed in the transfusion 
        medicine specialist by the clinician; this must be followed by 
        the investment of considerable time for prompt clinical 
        interactions to re-direct the clinician's practice. Many 
        studies have shown that ongoing interactions with clinicans can 
        have a positive impact. However, there is no support for this 
        activity, and only academic medical centers have the trained 
        staff and anything close to sufficient time to attempt this 
        effort. The monetary savings to the institution for reducing 
        component usage will probably not justify the many hours of 
        physician time required. The benefits of clinical consultation 
        that my transfusion medicine colleagues and I can offer 
        patients are just not available in most hospitals.
    Given the demographics of our population, the blood supply 
situation is only going to get worse. A study by the Office of 
Technology Assessment 15 years ago noted that while 12% of the 
population was age 65 or over, this segment accounted for 22% of all 
hospital admissions and 45% of all transfusions. The ``graying of the 
population'' will not only accelerate blood usage but also reduce the 
number of available donors. Fifteen years ago, there were 8 qualified 
potential donors for every potential recipient. In ten years, it is 
estimated that this ratio will have dropped to 3:1, expanding the 
difficulties in recruiting enough blood donors.
    We may already be seeing the tip of this iceberg with the recent 
data developed by the National Blood Data Resource Center, presented 
today by Marian Sullivan.


Will the periodic shortages we have been experiencing with increasing 
frequency become perpetual? Will the trends of increasing usage and 
decreasing availability soon combine to cause the death of a patient 
needing transfusion? What can we do to forestall this?
    Others will be speaking on efforts to increase blood recruitment 
success. As one who formerly directed a blood center, I will only offer 
the comment that recruitment efforts take place in the societal milieu. 
Clearly, societal attitudes about public service and volunteering have 
changed over the last several decades, and these changes place 
additional challenges before donor recruiters. The increasing workweek 
and the pressures for efficiency stemming from global competition make 
availability of donors at the workplace more difficult as well. 
Unfortunately, these challenges must be faced with decreased resources 
as blood collecting agencies are deferring more donors than ever before 
and spending greater proportions of their resources on testing--all at 
a time when hospitals are demanding reduced costs because of their 
financial pressures.
    What can be done to reduce blood usage? Frankly, I do not hold out 
the promise of significant reduction in usage because of the advancing 
age of the population and because of increased aggressiveness of a wide 
variety of therapies that require transfusion support. Greater use of 
autologous blood options is attractive but impractical in the current 
environment. Most approaches to autologous therapy are more expensive 
than depending on the (very safe) community blood supply. Until this 
blood supply is so short or undependable that elective surgery is 
frequently postponed, most will not opt for this approach. Furthermore, 
since an increasing proportion of patients are treated under some type 
of fixed payment system, hospitals have a strong financial incentive 
not to use more-expensive approaches. Indeed, the shortage may have to 
reach critical proportions before these alternatives are widely used. 
It is unlikely that one hospital would invest in a more-expensive but 
blood-conserving approach in order to increase the community's blood 
supply to be shared amongst hospitals that have maintained a less-
expensive system.
    Some blood conservation mechanisms are now fairly common in larger 
hospitals, and these do decrease reliance on the community supply of 
blood. For example, using equipment to recover red cells lost in 
surgical wounds for reinfusion back to the patient can decrease the 
transfusion of banked blood by 50% or more in cases that often require 
blood, such as cardiac, vascular and orthopedic surgeries. If the 
patient requires more than about two units of blood, this option may 
actually save money. Smaller hospitals find only occasional use for 
this equipment, however, and have not adopted it as widely. Other 
options, such as diluting the patient's blood with a salt solution 
while collecting several units at the start of a surgical procedure, 
generally save a unit of blood or less and are not cost-effective. The 
future advent of oxygen-carrying solutions will allow collection of 
more blood while keeping the patient's oxygen carrying capacity at a 
safe level, but the expected high cost of these solutions will not make 
their widespread use feasible in the current financial climate; even in 
cases with large blood losses, the savings to the community blood 
supply are very modest. Units of blood donated by patients several 
weeks ahead of surgery do save the need to call on the community blood 
supply as often. However, not all patients are in sufficiently good 
health to donate; unused units do not augment the blood supply since 
most patients either do not qualify as community blood donors or their 
units were collected sufficiently far enough ahead of surgery that 
little time remains after surgery to use them for another patient.
    Is medical practice likely to change sufficiently to avoid or delay 
the projected shortfall in blood availability? Physicians and surgeons 
have become accustomed to a safe and readily available blood supply, 
and new surgical techniques or chemotherapies are not sidelined because 
of a projected increased need for blood support. Certainly, more 
appropriate usage would reduce the demand a significant degree. 
However, it is difficult to make the argument to a physician that he or 
she should increase the risk of a heart attack or other bad outcome in 
his or her patient in order to maintain the blood bank's inventory so 
that another (unnamed, unknown) patient might have blood available. 
Increasing the knowledge base of clinicians about appropriate 
transfusion therapy would tend to decrease usage, but this will require 
concerted effort of the entire medical establishment. There are too few 
transfusion medicine specialists, concentrated primarily in academic 
medical centers, and there are too few resources to make a broad impact 
on medical practice in the short run.
    What is needed? The medical community will likely acclimatize 
itself to blood shortages through increased internal audits of blood 
transfusion decisions in each hospital and educational efforts to 
reduce the demand for blood. This Committee and Congress could provide 
assistance in a variety of ways. I would make a plea for funds for 
research and educational efforts, and I would ask that when the Amer


ican Association of Blood Banks comes before Congress each year to 
define areas in which heightened research activity would be beneficial 
that Congress accept these recommendations with the knowledge that all 
in society will benefit from these advances. Furthermore, Congress can 
provide needed assistance to us today in our mission by serving as the 
voice of the people, by helping to define for the blood banking 
community what society expects from its blood supply. We in the field 
will continue to strive for increased safety and improved availability 
regardless of the outcome of this Committee's deliberations. However, 
when the requirements of increased safety and tightening availability 
conflict, how should choices be made? The FDA, chastened by 
retrospective criticism of decisions made over 15 years ago, always 
opts for increased safety--regardless of the cost and with scant 
attention to the effect on supply. Recent decisions regarding the 
potential for transmission of spongiform encephalopathies through 
transfusion are an example of this. Many in our field believe the 
public still expects the impossible, a risk-free blood supply. The 
public's attention to AIDS and hepatitis has focused us on minuscule or 
improbable infectious disease risks while missing much larger 
opportunities to make transfusion safer, such as methods to ensure that 
units are transfused to the right patient. A clear statement of 
understanding that safety and availability may have opposing elements 
and a clear acceptance that a certain level of risk is unavoidable 
would help all blood bankers and transfusion medicine specialists deal 
with the realities of our situation more productively.
    In the same manner, I believe that Congress should recognize that 
blood is indeed different than other medical commodities. Including its 
provision in underfunded Medicare prospective payment systems and 
expecting that the free market will resolve all ills in the blood 
supply system is mistaken. Heaping additional safety requirements on 
the blood supply system by federal fiat without providing specific 
financial resources to accomplish these tasks creates unresolvable 
conflicts in the blood collection system. In the end, that constrained 
system must choose between measures that will augment safety or that 
will augment supply, a Hobbsian choice that none of us wish to make. I 
would urge that the important and sacred place that this precious, 
donated human resource has in the medical care system be recognized so 
that the public's desire for a safe and adequate blood supply can be 
met. Thank you.

    Mr. Upton. Thank you very much.
    Mr. Cox.
    Mr. Cox. Thank you very much.
    In particular, Dr. AuBuchon, your testimony has left us 
with a strong focus on concerns that we have about the safety 
of transfusions themselves and about receiving blood. But, just 
for openers, I want to make sure I have everybody's agreement 
that, in the United States today, the act of giving blood does 
not present risks to the donor. That is an exceptionally safe 
thing for every American to do; isn't that right?
    Mr. AuBuchon. That's absolutely correct. There is no way 
that the donor can get any infectious disease from the donation 
process. They will get coffee and cookies, but that's all they 
will get.
    Mr. Cox. While we are at it, because this is an open and 
most public hearing that the American people will pay some 
attention to, how often can one donate blood safely?
    Mr. AuBuchon. FDA regulations require donation no more 
frequently than once every 56 days or 8 weeks. That's based on 
the need for the donor to replenish their red cell supply. 
Other kinds of donations such as platelets or plasma can be 
given on a more frequent basis.
    Mr. Cox. You could, if you wanted to be especially public-
spirited, donate blood 4 or 5 times a year completely safely.
    Mr. AuBuchon. Indeed, you could donate theoretically up to 
6 times a year. Unfortunately, most American donors donate, 
however, once or, at most, twice a year. There are a few 
committed ones who donate at least a gallon each year, but most 
do not.


    Mr. Cox. Before I leave this topic, because I just want to 
make sure that everyone understands our object here is to 
encourage people to donate blood so that we can increase the 
blood supply and avoid the problems that Ms. Sullivan is 
warning about, a possible blood shortage for the whole country, 
what percentage of the eligible American population is it our 
best guess currently donates blood on a regular basis, at least 
once a year?
    Ms. Heinrich. The best information that we have is that 5 
percent of the eligible population is giving once a year.
    Mr. Cox. So it's even worse than voting?
    Ms. Heinrich. Yes.
    Mr. Cox. By a lot. And 95 percent of eligible Americans 
aren't yet doing the patriotic thing and donating their blood, 
and we all on this panel and all of you on that panel----
    Mr. Upton. That's until we pass campaign finance reform.
    Mr. Cox. [continuing] hope that this happens.
    Mr. Roslewicz, the Inspector General's report from 1995, 
which I've just again reread, uses the word expedite. And how 
did that word get in the report in 1995?
    Mr. Roslewicz. Okay. The process we use when we are 
conducting an audit is to submit a draft report for comments to 
the agency before we finalize it; and FDA, when they responded 
to our draft report--we didn't use the word expedite in the 
recommendations. We said FDA should just establish a timeframe.
    FDA had already, during the course of our audit, been 
working on making some revisions to the error and accident 
blood reporting process, so they asked us if we would in our 
final report use the word expedite, which would then sort of--
not sort of--it would show that they were in fact trying to 
correct the system and make improvements to it.
    Mr. Cox. Was that the Public Health Service?
    Mr. Roslewicz. It was the Public Health Service. At the 
time, Public Health Service was the oversight agency for all of 
the PHS agencies. So the Public Health Service Assistant 
Secretary would have responded for Food and Drug Administration 
back in 1995. Today, FDA would respond themselves to the draft 
report.
    Mr. Cox. So when they reviewed your draft report. They 
said, put in the word expedite, which according to its plain 
English meaning suggests hurry it up----
    Mr. Roslewicz. Exactly.
    Mr. Cox. [continuing] get it done?
    Mr. Roslewicz. From what they told us, they're already 
working on it. They had anticipated getting the proposed 
regulation out in November 1995.
    Mr. Cox. They wanted this new regulation out because there 
were a lot of people that aren't reporting either promptly or 
at all errors and accidents. And by errors and accidents we 
mean, for example, the release of blood units that are 
repeatedly reactive to tests indicating, for example, hepatitis 
or HIV? And we've all understood from your testimony that this 
doesn't happen all the time. It's rare that you would have to 
do a recall.
    But in order to determine when a recall is in order, you've 
got to have that information. If they don't send you timely 
reports, then FDA cannot function as an oversight agency.


    In order to fix this problem which you've identified a half 
decade ago, you recommended with the concurrence of the Public 
Health Service that the new regulations be expedited, and so 
they originally said that they were going to do it many years 
ago, and now they're talking about doing it in 2001. Now, when 
we live in this high-tech age where everything changes very, 
very fast, complex inventions are created and deployed in 
months, certainly a year or two would be adequate to do most 
complex things in our society.
    Why is it that the bureaucracy needs nearly half--this 
would be more than a half decade by the time they're done on 
their schedule--to read the comments and issue the regulation 
that originally they said should be expedited to deal with 
something as important as the safety of our blood supply?
    Mr. Roslewicz. Okay. We have the same question. When we 
went back in August of this year, at the request of the 
committee to ask that very question, we were told that they had 
multiple priorities going on at the same time.
    Mr. Cox. Did they ever tell you what they were?
    Mr. Roslewicz. No, we don't know what those priorities 
were.
    Mr. Cox. Do you believe the FDA commissioner when she says 
that safety of the blood supply is a top priority?
    Mr. Roslewicz. Do I believe her? Yes, I would certainly 
believe her.
    Mr. Cox. Even though it's taken a half decade to get this 
reg out?
    Mr. Roslewicz. This is something--FDA would have to respond 
to that better than I can. But my concern would be that, if 
there are these priorities, what are they? We would have to go 
back and do an audit to get you specific information. But, you 
know, we have not audited that specific aspect of what's 
happened after the issuance of our report.
    What we do do, though--we have in our organization, in the 
Inspector General's Office, what we call an Orange Book. In 
this Orange Book are all the unimplemented recommendations that 
we have made to the various agencies within our Department. And 
this Orange Book repeats these findings and recommendations 
year after year until they are either implemented or resolved 
in some manner.
    This particular report has been carried forth in all of our 
Orange Books, which is provided to the Congress as well as to 
the various components within our Department. So we do try to 
follow-up and make sure that these things don't fall off the 
scale. In this particular case, FDA is going to have to explain 
to you why it's taken so long. I can't speak for the FDA 
Commissioner.
    Mr. Cox. I thank you. And I thank you, Mr. Chairman.
    I especially want to thank our panel for your obvious 
interest in this subject, making sure that our blood supply is 
safe and that it's there that we don't have that shortage next 
year that Ms. Sullivan is warning us about.
    Mr. Upton. I would just note for the record that we've 
invited the FDA commissioner to come testify this next month 
when we continue these hearings.
    Mr. Strickland.


    Mr. Strickland. Thank you, Mr. Chairman, and I thank the 
panel.
    Mr. AuBuchon, during the early 1990's, primarily we think 
because of fear of contacting HIV, we found that many patients 
and families of patients contributed blood, for example, prior 
to surgery and thereby increased the blood supply. My 
understanding is that that practice has fallen off rather 
dramatically, and I was wondering if it was your feeling that 
we should encourage that kind of behavior as a way of releasing 
our supply of blood?
    Mr. AuBuchon. Preoperative blood donation became 
increasingly popular as the public's fears about HIV in the 
community blood supply increased from the mid-1980's through 
the early 1990's. Because of the public's recognition of the 
increased safety of the blood supply, beginning I would think 
in about the early 1990's, there was less motivation for 
patients to donate blood. It takes considerable motivation on 
the part of a patient to donate blood as they're preparing for 
elective surgery.
    And I think the understanding that the blood supply today 
essentially does not carry the risk of transmitting HCV or HIV, 
that the public is less interested in doing that. Once the 
community blood supply becomes so short that a patient may not 
be able to reliably schedule elective surgery, then there will 
be additional motivation for autologous donation. Until that 
happens, I think we will see a decline in preoperative 
autologous donation.
    Mr. Strickland. The second question for you, Doctor. In 
your testimony you talk about a lack of transfusion protocols 
that clearly define when a transfusion is appropriate, when it 
may not be necessary in medical situations. Why is it important 
that such protocols be developed and who should be responsible 
for the development of such protocols?
    Mr. AuBuchon. Medicine attempts to be science or data 
driven as much as possible, and any physician wants to know 
when he or she should apply a particular therapy or when it's 
not appropriate. Although I believe I'm up to date on medical 
literature in terms of transfusion, when I speak with a surgeon 
or a physician about when to transfuse, I almost never have 
absolute data in my back pocket to say clearly this situation 
has been studied and I can show you precisely that you should 
take the following course of action. I usually have to refer to 
studies that are similar and deal with patients who are in a 
similar situation, and we have to make our best guess jointly.
    Sometimes we guess wrong. The physician in charge of the 
patient does not want to avoid transfusing a blood component 
and risk a very serious outcome when the risk of transfusion is 
so low. If I go to a physician and say, if you don't transfuse 
this patient, he will do fine, and the surgeon may ask me what 
is the risk he will have a heart attack, and I will say it's 
probably very low. He says, one in a thousand, one in 10,000, 
what's the risk in AIDS, one in a million.
    Given those choices, the surgeon is going to transfuse. 
This will make the blood supply safer. The surgeon is going to 
move into that direction. So we need more data in order to 
establish a scientific basis for transfusion medicine.


    Mr. Strickland. I think what you're describing is the 
practice of the art of medicine versus the science of medicine, 
and that's why I believe medical decisions need to be made by 
persons who are trained physicians, not only in this situation 
but across the delivery of our medical services.
    In recent times, medical science has made great advances. 
And I'm wondering, in your judgment, are we approaching the 
point where blood substitutes may be practical as a way of 
increasing our supply and, if so, would you estimate when such 
practices may become cost-effective so that they could 
effectively alleviate concern about shortages?
    Mr. AuBuchon. I gave an hour-long lecture last week on that 
topic with 60 slides. I won't go into that detail for the 
subcommittee this morning.
    I do not believe that blood substitutes are going to make a 
major impact in the near future. There are artificial blood-
carrying solutions for fluorocarbons which may be used in some 
surgical situations to allow hemodilution immediately before 
surgery. However, for most patients, they are likely to save 
less than a unit of blood. The hemoglobin-based oxygen carrying 
solutions have a little further to go, I believe, before they 
are potentially licensable by the FDA.
    The problem is that their source of blood is going to be 
primarily human blood. There is not much outdated blood today, 
and with loss of hemoglobin in the preparation, there will not 
be a lot of this hemoglobin-based oxygen carrier solution 
available. It will also be extremely expensive. So I do not see 
these, quote, unquote, blood substitutes playing a major role 
in transfusion therapy in the near future.
    Mr. Strickland. Thank you.
    And, Dr. Heinrich, getting to this issue of preventing 
individuals who may have spent 6 months in the UK from donating 
blood because of the fear of the human form of the mad cow 
disease and given Dr. AuBuchon's contention that sometimes we 
focus on the least effective ways of increasing safety and 
neglecting others, looking at the loss that we would experience 
in the blood supply as a result of that decision, do you think 
it's justified and should we rethink whether or not that's a 
good practice?
    Ms. Heinrich. From the data that GAO collected, we found 
that there's an estimate that we would lose about 2.2 percent 
of units. It's our understanding that the various science 
advisory committees through FDA and the Public Health Service 
have said that, in terms of the science, we don't have all of 
the facts yet in terms of the possible transmission of a new 
variant CJD. And in terms of the timeframes, I think that the 
thinking was that 6 months is reasonable in terms of the kind 
of time, amount of time that one would have to have been in the 
UK.
    I think that the Department is also going to be continually 
monitoring this decision. They're going to be looking at this 
on a regular basis, to see if, in fact, there's a problem with 
the supply or if there's anything new that comes up in terms of 
science.
    Mr. Strickland. Mr. Chairman, could I ask just one quick 
follow-up with Dr. AuBuchon? Is that an example of where we may 
be focusing on an issue that has very minimal risk and thereby


perhaps not focusing or neglecting to focus on things that 
could be done that would have much greater impact on the 
supply?
    Mr. AuBuchon. Precisely. The risk of transmission of CJD 
through the blood supply is clearly there. It's a potential 
possibility. It's my diligent effort to find it amongst 
individuals who have come down with new variant CJD and were 
prior blood donors. No cases of transmission have been found. 
Yet every year in this country data from the FDA and data 
reported to the New York State Department of Health document 
that we kill 2 dozen patients by giving them the wrong unit of 
blood, yet there's no discussion of that.
    Mr. Strickland. Thank you. Thank you, Mr. Chairman.
    Mr. Upton. Thank you, Mr. Strickland.
    As I listen to the testimony--first of all, I appreciate 
again your testimony. And I just--the first question off the 
top of my head here, Ms. Sullivan, is, as you all through the 
NBDRC begin to collect monthly data next year, I would 
appreciate it if you could supply this committee with your 
results on a timely basis so we can continue to monitor this. 
If that would be possible, it would be terrific.
    Ms. Sullivan. Certainly.
    Mr. Upton. I'm a blood donor. But I will confess it has 
been a little--when I get over this cold, I've already 
instructed my staff to sign me up in Michigan.
    Dr. Heinrich, I listened to your testimony. You indicated 
that there was not a crisis, we are not in a crisis mode now, 
but in fact we are below a comfort level in many regions of the 
country, and in some cases, I would suspect that it's less than 
a day supply; is that right? How do those two statements 
comport instead of conflict?
    Ms. Heinrich. What we did is we looked at the overall 
numbers and found that, indeed, the decrease has been primarily 
in the autologous and directed donations, so that the community 
supply for blood overall, the decrease has been about 2.2 
percent. We have heard again anecdotally that there are some 
regional shortages at some times of the year and certainly for 
certain blood types, the rare types O and B.
    But on the other side of the equation is the fact that the 
ability of our major blood banking systems, the ability to 
shift blood from areas, regions where there are surpluses to 
areas where there is a need, seems to have made our system run 
rather efficiently to meet the demands.
    Mr. Upton. I know Richard Burr, who is the vice chairman of 
this subcommittee, represents North Carolina; and I believe a 
number of counties in his district are flooded.
    Ms. Heinrich. Yes.
    Mr. Upton. And I heard a report earlier this week on the 
news that, in fact, those areas impacted by the flooding--I 
suspect they would include New Jersey and some other places 
I've seen as well--have real trouble. And you believe then at 
this point from your overview that, in fact, those areas are 
covered sufficiently in terms of supply from other parts of the 
country?


    Ms. Heinrich. Our information would say that these national 
systems are able to accommodate regions when there is this kind 
of shortage.
    Mr. Upton. Mr. Roslewicz, what is the shelf life of a pint 
of blood after it's given until it has to be disposed?
    Mr. Bilbray. Whole blood.
    Mr. Roslewicz. Whole blood? I would have to defer to a 
doctor. I don't know the answer to that question.
    Mr. Upton. Dr. AuBuchon.
    Mr. AuBuchon. Whole blood itself can be stored for up to 35 
days. Most units of whole blood are separated into red cells 
and the plasm. The red cells can be kept for 42 days in the 
liquid state.
    Mr. Upton. The question, now that we have that answer, is, 
you indicated in your testimony that in terms of safety, in 
essence, only about 14 percent of the errors were reported in 
the first 30 days, which means that 85 percent are reported 
after 30 days; is that right?
    Mr. Roslewicz. That's correct. As a matter of fact, another 
13 percent are reported 6 months or later into years. So you 
have--there's a lot of--and it raises the question of, when you 
get a report that is a year old, sort of like getting an audit 
that is a year old, what good is it if you haven't had it when 
the incident happened; at least as early as possible, in order 
to make sure that the blood establishment took the proper 
actions to correct the problem.
    That's one of the reasons why I think it's important that 
they get these reports more timely, so that they can in fact 
make sure that these blood establishments are acting 
appropriately. There are close to about 3,000 of them out 
there. Any one of these 3,000 institutions could have some kind 
of an error or accident and it could happen daily. Without 
knowing exactly what the accident was and what actions were 
taken to correct it, it becomes questionable when a report 
comes in a year later as to the value of that.
    I realize in their proposal that they issued in September 
the FDA is recommending a 45-day maximum reporting period. 
That's something that FDA proposed--we did not give them what 
we thought was a reasonable period of time. But the issue 
you're raising about the shelf life is certainly something I 
think FDA needs to consider when they're making a 
determination.
    Mr. Upton. Do you know, though, if that consideration is 
going to be taken into effect with their proposed regs that 
they're planning to issue in 1901? Will they be looking at some 
gauge or standard to shorten that timeframe in terms of the 
error rate?
    Mr. Roslewicz. I hope they would do that. I haven't talked 
to them specifically about how they came up with the 45 days. 
It was something we did not do as part of the audit that we are 
testifying on today.
    Mr. Upton. Okay.
    Mr. Roslewicz. So I'm not sure as to what their basis was 
for the 45 days.
    Mr. Upton. Mr. Bilbray?
    Mr. Bilbray. Yes, Mr. Chairman.
    Ms. Sullivan, speaking to the FDA on the process--and I 
guess we were just talking about them trying to get their 
reports and their status-front loaded so you can respond to 
them. You know, I


look at 6 years being called expedited by the FDA and, you 
know, you kind of say, well, they were busy doing other things. 
And I guess, Dr. AuBuchon, it was probably because they've been 
blocking this licensing of blood substitutes as it goes through 
the process.
    I want to know when we get into this kind of a situation 
where we are being projected with a 2.2 reduction, do we have 
any strategy or is there any program being brainstormed to how 
they respond to get the public to respond to the crisis, if the 
crisis is created? And, Doctor, if you want to answer that, I'm 
sorry, I directed that to Miss Sullivan, but for any panelist.
    Ms. Heinrich. The Department of Health and Human Services, 
the HHS, has recommendations.
    First of all, they feel that it's very important to 
increase the monitoring, and I think we've heard that that is 
ongoing. There are recommendations to increase donations from 
the existing donor pool. There are recommendations to increase 
the donor pool since only 5 percent of those eligible are 
donating now. There are recommendations to improve donor 
relations, to develop public service announcements and to do 
studies so that we better understand the incentives for giving 
blood.
    And another one of their recommendations, there are a few 
others, but another one that I think people feel is very 
important is to address the economic issues that are facing our 
blood collection centers.
    Mr. Bilbray. My biggest concern is that if we really do 
have a plan that can be initiated as quickly as possible and to 
raise the public awareness--I mean, obviously, we could have--I 
know a lot of people would love to see Congress and the 
administration laid out on a gurney donating blood, and maybe 
more than we prefer, but that kind of public awareness, the 
ability to kick in that kind of program high enough, has 
anybody talked about that kind of high-profile response?
    Ms. Sullivan. Certainly. Within the private sector, the 
American Association of Blood Banks, also America's Blood 
Centers, and in fact a lot of the individual blood centers 
themselves have such plans, but resources are very limited. 
Obviously, education recruitment campaigns are very important. 
Plans have been developed particularly targeted to the younger 
generations, which is a considerable concern with respect to 
generating and encouraging new blood donors. And what is 
essentially needed are additional resources to support these 
education and recruitment campaigns.
    In addition, there are--there has been a lot of discussion 
of research activities, additional data collection activities 
that need to be undertaken to reduce the knowledge gap. 
Certainly research involving today's eligible blood donors, who 
gives blood, who doesn't give blood, why they don't give blood, 
how incentives factor into their blood donation decision, and 
then certainly the application of appropriate interventions and 
the effect of these interventions,these are all issues that we 
would all love to tackle if the resources were available.
    Mr. Bilbray. I would just ask, when you say resources, that 
we traditionally around here always talk spending more money on 
a new program rather than tapping into resources that are out 
there


already. The public relations and the public information--the 
public awareness potential that exists in this city and the 
ability for, you know, representatives from the city to go 
throughout the entire Nation on a ``weekend'' to raise that 
awareness, but that kind of coordinated effort, that, you know, 
popularizing, the whole issue has never been one--you see the 
President in foreign countries, but you don't see him on the in 
the West Wing giving blood. It may be one of those things that 
we talk about as a way--let's use this crisis as a way of 
raising it.
    The trouble is, we've got the problem, and, Dr. AuBuchon, 
we expose the risk of expanding the universe of blood donors. 
Is there--and my question is, is that a higher risk or a lower 
risk than utilizing those who have been in the United Kingdom 
and maintaining that pool?
    Mr. AuBuchon. You raise a good question, because whenever 
we defer a donor for whatever reason, that donor ultimately has 
to be replaced, if the supply is going to be maintained. And 
particularly when we are talking about deferring a relatively 
large proportion, say 2 percent of the donating population, we 
will have to replace them to some extent by new donors.
    New donors are known to be the riskiest donors, because 
they have not been previously tested for infectious disease 
markers, and their reasons for donating may not be as 
altruistic as the return repeat donor.
    We would like to see the donors that we have donate more 
frequently, but we realize there are economic pressures, social 
pressures and the like that not everyone is going to donate 
every 8 weeks. So we have to balance the risk involved in every 
decision.
    Mr. Upton. Excuse me just 1 second here. We have a series 
of votes. We have only about 4 minutes to go. I'm not one of 
those folks to miss votes. We will temporarily stop the 
proceedings, and we will come back at quarter of.
    [Brief recess.]
    Mr. Upton. I don't have to set the clock. We've got lively 
debate on the House floor. And we have a markup that's going on 
in another subcommittee, so members will probably be in and 
out.
    I have a couple more questions that I would like to ask.
    One, there's been a lot of attention with regard to this 
mad cow disease, and with the new proposal that's on the table, 
which is going to be implemented, a 6-month exclusion over a 
period of, what, 16 years, I guess it is. The estimate has been 
2.2 percent in terms of the drop-off of donors. Do all of you 
agree that that is probably about right?
    Ms. Heinrich. When GAO did its data collection, we tried to 
verify the numbers of people that go to the UK in any year. And 
in terms of the numbers of people--and this was the American 
Red Cross survey that gave us the estimate of 2.2, that this 
new regulation would affect about 2.2 percent of the supply. We 
think that that's pretty reasonable.
    What you don't know, though, is whether people, as this is 
publicized, how people will really respond to this. Will it 
increase people's concern and, therefore, they will not donate 
as they have in the past?
    Mr. Upton. One of the--Ms. Sullivan.


    Ms. Sullivan. If I could also add.
    Mr. Upton. Let me just clarify, too. When did that--when 
does that new regulation hit? Is it soon?
    Ms. Heinrich. Now.
    Mr. Upton. It's now. And when did it take effect?
    Mr. AuBuchon. Now.
    Ms. Sullivan. As soon as they can begin.
    Mr. Upton. August 17. Okay. Go ahead. I'm sorry to 
interrupt.
    Ms. Sullivan. The Red Cross data, the 2.2 percent primarily 
applies to whole blood donations. But it's also important to 
realize that apheresis--there also will be a hit on apheresis 
donations. Nine million platelets are transfused in this 
country each year approximately and, of those, about \2/3\ are 
collected by platelet phoresis. These donors actually donate, 
for the most part, more frequently and I have heard the figure, 
an average of 10 to 12 times per year. So the deferral could in 
fact hit that group even harder than the whole blood donor. So 
this is also something to consider.
    And also we can't really take into account without any data 
at this point, the effect, the indirect effect or the self-
deferral of donors who hear that they're deferring donors who 
have traveled to the UK, don't completely understand the 
deferral guidance, and they simply don't show up at the blood 
center because they assume that they landed in London 1 day, 
they may be deferred as well. So there will be probably an 
indirect effect as well.
    Mr. Upton. Now, your studies, when they commence next year, 
how quickly will you be able to ascertain whether that 2.2 
percent figure was correct, do you think?
    Ms. Sullivan. Well, we are hoping to be including some 
blood centers in our blood center sample that will be beginning 
some blood centers that will initiate the deferral or implement 
the deferral very soon, like before the end of the year.
    Mr. Upton. Before the end of 1999 or before 2000?
    Ms. Sullivan. Before the end of 1999. It will take some 
other blood centers longer to implement the deferral. They have 
to make changes in their SOPs, in their blood donor forms, 
their donation records. So they won't all begin essentially 
immediately or even within the next 30 days or so. But we will 
try and include some blood centers in our sample that are 
coming on-line early with the implementation of that deferral 
and try and get data as soon as we can.
    But it will be pretty limited. It will probably be 6 months 
or so before we have a sense.
    In addition, those data will need to be compared with data 
from the previous year, from the period when the deferral was 
not in effect by month. So we will need to go back 
retrospectively and collect some additional monthly data 
probably from last year for comparison.
    Mr. Upton. Dr. Heinrich, you indicated in your report 
that--I mean, this is fairly well-known, that O and the B 
donors or that blood supply is the shortest. I happen to be A. 
My wife would--I'm not going to get into that. Why is that? Is 
there any reason why O and B are traditionally on the short end 
of the stick?
    Ms. Heinrich. I would actually defer to Dr. AuBuchon on 
this.
    Mr. AuBuchon. There are several reasons for that.


    First of all, group O red cells can be transfused to any 
patient regardless of their ABO group. So in situations where 
we need to transfuse emergently, we don't have time to 
determine the ABO group. Or in some particular circumstances, 
such as in neonatal intensive care units, group O is the 
preferred type of blood to transfuse. That places a heavier 
burden on group O donors, which I happen to be one. And blood 
centers frequently call them to donate.
    Group B is in shorter supply than one might imagine, 
primarily because group B is more commonly seen in African 
Americans than in Caucasians. About 20 percent of African 
Americans are group B and only about 9 percent of Caucasians 
are group B. For whatever reason, the donation message is not 
received as well in minority communities. We are not as 
successful in recruiting blood donors from minority 
communities. So we are undercollecting group B in comparison to 
our use of group B.
    Mr. Upton. On page 2 of the GAO report, it states that 
about 4 percent of the allogenic blood supply expired without 
being transfused. Why would it have expired before it was 
shipped, do you know? Do you know the reason behind that?
    Ms. Heinrich. Why?
    Mr. Upton. Why would the shelf--I presume it's because it 
was there too long, right?
    Ms. Heinrich. I think that that would be the usual. Would 
you have anything more to say with that?
    Mr. AuBuchon. Yes, Mr. Chairman. About half to two-thirds 
of those expiring units are group AB, which, although it's the 
rarest type of blood, can only be given to group AB recipients, 
and since there are so few of those and their needs can be 
taken care of by any other blood group, the AB blood is more 
likely to outdate.
    The remainder are primarily group A, which, for the same 
reason, are usually only for group A recipients. So it's not a 
matter of logistics or having a better system to move the blood 
around. It's primarily this blood is just not needed.
    Ms. Heinrich. The demand.
    Mr. Upton. I understand. Thank you for that clarification.
    The GAO criticized the National Blood Data Research Center 
projection that the demand would outstrip available supply next 
year because the projection relied on the study that overstated 
the decline in blood supply. However, GAO noted that the supply 
of the imported blood decreased--allogenic and imported blood 
decreased 2.1 percent. The community supply decreased by 2 
percent, and that same portion of losses in autologous and 
directed donations would have to be replaced by units from the 
allogenic supply.
    Given those decreases and the expected loss of 2.2 percent 
because of the mad cow, isn't it still possible, do you think, 
that the demand could exceed supply next year?
    Ms. Heinrich. I think that the supply and demand of the 
blood system is very dynamic. And, as we've heard, recently 
some blood centers have said that their donations are up. We 
have to remember that this is data from 1997. So there are a 
number of unknowns on the supply side and, as we discussed, 
there are also a number of unknowns on the demand side.
    Mr. Upton. Ms. Sullivan, would you like to answer that? Or 
Dr. AuBuchon?


    Ms. Sullivan. We certainly maintain that a nationwide 
shortage could occur as early as next year, and we base that on 
the data that we collected.
    I would like to make a couple of points. To paint a picture 
of the U.S. blood supply that does not fully include autologous 
and directed donations, as the GAO has suggested, because they 
are pulling the curve down essentially faster than it should 
be, simply doesn't tell the whole story, and that's why we felt 
they needed to be included.
    Second, we think that it is clear, regardless of how you 
cut the numbers, that donations--if donations continue to 
decrease and usage is increasing, as it's likely to do, then 
the lines will eventually intersect, and whether it is next 
year or 5 years from now, we still need to take the same steps, 
we believe, to monitor the blood supply and avoid the 
situation.
    And we--as I announced today, we are taking steps to 
collect more recent data as quickly as we can, data from 1998 
and 1999, that will enable us to refine our estimate of the 
available supply for 2000.
    Mr. AuBuchon. Red cell use at our hospital had remained 
constant or slightly declined each year over the past 6 years. 
On average, about half a percent declined per year. I might 
like to take credit for that for working with our clinicians 
about better blood usage, but I'm not sure that really I can. 
However, in this year, our red cell usage has gone up 5 
percent, and that's without the addition of any new clinical 
programs, without closure of any hospitals in the area, for 
reasons that we can't define. We are doing more surgeries, and 
it relates--our increased usage of red cells relates to that, 
but the reason we are seeing more patients coming to us, we 
don't know.
    This is what is concerning to me knowing that the supply of 
blood is limited and may be headed downward, and it may indeed 
be that our usage is finally going upwards. We suppressed the 
usage in the mid-'80's, wringing some unnecessary transfusion 
out of the system. That change occurred because of some concern 
about HIV transmission. HIV certainly was not good, but the 
outcome in terms of becoming more conservative in blood 
transfusion was good, was useful.
    I think we have done about all that we can do for the near 
term in that, and as the population continues to get older, we 
will have more demand on medical services and more need for 
transfusion.
    Mr. Upton. You know, as a layperson looking at the blood 
givers and the different things that are out there to try and 
remind and encourage, it's the public service announcements on 
radio and TV, and it's different competitions--our church does 
a little bulletin thing down in the basement: Next Monday, it's 
going to be the day.
    And I know this week, when I was back in Michigan, I 
watched--Western Michigan University plays their big rival--
which is in Kalamazoo, which is, their big rival is the Central 
Michigan University, so they have an annual blood drive fight. 
The winner, whichever campus turns in more blood gets a nice 
award at halftime of the game, and it's traditional.
    As you've sort of looked at other communities across the 
country that often may be in a shortage of supply, what other 
things do you


think have worked effectively with the Red Cross and other 
groups in terms of, A, getting the message out before its dire 
straits like, you know, we are shipping people home from the 
hospital, whatever it might be? Or what other types of events 
have you seen that have been successful in raising the 
awareness of a community to let them know, in fact, there is a 
shortage and for folks to really come out and volunteer and 
donate a pint of blood?
    Ms. Heinrich. I'm sure others would like to contribute to 
the answer to this question.
    From our data gathering, I think that's an area that we 
don't know a great deal about, that we really feel that we 
found that the experts are saying that they need more 
information about how to effectively put forward campaigns. And 
I think that there's also an interest now in finding out how to 
target particular populations that would be a good and 
dependable donor pool, if you will.
    I think the other part of this is that the blood centers 
don't have incentives to collect more blood than they can use, 
and I think the balance that each center will try to achieve 
between blood collection, blood collection from a new pool and 
what they project their demand to be is a dynamic process that 
we don't know a great deal about.
    Mr. Upton. Are there some areas of the country that are 
traditionally more short than others in terms of having supply, 
and what are those? Where have they not done as good a job in 
other parts of the country by region?
    Ms. Heinrich. Our information says that New York, New York 
City, Miami or southern Florida, Los Angeles, San Francisco, 
seem to have chronic shortages. You probably want to add to 
that.
    Mr. Upton. Will your studies--in fact, as you do your 
monthly studies, will it look at region by region?
    Ms. Sullivan. Yes. We are selecting the sample so that it 
will be representative by region, by size of blood center and 
numerous other factors so that we will be able to analyze any 
potential shortages by region of the country.
    Mr. Upton. Dr. AuBuchon.
    Mr. AuBuchon. If I can just offer the comment. I'm not a 
specialist in donor recruitment, but I have worked in blood 
centers in the past. I don't think there's a magic bullet to 
donor recruitment. There's no one single thing that will work 
in all communities or with all potential donors. The bottom 
line is that it requires people to go out and talk to people. 
It requires public knowledge about the importance of blood 
donation, which has to begin with the childhood years and 
working up to the time when someone can be a donor. And it 
requires enough organizational skill and manpower to pull 
together a blood drive.
    I think we may be beginning to see the result of the 
constraints on health care spending as it's being trickling 
down to the blood centers. Hospitals have certainly seen 
difficult financial times over the last decade. They've placed 
pressure on all of their suppliers, including blood centers, to 
reduce costs.
    Blood centers have attempted to do that. They've also been 
faced with increasing demand for new tests and quality 
assurance approaches, regulatory requirements and the like. So 
they're being hit


from that side as well. And there just isn't--there aren't as 
many resources as there were in blood centers as there were in 
the past.
    I would think that recognition of the special nature of 
blood would be helpful and that there is an unusual commodity, 
it's donated. There's no payment for whole blood donation. The 
collection is handled by a not-for-profit blood center, 
community blood center or a large organization like the Red 
Cross, so not-for-a-profit blood center, without great 
resources, and the reimbursement is coming through a system 
that does not recognize blood as an individual cost item and 
yet the public is wanting more, more out of that system. So 
it's a difficult situation.
    Mr. Upton. Did either you or your organization, Ms. 
Sullivan, Dr. AuBuchon, provide comments to the FDA with regard 
to the new regulations that are supposed to be out?
    Ms. Sullivan. Certainly the American Association of Blood 
Banks, which my company is a subsidiary of.
    Mr. Upton. It was awhile ago, you know; 1996 was when they 
solicited the comments.
    Mr. AuBuchon. You're speaking of comments on error and 
accident reporting?
    Mr. Upton. Yes.
    Mr. AuBuchon. Yes, I did personally.
    Mr. Upton. Would you be able to provide us your comments to 
the subcommittee?
    Mr. AuBuchon. I will try to find them in my files, yes.
    Mr. Upton. You've gotten a new computer since then, so you 
have got to find them.
    All of us appreciate your testimony and your willingness to 
come up here today, sort of kicking off our series of hearings 
on this very important topic, and we appreciate that, providing 
us information that will certainly be used for questions, the 
FDA and others as they come up.
    And if you have additional comments or thoughts, please 
feel free to pass them along to any members of the subcommittee 
and the staff. We clearly are working very closely together.
    So thanks very much. You're excused. Have a nice day.
    [Whereupon, at 12:10 p.m., the subcommittee was adjourned.]
    [Additional material submitted for the record follows:]


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                     BLOOD SAFETY AND AVAILABILITY

                              ----------                              


                       WEDNESDAY, OCTOBER 6, 1999

                  House of Representatives,
                             Committee on Commerce,
              Subcommittee on Oversight and Investigations,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 10:30 a.m., in 
room 2322, Rayburn House Office Building, Hon. Fred Upton 
(chairman) presiding.
    Members present: Representatives Upton, Burr, Bilbray, 
Bryant, Bliley (ex officio) and DeGette.
    Staff present: Alan Slobodin, majority counsel; Anthony 
Habib, legislative clerk; and Chris Knauer, minority counsel.
    Mr. Upton. Okay. Good morning. This morning the 
subcommittee continues its oversight hearings on the safety and 
availability of the U.S. blood supply, and knowing that the 
chairman of the full committee, also a member of this 
committee, is here and knowing that he needs to be on the floor 
soon for the important debate on the Patients' Bill of Rights, 
I will yield for an opening statement to the chairman.
    Mr. Bliley.
    Chairman Bliley. Mr. Chairman, I want to thank you for 
these continued hearings concerning the safety and availability 
of the Nation's blood supply. I particularly want to welcome 
Dr. David Satcher and the other witnesses for the Department of 
Health and Human Services. As we learned at the previous 
hearing, the U.S. blood supply is tightening and will get even 
tighter. We need more blood. We also recognize that the U.S. 
blood supply has never been safer. Let me repeat that. It has 
never been safer.
    New technological advances can make the blood supply even 
safer, but we still can do more to reduce the risk. Errors and 
accidents in the blood supply, especially transfusion errors, 
remain a safety problem that can be reduced. In fact, the risk 
of a fatal transfusion from a transfusion error is about the 
same risk as getting a transfusion with the AIDS virus. One 
study, based on reports to the FDA, from 1990 to 1992 found 
that incompatible red blood cell transfusion continued to be 
the primary cause of preventable transfusion deaths and 
concluded that one-third of the deaths could have been 
prevented by following proper procedures.
    As we have learned, a well-designed reporting system is an 
effective safety management tool. For example, in the field of 
domestic airline safety, aviation reporting systems have helped 
contribute to a safety record of no fatalities in 1998. 
Unfortunately, the present FDA reporting system for errors and 
accidents at the blood supply


has several weaknesses. Some of these were identified by 
reports by the HHS Inspector General's Office and the General 
Accounting Office. Since the IG's Office issued recommendations 
4\1/2\ years ago, the weakness remains uncorrected, and FDA 
does not expect to publish a final rule on error and accident 
reporting until 2001.
    The American people should not have to wait until 2001 to 
have a stronger blood supply safety system. We can make getting 
a blood transfusion much more safe. There is an alternative 
reporting system with promising results that exists, and the 
FDA participated in its design. The alternative model is called 
the medical event reporting system for transfusion medicine, 
which was developed by Dr. Harold Kaplan and his team at the 
University of Texas. This reporting system is supported by a 
research grant funded by the National Heart, Lung, Blood 
Institute.
    Through this committee's investigation of blood safety, we 
have learned about the exciting possibilities of this new 
reporting system and brought this matter to the attention of 
Dr. Satcher. I am pleased that Dr. Satcher has indicated that 
he is taking action to see if it can be implemented. At the 
appropriate time, I intend to ask Dr. Satcher about how the 
Department can assume direct control over blood reporting and 
accident reporting, expedite a new policy and consider the 
medical event reporting system for transfusion medicine as the 
new reporting system for blood errors and accidents.
    Improving the reporting system is just one area this 
subcommittee is looking at to protect the Nation's blood 
supply. We want to be supportive of Dr. Satcher's efforts to 
increase blood donations. I believe the subcommittee and Dr. 
Satcher can work together to give the American people the blood 
they need with absolutely the most safety possible.
    And I thank you, Mr. Chairman, and regret that I am not 
going to be able to stay to hear the testimony of the 
witnesses.
    Mr. Upton. Well, I would note to all the folks that are 
here, not only are we very busy on the House floor, on votes 
that will commence in just a couple of minutes, but all of our 
subcommittees are meeting as well. Some of us are on another 
committee, as I serve on the Education Committee, and we are 
marking up Title I of the Elementary and Secondary Education 
Act. So you will see a lot of moving chairs as we work through 
this hearing this morning.
    We do welcome today's witness, Dr. David Satcher, who is 
the Assistant Secretary for Public Health, the U.S. Surgeon 
General and the Blood Safety Director, and we look forward to 
learning more about the views of HHS on the blood supply, the 
UK donor exclusion policy, strategies to increase the blood 
supply, error and accident reporting, and the HHS blood 
oversight system.
    At our previous hearing on September 23, we heard testimony 
that suggested that we are below the comfort level in some 
areas of our blood supply. The GAO testified that the blood 
supply as a whole is not in crisis, but there is a cause for 
concern about shortages of certain blood types or in certain 
regions. GAO confirmed that the available data showed that the 
blood supply has tightened, even though the blood supply has 
declined more slowly than assumed in the projections. The 
National Blood Data Resource Center, NBDRC, testified that if 
rates of overall blood collection and


transfusion that occurred between 1994 and 1997 continue, the 
U.S. may experience a national blood shortage as early as next 
year. Dr. James AuBuchon of the Dartmouth Medical School 
testified that given the demographics of our population, the 
blood supply situation is only going to get worse, and that he 
did not expect significant reductions in blood usage.
    At the same time our blood supply is tightening, HHS made a 
major policy change that could further reduce the blood supply. 
On August 17, 1999, FDA directed that individuals who had spent 
a total of 6 months or more in the United Kingdom between 1980 
and the end of 1996 be prohibited from donating blood because 
of concerns over the theoretical risk of spreading a new 
variant human form of mad cow disease. This new donor exclusion 
policy has been estimated to reduce the blood supply by 2.2 
percent. At the September subcommittee hearing, the GAO 
testified that this estimate appeared to be reasonable.
    At today's hearing, I would like to examine the strategies 
that Dr. Satcher and HHS are taking and considering to offset 
the shortages that may result from the U.K. donor policy.
    We will also follow up on a blood safety issue from the 
last hearing: error and accident reporting. On May 31, 1995, 
the Office of Inspector General, Department of Health and Human 
Services, IG, issued a report that concluded that the FDA could 
improve the safety of the blood supply by doing a better job of 
collecting data on errors and accidents made by hospitals and 
blood banks. The audit found that the FDA was not insisting 
that hospitals and blood banks submit error reports in a timely 
fashion, and that the FDA does not get these reports at all 
from unlicensed facilities that handle about 10 percent of the 
blood used in the United States.
    The IG made several important recommendations to address 
the issue, with which the FDA agreed. Yet here it is 4 years 
later, and the FDA has yet to issue a final regulation 
extending the reporting requirement to unlicensed facilities 
and requiring more timely reporting on the part of all of its 
facilities. The FDA has indicated that the final rule will not 
see the light of day until February of 2001, and this in spite 
of the fact that the Commissioner of the FDA has stated that 
blood safety is one of the agency's top priorities.
    One last issue we will want to discuss at the hearing is 
how well the new HHS blood oversight system is working. In July 
1995, the Institute of Medicine issued a report that concluded 
that there was a failure of leadership from the Public Health 
Service agencies that may have delayed effective action against 
AIDS-contaminated blood products. To address this problem, the 
report recommended that HHS reorganize its oversight of blood 
issues by establishing a blood safety director, a blood safety 
council and an expert panel. Starting in October of that year, 
HHS Secretary Donna Shalala instituted a number of changes, 
such as establishing the blood safety director as the Assistant 
Secretary of Health. Four years have nearly passed now since 
the HHS oversight system was established. It is certainly 
appropriate for this subcommittee to review what has been 
accomplished and what remains to be done in the stewardship of 
the blood supply.


    In addition to Dr. Satcher, I have also invited Secretary 
Shalala and FDA Commissioner Henney for this hearing. I had 
hoped, given the importance that both the Secretary and the FDA 
Commissioner have placed on blood safety, that they might have 
been able to join us today. Had they appeared with Dr. Satcher, 
it would have provided an even more powerful public statement 
from the administration about the importance of blood donations 
and blood safety. Since I intend this subcommittee to continue 
its oversight of the blood supply throughout this Congress, 
perhaps there will be another opportunity for these folks to 
appear before us.
    During this oversight hearing on blood safety and 
availability, the subcommittee will probably identify some 
areas where more could be done. I appreciate the difficulty of 
Dr. Satcher's task. I am strongly supportive of his goal and 
work to increase blood donations, and I am going to be playing 
my role by donating blood in Michigan next week.
    Again, the policy challenges facing the blood supply have 
changed in recent years, but some things about the blood supply 
have not changed. There is no substitute for blood, and we need 
blood donations. As Douglas Starr, the author of the book, 
``Blood,'' observed, ``Blood is a precious and dangerous 
medicine. We must be careful how we use it.''
    And I would yield for an opening statement to the vice 
chairman of the subcommittee, Mr. Burr.
    Mr. Burr. Thank you, Mr. Chairman. You stimulate me to look 
at my pocket and see if my due date is here for the next 
donation, and I am sure that it is.
    Let me take this opportunity to welcome the Surgeon General 
and to express the subcommittee's thanks for his diligence on 
this issue. I think it's safe to say that as we sit here today, 
not only is the blood supply safer, as you say in your 
testimony, but we also discover new health risks and technology 
changes when we're able to detect more things and also to check 
the blood supply.
    I think the challenge for us, though we can always find 
fault with Congress and with agencies, is to make a commitment 
that we will make sure that the government oversight and the 
policies we set in the future are as seamless as the technology 
and the health risks that we will face in the future; that it 
won't take an oversight committee of Congress or a delay from 
an agency to change the policy to reflect the safeguards that 
the American people need.
    I'm confident that we have the right formula in those 
agencies and the Surgeon General and in this Congress that we 
can accomplish this with the highest degree of confidence. I 
look forward to working with you, Mr. Chairman, and with the 
Surgeon General to make sure that seamless world is one that we 
can achieve.
    I thank you.
    Mr. Upton. Mr. Bilbray.
    Mr. Bilbray. Yes, Mr. Chairman. Mr. Chairman, I would like 
to echo Chairman Bliley's statement. I think a lot of us, as we 
approach these situations where we see that there's improvement 
can be done, we sort of forget about highlighting how much 
success we've had in the past. Let me just say as somebody 
who's had 25 years involvement in different public health 
issues and environ


mental health issues, we need to be reminded that the air today 
is cleaner than it has ever been in the history of the United 
States; that our water is cleaner than it's ever been in the 
history of the United States; our drinking water is safer than 
it's ever been in the history of the United States. There is 
less risk from hazardous waste today than there has ever been 
in the near past, and the fact is, our blood supply is safer 
than it has ever been in the history of this country.
    So I think starting from that basis, that we're not coming 
from a crisis of how terrible things are, but the fact that 
things are as good as they have been in the past, that we need 
to move forward and continue the process of improvement, 
continue to refine the safeguards, and I think that what we're 
looking for here now is how we can we do that fine-tuning to 
continue the evolution toward a safer, more healthy society for 
all citizens. And I appreciate the fact that we are trying to 
work together here in a bipartisan way with the administration 
and the Congress, and I look forward to us taking that next 
step. And there may not be a huge leap, but it's those small, 
little steps that have added up in the past, and those steps 
are the important steps that we need to make for the future.
    I yield back, Mr. Chairman.
    Mr. Upton. Thank you.
    Those of you all who heard those buzzers, it means we do 
have a vote on the floor. We'll temporarily adjourn. We will 
come back at about 11 o'clock.
    [Brief recess.]
    Mr. Upton. It must be 11 o'clock. We are going to keep the 
record open for any opening statements that other members may 
make. So I make unanimous consent that the record be open for 
any opening statements, and at this point we'll proceed with 
the opening statement of Dr. Satcher.
    As you know, it is customary of this subcommittee to take 
testimony under oath. Do you have any objection? Are you 
planning to have counsel with you or others?
    Mr. Satcher. No. I would like for the colleagues that I 
might call upon in the question period to stand with me and 
take the oath.
    Mr. Upton. If you could so identify them and have them 
maybe join with you, that would be perfect.
    Mr. Satcher. There will be three. Dr. Kathy Zoon is the 
Director of the Center for Biologics Evaluation and Research; 
and with her is Dr. Jay Epstein, who is Director of the Office 
of Blood Research and Review in the same center; and Dr. Steven 
Masiello, who is the head of the Office of Compliance and 
Biologics Quality. They might well be called during the 
question-and-answer period.
    Mr. Upton. If you all would raise your right hand.
    [Witnesses sworn.]
    Mr. Upton. You are now under oath, and again, we welcome 
you to this subcommittee, and you may proceed with your opening 
statement. Certainly, as a matter of courtesy, your statement 
in its entirety is made part of the record, and the time is now 
yours.


TESTIMONY OF DAVID SATCHER, ASSISTANT SECRETARY FOR HEALTH AND 
   SURGEON GENERAL, DEPARTMENT OF HEALTH AND HUMAN SERVICES, 
  ACCOMPANIED BY KATHRYN ZOON, DIRECTOR, CENTER FOR BIOLOGICS 
 EVALUATION AND RESEARCH, STEVEN A. MASIELLO, DIRECTOR, OFFICE 
   OF COMPLIANCE AND BIOLOGICS QUALITY, CENTER FOR BIOLOGICS 
 EVALUATION AND RESEARCH, AND JAY S. EPSTEIN, DIRECTOR, OFFICE 
 OF BLOOD AND RESEARCH REVIEW, CENTER FOR BIOLOGICS EVALUATION 
        AND RESEARCH, U.S. FOOD AND DRUG ADMINISTRATION

    Mr. Satcher. Thank you, Mr. Chairman and members of the 
Subcommittee on Oversight and Investigation of the Committee on 
Commerce. Thank you for inviting me to discuss the safety and 
availability of the blood supply. This is really a critical 
issue, and we appreciate this opportunity.
    Our Nation's blood supply is safer than it ever has been 
and is getting safer as we speak. Dr. AuBuchon, who testified 
before you last month, reported that just 2 years ago the risk 
of hepatitis C from blood transfusions was about 1 in 100,000 
transfusions, or about 120 cases a year. He also reported that 
the risk of HIV was about 1 in 500,000 transfusions, or about 
24 cases per year. We have made tremendous progress, especially 
when you reflect on the fact that it was not that long ago that 
the risk of hepatitis C was at least 50 times greater.
    One of my most memorable experiences as Director of the 
CDC, of course, was meeting with the National Hemophiliac 
Foundation a few years ago and revisiting their experience in 
the early to mid-1980's when over that half of that population 
was infected with HIV. We have come a long way, but the issue 
of the safety of the blood supply is still a very critical 
issue.
    We have recently introduced the nucleic acid test for 
hepatitis C and HIV into development. Most of the older tests 
which produce the results that Dr. AuBuchon described detect 
antibodies to these viruses, but in contrast, nucleic acid 
tests detect the viruses themselves. For this reason, nucleic 
acid tests may help us to close the so-called window period 
between the time an infectious agent appears in the blood and 
the time that infections can be detected.
    As you know, currently nucleic acid tests are 
investigational and are being evaluated widely using pools of 
donated blood. Even more sensitive nucleic acid tests performed 
on single units are under development. Collectively these 
advances should reduce the risk of transfusion-transmitted 
hepatitis C and HIV by a large order of magnitude and possibly 
even more.
    I want to say a word about what I think we've accomplished 
in terms of blood safety since we reorganized our strategy for 
protecting the blood supply. First, we have prioritized blood 
safety within the Department. Our efforts to increase the 
safety of the blood supply began in the earliest days of this 
administration. In July 1993, Secretary Shalala commissioned 
the Institute of Medicine to prepare a report on the 
introduction of HIV into the blood supply. She did this, as she 
said at the time, to ensure the safety of the Nation's blood 
supply against new challenges in future.
    The Institute of Medicine released its report in July 1995. 
On the same date that it was released, the Secretary directed 
Dr. Lee,


then the Assistant Secretary of Health and senior member of the 
Department, to review it. In October of that year, in testimony 
before Congress, the Secretary announced her concurrence with 
this report, and I must say I was then Director of the CDC, and 
I was involved in all of these deliberations. She also 
announced that she had designated the Assistant Secretary for 
Health to be the blood safety director for the Department. In 
addition, she announced the establishment of two high-level 
committees on blood safety and availability, one internal and 
one external to the Department.
    The Secretary concluded her testimony by saying blood and 
blood products will always be capable of transmitting diseases, 
and their use will never be completely free of risk. But for 
everyone who relies on blood and blood products to sustain 
life, the Federal Government will do everything in its power to 
reduce risk and to assure availability.
    We are implementing the Secretary's policy in three ways: 
No. 1, working for the timely introduction of new technologies 
such as the nucleic acid testing; two, a proactive response to 
the threats posed by emerging and reemerging infectious 
diseases such as transmissible spongiform encephalopathies; and 
three, increased attention to quality assurance, such as an 
emphasis on current, good manufacturing practice requirements.
    We believe that these three initiatives will permit us to 
achieve the degree of blood safety that the American people 
demand without compromising the blood availability that the 
American people need.
    What is our blood action plan? I feel it's important to 
stress in light of earlier discussions by the committee the 
commitment of the Food and Drug Administration to increasing 
effectiveness of regulation of the blood industry. The concrete 
expression of this commitment is the Blood Action Plan which 
was initiated in July 1997. The Blood Action Plan is one of the 
FDA's responses to the 1995 Institute of Medicine report and 
also to several congressional oversight reports since that 
time.
    The Blood Action Plan establishes a comprehensive review of 
all blood-related regulations. Most of this review has been 
completed. In May and August of this year, the FDA published 
direct final rules and companion proposed final rules that 
updated technical standards for blood and blood products. In 
August of this year, FDA proposed two additional rules, one on 
testing blood donors for infectious diseases and another on 
donor notification. But also in July of this year, FDA proposed 
an important consumer safety initiative, a tracking system for 
plasma derivatives from manufacturer through the distribution 
network to the end user, that will ensure prompt notification 
when indicated.
    Progress has been made in improving the responsiveness of 
the agency. Under the Blood Action Plan, FDA is harmonizing its 
new biologics license application for blood products with its 
new drug applications. In addition, I think it's important to 
note that the Food and Drug Administration is working with the 
CDC and NIH representatives and have formed an emerging 
infectious disease committee that has developed plans for 
responding to emerging infections that threaten the blood 
supply.


    I do want to point out, Mr. Chairman, that I think there 
are global implications to the safety of our blood supply, and 
as you probably remember, a few years ago when I was Director 
of CDC, we proposed a global system of surveillance and 
response for emerging infectious diseases, and that proposal 
was approved, and we are now in the process working with our G-
8 partners and others of implementing such a system.
    FDA has also recognized its field inspection programs and 
has reorganized these programs, and as a result, there has been 
considerable progress toward bringing the blood and blood 
product industries into full compliance with current good 
manufacturing practice requirements.
    In the past, we have talked about the hepatitis C look-back 
program, and in the interest of time, I will only mention the 
Department's initiative to notify all individuals who may have 
inadvertently been exposed to hepatitis C through blood 
transfusions. FDA has moved rapidly to issue guidance on this 
initiative and is moving rapidly as well to issue a final rule 
on this matter. I think the role of the CDC and the FDA in 
collaboration with the Agency for Health Care Policy and 
Research will allow us to implement an effective program and to 
evaluate that program as it goes forward. So we're committing 
to not only implementing this look-back, but being able to tell 
you how effective this program is being throughout the country.
    One of the major issues that you have discussed recently 
and that we have been concerned about is the defense against 
the transmissible spongiform encephalopathies. Over the past 4 
years, the Department has substantially updated its policies 
regarding TSEs, if you will. These include Creutzfeldt-Jakob 
disease, or CJD, and this new variant CJD, the human form of 
mad cow disease, if you will. Animal experiments indicate that 
both are potentially transmissible by blood transfusion, but 
it's important to point out that no actual case of this has 
been thus far observed in humans.
    This surveillance system that we have in place through the 
CDC really goes back to 1979, and we have been monitoring very 
closely for the occurrence of CJD and any form of it. So we're 
very confident about the data.
    Extensive epidemiologic data has permitted us to revise 
some precautions against CJD. However, new and disturbing 
information about this new variant CJD has recently become 
available. We have learned that the prions of new variant CJD 
are quite different from classic CJD in many ways, but let me 
say that this may explain why the clinical manifestation of the 
two diseases tend to be so different. We have learned that the 
new variant CJD forms deposits in peripheral tissues, like 
lymph nodes and the spleen and the tonsils, and there is some 
preliminary evidence in transgenic mice that suggests a role 
for certain blood cells in the pathogenesis of this disease, 
and I think you can see, therefore, why, even though there's no 
evidence that this is transmitted in the blood, we have not 
reached the level of comfort that would prevent us from taking 
action.
    We've learned that the risk of new variant CJD is uniformly 
distributed throughout the United Kingdom. In fact, the only 
definable risks of new variant CJD at present are long-term 
residence


in the United Kingdom and the methionine homozygosity at codon 
129 of the prion protein gene.
    The first critical piece of information we currently lack 
is the length of the incubation period between exposure to the 
agent of a new variant CJD and the onset of the symptoms. This 
is a really critical issue. I think if we were to assume that 
the incubation period in humans were the same as in cows, we 
would assume that it was about 5 years, and therefore, we would 
expect no more than about 500 victims. Even that assumption is 
open to some question. However, the incubation period in humans 
could be as much as 40 years, and that means that we could have 
as many as 500,000 victims of this new variant CJD.
    I think the other critical piece of information we 
currently lack is whether this new variant CJD is, in fact, 
transmitted by a blood transfusion in man. So far there is no 
evidence that this has occurred, and as you probably know, we 
have had no evidence that CJD itself has been transmitted 
through the blood and humans. And without going into a lot of 
detail, we have followed the evolution of this, especially 
looking at the hemophiliac population, persons with 
thalassemia, persons with sickle cell disease, all people who 
receive a lot of transfusions, and there's no evidence today 
that that population is at any greater risk for CJD than any 
others. So we are pretty comfortable, even though not 
comfortable to stop monitoring this very carefully, but we have 
no evidence to date that CJD itself is transmitted through 
blood transfusions.
    The Food and Drug Administration's Transmissible Spongiform 
Encephalopathy Advisory Committee made recommendations on June 
2 of this year regarding donor deferral based on a period of 
residence or travel in the United Kingdom to the blood safety 
committee which I chair, and we voted unanimously to support 
that, and it was really out of that committee that we 
recommended that persons who had spent up to 6 months in the 
United Kingdom between the years of 1980 and 1996 be deferred 
from blood transfusions. There is, as you know, some 
disagreement with that, but I do want to point out that we felt 
that if we were going to err, we should err on the side of 
being very cautious.
    We were concerned about the impact that this would have on 
the blood supply. According to our data and our estimates, this 
could potentially reduce the blood supply by 2.2 percent, but 
it would, on the other hand, take care of 87 percent of the 
days of risk that we would experience from that group of 
people. So we felt that this was the right decision. However, 
the main point I want to make today is that this is a decision 
that we will continue to revisit at least every 6 months. So as 
we speak, we are evaluating the impact that this decision is 
having.
    The next point I want to make is a word about the 
availability of blood and what we're trying to do to assure 
that blood availability is enhanced in this country. At the 
June 8 meeting of the Blood Safety Committee, I did appoint an 
Interagency working group to make recommendations to me about 
ways that we could enhance the blood supply, and they made 
their recommendations, which I have accepted, and there are 
five areas of recommendation.
    One is, of course, that we do a better job of monitoring 
the blood supply, and we have committed up to $300,000 in the 
current fiscal


year from NHLBI to purchase this information from the National 
Blood Data Resource Center. So we are going to be monitoring 
much more carefully the blood supply and seeing what's 
happening to donations.
    We're also going to do more to encourage the public to 
donate blood. I was very happy to hear about your commitment 
and others on the panel. I hope to do a much better job as 
Surgeon General of communicating to the American people in 
general the importance of donating blood, as well as donating 
organs. A lot of lives can be saved, and we're going to make 
that a much greater part of our deliberations.
    The NIH has committed $1.8 million in the current fiscal 
year to research strategies that can be used to enhance 
donation.
    The third thing that this committee recommended and we 
accepted was that we needed to work on improving the 
relationship between donors and the blood establishment. There 
are donors who complain about the experiences that they have 
when they go to donate blood. So we're going to see how we can 
really improve that relationship in many ways.
    We also are going to remove unnecessary restrictions to 
donations. This is a very important recommendation because we 
believe that there is much more blood available than we're 
receiving because of some unnecessary restriction. So we are 
going to review the current donor deferral policies, 
particularly in light of emerging technologies, such as nucleic 
acid testing. FDA's decision to reassess donations by 
individuals with hemochromatosis that was announced on August 
10 by Commissioner Henney is only one of several responses to 
this issue that we are now considering.
    And finally, we're going to address economic concerns of 
the blood industry as it relates to blood donations. What I 
didn't say, which I should mention because I don't know how 
many people are aware, that about 60 percent of the people in 
the population are really eligible for blood donation, and yet 
only about 5 percent are donating. The other thing, of course, 
is that of the people who donate, many of those persons could 
donate many more times a year than they are. Most of them 
donate once a year. So we are working on those two things at 
the same time.
    The other Departmental initiatives in blood safety which 
I'll mention just briefly as I close is to look at the issue of 
accidents and errors associated with blood administration, 
which Congressman Bliley mentioned. FDA has long recognized the 
importance of reporting investigation and correction of errors 
and accidents. The FDA has already used information learned 
from the errors and accident reports to identify areas where 
clinical practice and government regulations could be improved, 
and FDA issued a proposed rule in 1997 to require unlicensed, 
as well as licensed, institutions to file these reports, and 
they quantified a time period in which they should be filed. 
However, the final rule of this matter has yet to be issued.
    It is important to emphasize that the error and accident 
reporting required under this rule serves not to alert the FDA 
to emergencies, but to provide an additional layer of data for 
quality assurance for longer-term safety monitoring, audits and 
to help support for target inspections. The major proactive 
approach to assuring


high quality and compliance with the regulations of the blood 
industry is, in fact, FDA's regular inspection process. In 
fact, the vigorous and rigorous FDA inspection program has led 
in recent years to a number of major enforcement actions to 
help assure the safety of the blood.
    Mr. Chairman, I would like to join your fellow committee 
members who have thanked you for holding this hearing because 
you have raised awareness of an essential layer of the blood 
safety system. I want to assure you that none of us are waiting 
for the time required to issue a final rule to address this 
important matter. As you know, on August 13 of this year I had 
directed the Advisory Committee on Blood Safety and 
Availability to place this matter on their agenda. This is a 
very talented advisory committee, very diverse in terms of its 
expertise, and they will be looking critically at this matter. 
This meeting in which they will discuss this issue is scheduled 
for late January of 2000, and preparation for it is already 
under way.
    Congressman Bliley mentioned Dr. Harold Kaplan, professor 
of transfusion medicine, who has been awarded a research grant 
by the National Heart, Lung, and Blood Institute to study 
transfusion errors and how it might be reduced. The Department 
will promptly consider any recommendations that arise from this 
meeting. We will not wait until 2001 to respond. We will move 
as expeditiously as possible to put in place recommendations to 
enhance or reduce errors and accidents, and we'd be delighted 
to inform of you our response to these recommendations.
    Thank you.
    [The prepared statement of David Satcher follows:]
Prepared Statement of David Satcher, Assistant Secretary for Health and 
        Surgeon General, Department of Health and Human Services
    Mr. Chairman, Members of the Committee: Thank you for your 
invitation to discuss the safety and availability of the blood supply.
                   i. recent advances in blood safety
    Our nation's blood supply is safer than it ever has been, and it is 
getting safer even as we speak. Dr. AuBuchon, who testified before you 
last month, reported just two years ago that the risk of hepatitis C 
from blood transfusion was about one in one hundred thousand 
transfusions, or about 120 cases per year. He also reported that the 
risk of HIV was about one in five hundred thousand transfusions, or 
about 24 cases per year.
    Since then, nucleic acid tests for hepatitis C and HIV have been 
developed. Most older tests, which produced the results Dr. AuBuchon 
described, detect antibodies to these viruses. In contrast, nucleic 
acid tests detect the viruses themselves. For this reason, nucleic acid 
tests may help us close the so-called ``window period'' between the 
time an infectious agent appears in the blood and the time that 
infection can be detected.
    Currently, nucleic acid tests are investigational, and are being 
evaluated widely using pools of donated blood. Even more sensitive 
nucleic acid tests performed on single units are under development. 
Collectively, these advances should reduce the risk of transfusion-
transmitted hepatitis C and HIV by an order of magnitude, and possibly 
even more.
             ii. department accomplishments in blood safety
A. Prioritization of Blood Safety Within the Department
    Our efforts to increase the safety of the blood supply began in the 
earliest days of this Administration. In July 1993, Secretary Shalala 
commissioned the Institute of Medicine to prepare a report on the 
introduction of HIV into the blood supply.


She did this, as she said at the time, ``. . . to insure the safety of 
the Nation's blood supply against new challenges in the future.''
    The Institute of Medicine released its report in July 1995. On the 
day it was released, the Secretary directed Dr. Lee, then the Assistant 
Secretary for Health, and senior members of the Department to review 
it. In October of that year, in testimony before Congress, the 
Secretary announced her concurrence with the report. She also announced 
that she had designated the Assistant Secretary for Health to be the 
Blood Safety Director for the Department. In addition, she announced 
the establishment of two high-level committees on blood safety and 
availability, one internal and one external to the Department. The 
Secretary concluded her testimony by saying
        Blood and blood products will always be capable of transmitting 
        disease, and their use will never be completely free of risk. 
        But for everyone who relies on blood and blood products to 
        sustain life, the Federal Government will do everything in its 
        power to reduce risk and assure availability.
    We are implementing the Secretary's policy by:

1. Timely introduction of new technologies, such as nucleic acid 
        testing;
2. Proactive response to the threats posed by emerging and re-emerging 
        infectious diseases, such as transmissible spongiform 
        encephalopathies; and
3. Increased attention to quality assurance, such as emphasis on 
        current Good Manufacturing Practice requirements.
    We believe that these three initiatives will permit us to achieve 
the degree of blood safety that the American people demand without 
compromising the blood availability that the American people need.
B. Blood Action Plan
    I feel it is important to stress, in light of earlier discussion by 
this Committee, the commitment of the Food and Drug Administration to 
increasing the effectiveness of regulation of the blood industry. The 
concrete expression of this commitment is the Blood Action Plan, which 
was initiated in July 1997. The Blood Action Plan is one of FDA's 
responses to the 1995 Institute of Medicine report, and also to several 
congressional oversight reports since that time.
    The Blood Action Plan established a comprehensive review of all 
blood-related regulation. Most of this review has been completed. In 
May and August of this year, FDA published Direct Final Rules, and 
companion Proposed Final Rules, that updated technical standards for 
blood and blood products. In August of this year, FDA proposed two 
additional rules, one on testing blood donors for infectious diseases, 
and another on donor notification. Also, in August 1999, FDA proposed 
an important consumer safety initiative: a tracking system for plasma 
derivatives from manufacturer through the distribution network to the 
end user that will insure prompt notification when indicated.
    Progress has also been made in improving responsiveness of the 
Agency. Under the Blood Action Plan, FDA is harmonizing its new 
Biologics License Application for blood products with its New Drug 
Application. In addition, FDA, CDC, and NIH representatives have formed 
an Emerging Infectious Diseases Committee that has developed plans for 
responding to emerging infections that threaten the blood supply. FDA 
has also reorganized its field inspection programs. As a result, there 
has been considerable progress towards bringing the blood and blood 
products industries into full compliance with current Good 
Manufacturing Practice requirements.
C. Hepatitis C Lookback
    In the interest of time, I will only briefly mention the 
Department's initiative to notify all individuals who may have been 
inadvertently exposed to hepatitis C through blood transfusion. FDA has 
moved rapidly to issue Guidances on this initiative, and it is moving 
rapidly as well to issue a Final Rule on this matter. As part of this 
effort, CDC is coordinating a Hepatitis C Public Information Campaign 
and, in collaboration with FDA and the Agency for Health Care Policy 
Research, will carefully evaluate both the targeted and the general 
notification efforts.
D. Defense Against Transmissible Spongiform Encephalopathies
    Over the past four years, the Department has substantially updated 
its policies regarding the transmissible spongiform encephalopathies. 
These include Creutzfeldt-Jakob disease, or CJD, and new variant CJD, 
the human form of ``mad cow'' disease. Animal experiments indicate that 
both are potentially transmissible by blood transfusion, but no actual 
case of this has so far been observed in humans.
    Extensive epidemiologic data has permitted us to revise some 
precautions against CJD. However, new and disturbing information about 
new variant CJD has recently become available. We have learned that the 
prion of new variant CJD is different


from the prion of classic CJD. This may explain why the clinical 
manifestations of the two diseases are so different. We have learned 
that the prion of new variant CJD forms deposits in peripheral tissues, 
and there is some preliminary evidence in transgenic mice that suggests 
a role for certain blood cells in the pathogenesis of this disease. We 
have learned that blood from rodents experimentally infected with Mad 
Cow Disease can, under some circumstances, transmit it to other 
rodents. We have learned that the risk of new variant CJD is uniformly 
distributed throughout the United Kingdom. In fact, the only definable 
risks of new variant CJD at present are long-term residence in the 
United Kingdom, and methionine homozygosity at codon 129 of the PRNP 
gene.''
    The first critical piece of information we currently lack is the 
length of the incubation period between exposure to the agent of new 
variant CJD and the onset of symptoms. In cows it is five years. If it 
is also five years in people, there may be no more than 500 victims of 
this disease. However, if the incubation period is up to forty years, 
there could be more than 500,000 victims of new variant CJD.
    The other critical piece of information we currently lack is 
whether new variant CJD is in fact transmitted by blood transfusion in 
man. No such instance has yet been identified, but the possibility has 
not been excluded. Some have suggested that we take no action until the 
first case of transfusion-transmitted new variant CJD is documented. 
However, by that time, how many others might be irreversibly infected 
with a uniformly fatal disease that destroys the brains of its victims 
in the prime of their lives? We have chosen to reduce this risk by the 
limited methods now available to us, and not wait until the answer 
reveals itself.
    In formulating our policies, we have repeatedly invited comment 
from scientists, the blood industry, and the public on their perception 
of the risk to blood safety posed by new variant CJD to blood safety, 
the impact of any measures we might take to reduce that risk, and what 
we could do to minimize that impact. As we expected, the advice varied. 
For this reason, we followed the process established by Secretary 
Shalala in 1995, which was to bring this matter promptly to the highest 
level of the Department. The Food and Drug Administration's 
Transmissible Spongiform Encephalopathy Advisory Committee made their 
final recommendation on June 2 of this year regarding donor deferral 
based on a period of residence or travel in the United Kingdom; the 
Blood Safety Committee, which I chair, met on June 8. The Blood Safety 
Committee's recommendation was unanimous in favor of this precautionary 
measure. FDA announced this recommendation at its Blood Products 
Advisory Committee meeting on June 17, and FDA's Guidance to Industry 
was issued on August 16.
      iii. department actions to assure the availability of blood
    At the June 8 meeting of the Blood Safety Committee, I appointed an 
Interagency Working Group to identify strategies to increase the blood 
supply. I received their report on August 10, and discussed it at the 
August 26 meeting of the Advisory Committee on Blood Safety and 
Availability. I concur with each of their recommendations, both for the 
short and the long term, and I have directed the appropriate agencies 
to implement these recommendations as soon as possible. Much of this 
implementation has already occurred.
A. Monitor the Blood Supply
    The first recommendation of the Interagency Working Group was to 
institute prospective monitoring of the blood supply. The NIH has 
committed up to $300,000 in the current fiscal year to purchase this 
data from the National Blood Data Resource Center, beginning as soon as 
possible, and perhaps even this month. Plans for long-term management 
of this activity are currently under review.
B. Encourage the Public to Donate (And to Continue Donating)
    The second recommendation was to increase suitable donations. As 
the General Accounting Office report to your Committee pointed out, 
there are plenty of eligible donors; we simply need to find more 
effective ways to encourage them to donate. The NIH has committed $1.8 
million dollars in the current fiscal year to research in this area.
C. Improve Relations Between Donors and Blood Establishments
    The third recommendation was to improve relationships between 
donors and blood centers. While much of this task is the industry's, 
the Department will consider steps that it can take. For example, there 
may be ways to make required donor questionnaires less burdensome 
without making them less effective.


D. Remove Unnecessary Restrictions to Donation
    The fourth recommendation was to review current donor deferral 
policies, particularly in light of emerging technologies such as 
nucleic acid testing. FDA's decision to reassess donations by 
individuals with hemochromatosis that was announced on August 10 by 
Commissioner Henney is only one of several responses under active 
consideration by FDA.
E. Address Economic Concerns of the Blood Industry
    The fifth and final recommendation was to address economic 
pressures on the blood industry that may limit its performance. The 
Advisory Committee on Blood Safety and Availability reviewed this issue 
at its August 27 meeting. The Committee's recommendations are currently 
under review within the Department.
           iv. other departmental initiatives in blood safety
    Another issue that both we and you have under active review is 
accident and error associated with blood administration. FDA has long 
recognized the importance of reporting, investigation, and correction 
of errors and accidents. FDA has already used information learned from 
error and accident reports to identify areas where clinical practice 
and government regulation could be improved. FDA did issue a Proposed 
Rule in 1997 to require unlicensed as well as licensed institutions to 
file these reports, and to quantify the time period in which they 
should be filed. However, a Final Rule on these matters has not yet 
been issued.
    It is important to emphasize that the error and accident reporting 
required under this rule serves not to alert the FDA to emergencies, 
but to provide an additional layer of data for quality assurance, 
longer-term safety monitoring, audits, and to help target inspections. 
The major proactive approach to assuring high quality and compliance 
with regulations in the blood industry is FDA's regular inspection 
process. In fact, the vigorous FDA inspection program has led, in 
recent years, to a number of major enforcement actions which have 
helped assure blood safety.
    Mr. Chairman, I would like to join your fellow Committee members 
who have thanked you for holding this hearing, because you have raised 
awareness of an essential layer of the blood safety system. I want to 
assure you that none of us are waiting for the time required to issue a 
final rule to address this important matter. As you know, on August 13 
of this year I had directed the Advisory Committee on Blood Safety and 
Availability to place this matter on their agenda. This meeting is 
scheduled for late January 2000, and preparations for it are already 
under way. One of the invited speakers will be Dr. Harold Kaplan, the 
Professor of Transfusion Medicine at Columbia University, who has been 
awarded a research grant by the National Heart, Lung, and Blood 
Institute to study transfusion error and how it might be reduced. The 
Department will promptly consider any recommendations that arise from 
this meeting, and I would be delighted to inform you of our response to 
these recommendations as soon as it is formulated.
    I would be happy to answer any questions you may have.

    Mr. Upton. Well, thank you very much for your testimony, 
and again, I apologize for Members who are not here, but we do 
have a number of activities going on in committee that require 
all of our attention.
    As I indicated in my opening statement, I am planning to 
donate blood next week, and I am going to be donating it 
through my local Red Cross facility back in Michigan. We don't 
have votes on Monday, and I know that the Red Cross, of course, 
complies with all the regulations. They are, in fact, licensed. 
They have inspections. They have prompt reporting of any error 
and accident rates, and all of us want very much to know and be 
assured that, in fact, all of the blood supply, 100 percent, is 
sufficient in terms of its level and that it is safe.
    And one of the concerns that I know Chairman Bliley raised 
earlier and all of us share is that, in fact, we're not perhaps 
at that 100 percent level. And you referenced the regulations 
that were put out for comment back in 1997--a good year for the 
Michigan Wolverines, national champs, and we're looking to 
repeat again this year--but you know, 10 percent of the blood 
collected, in fact, goes


to unlicensed facilities that, as I understand it, are 
inspected maybe not more than once every 1 or 2 years. The 
definition of prompt reporting of errors and accident rates--
it's all relative. Who knows what it is. In fact, furthermore, 
we learned that there are a number of blood transfusion centers 
that have no oversight by the FDA at all but, in fact, are 
overseen by HCFA. Is that right?
    Mr. Satcher. Well, there are some programs that come under 
HCFA because they are funded through Medicare and Medicaid, so 
that is true.
    Mr. Upton. But there's a mishmash of stuff that does not 
sort of bring the full regulatory oversight to 100 percent of 
the blood supply; is that not right?
    Mr. Satcher. I would say that's correct, and I think that 
that's what we're looking to correct.
    Mr. Upton. Well, Chairman Bliley indicated earlier today 
when he was here at the committee that one-third of the 
transfusion-related deaths could have been prevented by 
eliminating human errors in the processing of blood. 
Unfortunately, the FDA has yet to implement the regulations 
providing for more timely reporting and more comprehensive 
reporting of the error and accident rates as recommended by 
both the GAO and the Inspector General, and there are a lot of 
us that are not happy about waiting until the year 2001. That's 
a long time away.
    Chairman Bliley raised earlier today that as the airline 
industry is required to promptly report all of the problems 
that may happen in the air. They have learned from those 
mistakes, and we had a 100 percent safety record, as I recall, 
this last year, no deaths. That has not been the case with 
blood safety. A question that I have for you, particularly as 
you look to the meeting that you referenced in January coming 
up a couple of months from now, would you be willing as the 
blood safety director to assume control over the policy of 
error and accident reporting, to put the medical event 
reporting system for transfusion medicine before that meeting 
and report back to this subcommittee next March or so on 
whether or not you can implement the error and accident 
reporting initiative way before they might otherwise come to it 
in 2001? Would that be something you'd be willing to discuss 
and put on the agenda?
    Mr. Satcher. Yeah. In essence, in our mind that's what I've 
done. My intent is that----
    Mr. Upton. In other words, we want someplace where the 
buck's going to stop, and we don't want to wait a couple more.
    Mr. Satcher. I take responsibility for blood safety and 
availability. I think my role as Assistant Secretary for Health 
puts me in charge of the Blood Safety and Availability 
Committee in the Department. We have an outside advisory 
council to whom we take issues so we can get the kind of input 
that we need to make the right decisions. So I take that 
responsibility very seriously, and I have talked with 
Commissioner Henney, and she is well aware that we're going to 
move forward when we get the information we need to deal with 
errors and accidents. We are not waiting until the year 2001.
    Mr. Upton. You think that you can implement a system that, 
in fact, will be in place way before 2001 so, in fact, 100 
percent of the


blood collected will be regulated and we can be assured that 
it's safe?
    Mr. Satcher. I don't want to preempt the committee.
    Mr. Upton. You've got a couple of----
    Mr. Satcher.  I don't want to preempt the January meeting. 
I can tell you what I think, but it wouldn't be fair for me to 
say to an advisory council, I want you to put this on your 
agenda, I want you to bring the best minds in the country to 
testify, and then when we finish that meeting, we're going to 
make a decision about how rapidly we can move, and I will 
report back to you. It is my intent to move as rapidly as 
possible, yes, but I do want to go through the process. I wish 
it would have happened faster, but this is where we are. We 
have set in this place, this process of bringing it before a 
very outstanding advisory council. Dr. Harold Kaplan will be 
there to testify, and we're going to move as rapidly as 
possible following that.
    Mr. Upton. Well, we'd like to light the fire underneath 
that meeting to be sure that it comes into place because we 
don't want to wait. We raised this at our hearing we had back 
in September. From 1997 to 2001 is too long. I don't know of 
any regulation in this administration or the last couple that 
has waited and languished that long on an issue that everyone, 
everyone will acknowledge is one of the most important things 
that we need to assure the American public that it is safe, 
particularly when we see the evidence that as much as 10 
percent has regulation that's pretty lax. Every year or 2 
someone might come by and inspect the records versus accurate 
and prompt reporting of any error or accident. If other 
agencies are able to do it, there's no reason why we can't try 
to expect the same for something just as vital as this one. 
Your leadership will be most appreciated in crossing that 
touchdown line.
    Mr. Satcher. I appreciate that. It's not my intent, and I 
try to avoid doing that, to make excuses for what has not 
happened, but in fairness to FDA and others, I don't think they 
have just been sitting and waiting. I think we have made a 
tremendous progress in this area while dealing with hepatitis C 
issues and several other major issues in blood safety where we, 
as you have pointed out, have made tremendous progress in the 
last 2 or 3 years. So they have not just been waiting, and I 
think if you look at the data in terms of the number of deaths 
that have occurred from blood transfusions, they have been 
coming down rapidly. I think it's about, what, 45 to 50 per 
year now based on, you know, the blood itself that's being 
transfused.
    We have made tremendous progress. We will not be satisfied 
until we have in place a system that is optimal for protecting 
the blood supply and the safety of the transfusion itself,but 
they have not just been sitting and waiting. They have been 
involved in a process that I would agree I think we can move 
more rapidly, and we're going to move more rapidly.
    Mr. Upton. So you are not happy about the delay either 
then?
    Mr. Satcher. I am not happy about the delay, but I also 
understand people have made a lot of progress in the system 
while we have been, as you say, waiting for the formal, the 
final rules.


    Mr. Upton. What would you say about the blood transfusion 
centers? Are their regulations that you would like to see come 
into place, put it under one body instead of others such as we 
have learned with HCFA?
    Mr. Satcher. Well, I think--again, I think that's what--I'd 
like to wait and see what works best. There is a reason for 
things being the way that they are in terms of efficiencies, 
and we're going to look at that. That is one of the issues that 
we will be looking at, but again, I get criticized when I don't 
allow the advisory council to advise us before we make 
decisions and commitments, and I don't want to be guilty of 
that, and I don't think it's the best way to run this 
operation. So I will listen very carefully to the input from 
that council and will act on the best information 
expeditiously. That I will promise you.
    Mr. Upton. Well, we look forward to hearing back.
    At this point, I yield to the vice chairman Mr. Burr.
    Mr. Satcher. If you would like to hear more details from 
Dr. Zoon.
    Mr. Upton. I'm sort of watching the clock. I didn't set 
this little timer here. Do you want to respond to that now? 
That would be terrific.
    Ms. Zoon. One thing I would like to ensure the committee is 
100 percent of the blood is regulated. That 10 percent of the 
blood supply which is supplied by registered blood banks in 
lieu of the 90 percent that's under licensed banks is regulated 
by FDA. They are required to maintain error and accident 
reports in their blood banks, and those are inspected when the 
FDA goes in there. Their submission of the reports to the FDA 
is voluntary, but their need to follow GMPs and establish error 
and accident reports and follow up on those error and accidents 
is part of our requirement.
    Mr. Upton. My point is, though, the inspections may lapse 
for as long as 20 or 24 months before someone actually comes by 
to sort of leaf through the material. Though the definition is 
we'd like you to report it today when you have an accident, in 
fact that doesn't happen.
    Ms. Zoon. And we agree with the committee, and it is being 
changed in the proposed rule to have those voluntary reports 
mandated, but if there are problems in a facility, our 
inspectors will follow up more frequently than the 1 or 2 
years, depending on the nature of the violations in the blood 
bank.
    Mr. Upton. But, see, one of the points I would like to make 
is here we have a problem that's been identified and you admit 
is a problem, and we'd like to change it. Why is it that it 
takes years to get even that part of it in place? What would be 
the problem of just promulgating a final rule that just deals 
with that, which then gives us all a little breathing room in 
terms of the safety of the blood supply?
    Ms. Zoon. Sir, we did propose the rule which includes the 
very blood banks that you have----
    Mr. Upton. I know that it is proposed, but it's not final.
    Ms. Zoon. And the FDA has gotten the comments back. We had 
97 comments back on the proposed rule, and many of these 
comments have been reviewed, categorized, and definitely we are 
moving forward on this rule. And clearly under Dr. Satcher's 
leader


ship, we will move as expeditiously as possible to finalize 
this rule, again, being mindful of the PHS Blood Advisory 
Committee. But one thing I want to assure the committee, and 
this is very important, that error and accidents are just a 
very small part of the surveillance procedures that we use for 
blood banks. We have--as I mentioned, there are not only error 
and accidents. We have adverse reports. We also have fatality 
reports, and I think this is very important because this 
requires the institutions to report to the agency immediately 
and then follow it up with a report within 7 days, and that is 
for the fatalities.
    In addition, we get annual reports. If there are medical 
device reports, they are also reported to the agency. In 
addition, we have guidances, inspection programs and recalls 
that we use as part of our compliance activities to ensure at 
least that this oversight of the blood safety program is dealt 
with, and while we recognize the importance of error and 
accidents as part of that, it is part of the bigger picture of 
the FDA surveillance of this system. And we treat this very 
seriously because we believe this is an important area of one 
of the five layers of blood safety.
    Mr. Upton. I would just like to say, I know that I am 
beyond my 5 minutes and I apologize to my friend and colleague 
Mr. Burr. But as I think about things, 1997 is a while ago, and 
to have only 97--I used to work at OMB, and I know what 
comments look like--and to have only 97 comments come in is not 
an inordinate number that someone can't begin to look through, 
even almost one a month, to try and get the darn thing done. To 
wait until 2001, I just think one death is too many. I would 
hate to welcome that family and say, if those regulations had 
only been in place like it was proposed, you know, years ago, 
we could have saved. I mean, it's just not acceptable. I don't 
know if you're able to do this, but can you share with this 
committee the 97 comments?
    Ms. Zoon. Yes, yes.
    Mr. Upton. Can I get copies of the 97? I'll look through 
them myself.
    Ms. Zoon. Yes.
    Mr. Upton. I look forward to doing that, but I don't think 
it will take years to finish that, particularly when I know 
that one of the top priorities of the Commissioner is blood 
safety. I mean, it doesn't seem like we're getting there--it's 
not right. The priority may not be there even though she is 
well-intended in stating such. I mean, we're just not seeing 
the results that we really ought to have. It's because of that 
stack of frustration that the chairman and others are looking 
at. Maybe we ought to transfer the authority to someone that we 
know is responsible and thoughtful and courageous and a good 
spokesperson in making sure that the job gets done.
    Mr. Satcher. As we speak, I take responsibility because in 
the Department I am responsible for the blood safety community. 
That includes FDA and NIH and CDC, and I have discussed this 
with Commissioner Henney, and we are going to move forward 
expeditiously. We are going to give time----
    Mr. Upton. Well, surprise us. Okay.
    Mr. Burr.
    Mr. Burr. I thank you, Mr. Chairman.


    Dr. Zoon, if you would just stay at the table, and I thank 
you for being here. Few people do I hold in as high a regard at 
the FDA as I do you, and I thank you.
    Just for the record let me say, Mr. Chairman, that if my 
memory serves me correctly, the time that it took to go from 
proposed to final rule on tobacco was 1 year with 1,000 
comments. So clearly when an agency is focused on completion, I 
think that significant increases can be made in how expeditious 
we move from proposed to final.
    Let me say that it's refreshing, Dr. Satcher, to hear you 
hold off and to say, I am going to wait for the advisory panel. 
Most people fold and go ahead and give the answer prior to 
getting the recommendation, and I commend you for doing it 
because that's the reason we have advisory panels, but they're 
overlooked in many cases.
    I thought, as Fred talked about blood donations, about my 
last one. It was a very tough process to go through. It was 
lengthy. The process time seemed to be doubled, if not tripled. 
There were questions that I had no clue as to why they asked 
them, and there were stations that I had to stop at that really 
did give me the impression that a bureaucrat set the system up 
versus somebody who's in the business of blood collection, and 
I think that was exacerbated by the fact that when I asked the 
individuals why they were there, they couldn't answer me. So I 
commend you on the efforts to streamline the process because I 
think that we're always limited in the potential pool. That 
pool is one that fluctuates up and down in the frequency of 
their donations, and I think right now we're trending in a 
direction, myself included, where the 55-day period which I 
usually aspire to religiously has slipped and slipped and 
slipped because of the time that's needed to drop by.
    Let me ask you a few questions relative to the blood 
collection. I think most banks have expressed increased 
difficulty with their collections. Do you believe it's today as 
easy for a blood bank to take one of the mobile units up to a 
factory, and collect blood as it was prior to our efforts?
    Mr. Satcher. That's a tough question. One of the reasons 
the blood supply is as safe as it is is that we have had to 
make the process tough in some ways, but I still believe, based 
on my own personal experience with donating blood, that it is 
fairly easy to collect blood. I think we have to look at that 
donor satisfaction issue, and I listed that as one of the five 
areas that we're going to be looking at. I believe that we can 
improve rather than just leave it like that on what we're doing 
now because I don't know if we have done what I would call the 
sort of quality-assurance-type strategies that we need to do to 
really make this process as efficient as possible.
    Mr. Burr. How much will technology play a role in our 
ability to expedite that process and to raise the assurance of 
a clean blood system in the next several years?
    Mr. Satcher. Well, you know, obviously, as I mentioned, 
technology will play a role, no question about it. The nucleic 
acid testing will certainly mean that some of the donors that 
we now either say no to or defer, we can really, really test 
the blood and know fairly comfortably that it is safe. So 
technology will continue to play


a major role, but also in just a repetitive way in which we're 
able to assess it.
    I mean, just to reflect on hepatitis C, we first discovered 
this virus in this country in 1988, and around July 1992, June, 
July, we had a screening test that allowed us to really 
adequately screen the blood for hepatitis C. The difference in 
term--and those are the figures that I gave you about the risk 
of 1 in 100,000 versus a risk of 1 in 200 of receiving 
hepatitis C through a blood transfusion. Technology is critical 
in this area. It is the area where we have to continue to 
invest in improving technology, but also improving the 
technology of the process of blood donation.
    Mr. Burr. Now, nucleic acid is still an investigational 
drug; it has not gone through approval?
    Mr. Satcher. Right.
    Mr. Burr. Let me ask you about another one, Dr. Zoon. 
Abbott Labs prism blood screening analyzer. It came before the 
FDA in a 510K in October 1997. It took 18 months to get that 
final 510K clearance. Now, there's a Federal statute under the 
FDA Modernization Act. We didn't meet it in this particular 
case, and I am not asking for specifics about this application. 
If I did that, I'd do it privately. But I guess my question to 
you is, how much better are we doing? Where are the priorities 
as it relates to how new technology expedites the process, and 
gives us a higher degree of assurance? We did it with nucleic 
acid, but not with this. What's the process we go through?
    Ms. Zoon. As you say, sir, the FDA Modernization Act had a 
number of provisions in it that the agency is currently 
implementing. CBER has a number of devices related to 
biological products, and those that are involved in blood 
screening lie under CBER's purview. We recognize the importance 
of high performance in this area, and, in fact, in the past 9 
months we have issued a device action plan at the Center for 
Biologics to deal with performance issues, inspections, 
communication and a variety of areas to affect devices, so that 
we are looking forward to improvements in this area and 
performance overall by focusing on this more.
    Mr. Burr. What is the percentage of applications that 
actually fall within that 90-day statute; do you know?
    Ms. Zoon. Well, there's a number of--there are--the Center 
for Devices and Radiological Health have by far the large 
majority of 510Ks. I don't have those numbers right here in my 
head, but we'd be happy to get back to you.
    Mr. Burr. Get back with me if mine are wrong, and according 
to recently released data, the FDA's Division of Blood 
Applications took first action within 90 days as required by 
the statute and the FAD's own performance goals in 36 percent 
of the cases. Now, if, in fact, my information is wrong, please 
let me know, but I would tell you that if you are looking for 
an area that we can have an immediate impact, let us get closer 
to 100 than zero as it relates to that statutory deadline of 
action on applications.
    Dr. Satcher, let me go somewhere that probably isn't 
directly relevant to this hearing, but I think that it's 
important. There is a huge debate that will continue for some 
time, and possibly action by HHS, as it relates to medical 
privacy. I've looked at your plan on the hepatitis C look-back. 
The way I envision some of the pro


posals as it relates to medical privacy, some go as far as an 
opt-in, opt-out on a patient's basis as far as the sharing of 
their data. Opt-out, it can go nowhere. It can be used for 
nothing. It cannot go into research for the purposes of drug 
and device development. But more importantly, when you lose the 
ability to have a key to identify the individual, how could 
that affect the public health of this country, and what would 
it do specifically to the ability to look back, whether it's 
hepatitis C, or if it's something 10 years from now, or all of 
a sudden there is a need to address a public health issue with 
individuals?
    Mr. Satcher. I think it's a critical issue, let me just put 
it that way. I think balancing patients' rights to privacy with 
the public health needs for research and investigation is one 
of the critical issues that we face. Obviously, it relates even 
to HIV name reporting which is being debated right now. For a 
lot of reasons you could argue that we need to treat HIV the 
same as we've treated other sexually transmitted diseases.
    I think we have not in this country arrived at a point that 
we have assured the population that there is not a risk of 
being identified. We have been through a difficult period, you 
know, Ricky Ray and other things I can remind you of, where 
people have actually suffered because of identity. So we're 
trying to overcome that. We're trying to overcome that fear, 
that distrust. We're trying to find ways to assure people that 
we can protect them while at the same time carrying out the 
public health needs to take control of an infectious disease 
epidemic like hepatitis C or HIV.
    Mr. Burr. Do you agree that Congress could go so far in the 
privacy effort that they could eliminate the ability for you as 
a Surgeon General, or CDC, or for anybody whose core function 
it is, to address the public health of the American people, 
that we would have an inability to look back, an inability, 
once technology allows us to find a genetic trait that may or 
may not be treatable, but we owe it to look back and notify the 
individual? Could we go so far that we couldn't have the 
ability to do that?
    Mr. Satcher. We could, but I think we have this need and 
this obligation to also protect the rights of people from 
abuse, and whether that occurs on a Federal level or State 
level or local level. So I think we're trying to balance these, 
and I think that does require us to do some things that are not 
necessarily optimal at the time in terms of the public health 
needs, but I think we always have to keep the public health 
needs of the Nation in the forefront while trying also to 
protect individuals.
    Mr. Burr. I would agree with you totally.
    Let me ask you relative to the technology infusion into 
this specific area of blood safety, if we went too far on the 
privacy issue, what does that do to the marketplace as it 
relates to what effort companies are going to make to develop 
technological advances in blood detection or any other areas?
    Mr. Satcher. Well, obviously, it could affect the market in 
terms of depending on what specifically we did.
    Mr. Burr. It's not a trick question. I am not trying to 
nail you on anything. I'm just trying to make everybody 
understand this is a much bigger issue.


    Mr. Satcher. It's a very important issue, there's no 
question about it, and I think the bottom line is--and it's not 
always easy to get to that bottom line--is that we've got to 
find a way to balance the public health needs on the one hand 
and the thing that we value so much in this country, the rights 
of individuals and the protection of individuals from abuse.
    Mr. Burr. If you couldn't identify the individuals who were 
exposed to mad cow disease, to follow them for whatever period 
of time we need to, to secure their safety, how much of a 
health risk is that in the U.S., if we don't know that it can 
be transmitted?
    Mr. Satcher. I don't know the answer to that question 
because----
    Mr. Burr. Nor do I.
    Mr. Satcher. As I have already said, if we don't even know 
yet whether or not it is possible for a new variant CJD to be 
transmitted in blood transfusions, we certainly don't know the 
risk that individuals provide to others in society. So we are 
still studying that issue very carefully. So I can't answer 
your question.
    Mr. Burr. If it could be transmitted, though, it would be 
important that we would know who was exposed, wouldn't it?
    Mr. Satcher. Yeah, but also you have to understand that 
we--what we need to be able to do is to detect any risk to the 
public that is in the blood supply. Many times the individual 
him or herself will not know that they have the risk in their 
blood. So our concern right now is our own ability to detect as 
early as possible any threat to the safety of the blood supply, 
and that's our major struggle.
    Mr. Burr. You have mentioned nucleic acid several times. 
How available is it to blood centers around the country?
    Ms. Zoon. While it's under investigational development, it 
has broad use--many blood centers have and institutions have 
taken it on under the clinical investigation phase to get 
experience with it and have been involved in these clinical 
trials. So it has a very broad base. I can't give you the 
percentage of implementation of NAT testing, or nucleic acid 
testing, for blood. It varies based on the agent. HCV and HIV 
are the two primary agents, and we could get you the exact 
numbers of how the percentage of what blood banks are using the 
NAT test for HCV and the NAT test for HIV.
    Mr. Burr. What I conclude from that answer is that if we 
looked at it on a percentage basis, it would be a very small 
percentage of the blood banks.
    Ms. Zoon. No. Actually Dr. Epstein just handed me 92 to 98 
percent of whole blood is already NAT-tested for HCV.
    Mr. Burr. Okay. Mr. Chairman, I thank you for the time that 
you were able to give me and would encourage you to give up on 
Michigan this year. They have no prayer.
    Mr. Upton. I just wished we played North Carolina and North 
Carolina State or any other, Wake Forest, it doesn't matter. 
The gentleman's time has expired.
    Mr. Burr. Mr. Chairman, can I make one correction? My crack 
staff behind me informed me that I needed to correct the record 
as it related to the comments on tobacco. There were 7,000 
comments on tobacco, which probably makes my point even a 
little heavier.
    Mr. Upton. But the problem is 6,000 of them were yours.


    Okay. I have a question with regard to the NAT testing. 
When I donate blood next week, I am going to ask about the NAT 
test. My sense is that it will be NAT-tested. Tell me exactly 
what happens. You said, what, 90 percent of the blood collected 
today is NAT-tested, nucleic-acid-tested?
    Ms. Zoon. Yes. It's investigational, so these are being 
studied in 92 to 98 percent of whole blood, and this is for 
hepatitis C virus, so I just want to make sure that's clear.
    Mr. Upton. Will they test it right there at the site?
    Ms. Zoon. Some blood banks will have their own laboratory. 
Others have centralized laboratories. I believe ARC has 
centralized laboratory testing.
    Mr. Upton. Okay. Part of the testimony that we heard in 
September was the concern that at some point next year, the 
trend lines will cross, and we will perhaps be in a real crisis 
as the number of donors and blood units has been on the 
decline, and the need for blood is increasing. And particularly 
with the new test that's now in place or the new question that 
if you have been in the UK from 1980 to 1996 for a period of 
more than 6 months during that period, you're asked to come 
back some other date, who knows when, but because of that 
decline, which is probably about as much as 2.2 percent, as I 
recall, that, in fact, the real comfort level for the blood 
supply, particularly in a number of regions around the country, 
could be in desperate need. Now, would you agree with that? Is 
your sense along the same lines?
    Mr. Satcher. It's a difficult question, but let me just say 
that there are several things happening at the same time, and 
the same day on which, of course, we acted on that proposal, 
which we will monitor every 6 months, we've also taken action 
relative to hemochromatosis. What impact will this have on the 
blood supply? It could increase the blood supply from 300,000 
units to 3 million units of blood a year. And then the other 
things that we are doing in terms of enhancing the blood 
supply--and on the other end, I think there's also some ways to 
be more efficient with how we use blood that we collect, and so 
all of these things are happening at the same time.
    We're going to be vigorous in our attempts to make sure 
that the blood supply continues to be adequate and it's 
enhanced, especially in the areas of plasma donation.
    Mr. Upton. I was a little surprised when the NBDRC 
testified, and I was a little surprised at that hearing that 
there was not a system now in place, at least monitored by the 
FDA or anybody else, that actually measures the units of blood 
on a monthly basis that are collected, and in fact, your 
statement as part of the record was that we are going to get 
data--and the NBDRC indicated they would share the data with 
this committee as well. I hope we don't have to pay $300,000 
for it.
    Mr. Satcher. You've already paid $300,000.
    Mr. Upton. Yeah, maybe we did. But I was surprised, I 
guess, that we've spent a lot of money. Over the last couple of 
decades looking at some of these trend lines, and yet there is 
not one thing that has been collected at least on a national 
basis until beginning of next year. What's your comment with 
regard to that?


    Ms. Zoon. Well, my only comment is that at this point in 
time, we recognize the need right now, especially with the 
current concerns regarding blood supply, to make sure that we 
have a vigorous program in the Department to look at this, and, 
in fact, this study is actually being funded by the National 
Heart, Lung, and Blood Institute and will be sharing the data 
with the FDA and the CDC and working with Dr. Satcher on the 
Blood Safety Committee to make sure that we use this 
information wisely to ensure an adequate blood supply.
    So we have not done this, to my knowledge, on a monthly 
basis or contracted this information, but we have--there have 
been other studies looking at blood donations, and that will be 
important additional information, as we go forward, to look at 
what initiatives we may need to follow.
    Mr. Satcher. And I think there is--we think that there is a 
lot of potential in going back to donors like yourself, and I 
don't know how often you donate, but there are a lot of people 
who take very seriously the donation of blood. Many of them 
only donate once a year, and so we can be much more aggressive 
in terms of trying to encourage people to donate more, but also 
that pool of people who are eligible who don't donate, so we're 
going to be working in all of these areas.
    Mr. Upton. Well, that second category is going to be 
considerably larger than the first one, I imagine. Maybe we 
just ought to get for happenstance a show of hands in this 
room, how many folks here have donated blood ever, raise your 
hand. I'm pleasantly surprised. And how many people have 
donated in the last year? My hand is down, too, but it will 
change next week.
    Mr. Satcher. That's an important question, and how do we 
get to the 60 percent. You see, I didn't raise my hand for the 
last year.
    Mr. Upton. Because the camera was on you.
    Mr. Satcher. No, no, because I travel. In my position, I 
travel a lot, and there are a lot of places where we travel 
that you're not eligible----
    Mr. Upton. We'd like you travel to Michigan. You can do it 
with me on Monday.
    Mr. Satcher. No. I travel to places where if you travel 
there, you're not eligible to donate blood, sometimes for 3 
years, and that's one of the ways we protect the safety of the 
blood supply.
    Mr. Upton. What are some of those countries? I will fill 
out the questionnaire when I am there on Monday, but what 
countries are----
    Mr. Satcher. Places that are high risk for malaria for 
example, sub-Saharan Africa, Southeast Asia, places where 
countries are still struggling with malaria, and hopefully 
we're going to solve that problem because the World Health 
Organization has made a real commitment to roll back malaria. 
But these are maybe 1 billion people in the world who are now 
at risk for malaria because of where they live. Generally, they 
are places where poverty is a major factor in terms of setting 
up the systems to prevent the spread of malaria and diseases 
like that. So if you travel to those areas, in order to 
optimally protect the safety of the blood supply, we ask 
people--we don't allow people to donate for quite a while.


    Mr. Upton. That's certainly a valid excuse. You don't need 
to submit anything in writing on that.
    One of the things you indicated in your statement was that 
the NIH has been authorized to spend $1.8 million to enhance 
and improve the number of folks that donate blood. Has that 
ever been done before? Has NIH been given that authority 
before? Have there been times that they have had----
    Mr. Satcher. They have a priority. What I don't know is if 
they have ever done it before. I don't think so.
    Mr. Upton. Do you know if they have done that before?
    Mr. Satcher. It's new. As far--I'm always hesitant to say 
it's never been done before.
    Mr. Upton. Especially under oath.
    Mr. Satcher. Yeah, that's right. But as far as we know, it 
has not been done before.
    Mr. Upton. And do you know when their report is going to be 
due or submitted? Do you know when that will be? It won't be in 
time for your January meeting, will it, or it will be? Good, I 
see a nod.
    Ms. Zoon. The money or the funding for the NBDRC is 
committed to produce monthly data is starting in October. So we 
should have our first report in November.
    Mr. Satcher. We don't know how much information we will 
have by then, so when we say monthly reports, some of those 
will be just process reports.
    Mr. Upton. I know that we asked for the same data, as I 
indicated a little earlier, so we are looking forward to seeing 
those trend lines particularly early next year when Congress 
comes back, after we finish at some point this year as well.
    Well, I appreciate you both coming up today, and we may 
have additional questions that other members of the panel may 
wish to submit. If you could respond to those in a timely 
basis, that would be terrific.
    We wish you well on your meeting. If you would like to take 
this gavel and rap some knuckles, it's yours, and you don't 
need----
    Mr. Satcher. We really appreciate your holding this 
hearing. I think it will help to move us forward. We appreciate 
your attention.
    Mr. Upton. We will be following it with rapt attention, I 
can assure you. Thank you very much. You are excused. Thank 
you.
    [Whereupon, at 12:10 p.m., the subcommittee was adjourned.]
    [Additional material submitted for the record follows:]

                      U.S. House of Representatives
                                      Committee on Commerce
                                                   October 21, 1999
The Honorable David Satcher
Assistant Secretary for Health and Surgeon General
Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201
    Dear Dr. Satcher: Thank you for your testimony on October 6, 1999 
concerning the safety and availability of the U.S. blood supply. I 
appreciate your commitment and hard work for maintaining the safety and 
availability of the nation's blood supply. As a follow-up to the 
hearing, I would appreciate your response to a question concerning the 
Hepatitis C education program.


    Hepatitis C virus (HCV) is the most common cause of post-
transfusion hepatitis. Overall, HCV is responsible for 15 to 20 percent 
of all cases of acute hepatitis and is the most common cause of chronic 
liver disease. Prior to 1992, blood was not routinely tested for HCV 
prior to transfusion. FDA regulations now require testing of all blood 
for HCV. HCV has become a major public health concern, and public 
health agencies have engaged in an active search to identify patients 
exposed to HCV-infected blood. In August 1997, the Department of Health 
and Human Services recommended a look-back and public education 
campaign.
    On March 5, 1998, you announced the HCV look back and education 
plan. You testified that HHS has ``established a comprehensive plan to 
address this significant public health problem. It is our intention to 
reach effectively as many people at risk as we can.'' My understanding 
is that rather than running a national campaign informing people at 
risk about the need to get tested for Hepatitis C, the Centers for 
Disease Control (CDC) is pilot testing transit ads in the insides of 
buses and other public transportation only in the Washington, D.C. area 
and Chicago, September 1-October 31, 1999. This month, the Michigan 
Hepatitis C Coalition is kicking off a statewide education campaign, 
Hepatitis C Awareness Month. I understand as many as 168,000 Michigan 
residents already may be infected with Hepatitis C. These residents and 
many other Americans would benefit from the Hepatitis C public 
education program.
    Given your commitment to a comprehensive campaign, when will the 
Hepatitis C public education program run nationally? In addition to 
providing a target date, please explain what information the CDC 
expects to gain from the pilot program and how this could affect the 
design and timing of the public education program.
    I would appreciate your response by November 12, 1999, for purposes 
of completing the hearing record. Thank you for your assistance. If you 
have any questions, please contact Alan Slobodin of the Committee staff 
at (202) 225-2927.
            Sincerely,
                                       Fred Upton, Chairman
                       Subcommittee on Oversight and Investigations
cc: The Honorable Tom Bliley, Chairman
   The Honorable John D. Dingell, Ranking Member
   The Honorable Ron Klink, Ranking Member Subcommittee on Oversight 
and Investigations
        Department of Health and Human Services    
                         Assistant Secretary for Health    
                                            Surgeon General
                                                  November 18, 1999
The Honorable Fred Upton
Subcommittee on Oversight and Investigation
Committee on Commerce
Room 2125, Rayburn House Office Building
Washington, D.C. 20515-6115
    Dear Mr. Upton: I am happy to respond to your inquiry of October 
21, 1999 regarding the Department of Health and Human Services' 
Hepatitis C Public Education Program.
    This program, which I announced in Congressional testimony on March 
5, 1998, has several components. These include education of healthcare 
professionals, education of the general public, and education of those 
at increased risk of hepatitis C virus (HCV) infection.
    Our efforts to educate healthcare professionals began in 1997. 
Prior to this time, many physicians had little knowledge of HCV 
infection, and there were differences of opinion among experts about 
how best to manage this condition. For this reason, a Consensus 
Development Conference was convened by the National Institutes of 
Health (NIH) in March 1997. Following this Conference, the NIH issued 
Management of Hepatitis C, based on evidence presented at the Consensus 
Conference. In November 1997, The Centers for Disease Control and 
Prevention (CDC), in collaboration with the Hepatitis Foundation 
International, produced an interactive satellite conference on HCV 
infection for primary care physicians, Hepatitis C: Diagnosis, Clinical 
Management, Prevention. The audiotape and other materials from this 
teleconference were mailed to 250,000 primary care physicians (family 
practitioners, internists, pediatricians, surgeons, and obstetrician-
gynecologists) during the summer of 1998.
    In July 1998, CDC convened a meeting of consultants to develop 
updated recommendations for the prevention and control of HCV infection 
and HCV-related chronic liver disease, including identification of 
persons at risk because of prior blood transfusion. In October 1998, 
Recommendations for Prevention and Control of


Hepatitis C Virus (HCV) Infection and HCV-Related Chronic Liver Disease 
was published as a supplement to Morbidity and Mortality Weekly Report. 
This supplement was mailed to both primary and specialty care 
physicians throughout the country. These publications provided a 
framework for developing health education messages concerning HCV 
screening, counseling, and prevention to the public.
    Initial public education activities begin in 1997 with the 
development of health communications materials on hepatitis C, risk 
factors for HCV infection, and HCV testing. These materials were 
developed by the CDC and the American Liver Foundation, the Hepatitis 
Foundation International, and the National Association of City and 
County Health Officials, with support from cooperative agreements 
funded by CDC. In early 1998, CDC began routine updates of information 
about HCV prevention, testing, and control on its website and on its 
Hepatitis Information Line.
    Development of national public education activities to encourage 
HCV testing of persons at risk because of prior blood transfusion began 
in February 1999. Contracts were funded for the development of public 
advertising and patient information brochures. Focus groups of 
individuals who had received transfusions were used in the development 
of these materials. On May 5, 1999, CDC hosted a press briefing about 
HCV at the National Press Club; this event was attended by over 100 
media representatives. Public transit advertisements based on these 
materials were run in Washington, D.C. and Chicago in September and 
October, 1999, at a cost of $70,000. The impact of this pilot program 
on the number of inquiries to the CDC Hepatitis Information Line, a 
manned hepatitis C hotline, and to the CDC hepatitis web site is 
currently being analyzed.
    CDC plans to expand this effort nationwide by making these 
materials available to national voluntary health organizations for 
distribution. In addition, through the CDC Foundation, partnerships are 
being developed for cosponsorship of an expanded national public 
advertising campaign that is to begin in early 2000.
    Also in early 2000, CDC plans to bring together national 
professional and voluntary health organizations whose patients have a 
high likelihood of having received a transfusion before July 1992 
(e.g., premature infants, persons who had heart surgery, women who had 
caesarean sections). The purpose of this meeting is to encourage these 
organizations to make their membership aware of the need for HCV 
testing for certain transfusion recipients and to share the materials 
developed by CDC.
    I would be happy to answer any additional questions you may have.
            Sincerely yours,
                                 David Satcher, M.D., Ph.D.
                 Assistant Secretary for Health and Surgeon General
                                 ______
                                 
                      U.S. House of Representatives
                                      Committee on Commerce
                                                   November 1, 1999
The Honorable David Satcher
Assistant Secretary for Health and Surgeon General
Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201
    Dear Dr. Satcher: Thank you for your testimony on October 6, 1999 
concerning the safety and availability of the U.S. blood supply. As a 
follow-up to the hearing, I would appreciate your responses to the 
following questions:
    1. The FDA, NIH, and U.S. Army held a September 27-28, 1999 
Workshop on ``Criteria for Safety and Efficacy Evaluation of Oxygen 
Therapeutics as Red Cell Substitutes.'' Given the potential shortages 
which could occur--either regionally or nationally--in the blood 
supply, some observers believe that oxygen therapeutics could provide a 
safe, effective, and readily available alternative to blood donations. 
What specific actions and timelines for implementation resulted from 
this Workshop?
    2. The General Accounting Office (GAO) indicated that ``one 
alternative being explored for handling issues of blood shortages and 
blood safety is the development of blood substitutes.'' The goal is to 
develop substitutes for red blood cells that are safe, do not require 
cross-matching or typing, have a longer shelf-life, are readily 
available in large quantities, and deliver oxygen therapeutically and 
quickly to tissues and organs. Given the potential of these alternative 
agents, what criteria would be considered for expedited review of their 
use for specific applications which could relieve shortages, either 
regionally or nationally, if and when they occur? If the criteria were 
satisfied, what steps would be taken to expedite review?


    3. As indicated by the GAO, the U.S. imports approximately 2% of 
its blood supply. Given the potential for shortages in the U.S. supply, 
how can HHS assure that any increased imports of blood will have the 
same level of quality--particularly considering donor exclusions like 
the ban on individuals who have resided in the U.K. for a cumulative 6 
months or more between 1980 and 1996?
    I would appreciate your response by November 15, 1999, for purposes 
of completing the hearing record. Thank you for your assistance. If you 
have any questions, please contact Alan Slobodin of the Committee staff 
at (202) 225-2927.
            Sincerely,
                                       Fred Upton, Chairman
                       Subcommittee on Oversight and Investigations
cc: The Honorable Tom Bliley, Chairman
   The Honorable John D. Dingell, Ranking Member
   The Honorable Ron Klink, Ranking Member Subcommittee on Oversight 
and Investigations
        Department of Health and Human Services    
                         Assistant Secretary for Health    
                                            Surgeon General
                                                  November 18, 1999
The Honorable Fred Upton
Subcommittee on Oversight and Investigation
Committee on Commerce
Room 2125, Rayburn House Office Building
Washington, D.C. 20515-6115
    Dear Congressman Upton: I am writing in response to your letter to 
me dated November 1, 1999 concerning the development of oxygen-carrying 
therapeutics as possible blood substitutes in light of possible blood 
shortages. At this time the approval of any such product is not 
imminent, since no candidate product has yet been shown to be safe and 
effective for a well-defined clinical indication. By way of 
clarification, it needs to be understood that oxygen-carrying 
therapeutics may not actually substitute for use of blood products. For 
example, products with a short duration of action in the body may prove 
useful as volume replacement solutions, but only as a temporary therapy 
until blood is available. Also, even if oxygen-carrying therapeutics 
can substitute for use of some blood components such as red cells, they 
cannot be expected to substitute for use of all blood components due to 
the complex nature or blood.
    FDA has been very active in its interactions with the industry that 
is developing oxygen-carrying therapeutics both through public 
discussions and regular meetings at the request of product sponsors. At 
these meetings, sponsors are given the opportunity to express their 
views and discuss their data. FDA understands industry's concerns about 
the often-difficult clinical studies that are necessary to validate 
these products. At the same time, FDA is appropriately concerned about 
the need for careful studies to establish the safety of oxygen-carrying 
therapeutics. As you know, there have been enormous strides made in 
recent years to make the United States blood supply highly safe. If a 
product is to be used as a substitute for blood, there should be 
assurance that it is at least as safe as blood. Studies to substantiate 
safety comparable to blood products necessarily are large, difficult 
and expensive.
    The following remarks address your specific questions as numbered 
in your letter:
    1. You asked what specific actions and timelines for implementation 
resulted from FDA's recent ``Workshop on Criteria for Safety and 
Efficacy Evaluation of Oxygen Therapeutics as Red Cell Substitutes.'' 
As a result of the valuable discussions from both industry 
representatives and academic researchers who are prominent in the 
field, FDA will develop an industry guidance document on the design of 
clinical trials to validate indications for oxygen-carrying 
therapeutics. According to established ``Good Guidance Practices'' the 
guidance will be distributed initially as a draft for comment, and then 
finalized for implementation after review of public comments. In this 
policy document FDA will address the various possible indications for 
these products and provide guidance an the data needed to validate 
different claims. FDA's Center for Biologics Evaluation and Research 
expects to develop the draft guidance by the end of Spring 2000. In the 
interim, FDA will continue to make its current thinking known through 
public statements and in meetings with product sponsors.
    2. You have asked what criteria would be considered for expedited 
review of these products. FDA is committed to a rapid approval of any 
product that addresses a significant unmet medical need such as novel 
use in a serious or life-threatening condition. Under the FDA 
Modernization Act of 1997, criteria for fast track approval were well 
defined. In particular, accelerated marketing approval can be granted 
to appli


cable drugs that have an effect on a surrogate marker that is 
reasonably likely to predict clinical benefit, As yet, such surrogate 
markers have not been established for validation of oxygen-carrying 
therapeutics. Nevertheless, FDA is working cooperatively with product 
sponsors to clarify the requirements for validation and thereby 
facilitate product development. For some indications, e.g., trauma, the 
endpoint of mortality is of overwhelming interest and it is possible 
that a surrogate may not be useful.
    3. You have asked how DHHS can assure that any increased 
importation of blood will maintain the U.S. standards for quality. As 
you know, FDA allows blood products to be imported under certain 
conditions. However, the blood that is imported for distribution in the 
U.S. is collected and processed only in FDA-licensed facilities. As 
such, the facilities are required to meet all of our standards 
including those for donor suitability, product testing, and good 
manufacturing practice. To insure compliance, U.S.-licensed foreign 
facilities are inspected according to the same standards as facilities 
located within our borders. Blood products that are not collected in 
licensed facilities may be imported for further processing solely for 
export under appropriate circumstances and conditions as determined by 
FDA. Such imported blood cannot be distributed for human use in the 
U.S., and the final manufactured product can only be exported. 
Therefore, the safety or availability of blood products in the U.S. 
would not be affected.
    I hope that these remarks adequately address your stated concerns. 
Please feel free to contact this office if you have additional 
comments.
            Sincerely yours,
                                 David Satcher, M.D., Ph.D.
                 Assistant Secretary for Health and Surgeon General
                                 ______
                                 
              Department of Health & Human Services
                               Food and Drug Administration
                                                  November 23, 1999
The Honorable Fred Upton
Chairman
Subcommittee on Oversight and Investigations
Committee on Commerce
House of Representatives
Washington, D.C. 20515-6116
    Dear Mr. Chairman: The Food and Drug Administration (FDA or Agency) 
appreciated the opportunity to accompany Dr. David Satcher, Assistant 
Secretary of Health and Surgeon General, at the October 6 hearing to 
discuss the present state of blood safety and availability. FDA 
appreciates and shares your concern about the safety of the blood 
supply. During the October 6 hearing Dr. Kathryn C. Zoon, Director, 
Center for Biologics Evaluation and Research (CBER), was requested to 
provide written answers to several questions for the hearing record. 
The questions and answers are provided below and the corrected 
transcript is enclosed. In addition, to assist the Committee in its 
consideration of blood safety issues, a more detailed explanation of 
certain aspects of FDA's blood safety program is provided.
Error and Accident Reports
    FDA is committed to finalizing the proposed rule on error and 
accident. FDA appreciates the concern expressed by you about the lack 
of required error and accident reporting for registered, but unlicensed 
blood banks. A more detailed explanation of the error and accident 
reporting function and its applicability to blood safety is provided 
below for your information.
    Error and accident reports are one of several safety layers FDA 
utilizes in monitoring the safety of the blood supply. FDA uses error 
and accident reports primarily to identify systemic problems for the 
entire industry. Inspections are the most important tool used to 
monitor industry compliance. Prior to inspection, and on an ongoing 
basis, FDA reviews previous inspection reports, fatality reports, 
adverse experience reports, medical device reports, annual reports and 
error and accident reports. During inspection, FDA reviews these 
reports to determine if the firm appropriately investigated the 
incident and implemented corrective action.
    There is, at times, a public misconception that recalls and 
withdrawals of products are dependent on the filing of error and 
accident reports to the Agency or that such actions are somehow delayed 
by the classification of such reports. This is not accurate. Blood 
establishments are required to take corrective actions immediately, 
independent of the reporting process. Blood establishments are 
ultimately responsible for the products they distribute. FDA monitors 
industry compliance with


standards but cannot function as the quality assurance unit for each 
manufacturer. It is the manufacturer's responsibility to comply with 
rigorous standards that are necessary to protect the blood supply. The 
error and accident reports constitute one facet of the system of 
overlapping surveillance. Primarily, these serve as one source of 
information on industry performance. The most critical problems that 
result in a fatality are brought to FDA's attention in a short time and 
investigated. As noted at the hearing, fatalities are required to be 
reported to FDA within seven days (21 CFR Sec. 606.170(b)).
    The requirement for blood establishments to file error and accident 
reports cannot itself provide an assurance that blood will be safe. The 
majority of errors or accidents are not life threatening and are 
detected and reported retrospectively during quality assurance 
activities or audits (21 C.F.R. Sec. 211.180 (e) and 21 C.F.R. 
Sec. 820.22 requires that audits be performed on at least an annual 
basis). The detection of errors and accidents allows firms to 
investigate and correct any deficiency in the system so that future 
errors can be prevented. On an industry wide basis, the actual 
reporting to FDA of errors and accidents enhances FDA's oversight. 
These reports assist the Agency to identify the need to develop new 
policy, to revise existing policy, to provide training to industry and 
FDA inspection personnel and to revise compliance programs as 
appropriate.
Licensed Blood Banks and Unlicensed Blood Banks (Registered)
    During the hearing on October 6 and the two other hearings held on 
blood safety and availability, licensed and unlicensed blood banks were 
discussed. To assist the Committee, the following information may be 
helpful.
    All blood banks are registered with FDA and are assigned 
registration numbers. The Public Health Service Act requires a firm to 
have a license in order to introduce biological products such as blood 
and blood products into interstate commerce. This is in addition to 
being registered with FDA. Although there are two types of facilities, 
there is no difference in the inspectional coverage or requirements to 
follow current good manufacturing practices (cGMPs) for licensed versus 
unlicensed blood banks. Routinely, all blood banks are inspected once 
every two years. Inspectional frequency of individual blood banks is 
increased, however, when there is a recent violative history.
Transfusion Services
    A number of questions were also raised during the hearing 
concerning transfusion services and we wanted to provide additional 
information for the Committee. Transfusion services routinely perform 
blood typing and crossmatching. Transfusion services do not collect 
blood or manufacture components. While the majority of transfusion 
services are inspected by the Health Care Financing Administration 
(HCFA), some transfusion services that perform some further 
manufacturing of blood products such as washing, freezing, 
deglycerolyzing, or irradiating are inspected by FDA. Because the 
Veteran's Affairs and military transfusion services are not regulated 
by HCFA, these facilities are also inspected by FDA.
    Transfusion services that are inspected by HCFA are usually small 
hospital or outpatient center blood banks that only perform blood 
typing, crossmatching and issue blood. As of November 1, 1999, the 
number of transfusion services, which do not collect blood or 
manufacture blood components, and are regulated by HCFA is about 5000. 
FDA's and HCFA's coverage and responsibilities for these facilities is 
discussed in the 1980 Memorandum of Understanding between FDA and HCFA, 
a copy of which is enclosed as Tab A.
Fatality Reports
    In the hearings held by the Committee there was uncertainty 
concerning the number and types of fatalities. As noted at the hearing, 
fatalities are required to be reported to FDA within seven days (21 CFR 
Sec. 606.170(b)). We are happy to provide the following information for 
clarification.
    The total number of fatalities reported to FDA in the last 3 years 
is:

FY 1999....................................................        64
FY 1998....................................................        85
January to September 1997..................................        57


    Of these fatalities, the following numbers and percentages refer to 
fatalities that occurred as a result of an individual receiving the 
wrong unit of blood:

FY 1999....................................................      7 (11%)
FY 1998....................................................     11 (13%)
January to September 1997..................................     14 (25%)




    These errors have been attributed to either laboratory staff or 
other persons outside the blood bank (usually nurses and medical staff 
in the OR, ER, ICU, or patient units), in the following numbers:


                                                             Lab   Other

FY 1999...................................................      4      3
FY 1998...................................................      6      5
January-September 1997....................................      8      6

Please note that CBER changed its reporting interval in October 1997 to
  reflect the fiscal year used throughout the Government.

    A small number of the laboratory errors are caused by laboratory 
personnel, usually phlebotomists, who do not work directly in the blood 
bank but who obtain blood specimens from patients for the blood bank to 
use in crossmatching. Errors caused by nurses and medical staff outside 
the blood bank can occur when a unit that has been correctly processed 
and labeled is given to the wrong patient. As mentioned above, please 
note that the number of fatalities caused by patients receiving the 
wrong unit of blood has decreased over the past 3 years.
Questions/Answers from October 6 Hearing
    Question: (Chairman Fred Upton) Could FDA provide the 97 docket 
comments received commenting on the 1997 proposed Error and Accident 
Rule?
    FDA has provided these comments previously to the Committee. All of 
the docket comments were provided electronically to Mr. Alan Slobodin, 
Committee Counsel, over several days, from September 26 through 
September 29.
    Question: (Mr. Richard Burr) According to his information, only 36% 
of device applications filed with CBER had a first action within the 
statutory deadline of 90 days.
    Please find enclosed at Tab B a chart entitled, CBER's Device 
Review Performance, which details FY99 and FY98 device review data for 
a number of categories. CBER is committed to improving its performance 
in this area. As was explained by Dr. Kathryn Zoon at the hearing, CBER 
has made considerable progress in improving device review times. 
Performance has been of concern in the past and in response to that 
concern, CBER held a stakeholders meeting in December 1998 specifically 
to discuss CBER's review of medical devices. One result of that meeting 
was the development of the CBER Device Action Plan (DAP). This DAP is 
provided at Tab C. The plan also can be found on FDA's website at 
www.fda.gov/cber.
    The plan went into effect on April 20, 1999. Since then, CBER has 
received 17 device submissions. Of these 17, 11 have had a first action 
completed on time while the remaining 6 submissions are pending and 
CBER anticipates completing the first action within the due date.
    In conjunction with the DAP, CBER also has conducted a number of 
activities that relate to the implementation of the Food and Drug 
Administration Modernization Act device provisions. These include the 
following:

CBER is working along with CDRH on device standards development and 
        guidances for In vitro Diagnostics.
CBER established a ``Device Information'' section on its home page that 
        includes:
    The Device Action Plan
    A list of medical devices regulated by CBER
    Device Approval Information
    FDAMA Guidances, Information on Preparation Device Marketing
    Submissions, & Intercenter Agreement between CBER and CDRH
In July 1999, CBER established mechanisms to meet the time periods 
        specified in FDAMA for the review of applications and 
        submissions.
CBER conducted scientific training to improve the skills of product 
        reviewers; many product reviewers also took courses sponsored 
        by CDRH.
CBER and the Health Industry Manufacturers Association (HIMA) 
        cosponsored a Vendor's Day for CBER staff to allow biological 
        device manufacturers to demonstrate new biological devices and 
        describe how they work.
A CBER sponsored public meeting and teleconference was held on November 
        15, 1999, with device stakeholders on the development of 
        regulations and guidance documents.
    Question: (Mr. Richard Burr) Why did it take 18 months for the 
Abbott Prism screening test to receive 510k clearance?
    The original submission for this device came to FDA in October 
1997, and the review was completed in November 1998. At that time, a 
period of 1 year for a blood device review was not uncommon in CBER and 
reflected the resource limitations in this program.


    Question: (Mr. Richard Burr) What percentage of facilities are 
using nucleic acid testing (NAT) for its blood donations?
    Information on implementation of NAT was provided to FDA in August 
and October by the American Association of Blood Banks based on a 
survey of blood centers and hospitals. As of October 1999, of the blood 
centers that collect approximately 92% of whole blood in the United 
States, close to 100% were using NAT for Hepatitis C Virus (HCV) 
screening. As of August 1999, approximately 65%-78% of these same 
centers were using NAT for HIV. Of hospitals that collect about 8% of 
the blood supply in the United States, approximately 10% (51 out of 500 
hospitals surveyed) were using NAT for HCV screening. These 51 
hospitals account for about 90% of hospital collections, so another 7% 
of the blood supply was being screened by NAT for HCV. As of August 
1999, the Department of Defense (DOD) had not yet implemented NAT 
testing. DOD collections represent about 1% of the blood supply. Since 
the test is not yet approved, all use is being conducted as part of 
clinical trials for the investigational product. Part of the 8% of 
blood that is collected by hospital blood banks is autologous blood, to 
be used by the donor only, and presents no additional risk of infection 
to the donor/recipient.
    We hope this information is useful and responds to your questions. 
We will be glad to answer any other questions you have.
            Sincerely
                                           Melinda Plaisier
                             Associate Commissioner for Legislation
Enclosures

cc: The Honorable Ron Klink
   Ranking Member
   Subcommittee on Oversight and Investigations
   House of Representatives

   The Honorable Tom Bliley
   Chairman, Committee on Commerce
   House of Representatives

   The Honorable John Dingell
   Ranking Member
   Committee on Commerce
   House of Representatives


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                     BLOOD SAFETY AND AVAILABILITY

                              ----------                              


                       TUESDAY, OCTOBER 19, 1999

                  House of Representatives,
                             Committee on Commerce,
              Subcommittee on Oversight and Investigations,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 9:30 a.m., in 
room 2322, Rayburn House Office Building, Hon. Fred Upton 
(chairman) presiding.
    Members present: Representatives Upton, Whitfield, Ganske, 
Bryant, Bliley (ex officio), and Green.
    Also present: Representative Combest.
    Staff present: Alan Slobodin, majority counsel; Anthony 
Habib, legislative clerk; Chris Knauer, minority counsel; and 
Brendan Kelsey, minority clerk.
    Mr. Upton. Good morning. Those bells, by the way, indicate 
we are going into recess for a short while. I think we are not 
expecting a vote for about an hour or so.
    This morning the subcommittee continues its oversight 
hearings on the safety and availability of the United States 
blood supply. At previous hearings we have heard from the GAO 
that the blood shortage situation was overstated. Today we will 
hear a much different story from the blood collection side. 
Today's testimony and reports from around the country indicate 
that our blood supply is below comfort level in many regions. 
More current information than that reviewed by the GAO suggests 
overall trends threaten the blood supply. For example, the 
American Red Cross will tell us that in the last 2 years, while 
they have seen blood collections increase by 8 percent, blood 
distribution to hospitals has increased even more, 11 percent.
    In August 1999, survey of members of America's Blood 
Centers showed a 7 percent increase in demand over August 1998. 
The Midwest has historically been the blood basket for the rest 
of the country. I understand from America's blood centers that 
some blood centers in the Midwest that have never or rarely 
gone on emergency appeal went on an emergency appeal this year, 
1999.
    This past summer, my home State of Michigan, the American 
Red Cross declared a blood alert in Michigan because of 
decreased donor turnout. The southeastern Michigan region of 
the Red Cross had less than 1 day's supply of blood in its 
inventory.
    One of the themes we will hear at this hearing is that 
national leadership is needed to support national blood 
donations. For the past month this subcommittee has held 
hearings on the safety and availability of the blood supply. I 
anticipate chairing further hear


ings on blood-related issues throughout this Congress. Last 
week in my home community, I donated blood and I urge others to 
donate blood as well. We will hear from one family today on how 
that blood donation truly is the gift of life.
    Without a significant effort to increase blood donations, 
our blood supply will gradually be outstripped by increased 
need. More Americans are living longer and require more 
operations and more blood transfusions. New safety 
requirements, new donor exclusion rules, and increased costs 
are pressuring the blood supply. Although we have heard 
differing assessments about the degree of seriousness of blood 
shortages, everyone is in agreement that action must be taken.
    To that end, at the October 6 hearing, Surgeon General 
David Satcher outlined a 5-point strategy for increasing the 
blood supply. As I indicated at that hearing, I will be 
supportive of Dr. Satcher's efforts to increase blood 
donations.
    This subcommittee and I will also point out ways to improve 
blood safety and availability. For example, Chairman Bliley and 
I are pushing to get improved blood safety reporting now. I 
look forward to the witnesses' testimony and am particularly 
interested in hearing about the blood banks' view on Dr. 
Satcher's plans and how they plan to increase donations.
    As we have learned, the U.S. blood supply is indeed 
fragile. This subcommittee will continue to monitor the 
situation, keep the blood supply on our radar screen, and 
support volunteer blood donations.
    And, in addition, I guess you could somewhat say, putting 
my money where my mouth is on this issue, in addition to 
personally donating blood this last week, I have joined the 
Congressional Honorary Host Committee for National Volunteer 
Blood Donor Month 2000. I want to encourage all members and 
staff in this Congress to participate in the Year 2000 Fight 
for Life on Capitol Hill, a friendly contest between Republican 
and Democrats, to see who donates more blood.
    [The prepared statement of Hon. Fred Upton follows:]
   Prepared Statement of Hon. Fred Upton, Chairman, Subcommittee on 
                      Oversight and Investigations
    This morning the Subcommittee continues its oversight hearings on 
the safety and availability of the U.S. blood supply. At previous 
hearings, we heard from the GAO that the blood shortage situation was 
overstated. Today we will hear a much different story from the blood 
collection side.
    Today's testimony and reports from around the country indicate that 
our blood supply is below comfort level in many regions. More current 
information than that reviewed by the GAO suggests overall trends 
threaten the blood supply. For example, the American Red Cross will 
tell us that in the last two years while they have seen blood 
collections increase by 8%, blood distribution to hospitals has 
increased by 11%. An August 1999 survey of members of America's Blood 
Centers showed a 7% increase in demand over August 1998.
    The Midwest has historically been the bloodbasket for the rest of 
the country. I understand from America's Blood Centers that some blood 
centers in the Midwest that had never or rarely gone on emergency 
appeal, went on emergency appeal in 1999.
    This past summer in my home state of Michigan, the American Red 
Cross declared a blood alert in Michigan because of decreased donor 
turnout. The southeastern Michigan region of the Red Cross had less 
than a one-day supply of blood in inventory.
    One of the themes we will hear at this hearing is the need for 
national leadership to support volunteer blood donations. I am 
delighted to provide some of this national leadership. For the past 
month, the Subcommittee has held hearings on the safety


and availability of the blood supply. I anticipate chairing further 
hearings on blood-related issues throughout this Congress. Last week in 
Benton Harbor, I donated blood. I urge others to donate blood. We will 
hear from one family today on how that blood donation truly is the gift 
of life.
    Without a significant effort to increase blood donations, our blood 
supply will gradually be outstripped by increased need. More Americans 
are living longer and require more operations and more blood 
transfusions. New safety requirements, new donor exclusion rules, and 
increased costs are pressuring the blood supply. Although we have heard 
differing assessments about the degree of seriousness of blood 
shortages, everyone is in agreement that action must be taken. To that 
end, at the October 6 hearing, Surgeon General David Satcher outlined a 
five-point strategy for increasing the blood supply. As I indicated at 
that hearing, I will be supportive of Dr. Satcher's efforts to increase 
blood donations. The Subcommittee and I will also point out ways to 
improve blood safety and availability. For example, Chairman Bliley and 
I are pushing to get improved blood safety reporting now.
    I look forward to the witnesses' testimony. I am particularly 
interested in hearing about the blood banks' views on Dr. Satcher's 
plans and how they plan to increase donations.
    As I have learned, the U.S. blood supply is fragile. This 
Subcommittee will continue to monitor the situation, keep the blood 
supply on our radar screen, and to support voluntary blood donation.
    And I am putting my money where my mouth is on this issue. In 
addition to personally donating blood, I have joined the Congressional 
Honorary Host Committee for National Volunteer Blood Donor Month 2000. 
I want to encourage all Members of Congress and their staff to 
participate in the year 2000 Fight for Life on Capitol Hill, a friendly 
contest between Republican and Democrats to see who donates the most.

    Mr. Upton. Mr. Chairman.
    Chairman Bliley. Thank you, Mr. Chairman, for these 
continued hearings concerning the safety and availability of 
the Nation's blood supply. I also want to thank you, Mr. 
Chairman, for your hard work in bringing attention to the U.S. 
blood supply and to thank you for stepping up to the plate and 
donating blood. I hope maybe it will slow you down a step or 
two on the tennis court when we next play.
    The blood supply, you know, ladies and gentlemen, is like 
an insurance policy. You don't think much about it until you 
need it. But most of us or our loved ones at some point in our 
lives will need blood.
    Today's testimony paints a troubling picture about whether 
we will have the blood we need. It is a more troubling picture 
about the blood supply than what we heard from the GAO at the 
September 23 hearing. On the front lines of blood collection in 
the United States, these blood centers represented before this 
subcommittee are seeing evidence of a blood system struggling 
to meet demand. For example, the American Red Cross will tell 
us that in the last 2 years, while they have seen blood 
collections increase by 8 percent, blood distribution has 
increased by 11 percent. Other testimony will show that some 
blood centers which usually do not resort to emergency appeals 
for donations during the year are making several such appeals 
this year.
    With the challenge to meet increased demand for blood 
products, today's witnesses are calling for national leadership 
to support volunteer blood donation. This committee, through 
these hearings on the blood supply, has stepped up to the plate 
to provide some of this leadership. We are pushing for more 
blood donations and for more safety of the blood supply. For 
example, on the blood safety front, I have pushed for a new 
reporting system for blood errors now, rather than wait for FDA 
to take at least 6 years to imple


ment recommendations from the HHS Inspector General to repair 
its flawed reporting system.
    I am pleased that at the last hearing, Surgeon General 
David Satcher was not only receptive to my request to implement 
a new reporting system for transfusion errors that will improve 
blood safety, but he announced that an outside HHS advisory 
committee will meet on this matter in January. I am optimistic 
that we can improve the safety of the blood supply just as we 
have done with the commercial airline safety and nuclear power.
    Fred Upton and I will continue to push for improvements and 
quick action on the U.S. blood supply.
    Mr. Chairman, I join your call to the American people for 
more blood donations. Just one pint of blood can save several 
people's lives. Thank you.
    Mr. Upton. Mr. Chairman, if I had known that by donating 
blood we could get a 12-0 score a couple days later, I would do 
it every week.
    Chairman Bliley. Then you better cut it off.
    Mr. Upton. Mr. Bryant.
    Mr. Bryant. Thank you, Mr. Chairman. I do want to thank you 
for holding this hearing and also for the work that you do in 
this area, and also as I listened to our full committee 
chairman, Mr. Bliley, I want to thank him also for his 
sponsorship of legislation in regard especially to the safety 
of our blood supply.
    Certainly the two issues that are important--and I am not 
going to go on and on because I am anxious to hear the very 
competent and qualified testimony from the panel that we have, 
panel of witnesses that we have today--but certainly what 
concerns all of us across this country is the two issues of 
supply: the amount of supply, the abundance of supply, and the 
safety of that supply. And certainly it is our responsibility 
as Members of Congress to, and particularly this committee and 
this subcommittee, to help oversee those two very important 
issues.
    So I think we are doing our job today as we have been in 
past hearings. I appreciate very much the testimony that we 
have had in the past, and certainly I think we are going to 
hear a little different version or story today. But I do 
appreciate our Surgeon General, Mr. Satcher, and some of the 
things he is recommending regarding the blood supply and safety 
issues.
    But again, I look forward to the testimony, not only 
listening to it, but also perhaps getting to read some of it. 
As those of you who have been in Washington know, sometimes the 
pulls and tugs of other committees come into play, and I have 
another subcommittee involving the Food and Drug Administration 
going on that will be starting at about 10 o'clock, so I am 
going to try to be shuffling back and forth between the two 
committees.
    Again, with that, I would yield back my time.
    [Additional statement submitted for the record follows:]
  Prepared Statement of Hon. Gene Green, a Representative in Congress 
                        from the State of Texas
    Thank you, Mr. Chairman, for scheduling this important hearing.
    There are several important issues to be discussed before this 
Committee today. Most importantly, however, is to examine recent trends 
that indicate that blood do


nations in this country are on the decline, and what that means for our 
nation's health care establishment.
    This trend, combined with the rise in demand for blood, due to an 
aging population and increased surgical procedures, is a real threat to 
our nation's health infrastructure and one that deserves the close 
scrutiny of this Committee.
    We should examine carefully all the options to addressing this 
situation, including the controversial proposal to allow the 
distribution of blood units that are gathered through the treatment of 
patients who suffer from hemochromatosis.
    We must insure that we first remove any and all financial incentive 
for donation before a policy like this is implemented, so as to remove 
the temptation for these patients to mislead hospital officials about 
their medical histories when they go in to give blood.
    Additionally, we must ensure that we act to protect the safety of 
the blood supply by supporting new rules designed to exclude donors who 
may have encountered previously unknown or unsuspected risk factors.
    An example of this would be the FDA's new donor exclusion policy 
concerning individuals who spent six months or more in the United 
Kingdom between 1980-1996. Because of the uncertainty surrounding how 
the so-called ``mad cow disease'' may or may not be spread, this action 
is an important step that will give us time to determine the 
seriousness of the threat while avoiding endangering the blood supply 
and those who depend on it.
    Again, Mr. Chairman, thank you for holding this hearing and I look 
forward to the testimony of the witnesses here today.

    Mr. Upton. Thank you. I would let everyone know here that 
we have a number of subcommittees that are meeting this 
morning, so we are all juggling our time constraints. We 
welcome everyone here. I would ask that the witnesses come to 
the table: Ms. Jacqueline Fredrick, CEO of the American Red 
Cross Biomedical Services; Dr. Celso Bianco, President of 
America's Blood Centers; Mr. and Mrs. Craig Sperry from the 
America's Blood Centers; and Dr. Susan Wilkinson, Deputy 
Director of the Clinical and Technical Services of Hoxworth 
Blood Center in Cincinnati, Ohio.
    Let me just say, I don't know whether you knew our normal 
practice before this subcommittee, but we take testimony under 
oath. Do any of you have objection to that?
    Hearing none, committee and House rules allow you to be 
represented by counsel. Do any of you need to be represented--
feel the need to be represented by counsel?
    If not, if you would stand and raise your right hands.
    [Witnesses sworn.]
    Mr. Upton. You are now under oath. For the purposes of 
introduction, I would like to introduce and recognize my friend 
and colleague from Texas, the chairman of the House Agriculture 
Committee, Mr. Larry Combest.
    Mr. Combest. Mr. Chairman, thank you very much for letting 
me come to introduce three of my constituents and three of your 
witnesses today with what is, I think, a very personal and 
heartfelt story. Craig, Jennifer, and Kirkland Sperry are from 
Canyon, Texas, in my district. I think that this is one of 
those great stories that had a wonderfully happy ending. That 
happy ending happens to be with us here today. But I think that 
Kirkland's father, Craig, best summed it up, and you will hear 
their full account, when he said that a person totally 
unbeknown to them was willing to give an hour of their time to 
allow blood to be--to donate blood in a very critical moment. 
That blood supply, literally one pint, saved Kirkland's life. I 
think it points out something we take for granted many, many 
times.


    Thank goodness, Kirkland is here. The Sperrys took their 
time to be here, and I appreciate very much, Mr. Chairman, your 
allowing me to come and introduce them.
    Mr. Upton. We appreciate your time as well. Since you are 
here, maybe we will start with the Sperrys, with their 
testimony. I want you to know we appreciate all of you sending 
your testimony in advance. It is made part of the record in its 
entirety. We would like you to limit your remarks, if you can, 
to about 5 minutes. I will set this very sophisticated timer. 
It has probably never been tested on eggs before, but I suspect 
it works. If you can limit your remarks to about 5 minutes, 
that will be terrific. We will all listen for that familiar 
chime at the end. We recognize the Sperrys first. Thank you for 
coming here this morning.

  TESTIMONY OF CRAIG AND JENNIFER SPERRY, C/O AMERICA'S BLOOD 
  CENTERS; SUSAN L. WILKINSON, DEPUTY DIRECTOR, CLINICAL AND 
TECHNICAL SERVICES, HOXWORTH BLOOD CENTER; JACQUELYN FREDRICK, 
    CHIEF OPERATING OFFICER, AMERICAN RED CROSS BIOMEDICAL 
 SERVICES, NATIONAL HEADQUARTERS; AND CELSO BIANCO, PRESIDENT, 
                    AMERICA'S BLOOD CENTERS

    Mrs. Sperry. Thank you for allowing us to be here. This is 
just a story that I am sure us, as well as other parents, or 
hopefully not many parents, have had to go through, the 
experience of having to have a pint of blood save your child's 
life.
    When Kirkland was born, he was diagnosed with a cardiac 
condition and a seizure disorder. We thought that that was the 
end of our problems, as you would think. But when he was 2 
months old, he developed the RSV virus, respiratory syncytial 
virus, and he progressed through that very well as far as being 
in the hospital.
    Then one night when we were about to be released, he ended 
up coding on us. We were sent out of the room and they were 
brought in, and they brought us over to the ICU, and they had 
done a blood gas. We thought getting through that was enough, 
but the doctor came out and said we have another problem. Of 
course, the first thought was maybe something happened with his 
heart. They came out and said that not knowing how it was, the 
virus was attacking his bone marrow and he needed a blood 
transfusion and he needed it now.
    Of course, my first reaction was, well, take my blood, 
because he and I are both AB positive. Well, he looked at me 
and said, you don't understand. We do not have enough time for 
you to give your blood and for it to go through all the 
testing.
    So we are like, okay, we will take that. Then he came back 
a few moments later and said, ``Hold on, let your family know, 
stay here, we may need you anyway, we can't find blood.'' Of 
course, knowing that he needs blood and they can't find it and 
they are saying we may still need you anyway, even though we 
don't have the time, it was hard to imagine--I had given blood 
in the past, taking it for granted when I needed it, or 
especially if my son or child needed it, it would be there.
    Just that moment of wonderment, of wondering if it is going 
to be there, was going to be there in time enough to make the 
changes that it needed to with it, it was definitely a moment 
unforgetting.


    Knowing that someone out there gave the little time it took 
to give blood, that we still have him here today. My husband 
put it pretty good one time. He asked what we would tell people 
to go give blood, and my husband said, I just challenge them to 
look in any child's face or look in my child's eyes and explain 
to them why they couldn't have taken that 30 minutes, 45 
minutes' worth of their time to save his life or save a 
person's life.
    It is very simple to do, and we are just grateful that 
someone gave that time to do it.
    Mr. Sperry. The only thing I would like to add is many 
people don't realize, and we didn't realize, when you have the 
need for blood, most of us take for granted it is there. When 
it is sometime for a blood transfusion or you go on the 
operating table, your blood is there. When the doctor comes 
back to you and says, We can't find the blood, it is not in 
this hospital, it is not in the other hospital, you start to 
wonder. Luckily for us, believe it or not, it was the last pint 
in the city of Amarillo we got, and he was headed out.
    So my wife said it, and that is what I have said, it only 
takes 30 minutes for someone to go give blood. Look in his eyes 
and that tells you what you get from giving blood. This little 
boy is alive. If you have watched him before this meeting 
started, he is healthy. It is a painless procedure, and I 
advise everybody to give blood. If they don't feel like they 
can, then you can look in his eyes and explain why.
    Mr. Upton. Boy, that was perfect. I even thought about 
maybe I should give you an extra 10 minutes since there are 
three Sperrys.
    But I would like to note that by unanimous consent, all 
members' statements will be made part of the record as well.
    Dr. Wilkinson, welcome.

                TESTIMONY OF SUSAN L. WILKINSON

    Ms. Wilkinson. Thank you very much. My name is Susan 
Wilkinson and I am pleased to be here today to speak on behalf 
of the American Association of Blood Banks. I currently serve 
as the President of the AABB, the professional association 
representing approximately 2,200 institutions, including 
community and Red Cross blood centers, as well as hospital 
transfusion services and 9,000 individuals involved in blood 
banking and transfusion medicine.
    AABB members are responsible for virtually all of the blood 
collected and over 80 percent of the blood transfused in the 
United States. The AABB would like to commend the subcommittee 
for holding this series of hearings addressing the critical 
public health issues related to blood safety and availability. 
We would also like to echo a statement made by Chairman Bliley, 
as well as several other members of the subcommittee and 
previous witnesses that you have heard, that the Nation's blood 
supply is safer than it has ever been.
    However, as you have heard from a variety of witnesses, 
safety cannot be considered in a vacuum. Congress and the 
country must also pay careful attention to assuring the broad 
and timely availability of safe blood and blood components.


    The AABB and professionals in blood banking and transfusion 
medicine throughout the country have serious concerns about the 
availability of the blood supply. Already there seem to be 
daily reports of isolated blood shortages across the country. 
In Cincinnati, where I serve as Deputy Director of Clinical and 
Technical Services at the Hoxworth Blood Center and on the 
faculty of the University of Cincinnati, we have issued an 
unprecedented four emergency appeals to date in 1999.
    In the past, we seldom had to resort to such appeals. 
Although these shortages are not necessarily nationwide and 
most often take place during particular times of the year, they 
raise health concerns for the blood providers and the patients 
we serve.
    As a national blood data resource center reported to the 
subcommittee last month, the best available data suggests if 
current trends continue, the demand for blood will surpass the 
supply as early as the Year 2000. If this forecast proves true, 
at a minimum, patients will have to delay elective surgeries, a 
somewhat misleading term in that certain cancer, orthopedic, 
and cardiac procedures are considered elective.
    The NBDRC data indicates that 8.6 percent of more than 
2,000 hospitals surveyed postponed elective surgeries due to a 
lack of blood and that nearly 25 percent experienced at least 1 
day in which nonsurgical blood needs could not be met.
    If a lack of blood leads to a patient not receiving timely 
treatment, he or she will certainly consider this a crisis. We 
strongly believe that the availability of the Nation's blood 
supply is a major public health issue that Congress, the 
administration, and the blood banking and transfusion 
communities cannot afford to ignore.
    Several factors contribute to the trend toward a decreased 
blood supply and increased usage and they include the 
following: First, with the aging population, more people are 
requiring transfusions and other blood-related therapies. 
Advances in many medical areas have led to the development of 
additional therapies necessitating increased blood usage, 
including cancer treatment, organ transplants, heart surgeries 
and other therapies.
    New safety measures, including policies requiring 
additional donor deferrals, have reduced and will almost 
certainly continue to reduce, the number of eligible donors.
    Finally, the challenges of assuring a continuing stream of 
committed blood donors and educating the public as to why 
donating blood is vital to our Nation's health have become 
increasingly difficult.
    The AABB strongly urges Congress and the administration to 
act now to ensure not only a safe, but an available blood 
supply as we enter the new millennium. We recommend the 
following steps be taken:
    First, in order to be prepared for potential shortages 
before they strike, the Federal Government should provide 
additional support for blood supply data collection and 
analysis.
    In 1996, recognizing the significant need for blood supply 
data, the AABB conceived and founded the National Blood Data 
Resource Center. In prior years, data had been collected by the 
Center for Blood Research at Harvard, which received funding 
from the National Heart, Lung and Blood Institute.


    When this Federal funding ceased, the AABB saw the need to 
fill this void. The AABB is very proud of the fine work the 
NBDRC has produced and is excited about its ongoing and future 
data initiatives. Annual support from Congress and NHLBI is 
needed to collect and analyze on a routine and timely basis 
information to better forecast and take steps to avoid possible 
blood supply shortages.
    The public and private sectors need to work together to 
increase retention and recruitment of blood donors. The AABB 
has been a supporter of many volunteer recruitment efforts, 
including the upcoming National Blood Donor Month initiative, a 
public outreach campaign to promote increased blood donations. 
On January 4, as Chairman Upton stated, Congress will help kick 
off this month with a ``Fight for Life Congressional Blood 
Drive Challenge.'' We are pleased to note that Chairman Upton 
and Representatives Brown and Waxman have agreed to serve on 
the honorary committee for this event and we hope other members 
of the subcommittee will also take this important challenge.
    Additional research regarding donor behavior and motivation 
is necessary to enhance donor retention and recruitment. The 
complexities associated with blood donation today, together 
with ever-increasing demand on personal time, have made the 
recruitment process more difficult than ever. The AABB has 
recommended that the government convene a national meeting to 
highlight recruiting efforts and to provide appropriate 
education on what makes recruitment successful and what makes 
it fail.
    Fourth, policymakers should thoroughly consider the 
implications of new blood safety initiatives on availability of 
this valuable resource. Efforts to enhance safety, even when 
the risks involved are theoretical, can have significant 
effects on the blood supply. For example, it is estimated that 
FDA's recent proposal to require deferral of donors who have 
spent at least 6 months in the United Kingdom between 1980 and 
1996 will eliminate 2.2 percent of donations. Moreover, it is 
particularly troubling that many of those deferred due to this 
policy will be the community's most relied upon repeat donors. 
Finally, government should help ensure that nonprofit blood 
centers and transfusion services have adequate resources 
available to support a safe and available blood supply.
    At the same time, costly new blood products and therapies 
are being introduced and the FDA is mandating new safety 
measures. Federal reimbursement for blood products and services 
is being severely limited. Nonprofit blood centers and 
financially strained hospital transfusion services do not have 
the capacity to absorb these additional burdens. A timely 
example is the recent Medicare proposal to establish a 
prospective payment system for outpatient services, including 
transfusion services. Under this proposal, blood services would 
be reimbursed at a level far below what they actually cost; in 
some instances, only one fourth of a procedure's true cost.
    Faced with such severe underpayments and already tight 
restricted budgets, many hospitals likely will not be able to 
offer patients these necessary services.
    My final comments to the subcommittee will address error 
and accident reporting. The AABB supports the goal of 
identifying errors and accidents as a means of ensuring that 
patients receive


quality care. Since 1958, the AABB has developed standards for 
voluntary compliance in blood collection and transfusion. The 
AABB also conducts independent assessments and accredits 
facilities, including blood collection centers and hospital-
based transfusion services that are in compliance with AABB 
standards and applicable Federal and State regulations.
    Since January 1998, the AABB has had in place a quality 
management system that requires that AABB-accredited facilities 
have in place a process to capture, assess, investigate and 
monitor errors and accidents. AABB's accreditation system is 
well recognized in the medical community, has been granted 
deemed status by HCFA under the Clinical Laboratory Improvement 
Act, as amended, and is formally recognized by the Joint 
Commission on Accreditation of Health Care Organizations. An 
error and accident reporting system should lead to corrective 
and preventive measures and be designed to facilitate the 
ultimate goal of promoting the best possible patient care.
    In conclusion, blood represents the unique public health 
benefit for the patients whose lives depend on this resource. 
We hope that Congress will work with the blood community in 
taking the above-mentioned steps to ensure a safe and available 
blood supply. Thank you very much.
    [The prepared statement of Susan L. Wilkinson follows:]
  Prepared Statement of Susan L. Wilkinson on Behalf of the American 
                       Association of Blood Banks
    My name is Susan Wilkinson and I am pleased to be here today to 
speak on behalf of the American Association of Blood Banks (AABB). I 
currently serve as President of the AABB, the professional association 
representing approximately 2,200 institutions, including community and 
Red Cross blood centers as well as hospital transfusion services, and 
over 9,000 individuals involved in all aspects of blood collection, 
processing, distribution and transfusion. AABB members are responsible 
for virtually all of the blood collected and over 80 percent of the 
blood transfused in the United States.
    The AABB would like to commend the Subcommittee for holding this 
series of hearings addressing the critical public health issues 
relating to blood safety and availability. We would also like to echo a 
statement made by Chairman Bliley as well as several other Members of 
the Subcommittee--the nation's blood supply today is safer than it has 
ever been. However, as you have heard from a variety of witnesses, 
safety cannot be considered in a vacuum; Congress and the country must 
also pay careful attention to assuring the broad and timely 
availability of safe blood and blood components.
Serious Concerns about Blood Availability
    The AABB and professionals in blood banking and transfusion 
medicine throughout the country have serious concerns about the 
availability of the blood supply. Already, there seem to be daily 
reports of isolated blood shortages in geographic communities across 
the country, from San Diego, to Detroit, to Pittsburgh. In Cincinnati, 
where I serve as Deputy Director of Clinical and Technical Services of 
the Hoxworth Blood Center and on the faculty of the University of 
Cincinnati, we have issued an unprecedented four emergency blood 
appeals this year. In the past, we seldom had to resort to such appeals 
and would go for a year without any. Although these shortages are not 
nationwide and most often take place during particular times of the 
year, they raise real health concerns for blood providers and the 
patients we serve.
    Moreover, as the National Blood Data Resource Center (NBDRC) 
reported to the Subcommittee last month, the best available data 
suggest that if current trends continue, the demand for blood will 
surpass the supply as early as the year 2000. If this forecast proves 
true, at a minimum, patients will have to delay elective surgeries--a 
somewhat misleading term in that certain cancer or heart surgeries are 
considered ``elective.'' The NBDRC data indicate that 8.6 percent of 
the more than 2,000 hospitals surveyed postponed surgeries due to a 
lack of blood and that nearly


25 percent experienced at least one day in which non-surgical blood 
needs were not met. If a lack of blood leads to a patient not receiving 
timely treatment, he or she will certainly consider this issue a 
crisis. We strongly believe that the availability of the nation's blood 
supply is a major public health issue that Congress, the Administration 
and the blood banking and transfusion medicine communities cannot 
afford to ignore.
Likely Causes of Increasing Blood Shortages:
    Several factors contribute to the trend toward a decreased blood 
supply and increased usage. They include the following.
     With the aging of the population, more people are 
requiring transfusions and other blood-related therapies. Persons aged 
65 or older receive twice as much blood per capita as younger 
individuals.
     Advances in a wide array of medicine have lead to the 
development of additional therapies necessitating increased blood 
usage, including cancer treatments, organ transplants, heart surgeries, 
and other therapies.
     New safety measures, including policies requiring 
additional donor deferrals, have reduced and will almost certainly 
continue to reduce the number of eligible donors. We are particularly 
concerned about the impact policies, such as the deferral of donors who 
have traveled to the United Kingdom for at least six months between 
1980 and 1996, will have on preventing reliable, repeat donors from 
providing this needed public health resource.
Ways to Ensure a Safe and Adequate Blood Supply:
    The AABB strongly urges Congress and the Administration to act now 
to ensure not only a safe, but an available blood supply as we enter 
the new millennium. We recommend that the following steps be taken in 
this effort.
     First, in order to be prepared for potential shortages 
before they strike, the federal government should provide additional 
support for blood supply data collection and analysis. In 1996, 
recognizing the significant need for blood supply data, the AABB 
conceived and founded the National Blood Data Resource Center. In prior 
years, data had been collected by the Center for Blood Research at 
Harvard Medical School, which received funding from the National Heart 
Lung and Blood Institute. However, when this federal funding ceased, 
there was a clear vacuum in public or private support for national 
blood data collection, which the AABB saw the need to fill. The AABB is 
very proud of the fine work the NBDRC has produced and is excited about 
its ongoing and future data initiatives. We are also very pleased that 
the NHLBI has agreed in the short-term to purchase data from the NBDRC, 
which will help enable the Center to gather more timely, monthly data 
regarding the blood supply. Additional, annual support from Congress 
and NHLBI is needed to collect and analyze on a routine, timely basis 
information to even better forecast and take steps to avoid possible 
blood supply shortages.
     The public and private sectors need to work together to 
increase retention and recruitment of blood donors. The AABB has been a 
supporter of many donor recruitment efforts, including the upcoming 
National Volunteer Blood Donor Month initiative. The AABB invites 
Members of the Subcommittee, their staffs and all of Capitol Hill to 
participate in this special event in January 2000. This annual event 
sponsored by a coalition of blood organizations spearheaded by the AABB 
and including America's Blood Centers and the American Red Cross 
involves a broad public outreach campaign to increase awareness about 
the need to donate blood and promote increased blood donations. On 
January 4, 2000, Congress will help to kick-off the month with the 
``Fight for Life Congressional Blood Drive Challenge,'' which pits 
Republicans and Democrats against each other in a friendly battle to 
see which side of the aisle can contribute the most blood. We are 
pleased to note that Chairman Upton and Representatives Brown and 
Waxman have agreed to serve on the honorary committee for this event 
and we hope that all of their colleagues on the Subcommittee will 
participate in this important effort.
     Additional research regarding donor behavior and 
motivation is necessary in order to enhance donor retention and 
recruitment. The complexities associated with blood donation today 
together with the ever-increasing demands on personal time have made 
the recruitment process more difficult than ever. Discussions during a 
variety of public meetings have revealed a lack of understanding of the 
full range of difficulties associated with recruiting and retaining 
donors. In this light, the AABB has recommended to the Advisory 
Committee on Blood Safety and Availability that the government convene 
a national meeting to highlight recruiting efforts and to provide 
appropriate education on what makes recruitment succeed and what makes 
it fail. The AABB also believes there is a need for research into 
behavioral sciences to determine what motivates individuals to donate. 
In 1998, the


AABB's National Blood Foundation (NBF) provided funding for an NBDRC 
survey regarding donation incentives. In the near future, the NBF will 
award an additional $175,000 grant to study the blood donation decision 
process. In addition, we recommend a critical review of donor 
suitability requirements to provide recommendations on how to 
streamline the process and delete unnecessary and outdated requests for 
information. Both federal and private support for research efforts is 
essential if we are to obtain critical information to increase 
donations as soon as possible, and before more drastic blood shortages 
occur.
     Policymakers should thoroughly consider the implications 
of new blood safety initiatives on availability of this valuable 
resource. Efforts to enhance safety, even when the risks involved are 
theoretical, can have significant effects on the blood supply. For 
example, it is estimated that FDA's recent proposal to require deferral 
of donors who have spent at least six months in the United Kingdom 
between 1980 and 1996 will eliminate 2.2 percent of donations. This may 
not seem like a high number, but when combined, each such chipping away 
at the blood supply can add up to a significant public health dilemma. 
Moreover, it is particularly troubling that many of those deferred due 
to this policy will be the community's most relied on repeat donors. In 
addition, the ensuing donation reductions are likely to be even more 
severe in certain locales--for instance, East Coast cities. We were 
pleased to hear that FDA intends to gather and analyze additional data 
regarding the impact on the blood supply as this deferral policy is 
implemented and scientific information about the actual threat of new 
variant Creutzfeldt-Jakob disease (nvCJD) transmission through blood. 
Blood availability should not be unduly reduced absent a true blood 
safety risk.
     Finally, the government should help ensure that nonprofit 
blood centers and transfusion services have adequate resources 
available to support a safe and available blood supply. At the same 
time costly new blood products and therapies are being introduced and 
the FDA is mandating new safety measures, federal reimbursement for 
blood products and services is being severely limited. Nonprofit blood 
centers and financially strained hospital transfusion services do not 
have the capacity to absorb these additional financial burdens.
    A timely example is the recent Medicare proposal to establish a 
prospective payment system for outpatient services, including 
transfusion services. Under this proposal, blood services would be 
reimbursed at a level far below what they actually cost. For example, 
Medicare would pay only $325 for therapeutic apheresis, a therapy used 
to treat individuals with severe medical conditions, including certain 
life-threatening blood disorders, which in reality costs closer to 
$1,400 to provide. Faced with such severe underpayments and already 
tightly restricted budgets, many hospitals likely will not be able to 
offer patients this necessary care.
     Shortfalls in blood-related reimbursement have even a larger 
impact in the inpatient setting, where the vast majority of blood 
services are provided. Medicare and private reimbursement payments lag 
far behind the state of blood-related care and medical technology. FDA 
and the blood community continue to move forward in requiring notable 
new blood safety measures. But the Health Care Financing Administration 
(HCFA) is not providing fair reimbursement to cover these safety 
measures. The AABB strongly urges Congress to act to ensure that 
Medicare provides fair payments for blood safety measures as soon as 
they are approved by the FDA. Just as blood safety is a national 
priority, assuring fair payments and patient access to quality blood 
therapies should be a priority as well. Recognizing this fact as well 
as the underlying reimbursement problem, the federal Advisory Committee 
on Blood Safety and Availability recently adopted a resolution 
recommending that the Secretary of the Department of Health and Human 
Services work with Congress to seek additional resources to support the 
introduction and maintenance of mandated blood safety measures. We hope 
that Congress will act immediately to ensure necessary coordination of 
blood-related policies at FDA and HCFA and other divisions of HHS. By 
enhancing reimbursement to fair levels, you can help guarantee that 
patients have access to the safest and best possible blood products and 
therapies.
Error and Accident Reporting
    Congress and other policymakers should also consider these 
decreases in reimbursement and the increasing budgetary constraints 
facing blood centers and hospital transfusion services, along with the 
all-important impact on blood safety and patient care, as you address 
the issue of error and accident reporting. The AABB supports the goal 
of identifying errors and accidents as a means of ensuring that 
patients receive quality care. Since 1958, the AABB has developed 
standards for voluntary compliance in blood collection, processing and 
transfusion. The AABB also conducts independent assessments and 
accredits facilities, including blood collection centers and hospital-
based transfusion services, that are in compliance with AABB's


Standards and applicable state and federal regulations. Since January 
1998, the AABB has had in place a quality management system that 
requires AABB-accredited facilities to have in place a process to 
capture, assess, investigate, and monitor events that deviate from 
accepted policy or procedure or that fail to meet AABB Standards and 
other applicable regulations and requirements. AABB's accreditation 
system is well-recognized in the medical community, has been granted 
deemed status by HCFA under the Clinical Laboratory Improvement Act, as 
amended (CLIA), and is formally recognized by the Joint Commission on 
Accreditation of Healthcare Organizations (JCAHO).
    In establishing an error and accident reporting system, we believe 
that the most important question is what will be done with the 
information collected. An error and accident reporting system should 
lead to corrective and preventive measures and be designed to 
facilitate the ultimate goal of promoting the best possible patient 
care. Policymakers must be aware that any new regulation which requires 
additional man-hours of data collection and submission, if gathered to 
no useful corrective purpose will only serve to further divert strained 
hospital staffing resources away from patient care. Such an outcome 
would threaten to worsen, rather than improve the safety of transfusion 
services.
Conclusion
    Blood represents a unique public health benefit for the patients 
whose lives depend on this resource. As the federal Advisory Committee 
on Blood Safety and Availability recognized during a recent meeting, 
blood merits special attention due to several of its unique 
characteristics--including the fact that it is a donated national 
resource and is provided, in the vast majority of cases, by nonprofit 
institutions. We hope that Congress will work with the blood community 
in taking the above-mentioned steps to ensure a safe and available 
blood supply.

    Mr. Upton. We do appreciate your work. Thank you.
    Ms. Fredrick, welcome.

                 TESTIMONY OF JACQUELYN FREDRICK

    Ms. Fredrick. Mr. Chairman and members of the subcommittee, 
I am pleased to be here today to discuss the issues of safety 
and availability of the Nation's blood supply. My name is 
Jackie Fredrick, and I am the Chief Operating Officer and 
responsible head of the American Red Cross Blood Services.
    Red Cross Blood Services is the Nation's largest supplier 
of blood products, serving more than 3,000 hospitals across the 
country. Today I want to address the vital public health issue 
of ensuring an adequate blood supply. I am going to highlight 
for you what the Red Cross has been doing to meet this 
challenge.
    As Chairman Bliley, Chairman Upton, and Surgeon General 
Satcher have all stated, the Nation's blood supply is safer 
than ever before. Now we must work together to make the same 
intellectual and financial investments to ensure the 
availability of the blood supply.
    During the past decade, the Red Cross has made substantial 
investments in procedures, programs and equipment to 
continually improve the safety of the blood supply. We have 
invested more than $300 million over the past 5 years alone in 
the establishment of eight state-of-the-art laboratories, a 
single computer system that maintains the world's largest blood 
donor data base, standard operating procedures in all of our 
blood centers, and an independent quality assurance program.
    Most recently, the Red Cross has been at the forefront in 
the implementation of nucleic acid testing, or NAT, having 
invested well over $17 million. I would refer you to my written 
statement for a thorough description of our surveillance 
programs for emerging infectious diseases and our error and 
accident reporting systems. We


are especially pleased to hear the subcommittee highlight the 
important research of Dr. Harold Kaplan, as the Red Cross has 
lent significant support to his project on error and accident 
reporting.
    Although blood safety is our top priority, we are strongly 
committed to increasing the availability of the blood supply. 
Compared to the more than $300 million that the Red Cross has 
invested to improve the safety of the blood supply, we have had 
only a small fraction of that amount available to us to invest 
in the availability of the blood supply.
    The Red Cross collected more than 6 million units of blood 
last year. Over the past 2 years, as you have heard, we have 
increased collections by 500,000 units, or 8 percent. During 
that same time period, however, our distribution of blood to 
hospitals has increased 11 percent.
    It is clearly evident that even in good times, the Nation's 
blood supply is fragile. While blood donations in some parts of 
the county are increasing, donations in other areas have been 
on the decline. From 1994 to 1999, the largest urban areas 
served by the Red Cross, such as Detroit, Philadelphia, and 
Baltimore, have experienced a decline in donations of more than 
9 percent. For that same time period, there has been an 8 
percent rise in donations in the rural midwestern areas of the 
country and an 11 percent increase in the Sunbelt and western 
portions of the country served by the Red Cross.
    With our nationwide blood system, we are able to move this 
precious resource wherever and whenever it is needed. Part of 
availability is making sure the right blood is in the right 
place at the right time, and the Red Cross last year moved over 
650,000 units of blood to areas of need.
    To counteract these supply and-demand trends, the Red Cross 
is engaged in a number of efforts to continuously recruit new 
donors and retain previous donors. These initiatives include 
implementing innovative donor recruitment and retention 
techniques using state-of-the-art technology; identifying best 
practices to be used throughout the Red Cross system; improving 
the convenience and comfort of the donation experience; 
reaching out to minority and youth populations; and 
investigating the use of technologies such as the Internet to 
reach current donors.
    If we are to cultivate the next generation of blood donors, 
we need to look to youth and segments of our society who have 
been underrepresented in the donor pool. Later this year the 
Red Cross will launch the first program in a 3-year minority 
recruitment initiative patterned after a highly successful 
program at North Carolina Central University, resulting in 
tenfold increase in donations. We currently are working with 
over 70 historically black universities and colleges on this 
effort.
    If we are to meet the public health challenge of an 
adequate blood supply, the Federal Government must partner with 
the Red Cross and our independent blood center colleagues. We 
must work together to ensure that appropriate resources, both 
human and monetary, are invested to meet the Nation's future 
blood need. This includes funding additional research on donor 
motivation, studies to help us monitor the supply, and 
especially blood utilization, public education campaigns 
targeted at making the public generally


aware of the critical importance of donating blood, and making 
the process more user friendly.
    Finally, because blood centers are operating in the same 
managed care environment as hospitals, we face similar pressure 
to reduce costs while increasing the quality of our services. 
We are very concerned about HCFA's proposed rule covering 
outpatient services, as it would not adequately cover the cost 
to hospitals for the majority of products and services provided 
by blood centers. The proposed rule jeopardizes Medicare 
patient access to the most lifesaving therapies.
    Mr. Chairman, I would like to join your fellow committee 
members who have thanked you for holding these hearings. They 
have assisted greatly in raising the awareness and importance 
of blood safety in our Nation. I also want to thank you 
personally for your commitment and your blood donation in Great 
Lakes. Our staff enjoyed your visit and expects you back in 
exactly 48 days.
    This concludes my prepared statement. I would be happy to 
answer any questions you or members might have.
    Mr. Upton. I thought it was 56 days.
    Ms. Fredrick. You donated last week.
    Mr. Upton. You are already counting. I understand.
    [The prepared statement of Jacquelyn Fredrick follows:]
  Prepared Statement of Jacquelyn Fredrick, Chief Operating Officer, 
                 American Red Cross Biomedical Services
    Mr. Chairman and Members of the Subcommittee: I am pleased to be 
here today to discuss the issues of safety and availability of the 
nation's blood supply. My name is Jackie Fredrick, and I am the chief 
operating officer and responsible head of American Red Cross Blood 
Services. Red Cross Blood Services is the nation's largest supplier of 
blood components, serving more than 3,000 hospitals across the country. 
Last year, we collected more than 6 million units of whole blood 
through the generous donations of approximately 4.5 million volunteer 
donors. Each day, 22,000 donors visit one of 400 Red Cross blood 
donation sites. For more than 50 years, the Red Cross has remained an 
innovator and a leader in transfusion medicine and research. The Red 
Cross has provided the nation with safe and reliable blood components 
and products for generations. Through blood services, the Red Cross is 
touching more lives than ever before.
    Today, I am here to address the vital public health issue of 
ensuring an adequate blood supply. I am going to highlight for you what 
the Red Cross has been doing to meet this challenge. We have made 
substantial investments to improve safety. Indeed, as Chairman Bliley, 
Chairman Upton and Surgeon General Satcher have all stated, our 
nation's blood supply is safer than ever before. Now, we must work 
together to make the same intellectual and financial investments to 
ensure the availability of the blood supply.
Safety Initiatives Undertaken by the Red Cross
    During the past decade, the Red Cross has made substantial 
investments in procedures, programs and equipment to continually 
improve the safety of the nation's blood supply. We have invested more 
than $300 million over the past five years alone in the establishment 
of eight state-of-the-art testing laboratories; a single, standardized 
computer system that maintains the largest blood donor database in the 
world; standardized operating procedures in our 37 Blood Services 
regions; and an independent quality assurance program with more than 
200 experts who monitor every aspect of our operations to ensure 
compliance with our standard operating procedures and all federal 
regulations.
    The Red Cross has been proactive in its efforts to ensure that new, 
viral screening tests are implemented as soon as they become available. 
Most recently, the Red Cross has been at the forefront in the 
implementation of nucleic acid testing, or NAT, having invested $17 
million on this effort. NAT, which the Red Cross is conducting under an 
Investigational New Drug protocol, has the potential to detect the 
actual DNA of the virus in a blood donation rather than waiting for the 
body's response to the virus through the creation of antibodies, as 
most currently licensed


tests do. As such, NAT may greatly reduce the ``window period''--the 
time between when an individual is infected and the point at which 
evidence of the virus can be detected in that person's blood. As 
Surgeon General Satcher stated, NAT will be especially helpful in 
screening donations from individuals newly infected with the hepatitis 
C virus (HCV) and the human immunodeficiency virus (HIV).
Red Cross Surveillance Activities
    Each year the Red Cross invests more than $20 million in basic and 
applied research at our Jerome H. Holland Laboratory for the Biomedical 
Sciences, one of the world's premier blood research facilities. At the 
Holland Laboratory, more than 270 world-class Red Cross scientists and 
technicians evaluate and monitor possible threats to the blood supply 
and develop cutting-edge technologies that bring innovative products 
and services to patients. We actively monitor and detect the emergence 
of infectious diseases through ARCNET, the most comprehensive blood 
collection-related epidemiological database in the world. This includes 
16 million records, with each record consisting of donor demographics, 
screening test results and deferral history.
    The Red Cross monitors the blood supply for emerging infectious 
diseases. For example, Holland Laboratory researchers have conducted a 
number of studies on Chagas disease and tick-borne diseases such as 
babesiosis. Red Cross regional staff are also involved in a study to 
assess the risk of bacterial contamination of blood products--referred 
to as the BaCon study.
    Surveillance within the Red Cross extends beyond research. Through 
its quality assurance program, the Red Cross has sophisticated 
surveillance programs in place to monitor and review all elements 
involved in collecting, manufacturing, testing and distributing blood 
components. For example, a system of ``In-Process Reviews,'' or IPRs, 
has been established at each of the Red Cross's eight national testing 
laboratories. IPRs consist of reviews and documentation of all critical 
control points in the testing process to ensure that testing 
technicians have performed each task in the testing process correctly. 
Another level of review follows the IPR and ensures that documentation 
for all testing is recorded correctly. Finally, there are quality 
control and quality assurance steps, which include another round of 
review of infectious disease test results and general system audits. 
Together these levels of review enable us to track and trend all 
unexpected outcomes and helps to ensure our compliance. Next year the 
Red Cross will implement a new laboratory information system that will 
automate many functions now performed by employees.
    For some time, the FDA has required licensed, registered blood 
establishments, including the Red Cross, to report errors and accidents 
as a tool to ensure the safety, potency and purity of blood and blood 
products. The Red Cross has achieved a high degree of compliance in 
reporting errors and accidents in a timely manner, as required by the 
FDA. The Red Cross encourages the application of any measures that may 
increase the safety of the blood supply including the research that is 
being conducted by Dr. Harold Kaplan that includes a new method for 
reporting errors and accidents. We were pleased to hear that Dr. 
Kaplan's important research was brought to the Subcommittee's attention 
at its last hearing. The Red Cross has lent significant support to this 
research because of its potential to enhance the current error and 
accident reporting system by assessing and correcting errors before 
they happen.
Ability of the Blood Supply to Meet Anticipated Patient Needs
    The Red Cross has not only committed financial resources, but also 
invested in human talent by bringing together the best in the field to 
make improvements to the safety of the blood supply. We are equally 
committed to blood availability. To address future needs in blood 
availability, however, we will need to make the same financial and 
intellectual investment as we have with blood safety.
    The Red Cross collected more than 6 million units of blood last 
year. We have seen an increase of 500,000 units in our collections over 
the past two years, an 8 percent increase. During that same time 
period, however, our distribution of blood to hospitals increased by 11 
percent. The increase in demand is also reflected in the fact that very 
few components expire before they can be used, and that number 
continues to decrease.
    Recent studies by the National Blood Data Resource Center (NBDRC) 
and the General Accounting Office (GAO) have highlighted concerns about 
the availability of blood components. Both NBDRC and the GAO cite 
trends in collections and demand for blood that point to possible 
widespread shortages in the near future. The Red Cross shares its data 
with the NBDRC, and during the time period of the NBDRC study (1994-
1997), we had a decline in donations of 2 percent, while the NBDRC 
report shows a similar nationwide decline of 5 percent. We look forward


to continuing our work with the NBDRC to build upon the progress that 
has been made in collecting comprehensive data on the supply and 
utilization of blood.
    Although we have seen an increase in donations overall, there are 
times when individual Red Cross Blood Services regions experience 
serious shortages of certain blood types. As the GAO pointed out in its 
study, shortages tend to be in specific blood types such as O and B, 
with type O in shortest supply because it is the universal blood type. 
Shortages tend to occur during the summer months and holiday seasons, 
and in times of bad weather. For example, in September, before 
Hurricane Floyd, Red Cross Blood Services regions in the Southeastern 
United States made sure that their hospitals had stocked shelves to 
meet patient needs. During and after Hurricane Floyd, many previously 
scheduled blood drives had to be cancelled throughout much of Virginia, 
North Carolina and South Carolina resulting in the loss of 
approximately 10,000 units to the Red Cross system. Through our 
nationwide system, the Red Cross was able to ensure that hospitals in 
this area of the country had an uninterrupted supply of blood 
throughout the storm and its aftermath with 18 regions shipping in 
approximately 8,000 units.
    It is clear that, even in good times, the nation's blood supply is 
fragile. While blood donations in some parts of the country are 
increasing, donations in other parts have been in decline. For example, 
from 1994-1999, the largest urban areas served by the Red Cross, such 
as Detroit, Philadelphia and Baltimore have seen a decline in 
collections of more than 9 percent. For the same time period, we have 
seen an 8 percent rise in donations in the rural Midwestern areas of 
the country. The Sunbelt and Western portions of the country served by 
the Red Cross have experienced an even more dramatic increase in 
donations--more than 11 percent during the past five years. The Red 
Cross nationwide blood services system allows us to move blood to 
hospitals wherever and whenever it is needed. During the past year, we 
made available 650,000 units from sections of the country where there 
was a sufficient supply to those areas where this resource was needed. 
Market research has indicated that donors are driven by altruistic 
reasons. Once their local community needs are met, they welcome the 
opportunity for their life-giving donation to help people in other 
parts of the country.
    The aging of the U.S. population impacts both the supply and demand 
for blood. As a group, older Americans (Americans over the age of 65) 
tend to require more blood than other age groups. In addition, as these 
individuals age, we lose our most dedicated, repeat blood donors. To 
meet anticipated future demands upon the blood supply, the Red Cross is 
working smarter and more efficiently to increase our collection base. 
We are applying the same proven techniques used by corporate America to 
understand and attract customers--and in our case to make blood 
donation more appealing.
    We are engaged in a number of efforts to continuously recruit new 
donors and retain previous donors. These initiatives include:

 implementing innovative donor recruitment and retention 
        techniques using state-of-the-art technology;
 identifying best practices to be used throughout the Red Cross 
        system;
 improving the convenience and comfort of the donation 
        experience;
 reaching out to minority and youth populations; and
 investigating other ways to apply technology, such as the 
        Internet, to reach potential and current blood donors.
    The Red Cross is currently piloting new blood drive scheduling 
software to improve the efficiency of blood drives, enhancing the 
experience for both the donor and blood drive managers. We are 
implementing a new nationwide telerecruiting system that allows the Red 
Cross to contact more donors, more often, and in a more efficient 
manner. Use of the Internet as a means of scheduling donor appointments 
also holds tremendous promise.
    As the Subcommittee has heard from other witnesses, the Blood Donor 
Record, or BDR, is a lengthy document that requires donors to answer 
very personal questions that are required by FDA standards. As part of 
our effort to use technology to make our system painless and paperless, 
we are working with leading technology companies to develop hand-held, 
computerized BDRs that will give blood donors more privacy and speed up 
the health history process.
    The Red Cross is striving to identify the most effective ways of 
doing business in donor recruitment and collections. Our PRIDE project 
team (Process Reengineering and Improvements Done by Everyone) is 
examining the best business practices in our system and ensuring their 
implementation throughout our 37 regions. The team's work encompasses 
donor recruitment and collections, production and distribution, sales 
and marketing, quality assurance, performance management and 
organizational design.


    As the Subcommittee has stressed, it is important not only to 
attract new donors, but to retain them after their initial experience. 
Research has indicated that donations from individuals who are repeat 
donors tend to be safer than those from first-time donors. The Red 
Cross has performed research on donor motivation and what it takes to 
bring people back. Through focus group research, we know that it is 
important for volunteer donors to feel a connection with the patients 
who benefit from the gift of their donation. We also know that donors 
find it important to be part of the Red Cross ``family.'' To drive this 
point home, we are conducting a pilot program in the Southeastern 
United States called ``Hero's Welcome,'' which shares the story of 
blood donation and the people it helps. As we approach the holidays and 
the year 2000 date change, the Red Cross is launching a special blood 
donation initiative called ``Millenium Hero.'' The program is intended 
to ensure adequate donations prior to and following January 1, 2000.
    Donor comfort is important to ensuring that people have as pleasant 
an experience as possible when they take time out of their busy 
schedules to donate. We are investigating the development of ergonomic 
chairs and looking for ways to measure donors' hemoglobin levels or 
``hematocrit'' without having to perform an ear or finger stick. Our 
goal is to foster an environment that is friendly and painless, as well 
as one that encourages repeat donations.
    If we are to cultivate the next generation of blood donors, we need 
to look to youth and segments of our society who have been 
underrepresented in the blood donor pool. Later this year, we will 
launch the first program in a three-year minority recruitment 
initiative. This exciting program, entitled ``The Power is in You,'' 
encourages blood donation by African Americans and is based on a highly 
successful effort at North Carolina Central University, spearheaded by 
Ted Parrish, which has increased blood donation on campus tenfold. The 
Red Cross currently has relationships with 76 of the 118 historically 
black colleges and universities. By working with historically black 
colleges and universities, we hope to increase blood donation on campus 
and throughout the African-American community.
    The Red Cross is launching regional and national youth recruitment 
initiatives, such as ``It's What's Inside That Counts'' and 
``Generation V,'' which enable high school and college blood drive 
coordinators and their teams to run frequent and successful blood 
donation programs. At the elementary school level, we have held blood 
drives in which children are first educated about the need for blood 
donation and then recruit their parents and teachers to donate blood. 
By teaching the importance of blood donation at an early age, we hope 
it will encourage these youth to become donors when they are old enough 
to do so.
Dedication of Red Cross Resources
    The possibilities to increase blood donation are numerous, and to 
us, exciting. As a not-for-profit organization, however, the Red Cross 
must be a careful and responsible steward of its funds, and scarce 
resources must be prioritized. Accordingly, our highest priority has 
been to increase the safety of the blood supply. As I said earlier, 
since 1994, the Red Cross has invested more than $300 million in 
technologies and systems to improve the safety of the blood supply. In 
comparison, during the same five-year period, we have had only a small 
fraction of that amount available to invest in the availability of the 
blood supply.
Need for Federal Support
    The federal government must partner with the Red Cross and our 
independent blood center colleagues to meet the public health challenge 
of an adequate blood supply. We must work together to ensure that the 
appropriate resources, both human and monetary, are invested to meet 
the nation's future blood needs. This includes funding additional 
research on donor motivation, studies to help us monitor the supply and 
utilization of blood, and public education campaigns targeted at making 
the general public aware of the critical importance of donating blood. 
In addition, the screening process for blood donors must be made more 
user-friendly. For example, the FDA should consider allowing blood 
centers to simplify the BDR, especially for repeat donors.
    We are committed to bringing the best science to the donor 
screening process. We view with concern, therefore, the recent 
recommendation from FDA requiring that anyone who has spent more than 6 
months in the United Kingdom between 1980 and 1996 be indefinitely 
deferred from donating blood. There is very little science supporting 
this deferral policy, yet it has been estimated that the nation could 
lose at least 2.2% of donations, almost 300,000 units per year, at a 
time when the blood supply is marginal. We encourage FDA to review this 
policy frequently, and we will assist them by providing whatever data 
is available and appropriate.


    Finally, because blood centers are operating in the same managed 
care environment as hospitals, we face similar pressures to reduce our 
costs, while improving the quality of our services. Reimbursement 
programs, such as those administered by HCFA and other third-party 
providers, must fully reimburse hospitals and blood centers to ensure 
that patients receive the newest and most innovative blood services. We 
are very concerned about HCFA's proposed rule covering out-patient 
services. As proposed, the rule would not adequately cover the costs to 
hospitals for the majority of products and services provided by the Red 
Cross. The proposed rule jeopardizes Medicare patient access to the 
most up-to-date lifesaving therapies. As the nation's largest provider 
of blood components, we will continue to work with Congress and HHS to 
ensure the formulation of a fair and reasonable reimbursement system.
    Mr. Chairman, I would like to join your fellow Committee members 
who have thanked you for holding these series of hearings. They have 
assisted greatly in raising the awareness of the importance of blood 
safety and availability. I also want to thank you for your personal 
commitment to ensuring that vital blood components are available for 
those in need, as evidenced by your recent donation at our Great Lakes 
Region. Our staff enjoyed the time that they spent with you last week 
and welcome your return 48 days from now.
    This concludes my prepared statement. I would be happy to answer 
any questions you or Members of the Subcommittee may have.

    Mr. Upton. Dr. Bianco.

                    TESTIMONY OF CELSO BIANCO

    Mr. Bianco. Mr. Chairman, thank you for your blood 
donation.
    Mr. Chairman and honorable members of the Commerce 
Committee, I am Dr. Celso Bianco, Vice President for Medical 
Affairs for the New York Blood Center. Today I am honored to 
represent America's Blood Centers as their President. ABC is 
the federation of independent community blood centers that 
provide about half of this Nation's volunteer blood donor 
supply.
    On behalf of ABC, I would like to applaud the committee, 
Chairman Upton and Chairman Bliley and Surgeon General David 
Satcher, for their efforts to enhance the safety of the blood 
supply through improved error and accident reporting. We 
address this topic in separate written comments to the 
committee. Today my comments will focus on five very important 
issues.
    First, we ask Congress to encourage the Department of 
Health and Human Services, HHS, to do what it can to ensure 
that a dependable supply of volunteer donor blood is available. 
Our written testimony contains copies of letters that outline 
specific actions that we believe HHS can contribute.
    Over the past 10 years, the need for blood has increased, 
as data from the national Blood Data Resource Center clearly 
demonstrates. At the same time, the number of Americans willing 
and able to voluntarily give blood has decreased.
    The number of those willing to donate has decreased because 
they are too busy and because there has been a decline in 
support from corporate America for voluntary blood donations by 
their employees. The number of those able to donate has 
decreased because the Food and Drug Administration continues to 
add new donor criteria.
    We agree with criteria that ensures a safer blood supply. 
However, we are deferring more and more perfectly healthy 
Americans because of speculation.
    Community blood centers are working hard to make sure that 
this potential crisis does not threaten the health of patients 
needing blood. It is very important to understand that often 
the need


for blood is urgent, meaning the blood needs to be already on 
the shelf when the emergency occurs. We just heard from Mr. and 
Mrs. Sperry about that. But ultimately, the blood needs to be 
there or lives will be lost. That is why we are so concerned 
when stocks of blood are low.
    Think of the Oklahoma City bombing, the shootings at 
Columbine, the school bus hit by the train. Most of the blood 
used to save those lives was given within the first few hours 
of the tragedy.
    We live on the edge. For instance, in New York today, we 
have a 3-day blood supply of the O-positive blood and 1\1/2\ 
days supply of the O-negative type blood. We have also asked 
HHS to eliminate unscientific barriers to donation, and to 
encourage eligible Americans to give blood. We believe that the 
national leadership must foster a culture of blood donation.
    The congressional challenge that you just talked about is 
an example of this type of leadership.
    Second, we recognize that FDA has made great contributions 
to blood safety in the past. However, we are now spending more 
and more resources chasing theoretical or minuscule risks, such 
as those from mad cow disease and malaria, instead of focusing 
on well-recognized problems. For example, we defer 50,000 
healthy people a year from donating blood because they visited 
Mexican resorts in areas defined as malarial zones. Not one of 
the 10 U.S. cases of transfusion-related malaria in the last 
decade was transmitted by someone that visited Mexico. They 
were all transmitted by people who emigrated to the U.S. from 
West Africa.
    Similarly, we will defer over 250,000 healthy donors who 
have traveled to the United Kingdom because of the theoretical 
risk of transmitting variant CJD. Instead, Congress should 
encourage FDA to focus on the over 200 Americans reported to 
FDA who have died because they got the wrong unit of blood, or 
because of bacterial contamination. In a 1997 report, the 
General Accounting Office recommended that FDA focus on these 
clerical errors and on preventable transfusion reactions.
    Third, we ask that Congress encourage FDA to use science as 
the basis for its decisionmaking and that FDA apply consensus 
development processes, like negotiated rulemaking, when 
considering controversial policies. At ABC's annual meeting 
this past February, FDA Commissioner Jane Henney called blood 
safety one of her highest priorities. She also pledged that FDA 
would again become a science-based organization. We are ready 
to contribute to joint efforts in this area. We are ready to 
accept decisions based on science.
    Fourth, we ask that Congress ensure proper representation 
of the blood service community on bodies that advise FDA. In a 
1996 study of the tragedy of AIDS in the blood supply in the 
early 1980's, the Institute of Medicine of the National Academy 
of Sciences recommended that FDA strike a proper balance in 
committee membership, but today there are no representatives of 
the blood community on FDA's most important Blood Products 
Advisory Committee.
    Fifth, we ask that Congress ensure the Health Care 
Financing Administration pays for blood safety mandates from 
FDA. Last April, Surgeon General Satcher said that, ``We as a 
society need to


assure unequivocally that the blood supply is safe.'' Dr. 
Satcher went on to state that we must be ready to pay for safe 
blood as a disease prevention, rather than spending money on 
treatments. We support Surgeon General Satcher. We understand 
that HCFA is looking at the best options to assure that the FDA 
blood safety mandates result in a timely change in HCFA's 
reimbursement to hospitals.
    In essence, we ask Congress to support volunteer blood 
donations, to focus FDA on demonstrated safety risks, to 
encourage science-based decisions, to ensure adequate 
representation of the volunteer blood center community in the 
Blood Products Advisory Committee, and to assure adequate HCFA 
reimbursement.
    I thank Congress for this opportunity. Please know that 
America's Blood Centers, the community blood centers, will do 
everything possible to assure the safest and most dependable 
blood supply possible. Congress must also do what it can to 
help us meet our goals.
    Thank you. I am open to questions.
    [The prepared statement of Celso Bianco follows:]
 Prepared Statement of Celso Bianco, President, America's Blood Centers
    Mr. Chairman and Honorable Members of the Commerce Committee. I am 
Dr. Celso Bianco, vice president for medical affairs for the New York 
Blood Center. Today, I am honored to represent America's Blood Centers, 
or ABC, as their president. ABC is the federation of the independent 
community blood centers that provide about half of this nation's 
volunteer donor blood supply.
    On behalf of ABC, I would like to applaud the Committee and Surgeon 
General David Satcher for their efforts to enhance the safety of the 
blood supply through improved error and accident reporting. We address 
this topic in separate written comments to the Committee. Today, my 
comments will focus on five very important issues.
    First, we ask Congress to encourage the Department of Health and 
Human Services (HHS) to do what it can to ensure that a dependable 
supply of volunteer donor blood is available. Our written testimony 
contains copies of letters that outline specific actions that we 
believe HHS can contribute. Over the past ten years, the need for blood 
has increased--as data from the National Blood Data Resource Center 
clearly demonstrate. At the same time, the number of Americans willing 
and able to voluntarily give blood has decreased. The number of those 
willing to donate has decreased because they are too busy and because 
there has been a decline in corporate America's support for voluntary 
blood donations by their employees. The number of those able to donate 
has decreased because the Food and Drug Administration (FDA) continues 
to add new donor deferral criteria.
    We agree with criteria that ensure a safer blood supply. However, 
we are deferring more and more perfectly healthy Americans because of 
speculation.
    Community blood centers are working hard to make sure that this 
potential crisis does not threaten the health of patients needing 
blood. It's very important to understand that often the need for blood 
is urgent, meaning the blood needs to be already on the shelf when the 
emergency occurs. We can tinker with the system through sharing of 
blood between blood centers and go out on emergency appeal. But 
ultimately, the blood needs to be there or lives will be lost. That's 
why we are so concerned when stocks of blood are low. Think of the 
Oklahoma City bombing, the shootings at Columbine, the school bus hit 
by the train. Most of the blood used to save those lives was given 
within the first few hours of the tragedy.
    We have also asked HHS to eliminate unscientific barriers to 
donation, and to encourage eligible Americans to give blood. We believe 
that the National leadership must foster a culture of volunteer blood 
donation.
    Second, we recognize that FDA has made great contributions to blood 
safety in the past. However, we are now spending more and more 
resources chasing theoretical or minuscule risks, such as those from 
mad cow disease and malaria, instead of focusing on well-recognized 
problems. For example, we defer 50,000 healthy people a year from 
donating blood because they visited Mexican resorts in areas defined as 
malarial zones. Not one of the 10 U.S. cases of transfusion-related 
malaria in the


last decade was transmitted by someone who visited Mexico! They were 
all transmitted by people who emigrated to the US from West Africa. 
Similarly, we will defer over 250,000 healthy donors who have traveled 
to the U.K. because of the theoretical risk of transmitting variant 
CJD. Instead, Congress should encourage FDA to focus on the over 200 
Americans reported to FDA who have died because they got the wrong unit 
of blood, or because of bacterial contamination. In a 1997 report, the 
General Accounting Office recommended that FDA focus on these clerical 
errors and on preventable transfusion reactions.
    Third, we ask that Congress encourage FDA to use science as the 
basis for its decisionmaking, and that FDA apply consensus development 
processes, like negotiated rulemaking, when considering controversial 
policies. At ABC's annual meeting this past February, FDA Commissioner 
Jane Henney called blood safety one of her highest priorities. She also 
pledged that FDA would again become a science-based organization. We 
are ready to contribute to joint efforts. We are ready to accept 
decisions based on science.
    Fourth, we ask that Congress ensure proper representation of the 
blood service community on bodies that advise FDA. In a 1996 study of 
the tragedy of AIDS in the blood supply in the early 1980s, the 
Institute of Medicine of the National Academy of Sciences recommended 
that FDA strike a proper balance in committee membership. But today, 
there are no representatives of the blood community on FDA's most 
important Blood Products Advisory Committee.
    Fifth, we ask Congress to ensure that the Health Care Financing 
Administration (HCFA) pays for blood safety mandates from FDA. Last 
April, Surgeon General Satcher said that, ``We as a society need to 
assure unequivocally that the blood supply is safe.'' Dr. Satcher went 
on to state that we must be ready to pay for safe blood as a disease 
prevention, rather than spending money on treatments. We support 
Surgeon General Satcher. We understand that HCFA is looking at the best 
options to assure that FDA blood safety mandates result in a timely 
change in HCFA's reimbursement to hospitals.
    In essence, this Committee and Congress can support the safety and 
availability of the volunteer blood supply by:

1. Supporting volunteer blood donations and encouraging HHS to make 
        this issue a National priority;
2. Focusing FDA on demonstrated safety risks;
3. Encouraging science-based decisions;
4. Ensuring adequate representation of the volunteer blood center 
        community in the Blood Products Advisory Committee; and
5. Assuring adequate HCFA reimbursement for measures that increase the 
        safety and availability of the volunteer blood supply.
    I thank Congress for this opportunity. Please know that America's 
Blood Centers, the community blood centers, will do everything possible 
to assure the safest and most dependable blood supply possible. 
Congress must also do what it can to help meet our common goals.
    Thank you.

    Mr. Upton. Thank you all very much.
    Again, we got a unanimous consent request earlier that all 
members' statements be made part of the record. At this point 
the members will be asking some questions. We will try to stick 
to this 5-minute time clock as well, as we rotate with 
questions here certainly before the votes.
    I have a question that I asked, I guess 2 weeks ago, at our 
hearing. I asked the audience, though not under oath: How many 
folks here have donated blood at least once in their lifetime, 
raise your hand?
    I am so glad. We want to make sure our blood competition 
drive is open to the press as well. Some of us feel like we 
give blood every day and they take it.
    How many people here have given blood in the last year 
raise your hand?
    Again, okay. Again I want to make the point you can do that 
every 56 days.


    The Sperrys, we appreciated your story, and even more for 
those in the audience. I don't know if they put these books out 
on the table, but there is a book that is a weekly calendar put 
out. We can make sure that anyone in the audience that would 
like one, we will make these available ``Pints for Half 
Pints.'' There is a story on a number of really remarkable 
kids, most of whom survived. But your son is there for the 
first full week in March. It is really a remarkable story, very 
touching for him and all of these wonderful children that were 
highlighted in this, and again it reminds us about the need for 
blood.
    It sort of reminded me as you told your story and as I read 
it in advance as well, in not only giving blood, that everyone 
that can ought to do so, but also the story of one of our 
colleagues, Bill Young, who has been a leader in the bone 
marrow tests. I was among many that participated in a drive 
here on Capitol Hill to have my blood marrow tested, stored in 
a bank, and I can hardly wait for the day when someone comes 
and calls and says, We need you, and I will be there. It is 
that type of volunteer effort that really does save lives. We 
witness your son, who has certainly been a little active this 
morning. We appreciate that.
    You know, I was on C-SPAN this morning, I did calls with my 
colleague, Mr. Strickland, who is a member of this subcommittee 
as well, and one of the calls that I received was, I believe, a 
gentleman from Kentucky, who on trips to Ohio had noticed a lot 
of people on crack. And his question to me, which I wasn't able 
to give him an answer, but I said I would ask this this 
morning, was whether or not these tests in the blood he donated 
last week--I know it is NAT-tested later on--my suspicion is 
that that NAT test, nucleic acid test, given the acronym NAT, 
does in fact weed out anyone that might have some illegal 
substance in their blood. Is that true, Ms. Fredrick? Do you 
want to answer that?
    Ms. Fredrick. That unfortunately is not true. The testing 
we do for viruses such as hepatitis and the HIV virus, those 
viruses happen to be present to a greater extent in people who 
use illegal drugs, but we have multiple layers of safety in the 
blood supply.
    The first layer is the health history and the questions we 
ask. Though we believe they are rather cumbersome, the purpose 
of those is to solicit truthful answers about risk activities 
that might put the donor----
    Mr. Upton. That is right. I did note to the gentleman that 
called that there was a lengthy questionnaire that took about 
10 or 15 minutes to fill out, because they wanted--I mean, the 
person that walked through with me, he made sure that 
everything was answered. I had one question on an 
anticholesterol drug that I take, and I told him about that, 
and he said that shouldn't warrant any trouble. But in fact 
that was a question.
    I noted, in fact, that there were some folks, I think there 
is a question on tatoos on that, whether you have had a tatoo. 
I remember that question, because I don't have any tatoos. I 
just checked no.
    But go a little bit more on the drugs. I am sorry to 
interrupt.
    Ms. Fredrick. As you know, we ask extensive questions about 
lifestyle. Those questions we do ask about illegal use of drugs 
for


injection, because mostly we are concerned about the 
transmission, obviously, of viruses such as hepatitis and HIV.
    The blood then goes on and is tested for those viruses, but 
in fact we cannot do testing for actual presence of any illegal 
drugs like crack cocaine.
    Mr. Upton. Okay. Mr. Green.
    Mr. Green. Thank you, Mr. Chairman. Again, thank you for 
calling this hearing. This is our third hearing. I was proud 
for a number of years to give blood, but I guess coming from 
Houston and my sinus problems, I have been rejected now for the 
last 4 or 5 years because of the medication.
    That is one of the questions I would ask. I understand, you 
know, and I have gone through the questionnaire, because 
frankly the church my wife and I attend, we have a blood drive 
as often as we can, the Shriners. There is an effort at the 
Texas Medical Center in Houston. But I think the outreach more 
is to nontraditional groups. I do know, for example, churches 
in my community that do it, so--because of the fear of the 
amount of blood supply and the shortness we have had, 
particularly over holiday periods of time.
    I know the tatoo issue and things like that. But that is 
one of the frustrations that I have tried to do, and I guess 
there is a fear because of whatever sinus medication or 
something you are taking. Doctor, could you answer that?
    Mr. Bianco. In general, we will not defer a donor because 
of a sinus medication. We will defer if they were recently 
taking an antibiotic because of the fear that there could be 
some bacteria in the blood that we take. As it is stored for 
several days, there is opportunity for those bacteria to grow. 
But just a sinus medication, just decongestants, should not be 
a call for deferral.
    But I think you hit a very important problem, Mr. Green. It 
is that because of concerns of safety, we have been 
overzealous, overcautious. Today, as I tried to say in this 
statement, we are deferring incredible amounts of healthy 
Americans because of the fear of that minuscule risk that is 
there, as if we could eliminate all the risk.
    What we are creating is the shortage on the other side. We 
discourage a lot of people. You had a reaction that is not the 
common reaction. Your reaction was to say, I can't give, I will 
get my church and groups to give. Most of the people that get 
deferred get very depressed, very upset, feel rejected, feel 
they are not healthy, and they have trouble dealing with that 
rejection. That is a network. They don't encourage other people 
to donate.
    We have to find ways to change that behavior. We have to 
find ways we are donating for the whole community. If we don't 
give, we help give.
    Mr. Green. I understand the reason. Maybe the pendulum 
swung so much because of the problems we had a decade ago with 
the quality of the blood supply because of the AIDS virus and 
some of the tragedies that we have seen. I don't know if I want 
to actually weaken it, but I also know maybe we need to--the 
questionnaire is involved, and I would hope that there would be 
other ways you could check the blood.


    Mr. Bianco. The quality of tests also has changed 
substantially, Mr. Green, particularly with the addition of the 
NAT testing that we just mentioned. It is our ability to detect 
those infections and to shorten what we call the ``window 
period'' to days. It is incredible in terms of reducing the 
risk of transmission of those viruses.
    So the history, medical history, becomes in a certain way 
as one of the layers a little bit less important than it was in 
the past.
    Mr. Green. Ms. Wilkinson, you make a point in your 
testimony that there are daily reports of isolated blood 
shortages. Again, my district in Houston, I know we have 
experienced that in geographic communities all across the 
country, from San Diego to Detroit to Pittsburgh. Can you put 
it in better context for us and explain why these sporadic 
shortages are occurring and why this is something we should be 
concerned about?
    Ms. Wilkinson. I think again it is really twofold. We see 
less people who are willing to donate. People have articulated 
people's busy lifestyles. I think support from corporate 
America has declined over the years. Again, bringing a mobile 
operation into an organization obviously takes time away from 
the job. So there has been less interest from corporate America 
in supporting the community blood program. I know in our 
community, this is an area we are trying to focus on very 
significantly, again in order to increase getting the donors in 
the door.
    Again, the other end of the spectrum is increased usage. We 
have seen at least in our community, a tremendous increase in 
blood products. Again, it goes back to procedures like more 
aggressive therapy for cancer treatment, transplants, traumas. 
They are able to get patients to hospitals much more quickly 
now because of air care support. Again, the likelihood of 
saving that person's life increases. But along with that comes 
the usage of blood and blood components. So I think all of 
those factors contribute to the shortages we are seeing.
    Mr. Green. Thank you, Mr. Chairman. I would just like to 
ask Ms. Fredrick, and Dr. Bianco also, if they would just 
address that sometime in other questions.
    Ms. Fredrick. I would say to you, for instance in Houston, 
like many of our urban centers, the medical intensity of the 
procedures that go on in our urban areas, this is where people 
come to have bone marrow transplants, open heart surgery. So 
you have a great need in the large urban areas of this country 
in the use of blood, and the population not able to meet all of 
those needs. So in many large areas, Houston to be one, not 
only does the local community support the blood supply, but 
actually communities throughout the country also support the 
blood supply.
    The other issue around that is our urban centers tend to be 
very diverse. We need to spend more time, more effort, in 
reaching out to all the different populations we have in our 
communities, the Hispanic population, the African American 
population, youth. That is a job we need to think more about, 
reaching different groups to encourage blood donation, because 
we are becoming a more diverse community, not less so.
    Mr. Bianco. Just to add a number to what Jackie just 
mentioned, Gulf Coast Regional Blood Center in Houston had an 
increase of 15 percent in demand for blood last year.


    Mr. Green. Thank you, Mr. Chairman. I can also share the 
doctor's concern because of the economy in Texas and people do 
spend a great deal of time, maybe a long weekend in Mexico, the 
west coast of Mexico, and that fear, I can understand that may 
be something we need to look at. Thank you, Mr. Chairman.
    Mr. Upton. Thank you. I do want to make sure that the 
record is correct, too, when I talked about tatoos. It is only 
if you have received a tatoo in the last year. Again, I don't 
have any.
    You have heard these buzzers. We have a vote on the House 
floor. So we are going to temporarily adjourn for about 15 
minutes and then come back. It will be about a quarter of.
    [Brief recess.]
    Mr. Upton. I think we are okay for a little while. We don't 
have votes for another hour.
    At this point, I yield to a member of the subcommittee, Mr. 
Bryant.
    Mr. Bryant. Thank you, Mr. Chairman. Let me begin by asking 
Dr. Wilkinson, as a lay person, a reformed lawyer, I don't know 
a lot about medicine, but I think there is a perception out 
there among the public that when you give blood, a lot of 
people don't want to give it unless there is an emergency, and 
then you can just run down there and give it. As was pointed 
out in the speakers' testimony, that is not always the case.
    Can you quickly, because I want to ask other panelists a 
couple of questions, tell us the timeframe involved and sort of 
walk us through? If you go and give blood, are you tested first 
to see if you are acceptable, and then do they have to test the 
blood? How quickly can that be done?
    Ms. Wilkinson. We don't pretest the blood. But let's say 
you decide you want to give blood; you come to the neighborhood 
blood center, and you will be asked to give some demographic 
information and then you will be given a health history form. 
This is the questionnaire that Mr. Upton referred to, that I 
guess can appear somewhat long to someone who may not have gone 
through the process before.
    Typically, a lot of blood centers will have a part of the 
form that is self-administered and ask general health questions 
about you as a donor. It will ask for medications you have been 
on. It will ask about any systemic diseases that you might 
possibly have that would disqualify you as a donor.
    I want to emphasize that all of this obviously is intended 
to protect the recipient; but there are some reasons that the 
questions are being asked, in fact, to protect the donor. So we 
don't draw blood when it is inappropriate for you as the donor.
    Mr. Bryant. I guess the real point of my question: How long 
would it take if you had that emergency and if you are relying 
on that, then I can run in and give blood--how long would it 
take to get that blood if it were acceptable to the recipient?
    Ms. Wilkinson. So it is available for distribution, it 
takes approximately 2 days.
    Mr. Bryant. That is a point I wanted to make. We have an 
audience that may be watching on television, and the fact is, 
it is not just a matter of walking down, taking your blood out 
of the body and giving it to someone else.


    Ms. Wilkinson. That is exactly right. From the day of 
donation, your unit goes through a number of test procedures 
with NAT. The turnaround time, most typically, blood centers 
are releasing products on the second day.
    Mr. Bryant. Dr. Bianco, you make some excellent points I 
think in terms of how we think of things in Washington, too. I 
think this panel has been really good on the practical side, 
kind of what I describe as where the rubber meets the road. 
This is where it happens. But you make some good 
recommendations. I wanted to quickly read those and see 
particularly if Ms. Fredrick or Dr. Wilkinson, anybody from the 
professional standpoint--certainly the Sperrys have an 
experience personally--but from a professional standpoint, if 
you have any disagreement.
    I think the five points you make that we ought to consider 
in Washington are having HHS take a stronger position on 
voluntary blood donation and encouragement. Number 2, focusing 
the FDA on demonstrated safety risk. Number 3, using science-
based decisions in making the determinations on whether to have 
these restrictions in place or not. I think that is very good, 
using sound science. Number 4, ensuring adequate representation 
of the volunteer blood community and their products advisory 
committee, which I think again is a very strong and ought to be 
an acceptable recommendation on your part. I think someone 
ought to have a presence on that panel and have input. And the 
fifth, assuring adequate HCFA reimbursement for measures that 
increase safety and availability of the overall blood supply.
    The trends are down in this country for all these reasons 
we have talked about, and it is time the government, the 
Federal Government, took notice of this. I think, again, those 
five recommendations are very strong, and I just wondered if 
Ms. Fredrick or Dr. Wilkinson--I know, Dr. Bianco, you feel 
that way or you wouldn't have made it. Do you all have any 
comments?
    Ms. Fredrick. Yes, I think we very much support what Celso 
said. We would also encourage the need to increase the funding 
and the intellectual capital we spend on this issue.
    If you look at the great progress we have made in safety in 
this country, it has come at a financial investment and an 
investment of experts, intellectual investments. We would like 
to see that same sort of investment now made in availability to 
draw on the partnership between the private sector and the 
public sector, government and blood centers, to really solve 
the issue of availability.
    Ms. Wilkinson. I would certainly concur with Celso's five 
recommendations. Again, I think it is very important that we 
emphasize some issues about educating the public on the need 
for blood donation and how in fact those products are used; the 
real patients, in fact, whose lives are changed by receiving 
that product from an altruistic donor.
    Mr. Bryant. If I may make one comment to follow up on my 
first comment to Dr. Wilson, there is a perception in the 
public if an emergency comes up, a shooting or the bridge 
collapses, that we can all run down there and give blood, but 
in fact there is a delay of up to 2 days before that blood can 
actually be used, and you have to have that blood in the bank, 
so to speak.
    Ms. Wilkinson. That is correct.


    Mr. Bryant. Literally and figuratively.
    Mr. Bianco. The word ``bank'' is what gives a false 
impression. It is a feeling people have that we open the door 
and it is all there, sitting on the shelf. It is not a bank, 
really. It is a pipeline. It is coming in every day, it is 
going out every day, and it doesn't last too long. A platelet 
donation we can use within 5 days. The maximum life for a unit 
of red cells is 42 days. So they are very short-lived products.
    Mr. Bryant. Thank you.
    Mr. Upton. Mr. Whitfield.
    Mr. Whitfield. Thank you, Mr. Chairman, and I apologize for 
being late and not hearing your testimony, although I did have 
an opportunity to read some of it. But the area that I just 
wanted to focus on briefly, you had talked about in your 
testimony, I guess it was Dr. Bianco, about the consensus 
development processes at FDA, and I had the impression that 
your view is that they are not operating with consensus 
development as it relates to blood.
    Would you elaborate on that just a little bit?
    Mr. Bianco. Yes. The relationship of blood centers--and I 
can understand historically why it happened, it all relates to 
the AIDS crisis--was during many years an adversarial 
relationship. On the other hand, I think that we have 
sufficient expertise within the blood transfusion community in 
which we can sit down around the table and make some very 
reasonable decisions.
    I think there are many examples that come from other 
agencies of the Federal Government, for instance the Energy 
Department, and the decisions about pollution standards and all 
that, that were achieved in terms that were much better for the 
American population, because everybody sat around the table, 
saw what is possible to do, and instead of just rules that were 
issued continuously, trying to control the process and 
sometimes a little bit out of focus.
    They were in focus a few years ago, but now the issues are 
different. So I think that if there was more interaction we 
would be more successful in reaching that.
    Mr. Whitfield. Is there anyone else who would like to 
comment on that general area?
    This Blood Products Advisory Committee, that is a committee 
at FDA; is that correct?
    Ms. Wilkinson. Yes.
    Mr. Whitfield. Are blood centers represented on that?
    Mr. Bianco. Currently there are no blood center members 
sitting on the committee. It used to be the tradition that one 
or two representatives of blood centers sat in the committee. 
Currently there are physicians, there are scientists, but there 
are no blood center persons.
    Mr. Whitfield. Who appoints those members to that 
committee?
    Mr. Bianco. FDA. The center for Biologic Evaluation and 
Research.
    Mr. Whitfield. Why would there not be a representative of 
the blood centers on there?
    Mr. Bianco. Again, I believe this is a concern that comes 
from the AIDS tragedy. It was a concern at one point in the 
early days in which there was a feeling that FDA was too close 
to the blood banking community and may not--by being too close, 
may not have


been as vigilant as they should be. So the pendulum, as 
somebody said, swung the other way, and so there has been a 
very big separation.
    So the committee was reconstituted in 1995 and the previous 
committee was dissolved, reconstituted, and from that point on, 
there were several representatives from advocacy groups like 
hemophilia groups, but there were no representatives of the 
blood banking community.
    Mr. Whitfield. So you feel like it has gone too far the 
other way now?
    Mr. Bianco. That is what I said in my testimony, it is just 
a reasonable balance.
    Mr. Whitfield. There was an example that someone gave about 
this malaria in Mexico.
    Mr. Bianco. That is the example that I also gave. The 
example is that we are concerned, obviously. We do not have a 
test that is practical for malaria screening of blood donors, 
and there have been for the last 20 or 30 years 1, 2, sometimes 
3 cases a year, sometimes no cases a year, among the 12 million 
units that are transfused. Malaria in general is benign, but it 
can be fatal on occasion.
    So we ask donors, in order to avoid people that could be at 
risk of transmitting malaria, we ask donors if they have been 
in a malarial zone. And we are too strict about that in the 
ways we do it, in my medical opinion; because we, for instance, 
had asked the FDA to consider a change that if people were just 
in a resort where there are no mosquitos, where everything is 
clean, they didn't leave at night to go walk by the forests or 
by the ruins near some Mexican resort, that those donors would 
be eligible to donate.
    But there have been very strict interpretations of those 
rules, and we cannot collect for a year a unit of blood from 
somebody that went to a resort in Mexico, some resorts in 
Mexico, that are in malarial zones. There are resorts not in 
malarial zones.
    Mr. Whitfield. Thank you.
    Mr. Upton. Dr. Ganske.
    Mr. Ganske. Thank you, Mr. Chairman.
    I am sorry I wasn't here for your presentation. I had a 
meeting with the Speaker. So I may ask some questions that have 
been asked before, but I think it is useful to go through some 
of this.
    I want to talk first about safety. I guess I would leave 
this for anyone on the panel to answer. But because there is a 
window for sero conversion for a number of diseases, what is 
the chance that a unit of blood could have the AIDS virus in 
it, but the test be negative?
    Mr. Bianco. The window period with the test, the officially 
sanctioned test that we have today for HIV, is a window of 16 
days between the date the average person is infected and the 
date when the virus appears in the circulation, we can detect 
it by the test.
    With the introduction of the NAT test, that window will be 
reduced to 11 days.
    Now, in the first 10, 11 days of the infection, the virus 
is not in the circulation, it is not in the blood. It is 
usually in the lymph nodes, starting to replicate. So the NAT 
testing will bring us the closest we can to closing that 
window.


    The risk before the NAT testing, derived from some very 
serious national studies, is 1 in 676,000. After the NAT 
testing, we don't have numbers measured, and the NAT testing is 
done under a research protocol, so we don't have a final 
figure, but we assume that will be way below 1 in a million.
    Mr. Ganske. How about hepatitis?
    Mr. Bianco. For hepatitis C, the window period is very long 
with the antibody test that we have. It is about 70 days 
between the date of the infection and the day on which the 
person develops the antibodies that we can detect. Again, NAT 
testing here is very useful because the viral load, the number 
of viral particles in the circulation, increases very rapidly, 
so the NAT testing in the format we are doing now in the 
research mode can reduce that window to about 2 weeks.
    Mr. Ganske. But that is in the experimental stage. That is 
not routinely being done?
    Mr. Bianco. It is being routinely done under our 
experimental protocol, an IND protocol approved by FDA. But the 
test is not yet licensed by FDA, but it is being done by the 
vast majority of the blood centers in the country.
    Mr. Ganske. What percentage of units of blood are tested 
that way before they go to a patient?
    Mr. Bianco. I would say way over 90 percent.
    Mr. Ganske. So we have a chance in 1 in 676,000 for HIV or 
for hepatitis?
    Mr. Bianco. We had a chance of 1 in 103,000. Now we believe 
it is again close to 1 in 600,000 to 1 in 1,000,000 after the 
NAT test.
    Mr. Ganske. Have there been documented cases in England or 
anywhere for the transmission of so-called mad cow disease 
through blood transfusion?
    Mr. Bianco. No.
    Ms. Wilkinson. No.
    Mr. Ganske. So do you agree with the ban on utilizing units 
of blood from people who spent a certain period of time in 
England?
    Mr. Bianco. No, I do not. I do not believe there is 
evidence, scientific evidence, that indicates that there is 
risk.
    Mr. Ganske. Does anyone else on the panel want to comment 
on that?
    Ms. Wilkinson. I agree with what Dr. Bianco just said. It 
is a theoretical risk only.
    Mr. Ganske. Does anyone pay for blood today? Do any of the 
blood collecting organizations pay somebody to donate blood?
    Mr. Bianco. Not in the whole blood sector. All donors in 
the AABB, American Red Cross, America's Blood Centers, are 
volunteer blood donors from the community, and that is why it 
is tough. The carrot is what we can do to their hearts and not 
the dollar bill.
    Mr. Ganske. How long has that policy been in effect?
    Mr. Bianco. The policy started effectively in the country 
in the late sixties and spread all over, so I would say by the 
mid-to-late 1970s, early 1980s, 100 percent of the whole blood 
collection.
    Mr. Ganske. How about plasma?
    Mr. Bianco. Plasma for the manufacturer of plasma products 
is collected from paid donors. But the plasma industry has a 
number


of safety measures, and some that we cannot use, like viral 
inactivation of the product, that guarantees safety.
    Mr. Ganske. Okay. And then my final question would be, and 
this would be for the entire panel, what is the single thing 
that government could do that would help increase blood 
donations? If we could start with Ms. Fredrick?
    Ms. Fredrick. I think the single thing government could do 
is increase the funding available to look at donor motivation 
studies, to understand the data and information on the blood 
supply, blood utilization in particular. We can probably get a 
lot of the data on blood collection because we are collectors, 
but in terms of how the blood is being used, projections into 
the future on how that is going to change is critical. Then I 
think to serve as a partner with us, bringing in private 
industry and the private sector to really address this issue 
with the same expertise that we have in corporate America to 
address other issues with regards to public.
    Mr. Bianco. I believe that Congress and the Federal 
Government can help us with leadership and resources. The 
moment that you, Mr. Upton, go and donate blood, you are 
sending a message. The moment government officials talk about 
blood donation, they are sending a message. They are making 
blood a new priority.
    The second thing is resources. Because of all the change in 
the health care system, we have limited resources at the 
present time and we have to focus our resources on the safety 
issues. The piece of the pie that we always dedicated to the 
recruitment of blood donors is shrinking. Very often we know 
what to do. We have people that for 30 years in my organization 
are experts at blood collection, going to places, convincing 
people, raising their spirits toward donation and events, but 
we don't have the resources.
    Mr. Ganske. Mr. or Mrs. Sperry, do you have a suggestion?
    Mrs. Sperry. I would like to comment. I appreciated Mr. 
Upton's remark in putting together a race or competition 
between them, and that puts a message that even though as every 
person has a busy life, Congressmen as well too, but they are 
taking their time to make that effort and go and give blood and 
to save a life. So to me that is the most important thing, is 
that if they can show yourselves doing that, that maybe the 
ordinary American person can look at themselves and say that I 
can make that same time as well. So I appreciate that effort.
    Mr. Ganske. So Congressmen who are experts at public 
relations can contribute.
    Dr. Wilkinson?
    Ms. Wilkinson. Well, I really support everything that 
everyone at the table has previously said. Again, I think it is 
a matter of making the public aware of the need, having the 
public understand what is involved in the donation process, and 
the recipients at the end of that process.
    I can't stress enough the resources issue. This has really 
become very critical to all of us, not only the blood 
suppliers, but the hospital transfusion services that are 
involved in issuing these products to the patient. The 
reimbursement and resource issue is a large one.
    Mr. Ganske. Thank you.


    Mr. Upton. Thank you, Dr. Ganske. I just want to note for 
the record that as we think about this competition in January, 
that two schools in Michigan actually do this routinely. 
Western Michigan University, which is in Kalamazoo, my 
district, and Central Michigan University, two terrific 
teaching universities in terms of educating teachers and 
putting them into the field, collected more than 1,000 units; 
in fact, I think it was 1,500 units were collected in the blood 
drive competition between those two schools. So we have a big 
challenge ahead of us on Capitol Hill in January.
    Ms. Fredrick, you indicated in response to Dr. Ganske's 
question about the money that NIH is going to be spending to 
increase donors, and at an earlier hearing, I don't remember if 
it was the first or second one we talked about, NIH being given 
$1.8 million, almost $2 million to look into increasing the 
number of donors. So we look forward to hearing from NIH at 
some time in the future with regard to what exactly they 
propose and whether those reforms or procedures are 
implemented, and in fact how that will be impacted. 
Particularly with the testimony that we heard at an earlier 
panel, an earlier day, from the NBDRC--is that right--yes, 
great acronym--but particularly as they get into monthly 
reports that they are going to be making available to this 
committee as well as to private sector folks and you all too, 
we will really have a fairly good handle, I think, in terms of 
the need and the donor base and exactly where we are, which we 
don't have today.
    The question that I have--actually a number of questions. 
We will see when this timer runs out before we move along. I 
have the blood shortages and related articles, excerpts from 
Regulatory Daily Report for the period 10-13-99, to October 13 
through 5-12--it must be 10-13-98, I will bet, through 5-12-99. 
Virtually every region of the country they talk about a 
shortage. It is alphabetical. So it is Alabama to California, 
Connecticut, Wyoming and South Carolina; specifically the 
regions. Michigan is included here as well, sadly; Detroit is 
earmarked and a number of things, southeastern Michigan.
    How is this report compiled? I am interested in how is this 
report put together, and when this happens. And I know Richard 
Burr, the vice chairman of this subcommittee, represents North 
Carolina, and one of the tragedies with Hurricane Floyd, not 
only did they have a large part of North Carolina maybe still 
under water, a real hardship for thousands of Americans, but 
one of the side lights that Mr. Burr related to me was that, in 
fact, a number of blood drives were cancelled because of the 
flooding, and therefore you could imagine, a number of the 
surgeries were cancelled as well, whether they be--certainly 
elective, but maybe even emergency.
    How do your organizations--I will be interested really from 
all three of you here--react? How does this system work? How do 
you identify before it is too late, and how is it that you 
actually take blood from one region that has a surplus and 
measure that and make sure that it gets to the region that does 
not? Ms. Fredrick? Walk us through this a little bit.
    Ms. Fredrick. Thank you. The way it works in the Red Cross, 
and I suspect we are a little bit different than the other 
organizations because we are in fact a self-contained 
organization, we have something called the National Inventory 
Management System,


NIMS, or the hub. The hub is in St. Louis, and it is actually a 
physical location where we can store excess blood from around 
the country. It is also a virtual inventory. Daily, our regions 
can report in their inventory levels. So on a weekly basis, I 
actually get a report, by region, that will show what the blood 
supply is in every region by blood type.
    What we do on a daily basis essentially is look at where 
the blood is needed and literally say, ``St. Paul, we need you 
to send blood to Detroit; this much at this time.''
    In the case of Hurricane Floyd, to give you an example of 
the fragility of the blood supply, we lost 10,000 donations in 
a 48-hour period, essentially from Daytona Beach up through, in 
fact, Baltimore.
    To give you an example, 10,000 units is what a whole large 
hospital might use in a year's worth of time. What we did is we 
essentially activated our national inventory system; 8,500 
units went from all of our blood regions that had blood into 
the five blood regions. We did it ahead of time because we have 
an early warning system for disasters.
    So literally we moved blood by telephone and computers, 
knowing where the excesses are and where the needs are. We also 
have a system called production planning that will actually 
take that down to the daily blood draw at a region and what 
will be made.
    So that is how we move it.
    Mr. Upton. You move it by Postal Service, by UPS, by 
Federal Express?
    Ms. Fredrick. Federal Express and UPS. Generally it is a 24 
hour--we need overnight service. So where we have to fly it, it 
is overnight. Now, we are lucky in that a lot of times we can 
drive it, like from Lansing to Detroit, for example. But, yes, 
we rely essentially on commercial carriers.
    Now, last January, as you and I were in Michigan, the 
problem was when the airport was closed, the airplanes couldn't 
land.
    Mr. Upton. Even people at the airport had trouble.
    Ms. Fredrick. So in that case, you go by land in whatever 
way you can. Most of the natural disasters we can anticipate. 
So you move blood ahead of time.
    Mr. Upton. Dr. Bianco, would you like to comment?
    Mr. Bianco. Yes. Our system, we are 73 independent blood 
centers, but we have a very cohesive group, and through ABC we 
do a lot of what we call resource sharing. We are actually 
launching in 2 weeks an Internet-based resource sharing, so the 
access and the needs are posted on the Internet and the 
exchanges--currently the system is done by fax.
    But essentially, yes, as our members in Florida are having 
troubles because of the lack of collections and all that, 
members in other areas will try to supply their needs and help 
them by shipping blood, but sometimes not really excess. 
Sometimes we all see the need is desperate in some places and 
we will cut down on a little bit of our supply to be able to 
help provide assistance.
    Mr. Upton. Do you assess that every week, or more often?
    Mr. Bianco. The system is not assessed. It is a voluntary 
system, and it is not assessed. So here what happens is that 
people will voluntarily part with a portion of their blood 
supply, and certainly


they will guarantee the needs of their community before they 
will ship some out. So not always, that resource sharing 
compensates for deficiencies in other areas.
    Mr. Upton. Dr. Wilkinson?
    Ms. Wilkinson. The AABB has a similar system, the National 
Blood Exchange. Again, people who have excess inventory will 
post that inventory through the exchange and people that have a 
need will query the exchange to see if blood is available.
    I would like to make a point to the subcommittee that 
people in blood centers typically do this on an informal basis 
as well. They typically know colleagues in other blood centers 
and they contact them on an individual basis to see if excess 
blood might be available for purchase.
    One of the things that at least I have noticed over time, 
and maybe Jackie also might want to comment on this also, is 
finding blood to purchase has become increasingly difficult. 
Typically in the country there were centers that you could rely 
on almost 100 percent to have some excess blood that would be 
available for sale and purchase in times of need. Those 
resources have gotten to be much less. And again, trying to 
find blood and resource share, this very valuable resource has 
become increasingly difficult.
    Mr. Upton. I ask for unanimous consent that Mr. Ganske can 
ask a quick question before we go to Mr. Bryant.
    Mr. Ganske. Thank you, Mr. Chairman. I'm assuming that 
nobody has asked a question about hemochromatosis patients, so 
I would like to get your testimony on this. First of all, why 
don't we go with Dr. Bianco. Can you describe what 
hemochromatosis is and how patients with that require frequent 
blood removal and whether then, in fact, this could be a blood 
supply source, and is there scientific data as to whether that 
would be a safe source?
    Mr. Bianco. Hemochromatosis is probably the most common 
genetic trait or disease in the population, the American 
population. The numbers vary but it affects basically from 5 to 
7 percent of the population. And it's a gene that is modified 
and that makes you absorb more iron than you should. And iron 
is the fundamental molecule of the hemoglobin that is in our 
red cells and help carry oxygen. The body doesn't have good 
mechanisms of getting rid of iron. An even so the person over 
the years goes accumulating iron; that iron deposits in the 
lung, in the kidneys, in the liver, and in the heart, and 
gradually will produce heart disease and diabetes and a number 
of complications.
    This is for the more serious cases, for the people that are 
homozygotes that receive the same gene from mom and dad. But 
there is information today, just published a few weeks ago in 
the medical scientific literature, that the heterozygotes that 
only have 1 of the 2 chromosomes, 1 of the 2 genes also 
accumulate more iron than they should.
    We only see today hemochromatosis people that already have 
the complications. But this is a very common gene in the 
population and these people benefit from donating blood. The 
rules that apply currently from FDA, even some of the standards 
that we have in our organization, is that we cannot use for 
transfusion a blood that is labeled what we call therapeutic 
phlebotomy; that is, a drawing


that was made with the only purpose of eliminating red cells 
from the individual.
    We have discussed a lot and this was discussed actually at 
a Blood Products Advisory Committee and the HHS Committee, that 
those individuals are perfectly normal. The only thing they 
have is a lot of iron. And they do not have diseases that are 
different than other people. They often come to blood centers 
to donate or they go to physicians' offices and they are 
charged a fee for that process.
    So actually what is in discussion is that if we remove the 
fee, so that would be an encouragement for people not to be 
totally truthful in their medical history and all of that, part 
of that blood, those that would be suitable, that would pass 
the medical history, that would pass all the tests that we use 
for transfusion. And we are all preparing submissions to FDA to 
attempt to do that. Now----
    Mr. Ganske. But there's no evidence that if you gave blood 
from a person with hemochromatosis that that could ever be 
transmitted to the recipient.
    Mr. Bianco. Oh, it's impossible. Because being a disease 
that is determined in your genes, it is determined from the 
moment that you are born, from the genes that you inherited 
from your parents.
    Mr. Ganske. Do you have an estimate for how many units you 
might have available if you were able to use?
    Mr. Bianco. The current estimates vary tremendously and 
they are all theoretical. There are estimates that we could add 
maybe 20,000, 30,000 units a year to 50,000 units a year in the 
country and there are estimates that are much higher if these 
larger populations were to donate. But I can tell you this will 
help but is not the solution to the supply.
    Mr. Ganske. Dr. Wilkinson, do you have any comments on 
that?
    Ms. Wilkinson. I want to echo Dr. Bianco's last comment. My 
perception of some of the things that I've read has been that 
hemochromatosis will make up for the shortfall that we have 
experienced with the deferral, the 6-month deferral with people 
who have been to the United Kingdom. Again there is no 
scientific evidence that says in fact it will make up the 
shortfall. And I'm concerned that people have looked at this 
too much as the answer for that shortfall.
    Mr. Ganske. Thank you. And I yield back, Mr. Chairman.
    Mr. Upton. The gentleman's time. All right. The gentleman 
from Tennessee, Mr. Bryant.
    Mr. Bryant. Thank you, Mr. Chairman. Ms. Fredrick when you 
talk about the Red Cross I think moving maybe last year 650,000 
units, how much is a unit?
    Ms. Fredrick. How much----
    Mr. Bryant. Is that a pint?
    Ms. Fredrick. Yes, it's about a pint, 500 cc's.
    Mr. Bryant. That's what a typical donor would give. They 
would donate a unit of blood, a pint of blood, when they go in 
to donate one time.
    Ms. Fredrick. Correct. And that unit of blood is called the 
whole blood and it is manufactured into multiple components. So 
you can make a red blood cell which is used to treat anemia, 
platelets which are used in bleeding disorders, cancer 
treatment, bone marrow transplantation, and then plasma which 
is also used in bleed


ing disorders. So when we move about 650,000 products, those 
primarily are the red blood cell portion of that whole blood 
donation.
    Mr. Bryant. For donors, is there an age-wise, an upper end 
or bottom end, is there a range that you cannot give blood; too 
young, too old?
    Ms. Fredrick. There is a bottom range, and it's 17 and 
older can donate. I think every State in this country has 
passed State laws that allow the 17-year-olds to give. And 
there really is no upper limit per se as long as you are 
healthy. I know of a donor who started donating after he was 80 
years old. So as long as you meet all of our health 
requirements, you can continue to donate blood.
    Mr. Bryant. I think what I get from all of your testimony 
is that again, as the people who are out there, not here in 
Washington but out there dealing with this problem on a daily 
basis, at a time when we seem to be excluding more people from 
donating blood; and the general trend for whatever reason out 
there, post-World War II people were more inclined to donate 
blood than we are today, being the selfish society that we've 
become. All those factors together at a time that that is 
happening, and blood donations--I think somebody said 1 percent 
a year--dropping 1 percent a year, that the need for this blood 
is becoming more as our society ages and as we get into more 
surgeries that are necessary, more elective surgeries and these 
kind of things.
    Do any of you have any--I know we've sort of talked around 
this a lot, but do you have any comments on general trends or 
any encouragement you can give us or anything else that you 
would like to not only tell this panel but to the people that 
might be watching this?
    Ms. Fredrick. I think you know half the people, I believe, 
in this country have experienced blood donation. So it's not 
that we don't have a pool of wonderful, willing people who 
donate blood. Our challenge is how we reach those individuals. 
And I think we have to draw on all the expertise in this 
country to understand how you reach individuals. Once you do, 
they are more than willing to donate blood. So our challenge is 
to determine how to do that: to use technology to our 
advantage, be it the new telemarketing systems; how you reach 
donors with direct mail; how you tell donors about people like 
the Sperrys.
    We know that people donate blood because they have a 
connection with the patient. And so how do we reach the donors 
and make the patient relevant? I believe there are enough 
people willing to donate in this community and in this country. 
It's our job to bring them in and invite them in to donate.
    Mr. Bianco. I think you made a very good point in the 
decline and the increase. An increase comes a lot from new 
medical technologies, too. There are the transplants. Bone 
marrow transplants today save thousands of kids with leukemia. 
The rate of cure of leukemia goes to about 73 percent today 
with a bone marrow transplant. It's incredible from what it was 
20 years ago. But they require a lot of blood to maintain those 
kids until the bone marrow takes and grows.
    And that's the example, for instance, in Mississippi Valley 
Regional Blood Center, they increased their collections. But I 
was looking at my notes here. They had an increase in 10.8 
percent dis


tribution because of changes in their oncology programs and all 
of that. In the Midwest area, that was always extremely 
successful in collecting blood.
    The other good point you made, people during the war had 
made that commitment and that generation is not donating as 
often. They can't. They have aged. We have to bring the new 
generations into the process. And the only way we'll do that is 
through leadership again. There are the techniques, we need the 
technology, but they need examples, they need people that they 
believe in so that they can commit themselves, competing with 
these millions of other things that we see every day from TV 
shows and all that, that are for them sometimes more important.
    Mr. Bryant. Thank you. Dr. Wilkinson do you have a brief 
comment?
    Ms. Wilkinson. Just finally, we live in the country that 
has the best medical care in the whole world. And again the 
reason for that good medical care is, as Dr. Bianco stated, our 
medical technology. Again, we're able to cure diseases that, 
you know, 15 years ago we couldn't necessarily cure. Blood is 
both a drug and a biologic. And currently the only way to get 
this drug and biologic is from another human being. And that's 
the message that we need to get out to others in this Nation so 
that they understand the need that we have to provide this as a 
lifesaving drug.
    Mr. Upton. Mr. Whitfield.
    Mr. Whitfield. Dr. Wilkinson, you had testified that the 
Federal Government should support blood supply data collection 
and analysis. Are you primarily talking about additional funds 
there, or were you referring to something else?
    Ms. Wilkinson. Well, I think I'm--I think we're seeking a 
mechanism for funding. Currently the National Blood Data 
Resource Center took over some activities that had been 
performed at Harvard previously. And one of the things that we 
became aware of was that currently there is no funding 
mechanism through, say, National Heart, Lung and Blood 
Institute to fund such an organization. And we're hoping that 
we can identify those mechanisms so that we can have an ongoing 
stream of funding to again collect current and accurate data.
    Mr. Whitfield. We've had a lot of hearings in this 
committee regarding organ donation and people signing cards on 
death that their organs will be given to other patients. Is 
there a program like that relating to blood or not?
    Mr. Bianco. No, but I think that you hit the nail on the 
head in that a similar program probably could make a tremendous 
contribution. We are aware that the Federal Government has made 
an investment. There's a beautiful Internet site actually 
explaining to people the organ donation programs. Many States 
have their own programs that encourage organ donations through 
driver's licenses, through other things. But again a question 
of awareness. It's a question of overcoming an initial 
resistance and maybe a little bit of anxiety about going to a 
blood center to donate a pint of blood. But at the moment they 
overcome, just at the end of that donation, you feel so elated 
that you did something great. But that is--that similarity 
between the two programs is remarkable.


    Mr. Whitfield. But there is no organized blood donation 
program.
    Mr. Bianco. Of this type, no, not yet.
    Mr. Whitfield. How many blood types are there, by the way?
    Mr. Bianco. There are many blood types but the fundamental 
blood types are the four types, A, B, AB, and O. And then among 
those, there is the RH type. Each one of them can be positive 
or negative. The most frequent blood type is the type O. But 
that's the universal type that is the blood that can be 
administered to every other person. The rarest actually is the 
type AB, this--a certain type that Sperry, that Kirkland had. 
But Kirkland could have--he is the universal recipient--he 
could have received any unit of blood available of a matched RH 
type.
    Mr. Whitfield. I yield back.
    Mr. Upton. They say round three. The United States writes 
the books on regulation and safety of blood supply. Would you 
not agree that our testing and our distribution system is 
second to none, and other countries would carefully watch what 
we do in terms of what we do? Would any of you disagree with 
that statement?
    Dr. Bianco.
    Mr. Bianco. I will not entirely disagree, but I think that 
in recent years we have been so concerned about the safety of 
everything, that for instance Europe has introduced task 
modifications, equipment, much before we did.
    Mr. Upton. Did they have the NAT test before we did in 
place?
    Mr. Bianco. NAT was--not before we did. It was more or less 
simultaneous. But for instance, the latest generation of the 
hepatitis C virus antibody test was in their blood centers 
about at least 2 years before it was in our blood centers. And 
certainly they do not have the rigorous demands that FDA makes 
of the manufacturers. But sometimes these processes could have 
been speeded up a little bit.
    Mr. Upton. Now, as I understand it, we have about 3 dozen 
deaths a year in this country because of errors that are made 
in the system. Is that about right? That's about the average?
    Mr. Bianco. The average because of errors that are 
fatalities is about 18 a year.
    Mr. Upton. Eighteen a year. And how would you describe 
those instances of fatalities? Would you say they're all 
clerical, that they might----
    Mr. Bianco. Those that I'm referring to----
    Mr. Upton. Mislabeled blood, from AB to O or whatever it 
might be, is that virtually the entire system would be 
mislabeling.
    Mr. Bianco. For those it's most--it was mislabeling, as you 
said, or the sample is collected from the wrong patient or the 
unit is hung on the wrong patient. That is a failure of 
identification.
    Mr. Upton. So they would list the wrong donor, then it 
would be----
    Mr. Bianco. Mistype; it would be the wrong type. There was 
a study that was performed in New York State in 1991 by the 
State Department of Health, using their reporting system, in 
which 1 in 12,000 units in the State in that year had been 
transfused to an unintended recipient.


    Mr. Upton. Really; 1 in 12,000.
    Mr. Bianco. Without fatalities in most of them because of 
the universal types, but the error occurred.
    Mr. Upton. Right. Now, your facilities that each of you 
represent, are they--they're all licensed; is that correct?
    Ms. Wilkinson. Yes.
    Mr. Upton. They're routinely inspected; right?
    Mr. Bianco. Right.
    Mr. Upton. And for errors, they're promptly reported, and I 
would imagine that those errors, when and if they occur, would 
be because they were mislabeled. Is that right or not? What 
type of errors would you see and notice that would be moved up 
the line?
    Ms. Wilkinson. You could really have a variety of errors. I 
mean, labeling could be one of the errors; but you might have 
some errors that were related to testing, errors that might 
have been related to the manufacturing process. I mean, there's 
a whole gamut of things that might be considered an error and 
reportable to the FDA.
    Mr. Bianco. Actually the major number from what I recall 
the statistics--and FDA has those statistics available--is what 
we call post-transfusion--post-donation communications, when we 
ask the donor to call us back if they feel something or if 
there is something wrong. And I would say that about half of 
the reports that we made is because somebody says, ``Oh, I went 
home and I realized that I went to a malarial area,'' and we'll 
pull those units and an error is defined or accident is defined 
by FDA as a unit that left our facility and that was not 
suitable for transfusion.
    Most of the errors that are reported are errors that 
involve violation of some small rule, and they don't really 
represent a risk to the recipient. But some of them are because 
they were mislabled, there was some error in the identification 
or somebody. But that's the nature of the error reporting. But 
the error reporting forces us to study what was the cause of 
the error, forces us to go review. And actually we have to 
submit to FDA, together with the error report and general 
information about how we investigated the error, and what we 
did to prevent it from occurring in the future.
    Mr. Upton. I don't know, Ms. Fredrick, if you wanted to add 
anything to that or not.
    Ms. Fredrick. No, I think Celso accurately described it. I 
think embedded underneath the accident and error reporting 
system that's really a requirement by FDA, I'm sure most of us 
have other surveillance systems that are designed to detect 
what we call event aberrations much earlier than the error and 
accident reporting system. So I think in this country, we've 
been very vigilant about building those systems in place, 
accumulating that data, even as Celso said, using it to 
actually improve the system.
    Mr. Upton. Let me ask one question, then I will yield to 
Mr. Bryant. When I gave blood last week and there was a 
comprehensive checklist that I circled yes or no based on what 
the question was, and the attendant there went through it all, 
and a couple questions I left unanswered or I had a question, 
it was very carefully gone through as to whether I was eligible 
or not.
    Dr. Wilkinson, Dr. Bianco, when folks--since I did it at my 
local Red Cross facility, is your check list identical? Is it 
virtually the


same? Are there some big differences? I mean, how is it that 
the----
    Mr. Bianco. It's virtually the same. There may be changes 
in words, there may be changes in----
    Mr. Upton. But you make the same sweeping test, then.
    Mr. Bianco. All are defined both by industry standards that 
actually are helped by AABB and by FDA guidances. And so all 
will ask about the similar subjects in a similar way in order 
to obtain the same information.
    Mr. Upton. Dr. Wilkinson.
    Ms. Wilkinson. That is correct. And any changes in a given 
institution's health history questionnaire must be approved by 
the FDA before implementation.
    Mr. Upton. Mr. Bryant.
    Mr. Bryant. I want to simply conclude my part of this 
hearing. I certainly thank you for doing this hearing and I 
want to conclude by thanking each one of you members of the 
panel for being here today, obviously very competent and 
qualified to be here and talk to us about this important issue.
    And I will just simply tell you that what you told us, at 
least I know in my case, was very insightful and most helpful 
to me in understanding this situation. Certainly I hope that we 
all as Members of Congress and this panel, that those that may 
be watching this via television have learned a lot about how 
simple and how safe the process is and how much, given again 
today's climate in this country of aging of people together 
with the medical technology that's increased the need for the 
use of blood, the medical technology that saves lives. I know 
in my district, in Memphis especially, and in Nashville, we 
have two really tremendous medical communities thriving, and 
hospitals and in other towns that I represent--I don't want to 
leave anybody out--but at this time when we need more people 
having that spirit of volunteerism coming out, and certainly 
coming from the volunteer State of Tennessee itself, I hope 
that we can certainly get our act together down there in terms 
of making sure that there's adequate blood donations made from 
our State and across the country.
    But again, thank you very much for your information and 
especially the comments on how we can work as a Congress to 
better help your effort. Thank you.
    Ms. Wilkinson. Thank you.
    Mr. Upton. Thank you, Mr. Bryant. I do have a couple more 
questions that I would like to ask before we adjourn, assuming 
no other members return.
    Has HHS been in touch with any of your organizations trying 
to help on public service announcements, whether it be on 
hepatitis C or increasing the number of donors in a variety of 
different regions in the country? That's one of the tasks that 
I think we charged them with. I wondered if they've actually 
begun to make any comment--make any contacts using your fine 
organizations.
    Mr. Bianco. There have been two things. There was a 
presentation at the latest meeting of the Blood Products 
Advisory Committee in which HHS presented a series of points in 
which what they felt from their internal committees could be 
helpful actions in


terms of increasing the blood supply. And I believe that Dr. 
Satcher mentioned that here at the first hearing.
    The second thing is that we were in contact with the 
National Institutes of Health, the blood--National Heart, Lung 
and Blood Institute. They are trying to convene a meeting in 
January to discuss the issues and to see how they could help. 
So that contact has happened. However, I hope that through--not 
however--but really I hope that through these mechanisms we 
will be able to obtain the resources that will allow us to go 
to these types of means of public health announcements and all 
that. But what we want is not just a public health 
announcement, we want you and leaders to be in those public 
health announcements. That's how you are going to help us.
    Mr. Upton. Well, I am looking forward myself to someday 
getting the gallon pin. And since I donated, they sent me a 
whole batch of material from my local Red Cross unit and they 
had all those listed, and there was even a 10-gallon pin that 
was awarded in our region.
    I asked the question when Dr. Satcher was here--did a fine 
job--but I asked the audience that they too, like I did today--
how many people had donated, how many again then had donated in 
the last year? And Dr. Satcher indicates that, Mr. Chairman, 
Fred--you notice I didn't raise my hand on the second question, 
and that's because I've been to a number of regions in the 
world that in fact once you visit, you're not allowed to donate 
blood, particularly from some parts of Africa and other places. 
I think he mentioned Togo--malaria-infested areas.
    Other than saying I wish I could find a place that doesn't 
have mosquitos and they would stay away from me--but as we look 
at malaria and as we look at what happened in New York the last 
couple weeks with--I think it's the West Nile mosquito-passed 
virus, we look at perhaps a new hepatitis strain which has been 
identified this past summer. We look at disease particularly I 
think in Central America, called Chagas. Don't have that in 
Michigan yet.
    But as you think about other bacterial contaminations, and 
as we see what happened in the U.K. with mad cow disease, and 
the new question now that is part of the form that all of us 
fill out when we donate blood, do you see movements similar to 
what we saw with mad cow disease that are going to restrict the 
donors or take potential donors out of play because of these 
West Nile, Chagas, those varieties of different events? Where 
do you see us headed toward that?
    Mr. Bianco. We are all concerned about the emergent 
infections and watching it very carefully. Centers for Disease 
Control has done a very nice job of surveillance and linking 
with all of us, including blood centers, to do that. It's 
possible that some mysterious agent 1 day comes, but 
fortunately all the agents that we have seen so far have not--
since AIDS--have not been threatening to the blood supply. 
Chagas has been in Latin America for many hundreds of years, 
maybe thousands of years. It is a serious problem in Latin 
American countries. And it is transmittable by transfusion. 
There are tests for Chagas. So if we ever saw, because of 
immigration or some issue, an increase in the prevalence of 
Chagas


disease in the country and there are several studies that from 
time to time are done, we would have the tests, we would have 
the means to control it.
    West Nile fever is the person is so sick that they can't 
think about donating blood. So the temperature that they took 
of you as you donated blood would have prevented such donation. 
But always we have to have our eyes and ears open to a 
potentially emerging threat. We are ready I think for it.
    Mr. Upton. I don't know if you wanted to comment.
    Last question I have is, as you indicated a little bit 
earlier, all of your facilities are regulated and routinely 
inspected--the works. Is there any reason to think that there 
is any blood donor facility in this country that shouldn't be 
under the same inspection guidelines that you face? I know 
they're all licensed but in some cases they're not inspected 
more than every year or 2. And obviously there are, I think, 
the guidelines across the State lines. If blood crosses State 
lines, then it's under the full review of the FDA. But it's my 
understanding that only about 90 percent of the facilities in 
fact are. And I just wonder about that remaining 10 percent, 
and I don't know of the 18 deaths that occur routinely, dozen 
and half, maybe a little bit more from time to time, I don't 
know how many of those actually come from facilities that may 
not be in the same ballpark as you all in terms of fully 
regulated and inspected.
    Ms. Wilkinson. One of the things about, say, the 
fatalities, regardless of whether a facility would be licensed 
by the Food and Drug Administration, they would still be 
required to report that to the FDA. And there would be an 
investigation of that accident through their district FDA 
office.
    Mr. Upton. But it's not as prompt though, right? It really 
is a question of being----
    Ms. Wilkinson. I really don't know about that. I can't 
speak to that because, again, I come from a licensed facility. 
But again, transfusion services typically are not licensed and 
many are not registered. There is currently a memorandum of 
understanding between the Food and Drug Administration and HCFA 
again to assess those facilities. I don't know to what extent 
those assessments are actually carried out. Again, the vast 
majority of organizations that are collecting blood certainly 
fall under the aegis of the FDA and are evaluated on a regular 
basis. I believe it's the transfusion services that you're 
speaking about that may fall through that process.
    Mr. Upton. And it's my understanding that transfusion 
deaths, when a transfusion death occurs, it has to be reported 
within 72 hours.
    Ms. Wilkinson. Well 24 hours telephonically and 72 hours 
written; yes.
    Mr. Upton. But errors not leading to deaths are.
    Ms. Wilkinson. Right. Right. And those are the--that was 
the genesis for the first guidance document or the first draft 
that we're still waiting for a final document on from the FDA.
    Mr. Upton. That's one of the things this subcommittee is 
trying to pursue, those regulations being put out earlier, 
we're hoping they would come into place well before the year 
2001, which seems to be about the time line that the FDA is 
currently embarking on.

    Ms. Wilkinson. Right.
    Ms. Fredrick. I think I want to echo what Susan said. The 
18 deaths you speak of are in the transfusion service and are 
not donor center deaths in the course of developing blood. But 
I think it would be our feeling that anybody who provides a 
blood product ought to fall under the same stringent set of 
guidelines. I think we have all invested, as we said, many, 
many, many millions of dollars to make sure our systems are 
prepared for the future and robust enough, and we would hope 
that the whole blood supply fell into those same regulations.
    Mr. Bianco. I want to support that very emphatically and 
say that every patient deserves the same quality of blood no 
matter where, no matter what in our country.
    Mr. Upton. Well, I don't think you can say it better than 
that. We appreciate your time this morning. I can assure you 
that this subcommittee will continue to move forward in the 
future on hearings to make sure that we have not only adequate 
levels but it continues to be safe. We appreciate your 
leadership and your testimony. And I guess I can say that 
without any of my Democrats present, that we look forward to 
beating them on January 4. And this hearing is now adjourned.
    [Whereupon, at 11:55 a.m., the subcommittee was adjourned.]
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