[House Hearing, 107 Congress]
[From the U.S. Government Publishing Office]



     AMERICA'S BLOOD SUPPLY IN THE AFTERMATH OF SEPTEMBER 11, 2001

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

                                HEARING

                               before the

                            SUBCOMMITTEE ON
                      OVERSIGHT AND INVESTIGATIONS

                                 of the

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                      ONE HUNDRED SEVENTH CONGRESS

                             SECOND SESSION

                               __________

                           SEPTEMBER 10, 2002

                               __________

                           Serial No. 107-137

                               __________

       Printed for the use of the Committee on Energy and Commerce


 Available via the World Wide Web: http://www.access.gpo.gov/congress/
                                 house

                               __________

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                            WASHINGTON : 2002
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                    COMMITTEE ON ENERGY AND COMMERCE

               W.J. ``BILLY'' TAUZIN, Louisiana, Chairman

MICHAEL BILIRAKIS, Florida           JOHN D. DINGELL, Michigan
JOE BARTON, Texas                    HENRY A. WAXMAN, California
FRED UPTON, Michigan                 EDWARD J. MARKEY, Massachusetts
CLIFF STEARNS, Florida               RALPH M. HALL, Texas
PAUL E. GILLMOR, Ohio                RICK BOUCHER, Virginia
JAMES C. GREENWOOD, Pennsylvania     EDOLPHUS TOWNS, New York
CHRISTOPHER COX, California          FRANK PALLONE, Jr., New Jersey
NATHAN DEAL, Georgia                 SHERROD BROWN, Ohio
RICHARD BURR, North Carolina         BART GORDON, Tennessee
ED WHITFIELD, Kentucky               PETER DEUTSCH, Florida
GREG GANSKE, Iowa                    BOBBY L. RUSH, Illinois
CHARLIE NORWOOD, Georgia             ANNA G. ESHOO, California
BARBARA CUBIN, Wyoming               BART STUPAK, Michigan
JOHN SHIMKUS, Illinois               ELIOT L. ENGEL, New York
HEATHER WILSON, New Mexico           TOM SAWYER, Ohio
JOHN B. SHADEGG, Arizona             ALBERT R. WYNN, Maryland
CHARLES ``CHIP'' PICKERING,          GENE GREEN, Texas
Mississippi                          KAREN McCARTHY, Missouri
VITO FOSSELLA, New York              TED STRICKLAND, Ohio
ROY BLUNT, Missouri                  DIANA DeGETTE, Colorado
TOM DAVIS, Virginia                  THOMAS M. BARRETT, Wisconsin
ED BRYANT, Tennessee                 BILL LUTHER, Minnesota
ROBERT L. EHRLICH, Jr., Maryland     LOIS CAPPS, California
STEVE BUYER, Indiana                 MICHAEL F. DOYLE, Pennsylvania
GEORGE RADANOVICH, California        CHRISTOPHER JOHN, Louisiana
CHARLES F. BASS, New Hampshire       JANE HARMAN, California
JOSEPH R. PITTS, Pennsylvania
MARY BONO, California
GREG WALDEN, Oregon
LEE TERRY, Nebraska
ERNIE FLETCHER, Kentucky

                  David V. Marventano, Staff Director

                   James D. Barnette, General Counsel

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

                                 ______

              Subcommittee on Oversight and Investigations

               JAMES C. GREENWOOD, Pennsylvania, Chairman

MICHAEL BILIRAKIS, Florida           PETER DEUTSCH, Florida
CLIFF STEARNS, Florida               BART STUPAK, Michigan
PAUL E. GILLMOR, Ohio                TED STRICKLAND, Ohio
RICHARD BURR, North Carolina         DIANA DeGETTE, Colorado
ED WHITFIELD, Kentucky               CHRISTOPHER JOHN, Louisiana
  Vice Chairman                      BOBBY L. RUSH, Illinois
CHARLES F. BASS, New Hampshire       JOHN D. DINGELL, Michigan,
ERNIE FLETCHER, Kentucky               (Ex Officio)
W.J. ``BILLY'' TAUZIN, Louisiana
  (Ex Officio)

                                  (ii)


                            C O N T E N T S

                               __________
                                                                   Page

Testimony of:
    Dariotis, Jeanne, President, America's Blood Centers.........    39
    Fitzpatrick, Colonel Glen M., Director, Armed Services Blood 
      Program....................................................     8
    Goodnough, Lawrence T., Professor of Medicine, Pathology and 
      Immunology, Washington University School of Medicine, on 
      behalf of the Society for the Advancement of Blood 
      Management.................................................    47
    Hauer, Jerome M., Acting Assistant Secretary, Public Health 
      Emergency Preparedness, U.S. Department of Health and Human 
      Services, accompanied by Jay Epstein, Director, Office of 
      Blood Research and Review, Center for Biological Evaluation 
      and Research, Food and Drug Administration.................     5
    Heinrich, Janet, Director, Health Care--Public Health Issues, 
      General Accounting Office..................................    12
    Jones, Robert L., President and Chief Executive Officer, New 
      York Blood Center..........................................    43
    Lipton, Karen Shoos, Chief Executive Officer, American 
      Association of Blood Banks.................................    29
    Ross, Allan S., Vice President for Technical Operations and 
      Biomedical Services, American Red Cross, National 
      Headquarters...............................................    33
Materal submitted for the record by:
    Dariotis, Jeanne, President, America's Blood Centers, letter 
      dated October 7, 2002, enclosing response for the record...    66
    Department of Health and Human Services, response for the 
      record.....................................................    82
    Fitzpatrick, Colonel Glen M., Director, Armed Services Blood 
      Program, response for the record...........................    85
    Food and Drug Administration, response for the record........    78
    Jones, Robert L., President and Chief Executive Officer, New 
      York Blood Center, letter dated October 7, 2002, enclosing 
      response for the record....................................    75
    Lipton, Karen Shoos, Chief Executive Officer, American 
      Association of Blood Banks, letter dated October 7, 2002, 
      enclosing response for the record..........................    62
    Ross, Allan S., Vice President for Technical Operations and 
      Biomedical Services, American Red Cross, National 
      Headquarters, letter dated October 7, 2002, enclosing 
      response for the record....................................    86
    Society for the Advancement of Blood Management, letter dated 
      September 30, 2002, enclosing response for the record......    70

                                 (iii)

  

 
     AMERICA'S BLOOD SUPPLY IN THE AFTERMATH OF SEPTEMBER 11, 2001

                              ----------                              


                      TUESDAY, SEPTEMBER 10, 2002

                  House of Representatives,
                  Committee on Energy and Commerce,
              Subcommittee on Oversight and Investigations,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 10:07 a.m., in 
room 2123, Rayburn House Office Building, Hon. James C. 
Greenwood (chairman) presiding.
    Members present: Representatives Greenwood, Burr, Bass, 
Fletcher, Deutsch, and Strickland.
    Staff present: Alan Slobodin, majority counsel; Peter 
Spencer, majority professional staff; Will Carty, legislative 
clerk; Chris Knauer, minority counsel; and Nicole Kenner, 
research assistant.
    Mr. Greenwood. The hearing will come to order.
    Good morning, everyone, and welcome. Our hearing today will 
center on America's blood supply in the aftermath of the 
horrific events of September 11, 2001.
    We recall the magnificent generosity of our friends and 
neighbors immediately following the terrible acts of September 
11. As President Bush observed in his speech to Congress and 
the Nation just 10 days after that awful day, ``We have seen 
the state of our union and the endurance of rescuers working 
past exhaustion. We have seen the unfurling of flags, the 
lighting of candles, the giving of blood.''
    We remember the stories and pictures of people from all 
walks of life donating their blood in New York, here in 
Washington, and around the country, often waiting in long lines 
to do so. Many of us here also stood in those lines in the days 
and weeks after the attacks.
    The nationwide donations added up quickly. Upwards of a 
half million more units of blood were collected in the 2 months 
following the attacks than was normal for that time of year, 
almost half again more supply than was usually collected.
    Sadly, this tremendous response to help others ran headlong 
into the limits of our blood supply system to store, maintain, 
and use donated blood. Thousands of donors were upset to read 
news reports that a large portion of the blood collected in 
this period had to be discarded. The system simply couldn't 
process and use all the blood safely before the value of this 
precious gift expired.
    Many in the blood supply community were also disappointed 
with such apparent wastefulness. Unlike ordinary citizens, they 
quickly became aware that there would be few survivors from the 
terrorist attacks, and thus only a limited need for emergency 
blood transfusions; yet, their mixed public responses led to a 
series of additional problems: strained resources, financial 
loss, donor confusion, and disenchantment with the system.
    We will learn this morning about how actions surrounding 
the September 11 blood donation response affected future 
donations. At the time, however, no one could reasonably 
anticipate the degree of extraordinary public response to pleas 
for blood donations, nor could anyone be certain in the days 
and weeks immediately following 9/11 that there would not be 
further incidents of terrorism that would dramatically increase 
the demands on our blood supply reserves. So, in that sense, 
the surplus was a sign of disasters that did not come and lives 
that were not lost. But the fact remains, the tremendous 
response to donate blood at that time exposed aspects of the 
management of our blood supply system that require close 
scrutiny if we are to improve the system.
    The need for and critical value of donated blood cannot be 
overemphasized. Every 3 seconds a patient in the U.S. requires 
blood, yet blood is a human tissue that cannot be manufactured, 
it can only be donated. Currently, only 5 percent of the 
eligible population donate, yet it is estimated that by the 
time we reach the age of 65, 60 percent of us will have relied 
on the use of another person's blood for our own survival. And 
since blood can be separated into such components as red blood 
cells, platelets, and plasma, the donation of just one pint of 
whole blood can help save four lives.
    This hearing will provide the subcommittee with an overview 
of the state of America's blood supply in the context of 
lessons learned and fixes under way following September 11. 
Much is involved to ensure that our Nation has a safe and ample 
supply of blood available to people who need it when they need 
it. The witnesses before us today possess expert understanding 
about these matters, and their different perspectives will 
certainly improve our own understanding. Today's inquiry begins 
with a look at the preparations by the blood community, 
including the Federal Government, for future disasters, 
terrorist attacks, or wars.
    By all accounts, the blood community has worked diligently 
to improve its ability to respond to future emergencies. After 
the attacks, the American Association of Blood Banks helped 
create the Interorganizational Task Force on Domestic Disasters 
and Acts of Terrorism. This task force offers, as I understand 
it, a new and potentially very valuable level of coordination 
within the community, an encouraging development that may help 
prevent wasteful donations in the future. I look forward to 
learning about the task force's work and in particular its 
recommendations. This past February, these recommendations were 
endorsed by the Department of Health and Human Services 
advisory committee on blood safety and availability, which 
recommended, in turn, that the Secretary adopt them.
    I look forward to learning the status of the efforts of the 
Department of Health and Human Services on this front, and in 
particular how it is deploying measures that respond to the 
advisory committee's recommendations. Our inquiry will also 
involve examining our preparedness in the broader context of 
the issues that confront our Nation's system for maintaining an 
adequate donor base and blood supply for everyday needs.
    As I noted earlier, the challenges of maintaining an 
adequate blood supply aren't just about emergencies. The 
tremendous surge in donations last fall did not last. On the 
contrary, while daily demands on the blood supply continue 
apace, donation levels this summer have reportedly been quite 
low, generating urgent appeals for people to give, something 
which I urge everyone in this hearing room to do. Maintaining a 
sufficient blood supply on the shelf is critical, but it is 
also critical that we maintain a safe supply of blood products; 
and that is why we will explore questions of safety and supply 
this morning, including recent concerns over the danger, if 
any, of the West Nile virus to our blood supply. How, for 
example, does the system respond to emerging risks and the 
related donor restrictions? What technologies and practices can 
help maintain adequate donation levels or help moderate 
increases in demand for blood?
    Fortunately, the available blood supply monitoring data 
have improved over the past several years. We now can get a 
better picture of the various factors that affect supply and 
demand. I asked the General Accounting Office to draw on this 
information to review some of the key issues relating to the 
adequacy of the blood supply, trends, emergency preparedness, 
and new safety guidelines, the mad cow disease-related donor 
restrictions in particular.
    The GAO's findings, which will be reported during the first 
panel, should help provide a framework for broader discussion 
of America's blood supply. There are many difficult challenges 
facing this portion of our public health system, but there is 
also, as the GAO report indicates, some encouraging news about 
the ability of the system to meet these challenges. Most 
importantly, we are blessed by the long history of Americans' 
generosity in donating their blood, a truly life-giving gift 
that is largely anonymous and intended for strangers. I hope 
through our hearing today we can help strengthen this 
foundation and strengthen public confidence in this system. I 
look forward to learning about the actions being taken by 
Federal Government and the rest of the blood community to 
strengthen America's blood supply system.
    Let me welcome the panelists and thank you all for coming 
to talk about these important matters this morning; and I 
recognize the ranking member, Mr. Deutsch, for an opening 
statement.
    Mr. Deutsch. Thank you, Mr. Chairman. And I appreciate the 
work of our committee and our staff on this issue over a very 
long period of time. In an effort really to hear the witnesses' 
testimony, I would yield back the balance of my time.
    Mr. Greenwood. Dr. Fletcher, do you care to make an opening 
statement?
    Mr. Fletcher. Mr. Chairman, thank you for holding this 
hearing, and I will just submit an opening statement in the 
interest of time. Thank you.
    Mr. Greenwood. The Chair thanks the gentleman. The Chair 
would ask unanimous consent that any opening statements 
submitted by members of the committee be included in the 
official record of the hearing.
    Without objection, so it shall be.
    [Additional statement submitted for the record follows:]

 Prepared Statement of Hon. W.J. ``Billy'' Tauzin, Chairman, Committee 
                         on Energy and Commerce

    Thank you Chairman Greenwood. And, let me also commend you for 
putting together what promises to be a very valuable hearing this 
morning on America's blood supply.
    The full Committee's jurisdiction covers many critical aspects of 
emergency and public health planning--from pipeline and port security 
to radiological and bioterror preparedness. And, we've been very busy 
this past year, especially since September 11, to help ensure we are 
better prepared for any future attacks or emergencies.
    The safety and availability of blood, for life-saving transfusions 
after public health emergencies or after risky surgery, is a vital 
element of America's public health preparedness. And this Committee 
takes very seriously its responsibilities to ensure an adequate and 
safe blood supply.
    Part of our responsibility involves maintaining confidence in the 
system. As you suggested, Mr. Chairman, the supply revolves around 
donors. The issue is very clear: lack of confidence can seriously 
reduce peoples' drive to donate. It can also affect the public's 
perception of the safety of the supply.
    We saw how confidence can be harmed in the months after September 
11 when an astounding amount of blood--more than 200,000 units, five 
times the normal rate I understand from the GAO--had to be discarded. 
Moreover, we'll learn today how the handling of the huge, heartfelt 
public response to donate had other potentially negative side effects.
    I'm very eager to learn about the status and current trends in the 
blood supply--and find out just what is being done to improve the 
response of the blood community next time.
    We all know there will be a ``next time'' whether it is a terrorist 
attack or natural disaster. So it is vital that we build on past 
lessons to be sure that this essential public health resource is not 
squandered. One lesson is very clear: That is that the best way to 
prepare for an emergency is to have safe blood, available already on 
the shelves of hospitals.
    I would like to know how the blood community is working to improve 
public donation levels. I would also like to know what the Health and 
Human Services' Office of Public Health Emergency Preparedness is doing 
to prepare for emergencies, as well as to improve public understanding.
    The General Accounting Office identifies some positive trends in 
donation levels--prior to September 11. While we still don't have a 
clear a picture about current trends, we certainly know not to let the 
responsible agency go too slow in taking corrective action to build on 
the gains of the past.
    There are questions about the blood supply that I hope this hearing 
will address. At the top of my list is some needed perspective on 
emerging disease threats. The GAO reports on the Mad Cow-disease 
restrictions. And I know some of the other panelists have informative 
views on these restrictions.
    We also have serious concerns about West Nile Virus, a topic of 
urgent interest to many of our constituents right now. In particular, 
I'd like to know HHS's--and FDA's--current assessment of the risks West 
Nile poses to the blood supply and the status of the development of 
diagnostic testing and screening methods. You should know, this 
Committee plans to monitor vigilantly the Department's progress here. 
We would like to be assured that the HHS will be capable of handling 
any emerging West Nile Virus threats before risks increase again with 
next spring's mosquito season.
    Finally, I'm interested to learn about some of the new ways of 
approaching blood supply preparedness. We should encourage innovative 
technologies and management methods that can help reduce demand on the 
system, after an emergency or in day to day operations. Again, we have 
some experts today who can speak informatively on this topic.
    Let me also welcome the witnesses, and thank you again, Mr. 
Chairman.

    Mr. Greenwood. Let me introduce the first panel. We are 
delighted to have Mr. Jerome M. Hauer, Acting Assistant 
Secretary of Public Health Emergency Preparedness from the 
Department of Health and Human Services. Good morning, sir. He 
is accompanied by Dr. Jay Epstein, Director of the Office of 
Blood Research and Review, Center for Biological Evaluation and 
Research of the U.S. Food and Drug Administration. Thank you.
    Colonel Glen Fitzpatrick, Director of the Armed Services 
Blood Program. Good morning, sir. And Dr. Janet Heinrich, 
Ph.D., Director of Health Care, Public Health Issues of General 
Accounting Office. Good morning. Good to have you with us, as 
usual.
    You members of the panel are aware that the committee is 
holding an investigative hearing, and when doing so we have had 
the practice of taking testimony under oath. Do any of you have 
objection to giving your testimony under oath?
    Seeing no such objection, I would advise you then that 
under the Rules of the House and the rules of the committee, 
you are entitled to be represented by counsel. Do any of you 
choose to be represented by counsel?
    Okay, in that case, if you would please rise and raise your 
right hand, I will swear you in.
    [Witnesses sworn.]
    Mr. Greenwood. You may be seated. You are under oath. And 
we will begin with you, Mr. Hauer. You are recognized for 5 
minutes for your opening statement.

   TESTIMONY OF JEROME M. HAUER, ACTING ASSISTANT SECRETARY, 
PUBLIC HEALTH EMERGENCY PREPAREDNESS, U.S. DEPARTMENT OF HEALTH 
   AND HUMAN SERVICES, ACCOMPANIED BY JAY EPSTEIN, DIRECTOR, 
  OFFICE OF BLOOD RESEARCH AND REVIEW, CENTER FOR BIOLOGICAL 
EVALUATION AND RESEARCH, FOOD AND DRUG ADMINISTRATION; COLONEL 
 GLEN M. FITZPATRICK, DIRECTOR, ARMED SERVICES BLOOD PROGRAM; 
   AND JANET HEINRICH, DIRECTOR, HEALTH CARE--PUBLIC HEALTH 
               ISSUES, GENERAL ACCOUNTING OFFICE

    Mr. Hauer. Thank you. Thank you, Mr. Chairman, and members 
of the committee, for the opportunity to be here today to 
comment on the newly released GAO report on the blood supply.
    Secretary Thompson and I are pleased to note that the 
report finds the Nation's blood supply to be generally 
adequate, despite donor restrictions. This is a well-deserved 
tribute to the American Red Cross, the members of America's 
blood centers and the remaining collection services, such as 
the Armed Forces Blood Program, which together collect nearly 
15 million units of blood each year. It is also an equally 
well-deserved tribute to the generosity of the American people 
and to our collective commitment to support each other in times 
of either individual or collective need.
    This commitment was reaffirmed by the overwhelming number 
of Americans who came out to give blood in the hours and days 
after September 11. One year later, the most important lesson 
to be learned from the response of these donors is that the 
selflessness and heroism on the streets of New York City 
pervades this country, and that it is something of which we can 
all be very proud.
    The other lesson is that we were not fully prepared to 
handle the large number of blood donations from so many 
generous Americans, which ended up exceeding the actual need. 
The blood community responded to this experience by joining 
together to form the American Association of Blood Banks 
Interorganizational Task Force on Domestic Disasters and Acts 
of Terrorism. I am a member of this task force and represent 
the Department on that task force.
    This task force met on December 11, 2001, and it has 
adopted a set of principles and an action plan for dealing with 
future events of this sort. The task force work product was 
publicly reviewed at the January 31, 2002, meeting of the 
Department's Advisory Committee on Blood Safety and 
Availability, and the Advisory Committee unanimously endorsed 
the task force's recommendations.
    Other speakers before you today will discuss these 
recommendations and they will get into more detail. I will 
simply say here that the Department of Health and Human 
Services remains actively involved in the task force and its 
individual members, and that the Department is prepared to 
implement the task force plans if the need should ever arise.
    Before leaving this subject, however, I want to point out 
that the Food and Drug Administration was exceptionally 
responsive to the needs of both public health and the blood 
industry during this difficult time, and I want to commend them 
publicly once again for their response. The FDA also conducted 
a comprehensive review of their capacity to address future 
demands of this sort on the blood supply, whether due to 
natural disasters or to terrorism. They too presented their 
plans to the Department's Advisory Committee on Blood Safety 
and Availability, and the advisory committee also unanimously 
endorsed their plans.
    Today, there remains some concern about the impact in some 
parts of the country of new blood donor deferral policies that 
will go into effect in October 2002. These policies are 
intended to decrease the possible transmission by blood of new 
variant CJD. The policies will have particular impact on New 
York City, which for some time has imported a substantial 
amount of its blood from Europe.
    The entire blood supply has anticipated this event, and 
plans have been made for other blood collection centers to 
provide blood to New York while its own facilities expand their 
operations. We will be monitoring the situation in New York 
very closely over the coming months. We anticipate that the 
Nation's blood suppliers will be able to meet this challenge, 
and we are pleased that the newly released GAO report concurs.
    Let me also mention that our system of preparedness has 
already been tested three times since September 11. In October 
of last year, we were challenged by the anthrax disseminated 
through the postal system. Despite other public health 
concerns, CDC and FDA managed to work very rapidly to assess 
the risk to the blood system, and to issue appropriate guidance 
on reasonable precautions.
    Second, in December of last year, at the time of the Winter 
Olympics in Salt Lake City, both industry and government 
mobilized fully and stayed on constant alert to ensure that any 
disruption or disaster that could have happened at the Olympics 
would be addressed with confidence in the safety of the blood 
and blood supply through the activation of existing plans.
    And, finally, we are now in the midst of an emerging 
epidemic of West Nile virus. Again, the public health agencies 
in collaboration with the blood industry have mobilized rapidly 
and are acting aggressively to define any possible risk from 
transfusions and to identify feasible and effective 
intervention strategies. The Department of Health and Human 
Services remains interested in receiving suggestions from the 
blood industry on how we can support their efforts to assure 
that the blood supply remains both adequate and safe both in 
times of peace and in times of national emergency. In 
particular, we will be receiving the most recent 
recommendations of the Advisory Committee on Blood Safety and 
Availability, which met last week.
    I appreciate the time, and I would be happy to answer any 
questions.
    [The prepared statement of Jerome M. Hauer follows:]

 Prepared Statement of Jerome M. Hauer, Acting Assistant Secretary for 
 Public Health, Emergency Preparedness, U.S. Department of Health and 
                             Human Services

    Thank you, Mr. Chairman and members of the Committee for the 
opportunity to be here today to comment on the newly released GAO 
report on the blood supply.
    Secretary Thomson and I are pleased to note that the report finds 
the nation's blood supply to be generally adequate, despite new donor 
restrictions. This is a well-deserved tribute to the American Red 
Cross, the members of America's Blood Centers, and the remaining 
collection services, such as the Armed Forces Blood Program, who 
together collect nearly 15 million units of red blood cells each year. 
It is also an equally well-deserved tribute to the generosity of the 
American people, and to our collective commitment to support each other 
in times of either individual or collective need.
    This commitment was reaffirmed by the overwhelming numbers of 
Americans who came out to give blood in the hours and days after 
September 11. One year later, the most important lesson to be learned 
from the response of these donors is that the selflessness and heroism 
we saw on the streets of New York City pervades this country, and that 
is something of which all of us can be very proud.
    The other lesson was that we were not fully prepared to handle the 
large numbers of blood donations from so many generous Americans, which 
ended up exceeding the actual need. The blood community responded to 
this experience by joining together to form the American Association of 
Blood Banks Interorganizational Task Force on Domestic Disasters and 
Acts of Terrorism. I am a member of this task force.
    The Task Force met on December 11, 2001, and it adopted a set of 
principles and an action plan for dealing with future events of this 
sort. The Task Force's work product was publicly reviewed at the 
January 31, 2002 meeting of the Department's Advisory Committee on 
Blood Safety and Availability, and the Advisory Committee unanimously 
endorsed the Task Force's recommendations.
    Other speakers before you today will discuss these recommendations 
with you in detail. I will simply say here that the Department of 
Health and Human Services remains actively involved with the Task Force 
and its individual members, and that the Department is prepared to 
implement the Task Force's plans if the need should ever arise.
    Before leaving this subject, however, I want to point out that the 
Food and Drug Administration was exceptionally responsive to the needs 
of both public health and the blood industry during this difficult 
time, and I want to commend them publicly once again for their 
response. The Food and Drug Administration also conducted a 
comprehensive review of their capacity to address future demands of 
this sort on the blood supply whether due to natural disasters or 
terrorism. They too presented their plans to the Department's Advisory 
Committee on Blood Safety and Availability, and the Advisory Committee 
also unanimously endorsed their plans.
    Today, there remains some concern about the impact in some parts of 
the country of new blood donor deferral policies that will go into 
effect at the end of October 2002. These policies are intended to 
decrease the possible transmission by blood of new variant Cruetzfeldt-
Jacob Disease, or vCJD. The policies will have particular impact on New 
York City, which for some time has imported a substantial amount of its 
blood from Europe.
    The entire blood industry has anticipated this event, and plans 
have been made for other blood collection centers to provide blood to 
New York while its own facilities expand their operations. We will be 
monitoring the situation in New York very closely over the coming 
months. We anticipate that the nation's blood suppliers will be able to 
meet this challenge, and we are pleased that the newly released GAO 
report concurs.
    Let me also mention that our system of preparedness has already 
been tested three times since 9/11. First, in October 2001 we were 
challenged by outbreaks of anthrax disseminated through the postal 
system. Despite other public health concerns, CDC and FDA managed to 
work very rapidly to assess the risk to the blood system and to issue 
appropriate guidance on reasonable precautions.
    Second, in December 2001, at the time of the Winter Olympics in 
Salt Lake City, both industry and government mobilized fully and stayed 
on constant alert to ensure that any disruption or disaster could be 
addressed with confidence in the safety and availability of blood 
through the activation of existing plans.
    And third, we are now in the midst of an emerging epidemic of West 
Nile Virus. Again, the public health agencies in collaboration with the 
blood industry have mobilized rapidly and are acting aggressively to 
define any possible risk from transfusions and to identify feasible and 
effective intervention strategies.
    The Department of Health and Human Services remains interested in 
receiving suggestions from the blood industry on how we can support 
their efforts to assure that the blood supply remains both adequate and 
safe, in times of peace and in times of national emergency. In 
particular, we will be receiving the most recent recommendations of the 
Advisory Committee on Blood Safety and Availability which met last 
week.
    I would be happy to answer any questions you may have.

    Mr. Greenwood. Thank you, Mr. Hauer.
    And I understand, Mr. Epstein, you are not making an 
opening statement but are there to assist in answering 
questions.
    Mr. Epstein. That's correct.
    Mr. Greenwood. Okay. Thank you.
    In that case, Colonel Fitzpatrick, you are recognized for 
your statement, please.

            TESTIMONY OF COLONEL GLEN M. FITZPATRICK

    Mr. Fitzpatrick. Chairman Greenwood, Mr. Deutsch, and 
members of the committee, thank you for the opportunity to 
address the issues regarding this blood supply in the United 
States--sorry. Thank you for the opportunity to address the 
issues regarding the blood supply in the United States since 
September 11, 2001. And I am thankful for the opportunity to 
inform you of the successful blood support provided to 
Operations Noble Eagle and Enduring Freedom.
    The Armed Services Blood Program Office was established as 
a field operation agency of the War Department in 1953. The 
mission of my office is to ensure that the elements of the 
Armed Services Blood Program and the services are always 
available and ready to collect, transport, and deliver blood 
anywhere in the world.
    During Desert Shield and Desert Storm, over 100,000 units 
of red blood cells were delivered and available for 
transfusion. The Department of Defense currently has over 
59,000 units of frozen red blood cells stored aboard ships in 
the Pacific and European theaters because it could take 7 to 10 
days to fully meet the needs of a major conflict in those 
theaters.
    However, frozen blood has limitations. It is expensive; 
there is a large logistical support tail. One technician can 
produce only 2 units per hour, and it is difficult to ensure 
that new required tests are accomplished on a product with a 
10-year shelf life. But, frozen red blood cells are currently 
the only alternative available when liquid red blood cells 
cannot be provided in sufficient quantity--that is, until the 
FDA finds a safe, and licenses a safe, blood substitute such as 
a hemoglobin-based oxygen carrier; and they are very engaged in 
that at this moment.
    I believe it is essential for this country to have reserves 
of liquid red blood cells immediately available for shipment. A 
national recruitment program could increase the available blood 
supply, in essence creating a national blood reserve that could 
be made available for homeland defense, military operations, 
and natural or man-made disasters.
    The attacks of 9/11 changed our perspective about many 
things, and as in many disasters brought blood donations, blood 
needs, and blood management to the forefront of the public and 
the media's minds. Just as people waited for hours to donate to 
civilian collection agencies, military donors turned out in 
record numbers. The Armed Services Blood Program Office 
supported Operation Noble Eagle by assessing blood needs in 
Washington, DC, and New York, and establishing an ad hoc blood 
management structure for the military logistic district of 
Washington.
    The grounding of all civilian aircraft created a situation 
never before encountered. Our office assisted with the movement 
of civilian and military blood products, test samples, and 
reagents by military aircraft. Tripler Army Medical Center in 
Honolulu, Hawaii, performed infectious disease testing for the 
blood bank of Hawaii because they normally ship their specimens 
to Washington State, and many military facilities stored blood 
collected by civilian agencies when their inventories exceeded 
their storage capacity.
    Support for Operation Enduring Freedom has required the 
collection by DOD and shipment of over 15,000 units of red 
blood cells to U.S. Central Command, European Command, Southern 
Command, and Pacific Command. This has truly demonstrated the 
ability of the elements of the Armed Services Blood Program to 
deliver blood products worldwide. These blood units have 
provided over 800 transfusions, and have been used by U.S. 
coalition and host military personnel. Should the operational 
tempo or the level of hostilities increase, it will be 
necessary to provide more blood worldwide as well as ensuring 
ample supplies here in case of another terrorist attack at 
home.
    In October 2001, the DOD faced the additional challenge of 
replacing 18 percent of the active duty population who were to 
become ineligible to donate because of travel to or residency 
in Europe. These individuals are now deferred to prevent the 
theoretical transition of mad cow disease through blood 
transfusion. To offset these deferrals, we hired recruiters and 
established recruiting campaigns focused on our basic training 
and initial entry sites. The service blood program offices 
should be commended for their ability to not only maintain 
collections at previous levels, but actually increase them to 
support Operation Enduring Freedom in the face of 18 percent of 
the population they serve having become ineligible to donate.
    You are probably aware of the critical appeals for blood 
donations that have occurred in many civilian communities this 
summer. The success of the DOD program in the face of these 
challenges and, sometimes, shortages in the civilian community 
makes it even more essential that the DOD maintain a vigorous 
collection program for readiness.
    It is the mission of the Armed Services Blood Program to 
ensure that no lives are lost because blood is not available. I 
hope you are assured by this testimony that the combined 
efforts of the Army, Navy, and Air Force blood collection and 
distribution facilities are accomplishing this mission.
    Thank you again for the opportunity to speak.
    [The prepared statement of Colonel Glen M. Fitzpatrick 
follows:]

 Prepared Statement of Col. Glen M. Fitzpatrick, USA, Director, Armed 
                         Services Blood Program

    I want to thank the committee for the opportunity to address the 
issues regarding the blood supply in the United States since September 
11, 2001. The Armed Services Blood Program Office (ASBPO) was 
established as a Field Operating Agency of the War Department in 1953 
after the Korean War. The military had learned from WWI, WWII, and 
Korea that it takes time to organize a blood collection and 
distribution system that is capable of supplying a product that 
requires special handling, e.g., maintaining a cold chain throughout 
its distribution and dealing with its short life (21 days at that 
time). The mission of my office has been to make sure that the Armed 
Services Blood Program (ASBP) is always ready to collect, transport, 
and manage blood anywhere in the world. We have proven over a number of 
conflicts that the elements of the ASBP can safely collect, store, 
manage, deliver and transfuse blood anywhere. During Desert Shield/
Desert Storm over 100,000 units of red blood cells were delivered and 
available for transfusion. The attacks of 9-11 changed our perspective 
about many things and, as in many disasters, brought blood donation, 
blood needs, and blood management to the forefront of the public and 
the press's minds. Any natural or man-made disaster has always elicited 
an overwhelming response from blood donors and 9-11 was no exception. 
Just as people waited for hours to donate to civilian collection 
agencies, military donors turned out in record numbers. If the towers 
had fallen differently, or there had been multiple attacks throughout 
the country, the blood needs could have been drastically different. As 
it turned out, precious little blood was needed, but on 9-12, 13 and 14 
there were many unknowns. Future blood needs could not be immediately 
predicted and people wanted to help by donating blood. Blood centers 
did not know if they should or how they could turn donors away. I would 
like to focus on the actions of the Department of Defense.
    The ASBPO responded just as other agencies did during and after 9-
11. Blood inventories were determined, blood needs in Washington, D.C. 
and New York assessed, and an ad hoc management structure for the 
Military District of Washington was put in place so that blood needs 
from any further attacks could be met. The grounding of all civilian 
aircraft created a situation never planned for within the United 
States. The ASBPO assisted with the movement of civilian and military 
blood products, test samples, and reagents by military aircraft when 
needed. Tripler Army Medical Center (TAMC) performed infectious disease 
testing for the Blood Bank of Hawaii (BBH) because BBH normally sends 
its samples to Seattle, Washington for testing and TAMC performs 
testing on-island. Many military facilities stored the blood collected 
by civilian agencies whose inventory exceeded their storage capacity. 
While civilian and military organizations rose to these challenges and 
maintained ample blood inventories for any further needs, it became 
apparent that too much blood might be collected and it was time to 
develop a clear message to the public thanking them for their response 
and asking that they return and donate in the future.
    Since the beginning of Operation Enduring Freedom (OEF), the DoD 
has shipped over 15,000 units of red blood cells in support of U.S. 
Central Command, U.S. European Command, U.S. Southern Command, and U.S. 
Pacific Command. This has truly been a global test of the ability of 
the Armed Services Blood Program to respond to military blood needs 
worldwide. These units have provided over 800 transfusions, and excess 
stocks have been transferred to coalition or host nation hospitals, or 
destroyed upon their expiration. While this may seem wasteful we know 
that it is essential to have a minimum inventory available at all 
casualty-receiving stations at all times. Should the operational tempo 
or the level of hostilities increase, it will be necessary to provide 
more blood overseas, as well as determine the most efficient means of 
meeting blood needs in case of another terrorist attack at home.
    In October of 2001 the DoD began deferring donors who had traveled 
to or lived in Europe to prevent the theoretical transmission of mad 
cow disease through blood transfusion. Initial estimates indicated that 
18 percent of the active duty population would be deferred for travel 
to Europe and United Kingdom, increasing the average deferral rate in 
DoD from 25% to 43%. To compensate for this, we hired recruiters and 
established recruiting campaigns focused on our basic training and 
initial entry sites. As you can see by the graph displayed (attached), 
we have managed not only to maintain collections, but actually 
increased them to support OEF. You are probably aware of the critical 
appeals for blood donations that have occurred in many communities this 
summer. This makes it even more essential that the DoD maintain a 
vigorous blood collection program.
    A year has passed and a number of changes have occurred in this 
country. An inter-organizational task force, including an ASBPO 
representative, has been formed to address blood management in the 
Federal Emergency Response Plan. House Resolution 3448 Section 121 
calls for a Strategic National Stockpile and authorizes a national 
stockpile of drugs, vaccines, biological products, medical devices and 
supplies to meet the health security needs of the U.S. Blood is a 
biological product, and a strategic reserve is needed to be able to 
respond immediately to any disaster.
    The DoD currently has over 59,000 units of frozen red blood cells 
stored on board ships and in the Pacific and European theaters because 
it could take 7 to 10 days to fully meet the needs of a conflict with 
liquid blood. However, frozen blood has a number of problems: it is 
expensive, there is a large logistical support tail, one technician can 
only produce two units per hour, and it is very difficult to insure 
that new required tests are performed on a product with a ten-year 
shelf life. Frozen red blood cells are the only alternative available 
when liquid red blood cells cannot be provided in sufficient quantity, 
until a safe blood substitute such as hemoglobin based oxygen carrier, 
is licensed by the FDA. If this nation had a national reserve of liquid 
red blood cells for use within the United States or in support of 
military actions overseas the need for large stockpiles of frozen red 
blood cells could be greatly reduced. Blood must be immediately 
available to have any impact on saving lives, and if a national reserve 
is to be created, the blood must be maintained at sites that could 
immediately package it for transport seven days a week 24 hours a day. 
The DoD already has two such sites, one at Travis Air Force Base in 
California, the other at McGuire Air Force Base in New Jersey. Each of 
these Armed Services Whole Blood Processing Laboratories (ASWBPL) can 
receive, test, store, and prepare for shipment 7,200 units of red blood 
cells daily.
    A national recruitment campaign could be developed to encourage the 
population to donate to the nearest blood donor center regardless of 
its affiliation. The most difficult part of such a program, should it 
be adopted as a goal of the inter-organizational task force, would be 
to develop a strategy for funding not only the collection and shipping 
of these units but the management structure needed to maintain, rotate 
and distribute them. I have written the chairman of the inter-
organizational task force proposing the establishment of a national 
blood reserve and requesting he form a work group of experts to 
determine the best approach to financing such an endeavor. I believe it 
is essential for this country to have reserves of liquid red blood 
cells immediately available for shipment, and stockpiles of frozen red 
blood cells at strategic locations that can be thawed and prepared for 
transfusion to supplement the local liquid inventory if necessary. Such 
a strategy will require the cooperation and coordination of multiple 
civil and government agencies, but most important of all will be the 
message to the public, asking for their support of a national blood 
reserve. To be successful, it will require the public to donate 
regularly in order to maintain the reserve of this short-lived product, 
which can only be used for 42 days and requires constant replenishment. 
If we come together to accomplish these goals, critical shortages and 
emergency appeals for blood should be the exception and a constant 
vital supply for homeland defense, military actions, and natural or 
man-made disasters will be available.
    It is the mission of the Armed Services Blood Program Office to 
insure that no lives are lost because blood was not available. I hope 
you are assured by this testimony that the combined efforts of the 
Army, Navy and Air Force blood collection facilities are accomplishing 
this mission. The creation of a national blood reserve could provide 
the same support for homeland defense.
    Thank you for the opportunity to address this committee.
    [GRAPHIC] [TIFF OMITTED] T1958.001
    
                   TESTIMONY OF JANET HEINRICH

    Ms. Heinrich. Mr. Chairman and members of the subcommittee, 
I am pleased to have the opportunity to testify as you consider 
the blood supply and its adequacy to meet the Nation's needs.
    The terrorist attacks 1 year ago reminded the Nation of the 
critical importance of a safe and adequate blood supply for all 
emergencies. Today, at your request, Mr. Chairman, we are 
releasing a report that summarizes several issues regarding 
blood safety and availability. My comments will focus on three 
of those topics: the adequacy of the blood supply, the response 
of blood suppliers to the September 11 attacks, and planning 
for future emergencies.
    Although no one data source has tracked the Nation's blood 
sup- ply in the past, all the sources we identified indicate 
that the na- tional supply has grown in recent years and was at 
historically high levels before the surge in donations that 
occurred after Sep- tember 11. Annual blood collections had 
increased substantially, 21 percent since 1997. These increased 
collections resulted in in- creased inventories of blood. For 
example, the New York Blood Center reported a 4 to 5 day supply 
in early September 2001. In hospitals that are part of the 
Department of Health and Human Services' Blood Sentinel 
Surveillance System reported 7 days of all blood types on 
average and approximately 6 days for Type O-nega- tive, the 
universal donor type.
    The limited information available to us indicates that 
blood collections to date in 2002 have been roughly comparable 
to the levels immediately prior to September 11, a year ago, 
although local blood shortages, as we have heard, have occurred 
from time to time.
    After the September 11 attacks, America's blood banks 
collected an unprecedented amount of blood in a short period. 
In response to the perception that blood would be needed to 
treat victims, Americans formed lines to give blood at 
hospitals and blood banks. HHS, America's Blood Centers, and 
the American Red Cross all issued requests for blood donations, 
although HHS and the American Blood Centers quickly stopped 
issuing requests when it became clear that there were few 
survivors of the attacks who needed transfusions.
    Many blood suppliers were reluctant to turn away potential 
donors. Estimates of the number of units collected nationwide 
in September and October 2001 that were in excess of average 
collections ranged from 475,000 to 572,000 units. This surge of 
donors stressed the collection system. Long waiting lines 
developed and increased errors in the collection process were 
reported. Far more blood was collected immediately after 
September 11 than was needed by survivors or that ultimately 
could be absorbed in the Nation's blood banks. Fewer than 260 
units were used to treat victims of the attacks, and of the 
roughly 572,000 additional units collected in response to 
September 11, we estimate that about 364,000 units or about 
two-thirds were utilized by the Nation's blood banks and 
approximately 208,000 units or about one-third expired and were 
discarded. All of these figures we consider to be 
underestimates of the total number of expired units because 
they do not capture units that expired in hospital inventories.
    Following the pattern of responses to previous disasters, 
the sharp increase in blood collections did not last, and the 
number of units collected had returned to the usual level by 
November. Since September 11, as we have heard, Federal public 
health agencies and blood suppliers have been critical of their 
responses to prior disasters, and have begun to plan a more 
effective response to future emergencies through an 
interorganizational task force. Organized by the American 
Association of Blood Banks, the focus has begun to shift away 
from increasing blood collections in an emergency to 
maintaining an adequate inventory of blood at all times.
    A recent report by the task force made recommendations for 
the emergency preparedness of the blood supply that were 
adopted by the HHS Advisory Committee on Blood Supply and 
Availability.
    In conclusion, although local shortages of blood occur from 
time to time, America's blood supply is generally adequate. 
There is clearly a need for ongoing monitoring of the blood 
supply, both supply and demand, to ensure that we have an 
adequate supply in the future. Experts stress that an adequate 
inventory on a daily basis is the most important factor in the 
initial response to a disaster. It is people who donate blood 
on a regular basis before a disaster who save lives.
    I would be happy to answer any questions.
    [The prepared statement of Janet Heinrich follows:]

  Prepared Statement of Janet Heinrich, Director, Health Care--Public 
             Health Issues. U.S. General Accounting Office

    Mr. Chairman and Members of the Subcommittee: I am pleased to have 
the opportunity to testify as the Subcommittee considers the blood 
supply and its adequacy to meet the nation's emergency needs. The 
terrorist attacks of September 11, 2001, reminded the nation of the 
critical importance of a safe and adequate supply of blood for 
transfusions. In recent years, an average of about 8 million volunteers 
have donated more than 14 million units 1 of blood annually, 
and approximately 4.5 million patients per year have received life-
saving blood transfusions, according to the American Association of 
Blood Banks (AABB).2 About 90 percent of the U.S. blood 
supply is collected by two blood suppliers, the American National Red 
Cross and independent blood banks affiliated with America's Blood 
Centers (ABC). Within the federal government, the Food and Drug 
Administration (FDA) is responsible for overseeing the safety of the 
nation's blood supply. The surge in donations after the terrorist 
attacks added an estimated 500,000 units to annual collections in 2001. 
The experience illustrated that large numbers of Americans are willing 
to donate blood in response to disasters. However, because very few of 
the units donated immediately after September 11 were needed by the 
survivors, this experience has also raised concerns among blood 
suppliers and within the government about how best to manage and 
prepare the blood supply for emergencies.
---------------------------------------------------------------------------
    \1\ A unit equals 1 pint.
    \2\ AABB is the professional and accrediting organization for blood 
suppliers and transfusion services.
---------------------------------------------------------------------------
    Today we are releasing a report that summarizes several issues 
regarding blood safety and availability.3 My comments will 
focus on three of the topics addressed in our report: the adequacy of 
the blood supply, the response of the blood suppliers to the September 
11 attacks, and their planning for future emergencies. Our report also 
describes recent changes in the price of blood and evaluates the 
potential impact of the new guidance from FDA that is aimed at reducing 
the risk of transmitting variant Creutzfeldt-Jakob disease, the human 
form of ``mad cow'' disease, through the blood transfusions.
---------------------------------------------------------------------------
    \3\ U.S. General Accounting Office, Public Health: Blood Supply 
Generally Adequate Despite New Donor Restrictions, GAO-02-754 
(Washington, D.C.: July 22, 2002).
---------------------------------------------------------------------------
    In brief, available data indicate that the blood supply has 
increased in the past 5 years and that it remains generally adequate. 
Blood collections increased 21 percent from 1997 to 2001, and 
collections in the first half of 2002 appear to have been roughly 
equivalent to the same period in 2001. There has been a corresponding 
rise in the number of transfusions from 1997 to 2001. Although local 
and temporary blood shortages occur from time to time, the inventory of 
blood in America's hospitals was at historically high levels before 
September 11 and has generally remained adequate through the first 8 
months of 2002. In the weeks immediately following September 11, blood 
collections increased nearly 40 percent over collections earlier in 
2001. Because only a small amount of blood was needed to treat 
survivors of the attacks, a nationwide surplus developed, which 
stressed the collection system. We estimate that about five times the 
usual proportion of units of blood became outdated and had to be 
discarded in the months following September 11. Monthly blood 
collections returned to pre-attack levels by November, following the 
pattern of collections after earlier emergencies. Blood suppliers and 
the federal government have begun to reevaluate how blood is collected 
during and after disasters to avoid repeating this experience and also 
to ensure that enough blood is available during emergencies. A task 
force including members from federal agencies and blood suppliers has 
been formed to coordinate the response in future emergencies to the 
need for blood. Insights from the experiences of September 11 and other 
disasters have led the task force to conclude that the need for blood 
in most emergencies can be best met by maintaining an adequate blood 
inventory at all times, rather than by increasing blood collections 
following a disaster.

                               BACKGROUND

    Sixty percent of the U.S. population is eligible to donate blood, 
but in any given year only about 5 percent of those who are eligible 
actually do so.4 Eighty percent of donors are repeat donors. 
A typical donor gives blood approximately 1.6 times per year, but 
donors may give 6 times per year, or every 8 weeks, which is the period 
the body needs to replenish red blood cells.
---------------------------------------------------------------------------
    \4\ To be eligible to donate, a person must be at least 17 years of 
age, weigh at least 110 pounds, be in good physical health, and provide 
a medical history.
---------------------------------------------------------------------------
    The two largest blood suppliers, the Red Cross and ABC, each 
collect about 45 percent of the nation's blood supply, and roughly 10 
percent is supplied by other independent blood centers, the Department 
of Defense, and hospitals that have their own blood banks. Suppliers 
test, process, and store the blood they collect, and ultimately sell it 
to health care providers. Liquid red blood cells have a shelf life of 
42 days, and a small proportion of the blood collected is not used 
during that period and is discarded. Most hospital transfusion services 
purchase blood and blood components under a contract with a local 
supplier, which describes the price and quantity of blood to be 
delivered. Blood suppliers use resource-sharing programs to help 
distribute blood from low-demand to high-demand areas. Taken together, 
the Red Cross, ABC, and AABB's National Blood Exchange redistributed 
about 1.4 million units of blood--over 10 percent of the nation's 
supply--among blood banks in 2000. In addition, the Red Cross has a 
nationwide inventory control system to facilitate the movement of its 
surplus blood.
    Under the Public Health Service Act and the Federal Food, Drug and 
Cosmetic Act, FDA regulates and licenses blood and blood products to 
ensure that they are safe. FDA has no authority to determine the amount 
of blood that should be collected or to compel suppliers to make 
products available. However, it can make recommendations related to the 
availability of blood during public health emergencies.5 For 
example, after the September 11 attacks, FDA issued emergency 
guidelines to speed the delivery of blood to areas affected by the 
attacks. Also within the Department of Health and Human Services (HHS), 
the Advisory Committee on Blood Safety and Availability provides advice 
to the Secretary of HHS and to the Assistant Secretary for Health on 
various issues involving the blood supply, including economic factors 
affecting cost and supply, as well as public health, ethical, and legal 
issues related to blood safety.
---------------------------------------------------------------------------
    \5\ For example, see 42 U.S.C. Sec. 247d (1994).
---------------------------------------------------------------------------
     THE BLOOD SUPPLY HAS INCREASED AND REMAINS GENERALLY ADEQUATE

    Available data indicate that the nation's blood supply has 
increased and remains generally adequate. Although local and temporary 
blood shortages occur from time to time, the inventory of blood in 
America's hospitals was at historically high levels before September 11 
and has remained adequate through the first 8 months of 2002.
    Although no one data source has comprehensively tracked the 
nation's blood supply in the past, all of the sources we identified 
indicated that the national supply has grown in recent years and was at 
historically high levels before the surge in donations that occurred 
after September 11. Annual blood collections have increased 
substantially--21 percent--since 1997, according to National Blood Data 
Resource Center (NBDRC) measurements and estimates of annual blood 
collections by all blood centers. (See fig. 1.) The number of units of 
blood collected annually increased from 12.4 million in 1997 to an 
estimated 15 million in 2001. (NBDRC estimated that 2001 collections 
would have reached 14.5 million units, 17 percent higher than in 1997, 
without the post-September 11 surge.)
    The increase in the blood supply has been echoed by a corresponding 
increase in the amount of blood transfused. (See fig. 1.) For example, 
NBDRC data indicate that the number of red blood cell units transfused 
rose 17 percent from 1997 to 2001, from 11.5 million to 13.5 million 
units. The annual number of units that were available but not 
transfused remained at about 1 million units.
    Blood inventories were generally adequate just prior to the 
September 11 attacks. The Red Cross reported that its total red blood 
cell inventory was 33 percent higher in August 2001 than it was in 
August 2000 and that its type O inventory was 83 percent higher than it 
was in August 2000. The New York Blood Center (NYBC) reported that it 
had a 4- to 5-day supply of blood on hand in early September 2001. On 
September 10, 2001, the median inventory for the hospitals in HHS's 
Blood Sentinel Surveillance System for all blood types stood at 
approximately 7 days, and for type O Rh-negative blood, at 6 
days.6
---------------------------------------------------------------------------
    \6\ The hospitals in HHS's surveillance system are not a 
statistically representative sample of the nation's transfusion 
centers. However, collectively they account for about 10 percent of the 
blood transfused nationally, and hospitals throughout the country are 
included in the sample.
---------------------------------------------------------------------------
    The limited information available to us indicates that blood 
collections to date in 2002 have been roughly comparable to the levels 
immediately prior to September 11. According to NBDRC data, collections 
for the first half of 2002 have been similar to the same period in 
2001. The hospital inventories measured by HHS's Blood Sentinel 
Surveillance System in mid-August 2002 were similar to those levels 
measured just prior to September 11, 2001.

BLOOD COLLECTED IN RESPONSE TO SEPTEMBER 11 STRESSED COLLECTION SYSTEM 
                        AND RESULTED IN SURPLUS

    The high volume of blood donations by volunteers immediately after 
September 11 stressed the collection system and resulted in a national 
surplus. Monthly blood collections increased nearly 40 percent over 
collections earlier in 2001 in the weeks immediately following 
September 11, but there was little additional need of blood for 
transfusions. The nationwide blood supply was substantially greater 
than needed for transfusions. Consequently, the proportion of units 
that expired and were discarded in October and November 2001 was five 
times higher than the proportion that expired in an average 2-month 
period earlier in 2001.
    America's blood banks collected an unprecedented amount of blood in 
a short period after the September 11 attacks. In response to the 
perception that blood would be needed to treat victims, Americans 
formed lines to give blood at hospitals and blood banks even before a 
call for blood went out. HHS, ABC, and the Red Cross all issued 
requests for blood donations, although HHS and ABC quickly stopped 
issuing requests when it became clear that there were few survivors of 
the attacks and therefore little need for additional blood for 
transfusions. Many blood suppliers were reluctant to turn away 
potential donors, however, and some hospitals that did not have their 
own blood banks responded to the surge in volunteers by collecting 
blood anyway. NBDRC estimated that total blood collections in the 
United States were 38 percent higher in September 2001 than average 
monthly collections earlier in 2001. The Red Cross reported that its 
national blood collections during the week of September 11 more than 
doubled compared with the preceding weeks. Estimates of the number of 
additional units collected nationwide in September and October 2001 in 
response to the September 11 attacks range from 475,000 to 
572,000.7 Following the pattern of responses to previous 
disasters, the sharp increase in blood collections did not last. While 
higher than usual blood collections continued for several weeks after 
September 11, the number of units collected had returned to the 
baseline level or slightly below it by the beginning of 
November.8 (See fig. 2.)
---------------------------------------------------------------------------
    \7\ P.J. Schmidt, ``Blood and Disaster--Supply and Demand,'' New 
England Journal of Medicine, vol. 346, no. 8 (2002), 617-20.
    \8\ Because donors can give blood only every 8 weeks, large numbers 
of regular donors who give immediately after a disaster may skip their 
next planned donation, thus causing postdisaster inventory to dip below 
normal levels.
---------------------------------------------------------------------------
    This surge of donors stressed the collection system. Shortages in 
blood collecting supplies, phlebotomists (technicians trained to 
collect blood), and storage capacity occurred as more potential donors 
arrived. Long waiting lines developed because there was insufficient 
staff to draw blood. Increased errors in the collection process at some 
blood banks accompanied the surge in donations. As much as 20 percent 
of some blood banks' donations was collected improperly and had to be 
discarded, primarily because individuals had not completed the donor 
questionnaire correctly.9
---------------------------------------------------------------------------
    \9\ American Association of Blood Banks: Interorganizational Task 
Force on Domestic Disasters and Acts of Terrorism, Report and 
Recommendations (Bethesda, Md.: Jan. 31, 2000) http://www.aabb.org/
Pressroom/In__the__News/idfddat013002.htm (downloaded on Feb. 5, 2002).
---------------------------------------------------------------------------
    Far more blood was collected immediately after September 11 than 
was needed by survivors or than ultimately could be absorbed by the 
nation's blood banks. Fewer than 260 units were used to treat victims 
of the attacks. A portion of the surplus went unused, expired, and was 
discarded. NBDRC surveyed a nationally representative sample of 26 
blood suppliers and found that about 10 percent of the units collected 
in September and October 2001 by the suppliers it surveyed expired and 
were discarded. This was nearly a fivefold increase in the proportion 
of units these suppliers discarded because they had expired in the 
first 8 months of 2001. Of the roughly 572,000 additional units 
collected in response to September 11, we estimate that about 364,000 
units, or about two-thirds, entered the nation's blood inventory and 
that approximately 208,000 units, or about one-third, expired and were 
discarded. All of these figures underestimate the total number of 
expired units because they represent expirations at blood suppliers 
only and do not capture units that expired in hospital inventories.
    Some blood banks also suffered serious financial losses, as they 
incurred the costs of collecting and processing units of blood they 
could not sell. For example, the New York Blood Center claimed it lost 
from $4 million to $5 million and suffered a nearly threefold increase 
in the number of units it had to discard when blood donated in response 
to the attack expired.

BLOOD SUPPLIERS ARE FOCUSING EMERGENCY PLANNING ON MAINTAINING ADEQUATE 
                               INVENTORY

    Incorporating the lessons learned from past disasters, blood 
suppliers and the federal government are reevaluating how blood is 
collected during and after disasters and are focusing on maintaining a 
consistently adequate inventory in local blood banks in preparation for 
disasters and not collecting more blood after a disaster than is 
medically necessary.
    Since September 11, federal public health agencies and blood 
suppliers have been critical of their responses to prior disasters and 
have begun to plan for a more effective response to future emergencies. 
Through an interorganizational task force organized by AABB in late 
2001, the focus has begun to shift away from increasing blood 
collections in an emergency to maintaining an adequate inventory of 
blood at all times.10 This shift was prompted by the 
realization that a surge in blood collections following a disaster does 
not help victims because disaster victims rarely require many units of 
blood and because newly collected blood cannot be used 
immediately.11 For example, as with September 11, only a 
small percentage of the additional blood collected after the Oklahoma 
City bombing was transfused into victims (131 units of more than 9,000 
units collected). Moreover, the units used to treat victims in the 
hours after a disaster are those already on hand at the treating 
hospital or local blood bank.12 It takes 2 days to 
completely process and test a unit of newly donated blood, so existing 
stores of blood must be used to treat disaster casualties. Finally, 
military experts and blood industry officials told us that it is 
unlikely a discrete disaster would require more blood than is normally 
stored in the nation's blood inventory. They noted that large amounts 
of blood have not been needed in building collapses (like the September 
11 attacks and the Oklahoma City bombing), nor would blood transfusions 
be a likely treatment for illnesses caused by a bioterrorism attack. 
Nonetheless, disaster scenarios that have not yet been identified may 
require more blood than is currently envisioned.
---------------------------------------------------------------------------
    \10\ The AABB Interorganizational Task Force on Domestic Disasters 
and Acts of Terrorism. Members include the HHS Office of Public Health 
Preparedness, FDA, Department of Defense, Centers for Disease Control 
and Prevention, the Red Cross, and ABC.
    \11\ P.J. Schmidt, ``Blood and Disaster--Supply and Demand,'' 617-
20.
    \12\ In an emergency, blood that has not been fully tested may be 
used in lifesaving circumstances. In such circumstances, the requesting 
physician must sign a statement indicating that the clinical situation 
is sufficiently urgent to require the release and use of blood before 
the completion of testing.
---------------------------------------------------------------------------
    A report by the AABB task force made recommendations for the 
emergency preparedness of the blood supply that were adopted by the HHS 
Advisory Committee on Blood Safety and Availability. The 
recommendations are aimed at having federal and other organizations 
that are involved in the collection or use of blood coordinate their 
actions in an emergency. For example, the task force recommended that 
all blood banks--not just the Red Cross as is now the case--be 
designated as suppliers of blood in an emergency and that the Assistant 
Secretary for Health serve as the spokesperson for all organizations 
involved in managing and transporting blood in an emergency. 
Recognizing that an adequate blood inventory in an affected area is the 
most important factor in the initial response to a disaster, the task 
force also recommended that blood banks maintain a 7-day supply of all 
blood types at all times.
    Both the Red Cross and ABC are independently pursuing their own 
plans to meet emergency and long-term needs. The Red Cross expects to 
increase annual collections by 9 percent during each of the next 5 
years. The Red Cross also plans to implement a ``strategic blood 
reserve'' within the next 5 years using preregistered donors and a 
limited stock of frozen blood cells. ABC has established a ``national 
strategic donor reserve'' through which it can call on the donors it 
has registered, if needed.

                        CONCLUDING OBSERVATIONS

    Although local and temporary blood shortages occur from time to 
time, America's blood supply is generally adequate. The blood 
community's response to disasters can be improved, and the community is 
beginning to take the necessary steps to learn from past experiences. 
The interorganizational task force organized by AABB has involved the 
blood community in efforts to more effectively plan for future 
disasters. In addition, the Red Cross and ABC are independently taking 
steps to meet emergency requirements.
    Mr. Chairman, this concludes my prepared statement. I would be 
happy to respond to any questions you or other Members of the 
Subcommittee may have at this time.
[GRAPHIC] [TIFF OMITTED] T1958.002

    Mr. Greenwood. Thank you, Dr. Heinrich, for your testimony.
    The Chair recognizes himself for 10 minutes for questions, 
and let me address my first question to you, Mr. Hauer.
    We note that the HHS Advisory Committee on Blood Safety and 
Availability advises the Assistant Secretary for Health, and 
you are the acting Assistant Secretary for Public Health 
Emergency Preparedness. In addition, the advisory committee on 
February 1, 2002, recommended that HHS should act to promote 
and coordinate a single consistent public message on blood 
issues, and that the ultimate spokesperson for the blood 
community should be the Assistant Secretary for Health or her 
designee.
    Should the subcommittee construe your appearance today as 
meaning that Secretary Thompson has designated you as the 
ultimate Department spokesperson for blood issues? And, if not, 
who is?
    Mr. Hauer. No. The Assistant Secretary For Health is 
coordinating the blood-related issues within the Department. I 
was asked to testify, one, because I came out of the blood 
banking community; and two, I am working on the task force and 
coordinating with the Assistant Secretary for Health to ensure 
that as we move forward we have a coordinated message with the 
blood community and the public.
    Mr. Greenwood. Okay.
    Has HHS updated its disaster plan for Emergency Support 
Function, Function 8 under FEMA, in light of September 11?
    Mr. Hauer. We have gotten some recommendations from the 
blood community which we are completely in agreement with. We 
have sent those over to FEMA to be incorporated when a new ESF-
8 supplement to the Federal response plan comes out.
    Mr. Greenwood. Is that recommendation in writing? Is that a 
formal document?
    Mr. Hauer. I believe it is, but I would have to check and 
get back to you.
    Mr. Greenwood. Let me turn to Dr. Epstein. Do you know 
whether any advances are being made in developing a reliable 
diagnostic test for screening mad cow disease?
    Mr. Epstein. Technical scientific progress is being made, 
but at the present time there is no test anywhere close to 
being practical. The existing methods are sensitive for 
detecting the abnormal prions in tissues, but they are not 
sufficiently sensitive to detect that infectivity in blood.
    Mr. Greenwood. So what are the measures that this country 
is taking to protect receivers of blood donations from 
potential harmful effects of mad cow disease?
    Mr. Epstein. Basically, we do two things. We protect our 
population by keeping the bovine form of the disease out of our 
country, and we restrict donations by individuals who may have 
been exposed to mad cow disease by eating contaminated beef in 
locations abroad.
    Mr. Greenwood. So how do you do that? For instance, I have 
been--I have traveled to Europe once in the last several 
months. Am I excluded from donating?
    Mr. Epstein. No. That would not be a sufficient exposure to 
exclude you. At the present time, based on a guidance that 
became effective in January of this year, we defer persons who 
have been exposed in the United Kingdom for 3 months or more 
between 1980 through 1996, when food safety controls became 
adequate.
    Mr. Greenwood. Let me interrupt you for a second. So just 
having been there for a 3-month duration is sufficient to be 
deferred?
    Mr. Epstein. Yes, it is.
    Mr. Greenwood. Okay. Go ahead. Continue.
    Mr. Epstein. Additionally, we call for a deferral of 
persons who lived in France for 5 or more years from 1980 to 
the present time, because there is less confidence that their 
foodborne epidemic is controlled.
    We defer persons in the military or their dependents who 
lived for 6 months or more on military bases in Europe. We 
distinguish time periods either north of the Alps 1980 through 
1990, or other locations, basically south of the Alps 1980 
through 1996. The reason for these deferrals is that there was 
a program within Department of Defense specifically to procure 
beef products from the United Kingdom during these periods.
    We additionally recommend deferring persons who have 
received a blood transfusion in the United Kingdom since 1980 
to the present. And, effective October 31 of this year, we 
additionally recommend implementation of a deferral for persons 
who have lived 5 or more years in any part of Europe, including 
the UK, between 1980 and the present.
    Mr. Greenwood. Is there indication--have there been 
indications in those countries that, in fact, mad cow disease 
has been transmitted through transfusion?
    Mr. Epstein. No. There is no documented case of transfusion 
anywhere in the world. However, the suspicion is quite real, 
based on evidence from experimental models in animals. 
Transmission of transmissible spongiform encephalopathies has 
been shown in mice, in hamsters, and most recently, with the 
bovine agent, it was shown from sheep to sheep. These 
experiments have raised concern because they have demonstrated 
infectivity in the blood and they have also demonstrated actual 
transmission by transfusions.
    Mr. Greenwood. I see.
    Mr. Epstein. But again, there is no human case that has 
ever been proven. But we haven't had that long to experience 
the human form of mad cow disease, and that creates a degree of 
uncertainty.
    Mr. Greenwood. So you are erring pretty much on the side of 
caution.
    Why does the duration of one's visit--is there a cumulative 
issue here, or is it just a question of the odds over time of 
consuming contaminated meat?
    Mr. Epstein. Well, that is not known to science, 
unfortunately. However, the model that we applied to assess 
risk was that it would be linearly related to exposure time. 
And we don't really know whether that is because it is 
cumulative or just, the longer you are there, the bigger your 
chance of a one-time hit. But it is a reasonable model because 
we do know that the cases that have appeared have been in 
people with fairly prolonged exposure. We also estimated the 
risk differentially based on the amount of contaminated beef, 
reckoning the highest levels to be in the UK; and then, on a 
sliding scale, we created risk-based adjustment for France, 
which is second highest, and then Europe in general.
    Mr. Greenwood. Is the NIH or anyone else actively funding 
and pursuing research for developing a diagnostic test for mad 
cow disease?
    Mr. Epstein. I know that within the FDA we have our own 
program on development of diagnostic tests. I am not prepared 
to speak to NIH in general. I apologize.
    Mr. Greenwood. All right. The New York Times--this is also 
for you, Dr. Epstein.
    The New York Times reported on Friday, September 6, that 
the Federal estimate of West Nile cases is one or two per 
10,000 transfusions, and suggested that was high. Do you know 
how that was estimated?
    Mr. Epstein. Yes. There was a recent publication by 
scientists at the Centers for Disease Control who studied the 
epidemic in 1999 in Queens, New York. And based on the 
frequency of detection of positives, they estimated the 
frequency with which a donor might be acutely infected and have 
the virus in the blood. And that was then used to estimate the 
risk of a contaminated unit being given to a recipient.
    That risk was placed on average at about 1 to 2 per 10,000, 
or, in ball park figures, 1 in 5,000. There was of course a 
confidence range. It was also noted in that paper, and 
consistent with previous publications, that the risk of 
actually developing disease after infection with that virus is 
less than 1 percent. However, we do have to recognize that 
blood recipients have a larger proportion of immune-compromised 
and older individuals than the population in general. So, that 
figure perhaps should be--may need to be reconfirmed. But, that 
was the basis of the estimate, namely the 1999 sero asurvey in 
Queens, New York.
    Mr. Greenwood. So what are the precautions that are being 
taken right now, or--and/or contemplated so as to protect the 
blood supply from the adverse potential adverse impacts from 
West Nile?
    Mr. Epstein. At the present time we are limited because 
there are no practical tests to screen for the infection in a 
donor. What we have recommended is as follows: on August 17, we 
alerted the blood bank organizations to be vigilant in 
excluding individuals who might have early symptoms of illness 
consistent with West Nile virus, which would exclude an 
individual with flu-like syndrome or fever or severe headache 
as already stated in existing regulations and guidance.
    Additionally, we have taken prudent precautions; in cases 
where there have been investigations of a possible 
transmission, we have advised the blood centers to retrieve any 
unused blood components that were on the shelf from those 
donors who may potentially have transmitted to a recipient. So 
that is where we stand now.
    Unfortunately, additional deferrals based on donor 
screening are not feasible; 80 percent of the infections that 
are community-acquired are asymptomatic, and so there would be 
no way to sort them out.
    Mr. Greenwood. Let me quickly pose a question to you, 
Colonel Fitzpatrick. What has the Department of Defense learned 
from its hemoglobin based--its program about boosting blood 
supply, such as the use of artificial--use of artificial blood 
or hemoglobin-based oxygen carriers for extending the shelf 
life for blood from 42 days to 70 days? What is the--what have 
we learned from your program of research?
    Mr. Fitzpatrick. Mr. Greenwood, the research has been 
conducted at Walter Reed Army Institute of Research. And I 
could speak generally, but for specific questions, I would have 
to come back to you on that.
    We have learned that it is possible to extend the shelf 
life to 70 days with in vivo studies. The hemoglobin-based 
oxygen research is primarily being done in the civilian sector. 
And while we are maintaining our knowledge of what is going on 
there, we aren't actively doing research in that area at this 
point.
    Mr. Greenwood. Okay. My time has expired.
    The Chair recognizes the gentleman from Florida for 10 
minutes.
    Mr. Deutsch. Thank you, Mr. Chairman. If everyone who is 
not--I guess besides Dr. Heinrich--the other members of the 
panel who are not with the GAO, the GAO conclusion that the 
blood supply is generally adequate, would you agree or disagree 
with that statement?
    Each of you can respond.
    Mr. Hauer. We would agree with that statement.
    Mr. Deutsch. And Mr. Epstein?
    Mr. Epstein. Yes, we generally agree. What we recognize is 
that there have been significant reports of spot shortages, and 
so the problem here is a relatively low inventory and transient 
dislocations. What we also see, consistent with the GAO report, 
is that the long-term trend has been a consistent increase in 
the blood supply meeting need.
    And so the challenge is how to smooth out these peaks and 
valleys, and move the system toward a better steady state. But 
that is not inconsistent with the conclusion of the report. We 
think that there are enough donors out there and that there is 
the ability within the system to make adequate collections.
    But we do need to make improvements, figuring out how to 
bring the donors in as needed.
    Mr. Deutsch. Colonel Fitzpatrick?
    Mr. Fitzpatrick. Mr. Deutsch, I can speak to the adequacy 
of the military blood supply. As you can see by the statement, 
we have been able to provide the blood needed for Department of 
Defense needs.
    As for the civilian sector, when we were provided the 
report, we agreed that it was adequate; however, the definition 
of adequacy varies from individual to individual, and there is 
adequate blood to meet the patients' needs. I would agree with 
Dr. Epstein that it is a matter of making sure the distribution 
is appropriate to meet all the patients' needs and the 
determination by the interorganizational task force based on 
current circumstances of what is a not merely adequate supply, 
but a recommended supply within the country.
    Mr. Deutsch. Dr. Heinrich, would you want to respond to 
either one of those critiques?
    Ms. Heinrich. Thank you for the opportunity to respond.
    The message, I think, is quite consistent; if you look 
nationally, overall, and you look at the trends, we have a 
better supply now than we did, say, in 1997. But we are also 
saying that we recognize that there are these spot shortages, 
and we also recognize that the movement of excess blood in one 
region to another region is a very important aspect of the 
adequate supply.
    Mr. Deutsch. Thank you. The two or three major lessons that 
can be applied to the overall health of U.S. blood supply as a 
result on the experience of 9/11, what would you point out as 
the major lessons?
    Mr. Hauer. I think that, you know, as we see during any 
major incident, Oklahoma City--even in local types of events, 
when a police officer is shot in a community, we see enormous 
spikes in the number of people that want to give blood.
    I think that we have to look at the type of event, assess 
the needs, and determine whether or not we are going to need 
significant quantities of blood. There are types of incidents 
that do require significant quantities of blood and some that 
don't. Biological incidents, chemical incidents tend not to 
need that much blood. Bombings, the type of incidents we saw 
last September, tend to require more blood. But, you know, 
unfortunately in New York City most of the victims succumbed to 
the collapse.
    We need to get a message out, and we need to have a 
consistent message among the blood community and with HHS so 
that when there is a need for blood, we get out there and ask 
for it; when there is not a need for blood, we don't get out 
and ask for it. And I don't think that happened last year.
    As a result of the mixed messages last year, one of the 
things we have done is invited all the members of the blood 
banking community to be part of our command structure at HHS so 
that in the event of a terrorist attack or other major 
incident, we have representatives from the various 
organizations in our command center so that if they are having 
difficulty with blood, moving blood, with regional shortages of 
blood; or if, in fact, they don't need blood and people are--
you know, it's the way our country responds to these kind of 
incidents.
    People are wonderful in that they want to try and do 
something, but sometimes we need to delay those donations and 
get people to donate on a more scheduled basis down the road as 
opposed to everybody doing it right after the incident. We are 
ensuring that we have a consistent message to the public. And 
finally, we are looking at the whole issue of having some kind 
of strategic reserve as a part of this, and we are trying to 
sort through that issue as well.
    Mr. Deutsch. Dr. Epstein? Any lessons from 9/11?
    Mr. Epstein. No. I think that's a complete description.
    Mr. Deutsch. Colonel?
    Mr. Fitzpatrick. Congressman Deutsch, I think the basic 
lesson from the military aspect was the wisdom of my 
predecessors in creating our program. We know that blood has to 
be on the shelf and available in order to immediately impact 
survival of patients and casualties, and as a result of that, 
we have a command and control and organizational structure to 
meet that need outside of our borders. We learned that it is a 
requirement now to meet that need within our borders, and the 
interorganizational task force that's been formed I think is 
addressing that, and it will meet that need once they have 
provided all their recommendations.
    Mr. Deutsch. Dr. Heinrich? Lessons of 9/11?
    Ms. Heinrich. I think that the unified message is a very 
important lesson, and to do that well, I think HHS and the 
blood suppliers have to find new ways of working with the 
media. Coordination certainly was something that was needed and 
that people have been critical about. An adequate supply on a 
daily basis I think is the--well, one aspect that from GAO's 
perspective we find very interesting, and the part of that that 
I think has not been focused on enough is the need for data on 
what that supply is. And we are concerned actually that the 
current efforts to have good data on the supply are not 
adequate.
    Mr. Deutsch. If I could follow up--I want to have a chance.
    Mr. Hauer, I think you pointed out great lessons. If you 
could follow up on what is HHS doing to implement the shelf 
life, the--really scheduling, you know, of donations. I mean, 
what is actually being done to follow up on those lessons?
    Mr. Hauer. Part of that has to occur during--following an 
incident. Following an incident, we need to stem the tide of 
donors early on because, again depending on the nature of the 
incident, people want to feel like they are doing something, 
and giving blood is one way that they respond. Unfortunately, 
they overwhelm the blood centers. The--and much of that blood, 
as we saw following September 11, is not needed.
    What we need to do is, again, as you just heard, have a 
consistent message with the media so we get people to defer 
media donations, and defer over time--and donate over time to 
augment the blood supply. If, in fact, we have a catastrophic 
event where we do need blood, then we will have to address it 
and get people in immediately to augment the blood supply that 
is immediate--needed immediately.
    But, you know, I think that the basic issue comes down to 
getting people to donate blood on a regular basis and getting 
people to donate blood during these times when we see these 
spot shortages. And, you know, those occur at various times of 
the year. Around the Christmas holidays we see that the blood 
supply tends to drop off.
    When I worked with Dr. Page, in Boston, we saw that during 
the summer we had a terrible time getting blood because 30 
percent of our donor population left town when the students 
left town, so we see a decrease in the blood supply. It is a 
matter of making sure that people give blood on a regular basis 
and not just during those----
    Mr. Deutsch. Again, if I can try to just focus a little 
bit. I mean, you have articulated the problem extraordinarily 
well.
    What about the solution? I mean, you keep saying we are 
going to try to do something.
    Mr. Hauer. Well, we are working with the various blood 
organizations to, one, ensure that we have a coordinated 
message following an incident, because that, I believe, is what 
your question is. Your question is--was, what do we do 
following an incident to ensure that we have a scheduled----
    Mr. Deutsch. So you basically have a plan for the next 
incident; is that the----
    Mr. Hauer. Well, we are working on a plan and we are 
talking with the blood organizations. I have personally met 
with the various blood organizations to ensure that they are 
part of our process and in our command center following an 
incident so that we can coordinate when we need blood and when 
we don't need blood, and have a consistent and coordinated 
message.
    Mr. Deutsch. Thank you. My time has expired.
    Mr. Greenwood. The Chair thanks the gentleman. Before I 
recognize the gentleman from New Hampshire, just one quick 
follow-up question.
    If next week or next month we had an event where we had 
thousands and thousands of Americans going to donate blood, and 
it looked like we were going to have this oversupply problem 
where we would have blood discarded, who would--who opens the 
book and says, okay, it is now time for me, the Secretary or 
someone else, to launch our communication efforts so we 
communicate with the donating public, as well as the--all of 
the blood centers, that we have more than a sufficiency of 
supply?
    Is that--whose responsibility is that?
    Mr. Hauer. That would be done between myself, the FDA, and 
the ASH. And the three of us would coordinate, look at where we 
are with the type of incident, the needs of the incident, and 
the current blood supply. We would be talking with the blood 
community. And if, in fact, there was an overdonation at that 
point in time or we anticipated there would be an overdonation, 
we would make a recommendation to the Secretary.
    Mr. Greenwood. And so you have a system whereby you know 
how to measure that, you know how to immediately, or in a 
timely fashion, get the word to the blood centers and then get 
the word to the public? Somebody has a notebook that says, here 
is how we do our media program to inform the public that they 
don't need to get in line any longer?
    Mr. Hauer. We would ask the Secretary or recommend to the 
Secretary at that point in time that he get out and communicate 
with the public. We would have the various blood organizations 
doing that. And again, part of our goal is to work with the 
blood organizations. HHS historically during these types of 
incidents has not had the blood organizations as part of the 
strategy at the headquarters level, and I think that is where 
one of the disconnects has been. And we have now fixed that 
issue.
    Mr. Greenwood. Okay.
    The Chair recognizes the gentleman from New Hampshire, Mr. 
Bass, for 10 minutes for inquiry.
    Mr. Bass. Thank you very much, Mr. Chairman. And I love the 
GAO, because they produce reports that you get the whole report 
in the title. Blood Supply Generally Adequate Despite New Donor 
Restrictions. It's the whole thing. And then you read more if 
you want to turn and look a little bit more.
    But, Dr. Heinrich, I was wondering if you could review, 
please, the nature or level at which the Federal Government has 
been involved in monitoring the Nation's blood supply.
    Ms. Heinrich. There was a longstanding effort to fund the 
monitoring of the adequacy of the blood supply up until about a 
year and a half ago, a couple of years ago. And that funding 
then stopped. They actually funded the American Association of 
Blood Banks and their data center to do that work.
    Then, recently, within the Office of the Secretary there 
was an effort to monitor the demand for blood; so they 
developed a sample of hospitals that they routinely collected 
information on in terms of how much blood they had on hand and 
how much they were using.
    What the future of that program is, I can't say. Maybe 
others here from the Department could speak to that. We have 
heard that the future of that may be uncertain.
    So we have heard that there may be efforts by the Food and 
Drug Administration to develop some type of monitoring program. 
Again, I don't have specifics on that. Maybe the others could 
speak to that. But in essence--well, and certainly the 
Department of Defense has their efforts to monitor the blood 
that they collect and that they use, but here, there isn't an 
overall national data collection system.
    Mr. Bass. Do any of you other witnesses have any comments 
about that?
    Mr. Hauer. Yes. Dr. Epstein and I were just talking about 
that.
    One of the things that we are going to be doing, because it 
is an issue, there is no centrally coordinated national data 
system for looking at the blood supply. And that is one of the 
things we are going to have to address, and we are going to 
have to address that very quickly. And Dr. Epstein and I were 
just addressing setting up a meeting with the blood 
organizations, AABB and the Red Cross, relatively quickly to 
look at how we would put a system like that in place. There are 
some disjointed systems out there, but there is not one central 
system.
    Mr. Bass. Is the monitoring of the Nation's blood supply 
part or relevant in terms of the issue of homeland security? 
And, if so, is there anything in that legislation that makes--
that affects in any way this challenge?
    Mr. Hauer. I don't know that there is anything in the 
legislation about the blood supply or the monitoring of the 
blood supply, but HHS does monitor components and has sentinel 
blood sites that are monitored to look at generally where the 
blood supply is at. But as much as we are doing--Secretary 
Thompson has got an enormous initiative to connect hospitals 
and public health agencies so that we have a better 
understanding of surveillance of disease. There is certainly 
the infrastructure in place, and I think there is an 
opportunity here to do the same type of thing with the blood 
supply.
    Mr. Bass. So the conclusion is there is no--there is no 
monitoring or inventorying at this point, but you're planning 
to meet----
    Mr. Hauer. No, there is monitoring, and there is 
inventorying. It's not done centrally, and it's not done as 
comprehensively as I think the GAO is talking about, and that's 
one of the things we need to address.
    Mr. Bass. Okay. Mr. Hauer, GAO reported, as have others, 
that the emergency response of September 11 led to large 
amounts of blood being discarded. What actions is the 
Department taking to avoid this problem in future emergencies?
    Mr. Hauer. Well, I believe that my comments to--earlier on 
alluded to that. We--the amount of blood that was discarded was 
because we had this overwhelming number of people show up at 
blood banks who wanted to do something. They wanted to help. 
But blood has a finite shelf life, and they all showed up at 
once within a short period of time, and much of that blood 
outdated. What we need to do is let people know that blood is 
needed over a period of time following an emergency and not 
just in the immediate aftermath of the emergency and get people 
to defer their donations for periods of time following an 
incident or donate at times distant from the emergency, which 
is sometimes frustrating.
    But the reality is getting everybody in to donate. You 
would predict in an event like the World Trade Center, where 
most of the people succumb to the incident rather than being 
injured, that there would be a less of a demand for blood than 
you would have thought; and you know, unfortunately, it is a 
very frustrating issue for us because people want to help. 
Donating blood is a very tangible way to help, and they feel 
like they're contributing, and that's just, you know, it's 
human nature. And it's a wonderful thing. But we have seen this 
over and over again following major incidents where much of the 
blood winds up outdating.
    Mr. Bass. What's the shelf life of blood?
    Mr. Hauer. Forty-two days.
    Mr. Bass. Forty-two days. Does freezing it--or is there any 
other way to extend that shelf life?
    Mr. Hauer. Yeah. You can freeze blood, but there are 
obstacles to taking blood that's donated and freezing it. First 
of all, some centers don't do a lot of freezing; and, you know, 
it's expensive. I mean, there's a number of issues with taking 
all this blood before it outdates.
    Jay, did you want to----
    Mr. Epstein. Sure. There are several technical issues. You 
basically want to assure two things. You want to insure 
integrity of the red cells after they're thawed, and you want 
to insure that they're sterile so that you don't transmit 
bacterial and fungal infections. And the current systems are 
largely manual. FDA has approved an automated system that 
provides for sterile freezing and thawing that extends shelf 
life from the current 24 hours for the manual system to 14 
days. Those have not been widely implemented yet and they have 
a narrow set of constraints. People would like to validate 
different volumes, different preservative solutions, different 
rejuvenation solutions.
    Another issue is that you have to act quickly. If you don't 
revitalize the red cells, you have to freeze them within 6 
days. That opportunity is not always available. So there are a 
lot of safety validation issues that have to be addressed.
    Above and beyond that, although the frozen red cell has a 
10-year shelf life under licensing, the standards for donor 
suitability do evolve over that time period. So you may have 
frozen the blood safely, but, 3 or 5 years later there may be a 
different standard for what's considered an acceptable 
donation. That's one problem. And then, in addition to the cost 
issue, which is very significant, as mentioned by Colonel 
Fitzpatrick, there's the problem that it's a very labor 
intensive procedure and you can only produce units at a very 
slow rate.
    So all of these factors conspire against rapid use of a 
frozen inventory.
    Now, whether frozen inventories would have a benefit as a 
back-up for rapid release of liquid inventories has yet to be 
really thought through by the system as a whole. So basically 
FDA's point of view is we're supportive of the concept of 
developing blood reserves. We are focused on the concept that 
it has to be done safely and fully consistent with all 
applicable standards and we are cooperative with the 
initiatives both by Department of Defense and the civilian 
blood organizations to try to come up with a coherent plan for 
how to create usable liquid and frozen reserves.
    Mr. Bass. Thanks. One last question, Mr. Hauer, and if 
you've already answered this, you know, just a one-sentence 
summary is fine. But does the Department have an effective 
emergency response plan for providing massive amounts of blood 
in cases of--there's--you know, if there's some huge national 
disaster and there are many survivors needing blood.
    Mr. Hauer. We rely on the Red Cross and the blood centers 
to do that.
    Mr. Bass. Okay. Thank you, Mr. Chairman.
    Mr. Greenwood. The Chair thanks the gentleman.
    Finally, Mr. Hauer, could you just remind us or make sure 
that we are clear on what is the status of the advisory 
committee's recommendations being adopted formally by the 
Department.
    Mr. Hauer. Jay, did you--do you want to--let me let Dr. 
Epstein address that.
    Mr. Epstein. Yes. There are two sets of recommendations, 
first from February 2002, and then we just had a meeting 
September 5 of last week where the recommendations are not yet 
formally made to the Department, so they are not yet under 
consideration by the Department. I believe that the Department 
has responded to the February recommendations: As Mr. Hauer 
stated, there is Department support for modification of the 
Emergency Support Function number 8 under the FEMA emergency 
plan; and Mr. Hauer's own participation in the 
interorganizational task force on disasters and supply bespeaks 
the response to the recommendation to make the role of that 
coordinating body primary in regard to preparedness. So I think 
that's the general thrust.
    Mr. Greenwood. Thank you. I thank you. The Chair thanks 
each of the witnesses, and you are excused.
    For the benefit of the next panel, as you can tell, we have 
three votes on the floor, so we will recess now for about 20 
minutes and should be back here just a little bit before 11:30. 
The committee is in recess.
    [Brief recess.]
    Mr. Greenwood. The Chair apologizes to our panel for the 
length of the wait, but it took a little while longer than I 
thought to get those votes concluded. We should have time now 
to get all of your testimony in before the next series of 
votes.
    I welcome our next panel consisting of Ms. Karen Shoos 
Lipton, Chief Executive Officer of the American Association of 
Blood Banks; Mr. Allan S. Ross, Vice President for Technical 
Operations and Biomedical Services, the American Red Cross; Ms. 
Jean Dariotis, is that correct?
    Ms. Dariotis. Correct.
    Mr. Greenwood. President of America's Blood Centers here in 
Washington. She is accompanied by Dr. Robert Jones, the 
President and Chief Executive Officer of the New York Blood 
Center.
    On behalf of the Society for the Advancement of Blood 
Management, Dr. Lawrence Goodnough--is that pronounced 
correctly?
    Mr. Goodnough. Yes, sir.
    Mr. Greenwood. Goodnough--Professor of Medicine, Pathology 
and Immunology at the Washington University School of Medicine.
    We thank all of you for your help this morning and look 
forward to your testimony. As you heard from the--me say to the 
last panel, we are holding an investigative hearing, and it's 
our practice when doing so to take testimony under oath. Do any 
of you have any objections to offering your testimony under 
oath?
    I should advise you then that under the rules of this 
committee and the House of Representatives you are entitled to 
be represented by counsel. Do any of you wish to be represented 
by counsel? I didn't think so.
    Okay. Then if you would rise and raise your right hand.
    [Witnesses sworn.]
    Mr. Greenwood. You are under oath.
    Ms. Lipton, you are recognized for 5 minutes to give your 
statement, please.

   TESTIMONY OF KAREN SHOOS LIPTON, CHIEF EXECUTIVE OFFICER, 
   AMERICAN ASSOCIATION OF BLOOD BANKS; ALLAN S. ROSS, VICE 
  PRESIDENT FOR TECHNICAL OPERATIONS AND BIOMEDICAL SERVICES, 
  AMERICAN RED CROSS, NATIONAL HEADQUARTERS; JEANNE DARIOTIS, 
PRESIDENT, AMERICA'S BLOOD CENTERS; ROBERT L. JONES, PRESIDENT 
    AND CHIEF EXECUTIVE OFFICER, NEW YORK BLOOD CENTER; AND 
  LAWRENCE T. GOODNOUGH, PROFESSOR OF MEDICINE, PATHOLOGY AND 
IMMUNOLOGY, WASHINGTON UNIVERSITY SCHOOL OF MEDICINE, ON BEHALF 
     OF THE SOCIETY FOR THE ADVANCEMENT OF BLOOD MANAGEMENT

    Ms. Lipton. Thank you very much.
    Mr. Chairman and members of the subcommittee, thanks for 
the opportunity to testify today. I am the Chief Executive 
Officer of the American Association of Blood Banks, the 
professional association representing approximately 1,800 
institutions, blood centers and transfusion services and 8,000 
individuals involved in all aspects of blood banking and 
transfusion medicine. AABB's members are responsible for 
virtually all the blood that's collected in the United States 
and approximately 70 percent of the blood that's transfused in 
the United States.
    I am going to begin by focusing on the blood community's 
effort to insure that there's an adequate blood--that there's 
adequate blood available to treat all patients in need in the 
event of a disaster, and then I will briefly touch upon steps 
the government should take to insure patients have access to an 
adequate supply at all times.
    Based on lessons learned from the September 11 attacks, the 
blood community recognized the need to develop a response plan 
to future disasters and acts of terrorism. The AABB 
Interorganizational Task Force on Domestic Disasters and Acts 
of Terrorism was formed in December 2001, to help insure that, 
in the event of a disaster, blood collection and distribution 
efforts are managed properly, with the public receiving clear 
and consistent messages regarding the status of America's blood 
supply.
    The AABB serves as the coordinating entity for the task 
force, and other task force members include America's Blood 
Centers, the American Red Cross, Blood Centers of America, the 
American Hospital Association and a number of government 
agencies, including the Department of Health and Human Services 
Department of Defense, the Centers for Disease Control and 
Prevention and the FDA. I would particularly like to 
acknowledge the involvement and active participation of the FDA 
and Mr. Jerome Hauer in the task force deliberations.
    The task force has identified three primary lessons that we 
learned from the September 11 disaster. The first is the need 
to control collections in excess of actual medical need, the 
second is the need to insure that facilities maintain adequate 
inventories to prepare for disasters at all times in all 
locations, and the third is the need for overall inventory 
management within the United States.
    In order to mitigate the problems created by collection in 
excess of actual need and to insure that the blood community 
can respond effectively in future disasters the task force has 
developed a plan of action. In the event of a disaster, the 
AABB will immediately convene a meeting of task force 
representatives and establish contact with the blood centers 
affected. Affected blood centers--those are the blood centers 
that serve the affected disaster area--will be responsible for 
communicating with their customer hospitals to ascertain 
medical need that's based on casualty estimates; and the blood 
centers are also responsible for assessing the available local 
supply and for communicating that information immediately to 
the task force. If applicable, the task force will identify 
sites with existing excess blood inventory and determine, along 
with the affected blood centers, the need, if any, for blood 
shipment and the logistics of such shipments.
    In addition, the task force will be responsible for helping 
to develop a single, consistent public message and will work 
with HHS to disseminate this message to the public.
    This plan of action is detailed in an operations handbook 
that the task force has drafted to help blood collectors and 
hospitals prepare for and respond to potential disasters. The 
handbook has been distributed in draft form to blood centers 
nationwide, and a final version will be widely distributed this 
fall. We have also sent letters under the logos of all of the 
blood organizations to all of our members and to hospitals 
alerting them to the existence of this task force, their 
activities and the operations handbook.
    The task force recognizes that the provision of blood in 
response to a disaster requires that an adequate supply be 
available in every community, every day. The blood on the shelf 
of the blood centers and hospitals in the affected area is the 
single biggest determinant of the success of the blood 
communities' first response in a disaster.
    Persistent seasonal and regional shortages of blood are the 
major barrier to responding to immediate medical need in any 
community. The task force strongly believes that any planning 
for future disasters should include the recommendation that all 
blood centers have available a 7-day supply of blood at all 
times.
    Information that's just released from the 2001 National 
Blood Collection and Utilization Survey conducted by our 
subsidiary, the National Blood Data Resource Center, reveals 
that 2002 collections and inventory totals remain unchanged in 
comparison with pre-September 11, 2001, measurements and that 
fully 12.8 percent of responding hospitals--that is 139 out of 
1,086 hospitals--reported cancellation of elective surgeries in 
2001. That's nearly two times as many as reported cancellations 
in 1999.
    The government must play a role in insuring the ongoing 
availability of blood. First, the government must support 
public awareness campaigns that are designed to highlight the 
importance of blood donations in the American public and the 
role of blood donation in disasters. Currently, the AABB is 
working with the American Red Cross and America's Blood Centers 
to develop a multi-year, unbranded blood donation public 
education and awareness campaign, which we hope will be 
launched in the not-too-distant future. The Federal Government 
has funded public awareness campaigns about other public health 
issues such as organ tissue and marrow donations. Blood 
donation, which touches millions of lives each year, clearly 
merits a similar commitment.
    In addition, in order for us to accurately gauge whether 
the supply on the shelf will be adequate to meet patients' 
future blood needs, it's crucial that the government support 
collection of long-term, quantitative blood supply and 
utilization data. Unfortunately, the government has not made 
any long-term commitments to collecting this data; and unless 
the government financially supports the collection of 
quantitative data sufficient to forecast future blood supply 
trends and predict shortages, we will continue to operate with 
only today in mind and without any reliable picture of what the 
Nation's blood needs will be in the future.
    Last, when making any blood-related policies, including 
donor deferral policies, the Federal Government must carefully 
consider the potential impact on the blood supply, both 
national and regional. For epidemiologic and demographic 
reasons, different deferral policies may affect certain regions 
of the country more than others. And although the blood supply 
may be generally adequate, if there is a supply problem in any 
part of the country, in any blood type, on any day, there's a 
shortage.
    AABB thanks the subcommittee for holding this hearing and 
hopes that you will act to insure the Federal Government steps 
forward in supporting these critical initiatives. Thank you.
    [The prepared statement of Karen Shoos Lipton follows:]
Prepared Statement of Karen Shoos Lipton, American Association of Blood 
                                 Banks
    Mr. Chairman and Members of the Committee, thank you for the 
opportunity to testify today regarding issues affecting the nation's 
blood supply, and in particular the blood community's efforts to ensure 
there is adequate blood available to treat all patients in need in the 
event of a domestic disaster. Today, I am speaking to you as Chief 
Executive Officer of the American Association of Blood Banks (AABB), 
the professional association representing approximately 1,800 
institutions--including blood centers as well as hospital transfusion 
services--and 8,000 individuals involved in all aspects of blood 
banking and transfusion medicine. AABB's members are responsible for 
virtually all of the blood collected and approximately 70 percent of 
the blood transfused in the United States.

                         DISASTER PREPAREDNESS

    Based on lessons learned from the September 11 attacks, the blood 
community recognized the need to develop a response plan to future 
domestic disasters and acts of terrorism. The AABB Interorganizational 
Task Force on Domestic Disasters and Acts of Terrorism was formed in 
December 2001 to help ensure that ( in the event of a national disaster 
( blood collection efforts run smoothly and are managed properly, with 
the public receiving clear and consistent messages regarding the status 
of America's blood supply.
    The AABB is serving as the coordinating entity for the task force. 
Other task force members include: America's Blood Centers (ABC), 
American Red Cross (ARC), Blood Centers of America/hemerica (BCA), 
Armed Services Blood Program Office (ASBPO), Centers for Disease 
Control and Prevention (CDC), Department of Health and Human Services 
(HHS), Food and Drug Administration (FDA), American Hospital 
Association, Advanced Medical Technology Association (AdvaMed), the 
Plasma Protein Therapeutics Association (PPTA), and the American 
Association of Tissue Banks.
    The Task Force has identified three primary lessons learned from 
the September 11 disaster: 1) the need to control collections in excess 
of actual medical need, 2) the need to ensure that facilities maintain 
adequate inventories to prepare for disasters at all times in all 
locations across the country, and 3) the need for overall inventory 
management within the United States. Specifically, the Task Force 
recommends a minimum seven-day supply of red blood cells be maintained 
in order to prepare for a disaster. The Task Force is in the process of 
defining what constitutes a seven-day inventory.
    In order to mitigate the problems created by collection in excess 
of actual medical need and to ensure the capability of the blood 
community to respond effectively in future disasters, the Task Force 
has developed a plan of action. In the event of a disaster, the AABB 
will immediately convene a meeting of task force representatives and 
establish contact with the local blood center(s) affected. Local blood 
center(s) will be responsible for ascertaining medical need based on 
casualty estimates, assessing available local supply and communicating 
that information to the Interorganizational Task Force. If applicable, 
the task force will identify sites with existing excess blood inventory 
and determine, along with the affected blood center(s), the need, if 
any, for blood shipment and the logistics of such shipments. In 
addition, the task force will be responsible for developing a single, 
consistent public message and will work with the Department of Health 
and Human Services (HHS) to disseminate this message to the blood 
community.
    This plan of action is detailed in an Operations Handbook the Task 
Force has drafted to help blood collectors and hospitals prepare for 
and respond to potential disasters. The Handbook, which has been 
distributed in draft form to blood centers nationwide, contains 
information on preparation steps, activation (i.e., step-by-step 
response), training materials and reference materials (e.g., important 
phone numbers, etc.). The Handbook also contains a hospital supplement 
focusing on hospital transfusion services. In addition, the Handbook 
distinguishes between ``traditional' disasters and biological events, 
which are likely to affect donor suitability more than demand for 
blood. The Task Force will incorporate comments on the draft into a 
final version of the Operations Handbook, which will be widely 
distributed this fall.
    The Task Force also has been busy this year working on other 
related projects. This past winter, the Task Force created a test pilot 
to operate during the winter Olympics in Salt Lake City. Before the 
Olympics began, representatives of the Task Force met with the two 
blood suppliers for Salt Lake City. Both suppliers agreed to work 
together to assess medical need should a disaster occur and to work 
with the Task Force on a coordinated national response. Redundant lines 
of communication among the Task Force and the blood centers were 
established. In addition, since the major supplier in that area, the 
American Red Cross, already had an extensive disaster plan in place in 
Salt Lake, the Task Force plan was integrated into their plan through 
the creation and distribution of a shared document with specific 
instructions and defined communication lines should an event occur. 
Fortunately, our efforts were not needed, but this served as a valuable 
pilot in establishing a coordinated approach to disaster preparedness.
    In addition, the Task Force has served as an effective mechanism 
for bringing together the blood community to discuss and develop 
positions regarding individual disaster-related issues that could 
affect the blood supply. For example, the Task Force wrote to the 
Department of Health and Human Services about a variety of issues 
relating to the blood supply that it felt should be carefully 
considered before the Department developed any new policies calling for 
widespread smallpox immunization. Immunization against or exposure to 
individual biological agents could adversely affect the blood supply by 
expanding, at least temporarily, the population of unsuitable donors. 
Because we are already faced with persistent, regional blood shortages, 
it is critical that the government carefully address the effects any 
bioterrorism policies could have on blood availability. Whenever 
possible, the AABB believes it is most effective and efficient for the 
entire blood banking community to speak with one voice on such 
important policy matters, and the Task Force enables us to do just 
that.

                   IMPORTANCE OF BLOOD ON THE SHELVES

    The AABB and the Interorganizational Task Force recognize that the 
provision of blood in response to a disaster requires that an adequate 
supply of blood be available in every community, every day. The blood 
on the shelf of the blood centers and hospitals in the affected area is 
the single biggest determinant of the success of the blood community's 
first response to a disaster. Persistent seasonal and regional 
shortages of blood are the major barrier to responding to immediate 
medical need in any community. For that reason, the Task Force strongly 
believes that any planning for future disasters should include the 
recommendation that all blood centers have available a seven-day supply 
of blood at all times. Continuing and effective communication to the 
public through multi-year public education and awareness programs, of 
this real need is of critical importance to the public health of this 
country.
    The government must play a role in ensuring the ongoing 
availability of blood. First, the government needs to support needed 
public awareness campaigns designed to highlight the importance of 
blood donations to the American public. Currently, the AABB is working 
with the American Red Cross and America's Blood Centers to develop a 
multi-year, unbranded blood donation public awareness campaign, which 
we hope will be launched in the not-too-distant future. The federal 
government has funded public awareness campaigns about other public 
health issues, such as the currently funded program for organ, tissue 
and marrow donations. Blood donation, which touches millions of lives 
each year, clearly merits a similar commitment.
    In addition, in order for us to accurately gauge whether the supply 
on the shelf will be adequate to meet patients' blood needs in the 
future, it is crucial that the government support collection of long-
term, quantitative blood supply and utilization data. Unfortunately, 
the government has not made any long-term commitment to collecting this 
necessary, representative data. Unless such a commitment is made and 
the government financially supports the collection of quantitative data 
sufficient to forecast future blood supply trends, we will continue to 
operate with only today in mind, and without any reliable picture of 
what the nation's blood needs will be in the future.
    Lastly, when making any blood related policies, including donor 
deferral policies, the federal government must carefully consider their 
potential impact on the blood supply, both national and regional. For 
epidemiologic and demographic reasons, different deferral policies may 
affect certain regions of the country more than others. If there is a 
supply problem in any part of the country, in any blood type, there is 
a shortage. Patient access to an available blood supply is clearly a 
safety issue as well as a public health priority.
    The AABB thanks the Subcommittee for holding this hearing and hopes 
that you will act to ensure the federal government steps forward in 
supporting these critical initiatives aimed at promoting a safe, 
available blood supply.

    Mr. Greenwood. Thank you.
    Now Mr. Ross.

                   TESTIMONY OF ALLAN S. ROSS

    Mr. Ross. Chairman Greenwood, Ranking Member Deutsch and 
members of the subcommittee, my name is Allan Ross; and I'm 
Vice President of Technical Operations for Biomedical Services 
at American Red Cross. Thank you for inviting me to discuss the 
work of the Red Cross following the September 11 attacks and to 
insure blood products are available should another attack 
occur, or a major natural disaster occur.
    In the year following September 11, the most important 
lessons learned in the blood banking community have been an 
understanding that we must work collaboratively and a consensus 
that the daily inventory of blood components must be 
substantially increased. As we face the new reality of 
terrorist attacks on American soil that may result in mass 
casualties, the blood banking community and public health 
officials must work together to address the long-standing 
challenge to build a stable and sustained blood supply.
    Today I'd like to highlight for the subcommittee our 
strategies related to blood preparedness, including: our 
collaboration with our blood banking and public health 
colleagues to prepare for future disasters; the consensus that 
is evolving as to what truly constitutes an adequate inventory 
and our measures to effectively manage existing and projected 
patient needs; and our efforts to increase blood donation 
through market research, public awareness and outreach 
programs.
    Blood preparedness is comprised of a readily available 
supply of blood components matching projected patient needs, 
effective management of current inventory and healthy blood 
donors close at hand when needed. You have just heard from the 
AABB about the recently established task force. This is a major 
step forward in our preparedness efforts. Now we have an 
effective means for the blood banking organizations and Federal 
Government officials to coordinate efforts before and after 
disaster strikes. The Red Cross is pleased to be part of this 
important initiative.
    Another example of increased collaboration between the 
blood banking and health care communities was the unprecedented 
joint national blood appeal in June of this year to immediately 
bolster blood inventories. The Red Cross worked closely with 
government officials, the AABB, America's Blood Centers, the 
American Hospital Association and the American Public Health 
Association to issue a joint appeal for blood donors to enhance 
blood supplies this past summer.
    Although this effort increased blood availability for a 
portion of the summer, our current inventory level is just 
slightly above what we classify as critical and that's about 
50,000 units on hand. That's just over 2 days supply, which 
brings me to the important issue of what constitutes an 
adequate blood supply. Maintaining a 3-day inventory is not 
sufficient to handle normal usage and be prepared for a 
catastrophic event. There is a growing consensus that an 
optimal supply is more in the range of 7 days.
    The Red Cross has enhanced its inventory management system 
to insure that blood products are available where they are 
needed. This system is comprised of three components: planning 
the balance between units collected and units distributed among 
our 36 blood regions, managing the units and inventory at our 
36 blood regions, and working with hospitals to balance their 
inventory levels.
    As we move toward an increasing inventory of 7 days, there 
is a cost to preparedness that we must recognize. We need to 
work together to educate the public that blood, like 
pharmaceuticals, must be stockpiled in order to be readily 
available to respond to any event. It is important that the 
public understands that some blood may eventually outdate and 
not be used. This is the cost of preparedness, our insurance 
policy to cover us in the event of disaster.
    Public awareness of the need for blood is key to insuring a 
new generation of donors. Within the past year we have begun to 
share research on donor motivations with our blood banking 
colleagues. Working together, the blood banking community is 
examining ways to identify those segments of the population 
most likely to donate and better use scarce resources to target 
them. In addition, paid advertising is a more effective tool to 
recruit and retain blood donors than PSAs. However, our ability 
to use paid advertising on a regular basis has been limited due 
to cost constraints.
    We are trying to recruit new donors and buildupon our 
relationships with existing donors through the Internet, 
especially youth. Approximately 20 percent of first-time donors 
who gave immediately following the September 11 attacks were 
high school and college age, 25 years or younger. The Internet 
provides an effective way to encourage these individuals to 
become regular blood donors.
    At the beginning of this month the American Red Cross 
launched a public awareness and education campaign called 
Together We Can Save a Life. This is supported by Microsoft, 
Yahoo and America Online; and those of you here today are in a 
unique position to educate the public about the need for blood 
and the importance of blood preparedness.
    We are grateful for the leadership many in Congress have 
shown through regular blood donations in your home districts or 
here on Capitol Hill and your support in getting the message 
out to the public. Special thanks to Congressman Bass for his 
leadership and the New Hampshire congressional delegation and 
their promotion of the importance of donating blood.
    In summary, the horrific events of September 11 challenged 
the blood banking community and made all of us look at ways we 
could better support the country's preparedness efforts. 
Through collaboration, management of inventories and increased 
public outreach, we are working toward ending the cylical 
shortages we have faced for more than 50 years. Of course, none 
of this will be easy. Success will require that all involved, 
the blood banking community, hospitals and the Federal 
Government work collaboratively. Together we can buildupon the 
renewed spirit of civic engagement in this country and recruit 
a new generation of altruistic blood donors committed to give 
regularly to benefit fellow citizens.
    Thank you.
    [The prepared statement of Allan S. Ross follows:]

Prepared Statement of Allan Ross, Vice President, Technical Operations, 
                Biomedical Services, American Red Cross

    Chairman Greenwood, Ranking Member Deutsch and members of the 
subcommittee, my name is Allan Ross and I am the Vice President of 
Technical Operations for Biomedical Services at the American Red Cross. 
I am pleased to be here today to discuss the work of the Red Cross in 
the aftermath of the September 11 attacks on our country to ensure that 
we are prepared to support the need for blood products following 
another terrorist attack or a major natural disaster. In the year 
following September 11, the most important ``lessons learned'' in the 
blood banking community have been:

 An understanding that we must work collaboratively; and
 A consensus among government and blood suppliers that we must 
        significantly increase the daily inventory of blood components 
        if we are to be adequately prepared.

    Blood is one of the cornerstones of medicine. It is a precious 
public health resource made available only through volunteers who 
generously give part of themselves to help patients in need. The Red 
Cross supports almost one-half of the nation's blood supply through our 
system of 36 blood regions across the country, serving more than 3,000 
hospitals. Last year, we collected more than 6 million units of whole 
blood through the generous donations of approximately 4.5 million 
donors.
    As a single organization with a nationwide presence, Red Cross is 
able to move products where they are needed. This is especially 
important in the current environment where the nation must now be 
prepared for both natural disasters and acts of terrorism. The Red 
Cross is committed to meeting the challenge of developing a stable and 
sustained blood supply to prepare for everyday needs and for the new 
reality of terrorist attacks on American soil that may result in mass 
casualties.
    Today I would like to highlight for the Subcommittee Red Cross' 
strategies related to blood preparedness, including:

 Collaboration with our blood banking and public health 
        colleagues to prepare for future disasters;
 Consensus as to what constitutes an adequate inventory and 
        measures to effectively manage the inventory to meet existing 
        and projected patient needs; and
 Efforts to increase blood donation through market research, 
        public awareness and outreach programs.
              building preparedness through collaboration

    Blood preparedness is a readily available supply of blood 
components matching projected patient need, effective management of 
current inventory and healthy blood donors close at hand when needed. 
Representatives from the American Association of Blood Banks have 
briefed the Committee on the recently established Inter-organizational 
Task Force on Domestic Disasters and Acts of Terrorism. The Task Force 
provides an effective means for the blood banking organizations and 
federal government officials responsible for disaster preparedness and 
public health to coordinate efforts before and after disaster strikes. 
The Red Cross is pleased to be part of this important initiative to 
ensure that we are prepared for any and all hazards, by maintaining an 
adequate inventory at all times. For the first time, through the Task 
Force, the entire blood banking community and public health officials 
will have an effective means of:

 Assessing the need for blood donations following a mass 
        casualty event;
 Coordinating public messaging of the need for blood donations; 
        and
 Coordinating the transportation of blood components where 
        needed.

    Another example of the increased collaboration between the blood 
banking and healthcare communities was the unprecedented joint national 
blood appeal issued on June 25, 2002, to immediately bolster blood 
inventories and educate Americans about the everyday need for blood. 
Red Cross worked closely with government officials, the American 
Association of Blood Banks, America's Blood Centers, the American 
Hospital Association, and the American Public Health Association, to 
issue a joint appeal for blood donors to enhance blood supplies this 
summer and throughout the year. By leveraging each organization's 
relationships with the media, we were able to reach the public in more 
than 60 major media markets, including New York, Philadelphia, Chicago, 
Detroit, Boston, Miami, Atlanta and Los Angeles. It is our 
understanding each of our organizations saw an increase in presenting 
donors, and specific to the Red Cross, our projected collections for 
the July 4th holiday week increased by 8,000 units, and scheduled 
appointments increased by 6,000 to 9,000 per week for several weeks 
after the holiday. Although this effort increased blood availability 
for a portion of the summer, our inventory level as of August 30 was 
just slightly above what we classify as ``critical'', or 50,000 units 
on hand equaling a two-day supply.

     A STABLE, SUSTAINED BLOOD SUPPLY `` FOUNDATION OF PREPAREDNESS

    Our nation has suffered from seasonal and cyclical blood shortages 
for more than 50 years. Prior to September 11, the need to develop a 
stable and sustained blood supply to meet increasing patient needs and 
hospital demand for these life-saving products was readily apparent. In 
the summer of 2001, as the Department of Health and Human Services and 
the blood banking organizations wrestled with the issues surrounding an 
expansion of the donor deferral criteria related to new variant 
Cruetzfeld-Jakob disease (vCJD), the discussion centered on the fragile 
state of the blood supply. Traditionally, we have struggled to maintain 
an inventory ranging from one to three days. Donated units of blood can 
be processed into three primary components: red blood cells, platelets 
and plasma. One donation can yield platelets for cancer patients; red 
cells for surgery, anemia and accident victims; and plasma for burn 
patients. The challenge is to constantly replenish our inventories as 
the shelf life for red blood cells is 42 days, and only 5 days for 
platelets.
    Maintaining a three-day inventory is not sufficient to handle 
normal usage and be prepared for a catastrophic event. There is a 
growing consensus among policymakers and the blood banking 
organizations that an optimal supply is more in the range of 7 days.
    The Red Cross blood services system collects, processes, and 
distributes blood components through our 36 blood service regions. In 
order to ensure an adequate supply of blood products for these regions, 
we have established an inventory management system that provides a 
mechanism to ensure blood products are available where they are needed. 
This system is comprised of three components:

 Planning the balance between units collected and units 
        distributed among the regions
 Managing the units in inventory at the regions
 And working with hospitals to balance their inventories.
    Through this integrated approach, the Red Cross determines, on a 
quarterly basis, an 18-month demand forecast. We do this by analyzing 
the requirements of our hospital customers and our collections 
forecasts. To determine the optimal inventory level, the Red Cross must 
balance:

 The total demand requirements provided by hospital customers;
 The lead time to increase collections, processing of units and 
        distribution to hospitals;
 Customer service levels;
 The day to day volatility of demand;
 The shelf life and expiration cycle for each blood component; 
        and
 The right mix of blood types matched to blood usage (with 
        particular emphasis on the need to collect proportionately more 
        blood group O units).
    Through this analysis we are able to balance the needs among the 
regions and forecast the collections we will need to ensure an adequate 
blood supply.
    On a monthly basis we measure the forecasts and compare them to our 
actual collections. We are then able to determine the causes for the 
differences between forecasts and our actual collections and make 
needed adjustments to the 18-month forecast. We also conduct a daily 
analysis of our forecasted inventory levels with the requirements of 
each region, and are then able to identify excess blood in our system 
and move it to hospitals in areas of the country where additional 
products are needed. These quarterly, monthly, and daily analyses are 
performed so as to provide the most efficient use of blood donated to 
the Red Cross by generous Americans throughout our country.
    There is a cost to blood preparedness that must be recognized. 
Despite our best efforts, there will continue to be a certain 
percentage of units that will outdate before they can be transfused. 
Currently, between 1 to 2 percent of blood products nationwide expire 
before a hospital can use them. As the inventory is increased to 7 days 
in order to meet increased demand and prepare for a possible mass 
casualty event, the number of units outdating will increase. The Red 
Cross and our blood banking colleagues are careful stewards of the 
units voluntarily donated to us by altruistic individuals. As we move 
forward in our preparedness efforts, the public needs to be educated 
that blood, like pharmaceuticals, must be ``stockpiled'' in order to be 
readily available to respond to any event. It is important that the 
public understands that some blood may eventually outdate and not be 
used. This is the cost of preparedness `` our insurance policy to cover 
us in the event of disaster. If the Red Cross is to achieve and 
maintain an optimal inventory, we need 25,000 donors to visit one of 
over 400 Red Cross fixed donation sites, or one of hundreds of our 
mobile donation sites each day.

             NEW INITIATIVES TO INCREASE BLOOD AVAILABILITY

    Over the past decade, the Red Cross has invested over $335 million 
in technologies and systems to improve the safety of the blood supply. 
In comparison, during the same period, we have had only a small 
fraction of that amount available to invest in the availability of the 
blood supply. Despite our extensive efforts to build public awareness 
of the need for blood, significant challenges remain. As a group, 
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. The challenge to the blood banking 
community, the federal government, and the American public is to ensure 
these dedicated donors are replaced with a new generation of donors 
ready, willing, and able to provide a life-saving resource
    The Red Cross is working on a number of initiatives to help make 
that happen. I would like to outline a few these programs in order to 
highlight the breadth of work we are undertaking to ensure an adequate 
supply of blood.
Research Sharing
    The Red Cross and our blood banking colleagues have begun to share 
the research we have performed individually on donor motivations. In 
research performed several years ago, we found that our most loyal 
donors also volunteer their time with non-blood organizations. With the 
hectic pace of today's society these individuals are finding less time 
to donate blood. Working together, the blood banking community is 
examining ways to overcome these problems by undertaking studies to 
help identify those segments of the population most likely to donate. 
Through this market segmentation, we will then be able to better 
utilize scarce resources to target those individuals most likely to 
donate and donate frequently.
    One of the important issues that collaborative research efforts can 
address is the true size of the population that is eligible to donate. 
The estimate that only 5% of the population eligible to donate do so, 
is based upon research that is relatively dated.

Public Awareness and Education Efforts
    In a recent public opinion poll conducted by the Red Cross of more 
than 1,000 Americans, we learned that a majority of respondents 
underestimated the everyday need for blood and overestimated the 
availability of the blood supply. Through this and other information, 
the blood banking community has been working on a non-branded, multi-
year joint campaign to increase public awareness on the need for blood. 
As part of this effort, the blood banking community will: provide 
information to the general public on the need for a new generation of 
donors; produce and execute national media campaigns; perform market 
research; and, collaborate on other activities to raise the awareness 
of the vital need for Americans to donate blood.
E-marketing strategies
    While it is vital that we attract new donors, it is equally 
important that we retain them after their initial experience. The Red 
Cross is leveraging the power of the Internet to recruit new donors and 
build upon relationships with existing donors to ensure that we 
continue to grow the blood supply. Previously we have relied upon 
traditional media and other channels to reach the public, i.e. direct 
mail, television and radio ads, many of them public service 
announcements. The Red Cross has found the use of paid advertising to 
be an effective tool to recruit and retain blood donors. However, our 
ability to use paid advertising on a regular basis has been limited due 
to cost constraints. We are now exploring the use of regular emails to 
potential and existing members of the Red Cross as an education tool.
    This is a medium that is particularly attractive to youth, our next 
generation of blood donors. Approximately 20% of first-time blood 
donors who gave immediately following the September 11 attacks were 
high school and college-age (25 or younger). The Internet provides an 
effective way to encourage these individuals to become regular donors. 
At the beginning of this month, the American Red Cross launched a 
public awareness and education campaign--``Together, We Can Save a 
Life''--with the support of Microsoft, Yahoo! and America Online. The 
campaign will educate Americans about the importance of giving blood on 
a regular basis and for a lifetime. Americans can now learn more about 
the crucial need for blood donations and how to schedule appointments 
through online features (such as http://blood.givelife.org and AOL 
Keyword: Gift of Life), links and PSAs running throughout MSN, Yahoo! 
and AOL properties. The participating technology companies estimate 
that millions of people will view the four-week campaign from the 
participating companies' sites alone. With the help from these leading 
technology companies, the American Red Cross is leveraging the power of 
the Internet to increase blood donations and ensure a safe and stable 
blood supply in support of our nation's public health and security.

Role of Congress and Federal Government
    Elected officials at all levels of government are in a unique 
position to educate their constituents and target audiences about the 
need for blood and the importance of blood preparedness.
    We have worked extensively with Members of Congress to promote 
public awareness of the need for blood. Members of Congress have 
provided vital leadership to help ensure an adequate blood inventory is 
available throughout the country. This support has come in the form of 
regular blood donations at home and at the seven Red Cross blood drives 
held annually on Capitol Hill; public service announcements; newspaper 
editorials; and speeches on the floors of the House and Senate and at 
home in their districts.
    As you have heard today, HHS is focused on this public health issue 
as well, and has highlighted the need for federal government support of 
public awareness and the monitoring of blood availability through the 
HHS Advisory Committee on Blood Safety and Availability and the FDA. 
Red Cross has also worked with HHS on the ``Gift of Life'' donation 
initiative to increase awareness and promote donation of organs, and 
the corresponding need for blood for transplantation procedures.

                               CONCLUSION

    The horrific events of September 11 challenged the blood banking 
community and made all of us look at ways we could better support the 
country's preparedness efforts for future natural disasters or acts of 
terrorism. Through the work of the AABB Inter-organizational Task Force 
on Domestic Disasters and Acts of Terrorism, the Red Cross and our 
colleagues have taken major steps to ensure a coordinated response to 
such events in the future. The continued refinement of the Red Cross 
inventory management system will provide us with a means to ensure the 
most efficient use of blood that is donated by generous Americans 
throughout our country. New initiatives to increase public awareness 
for the need for blood and activities to recruit and retain a new 
generation of dedicated blood donors will hopefully move us away from 
the cyclical shortages the community has faced for over 50 years.
    Of course, none of this will be easy. The events of September 11 
taught all of us that we must be prepared. Success will require that 
all involved `` the blood banking community, hospitals, HHS, FDA, and 
CDC `` work collaboratively. Together, we can build upon the renewed 
spirit of civic engagement in this country, and engage a new generation 
of altruistic blood donors, committed to give regularly to benefit 
their fellow citizens. We have no option on this matter and the Red 
Cross is committed to doing all we can to provide this life-saving 
resource wherever and whenever it is needed.

    Mr. Greenwood. Thank you, Mr. Ross.
    Ms. Dariotis.

                  TESTIMONY OF JEANNE DARIOTIS

    Ms. Dariotis. Thank you.
    Mr. Greenwood and the honorable members of this oversight 
committee, I am Jeanne--is that better? My name is Jeanne 
Dariotis. I'm the President of America's Blood Centers, and I'm 
the Chief Executive Officer of the Southeastern Community Blood 
Center located in Tallahassee, Florida. On behalf of ABC 
members nationwide, I thank the committee for the opportunity 
to testify and comment on the availability and safety of blood 
and blood products in the United States. I'm here to ask you 
for support and acknowledgment that our fragile blood supply is 
an important public health and safety issue.
    America's Blood Centers, or ABC, is the national network of 
75 not-for-profit community-based blood centers which provide 
nearly half of the U.S. And one-quarter of Canada's blood 
supply to over 3,300 hospitals. In the United States, America's 
Blood Centers members are located in 45 States and serve more 
than 140 million people from over 500 blood donationsites. ABC 
members have been committed to serving the needs of their local 
communities since the 1940's. Indeed, one of ABC's founding 
members is the Blood Bank of Hawaii, which was formed in the 
days following the attack on Pearl Harbor. ABC members save 
over 2 million lives each year by providing volunteer blood 
donations. Our members were also the first to respond to 
national tragedies like the Oklahoma City bombing, the 
Columbine shootings and the September 11 attacks.
    It's important to note the remarkable safety of the U.S. 
blood supply today. Twenty years ago, some blood transfusions 
were infecting thousands of transfusion recipients with HIV and 
hepatitis. Today, an HIV transmission from blood is a rare 
event, estimated at less than one in 2 million transfusions, so 
rare it makes national headlines. Even transfusion related 
hepatitis is now equally rare. Many other viruses have been 
eliminated from transfusions, and today the U.S. Blood supply 
has never been safer.
    The reasons for this increased safety are twofold. First, 
new leading-edge technology for testing blood has been 
introduced to blood screened almost yearly. Second, individuals 
are deferred as would be donors if they have identifiable risk 
factors for an infection, such as the new donor deferral for 
Mad Cow Disease that eliminates potential donors based on 
travel or living in Europe.
    Unfortunately, these precautionary deferrals also eliminate 
millions of perfectly safe and willing donors. It is these 
deferrals such as the recent Mad Cow deferrals, along with the 
aging population that is donating less but using more blood, 
which are the leading causes of increased blood shortages.
    The new Mad Cow deferrals could cause a crisis in New York 
City in the coming weeks as New York City, which has been 
dependent on blood from Europe for over 25 years, will no 
longer be able to import blood because of the New FDA 
requirements. ABC members and others are sending unprecedented 
amounts of blood to New York, primarily to the New York Blood 
Center, one of our members. We are all working hard to prevent 
a crisis in New York, but there's no guarantee that one can be 
averted.
    Blood shortages also exist all over America, as we all are 
aware. Indeed, blood shortages are in the news more than ever 
in history. Are patients dying from these shortages? We have no 
way to tell for sure. Hospitals and blood centers have become 
very skillful at managing meager blood supplies and preventing 
tragedies from occurring. But reports of wasted organs are 
increasing, and each day necessary surgeries are canceled or 
postponed for the lack of an adequate supply in the hospital.
    As we know from experience in responding to major 
disasters, it is the blood on the shelves that saves lives, not 
the blood collected from those who line up when a tragedy 
strikes. It takes well over 24 hours from the time of a 
donation until blood is ready to be used by a patient. Today 
there is less than a 3-day supply nationwide. Never in modern 
times have our reserves been lower.
    In these days of heightened concern for attack, our blood 
supply is inadequate to deal with a major disaster because, as 
I said before, it's the blood on the shelves that saves lives. 
We must respectfully disagree with the GAO report that today's 
blood supply is adequate. One year ago today, September 10, 
most communities around the United States had a 3 to 5-day 
blood supply and thus were prepared to deal with a local or 
national emergency requiring massive amounts of blood. Today, 
many communities have a 2 day or less supply and are not 
prepared to meet even a local emergency, much less a disaster 
or national emergency.
    As I said, shortages are worsening because demand is 
growing and the eligible donor base is shrinking. Demand 
continues to increase because of the aging patient population 
and the increased use of blood for medical procedures such as 
organ and marrow transplants and more aggressive chemotherapy. 
Our volunteer donor base is also aging as the population ages. 
We must now resort to emergency blood appeals during the time 
of the year that used to be periods of abundance. We cannot 
continue to rely on urgent appeals to solve our problems 
because they're only a temporary fix. And at some point the 
media and public stop listening. Needless to say, the fragility 
of the blood supply is an urgent public health issue.
    What's the answer? Blood centers are pouring millions more 
dollars into marketing research and advertising to persuade 
millions of eligible people to give blood and to give it 
routinely, not just when a tragedy occurs. Blood saves more 
than 4 million Americans every year, and we are struggling to 
meet the demand.
    We need help. We can't do it alone. Both Congress and the 
administration have key roles in assuring readiness in 
America's blood supply.
    Last year, America's Blood Centers met with Secretary 
Thompson about the issue of shortages and its effect on the 
public health. At the Secretary's request, ABC developed and 
submitted a blood action plan that HHS could use to help 
increase donations for blood. A copy of that plan has been 
attached. Despite the Secretary's pledge and numerous attempts 
in follow-up, no action has been seen from HHS to help bolster 
supply.
    While HHS has rightly placed a emphasis on blood safety, 
they have not focused on the adequacy of the supply. We need a 
designated person inside HHS that focuses on blood availability 
and coordinates this very important public health issue with 
the private sector. We suggest that, as they do for organs, 
tissue and marrow, the Health Resources and Services 
Administration be charged to work with the private sector on 
helping to assure an adequate blood supply.
    HHS could also do simple things such as credibly 
reinforcing the need for Americans to give blood through the 
sponsorship of an advertising campaign, by asking celebrities 
to donate their time, and by having high officials regularly 
donate on camera.
    Congress, too, can help by assuring funding for new public 
health educational initiatives and blood donations, by 
encouraging every Congressman and Senator who can to give blood 
publicly and frequently, and by working with their local blood 
suppliers to participate in public events that would help 
create a culture of donation in the United States.
    If merely 1 percent of the public--only 2 million more 
Americans--would give blood, shortages would end and reserve 
supplies would swell. But even 2 million donations today won't 
meet tomorrow's needs. We need HHS's help to work in 
partnership with the private sector to help assure tomorrow's 
blood supply.
    I thank the committee for the opportunity to speak on these 
very important issues. I would like to introduce Dr. Robert 
Jones of the New York Blood Center, and he will speak about 
some of the unique blood supply problems of his center.
    [The prepared statement of Jeanne Dariotis follows:]

   Prepared Statement of Jeanne Dariotis, President, America's Blood 
                                Centers

   Mr. Greenwood and honorable members of this Oversight Committee, I 
am Jeanne Dariotis, president of America's Blood Centers and CEO of the 
Southeastern Community Blood Center in Tallahassee Florida. On behalf 
of ABC members nationwide, I thank the Committee for the opportunity to 
testify and comment on the availability and safety of blood and blood 
products in the United States. I am here to ask for support and 
acknowledgement that our fragile blood supply is an important public 
health and safety issue.
    America's Blood Centers, or ABC, is the national network of 75 not-
for-profit community-based blood centers, which provide nearly half the 
US and one-quarter of Canada's blood supply to over 3,300 hospitals. In 
the US, America's Blood Centers' members are located in 45 states and 
serve more than 140 million people from over 500 blood donation sites. 
ABC members have been committed to serving the needs of their local 
communities since the 1940s. Indeed, one of ABC's founding members is 
the Blood Bank of Hawaii, which was formed in the days following the 
attack on Pearl Harbor. ABC members save over 2 million lives each year 
by providing volunteer blood donations. Our members were also the first 
to respond to national tragedies like the Oklahoma City bombing, 
Columbine shootings and September 11th attacks.
    It is important to note the remarkable safety of the US blood 
supply today. Twenty years ago, some blood transfusions were infecting 
thousands of transfusion recipients with HIV and hepatitis. Today, an 
HIV transmission from blood is a rare event--estimated at less than one 
in 2 million transfusions--so rare it makes national headlines. Even 
transfusion-related hepatitis is now an equally rare event. Many other 
viruses have been eliminated from transfusions and today the US blood 
supply has never been safer. The reasons for this increased safety are 
two-fold. First, new leading edge technology for testing blood has been 
introduced to blood screening almost yearly. Second, individuals are 
deferred as would-be donors if they have identifiable risk factors for 
an infection, such as the new donor deferral criteria for Mad Cow 
Disease that eliminates potential donors based on travel or living in 
Europe.
    Unfortunately, these precautionary deferrals also eliminate 
millions of perfectly safe and willing donors. It is these deferrals, 
such as the recent Mad Cow deferrals, along with an aging population 
that is donating less and using more blood, which are the leading 
causes of increased blood shortages.
    The new Mad Cow deferrals could cause a crisis in New York City in 
the coming weeks as New York City, which has been dependent on blood 
from Europe for over 25 years, will no longer be able to import blood 
because of new FDA requirements. ABC members and others are sending 
unprecedented amounts of blood to New York, primarily to the New York 
Blood Center, an ABC member. We all are working hard to prevent a 
crisis in New York, but there is no guarantee that one can be averted.
    Blood shortages also exist all over America, as we are all aware. 
Indeed, blood shortages are in the news more than ever in history. Are 
patients dying from these shortages? We have no way to tell for sure. 
Hospitals and blood centers have become very skillful at managing 
meager blood supplies and preventing tragedies from occurring. But 
reports of wasted organs are increasing and each day necessary 
surgeries are cancelled or postponed for lack of an adequate blood 
supply in the hospital. As we know from experience in responding to 
major disasters, it is the blood on the shelves that saves lives--not 
the blood collected from those who line up when a tragedy strikes. It 
takes over 24 hours from the time of donation until blood is ready to 
be used by a patient.
    Today there is less than a three-day supply nationwide. Never in 
modern times have our reserves been lower. In these days of heightened 
concerns for attacks, our blood supply is inadequate to deal with a 
major disaster.
    As I said, shortages are worsening because demand is growing and 
the eligible donor base is shrinking. Demand continues to increase 
because of the aging of the patient population and increased use of 
blood for medical procedures such as organ and marrow transplants and 
more aggressive chemotherapy. Our volunteer donor base is also aging as 
the population ages. We must now resort to emergency blood appeals 
during times of the year that used to be periods of abundance. We 
cannot continue to rely on urgent appeals to solve our problems because 
it's only a temporary fix, and at some point the media and public stop 
listening. Needless to say, the fragility of the blood supply is an 
urgent public health issue.
    What's the answer? Blood centers are pouring millions more dollars 
into marketing research and advertising to persuade millions of 
eligible people to give blood and give it routinely, not just when a 
tragedy occurs. Blood helps save more than 4 millions Americans every 
year and we are struggling to meet that demand.
    We need help. We can't do it alone. Both Congress and the 
Administration have key roles in assuring readiness in America's blood 
supply.
    Last year, America's Blood Centers met with Secretary Thompson 
about the issue of shortages and its affect on the public health. At 
the Secretary's request, America's Blood Centers developed and 
submitted a Blood Action Plan that HHS could use to help increase 
donations for blood. A copy of that plan is attached to my testimony. 
Despite the Secretary's pledge and numerous attempts in follow-up, no 
action has been seen from HHS to help bolster supply.
    While HHS has rightly placed a heavy emphasis on blood safety, they 
have not focused on the adequacy of the supply. We need a designated 
person inside HHS that focuses on blood availability and coordinates 
this very important public health issue with the private sector. We 
suggest that, as they do for organs, tissue and marrow, the Health 
Resources and Services Administration be charged to work with the 
private sector on helping to assure an adequate blood supply.
    HHS could also do simple things such as credibly reinforcing the 
need for Americans to give blood through sponsorship of an advertising 
campaign, by asking celebrities to donate their time to this worthy 
cause, and by having high officials regularly donate on camera.
    Congress, too, can help by assuring funding for new public 
educational initiatives on blood donation, by encouraging every 
Congressman and Senator who can to give blood publicly and frequently, 
and by working with their local blood suppliers to participate in 
public events that would help create a culture of donation in the US.
    If merely one percent more of the public--only 2 million more 
Americans--would give blood, shortages would end for the time being and 
reserve supplies would swell to safe levels. But even 2 million more 
donations today won't meet tomorrow's needs. We need HHS's help to work 
in partnership with the private sector to help assure tomorrow's blood 
supply.
    I thank the Committee for the opportunity to speak on this issue.

    Mr. Greenwood. Dr. Jones, you are recognized.

                  TESTIMONY OF ROBERT L. JONES

    Mr. Jones. Mr. Chairman and members of the committee, thank 
you and America's Blood Centers for the opportunity to briefly 
share our experience and views. I'm Dr. Robert Jones, President 
and CEO of the New York Blood Center, which supplies blood to 
200 hospitals in the New York and New Jersey area.
    I ask that my complete written statement be included in the 
record and please refer to it for the details of my brief oral 
statement.
    The aftermath of the attack on our country, in combination 
with the implementation of new blood donor deferrals for the 
human form of Mad Cow disease, have seriously reduced the 
ability of the Nation's blood collectors to supply our 
hospitals adequately with life-saving blood. No part of the 
country has been impacted more by both events than the New 
York/New Jersey metropolitan area. Blood donations are down by 
20 to 25 percent from necessary levels since implementing FDA's 
vCJD donor deferral guidance in June, and please refer to 
graphs in my written statement.
    We urge immediate Federal funding for our national blood 
donor awareness campaign. At the same time and as importantly, 
we urge immediate examination of the value of blood safety--
some blood safety measures, such as the vCJD deferrals, which 
may inadvertently cause patient safety problems that arise 
because blood supplies are not adequate for hospital care or 
emergency preparedness needs.
    Thank you.
    [The prepared statement of Robert L. Jones follows:]

  Prepared Statement of Robert L. Jones, President and CEO, New York 
                              Blood Center

    Mr. Chairman and Members of the Committee, I am Dr. Robert Jones, 
President and CEO of the New York Blood Center. My career spans a 
spectrum of medical practice, medical research, hospital 
administration, health care regulation and now blood center 
administration. I appreciate the opportunity to participate in today's 
hearing on the safety and availability of the nation's blood supply.
    The New York Blood Center (NYBC) is the nation's largest 
independent community-based blood collection and distribution 
organization in the country, serving the New York and New Jersey area 
for nearly 40 years. Today we supply over 200 hospitals and serve 20 
million people in New York, New Jersey, and Connecticut with life-
saving transfusion products. NYBC is also home to the Lindsley F. 
Kimball Research Institute, one of the world's leading centers for 
basic and applied research in hematology and transfusion medicine.
    NYBC provides blood and blood products for more than one million 
transfusions annually, nearly ten percent of the national supply. Close 
to 2,000 donations are needed daily in the metropolitan area that we 
serve, an area with one of the most diverse populations in the world.
Blood Supply Safety and Availability after September 11:
    One year ago our lives changed forever as we experienced the 
terrible attack on our country and our way of life. In our world of 
blood collections and transfusion medicine the world changed 
dramatically as well.
    Prior to September 11, the blood world was intensively involved in 
debate over new Food and Drug Administration blood donor criteria 
limiting the eligibility of blood donors who had traveled to countries 
where there are cases of bovine spongiform encephalopathy (BSE), also 
known as mad cow disease. The FDA guidelines were based on the 
theoretical risk of transmission of variant Creutzfeldt-Jakob Disease 
(vCJD, Mad Cow Disease) in humans by blood transfusion; there are no 
documented cases to date where this has actually occurred.
    The impact of the vCJD guidance deferring blood donors was 
predicted to be substantial, and preparations were already underway to 
deal with the loss of blood donors along with the elimination of the 
Red Blood Cell (RBC) supply that was routinely imported from Europe for 
New York Blood Center.
    As the disaster of September 11 unfolded, an unprecedented surge of 
blood donations brought a new set of problems of oversupply that none 
of us would have predicted. Our immediate reaction was to assume, at 
least hope, that the problems of lagging blood donations and short 
supply, with which we have struggled for years, would no longer be with 
us. But in the months after 9/11, we began dealing with the unfortunate 
circumstance of discarding thousands of red blood cell units for which 
there were no transfusion recipients. This began precisely 42 days 
after the disaster (the shelf life of these products) and continued for 
months afterward as donations continued to be strong through December 
and January.
    Since we believed that this phenomenon of rising donation levels 
would not be sustained, we continued our preparations for the 
implementation of vCJD donor deferrals, the first phase of which was 
scheduled for May 31, 2002. We made major investments in new donor 
recruitment and collections capacity and new agreements for sharing 
surplus RBC supply from other U.S. blood collection agencies such as 
members of America's Blood Centers (ABC centers), Blood Centers of 
America (BCA), and the American Red Cross (ARC).
    Our instincts about the donations trend were correct as we saw the 
surge of last September and October return to our baseline in November 
and descend into a trough that continued into May of this year (see 
figure one). We now calculate a net loss to our available supply of 
over 21,000 units or about 5% of our annual whole blood collections, 
which occurred as a result of the 9/11 disaster.
FDA Guidance and vCJD Deferrals:
    Last summer, when estimating the impact of the proposed FDA 
guidance on our blood donor base, we surveyed our donors and found that 
the percentage of donors that fit the vCJD criteria would be 7-8%, 
which translates into a loss of about 10% of our donations in the New 
York metropolitan area. Since June 1, 2002, when the first phase of 
FDA's vCJD deferral criteria was implemented, we have experienced a 
surprising and catastrophic loss of donations, however: 20-25% below 
our expected blood collection levels.
    The current loss of eligible donors is compounded by the self-
deferrals of those who perceive that they fit the deferral criteria 
plus a difficult to quantify donor apathy. As we interview donors and 
donor group leaders, we believe that the apathy is due to anger with 
blood collectors over discarding units, the poor understanding of blood 
perishability, and the economic impact of the disaster which has left 
many of our corporate donor partners downsizing and with low company 
morale. We are now urgently extending our efforts at trying new donor 
recruitment strategies and finding new donor groups to make up for this 
shortfall in donations.
    Although we remain optimistic, if donation rates do not improve, 
our supply assumptions that rely on obtaining other U.S. supply will 
not be sufficient to provide an adequate supply of RBCs to metropolitan 
New York/ New Jersey area hospitals. It will also raise the difficult 
financial issue of whether we can sustain our capacity to collect blood 
that we have so deliberately built up over the years at the cost of 
substantial community resources.
    As previously mentioned, our RBC supply status since 9/11 was 
remarkably high through the first few months after the disaster (see 
figure two). In the first months of this year, the fall off in 
donations was compensated for by new supply coming from other U.S. 
suppliers plus the continuance of the European supply--the majority of 
which was lost after May 31 due to the new FDA guidance. After a peak 
in the spring, our supply has progressively deteriorated this summer to 
levels that are now below what we experienced prior to 9/11.
    Our overall supply curve does not depict the type-specific donation 
problem experienced by all blood collectors. Because Rh-negative 
donations fall below transfusion demand, during these shortages we have 
had to reduce our supply to our hospitals of type O-negative and type 
A-negative units for almost the entire summer. Therefore we have been 
in short supply of these RBC types in spite of having the overall RBC 
supply that appears to be adequate. Given the surprising donation 
deficits we are now encountering, the efforts we made to build a 
cushion of supply for the loss of Euroblood may now prove to be 
insufficient for patient care and emergency preparedness needs.
    Considering the problems with donations that NYBC and most other 
blood collection agencies that we know have experienced in recent 
months, it appears that the impact of the FDA vCJD guidance is greater 
than anticipated and threatens to severely weaken our national ability 
to provide for patients who need transfusion, not to mention our needs 
for emergency preparedness. Although our supply issues have been 
limited to Rh-negative RBCs so far, we understand that many other parts 
of the country have experienced blood supply shortages for the entire 
summer.
    It appears that the convergence of several factors--post 9/11 
apathy, the reaction to negative publicity about blood donations being 
discarded, and the new vCJD deferrals--have produced a situation that 
rivals historic blood shortages of similar severity.
    These acute and chronic blood shortages are causing disruption and 
problems in patient care in our nation's hospitals. Delay of surgical 
procedures, loss of organs for transplantation due to low blood 
availability, and patients being diverted from emergency rooms with 
inadequate blood supplies are becoming more frequent during these 
shortages. Increasingly transfusion specialists must substitute type-
mismatched blood (Rh-positive for Rh-negative) because there is not 
enough type-specific blood available. These practices carry measurable 
risk that should be incorporated into the total risk assessment for 
blood safety. Such low blood supplies also present a significant 
vulnerability for our nation's newly identified needs for emergency 
preparedness.
    As we survey this medical landscape, the question should arise as 
to whether we are introducing greater risk to patients by restricting 
the blood donor base than we are by protecting patients from the 
theoretical or remote risk of transmission of infectious disease. The 
problem, in our view, is that risk assessment is done only in the 
isolation of a specific issue and not examined against the background 
of supply losses all along the supply chain. All subtractions from the 
blood supply due to donor deferrals, blood testing, processing, 
distribution, inventory management, etc. are cumulative, and take away 
from the total available units for transfusion.
    In fairness to the regulators who make the difficult decisions that 
protect the safety of blood, the public perceptual and political logic 
behind these policies is understandable. They view these decisions as 
public health policy and the blood supply as an elastic resource that 
can expand to meet public need. What we have learned in the past few 
years is that the supply is not as elastic as necessary to adapt to 
policies of this impact without the danger of jeopardizing patient 
care. In our estimation as a medical care provider, and from my own 
experience as a physician and hospital administrator, this is where the 
medical logic of these policies falls short. All of the transfusion 
specialists with whom I have spoken agree with this view.
NYBC Recommendations:
    Given the fragile state of the national blood supply, some current 
regulatory policies may be producing greater patient danger than blood 
safety protection. In addition to a nationwide federally sponsored 
program of blood donor awareness and recruitment, we urge the immediate 
review of the vCJD deferral policy against the realities of the total 
risk of transfusion to patients including those cited above. This 
review should be performed as a collaboration of federal regulators and 
transfusion medicine practitioners, who are closest to patient care. We 
also urge FDA to examine its blood safety policies--historic, current 
and future--on a regular basis against the risk of short supply.
    The events of last September 11th bring new meaning to emergency 
preparedness and the importance of an immediately available blood 
supply. We were fortunate last year that we had adequate blood on the 
shelf for the events of 9/11, even though tragically not much blood was 
needed. However, blood donor restrictions that continue to erode the 
nation's blood donor base do not prepare us for another terrorist 
attack that could require a blood supply that is not on the shelf. This 
is another unfortunate but, in today's world, necessary example of how 
medical logic must be incorporated into decisions that impact on the 
safety and availability of the nation's blood supply.

[GRAPHIC] [TIFF OMITTED] T1958.003

    Mr. Greenwood. Thank you, Dr. Jones.
    Dr. Goodnough.

               TESTIMONY OF LAWRENCE T. GOODNOUGH

    Mr. Goodnough. Mr. Chairman and members of the committee, I 
am Vice President of the Society for the Advancement of Blood 
Management, or SABM, and Director of Transfusion Services at 
Barnes Jewish Hospital, a 1,200 bed hospital complex in St. 
Louis. Thank you for the opportunity to present the role of 
SABM in the preservation of the national blood inventory.
    We are a nonprofit, multi-disciplinary organization of 
medical professionals who are dedicated to the promotion of 
blood conservation and appropriate utilization of blood and 
blood components. These two goals have significant implications 
for the successful management and preservation of the national 
blood inventory.
    First, one mission of SABM is to make blood conservation 
the standard of care so that blood transfusions are reserved 
for those patients who must depend on the national blood 
inventory because of their urgent or emergent needs. To this 
end, SABM has supported more than 40 symposia and continuing 
medical education events since 9/11.
    Second, we have initiated a collaboration with the military 
services and the trauma program of the Medical College of 
Pennsylvania in the development of STORMACT. That is, 
Strategies to Reduce Military and Civilian Transfusions. A 
series of seven symposia has resulted in the development of a 
consensus statement, along with an algorithm for guiding 
resuscitation of the trauma victim. We believe this will help 
use more efficiently and effectively the estimated 2 million 
blood units transfused yearly, representing 18 percent of all 
blood transfused in the United States for trauma 
resuscitations.
    Blood conservation with bloodless management refers to 
medical care with minimal or no use of allogenic blood 
transfusion. This goal can be considered in four clinical 
settings: when patients are Jehovah's witnesses, when blood may 
not be available, when safe blood is not available, or when 
blood is medically contraindicated. Trauma and massive blood 
loss settings are examples of the need for bloodless management 
when blood may not be available or is in short supply. 
Additionally, an estimated 13 million units donated worldwide 
are not tested for the human immunodeficiency virus or 
hepatitis viruses, settings in which safe blood is not 
available. Finally, blood transfusion can be regarded as 
medically contraindicated in certain clinical settings such as 
autoimmune hemolytic anemias. Blood conservation with bloodless 
management is properly a goal in each of these instances.
    Furthermore, the surplus of available blood--that is, the 
difference between blood collected and blood tranfused--has 
declined in the U.S. From an estimated 7.4 percent surplus in 
1997 to 4.8 percent in 2000, as detailed in table 3 in the 
supplemental materials, due to a combination of increased 
demand for blood coupled with loss of blood donors. Strategies 
that exploit appropriate combinations of drugs, technologic 
devices and medical or surgical techniques, along with 
interdisciplinary team approaches that combine specialists who 
share a commitment to minimizing use of blood products are 
therefore important to the preservation of the national blood 
inventory.
    Preoperative autologous donation is one such strategy. 
Patients who predonate their own autologous blood before 
elective surgery essentially help preserve the national blood 
inventory by providing their own blood needs. However, this 
activity has declined substantially since 1992 when autologous 
blood represented 5 percent of all blood transfused to an 
estimated 3 percent of blood transfused in 2000, again in table 
3 of the supplemental materials.
    Patients scheduled for elective surgical procedures such as 
total joint replacement or radical prostatectomy together 
comprise approximately a half a million surgical procedures 
yearly that are particularly suitable for patients to undergo 
pre-donation of their own blood.
    Pharmacologic interventions are a second approach. Agents 
that stimulate red blood cell production such as erythropoietin 
therapy and iron therapy are useful in restoring hemoglobin 
levels in patients who are anemic. Artificial oxygen carriers 
are under development.
    Acute normovolemic hemodilution, or ANH, is a third option. 
ANH is a low-cost and effective blood conservation technique 
that can significantly reduce loss of red cell volume in 
surgical patients with high expected blood losses. During ANH 
several units of blood are collected from a patient immediately 
before or after the induction of anesthesia and replaced with 
either a crystalloid or colloid solution or both. Although 
blood loss during surgery remains essentially unchanged, fewer 
red blood cells are lost during the surgical procedure because 
the patient's own blood has been diluted. At the conclusion of 
surgery or at a transfusion trigger the collected blood is 
returned to the patient.
    Blood recovery and reinfusion is a fourth strategy. 
Autologic blood salvage involves the recovery of the patient's 
shed blood from a surgical wound, washed or filtered and 
reinfused into the patient. Reinfusion can be performed 
continuously during surgery or after surgery. Autotransfusion 
is an effective blood conservation option for surgical 
procedures characterized by massive blood loss.
    In conclusion, there are a number of safe and cost-
effective therapeutic options for the management of patients 
without blood transfusion. Improved education regarding 
transfusion alternatives, along with commitment and 
collaboration from all involved disciplines, would help achieve 
a goal of blood conservation and bloodless management.
    I would be happy to answer any questions that you might 
have. Thank you.
    [The prepared statement of Lawrence T. Goodnough follows:]

 Prepared Statement of Lawrence T. Goodnough, Vice President, Society 
                for the Advancement of Blood Management

                                PREFACE

    The Society for the Advancement of Blood Management (SABM) is a 
non-profit, organization of multi-disciplinary medical professionals 
who are dedicated to the promotion of blood conservation in the use of 
blood-sparing technologies and appropriate utilization of blood and 
blood components. These two goals have significant implications for the 
successful management and preservation of the national blood inventory.

                              INTRODUCTION

    Blood conservation with bloodless management refers to medical care 
with minimal or no use of allogeneic blood transfusion. This goal can 
be considered in four clinical settings: when patients are Jehovah's 
Witnesses; when blood may not be available; when safe blood is not 
available; and when blood is medically contraindicated. Trauma and 
massive transfusion settings are examples of the need for bloodless 
medicine when blood may not be available or is in short supply. 
Additionally, an estimated 13 million units of donated blood worldwide 
are not tested for the human immunodeficiency virus or hepatitis 
viruses, settings in which safe blood is not available. Finally, blood 
transfusion can be regarded as medically contraindicated in autoimmune 
hemolytic anemias. Blood conservation with bloodless management is 
properly a goal in each of these instances.
    Exposure of patients to allogeneic transfusion can be minimized or 
avoided by the systematic use of multiple blood conservation 
techniques. Such strategies exploit appropriate combinations of drugs, 
technological devices, and surgical/medical techniques. It also demands 
an interdisciplinary team approach, combining medical, surgical, and 
other specialists who share a commitment to avoiding the use of 
allogeneic blood transfusion. An overview of the general principles of 
medical and surgical care to minimize or prevent allogeneic transfusion 
is presented in Table 1.
    Current utilization of technologies or techniques to reduce 
allogeneic blood transfusion is variable. 1,000 U.S. hospitals reported 
that preoperative autologous blood donation (PAD) and cell salvage 
programs were widely (>80%) available.\1\ However, while pharmaceutical 
agents such as aprotinin and erythropoietin (EPO) were available in 61% 
and 43% of hospital respondents, these two agents were ``never'' or 
``almost never'' utilized at 81% and 91% of the sites, respectively. 
Despite its worldwide approval in the surgical setting beginning in 
1993, acceptance of EPO therapy as an alternative to blood transfusion 
has been slow.\2\
    Notwithstanding recent improvements in blood safety, a finite risk 
of transfusion-transmitted infections remains,\3\ along with risks from 
new and unknown pathogens. Minimizing blood transfusion has therefore 
become a desirable goal in surgical procedures for all patients.\4\ 
Furthermore, the fractional margin of available allogeneic blood (the 
difference between blood collected and blood transfused) has declined 
from an estimated 7.4% in 19973 to 4.8% in 2000,\5\ due to increased 
demand for blood coupled with loss of blood donors. Strategies that 
exploit appropriate combinations of drugs, technological devices, and 
surgical/medical techniques,\6\,\7\ along with an 
interdisciplinary team approach that combines specialists who share a 
commitment to minimizing use of blood products, are therefore important 
to the preservation of the national blood inventory.

            BLOOD MANAGEMENT DURING THE PREOPERATIVE PERIOD

    Thorough preoperative planning is essential to reducing or avoiding 
perioperative allogeneic transfusion. Preoperative assessment requires 
accurate history taking and physical examination. Attention should be 
paid to any personal or family history of bleeding disorders. In 
patients requesting transfusion-free care who require major cardiac and 
orthopedic surgical procedures, aggressive preoperative workups have 
yielded excellent results.\8\,\9\ Table 2 summarizes 
presurgical assessment and planning.

Optimize Preoperative Hemoglobin Level
    Patients with low hemoglobin levels prior to surgery are at higher 
risk of receiving allogeneic transfusion. To minimize this risk, 
patients should have their red cell mass increased preoperatively. The 
use of recombinant human erythropoietin (EPO) and/or iron therapy has 
been effective for this purpose (see pharmacologic strategies).

Preoperative Blood Conservation
    A simple measure to conserve the patient's own blood consists of 
restricted diagnostic phlebotomy (reducing the number of tests and the 
volume of blood withdrawn).\10\ Another measure is careful management 
of anticoagulation, including discontinuation or substitution of agents 
that could adversely affect clotting in the perioperative period (e.g., 
ASA and medication containing aspirin, NSAIDs, antiplatelet agents, 
anticoagulants).

Preoperative Autologous Donation (PAD)
    Patients who predonate their own (autologous) blood before elective 
surgery essentially help preserve the national blood inventory by 
providing their own blood needs. However, this activity has declined 
substantially since 1992, when autologous blood represented 5.0% of all 
blood transfused, \3\,\11\ to an estimated 3.0% of blood 
transfused in 20005,\12\ (Table 3).

                       INTRAOPERATIVE MANAGEMENT

Surgical Approaches to Reducing Blood Loss
    The principles of surgical and anesthetic bloodless management are 
summarized in Table 4. The sine qua non of reducing transfusion need in 
surgical patients is to prevent blood loss. Surgeons are trained in the 
art of gentle tissue handling, recognition and avoidance of potential 
bleeding sources and rapid control of unexpected hemorrhage to 
accomplish this goal. Traditionally, this has been accomplished with 
electrocautery, utilizing either monopolar or bipolar instruments.\13\ 
Newer modifications to electrocautery include the use of an argon beam-
enhanced device that produces a stream of argon gas around the cautery 
tip that can coagulate vessels up to 3 mm in diameter while minimizing 
tissue trauma.\14\

Anesthetic Techniques
    The use of controlled hypotensive anesthesia, maintenance of 
normothermia, blood cell salvage, and tolerance of normovolemic anemia 
are all associated with reduced surgical blood loss. Data suggest that 
each can contribute to reduction of bleeding.\15\ Surgical and 
anesthetic blood management and conservation methods are summarized in 
Table 5.

Acute Normovolemic Hemodilution (ANH)
    Acute normovolemic hemodilution (ANH) is a low-cost and effective 
blood conservation technique that can significantly reduce loss of red 
cell mass in surgical cases with a high-expected blood loss.\16\ During 
ANH, several units of blood are collected from a patient immediately 
before or after the induction of anesthesia and replaced with either a 
crystalloid or colloid solution or both. Although bleeding during 
surgery remains essentially unchanged, blood lost during the surgical 
procedure contains fewer red cells and clotting factors because the 
patient's blood has been diluted. At the conclusion of surgery or 
transfusion trigger, collected blood may be returned to the patient.
    ANH offers several practical advantages over PAD. Minimal 
preoperative preparation and negligible patient inconvenience makes it 
suitable for both urgent and elective procedures. Moreover, ANH units 
are collected and stored at room temperature at the patient's bedside, 
thus reducing the administrative costs associated with collection, 
storage and testing of PAD units as well as the risk of human 
error.\17\

Blood Recovery and Reinfusion
    Autologous blood cell salvage (intraoperative autotransfusion) 
involves recovery of the patient's shed blood from a surgical wound, 
washing or filtering, and reinfusion of the blood into the patient. 
Reinfusion can be performed continuously during surgery. 
Autotransfusion is an effective blood conservation option for surgical 
procedures characterized by massive blood loss or where religious 
objections exclude the use of allogeneic blood. Technological advances 
have increased system automation. Furthermore, newer devices can 
process very small blood volumes (30 mL or less), require low priming 
volumes, and offer higher processing speed and better end product 
quality.
    Cell recovery devices have been used extensively in surgery and 
have found their place in cardiac, orthopedic, vascular and trauma 
procedures. Evidence suggests that blood recovery is cost effective 
when there is a high-expected surgical blood loss or when hospital stay 
can be reduced.\18\,\19\ Table 6 provides estimates of the 
blood sparing potential of several blood conservation techniques 
available for bloodless management.

                          POSTOPERATIVE PERIOD

    Methods relevant to the immediate postoperative period include 
close surveillance for bleeding, adequate oxygenation, restricted 
phlebotomy for diagnostic tests, postoperative cell salvage, 
pharmacologic enhancement of hemostasis, avoidance of hypertension, 
tolerance of normovolemic anemia and meticulous management of 
anticoagulants and antiplatelet agents.

Tolerance of Anemia
    Although hemoglobin level as a transfusion trigger has been 
drifting downward over the years, reproducible criteria for RBC 
transfusions are lacking. Historically, an arbitrary hemoglobin level 
of 100 g/L has been used as a trigger to transfuse. This practice 
continues despite recent studies indicating that patients are able to 
tolerate lower hemoglobin levels than previously believed.\20\ A recent 
randomized, controlled trial involving 838 normovolemic critically ill 
patients demonstrated that a restrictive red cell transfusion strategy 
(hemoglobin level between 70 and 90 g/L) was as safe as a liberal 
transfusion strategy (hemoglobin level between 100 and 120 g/L) in 
critically ill patients,\21\ with the exception of patients with 
ischemic cardiovascular disease.\22\

Erythropoietin Therapy
    A review recently summarized knowledge gained regarding the 
relationship between erythropoietin, iron, and erythropoiesis in 
patients undergoing PAD (as a model for blood loss anemia), with or 
without EPO therapy.\23\ Endogenous erythropoietin-mediated 
erythropoiesis in response to PAD under standard conditions of one 
blood unit donated weekly, in this setting generates 397 to 568 ml RBC, 
or the equivalent of two-to-three units of blood. Exogenous 
erythropoietin (EPO) therapy in patients undergoing PAD generates 358 
to 1102 ml, or the equivalent of two-to-five units of blood. Red blood 
cell expansion is seen with an increase in reticulocyte count by day 
three of treatment in non-anemic patients treated with EPO who are 
iron-replete.\24\ The equivalent of one blood unit is produced by day 
seven and the equivalent of five blood units produced over 28 days.\25\ 
If three to five blood units are necessary in order to minimize 
allogeneic blood exposure in patients undergoing complex procedures 
such as orthopedic joint replacement surgery, the preoperative interval 
necessary for EPO-stimulated erythropoiesis can be estimated to be 
three to four weeks.

Iron Therapy
    In circumstances with significant ongoing iron losses, oral iron 
does not provide enough iron to correct the iron-deficient 
erythropoiesis, and intravenous iron therapy should be considered. 
Renal dialysis patients have such blood losses, and the role of 
intravenous iron therapy has been best defined in clinical trials 
achieving target hematocrit levels in this setting. Addressing iron 
deficiency with intravenous iron therapy allows correction of anemia 
along with utilization of lower erythropoietin dosage.\26\ Other common 
clinical settings include pregnancy \27\ and patients with 
dysfunctional uterine bleeding who are scheduled for hysterectomy.\28\

                          FUTURE DEVELOPMENTS

Artificial Oxygen Carriers
    There has been accelerated progress in the development of 
artificial oxygen carriers (AOC).\29\,\30\ Potential 
advantages for cell-free hemoglobin solutions and perflurocarbon 
emulsions include the absence of immunogenic cell membranes and 
prolonged shelf life at room temperature storage. Possible 
disadvantages of such products include interference with some 
laboratory tests, a relatively short time in circulation (24-48 h),\32\ 
nitric oxide mediated vasoconstriction, and gastrointestinal 
discomfort.\33\-\36\
    The principal clinical investigations for the AOC's currently are 
in patients with trauma \37\ and in patients who are undergoing 
surgery, with or without acute normo-volemic hemodilution. The 
rationale for the use of AOC with hemodilution is three-fold: (i) the 
cellular hemoglobin collected during hemodilution would be used to 
replace the hemoglobin solution or other synthetic oxygen carrier as it 
is eliminated; (ii) the use of AOC would permit more aggressive 
hemodilution with lower targeted cellular hemoglobin levels than would 
otherwise be tolerated and (iii) an AOC could serve as a replacement 
fluid during blood loss.\38\ If approved, they would most likely be 
applied in surgical settings including military casualties, civilian 
trauma patients, and massive surgical blood loss settings. Potential 
applications for medical settings include autoimmune hemolytic anemias 
\39\,\40\ and in patients with sickle cell vaso-occlusive 
crises.\41\ Enhanced oxygen delivery to the microcirculation by these 
carriers may also lead to applications in other patients with acute 
organ ischemia, such as myocardial infarction or cerebrovascular 
accidents.

          THE SOCIETY FOR THE ADVANCEMENT OF BLOOD MANAGEMENT

    For many years, the need for an organization dedicated to 
optimizing the field of blood management has been recognized from 
different fields within medicine. Recently several organizations have 
emerged, some run by blood center coordinators, some by nurses, some 
from overseas, but none by physicians who are both thought leaders and 
who recognize a need not being met by national and international blood 
organizations. These visionary individuals have provided the beginnings 
for a structural solution to the problem of blood management.
    The vision for this solution is embodied by the mission statement 
and founding principles set out by the Society for the Advancement of 
Blood Management:

Need for New Ways of Thinking:
 Evolve overall thinking so that blood management initiatives 
        will become the universal standard of care. Transfusions will 
        become the last indication instead of the first resort. We want 
        transfusions to be viewed as the alternative.
 Advance the principles of blood management due to: (1) low 
        inventory of blood; (2) high cost of blood transfusions and; 
        (3) risk associated with blood transfusions; and (4) consumer 
        demand
Need for Information Dissemination:
 Lack of knowledge (not lack of alternatives to blood 
        transfusion), is the main limitation of current inadequate 
        application of blood management strategies.
Need for Commitment to Total Blood Management Care:
 Build partnerships with organizations representing all facets 
        of blood management care (ie. ARC, AABB, ASHE).
Need for Physician Advocates:
 Successful adoption of blood management strategies needs to be 
        driven by clinically-active, well recognized physicians at each 
        medical center.
Need for Optimizing Perioperative Status (restoring red blood cell 
        mass):
 Need pre-operative use of alternatives (i.e., increasing red 
        blood cell mass), so that post-operative transfusions occur 
        less often.
Need for Universal Guidelines:
 Evidence-based: Limit exposure to allogeneic blood.
 Incorporate rationale transfusion guidelines: Document 
        physiological need.
Need for Universal Registry Tracking Patient Outcomes:
 Helps to move the concept from individual specialty to 
        standard or ``best practice''
 Facilitate cooperation among centers to share data.
Lack of algorithm-based guidelines that are evidence based, 
        Inconsistent Guidelines
 Lead to different criteria and therefore cause lack of 
        universal approach to blood management (e.g., anesthesia 
        directs transfusion in Europe but not in the US).
Physician Behavior
 Many do not perceive problems (i.e., risk, cost, conservation) 
        with use of allogeneic blood.
Competitive Environment
 Requires a coalition of multiple organizations which may have 
        conflicting opinions/agendas.
 Many do not realize that promoting optimal blood management 
        will benefit all bloodless programs/centers not undermine them.
Perception of High Cost
 There is a perception that blood management strategies come at 
        a high cost. The reality is that alternatives may be less 
        costly than obtaining and maintaining blood.
The major goals of SABM were established to:
 Provide physician-led initiatives into rationale approaches to 
        blood management. The current ways of looking at alternatives 
        to transfusions needed to be changed.
 A data registry modeled after successful outcomes-oriented 
        registries (e.g., Northern New England Cardiovascular Disease 
        Registry) will allow proper examination of clinical issues 
        raised by controlled clinical trials indicating avoidance of 
        blood transfusions results in improved outcomes in several 
        studies examining this specific question.
 Therefore, as one of its charters, SABM will incorporate what 
        is now and has been called ``alternatives to transfusion'' to 
        become an INTEGRAL PART OF MODERN ANEMIA & TRANSFUSION 
        ALGORITHMS incorporating blood product sparing modalities of 
        treatment, i.e. change the practice of ``give a transfusion 
        first'' to ``give a transfusion last''.
    The Society looks to establish relationships with all professional 
societies concerned with blood and blood management, with physicians in 
academia and private practice, with industry and government in order to 
incorporate rationale blood management resulting in coherent ``best 
practice'' algorithms and guidelines. The Society has taken its mission 
to be concerned primarily with issues surrounding ACUTE ANEMIAS.
    After the consensus meeting in August, 2001, a Board of Directors, 
a set of Society Bylaws, a non-profit incorporation, a Membership 
policy and application, a Web site ( www.SABM.org) and funding outreach 
were developed.
    Funding efforts are ongoing; a new educational outreach program is 
being established during September, 2002 to incorporate Web-based 
tutorials and world-wide recruitment of student members.
    Our presence has already been instrumental in the US military 
revising resuscitation algorithms by the STORMACT series of meetings 
(see below). These invitations to present modern blood management 
strategies resulted in immediate implementation of revised battlefield 
resuscitation methods. STORMACT (Strategies TO Reduce Military And 
Civilian Transfusions) continues to bring modern blood management to 
military physicians.

                               CONCLUSION

    In conclusion, there are a number of safe and cost-effective 
therapeutic options for the management of surgery patients without 
allogeneic blood transfusion. Future developments in the field are 
summarized in Table 7 and examples of biotechnology products that can 
serve as alternatives to blood products are listed in Table 8. Improved 
education regarding transfusion alternatives , along with commitment 
and collaboration from all involved disciplines, will help achieve the 
goal for bloodless medicine.

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shock. JAMA 1999; 282:1857-1864.
    37. Cothren C, Moore EE, Offner PJ, Haenel JB, Johnson JL. Blood 
substitute and erythropoietin therapy in a severely injured Jehovah's 
Witness. N Engl J Med 2002;346:1097-1098.
    38. Brecher ME, Goodnough LT, Monk T. The value of oxygen-carrying 
solutions in the operative setting, as determined by mathematical 
modeling. Transfusion 1999;39:396-402.
    39. Mullon J, Giacoppe G. Clagett C. McCurie D, Dillard T. 
Transfusions of polymerized bovine hemoglobin in a patient with severe 
autoimmune hemolytic anemia. N Engl J Med 2000;342:1638-1643.
    40. Klein HG. The prospects for red cell substitutes. N Engl J Med 
2001;342:1666-1668.
    41. Raff JP, Dobson CE, Tsai HM. Transfusion of polymerised human 
haemoglobin in a patient with severe sickle-cell anemia. Lancet 
2002;360:464-465.
   Table 1. General Principles of Blood Conservation with Bloodless 
                               Management
1. Formulate a plan of care for avoiding and controlling blood loss 
        tailored to the clinical management of individual patients, 
        including anticipated and potential procedures.
2. Employ a multidisciplinary treatment approach to blood conservation 
        using a combination of interventions.
3. Proactive management by the lead clinician: anticipate and be 
        prepared to address potential complications.
4. Promptly investigate and treat anemia, preferably preoperatively.
5. Decisive intervention, including surgery, should not be delayed in 
        the actively bleeding patient. In general, avoid a ``watch and 
        wait'' approach to the bleeding patient.
6. Exercising clinical judgment, be prepared to modify routine practice 
        when appropriate.
7. Consult promptly with senior specialists experienced in blood 
        conservation at an early stage if there is physiological 
        deterioration or if complications arise.
8. Transfer a stabilized patient, if necessary, to a major center 
        before the patient's condition deteriorates.
9. Restrict blood drawing for laboratory tests.
10. Decrease or avoid the perioperative use of anticoagulants and 
        antiplatelet agents.
11. Emergencies: establish in advance a management plan for rapid 
        location and arrest of hemorrhage, as well as for transfer to 
        an appropriate center. Avoid delay.
             Table 2. Preoperative Assessment and Planning
Methodical history taking, physical examination, supplemented by 
        judicious laboratory tests
Identify appropriate combinations of strategies for prevention and 
        treatment of anemia and/or bleeding
Optimize preoperative hemoglobin level with erythropoietin, iron, 
        folate, vitamin B12Avoid pharmacologic coagulopathies
Manage anticoagulation
Restrict diagnostic phlebotomy

                                           Table 3. Collection and transfusion of autologous blood in the USA*
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                                  2000
                             Source                                  1980       1986       1989       1992       1994       1997       1999      (est)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfused:
  Total.........................................................      9,934     12,159     12,059     11,307     11,107     11,476     12,389     12,540
  Autologous....................................................         NA         NA        369        566        482        421        367        390
  (% of total)..................................................  .........  .........     (3.1%)     (5.0%)     (4.3%)     (3.7%)     (3.0%)     (3.0%)
Collected:
  Total.........................................................     11,174     13,807     13,554     13,169     12,908     12,550     13,649     13,140
  Autologous....................................................         28        206        655      1,117      1,013        611        651        640
  (% of total)..................................................    (0.25%)     (1.5%)     (4.8%)     (8.5%)     (7.8%)     (4.9%)     (4.7%)     (4.9%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
NA, not available. From Goodnough LT et al. N Engl J Med 1999;340:439-47 and the National Blood Data Resource Center.

Table 4. Surgical and Anesthetic Principles of Blood Conservation with 
                          Bloodless Management
1. Preoperative Assessment/Planning: management of anemia, management 
        of anticoagulation and congenital and drug-induced 
        coagulopathies, prophylactic interventional radiology/
        embolization, prescribing/scheduling of cell salvage apparatus, 
        restricted diagnostic phlebotomy.
2. Intraoperative Blood Conservation: meticulous surgical hemostasis, 
        blood salvage, hemodilution, pharmaceutical enhancement of 
        hemostasis, maintenance of normothermia, surgical positioning 
        to minimize blood loss and hypertension.
3. Postoperative Blood Conservation: blood salvage, tolerance of 
        anemia, optimum fluid and volume management, restricted 
        diagnostic phlebotomy, adequate analgesia, maintenance of 
        normothermia.
4. Maintain appropriate fluid resuscitation. Significant normovolemic 
        anemia is well tolerated in hemodynamically stable patients.
5. In actively bleeding patients, the first management priority must be 
        to stop the bleeding. Avoid attempts to normalize blood 
        pressure until hemorrhage is controlled.
6. Prevent or treat coagulation disorders promptly.
7. Oral or parenteral iron may be used to improve iron stores. 
        Recombinant (synthetic) human erythropoietin (rHuEPO) 
        effectively increases red cell mass.
8. Hematology/oncology: aggressive rHuEPO and iron therapy for 
        prophylaxis of anemia, individualized chemotherapy protocols to 
        minimize hematologic toxicity, pharmacologic prophylaxis and 
        treatment of bleeding, tolerance of anemia, and restricted 
        diagnostic phlebotomy.
       Table 5. Anesthetic and Surgical Blood Management Methods
Rigorous hemostasis and surgical technique
Surgical positioning of patient
Tourniquets
    Hemostatic surgical devices
    Electrocautery
    Electrosurgery (diathermy)
    Ultrasonic scalpels
Local vasoconstrictors
Preoperative (prophylactic) and therapeutic angiographic embolization
Mechanical occlusion of bleeding vessels
Topical hemostatic agents and tissue adhesives/sealants
    Fibrin glue
    Tissue adhesives
    Collagen, oxidized cellulose
Autologous Techiques
    Blood cell salvage devices (intraoperative and postoperative)
    Hemodiluution
Pharmacologic prophylaxis of bleeding
    Antifibrinolytics (tranexamic acid, aminocaproic acid)
    Aprotinin
    Desmopressin
Control of intraoperative and postoperative hypertension
Controlled hypotensive anesthesia
Maintenance of normothermia
Tolerance of normovolemic anemia
Fluid and volume management
    Colloids
    Crystalloids
Oxygen Therapeutics (Red-Cell Substitutes)
    Synthetic oxygen-carrying fluids
    Modified hemoglobin-based solutions

   Table 6. Approximate Contributions of Selected Modalities to Blood
                  Conservation in the Surgical Patient
------------------------------------------------------------------------
                                                    Blood Units
------------------------------------------------------------------------
Preoperative Options
  Tolerance of anemia (reduce transfusion                     1-2 units
 trigger)................................
  Increase preoperative RBC mass.........                       2 units
  Preoperative autologous donation.......                     1-2 units
Intraoperative Options
  Meticulous hemostasis and operative                   1 or more units
 technique...............................
  Acute normovolemic hemodilution........                     1-2 units
  Blood salvage..........................               1 or more units
Postoperative Options
  Restricted phlebotomy..................                        1 unit
  Blood salvage..........................                        1 unit
------------------------------------------------------------------------

Table 7. Future Developments
 There is a need to develop educational curricula focused on 
        clinical aspects of transfusion practice and the use of 
        transfusion alternatives.
 The safety and effectiveness of lowering transfusion triggers 
        and acceptance of anemia as reasonable blood conservation 
        options needs reassessment.
 Red-cell and platelet ``substitutes,'' now in various stages 
        of clinical trials, hold out new therapeutic options.
 Wider use of hematopoietic agents, including new products now 
        in clinical trials (e.g., new forms of recombinant 
        erythropoietin, recombinant thrombopoietin), will reduce 
        dependence on allogeneic blood
     Table 8: Examples of biotechnology products that can serve as 
                     alternatives to blood products
Erythropoiesis stimulants
    erythropoietin
    novel erythropoietin stimulating factor
Hemostasis
    recombinant factor VIIa
    recombinant factor VIII
    recombinant factor IX
Artificial oxygen carriers
    hemoglobin solutions
    perfluorocarbons
Anticoagulants
    antithrombin III
    activated protein C
Modified Blood Components (under development)
    Platelet membrane preparations
    Enzyme-treated red cells devoid of blood group antigens
    Ex-VIVO stem cell expansion
    Dendritic cell vaccines

    Mr. Greenwood. Thank you, Dr. Goodnough.
    The Chair recognizes himself for 10 minutes for questions.
    Let me ask this question of the blood banks. If the New 
York Blood Center runs short on blood, can you or other blood 
banks help them out?
    Mr. Ross. As I mentioned in my testimony, the American Red 
Cross is at about 2 days supply, which is much less than 
optimal for us. We are helping New York with whatever we can, 
but we do not have the supplies right now to help them.
    Mr. Greenwood. Anybody else want to comment on that?
    Ms. Dariotis. Yes. The America's Blood Centers have been 
shipping blood to New York on a regular basis starting in the 
spring of this year, but it is just helping them tread water, 
so to speak. We do not have the reserves, much like the Red 
Cross, to meet a national crisis should that happen for them.
    Mr. Greenwood. Did you, in your testimony, identify what it 
would take in terms of an increased number of Americans 
donating blood to--we have 60 percent are eligible and only 5 
percent of them--so that's 3 percent of America's population is 
donating the blood that 60 percent of us are going to end up 
using in our lives. What would it take in order to--what 
percentage of Americans would need to give blood so that we 
would be out of the water treading stage?
    Ms. Dariotis. I think we estimated that an additional 1 
percent, or approximately 2 million more donors, would help us 
all.
    Mr. Greenwood. That's not very much, is it?
    Ms. Dariotis. It doesn't seem like a lot, does it?
    Mr. Greenwood. No.
    I wanted to follow up. I might make a concrete suggestion 
that the blood banks get in touch with me. We will have a 
meeting afterwards. I think it would be a good idea if we 
marked a day on the calendar and get every Member of Congress 
to see if he and she can do an event in their district on the 
same day and invite much of the public to come in and donate 
blood on that day as possible; and maybe we will get some 
celebrities to join us or something like that and try to have 
some fun with it. But it would be a suggestion that you make. 
It's one that I had thought about before when I visited my own 
blood bank in Philadelphia, and we should follow up on that.
    Ms. Dariotis. Thank you. We would welcome that support.
    Mr. Greenwood. Let me ask another question. The blood 
experts tell us that we need more of certain blood types such 
as O and less of others such as AB and A. The equipment exists 
to take double units for O donors, plasma from ABs and only the 
platelets from As, but according to Douglas Starr in the July 
29, 2002, issue of the New Republic, most blood centers still 
use the take-it-all approach. Is this true?
    Ms. Dariotis. Well, it sounds good in theory. I'll start. 
But talking your donor into being that A that wants to donate 
only platelets or that AB that only wants to give plasma is a 
tricky operation. We do all of those things. We do do double 
red cells. We do try to draw only Os. But the ideal is 
difficult when you get down to a volunteer blood donor and 
convincing them that you have the right idea for how they 
should donate their blood.
    Mr. Greenwood. Well, how does it change the experience for 
the donor?
    Ms. Dariotis. Most of the donors, if you do an automated 
procedure, it will take longer. Some donors are leery of an 
automated procedure. Some relish it and think it's wonderful. 
But that's the main difference, that it usually the extends the 
time of their donation.
    Mr. Greenwood. It's just the time factor? They don't have 
to get jabbed more frequently or----
    Ms. Dariotis. Well, no. It's just one jab. And sometimes 
they will experience a little discomfort from some of the 
anticoagulants that we might be using. We can manage that quite 
well. Usually, it's a time commitment to the donor or just the 
fact that it's different.
    Mr. Greenwood. Okay. Anybody else want to comment on that?
    Mr. Ross. Yes. Another limiting factor is about 65 percent 
of our blood is collected on mobile blood drives throughout the 
country in rural areas. Transporting these very expensive, 
highly complex pieces of equipment that actually perform the 
automated collections can be problematic and you end up having 
to revalidate them. Sometimes they get damaged in transport, 
and it's just not an optimal situation. But the automated 
technology is something that we are all implementing as quickly 
as we can, and it will help us as we move forward.
    Mr. Jones. Mr. Chairman, I wonder if I could make a comment 
on an earlier statement you made. There is this lore that 60 
percent of the population is eligible and only 5 percent 
donate. Those are old figures and most people, certainly at 
this table, think that those need to be updated; and we are 
actually launching a study. So, for example, if you study the 
60 percent, there are about a third of those people, if you do 
market research, who would say they would never donate, no 
matter what you did. You can't count those people as eligible 
donors. So we need to get more sophisticated about that donor 
base to find out really how big the real donor base really 
might be.
    Mr. Greenwood. Yes, Ms. Lipton.
    Ms. Lipton. Yes. I also might add I think one of the 
concerns that we are all trying to deal with is understanding 
the demographics. As we look at it in the year 2012 I think we 
are going to have--2020--12 million people moving into the 
population who are most at risk for transfusion. And if you 
look at the most recent census data we do not have a group of 
younger people underneath that that are in a pyramid structure. 
We are unique throughout the world in terms of our 
demographics. But we have an older population that's living 
longer, and we don't have a group of younger donors coming up 
underneath it. So I think we really need to think long and 
hard, you know, about the future strategies for blood supply; 
and I think it's going to become very critical.
    Mr. Greenwood. All right. Back in January the task force 
found that there are no currently identified scenarios in which 
the need for blood and/or blood components would be beyond the 
capabilities of the blood community to provide. Is this still 
the blood community's position?
    Ms. Lipton. Perhaps I could respond to that. I think the 
answer is yes. One thing that we would be concerned about, not 
in terms of blood supply to the patient but really the effect 
on the donors in the event of a biological attack, because if 
we had a smallpox outbreak it is very possible that you could 
see in a specific area that a number of donors could no longer 
donate and we would have to be involved in shipping blood in. 
But I do think that we have studied very carefully both past 
history and worked with the Department of Defense and all the 
blood organizations; and, sadly, we believe that it is true 
that in most of the things that--anything that we can conceive 
of, we would not have a need for blood beyond which we could 
provide.
    Ms. Dariotis. But I think we are talking about the kind of 
response that we expect to see in those types of disasters 
where the donors line up. But, again, we have to remember that 
if there is an immediate mass need it's still, as we have all 
been concerned, it's having that daily blood on the shelf that 
will start out the support; and then we know the donors will be 
there to help us.
    Mr. Jones. I think the other--we haven't really considered, 
I don't think, what a nuclear event might be, and the impact on 
that would probably bring about a lot more demand for blood and 
blood products which we might not have on the shelf today if it 
were really an event that involved a dense population area. 
Therefore, we would have to really get into moving it around; 
and I'm not sure we're prepared for that, in my opinion.
    Mr. Greenwood. Dr. Goodnough, do you want to offer your 
perspective on that question?
    Mr. Goodnough. Well, perhaps if I could put my hat on as 
Director of Transfusion Service at a very large hospital. We 
have had to cancel or reschedule elective surgery three times 
since calendar year 2000 because we didn't have enough blood 
group O or blood group A, and we have almost had to cancel or 
reschedule elective surgery several times because of platelet 
availability issues.
    When we open up for business in the morning, we need 110 
units of blood group O and blood group A on hand, 30 for the 
trauma program, 30 for the transplant program and then 40 for 
everybody else in a 1,200 bed hospital; and three times in the 
last 2 years we have had to reschedule elective surgery. So we 
have an ongoing concern about blood inventory, and we are part 
of Dr. Heinrich's blood surveillance program. We are 
participating in that and trying to get a handle on blood usage 
at the hospital level.
    Mr. Greenwood. I think--Ms. Dariotis, I think you made 
reference to organs expiring or going bad or becoming useless 
because of postponed surgery. Is that a serious--I mean, I've 
done a lot of work in organ donation and I know how dismal our 
ability to keep up with the demand is there. That's shocking to 
learn that--of the relatively few organs that we have available 
that we are losing them because of lack of blood availability.
    Ms. Dariotis. I don't think we are sure of the exact 
numbers. I think the problem for us all, and speaking as a 
community-based blood center, is hospitals are reluctant to 
talk about the fact when they cancel surgery. They're reluctant 
to talk about the fact that they may not be able to have enough 
blood on the shelf. I mean, I know I have that local 
experience, so I'm not sure we have all the data out there that 
tells us the true adequacy of our suppliers. So don't--we 
challenge the GAO. We do not believe the supply is adequate.
    Mr. Jones. If I could just add one more practice in 
transfusion medicine that's becoming more common, and that is 
when you don't have type O--don't have type RH negative blood 
available, frequently--more and more frequently patients are 
receiving type RH positive blood to substitute for RH negative. 
This is a type mismatch which doesn't matter so much on the 
first transfusion, but if that patient needs blood again they 
can't receive RH positive blood. So it's an evolving practice 
that's being driven by shortages of RH negative and the blood 
supply in general.
    Mr. Goodnough. If I could address your organ donation 
question, we make an internal decision not to shut down the 
trauma program and not to shut down the transplantation program 
so we always have blood for them. That's why we consider 
rescheduling elective surgical procedures.
    Mr. Greenwood. Thank you.
    The gentleman from Florida.
    Mr. Deutsch. Thank you, Mr. Chairman.
    Most of you, if not all of you, were here and in our prior 
panel; and I asked this question of the prior panel as well. 
The GAO conclusion that the blood supply is generally adequate, 
if each of you could respond to that, I would appreciate it. 
Ms. Lipton.
    Ms. Lipton. I think the blood supply is generally adequate 
except on the days when it's not; and I think the AABB would 
say, no, it is not generally. It might be generally adequate. 
It is not adequate to do what we need to be doing in the United 
States.
    Mr. Deutsch. Mr. Ross.
    Mr. Ross. The American Red Cross blood supply is not 
adequate at a 2-day level. I am not sure the data set or the 
time period that the GAO took their survey of inventories as I 
have not seen the report. But certainly September 10, 2001, 1 
year ago today, we had 80,000 units inventory, and today we 
only have 50,000. So I would say it's not adequate.
    Ms. Dariotis. I think I will repeat what I said. We don't 
believe the blood supply is adequate. Maybe adequate to avoid 
canceling some surgeries, but it depends on the area of the 
country, and we--I think our efforts with that task force to be 
able to move blood around will help to address emergencies but 
will not help--we don't have enough blood on the shelf at any 
given day.
    Mr. Jones. At a meeting last week we heard a lot about 
regional shortages and seasonal shortages, and I would just 
remind you that when there's a regional shortage in the New 
York area it involves 20 million people. A regional shortage in 
a smaller population may not be quite so serious. But we 
experience regional shortages frequently.
    Mr. Goodnough. Yes. I would second the idea that I feel 
that the blood supply is not adequate, and there are two points 
of emphasis. One is that a unit of blood conserved is a unit of 
blood preserved; and, second, the national blood inventory 
should be a resource for people who cannot plan ahead. That is 
for urgent or emergent surgeries. For elective surgery or 
medical settings, which we estimate comprises 20 percent of all 
blood transfused, alternative strategies to blood transfusion 
are available and should be the treatment of choice.
    Mr. Deutsch. Sometimes I wish we had both panels here so 
they can try to defend themselves.
    All right, one of the things that each of you I guess has 
pointed out, I guess the various regional, seasonal, in some 
cases daily shortages. Could you describe just a little bit how 
blood centers who are not collecting enough blood that is 
needed for life-sustaining procedures and surgeries, how do 
they shift the blood around from different regions, different 
groups? If someone could just give us that sense.
    Mr. Ross. Yeah. The American Red Cross has 36 blood regions 
throughout the United States. We have an active inventory 
management system where we have conference calls that go on 
daily on a regional basis and on a national basis where we 
attempt to balance the inventory throughout the system. We will 
move blood to any part of the country or to any blood center 
that needs it when we have it. So that's our attempt. It's just 
a balancing system.
    Ms. Dariotis. I think when you talk at the local level, if 
you're talking within my community blood center, it's a lot of 
running around with our couriers grabbing blood from one 
hospital and carrying it to the next hospital as we call our 
friends and beg for help. Because they will do the same with 
us, and we will provide that same level at the national level. 
ABC has the ability to communicate through our e-mail network 
the emergent needs of our centers and can look for individual 
support, and we will see centers commit and moving blood around 
the United States that way.
    Mr. Deutsch. And Dr. Jones.
    Mr. Jones. Because of our increased demand in the hospitals 
in our area, we seem to be the center that's always cited as 
always being short. I can just say that we have relationships 
with virtually every large and even a lot of small blood 
collectors around the country. We have two full-time people 
that manage this day-to-day. So I think we have a pretty good 
way of receiving blood and finding out where it is, and that's 
less formal than the Red Cross, but is seems to work.
    Ms. Lipton. The AABB also runs the National Blood Exchange 
which is an exchange program that attempts to really alleviate 
these imbalances of supply. It's accessible to any blood 
collector who meets AABB standards and is accredited by us. 
They can ship blood, and it's open to any hospital, and we 
actually ship quite a few units through the National Blood 
Exchange. We operate 24/7. Our people are on beepers and 
available to inventory managers across the country every day.
    Mr. Deutsch. Each of the industry representatives here has 
described a blood shortage that exists; and I guess, even 
saying that, you know, the projections are that it will worsen. 
Can you describe--and you have mentioned some things--but both 
steps that are being taken by the blood community to boost this 
percentage--and, again, you have talked a little bit, but if 
you can focus in on what HHS can do to assist this effort as 
well.
    Ms. Lipton. I think the single biggest thing would be for 
us to see an initiative as exists right now with organ 
donation. Blood donation is, ``part of that program,'' but it's 
really the stepchild of the program. It's incorporated into the 
title, but there really isn't anything underneath the program. 
And we believe that if organ donation is important, organ 
transplantation can't happen without blood donation, and we 
would like to see really some money put into that effort 
working with the blood organizations as to what we are doing.
    As I said, we are all trying to work together to get an 
unbranded, multi-year campaign that is not a funded campaign at 
this moment. And to really reiterate what Allan Ross said, all 
of this is a matter of money. And it costs money and it really 
isn't a matter of public service advertising. It's paid 
advertising.
    Mr. Greenwood. The Chair thanks the gentleman.
    We have votes, so I'm going to try to squeeze a question or 
two in before we go, and then we will adjourn. This is for Mr. 
Ross.
    Last fall, the Red Cross announced a crash program to 
freeze 100,000 units of blood. According to an article by 
Douglas Starr in the July 29, 2002, New Republic, the Red Cross 
ended up only freezing fewer than 10,000 units while tens of 
thousands of others continued to accumulate and contributed to 
the overall waste. Mr. Starr writes that this resulted in a 
lack of glycerol needed to protect the red cells from breaking 
as well as a lack of aluminum canisters freezing bags and even 
FDA approval to use the freezing process chosen. The question 
is, is this report by Mr. Starr accurate?
    Mr. Ross. The Red Cross developed the capacity to freeze 
upwards of 100,000 red cells by October 5, 2001. We ceased to 
freeze because of issues surrounding the technical aspects that 
Dr. Epstein referred to in his previous testimony. It will be 
about 20 months before we can get the program back on track in 
order to adopt the new technology which provides 14-day post-
thaw dating, but we still have the capacity to freeze 100,000 
units if necessary. We have all the necessary supplies, all the 
necessary reagents, and all we need are the units.
    Mr. Greenwood. Okay. We're going to stop here. Thanks to 
the witnesses for testifying, and we will keep the record open.
    There's some--if it weren't for the vote, there were some 
other questions that I'd like to ask you, so with your 
permission and with unanimous consent we will submit some of 
those questions in writing to you and ask that you respond to 
the committee.
    Thank you again. The hearing is adjourned.
    [Whereupon, at 12:40 p.m., the subcommittee was adjourned.]
    [Additional material submitted for the record follows:]

                        American Association of Blood Banks
                                                    October 7, 2002
The Honorable James C. Greenwood
Chairman
Subcommittee on Oversight & Investigations
Committee on Energy and Commerce
U.S. House of Representatives
Washington, DC 20515-6115
    Dear Chairman Greenwood: On behalf of the American Association of 
Blood Banks (AABB), I am writing in response to your September 20 
letter outlining questions from Members of the Subcommittee that will 
be included in the record of the Subcommittee's September 10 hearing 
regarding the blood supply. The AABB appreciated the opportunity to 
participate in this hearing and offers the following responses to your 
questions.
    Question 1. Because of screening for blood-borne diseases, donors 
have more questions to answer and the donation process takes more than 
an hour on average. Are the blood centers taking any actions to make 
blood donation less complicated and less time-consuming? For example, 
are donor questionnaires being automated? Is this a good idea?
    Response. The AABB is very aware that the blood donation process is 
viewed as complicated and time-consuming and has undertaken a major 
effort in concert with the rest of the blood banking community to 
address the issue of donor history questions. In June 2000, the AABB 
initiated activities of an interorganizational task force to streamline 
the uniform donor history questionnaire. This task force is composed of 
representatives from AABB, America's Blood Centers, American Red Cross, 
Armed Services Blood Program, and Plasma Protein Therapeutics 
Association, and liaisons from the Centers for Disease Control and 
Prevention (CDC) and Food and Drug Administration (FDA). Members 
include an ethicist public member, a statistician, and survey design 
experts.
    In March 2002, the task force submitted its proposal to the FDA for 
review and approval. That proposal includes:

 a revised full length questionnaire for first time and 
        infrequent donors;
 an abbreviated questionnaire for frequent donors and proposed 
        guidelines for its use;
 a medication deferral list as a companion document to both the 
        full length and abbreviated questionnaires;
 new donor educational materials; and
 user brochures which contain instructions for blood centers 
        and for donor screeners regarding how the new material should 
        be utilized.
    Donor comprehension of both the full length and abbreviated 
questionnaire have been tested using focus groups conducted by the task 
force and one-on-one cognitive interviews conducted by the CDC's 
National Center for Health Statistics. This is the first time that all 
donor questions have been subjected to a rigorous evaluation.
    These new materials are expected to improve the donor screening 
process and at the same time maintain a high level of safety of the 
blood supply. The new questionnaires are user friendly and easy to 
follow. Since the questionnaire is designed to be self administered, 
the donor may proceed at his/her own pace. Rather than long involved 
questions that must be answered by all donors, the questionnaire uses 
broad ``capture'' questions. For example, if a donor indicates he or 
she has not traveled outside the United States, there is no need to 
query the donor about travel destinations that might require deferral. 
If the donor indicates he or she has traveled outside the United States 
then the donor screener will ask follow-up questions as advised by the 
detailed flow charts in the user brochure. The abbreviated 
questionnaire is expected to be especially helpful in decreasing the 
time for frequent donors.
    In June 2002, FDA presented this proposal to its Blood Products 
Advisory Committee (BPAC), which in turn unanimously endorsed it. At 
the September BPAC meeting, FDA asked the committee to consider the 
question of self-administration of the questionnaire for all donors, 
including first time donors. BPAC endorsed the concept of self-
administration. The Interorganizational Task Force on the Uniform Donor 
History Questionnaire is eagerly awaiting a response from the FDA so 
that implementation can begin.
    Implementation of this revised questionnaire will represent a 
significant step forward. However, in the future additional steps to 
simplify and improve further the donor questioning process will be 
needed. The number and complexity of questions are directly related to 
the broad scope of regulations and guidance documents issued by FDA. As 
our task force developed the revised uniform donor history 
questionnaire over the last year, FDA explicitly stated that it would 
not consider revising certain questions at this time. For example, even 
though certain questions, such as the one dealing with Creutzfeldt 
Jacob disease (CJD),1 are of little value in enhancing blood 
safety and potentially confuse donors, FDA requires that they remain on 
the questionnaire. The AABB is hopeful that in the future FDA will work 
with us to further simplify the process by editing or deleting such 
questions.
---------------------------------------------------------------------------
    \1\  CJD, or Creutzfeldt Jacob disease, is a condition that is 
distinct from variant Creutzfeldt Jacob disease (vCJD). Scientific 
evidence affirmatively suggests that CJD is not transmissible by blood.
---------------------------------------------------------------------------
    In addition, as testing for infectious disease becomes more 
effective, the utility of some existing questions has been greatly 
reduced. The AABB believes that FDA could simplify the donor 
questioning process without adversely affecting blood safety.
Automation of donor questionnaires
    The AABB supports computer assisted self interviewing (CASI) and 
the task force designed the questionnaires with that possibility in 
mind. Not all blood centers, however, will be able to adopt automation 
in the immediate future. For that reason, the task force determined 
that the questionnaire itself should be improved as the first step 
toward automation. Broad capture questions with additional follow-up 
questions are ideally suited to a computerized interview. Automating 
the process, as well as improving the questions, will continue to be 
the focus of the task force's future activities.
    Question 2. The GAO reports that blood collections have increased 
21% between 1997 and 2001, and that collections for the first half of 
this year are on pace with the same period in 2001. Even with the 
recent donation shortfall this summer, these emerging data suggest 
collections, overall, have been on the upswing. Do you tend to agree 
with GAO's general finding with regard to donation trends? Why?
    Response. The AABB believes that the 21 percent figure used by GAO 
is misleading. GAO's assertion that collections increased 21 percent 
between 1997 and 2001 may be based on collection data from the National 
Blood Data Resource Center (NBDRC). However, neither the NBDRC nor the 
AABB agree with the calculations and analysis used to arrive at this 
figure.
    According to monthly data collected by NBDRC, 2001 collection 
levels were relatively level, over the prior year, not significantly 
increasing prior to September. NBDRC data suggest that most of the 
increase in collections experienced in 2001 was due to post-September 
11 donations. After the first six months of 2001, NBDRC projected that 
year would end with approximately 14.5 million units collected, as 
compared with 12.6 units collected in 1997. Had the September 11 
anomaly never occurred, NBDRC estimates that there would have been 
closer to a 15 percent increase in collections from 1997 to 2001.
    Going forward, NBDRC's monthly collection data from the first six 
months of 2002 suggest that collections during that period were roughly 
comparable to collections during the same six-month period in 2001. It 
should also be noted that GAO's report covers the period before June 
2002, when FDA's new donor deferral policies relating to variant 
Creutzfeldt Jacob disease (vCJD) were fully implemented. These policies 
resulted in increased deferrals and likely a reduction in collections, 
although the exact number is not known due to a lack of accurate 
analytical data.
    It is important to note that blood supply is a function of both 
collections and utilization. If supply is to be sufficient, donations 
must increase at a rate that exceeds the increase in utilization. 
According to NBDRC data, usage of whole blood and red blood cells (RBC) 
increased significantly in 2001 versus 1999. This increase in 
utilization is expected to continue this year and into the future. 
Increased collections will be needed to keep pace with this increase in 
demand.
    A troubling sign that demand may be surpassing supply, at least in 
certain communities at certain times, is the increase in hospitals 
postponing surgeries due to insufficient blood inventory. NBDRC data 
from its 2001 Biennial Nationwide Blood Collection and Utilization 
Survey indicate a significant increase in the number of hospitals that 
had to cancel or postpone surgeries in 2001 due to blood shortages. The 
percentage of hospitals in the NBDRC survey that reported such action 
in 2001 was 12.8, compared to 7.4 in 1999. Another hospital survey 
conducted by the American Hospital Association in 2001 indicated 
similar shortage problems. In the AHA survey, 57 percent of hospitals 
experienced a blood shortage in 2001. According to AHA, ``blood 
shortages cause interruptions in hospital operations and patient care, 
such as cancelled or rescheduled surgeries, and ambulance diversions. 
One in three hospitals reported that shortages are growing more 
severe.'' 2
---------------------------------------------------------------------------
    \2\ ``Statement of the American Hospital Association before the 
Advisory Committee on Blood Safety and Availability of the Department 
of Health and Human Services,'' Sept. 5, 2002.
---------------------------------------------------------------------------
    In addition, in order to meet patients' needs, one must consider 
not only the overall statistics regarding blood collections in general, 
but also the collection and inventories of distinct blood types in all 
regions of the country. For example, less than a three-day supply of O 
negative red blood cells in any community may indicate a shortage, 
despite a sufficient supply of red cells of other types.
    Question 3. Your testimony raises a point about donor deferral 
policies affecting different regions in different ways, due to 
demographics and so forth, and that federal policy makers must take 
this into account. Please explain how the blood community is working to 
respond to this issue. Is it going to provide a coordinated response to 
these safety and risk decisions?
    Response. FDA blood-related regulations, like AABB Standards, are 
applied uniformly across the country. Nonetheless, regulators as well 
as the blood community itself must be aware of the unique issues and 
needs facing distinct regions of the country. In this light, the blood 
community and policy makers should, when possible, facilitate the 
distribution of blood to communities in need.
    Currently the distribution of blood among various regions of the 
country is quite efficient. Systems such as the AABB's National Blood 
Exchange allow for resource sharing by blood centers and hospitals with 
surpluses to facilities facing shortages. However, there are inherent 
difficulties in relying on external supplies to address possible blood 
shortages. A local blood center, understandably, will always provide 
for its own community first and outside regions later. Therefore, the 
answer to addressing blood shortages lies in increasing the amount of 
reserve available to all patients across the country.
    In this light, the AABB is currently discussing with blood centers 
and the Armed Services Blood Program the possibility of establishing a 
national blood reserve. A national reserve is needed to use in case of 
a military conflict, domestic disaster or act of terrorism. In 
addition, such a reserve could be used to meet a serious blood shortage 
in a particular region of the country, assuming existing resource 
sharing agreements were not adequate.
    Question 4. Dr. Jones of the New York Blood Center states ``the 
overall supply curve does not depict the type-specific donation problem 
experienced by all blood collectors.'' Are we measuring the wrong way? 
What is the industry doing about this? The federal government?
    Response. It is critical that blood supply data include information 
about the collection, inventories and utilization of specific blood 
types. Gross data alone are not sufficient. Some blood types are in 
greater demand than others. The particular phenotypic mix needed to 
serve one region's population will differ from the mix needed in 
another region, depending on racial and other demographic factors. For 
example, the phenotypic needs in New York City do not match those in 
Iowa.
    Since 1999, the NBDRC has collected and analyzed quantitative 
national blood supply data by blood group and type through its Biennial 
Nationwide Blood Collection and Utilization Survey. This survey 
provides detailed annual data from both blood centers and hospitals 
describing units collected, processed, distributed, transfused and 
outdated. The whole blood/red blood cell distribution, transfusion and 
outdate data are stratified by blood group and type. The NBDRC is the 
sole provider of weighted national estimates for these blood services 
activities, which it monitors over time.
    For the past 18 months the NBDRC has also collected monthly type-
specific collection, inventory and distribution data from a 
statistically representative sample of U.S. blood centers. In addition, 
NBDRC gathers annual collection data by blood group and type from a 100 
percent sample of U.S. blood centers by QuiKount, a web-based survey 
conducted in odd-numbered years.
    However, the ability of NBDRC to continue collecting such data is 
in question. Absent a commitment of federal funding, the NBDRC will not 
be able to continue these critical efforts.
    Unfortunately, the federal government has not demonstrated an 
ongoing, reliable long-term commitment to collecting blood supply data, 
including type-specific collection and utilization data. Current 
federal government blood supply data collection programs are ad hoc, 
seemingly uncoordinated and lacking a long-term vision and commitment. 
If the United States is to adequately understand the dynamics of blood 
supply and demand, and, ultimately, to anticipate future blood needs, 
such a commitment is essential. Frequent, uninterrupted quantitative 
data collection is needed to forecast supply and demand, and, 
therefore, to avoid shortages.
    Question 5. What were the recent (September 5) Advisory Committee 
on Blood Safety and Availability's recommendations to the HHS?
    Response. s a memorandum from CAPT Lawrence C. McMurtry, Acting 
Executive Secretary, Advisory Committee on Blood Safety and 
Availability, summarizing the meeting, including the resolutions passed 
that day.
    Question 6. What will a seven-day supply look like? Is it seven-day 
supply at each hospital, blood center?
    Response. This supply should be a seven-day supply at every blood 
center. As stated during the hearing, this figure represents the goal 
in seeking to prepare for a potential disaster or act of terrorism. 
Today, the supply in almost all blood centers falls notably below this 
target.
    Question 7. Although there is public concern over wastage, and the 
industry recommendations to avoid this in the future, the Red Cross 
testimony suggests a seven-day goal will increase wastage. Will this be 
significant? How does the blood community plan to address public 
concerns about increasing wastage?
    Response. Moving to a seven-day supply may well increase the number 
of blood components that go unused. However, it is important to note 
that in most cases at least one component from each blood donation will 
be used to benefit patients, even if the red blood cells, which have a 
relatively short shelf life, need to be discarded due to outdating. The 
blood community will work hard to limit the discard of outdated 
components as much as possible, through rotation of more recently 
collected units and other measures.
    The blood community, along with policy makers and other interested 
parties, must work together to educate the public about the inevitable 
necessity to discard certain blood components in order to maintain an 
overall adequate blood supply. Together we should send a uniform 
message to the public focusing on the need to maintain an adequate 
supply of all blood types at all times.
    Question 8. Does the industry believe the nvCJD (Mad Cow disease) 
restrictions should be relaxed?
    Response. The AABB does not believe that the FDA's recent deferral 
policies relating to vCJD should be relaxed at this time. However, the 
AABB believes that the impact of this policy on the blood supply 
nationally and regionally should be carefully monitored. If it appears 
that the blood supply in any particular region is no longer adequate 
due to the implementation of this new policy, then the FDA and the 
blood community may need to reconsider the policy and/or explore 
additional means of ensuring that blood is readily available to 
patients in such regions. In addition, FDA must continually reevaluate 
information relating to this policy and reconsider the policy as 
updated information becomes available. Such donor deferral policies 
must be based on current scientific knowledge.
    The AABB appreciates your ongoing interest in the safety and 
availability of the nation's blood supply. We welcome the opportunity 
to work with you and other policy makers to ensure patient access to a 
safe, readily available blood supply. If you have additional questions 
or require further information, please do not hesitate to contact me or 
Theresa Wiegmann, AABB director, Division of Government and Legal 
Affairs.
            Sincerely,
                                     Karen Shoos Lipton, JD
                                            Chief Executive Officer
                                 ______
                                 
                                    America's Blood Centers
                                                    October 7, 2002
The Honorable James C. Greenwood
Chairman, Subcommittee on Oversight and Investigations
2125 Rayburn House Office Building
Room 2436
Washington, D.C. 20515
    Dear Congressman Greenwood: Pursuant to your letter of September 
20, 2002 and in follow up to my testimony before the House Energy and 
Commerce Subcommittee on Oversight & Investigations on September 10, 
2002, I am submitting answers to your questions.
    Question 1. Because of screening for blood-borne diseases, donors 
have more questions to answer and the donation process takes more than 
an hour on average. Are the blood centers taking any actions to make 
blood donation less complicated and less time-consuming? For example, 
are donor questionnaires being automated? Is this a good idea?
    Response: America's Blood Centers has been working diligently over 
the last four years with the American Red Cross (ARC) and the American 
Association of Blood Banks (AABB) in trying to develop more efficient, 
yet effective ways of screening donors. However, regulatory concerns 
from FDA require validation that new methods (such as computer-assisted 
screening, self-administered health histories, shortened questionnaires 
for repeat donors, dropping oral questioning, etc.) are no less 
effective than current methods. Such proof has been difficult and time 
consuming to obtain. Consequently, progress has been very slow.
    We understand FDA's concerns in this area, however. Methods for 
screening donors by health and behavior history remain the primary way 
of reducing the risks of transmission for diseases we either do not or 
can not test for, or where tests still have a ``window'' (i.e., the 
interval between infection and when a test turns positive). The current 
donor screening system has evolved over the last twenty years as the 
effective ``overlapping layers of protection.'' For example, the rates 
of disease markers in volunteer blood donors are roughly one one-
hundredth of that found in the general population. Said another way, we 
eliminate over 99 percent of infected donors even before we collect and 
test the blood. The problem is that the long and involved screening 
adds considerable time to the donation process, which we know is 
discouraging to would-be and repeat donors. The difficulty, then, comes 
in trying to peel away some of the layers of screening and substituting 
them with ones that are more efficient but as effective.
    Having said the above, the national blood organizations have 
recently submitted proposals to FDA for shortening the health history 
and are awaiting a favorable response.
    Question 2. The GAO reports that blood collections have increased 
21% between 1997 and 2001, and that collections for the first half of 
this year are on pace with the same period in 2001. Even with the 
recent donation shortfall this summer, these emerging data suggest 
collections, overall, have been on the upswing. Do you tend to agree 
with GAO's general findings with regard to donation trends? Why?
    Response: ABC agrees with the GAO that blood collections in the 
United States have increased, but strongly disagrees with their 
conclusion that this increase has kept pace with demand. The GAO report 
covers a period of tremendous instability in our nation's blood 
donations and does not include the period of substantial drops in 
donation rates since June 1, 2002 when half the nation's blood 
collectors implemented new vCJD guidance. While ARC initially reported 
little impact of their vCJD deferral policies, their earlier 
implementation dates coincided with the surge of donations after 
September 11th. ARC now reports critical blood shortages with severe 
reductions in donation rates. None of this is addressed in the GAO 
report.
    In addition, the GAO report bases much of their assessment of the 
blood supply on information gathered from sentinel hospitals. Hospitals 
are an insensitive barometer of supply; blood centers are a far more 
reliable gauge of supply variances. Blood centers work hard to maintain 
in their hospitals whatever supply the hospitals may require to assure 
that the blood is on the shelves when needed by patients. Thus, blood 
center inventories, which are a buffer against emergencies, may drop to 
low levels long before the impact is felt by local hospitals.
    ABC's data indicate that the available blood supply in the period 
before September 11, 2002 as compared with the months before to 
September 10, 2002 (the release date of GAO's report on the blood 
supply) has decreased from an average of between four to five days to 
less than three days supply on the shelves of blood centers. This low 
supply means many communities around the country have not recently had 
an adequate blood supply to meet the needs of a major local disaster. 
This fact is bolstered by AABB's testimony that the number of canceled 
non-emergency surgeries in hospitals has increased over the last year 
because of increasing blood shortages. The American Hospital 
Association also conducted a survey last year showing increasing 
cancellations of non-emergency surgeries.
    The simple facts are that blood demand is increasing because of an 
aging population and expansion of blood-consuming medical and surgical 
therapies, while we continue to indefinitely defer willing donors 
because of precautionary measures. The lives of over four million 
Americans depend on blood transfusions, yet less that three percent of 
the population donates the 15 million or so units of blood needed to 
support patients. Tens of millions more Americans are healthy enough to 
give blood but are difficult to reach for a variety of reasons.
    Blood centers are pouring millions of dollars into new resources to 
boost donations, but are hard pressed to meet these competing trends of 
increased blood need and the elimination of willing donors. As ABC 
testified, the blood community needs help. We require more national and 
high level attention on the problems of blood supply to convince many 
busy Americans to assure the blood will be there when it is needed.
    Question 3. Ms. Lipton's testimony raises a point about donor 
deferral policies affecting different regions in different ways, due to 
demographics and so forth, and that federal policy makers must take 
this into account. Please explain how you are working to respond to 
this issue. Is ABC going to provide a coordinated response to these 
safety and risk decisions?
    Response: Yes. ABC traditionally works with FDA, locally affected 
blood centers and the other national blood organizations to assess the 
impact of any new donor deferrals. It is true that such policies 
frequently impact areas of the US differently.
    For example, we know that the impact of the Mad Cow Deferrals of 
recent years has hit the coastal cities more than the heartland (and 
more East Coast than West) because of the travel patterns of the 
populations that live in those areas. No recent deferral has had more 
varied local impact than the Mad Cow Deferrals that took place in June 
2002. Areas of the US with high active or retired military populations 
have seen deferral rates climb as high at 10 percent, even among high 
school donors (for military dependants who spent time on bases in 
Europe). Our response is to try and compensate by increasing 
collections and/or contracts for imports of blood from other areas of 
the US.
    When this month's next round of Mad Cow Deferrals are implemented, 
the impact will be felt most acutely in New York City, as the deferral 
will halt the supply of so-called Euroblood. ABC members have boosted 
imports to the New York Blood Center by nearly an additional 75,000 
units in the last year. However, we know that for reasons mostly 
related to 9-11, New York's blood collections have fallen in 2002 
rather than increased as planned. Health and blood officials are 
concerned that the loss of Euroblood will create a public health 
crisis. Media appeals may help in the shortterm, but it is unclear how 
the needs of New York can be addressed in the long term, given the 
spreading shortages around the US. ABC will do its best to help.
    Another aspect of the regional differences in impact of a new 
deferral policy is that export blood centers, which are mostly rural, 
can easily absorb a new donor deferral policy. But such policies also 
severely reduce their available exports. Thus, urban centers, which are 
often dependent on imports from rural centers, experience a double hit 
from new deferral policies, i.e., both reduced local collections and 
reduced shipments of blood from rural centers. This double hit has 
certainly been seen with the latest round of Mad Cow Deferrals and 
their impact on urban and import-dependent centers in cities such as 
New York, Pittsburg, Chicago and Los Angeles.
    Question 4. Dr. Jones of the New York Blood Center states ``the 
overall supply curve does not depict the type-specific donation problem 
experienced by all blood collectors.'' Are we measuring the wrong way? 
What is the industry doing about this? The federal government?
    Response: Group O blood has always been used disproportionately in 
trauma. As the blood group in greatest demand, Group O is in the 
shortest supply when blood demands increase and new deferrals are put 
in place.
    For this reason, the ABC ``Stoplight'' (on www.americasblood.org), 
which daily measures the blood supply provided by ABC members, uses 
Group O as the lead indicator for determining a shortage and ``days of 
supply.'' The definitions used in the Stoplight are enclosed with this 
letter. Although ``days of supply'' is a surrogate marker for actual 
numbers, we believe the Stoplight represents a more sensitive way to 
measure supply because it takes into account local variances in how 
supply is distributed, measured and responded to.
    Question 5. What will a seven-day supply look like? Is it seven-day 
supply at each hospital, each blood center?
    Response: While there is a proposal that blood centers try to 
achieve a seven-day supply to meet emergency demands for blood, there 
is no national consensus whether this is either the best or only way to 
meet extraordinary needs for blood. In reality, when the average 
national supply is less than three days for a sustained period, as it 
is now, it is more important to determine how the current day-to-day 
needs will be met, rather than to set a seemingly desirable but 
unrealistic goal.
    To explain, blood centers around the country have set levels for 
ideal local supply based on historical need. This may rage from a 
three-day to a ten-day blood center supply (i.e., the blood on the 
shelves of blood centers). The factors in setting a high or low blood 
center inventory goal include whether the blood center manages hospital 
transfusion services (as is done in many parts of the US), what supply 
would be needed to respond to a major local disaster (as determined in 
disaster preparedness models), and whether in an emergency extra supply 
can easily be shipped in from other nearby blood centers. Based on 
these factors, most blood centers believe that a three to five day 
supply of Group O red blood cells is ideal. Blood centers that are also 
the transfusion services for area hospitals will attempt to maintain an 
inventory at twice that level. Where the blood centers are not also the 
transfusion services, most area hospitals will maintain another three 
to five days' worth of supply. Much of that is committed (i.e., 
``crossmatched'') to specific patients, although it could be diverted 
for general use in an emergency. So all totaled, based on current goals 
(and not in times of severe shortages), the US already maintains a six 
to ten day blood supply.
    A realistic alternative to every blood center attempting to boost 
their local supply would be in better assuring transportation in times 
of a disaster whereby thousands of units already in inventory could be 
shipped within a few hours from larger designated ``reserve hub'' blood 
centers to an area with extraordinary need. Such an alternative is 
based on what already happens informally in times of disaster. ABC has 
discussed this model with the military blood program (for meeting both 
military and domestic needs), and it is under consideration by the 
blood Interorganizational Task Force on Domestic Disasters and Acts of 
Terrorism.
    Question 6. Although there is public concern over wastage, and the 
industry recommendations to avoid this in the future, the Red Cross 
testimony suggests a seven-day supply goal will increase wastage. Will 
this be significant? How do you plan to address public concerns about 
increasing wastage?
    Response: As stated above, a seven day supply would be difficult to 
manage and could significantly increase wastage. However, public 
concerns could be addressed by relaying that this is the price of 
preparedness. Certainly, the public is aware that America's current 
preparedness consumes billions of dollars in added resources. As 
suggested above, there may be other ways to address disaster 
preparedness, especially in times when we struggle to meet non-disaster 
blood demands.
    Question 7. Do you believe the nvCJD (Mad Cow Disease) restrictions 
should be relaxed?
    Response: ABC has consistently warned HHS about the ramifications 
of these deferrals on the supply of blood and has asked for specific 
assistance from HHS to deal with the resulting shortages, to no avail. 
These deferrals are a major contributor to increasing shortages around 
the country. As noted above, the next round of deferrals, which take 
place at the end of this month, could have a devastating impact on 
patients in the New York City area.
    HHS and FDA have vowed to review the risk/benefits of the 
precautionary Mad Cow Deferrals based on emerging data from Europe. We 
have urged that be done at least every six months (such as at meetings 
of FDA's Transmissible Spongiform Encaphalopathies Advisory Committee).
    In summary, we thank you, Mr. Greenwood, and the committee for 
holding the September 10, 2002 hearing on the important issue of 
``America's Blood Supply'' in the Aftermath of September 11, 2001.
    To reiterate three important points made in my testimony and in the 
above answers to your questions:

 The blood supply is very fragile and may not meet future 
        patient needs. Blood use is increasing at a time when our donor 
        population is aging and as increasing precautionary 
        restrictions are being placed on otherwise healthy individuals 
        willing to give blood.
 The private sector needs a designated office inside HHS that 
        focuses on blood availability and coordinates this important 
        public health issue with the private sector. We suggest that, 
        as they do for organs, tissue and marrow, the Health Resources 
        and Services Administration be charged to work with the private 
        sector on helping to increase the public support for assuring 
        an adequate blood supply.
 Congress can help by assuring funding for new public 
        educational initiatives on blood donation, by encouraging every 
        Congressman and Senator who can to give blood publicly and 
        frequently, and by working with their local blood suppliers to 
        participate in public events that would help create a culture 
        of donation in the US.
    Regarding the last point, ABC staff will be in touch with committee 
staff to talk about your idea of helping to spotlight the need for 
blood donations by hosting a Congressional event.
    Thank you again for your efforts.
            Sincerely,
                                            Jeanne Dariotis
                                                          President
                         stoplight definitions
    Green = 3-day available supply* or more of all red blood cell types 
= Preferred Level, or enough blood for one major emergency to strike. 
No special action required.
    Yellow = 2-day available supply = Minimum Safe Level = Don't have 
enough blood to release to take care of patients in a major trauma or 
emergency. Actions may include scheduling special blood drives, going 
out on appeal to the media and/or cutting back on routine stock orders 
for consignees.
    Red = 1-day available supply or less = Critical Level = Not enough 
blood on hand to meet routine or emergency needs. Actions may include 
evaluating hospital inventories (to anticipate transfers as needed), 
triaging of blood orders based on need, and advising physicians to 
cancel non-urgent surgeries if supply decreases to half-day or less.
                                                       June 1, 2002

    *Available supply excludes blood being held for completion of 
processing (such as awaiting test results); that is, the definition 
includes blood available for distribution to consignees. Some centers 
may use Group O as the sole or primary indicator available sufficient 
supply.
                                 ______
                                 
            Society for the Advancement of Blood Management
                                                 September 30, 2002
The Honorable James C. Greenwood
Chairman, Subcommittee on Oversight & Investigations
U.S. House of Representatives
Committee on Energy and Commerce
2125 Rayburn House office Building
Washington, D.C. 20515
    Dear Congressman Greenwood: Thank you for your letter dated 
September 20 containing specific questions concerning the nation's 
blood supply and the efforts and accomplishments of the Society for the 
Advancement of Blood Management. We appreciate the opportunity to 
follow upon our testimony of September 10th before your Subcommittee.
    Question 1. Although your organization was only established 
recently, can you cite some real-life examples of how blood 
conservation initiatives are helping the management of the blood 
inventory?
    Response. Attached to the end of this letter is a partial list of 
the activities of SABM over the past year. Through education, 
demonstration of clinical efficacy and peer-reviewed medical 
publication, the improvement of outcomes by following the dictum, 
``transfuse last'' rather than the current practice of ``transfuse 
first'' preserves the store of donated blood for the most needy 
patients. Hospitals following these practices can and do reduce blood 
transfusions by 50% while improving outcomes through better medicine. 
This result is by no means unique as over 150 United States hospitals 
with similar programs continue to reduce blood usage in both medical 
and surgical patients. Major liver surgery, cardiac surgery, and bone 
marrow transplantation are all being done successfully by SABM members 
without the need for transfusion or with vastly reduced transfusion 
requirements. SABM has shown transfusion reduction does not require 
expensive technology. Rather, significant reductions can be 
accomplished through attention to detail, careful patient management, 
reduction of phlebotomy and acceptance of a lowered transfusion 
trigger. These are all included in SABM educational programs.
    Question 2. If blood conservation measures were adopted more 
widely, how would supply requirements of the nation's blood supply be 
affected?
    Response. Surveys of current transfusion practices in the United 
States show that identical patient populations, e.g., cardiac surgery 
patients, are transfused at different hospitals at rates that range 
between less than 50% to 100%. The decision to transfuse is most often 
based on long standing local habits, i.e., ``we've always done it that 
way,'' and outdated physician knowledge rather than medical necessity. 
Widespread adoption of blood conservation and management can reduce 
this unnecessary blood usage, thereby decreasing the demand on the 
blood supply, and preserving the blood supply for patients who are in 
true medical need. Based on our experience, we believe that a 50% 
reduction in supply requirements is currently possible.
    Question 3. Are there inherent dangers in adopting blood 
conservation measures?
    Response. The basic tenet of medical care is to first, do no harm. 
Risk to patients can be classified broadly into those inherent in a 
product, those unique to patients, and those caused by inappropriate 
treatment or incorrect use of a product, i.e., iatrogenic. Blood 
conservation measures include cessation of blood loss, careful surgical 
technique to avoid blood loss, transfusion at a lower hemoglobin level, 
and use of the patient's own blood. Stopping bleeding and preventing 
blood loss during surgery are common sense measures that have no 
inherent dangers. The absolute, lowest or critical hemoglobin is as yet 
unknown. SABM's experience has shown that successful outcomes in 
severely anemic patients who refuse transfusion is now commonplace, 
showing that the risk of limiting transfusion has minimal relative 
risk. Techniques to use the patient's own blood include pre-deposit, 
cell salvage and hemodilution. Pre-deposit carries the same risks 
inherent in collection and storage of blood and is less of a risk than 
using allogeneic blood. The technologies of cell salvage and 
hemodilution have evolved to the point that risk results only from 
incorrect use. Drugs used in blood conservation have some inherent 
risks as do any medications, but their risk to benefit ratio is minimal 
if they are used correctly. SABM generally agrees that adequate fluid 
resuscitation and volume replacement, well-controlled cardiovascular 
vital signs, and sufficient oxygen delivery to vital organs such as the 
heart, brain and kidneys are keys to maintaining and restoring health.
    Blood transfusions have the potential benefit of delivering some 
oxygen to tissues and as volume replacement. This past month's major 
events in blood news (absent the Congressional hearing and SABM 
Symposium in Washington, DC) underscore typically and increasingly 
relevant blood safety issues: First, the West Nile virus is present in 
the national blood supply but is not detectable. Second, the September 
25, 2002 issue of the Journal of the American Medical Association 
describes prospective data on 4,670 critically ill patients. Patients 
who receive transfusions are associated with diminished rather than 
improved organ functions and a shortened life expectancy. An 
accompanying Editorial reviews this article and 21 other pertinent 
medical articles urging vigorous examination of blood conservation 
strategies for critically ill patients for their apparent savings in 
morbidity and mortality. SABM believes that appropriate use of blood 
conservation eliminates the risks inherent in allogeneic blood. 
Existing and currently accumulating evidence of an improvement in 
outcomes in the non-transfused patient suggest that the adoption of 
blood conservation strategies benefits patient, institution, and payer 
alike.
    Question 4. How best can blood conservation measures be deployed in 
preparation for a large scale disaster where blood would ordinarily be 
required in large amounts?
    Response. SABM seeks a venue to present just such measures for 
large scale deployment. Several blood conservation strategies when 
combined, lead to significant savings of blood. Products currently in 
the drug and device approval process are in need of faster progress 
with real-world clearances for limited observational assessments. 
Artificial oxygen carriers, which have been approved for use outside 
the United States, appear more than promising as initial fluids for 
resuscitation of traumatically injured patients. These agents can be 
stored and transported without the Spartan requirements needed for 
blood. Their early use in a large-scale disaster can reduce blood 
wastage. Unfortunately, lacking regulatory guidance, they are used now 
only in the context of ``compassionate care'' in patients who refuse 
human blood transfusions. Although multiple studies of these agents 
have been done, they have all addressed their use as absolute 
substitutes for blood, a goal they may never be able to achieve. As a 
result, they are languishing in the regulatory bog. Hemostatic agents 
and dressings that can staunch overwhelming bleeding are in a similar 
regulatory status despite excellent clinical efficacy in disaster 
victims in Israel. A fresh look at the potential of oxygen therapeutics 
and hemostatic agents and some forward movement are needed.
    Question 5. How does the STORMACT (Strategies TO Reduce Military 
And Civilian Transfusions) work that your organization has been doing 
with the military bear on the issue of the national blood supply?
    Response. A high percentage, between 50-70% of blood transfusions, 
are given in the urgent or emergent critical care setting of the trauma 
ward, surgery or intensive care unit. When blood conservation measures 
are employed in this setting, dramatic reductions in transfusions are 
observed. Similarly, the US soldier in combat faces a situation where 
blood conservation measures are mandatory. Blood is simply not 
available on the battlefield so conservation measures are an absolute 
requirement to preventing death from exsanguination. When reviewing 
battlefield resuscitation practices on the advent of entering 
Afghanistan, the existing battlefield resuscitation practice dated to 
the Vietnam era. Military medical leaders decided to critically examine 
and modernize these practices. SABM was called and STORMACT was created 
in October, 2001. Learning of the existing practice, SABM recommended 
changing the resuscitation fluid from a water-based solution to a 
thicker, colloid based intravenous solution, a so-called ``volume 
expander'' which remains within the circulation far longer. The amount 
required is also half of the water-based solution in size and weight. 
Furthermore, the integrated approach practiced in blood conservation 
translates to the civilian trauma setting as well. Israeli trauma 
physicians use advanced blood conservation techniques learned from the 
Israeli Defense Forces. The Israeli's have available pharmaceutical 
compounds which can and usually do stop hemorrhage and have been shown 
to save lives following severe trauma. These are also bogged down on 
the slow track rather than the express track of the US regulatory 
process. As such, by regulation, they are unavailable to our US 
military troops until cleared.
    The relevance to the national blood supply is twofold: first, the 
military collects, stores, and then disposes of tremendous amounts of 
unused blood at great expense. Records from the Gulf War as well as 
Operation Enduring Freedom show that the majority of the blood assigned 
to our forces was never used and was discarded as an outdated, unusable 
product. Second, blood conservation and the practice of using 
alternatives to blood transfusions help immensely in conserving blood 
for the truly needy.
    Thank you for your interest in blood conservation as a central 
strategy in the preservation of the national blood supply. References 
used appear at the end of the document.
    For the Society for the Advancement of Blood Management, we remain,
            Sincerely yours,
                                        Richard Spence, MD,
                                                          President
                             Aryeh Shander, MD, FCCM, FCCP,
                                                 Executive Director
                                      Henry Bennett, Ph.D.,
                                                      Administrator
2001-2002 activities (partial list) of the society for the advancement 
                          of blood management

August 11, 2001,
Founding Meeting, Four Seasons Hotel Vancouver, British Columbia

September 19-20, 2001, XVIII Congress of the Brazilian College of 
Hematology, Sao Paulo, Brazil, ``History and Actual State of Art in 
Bloodless Medicine and Surgery'' and ``Reducing Blood Loss and Managing 
Extreme Anemia in Intensive Care''

September 29, 2001, Board of Directors Meeting, Arizona Biltmore Resort 
and Spa Phoenix, AZ

September 30, 2001, ``Iron, Erythropoiesis, and Physiology of 
Erythropoietin Response to Anemia,'' 2001 Symposium on Blood 
Conservation in Medicine and Surgery, Phoenix, AZ

October 8, 2001, STORMACT I, Hahnemann Medical School Philadelphia, PA

October 22, 2001, ``Anemia and Erythropoietin'' Hematology/Oncology 
Grand Rounds, University of Michigan, Ann Arbor, MI

November 6, 2001, Ontario Hospital Association Blood Issues Session 
Managing Scarce Blood Resources: Alternative Solutions Today, 
``Administrative Issues Involved with Establishing a Program of 
Bloodless Medicine and Surgery''

November 17, 2001, 1st SABM Regional & Board of Directors Meeting, The 
W New York Union Square New York, NY

November 20, 2001, Presentation on promoting blood conservation within 
the Federal expenditures on healthcare, Department of Health and Human 
Services Washington, DC

November 28-29, 2002, Bloodless Medicine & Surgery Conference Warsaw, 
Poland, ``Tolerance of Anemia and Reduced Circulating Blood Volume''

December 5, 2001, STORMACT II, Naval Medical Research Center in Silver 
Spring, MD

January 9, 2002, Pinnacle Health System, Harrisburg, PA, ``Transfusion 
Practice: A Time for Change''

January 22, 2002, ``The State of Anemia,'' Medical Grand Rounds, Case 
Western Reserve University, Cleveland

January 25, 2002, STORMACT III, Four Seasons San Diego, CA

January 25, 2002, ``Iron Dependence of Erythropoiesis in the presence 
and absence of erythropoietin therapy,'' Master Class in Nephrology, 
Berlin

January 26, 2002, 2nd SABM Regional Meeting, Four Seasons Resort 
Aviara,, 7100 Four Seasons Point Carlsbad, CA 92009

February 4-5, 2002, 10th Winter Symposium on Intensive Care Medicine 
Crans Montana, Switzerland, ``Perioperative Blood Management'' 
``Erythropoietin in the ICU''

February 8, 2002, Medical Symposiums, Incorporated, and the Texas 
College of Emergency Physicians present Emergency and Critical Care 
Medicine, Saint Martin French West Indies, ``Blood Substitutes''

February 9, 2002, American College of Surgeons San Juan, Puerto Rico, 
``Artificial Oxygen Carriers in Bloodless Surgery''

March 8, 2002 ``The State of Anemia.'' Ohio State Cancer Center, 
Columbus, Ohio

March 7, 2002, Northside Hospital & Heart Institute-St. Petersburg, FL, 
``Transfusion Practice: A Time for Change''

March 15, 2002, ``The State of Anemia,'' Cancer Center Rounds, Henry 
Ford Hospital, Detroit, MI

March 23, 2002, Blood Conservation Symposium, Johanniter Hospital 
Oberhausen Oberhausen, Germany, ``Permissive Anemia'' ``Indications for 
Acute Normovolemic Hemodilution.''

April 5, 2002, STORMACT IV, Hurlburt Field 100 Bartley Street, Suite 
210E Hurlburt, FL

April 8, 2002 Euroanesthesia Industrial Luncheon Workshop Nice 
Acropolis Center Nice, France, ``Oxygen Therapeutics: Structure and 
Clinical Correlation''

April 8, 2002, ESA/EAA Industrial Luncheon Workshop Nice Acropolis 
Center Nice, France, ``Oxygen Carriers: Preclinical Overview and 
Rationale for Use''

April 15, 2002, STORMACT Roadshow, Walter Reed Bethesda, MD

April 17, 2002, Transfusion Practice: Outcomes and Economics, 
Hackensack University Hospital, Hackensack, NJ

April 19, 2002, Transfusion Practice: A Time for Change, 2nd 
Panhellenic Transfusion Congress, Patras, Greece

April 20, 2002, J Soc Anesth Annual Meeting, Fukudka, Japan, 
``Perioperative Transfusion Strategies in the U.S.''

April 21, 2002, A Live CME Lunch Symposium at the Society of 
Cardiovascular Anesthesiologists 24th Annual Meeting, Optimization of 
Fluid Management: An Outcome Based Approach, New York Marriott Marquis

April 22, 2002, Third Annual NATA Symposium, Rome, ``RBC vs. 
Erythropoietin Therapy.''

April 29th, 2002, NY Regional Blood Center, ``Blood Rounds on the Net'' 
Live teleconference on blood conservation techniques for clinicians 
sponsored by the primary blood bank for the New York City region

May 2, 2002, First Annual Northwest Conference on Bloodless Medicine 
and Surgery. Swedish Medical Center, Seattle, ``Erythropoietin, Iron 
and Erythropoiesis.'' ``Transfusion Guidelines''

May 7, 2002, Anemia in the ICU Patient, University of Missouri 
Department of Surgery, Columbia, MO

May 9, 2002, Transfusion Practice: A Time for Change, Huntsville 
Hospital, Huntsville, AL

May 14, 2002, STORMACT Roadshow, Overview--Blood Management Issues in 
2002 and Beyond--Military and Civilian Perspectives, STORMACT IV, 
Brooke Army Medical Center, San Antonio, TX

May 15, 2002, Transfusion Practice: A Time for Change, St. Joseph's 
Medical Center, St. Louis, MO

May 18, 2002, The Carolinas Regional Symposium on Blood Management, 
Spartanburg Regional Healthcare System and supported by restricted 
educational grants donated by the Society for the Advancement of Blood 
Management and OrthoBiotech

May 24-26, 2002, A Curriculum in Bloodless Medicine and Surgery, 
Osterreichischer Kongress uber Blutsparende Medizin, Vienna, Austria

May 30-31, 2002, AABB Oxygen Therapeutics Conference, Bethesda, MD, 
``Oxygen Therapeutics and Their Role in Medical Anemias'' ``Clinical 
Uses of Oxygen Therapeutics''

May 31, 2002, ``The State of Anemia.'' University of California at 
Davis Oncology Journal Club, Sacramento, CA

June 7, 2002, STORMACT V, Englewood Hospital and Medical Center 
Englewood, NJ

June 20, 2002, Transfusion Practice: A Time for Change, North Broward 
Hospital, Ft. Lauderdale, FL

July 12, 2002, SABM Board of Directors Meeting, Courtyard Marriott 21 
North Juniper Street Philadelphia, PA

July 25, 2002, Clinical Uses of Oxygen Therapeutics, Mt. Sinai School 
of Medicine, New York, NY

August 6, 2002, Anemia in the ICU, Shawnee Mission Medical Center--
Shawnee Mission, Kansas

August 7, 2002, Anemia in the ICU, Luke's Medical Center--Kansas City, 
Missouri

August 15, 2002, Clinical Uses of Oxygen Therapeutics, Legacy Good 
Samaritan Hospitals, Portland, OR

August 22-23, 2002, Blood Management 2002 and Beyond, 17th Annual 
Surgery for Trauma Day, USUHS, Bethesda, MD

September 10, 2002, SABM invited testimony, US House of Representatives 
Committee on Energy and Commerce, Subcommittee on Oversight & 
Investigations, ``America's Blood Supply in the Aftermath of September 
11, 2001'' Washington, DC

September 20-21, 2002, SABM 2002 Symposium, Grand Hyatt Washington 
Washington, DC

Publications (partial list):
    V. Martyn, S.L. Farmer, M.N. Wren, S.C.B. Towler, J. Betta, A. 
Shander, R.K. Spence, M.F. Leahy. The theory and practice of bloodless 
surgery. Transfusion and Apheresis Science; 2002;27(1):29-43.
    Goodnough LT, Shander A, Spence RK, Bloodless Medicine, (Accepted 
for publication in British Medical Journal).
    Scott-Connor CEH, Spence RK, Shander A, Singleton C, Bennett HL, 
Rock WA. Hemostasis, Thrombosis, Hematopoiesis and Blood Transfusion, 
The Physiologic Basis of Surgery, 3rd ed., ed. Patrick O'Leary, MD, 
Lippincott Williams-Wilkins, Philadelphia, PA; 2002:pp. 531-576.
    STORMACT: Advances in Battlefield Resuscitation, Freilich D, 
Goodnough L, Kaplan LJ, Kellum JA, Spence RK, Shander A, Wright J, In 
press.
Current Research Activities:
    COGNIGEN Trial of Blood use in Cardiac and Orthopedic Surgery, 
Principal Investigator--Aryeh Shander, MD. Englewood Hospital.
    A Microeconomic Analysis of the Cost of Blood Transfusion, Richard 
K. Spence MD, Birmingham Baptist Health Systems, Birmingham, Alabama.
    Blood Transfusion, Survival and Cancer Recurrence in 19,333 
Patients, Richard K. Spence MD, Birmingham Baptist Health Systems, 
Birmingham, Alabama.
    Nadir Hemoglobin and its Impact on Survival in the Acutely Bleeding 
Patient, Richard K. Spence MD, Birmingham Baptist Health Systems, 
Birmingham, Alabama, Aryeh Shander, MD. Englewood Hospital.
    HLK 213: Phase II Randomized, Single-blind, Controlled Clinical 
Trial to Evaluate the Efficacy ands Safety of Hemolink TM in 
Subjects Undergoing Primary Coronary artery Bypass Grafting Surgery--
several SABM member centers
    HLK 214: Phase II Randomized, Single-blind, Controlled Clinical 
Trial to Evaluate the Efficacy ands Safety of Hemolink TM in 
Subjects Undergoing Revision Coronary artery Bypass Grafting Surgery--
several SABM member centers
Grant Applications:
    NIH RO1 grant application--Promoting Physician Change in 
Transfusion Practice--submitted in response to RFA-HL-01-011, Trials 
Assessing Innovative Strategies to Improve Clinical Practice.
    NIH RO1 grant application--Hemostatic Mechanisms of recombinant 
Factor VIIa During and Following Surgery--submitted in response to RFA 
HL-02-001, Transfusion Medicine/Hemostasis Clinical Research Network.
References used in this letter:
    2002Vincent JL, Baron J-F, Reinhart K, et al. Anemia and blood 
transfusion in critically ill patients. JAMA, 288: 1499-1507.
    2002 Hubert PC, Fergusson DA. Red blood cell transfusions in 
critically ill patients. (Ed.) JAMA, 288(12): 1525-6.
    PUBLIC HEALTH: Blood Supply Generally Adequate Despite New Donor 
Restrictions, Report to the Chairman, Subcommittee on Oversight and 
Investigations, Committee on Energy and Commerce, House of 
Representatives, GAO-02-754, Washington, D.C.: United States General 
Accounting Office.
    2001 Ozawa S, Shander A, Ochani TD. A practical approach to 
achieving bloodless surgery. AORN J., 74: 34-47.
                                 ______
                                 
                                      New York Blood Center
                                                    October 7, 2002
James C. Greenwood
Chairman
Subcommittee on Oversight and Investigation
House Committee on Energy and Commerce
U.S. House of Representatives
Washington, DC 20515-0115
    Dear Chairman Greenwood, I briefly testified during your hearing 
entitled ``America's Blood Supply in the Aftermath of September 11, 
2001'' held on September 10, 2002 when I accompanied America's Blood 
Centers and presented the experience of the New York Blood Center 
(NYBC) and the New York metropolitan area with the nation's blood 
supply. NYBC has been the blood center most impacted by recent events, 
including September 11.
    I appreciate the opportunity to submit our responses to the follow 
up questions you sent to ABC, AABB and others. Also attached is a paper 
I wrote called ``How Big is the Room?'' which proposes a collaborative 
study of the entire chain of events that impact the blood supply and 
its availability for patients. I have circulated this paper to many in 
the industry and have received unanimous support and willingness to 
contribute. What is troubling now is that there is no comprehensive 
understanding of how all the recruiting functions, donor restrictions, 
blood testing, processing and distribution impact on the total supply. 
In effect, we are flying blind and really have no precise sense of how 
close we might be to catastrophic blood inadequacy that could acutely 
or more likely chronically impair our ability to care for patients 
needing blood transfusions.
    I have proposed a collaborative program whereby total risk is 
assessed. This risk includes the current and future blood safety 
regulations in light of the risks to patients of not receiving adequate 
supplies of blood.
    I hope your subcommittee takes these concepts into consideration 
and that we can move forward with FDA and other regulators of blood 
safety to a more comprehensive and rational approach. Thank you for 
considering our views and including them in the record.
            Sincerely,
                                                Robert L. Jones, MD
Cc: Peter Deutsch, Ranking Member of the Subcommittee
Attachments
 Responses to Chairman Greenwood's Follow Up Questions on ``America's 
         Blood Supply in the Aftermath of September 11, 2001''
    Question One: Because of screening for blood-borne diseases, donors 
have more questions to answer and the donation process takes more than 
an hour on average. Are the blood centers taking any actions to make 
blood donation less complicated and less time-consuming? For example, 
are donor questionnaires being automated? Is this a good idea?
    Response: Blood donor questionnaires are becoming so complex that 
they may be losing their value by confusing blood donors or by 
promoting indifference to the questions. Blood centers are always 
trying to simplify the process, but regulation frequently inhibits 
innovation because of the approval process and restrictions that 
mandate certain processes. It is a very good idea to automate the 
questionnaire administration process but FDA requires that many of the 
questions be asked by trained personnel directly with the donor, thus 
losing much that is gained from automation.
    The FDA adds questions without any validation testing as to their 
comprehension or efficacy in eliciting the proper information. On the 
other hand, FDA will require that any blood center proposal for changes 
be accompanied by data that assures that the blood supply will not be 
made less safe. Few organizations have the resources to carry out such 
studies which, by nature, need to be extremely large due to the low 
number of deferrals any particular question may capture.
    FDA has recently come out with a draft guidance entitled 
``Streamlining the Donor History Form'' which requires that all 
questions be asked verbally of first time donors as well as new 
questions of repeat donors or those who have not donated for a 
specified period of time. This new requirement would slow down the 
process tremendously, require additional resources (staff, space) be 
added, and create an untrackable system where it would be impossible to 
determine if any questions had been added since a donor had last given. 
Computer-assisted administration of questionnaires might be useful but 
would also require additional resources (funds for technology, 
logistics for bringing hardware out on blood drives, etc).
    Question Two: The GAO reports that blood collections have increased 
21% between 1997 and 2001, and that collections for the first half of 
this year are on pace with the same period in 2001. Even with the 
recent donation shortfall this summer, these emerging data suggest 
collections, overall, have been on the upswing. Do you tend to agree 
with GAO's general findings with regard to donation trends? Why?
    Response: While there are clear and persistent trends showing 
increases in blood donations on both a national and annual basis, the 
magnitude of these increases are not keeping pace with either the 
increased utilization of blood products or the constant erosion of the 
blood donor base and supply. The donor base erosion is due to 
increasingly frequent introduction of ``blood safety'' precautions 
that, while causing large decrements in supply, are sometimes producing 
only marginal, if any, demonstrable increase in blood safety.
    The GAO report primarily covers the years 1997 through 2001, a 
period of tremendous instability of the blood donation pattern of the 
nation. It does not include data from June 2002 to the present, when 
half the nation's blood collectors implemented the new vCJD guidance 
and experienced substantial drops in donation rates. In the GAO report, 
Red Cross reported little impact of implementing their own deferral 
policies, although their implementation dates of last fall coincided 
with the surge of donations after September 11. However, they now 
report critical blood shortages with severe reductions in donation 
rates, along with the rest of the country's blood collectors, and admit 
that loss of donors from the vCJD policies may reduce their ability to 
respond to seasonal donation losses. None of this more recent data is 
addressed in the GAO report.
    Question Three: Ms. Lipton's testimony raises a point about donor 
deferral policies affecting different regions in different ways, due to 
demographics and so forth, and that federal policy makers must take 
this into account. Please explain how you are working to respond to 
this issue. Is ABC going to provide a coordinated response to these 
safety and risk decisions?
    Response: An all-voluntary blood supply depends heavily on local 
community commitment to blood donations that at least perceptually are 
targeted for local use. Blood programs tend to take care of their 
community blood needs first before exporting blood for use in another 
part of the country. Economics does play a role in increasing 
geographic elasticity and willingness to move blood from areas of 
excess to areas of increased donation difficulties and shortages. 
However, the volumes of excess blood available are also subject to 
seasonal variation, thereby increasing the vulnerability of areas where 
donations are inordinately impacted by regulation.
    Question Four: Dr. Jones of the New York Blood Center states ``the 
overall supply curve does not depict the type-specific donation problem 
experienced by all blood collectors.'' Are we measuring the wrong way? 
What is the industry doing about this? The federal government?
    Response: Type-specific shortages have always been the rule. The 
nation's and local blood supply are routinely short of all Rh negative 
blood and seem never to have adequate supplies of type O and type B. 
These types are in high demand relative to collections.
    Two methods are emerging to attempt to create better balance 
between collections and transfusion type mix. One is increasing use of 
automated collections which allows for greater productivity in the 
donation process. For example, donors can give two units of red blood 
cells via automation, therefore increasing the yield per donation for 
specific blood types such as O negative. Another method is to target 
racial and ethnic groups that have higher percentages of certain blood 
types such as the Hispanic groups that have a higher percentage of type 
O blood.
    Another more dangerous way of dealing with type-specific shortages 
is the hospital practice of giving Rh positive blood to Rh negative 
recipients. This practice can save lives in the short term but 
sensitizes the recipient to the Rh positive blood and if the recipient 
ever receives another Rh positive (emergency) transfusion a severe and 
possibly fatal transfusion reaction would occur.
    Question Five: What will a seven-day supply look like? Is it seven-
day supply at each hospital, each blood center?
    Response: A seven-day supply would be what is on the shelf at a 
blood center including blood being processed for use. Since processing 
takes about two days, the net immediately transfusable supply is five 
days. This does not include the supply that is in the hospitals, which 
is usually two to five days in our experience.
    Question Six: Although there is public concern over wastage, and 
the industry recommendations to avoid this in the future, the Red Cross 
testimony suggests a seven-day supply goal will increase wastage. Will 
this be significant? How do you plan to address public concerns about 
increasing wastage?
    Response: There is little question that having a seven-day supply 
will increase wastage. However, most of this wastage will be in the 
common or more plentiful blood types such as Type A and AB. The type-
specific collection strategies mentioned above should help this 
problem.
    Question Seven: Do you believe the nvCJD (Mad Cow disease) 
restrictions should be relaxed?
    Response: Yes. We believe the restrictions should be changed. The 
FDA Transmissible Spongiform Encephalopathies Advisory Committee made 
sensible recommendations when they applied the precautionary principal 
regarding BSE and vCJD to the United Kingdom where 98% of the bovine 
disease and 98% of the human disease are found. It is prudent to 
restrict donations from residents and long-time visitors to the UK 
until the scope of the vCJD problem is better defined. However, 
extension of the vCJD donor restriction to all of continental Europe 
cannot be supported either scientifically or medically by logical 
extension of the precautionary principal and, certainly, by its major 
detrimental effect on the blood supply. We would recommend relaxing the 
pan-European restriction until there is definite epidemiological 
evidence to support it.
                                 ______
                                 
                          How Big is the Room?
            theoretical limits to blood donations and supply
                          Robert L. Jones, MD

    Donated blood for transfusion is a cornerstone of hospital medical 
practice. But recent years have seen blood shortages of increasing 
severity--particularly of red blood cells. Accepted industry lore 
asserts that up to 60% of the population is eligible to donate blood 
but only 5% donate at present. This estimate, based on historic US 
demographics, leaves the impression that there is essentially an 
unlimited reserve of blood donors and donations to meet our nation's 
transfusion needs. However, the experience of the blood donor 
organizations across the country suggests that this blood donor reserve 
is increasingly difficult to recruit, smaller than we thought, or both.
    Although positively motivated by blood safety and efficacy, 
technology and regulation have taken a measurable toll on the number of 
donations contributing to our national blood supply. Each regulatory or 
technologic intervention applies to one or more points along the supply 
chain of blood production--beginning at donor recruitment through 
collections, processing, testing and distribution. The supply chain is 
linear and what seems not appreciated is the additive impact of the 
interventions on the available donor pool and ultimately the supply of 
red cells for transfusion. As we conceptualize the supply chain and 
make assumptions about the beginning donor pool, it is possible that by 
understanding the impact of each intervention we could more accurately 
estimate the actual size of the potential donor base and thus the 
potential blood supply under various circumstances.
    Given persistent and worsening state of blood shortages, it seems 
prudent to study the supply chain in order to estimate the true 
magnitude of the nation's blood donor pool and thus the upper limit of 
the US blood supply available for transfusion. The study would look at 
each segment of the supply chain and calculate the supply removed from 
the total resulting supply from each intervention, either regulatory or 
technologic. For example, donor deferrals remove a calculable 
percentage of the eligible donors depending on the criteria. There are 
also donors lost who perceive they fall into the criteria--a more 
difficult estimate. Other examples are those who are either deferred or 
whose donations are discarded because they test positive for a viral 
marker. There are also those who are false positives or have 
indeterminate results. Then there are the effects of technology applied 
directly to the blood products such as the loss of red blood cells 
produced by leukofiltration. Finally, we should consider the impact of 
pathogen reduction technology on the transfusable cells.
    All of these factors can be integrated into a retrospective meta-
analysis of this important subject. A diverse group of individuals 
familiar with various parts of the supply chain would be gathered to 
make determinations of impact at each point of intervention. The goal 
of the group would be to examine all interventions in total to 
determine 1) an estimate of the true size of the US blood donor base, 
and 2) an estimate of the upper limits of a volunteer blood supply as 
currently structure in the US.

[GRAPHIC] [TIFF OMITTED] T1958.004

    The figure above represents the framework of such a study 
and how graphically such subtractions from the blood supply 
could be shown. The actual segments and numerical contributions 
would be determined by the study. Those shown are only 
preliminary and speculative as to magnitude.
                                ------                                

      Response for the Record of the Food and Drug Administration
    The following is being provided in response to the follow-up 
questions from the September 10, 2002 ``America's Blood Supply in the 
Aftermath of September 11, 2001'' Hearing before the House Energy and 
Commerce Subcommittee.
    Question 1. Based on FDA's experience in reviewing and evaluating 
new safety tests to screen the blood supply, what would be involved in 
developing a blood screen for West Nile Virus?
    Response: Three factors are critical for development of a blood 
screen for infection with West Nile Virus, namely identification and 
development of appropriate test technology, manufacture and validation 
of tests by industry sponsors, and for licensure, meeting standards for 
test performance, including sensitivity and specificity.
    Because individuals may be infected with West Nile Virus without 
experiencing symptoms, donor deferrals based on symptoms, although 
useful, have limited value. Therefore, while the true risk is unknown 
and under study, we currently believe that testing for infection with 
West Nile Virus will likely be necessary if the WNV epidemic continues 
in the U.S. It is known that there is a short period (about 2 week or 
less) when recently infected persons may have virus in their blood in 
the absence of antibodies. Also, the limited available data suggest 
that virus is no longer present when antibodies become detectable. For 
these reasons, scientists believe that the most promising technology 
for donor screening is direct detection of the West Nile Virus itself, 
rather than antibodies to the virus. Also, a direct test for West Nile 
Virus must be sensitive enough to detect the relatively low levels of 
virus that are found in the blood of asymptomatically infected 
individuals. At this time, the best candidate technology is thought to 
be nucleic acid amplification, although other methods, such as tests 
for virus proteins may be feasible. Nucleic acid tests have already 
been successfully licensed to screen blood for Hepatitis C and HIV. 
Discussions are underway among the CDC, FDA and industry both to 
encourage and facilitate studies to determine whether existing nucleic 
acid amplification technology platforms for detection of Hepatitis C 
and HIV could be rapidly adapted for blood bank use to detect West Nile 
Virus and to stimulate the development of other approaches to address 
the problem of donor screening.
    Because it has the greatest capacity and experience to address the 
problem, it is important that industry step forward and take the lead 
in the development and manufacture of a suitable test for West Nile 
Virus. FDA has already contacted potentially interested industry 
members to inform them of the need for test development, and we believe 
that industry is responding. On September 20, 2002, FDA, CDC, and 
representatives from several State Public Health Laboratories and blood 
organizations participated in a meeting organized at by the American 
Association of Blood Banks and AdvaMed to engage members of the device 
industry in a discussion of practical issues related to developing a 
test for West Nile Virus and ways to accelerate test development. We 
discussed the available technologies, possible technology transfer, and 
FDA's willingness to work closely and flexibly with industry to 
facilitate test development. In order to facilitate test development, 
the FDA, CDC, and certain State Public Health Laboratories and blood 
organizations already have agreed to create mechanisms to share 
positive samples and other materials that can be used as reference 
materials to facilitate test development and standardization, including 
regulatory controls.
    In a number of meetings with potentially interested industry 
sponsors, FDA has made it clear that it seeks to encourage widespread 
availability and studies of donor testing for WNV under Investigational 
New Drug (IND) applications as soon as possible to screen for West Nile 
Virus infections at blood centers in areas in need, even before 
licensing. FDA has also discussed its current thinking on standards for 
licensure of a donor-screening test for West Nile Virus. Additionally, 
FDA is planning to announce a public scientific meeting in early 
November to discuss technological issues related to test development 
for West Nile Virus, to present FDA's current thinking regarding test 
development, availability under IND licensure, and to further encourage 
test development. To date, we have been gratified by the level of 
interest and initiative shown by the diagnostic testing industry, and 
the potential of public-private interactions to facilitate these 
activities. While there are significant technological barriers for 
industry to overcome, based on their stated plans and capabilities, we 
are hopeful that a suitable screening test can be made widely under IND 
by next year's transmission season.
    Question 2. Please update the Committee on the status of 
development of a West Nile Virus vaccine. Also, please comment upon the 
risk issues surrounding vaccines (particularly the Smallpox vaccine) 
and the blood supply.
    Response on the development of a vaccine for WNV: While there is 
currently no licensed vaccine available to prevent WNV infection, FDA 
is aware of several approaches to vaccine development and believes that 
vaccination is a potentially viable strategy to address this increasing 
public health threat. Because of the increased presence of WNV in the 
U.S., the National Institute of Allergy and Infectious Diseases (NIAID) 
has supported research in this area. NIAID announced that in 1999 it 
funded a fast-track project to develop a candidate WNV vaccine with 
Acambis PLC. As reported in ``Trends in Molecular Medicine 7:350-
254(2001),'' Acambis has developed a live-attenuated vaccine candidate 
for WNV. For this reason, it is possible that future vaccine recipients 
may need to be deferred from blood donations for the period of viremia, 
which is still to be accurately determined.
    Scientists at CBER are also engaged in studies which may hold 
promise for developing a vaccine effective against WNV. Most people who 
become infected with WNV will have either no symptoms or only mild 
ones. More severe disease occurs in approximately 1/150 of those 
infected and is manifested as encephalitis, meningitis, 
meningoencephalitis, or flaccid paralysis. Encephalitis refers to an 
inflammation of the brain; meningitis is an inflammation of the 
membrane around the brain and the spinal cord, and meningoencephalitis 
refers to the combination of both. Flaccid paralysis is a condition of 
weakness or paralysis that resembles poliomyelitis. There are currently 
no drugs on the market to treat this virus, although two drug products 
are currently being studies under IND. Given the important and 
increasing public health impact of WNV infection, including the 
potential threat to blood safety, and the lack of available vaccines 
and therapeutic measures, FDA places a high priority on facilitating 
the development and review of potential vaccines and therapeutic 
products for WNV infections.
    Response to risk issues surrounding vaccines and the blood supply: 
Blood donors are usually deferred for two to four weeks after receiving 
a live vaccine. In the case of smallpox vaccine, which is a live virus 
vaccine (vaccinia virus) that is administered by puncturing the skin, 
it is not certain whether the blood of vaccinees contains the live 
vaccine virus, or for what time period such a condition could persist. 
For these reasons, FDA is cooperating in research studies to define 
frequency and duration of viremia in persons who receive smallpox 
vaccine. Therefore, until further information is available, FDA 
believes precautions will be needed to prevent transmission of the 
vaccine virus by transfusions, especially to those blood recipients who 
may have depressed immunity. Such a precaution may involve temporary 
deferral of blood donors who have received the smallpox vaccine. FDA is 
developing a guidance document for blood establishments that will 
provide recommendations for deferral of blood and plasma donors who 
have recently received a smallpox vaccination, or contacts of such 
persons who develop evidence of infection with the vaccine virus.
    The U.S. Government has a plan under consideration, which would 
vaccinate first responders prior to any smallpox attack. This plan is 
not expected to significantly diminish the blood supply, because 
relatively few people would be vaccinated at one time. To address the 
possibility of mass vaccination over a period of time, prior to a 
smallpox attack, FDA will work with blood organizations, including the 
AABB Interorganizational Task Force on Domestic Disasters and Acts of 
Terrorism (which includes representatives from the American Red Cross) 
and with organizers of the vaccine program within DHHS, to formulate 
strategies that would alleviate any impact on the blood supply.
    The recently announced plan to institute urgent mass vaccination of 
the U.S. population if there is a smallpox attack, could have a major 
potential impact upon the blood supply, if it were to be implemented in 
an emergency situation, and blood donors who had received smallpox 
vaccination were to be deferred from donation. FDA, in discussion with 
its PHS partners and OPHP, is actively considering potential strategies 
to best address this scenario.
    Question 3. Assistant Secretary Hauer, in his testimony (page 2), 
references FDA's recommendations--endorsed by the Department's Advisory 
Committee--to address future emergency demands on the blood supply. 
Please outline these recommendations and the status of their 
implementation.
    Note to OL: DHHS can add additional information as needed.
    Response: The CBER strategic plan that was endorsed by the DHHS 
Advisory Committee for Blood Safety and Availability contains four 
elements that are intended to protect the blood supply and assure blood 
availability in the face of potential disruptions and biological 
threats from terrorism.

 Actions to protect the blood supply
 Actions to assure continued supply
 Actions to treat affected individuals
 Outreach activities
    Specific working groups have been established to ensure progress in 
each area, based on available funding. The accomplishments to date of 
the CBER strategic plan include:

 CBER has developed a set of standard SOPs for responding to a 
        real or potential bioterrorist threat. Following these 
        procedures, FDA staff responded well to simulated smallpox and 
        botulinum bioterrorist events.
 FDA has collaborated with the NIH, CDC and DOD to develop a 
        bioweapons agent list of concern to the blood supply. These 
        agents could potentially be transmitted by asymptomatic donors 
        exposed to a bioweapons agent. The list provides a focus for 
        the development of prevention measures.
 In collaboration with the CDC, NIH and DOD, CBER scientists 
        are developing gene chip microarray and other sensitive 
        detection systems that could be used to detect bioterrorist 
        agents. When fully developed these systems would be used, when 
        needed, to assess the threat of bioterrorist agents in blood 
        and blood products as part of FDA's lot release program. As 
        appropriate, CBER will work with the blood industry to assist 
        in transfer of the technology to diagnostic product 
        manufacturers to accelerate the development of donor screening 
        tests for bioterrorist agents. The knowledge gained will also 
        assist in facilitating the review of test kits that may be 
        submitted to FDA to assure the safety of donated blood.
 CBER scientists are researching pathogen inactivation/removal 
        methods that could be used to protect blood and blood products 
        from bioweapons.
 Immunization of the public at large with live virus vaccines 
        poses potential challenges to blood safety due the possibility 
        that live virus could persist for a period of time in the blood 
        of a recent vaccinee. In response to the potential threat of 
        smallpox, the government has identified a stockpile of vaccine 
        for the entire country. Immunization of large numbers of the 
        population poses its own concerns including the potentially 
        serious impacts of live virus vaccination on individuals with 
        compromised immune systems and the potential impact of the 
        temporary deferral of large numbers of immunized individuals 
        from blood donation. To address these concerns, FDA has taken 
        the following steps:
     FDA is preparing a guidance document on the deferral of 
            donors who have been immunized to prevent smallpox.
     FDA is working with CDC and manufacturers to help 
            facilitate the development and availability of Vaccinia 
            Immune Globulin (VIG) used to treat individuals with 
            compromised immune systems who may be exposed to the 
            vaccine and to treat severe complications of the vaccine.
     There has been monthly monitoring of VIG supplies and 
            doses available
     Cooperative communication with VIG manufacturers, the 
            Department of Defense, and CDC concerning VIG potency and 
            availability, monitoring of VIG studies, and progress 
            towards licensure.
 DHHS and CBER participate actively in the AABB Inter-
        organizational Task Force on Disasters and Bioterrorism. This 
        group has been formed to help to manage blood supplies in the 
        face of disruptions from natural or man-made causes.
 Following the tragic anthrax attacks of last year, the FDA 
        issued guidance to industry on deferral of donors potentially 
        exposed to anthrax and the retrieval of blood products. FDA is 
        preparing a guidance document to address donor and product 
        management in the face of possible or confirmed infections with 
        West Nile Virus. Additionally, FDA is taking steps to 
        accelerate the development of a screening test for West Nile 
        Virus infections in donors. These actions are being viewed 
        concurrently as a model for actions that would be taken to 
        address emergence of a bioterrorism agent as a blood safety 
        threat.
    Question 4. Some experts believe that the blood supply could be 
boosted by making it much easier for blood centers to accept blood 
donations from patients who have a genetic condition that causes an 
iron-load (called hemochromatosis) requiring periodic blood-letting and 
whose blood could provide thousands of units for donations. But only 29 
out of the nation's 4,000 blood centers used donations from these 
patients because it requires special permission from the FDA and extra 
expense. Is the FDA considering any new policies to make it easier for 
blood centers to accept donations from patients who have 
hemochromatosis?
    Response: Hereditary hemochromatosis (HH) is an inherited disorder 
of iron metabolism that results in iron accumulation and damage in 
multiple organs. Early initiation of therapeutic phlebotomies to remove 
iron, which is present in red cells, may restore a normal life 
expectancy and improve symptoms in these patients. Although FDA allows 
blood from patients with HH or other conditions that was drawn for 
therapeutic reasons to be used for transfusion, FDA regulations (21 CFR 
640.3(d)) require that such blood be labeled with the disease state 
that necessitated the therapeutic phlebotomy. Because blood centers 
charge HH patients for the therapeutic phlebotomies, there has been a 
concern that patients with HH who also had risk factors that would 
cause them to be deferred would deny risks to avoid payment for the 
phlebotomy.
    On April 29, 1999, the Public Health Service Advisory Committee on 
Blood Safety and Availability (ACBSA) recommended that the Department 
of Health and Human Services (DHHS) ``create policies that eliminate 
incentives to seek [blood] donation for purposes of phlebotomy'' from 
patients with diagnosed hemochromatosis who require phlebotomy as 
therapy for their disorder. Further, ACBSA recommended that DHHS 
``create policies that eliminate barriers to using this resource'' to 
augment the country's blood supply. This issue was further discussed at 
the FDA Blood Products Advisory Committee meeting on September 16, 
1999. Based on the recommendations of BPAC, FDA issued Guidance for 
Industry: Variances for Blood Collection from Individuals with 
Hereditary Hemochromatosis (August 2001). In its guidance document, FDA 
stated its recommendations that use of blood from patients with 
hemochromatosis can be permitted in the absence of special labeling and 
without the restriction of one donation per eight weeks if: 1) the 
individual meets all other suitability requirements, and 2) the 
establishment does not charge a fee for any phlebotomies performed on 
individuals with HH including those who do not meet suitability 
requirements.
    At present, FDA is allowing establishments to obtain a variance 
from the special labeling and donation frequency requirements so long 
as the establishment meets the conditions stated in the guidance. That 
is, the individual meets all other suitability requirements, and the 
establishment does not charge a fee for phlebotomies performed on any 
individual with HH. A persisting obstacle to increased donations by 
individuals with HH remains reimbursement for the phlebotomy. Also, 
management of phlebotomies for HH donors requires considerable 
logistical support that is difficult for many blood centers to develop 
and maintain.
    Question 5. Two years ago, the HHS Advisory Committee on Blood 
Safety and Availability voiced support for moving the error-and-
accident reporting system toward a no-fault reporting system to 
encourage more reporting and better use of data to produce better blood 
safety, such as continually reducing the probability of transfusing an 
incompatible blood type to a patient. Is FDA taking actions to move the 
blood error-and-accident reporting system toward a no-fault reporting 
system such as the one used in commercial civil aviation?
    Response: In April 2000, the Advisory Committee on Blood Safety and 
Availability considered the issue of a national reporting and analysis 
system as a basis ``to reduce and prevent morbidity and mortality due 
to human and system error.'' The committee acknowledged ``the right of 
patients to know of any risk or harm suffered as a consequence of any 
error or accident related to blood products received'' and endorsed the 
concept of a voluntary system for reporting information, so long as the 
acts were not reckless or intentional. At the same time, the Advisory 
Committee recognized that ``these error management systems should 
complement, and not replace, current regulatory activities, notably but 
not exclusively in the area of product safety.''
    FDA agrees that a mandatory reporting system for errors and 
accidents is necessary for ensuring patient protection while a 
voluntary anonymous reporting system also may have benefit and can be 
complimentary. CBER's Biological Product Deviation Reporting (BPDR) 
system, implemented on May 2001, collects and analyses events that may 
affect the safety, purity, and potency of biological products. This 
system was previously known as Errors and Accidents and has been 
extended to apply to all blood establishments, including hospital 
transfusion services, rather than only to licensed blood 
establishments. The BPDR system is an important component in the 
Center's overall efforts of assuring blood safety by providing CBER 
with timely information on real or potential recalls, significant 
problems that may exist at a given establishment which require 
investigative follow up, as well as an indication of broader problems 
in manufacturing across the industry. Although not a ``no-fault'' 
system, the individual report data are collected with the further 
intent of identifying and sharing with industry areas where processes 
can be improved. Such areas can then be targeted generally for focus 
during inspections by our field investigators or to identify problems 
at particular establishments.
    The ``Medical Event Reporting System-Transfusion Medicine (MERS-
TM)'' is an error reporting system that was developed with funding from 
the NIH and now is in use at some blood centers as a funded pilot 
project. Dr. Harold Kaplan, Columbia Presbyterian Hospital, NYC, is the 
leading investigator. MERS-TM serves as a model for non-punitive, no 
fault, medical event reporting system. Although it is not a system 
designed for reporting information to FDA, we have encouraged its use 
and see this as an adjunct system that provides useful information to 
address events that may contribute to errors in transfusion medicine. 
FDA encourages the use of all means of identifying and managing of 
product deviations, including a supplemental system such as MERS-TM.
    The issue of errors and accidents related to transfusion is part of 
a larger DHHS initiative on patient safety in which FDA participates 
actively.
                                 ______
                                 
  Response for the Record of the Department of Health & Human Services
    Question #1 Please clarify whether the recommended changes to a new 
Emergency Support Function 8 supplement to the Federal response plan, 
which you testified you forwarded to FEMA, have been in writing and 
please share them with the Committee, if this is the case.
    Answer #1 We have no written changes to the ESF#8 supplement to the 
FRP. Bob Jevec from DPD confirmed this through John Baab at OER. Bob 
states that we were awaiting decisions on departmental assignments 
before suggesting changes to the FRP.
    Question #2 Please clarify which federal public health agencies are 
funding research for developing a diagnostic test for screening for new 
variant Creuztfeld-Jakob Disease.
    Answer #2 Description of the Federal Agencies that are supporting 
development of diagnostic tests for variant Creutzfeldt-Jacob Disease 
(vCJD).
    The two Institutes at the NIH supporting development of assays for 
CJD and vCJD are NHLBI and NINDS. NHLBI and NINDS are currently 
supporting two contracts on CJD/vCJD test development. The two 
contractors are the University of California, San Francisco (PI Stanley 
Prusiner, M.D.) And Baltimore Research and Education Foundation (PI 
Robert Rowher, Ph.D.). This program ends in September 2005.
    The NHLBI is also supporting an RFA on the development of assays (3 
grants) that are due to expire August 2003.
    Also, the Department of Defense is soliciting contract proposals to 
develop tests for transmissible spongiform encephalopathies (TSE) which 
can include vCJD. DOD plans to support research in other areas of TSE 
as well (e.g., chronic wasting disease, etc.). This program is being 
managed by the DOD Office of Congressionally Directed Medical Research 
Programs. This program is called the National Prion Research Program.
    Question #3 Please update the committee on the status of research 
and development of ``artificial blood'' products.
    Answer #3: What follows is an article from the Boston Globe dated 
10/02/02 telling about FDA's acceptance of an application by Biopure to 
have its product Hemopure reviewed. This is significant because Baxter 
Healthcare and its partner in artificial blood, Alliance Pharmaceutical 
have had to suspend further testing of its product, Oxygent, due to 
lack of funding. Additionally, the only other U.S. company researching 
hemoglobin based oxygen carriers (HBOCs), Northfield Laboratories, has 
stated that it will probably have to conduct new clinical trials.
    A Canadian company, Hemosol, has suffered clinical trial delays and 
recently had to cut staff in an effort to conserve cash.
    Last month Biopure revealed that it had received a grant from DOD 
totaling more than $900,000 to develop a blood substitute for use in 
military trauma cases.
Boston Globe Article 10/02/02
    In a major milestone in its 18-year effort to develop a 
controversial blood substitute of human use, Biopure Corp. of Cambridge 
yesterday said the US Food and Drug Administration had accepted its 
application for the product, Hemopure.
    The FDA is expected to take 10 months to respond fully to the 
application, which was submitted in late July. The agency could ask for 
additional information or further clinical testing, potentially 
delaying a definitive decision on the product, which is approved for 
sale only in South Africa.
    Still, the news is a big boost for Biopure, which last year delayed 
its plans to file the FDA application, infuriating many investors and 
raising doubts about the product's ultimate viability. Biopure shares, 
which has lost more than 80 percent of their value in the past 12 
months, gained 64 cents, or 19.3 percent, to close at $4.14 on volume 
of 402.800 shares yesterday.
    Thomas A. Moore, Biopure's new president and chief executive, said 
the company learned the news at 2 p.m. yesterday in a phone call from 
FDA just prior to receiving an official fax.
    ``While the FDA will decide whether our application is approvable, 
this acceptance is further affirmation of the substantive clinical data 
we've amassed,'' More said. ``This latest `first' for Biopure should 
help support our efforts to establish new business relationships and 
product indications.''
    Moore said Biopure is in advanced talks with a Far East 
manufacturer, whom he declined to identify, which would invest in the 
company and build a production plant to serve Asian markets. The two 
firms have signed a nonbinding letter of intent, he said, and plan to 
complete a binding contract by the end of the month. The partner firm 
would invest $15 million in Biopure over 10 months, purchase $15 
million of Hemopure, and would invest up to $145 million in the 
manufacturing plant.
    If the deal comes to fruition, it could give Biopure some needed 
breathing room. In addition to the delays in filing its so-called 
Biologic License Application with the FDA, the firm faced a cash crunch 
earlier this year. The firm's shares fell below a minimum price 
necessary for the company to draw on a credit line it had arranged by a 
French company. Instead, the firm had to sell several blocks of shares 
to investors in private placement.
    Moore said Biopure has more than $25 million in cash on hand, down 
from about $30 million July 31.
    More than 12 million units of blood are transfused each year.
    Companies racing to supply a viable blood substitute, or oxygen 
therapeutic, as they are now called, claim there is a growing shortfall 
of blood for patients who need transfusions. Some estimate the 
potential market is in excess of $12 billion.
    Hemopure is made from cow's blood, from which the hemoglobin is 
extracted and treated to remove any diseases or pathogens. The so-
called bovine hemoglobin is suspended in a saline solution.
    According to doctors who have worked with Hemopure, the artificial 
blood seems to have some advantages compared to the real thing. In the 
body, red blood cells carry oxygen, but they can only release it to 
tissues when they are in contact with the capillary wall. Hemopure can 
release oxygen without direct contact. In addition, it can penetrate 
further into tissues than red blood cells can, potentially applying 
oxygen more effectively than real blood.
    But there are significant drawbacks. Hemopure rapidly breaks down 
in the body, and is filtered out by the liver. A unit of Hemopure has a 
half-life of 24 hours, so the benefits of a Hemopure transfusion 
rapidly decline. And it is costly: Biopure estimates it costs $700 to 
produce a unit of Hemopure. Blood in hospitals costs between $100 and 
$200 a unit.
    In another milestone, Moore sad that Biopure had sold its first 
commercial units of Hemopure in Mozambique. South Africa last year 
became the first country to approve Hemopure for sale, and the 
Mozambique sales come under that regulatory approval. The company 
hasn't yet sold Hemopure in South Africa. Instead, it is providing the 
product for free as it conducts a wide-scale education and training 
effort for South African physicians. The quantities sold in Mozambique 
are too small to have a material impact on the firm's results.
    In addition, Moore said, the firm is awaiting FDA approval of an 
upgrade to its Cambridge plant that would enable it to sell units of 
blood substitute for dogs. Until it receives that OK, Oxyglobin 
produced at the Cambridge plant must be held in inventory. Though sales 
of Oxyglobin has been below expectations, they provide Biopure with 
revenue stream while it continues its efforts to commercialize 
Hemopure.
    ``We're hopeful of resuming shipments in October or November,'' 
said Moore.
    Meantime, the company is also preparing regulatory filings for 
approval to sell Hemopure in the European Union and other overseas 
markets.
    But Biopure faces additional challenges while it awaits further 
discussions with the FDA. Construction on a Hemopure production plant 
in South Carolina, which was to begin in February, is still delayed. 
The local firm that plans to build the $120 million plant still hasn't 
closed on its financing, Moore said. Once the money is in hand, Biopure 
still has to execute a lease on the facility before construction can 
begin.
    Other firms working to commercialize blood substitutes include 
Hemosol Inc. of Toronto and Northfield Laboratories Inc. of Evanston, 
Ill. Biopure's product contains hemoglobin isolated from cow's blood.
    Question #4 According to testimony submitted by America's Blood 
Centers, at Secretary Thompson's request America's Blood Centers 
developed and submitted a blood action plan that HHS could use to help 
increase donations for blood. Despite the Secretary's pledge and 
numerous attempts in follow-up, no action has been seen from HHS to 
help bolster supply. Does HHS have a view on ABC's action plan and in 
any event, what action is the Department talking to ensure adequate 
availability of the U.S. blood supply?
    Answer #4 Secretary Thompson is vitally interested in encouraging 
organ donation and have instituted a program call Donate Life, the aim 
of which is to increase public awareness and participation in an organ 
donation program. He is currently researching ways the Department can 
take a leading role in increasing the donation of blood as well. When 
the Advisory Committee on Blood Safety and Availability met on 
September 5, 2002 one of its recommendations was that the Department 
promote increased public awareness of the ongoing need for routine 
blood donations by healthy persons and address methods to alleviate 
seasonal short-falls.
    Question #5 Has HHS examined any data or information relating to 
the experiences in Israel and how its Mogen David Blood Services are 
maintaining blood supply in the face of emergencies over the last year? 
What has HHS found?
    Answer #5 Following is an abstract of an article submitted to the 
journal Transfusion regarding the utilization of blood in Israel. The 
actual blood transfused is obtained by local donors as a result of 
local appeals.
    CAPT Barbara Silverman, M.D., M.P.H., visited MDA in June of 2002 
to analyze MDA supply and utilization data and compare the MDA 
experience to that of three community sites participating in the PHS 
sentinel surveillance system. Supply and utilization data were 
available for the period from October 200-June 2002. MDA also provide 
detained data on the number and severity of casualties due to terror 
episodes occurring from January 1-June 15, 2002. The following is 
excerpted from a draft manuscript describing the MDA experience and the 
impact of multi-casualty terrorist events on the Israeli blood supply:
    In the event of a multi-casualty event in Israel, responding 
ambulance personnel rank severity of injuries as light, moderate, 
severe and very serve MDA contacts hospitals slated to receive 
casualties, consults with them regarding their current blood stocks, 
and using a predetermined formula, calculates the number and type of 
additional units to be sent to these hospitals. Previous MDA experience 
has suggested that an individual wounded in a terror attack will 
require, on average, 3 units of blood, 1.1 units of plasma, 0.11 units 
of plasma, 0.11 units of platelets and 0.27 units of cryoprecpitate. 
However, there is concern that changes in the character and location of 
terrorist attacks, shorter response time by emergency personnel, and 
other factors may result in larger numbers of more severely wounded 
patients surviving to receive in-hospital treatment, resulting in 
higher per-patient blood utilization.
    We considered data from 24 episodes occurring on 30 days between 
January 15, 2002 and June 15, 2002. These episodes resulted in a total 
of 176 deaths in the immediate aftermath of the events, 225 persons 
with moderate or severe injuries, and 899 with minor injuries. Injured 
persons were transported to a total of 20 hospitals. Mortality figures 
do not include individuals who may have died later as a result of 
injuries sustained during these events. In response to these events, 
MDA supplied 2712 units of blood (approximately 12 units per severely 
or moderately injured victim) and 1711 units of components to receiving 
hospitals that requested them. Hospitals that received causalities did 
not always request additional blood supplies. Blood supplied to 
hospitals in response to terrorist attacks constituted 3% of total 
units provided during the period from January 15, 2002 through June 15, 
2002, and on average, 14% of total units (95% CI 3%-54%) provided on 
the affected days. MDA supplied a mean of 676 units per day to 
hospitals on days on which no such events occurred, a difference that 
was not statistically significant.
    We attempted to determine whether units of blood supplied to 
hospitals in response to terrorist incidents tended to be used 
immediately or merely bolstered hospital inventory. For all twenty 
hospitals that received casualties from terrorist events, we compared 
mean inventory for the three-day period beginning with a terrorist 
event to mean inventory on all other days. Mean blood inventory 
following a request for blood was slightly lower than mean daily 
inventory on other days (83 vs 89 units), although this difference was 
not statistically significant. This finding suggest that the amount of 
blood supplied to hospitals in response to terrorist episodes was used 
quickly rather than inflating inventory.
    We plan to extend this analysis by gather patient-specific 
utilization data from hospitals. By doing so, we will be able to 
calculate initialization by severity of injuries and determine whether 
the algorithm currently in use by MDA for estimating the number of 
units to distribute per injured patient is appropriate or should be 
revised.
                                 ______
                                 
Response for the Record of Colonel Glen M. Fitzpatrick, Director, Armed 
                         Services Blood Program

        QUESTIONS FROM SUBCOMMITTEE CHAIRMAN JAMES C. GREENWOOD

    Question 1: Dr. Fitzpatrick, please provide more detail to the 
Committee on the status of the research at Walter Reed Army Institute 
of research to extend the shelf life for blood from 42 days to 70 days. 
Also, please discuss how much impact such an extension would have on 
the blood supply levels.
    Answer: Research continues at the Walter Reed Institute of Research 
into extending storage of red blood cells at 4 deg.C to at least 10 
weeks (70 days). Preliminary human studies have been successful, but 
additional in vivo trials at multiple centers are required in order to 
collect enough information for FDA licensure. Fielding is dependent on 
finding a corporate partner for commercial development. No such company 
has been identified yet. Other projects underway to improve blood 
support to the field include: (1) developing with corporate partners a 
small container that will maintain blood at the proper temperature for 
at least 48 hours in the most severe of field environments; (2) 
extending the shelf life of frozen red bloods cells after thawing 
beyond 2 weeks (14 days); (3) corporate partnering for the study of 
blood ``sterilization'' to reduce the risk of transmission of 
infectious agents; (4) coordination of a trauma treatment protocol for 
hemoglobin-based oxygen carriers (HBOC, also referred to as ``blood 
substitutes''); (5) preparing freeze-dried plasma--plasma is currently 
stored and shipped frozen, freeze-drying it will significantly reduce 
the logistical requirements; (6) collaborating with industry to produce 
a universal plasma in order to eliminate the requirement for blood 
typing for plasma; (7) methods to improve blood clotting using platelet 
microparticles, freeze-dried platelets, and other agents such as 
recombinant factor VIIa.
    Increasing the shelf life of refrigerated red blood cells from 42 
to 70 days would significantly reduce the logistical burden of 
supporting contingencies such as Operation Enduring Freedom and 
continuing operations such as ongoing in Bosnia and Kosovo. Most 
military operations do not use a lot of blood treating patients, but 
because of the potential for casualties, blood must be immediately 
available (on the shelf) at all medical units that could potentially 
treat casualties. Units supporting operations far forward, such as the 
Forward Surgical Teams, must accomplish resupply as often as every two 
to three weeks. This could expose medical personnel to hazardous 
conditions, as they may have to cross potentially hostile and dangerous 
areas to acquire fresh units. Increasing the shelf life from 42 to 70 
days could reduce the blood requirement by half, decreasing hazards to 
deployed medical personnel, shipping costs, and donation requirements. 
The Armed Services Blood Program has provided over 16,000 units of red 
blood cells to Operation Enduring Freedom. Increasing the shelf life 
would significantly reduce this requirement.
    Question 2: Dr. Fitzpatrick, in testimony from the American 
Association of Blood Banks and others, there is a discussion of a goal 
of a 7-day blood supply on the shelves--up from roughly a 2- or 3-day 
supply at present. You discuss a strategic reserve in your testimony. 
Please describe how this relates to the domestic blood community's 7-
day ``supply on the shelf'' goal? Which approach would be more cost-
effective to achieve, in your opinion?
    Answer: The goal of increasing the national blood supply from a 2- 
to 3-day level to a 7- to 10-day level and having a national blood 
reserve are not mutually exclusive. In fact, I believe one supports the 
other. The key differences are in the ability to rapidly mobilize and 
move a large number of units of blood to sites within the continental 
United States or to sites abroad in support of either civil or military 
needs.
    One issue needing clarification is the definition of a 7- to 10-day 
supply. Neither the government nor the blood industry really knows what 
a 7- to 10-day supply is and have not agreed on a method to determine 
that number. Most hospitals maintain a 5- to 10-day supply, while the 
supply at the blood centers fluctuates from as low as 2 days to as high 
as 10, but this is not seen at the hospital level because hospital 
inventories can be maintained even when the collection centers have 
only a 2- to 3-day supply.
    Increasing the national inventory to a 7- to 10-day supply provides 
a reasonable margin of safety for absorbing periods of decreased 
donations, but may not meet the need of creating a national reserve 
because the blood may not be near a civil or military airport and is 
under the control of the local donor center or hospital. Additionally, 
there is no process or system established to determine if the 
``reserve'' should be mobilized. Procedures would need to be 
established to procure and move the blood units to the desired 
location. I believe the Inter-Organizational Task Force formed to 
address blood management in an emergency should address these issues 
and provide such a plan to Congress and Secretary Thompson. A key 
element of both solutions is a National Blood Donor recruitment effort 
supported by Congress and the Department of Health and Human Services.
                                 ______
                                 
                                         American Red Cross
                                                    October 7, 2002
The Honorable James C. Greenwood
Chairman
Subcommittee on Oversight & Investigations
2436 Rayburn House Office Building
Washington, DC 20515-3808
    Dear Chairman Greenwood: Provided below are the American Red Cross 
responses to your letter of September 20, 2002, requesting additional 
information following the September 10, 2002 hearing before the Energy 
and Commerce Subcommittee on Oversight and Investigations.
    We are pleased to work with you and the Subcommittee on the 
important issues related to blood preparedness. Jan Lane, Vice 
President, Government Relations, is available to answer any questions 
or provide any additional information that may be needed. She can be 
reached at 202-639-3482.
            Sincerely,
                                              Allan S. Ross
        Vice President Technical Operations and Biomedical Services
cc: Honorable Peter Deutsch, Ranking Member
   Subcommittee on Oversight & Investigations

    Question # 1--Because screening for blood-borne diseases, donors 
have more questions to answer and the donation process takes more than 
an hour on average. Is the Red Cross taking any actions to make blood 
donation less complicated and less time consuming? For example, are 
donor questionnaires being automated? Is this a good idea?
    Response: The Red Cross has been working with the American 
Association of Blood Banks (AABB) Uniform Donor Questionnaire Task 
Force to examine ways to validate questions posed to blood donors to 
determine accurate health histories. This effort will help ensure that 
the questions we ask our donors are clearly understood, elicit accurate 
responses, and provide information the blood banking community needs to 
ascertain whether the potential donor is eligible to donate. A 
validation of the donor history questionnaire has been completed and we 
believe implementation of this questionnaire will assist in minimizing 
the time involved in the donation process.
    The blood banking community has also been urging the Food and Drug 
Administration (FDA) to consider approving Self-Administered Health 
Histories (SAHH) to expedite the donation process. SAHH allow donors to 
answer a series of questions about their medical history without direct 
oral questioning by a blood bank staff member. Data presented at a 
recent Food and Drug Administration (FDA) Blood Products Advisory 
Committee (BPAC) meeting highlighted the accuracy of this method in 
eliciting truthful answers from potential donors. When approved by the 
FDA this process will decrease the amount of time need to donate blood.
    Finally, the Red Cross is committed to automating the donor 
questionnaire process through our electronic Blood Donor Registration 
project. This project will allow donors to answer medical history 
questions through an electronic format. This process is expected to 
save time for the donor and reduce the potential for errors, market 
withdrawals and recalls.
    Question #2--The GAO reports that blood collections have increased 
21% between 1997 and 2001, and that collections for the first half of 
this year are on pace with the same period in 2001. Even with the 
recent donation shortfall this summer, these emerging data suggest 
collections, overall, have been on the upswing. Do you tend to agree 
with GAO's general findings with regard to donation trends? Why?
    Response: Red Cross whole blood collections increased 18% between 
calendar years 1997 and 2001; however, 1997 was one of the lowest 
collection years on record. It is also important to note that while 
collections have increased, distributions to the hospitals we serve 
have increased at an even more rapid rate. In regard to collections, if 
comparisons are made between fiscal year 2000-2001 and fiscal year 
1985-1986, when collections were fairly high, it becomes evident that 
the growth in collections has remained relatively flat (i.e., only a 3% 
growth rate over the entire period, or 0.2% annually).
    Whole blood collections for the Red Cross from January 2002-August 
2002 were at 4,309,220 units. This represents a decrease of 1% from the 
same time period in 2001. Because collections are unlikely to be as 
high in September and October 2002 as they were in 2001, our 
collections are expected to be 4% to 5% lower in calendar 2002 when 
compared to 2001. Provided below are the number of whole blood units 
collected by the Red Cross since FY 1986.
    Red Cross Fiscal Year Collection History: 1985-86 $6,185,905; 1986-
87 $6,422,788; 1987-88 $6,268,119; 1988-89 $6,264,622; 1989-90 
$6,382,565; 1990-91 $6,091,984; 1991-92 $6,012,246; 1992-93 $5,848,743; 
1993-94 $5,782,087; 1994-95 $5,743,861; 1995-96 $5,783,861; 1996-97 
$5,626,689; 1997-98 $5,907,711; 1998-99 $6,107,330; 1999-00 $6,279,839; 
2000-01 $6,377,292; 2001-02 $6,789,097; and 2002-03 $6,474,402 (goal).
    Question # 3--Ms. Lipton's testimony raises a point about donor 
deferral policies affecting regions in different ways, due to 
demographics and so forth, and that federal policy makers must take 
this into account. Please explain how the Red Cross is working to 
respond to this issue. Is it going to provide a coordinated response to 
these safety and risk decisions?
    Response: Ms. Lipton stated ``. . . when making any blood related 
policies, including donor deferral policies, the federal government 
must carefully consider their potential impact on the blood supply, 
both national and regional. For epidemiologic and demographic reasons, 
different deferral policies may affect certain regions of the country 
more than others. If there is a blood supply problem in any part of the 
country, in any blood type, there is a shortage. Patient access to an 
available blood supply is clearly a safety issue as well as a public 
health priority.''
    Ms. Lipton stated that policy makers should be aware of the impact 
of deferrals locally and nationally, but we do not interpret her 
statement to convey that deferral policies should vary based on 
geography. Clearly any effect upon the adequacy of the blood supply 
must be taken into consideration when examining potential criteria to 
defer blood donors. However, if a deferral policy will increase safety 
or confidence in the blood supply, it should be implemented--even if 
this means that the blood banking community must intensify its donor 
recruitment initiatives to offset potential donor losses.
    Historically, certain areas of the country are able to collect more 
blood than is used; the converse is also true. A number of factors 
contribute to this situation. For example, a larger proportion of the 
population in rural areas tend to donate blood as compared to more 
urban areas. However, the amount of blood transfused per capita in 
urban areas is significantly higher than in rural areas. This is not 
surprising in view of the fact that most major medical centers are 
located in metropolitan areas and many patients, even from rural areas, 
are treated in these centers for more complex medical situations. In 
general, donor deferral rates in various geographic areas only 
contribute marginally to differences in blood collections in varying 
parts of the country.
    On September 5, 2002, at the U.S. Department of Health and Human 
Services (HHS) Advisory Committee on Blood Safety and Availability 
(ACBSA), the Red Cross presented information on how we manage the blood 
supply among our 36 blood regions as a single system (see attachment 1 
for a map of the areas of the country served by these regions). The Red 
Cross monitors blood inventory by all eight blood types in each region 
every day, along with projections for collections and usage in the 
coming weeks. Based on that information, projections of local 
inventories are made, and blood is shipped among the regions to 
equitably allocate blood throughout our system. Through this inventory 
management system, the Red Cross is able to respond to different 
donation and hospital usage rates to ensure blood is available wherever 
and whenever it is needed.
    Question #4--Dr. Jones of the New York Blood Center states ``the 
overall supply curve does not depict the type-specific donation problem 
experienced by all blood collectors.'' Are we measuring the wrong way? 
What is the Red Cross doing about this? The federal government?
    Response: Dr. Jones of The New York Blood Center (NYBC) spoke about 
a recent trend of having to utilize Rh positive blood for certain Rh 
negative patients. This indicates an increasing shortage of Rh negative 
blood, which is essential for many Rh negative patients. The Red Cross 
has also experienced a greater difficulty in maintaining an adequate 
supply of group O blood, the universal donor blood type.
    In leveraging our national presence to minimize the effect of 
shortages, the Red Cross uses our inventory management system to 
balance type-specific blood excesses and needs. The inventory in our 36 
Blood Regions is monitored daily to determine where our inventory does 
not match the needs of the hospitals we serve. In these cases, excess 
blood in one Blood Region may be moved to another Blood Region to 
satisfy type-specific needs.
    The Red Cross has also recognized the demographic changes occurring 
in our country and the importance of collecting blood from a more 
diverse donor population. To address this problem, there is an ongoing 
focus on collecting blood from group O individuals and other specific 
types to match our collections strategies with patient needs.
    Question #5--What will a seven-day supply look like? Is it seven-
day supply at each hospital, each blood collection center?
    Response: The Red Cross uses a three-month rolling average of its 
gross total weekday distributions to determine its one-day supply level 
by blood type and blood region. This number fluctuates monthly as 
determined by the rolling average. The current one-day supply for the 
Red Cross system is 25,163 units of red blood cells. The seven-day 
supply level is currently 176,141 units of red blood cells. This 
quantity is a sum of all blood types in all regions.
    The Red Cross inventory management plan is to maintain a seven-day 
supply level at each of its 36 blood regions. Hospital inventories are 
based on several factors, including but not limited to blood usage 
requirements, contingency planning, storage capacity, delivery 
schedules from the blood region, distance from the blood region, and 
type of healthcare facility (large metropolitan versus small rural). 
Hospital inventories normally range from one-day to fourteen-days, 
depending on the above factors.
    The American Red Cross is pursuing a number of initiatives to 
enhance our collections efforts to support a 7 day inventory. We have 
recently completed significant market research to better understand the 
attitudes of the American public regarding blood donation. Our goal is 
to use the data collected from this survey to understand which segments 
of the population have a greater affinity to the Red Cross and blood 
donations; understand the marketing approaches that need to be taken to 
encourage donations; and, implement the tactics that need to be 
executed to ensure more frequent donations by current donors. In 
collaboration with the American Association of Blood Banks and Americas 
Blood Centers, the Red Cross is launching a campaign in Spring 2003 
that will serve the dual purpose of helping improve our current 
collections and improve future inventories through a large scale public 
education and awareness campaign. Additionally the Red Cross is looking 
at several other initiatives including establishing national account 
relationships, co-branding with our partners both in the blood banking 
industry and with our partners in corporate America, and expanding our 
collegiate activities--all with the intent of boosting the blood supply 
in the country.
    Question #6--Although there is public concern over wastage, and the 
industry recommendations to avoid this is the future, your testimony 
suggests a seven-day supply goal will increase wastage. Will this be 
significant? How does the Red Cross plan to address public concerns 
about increased wastage?
    Response: Outdates are predominantly determined by two factors: the 
first factor is the balance between the blood types collected versus 
the blood types distributed. If there is a blood type imbalance (e.g., 
more group AB's are collected than distributed), outdates of a 
particular blood type may increase because of a lack of demand. The Red 
Cross and others are attempting to address this situation by automating 
collection processes, which will enable us to collect only the blood 
component we need from certain blood group donors. Full implementation 
of this type of technology will take years to implement because of cost 
and space issues.
    The second major factor that can result in outdates is the shelf 
life of red cells (42 days). Red cell units are distributed to 
hospitals everyday where they are either transfused or remain at the 
hospital for inventory purposes. In some cases, the red cell unit is 
returned back to the blood region and attempts are made to transfer the 
unit to a hospital that has a greater demand. The amount of time 
remaining on the unit when it is returned is a determining factor as to 
whether or not the unit will be used. The shorter the expiration date, 
the greater the possibility the red cell unit will not be used. Blood 
regions work very closely with hospitals to balance the on-hand 
hospital requirements and the dating of the hospital inventory to 
minimize outdating of blood products.
    There is a cost to blood preparedness that must be recognized. 
Despite our best efforts, there will continue to be a certain 
percentage of units that will outdate before they can be transfused. 
Currently, between 1 to 2 percent of blood products nationwide expire 
before a hospital can transfuse them. This minimal outdating means that 
the system is functioning properly. If there was no outdating of blood 
products, the result would be cancellations of surgeries and blood not 
being available during emergencies.
    As the inventory is increased to 7 days to meet increased demand, 
the number of units outdating will correspondingly increase. The Red 
Cross and our blood banking colleagues are careful stewards of the 
units voluntarily donated to us by altruistic individuals. The goal is 
to achieve a seven-day inventory level while maintaining a balance 
between blood types collected versus blood types used.
    Question #7--Does the Red Cross believe the nvCJD (Mad Cow disease) 
restrictions should be relaxed?
    Response: The Red Cross believes the current deferral criteria 
should not be changed. We formally review our donor deferral practices 
annually and specifically consider our practices regarding vCJD during 
this review. Notwithstanding the fact that our deferral practices and 
criteria may require more effort to recruit suitable/qualified donors, 
our intentionally methodical and conservative approach gives us better 
assurances that we are providing the safest blood to the patients we 
serve. We will continue to reevaluate our current deferral practices to 
ensure a safe and available blood supply.
    Question #8--If there were another emergency such as September 
11th, would the Red Cross urge people to donate even if there was 
enough blood on the shelf so that the blood could be used for the 
strategic blood reserve?
    Response: The Red Cross is committed to working with the AABB 
Inter-organizational Task Force and The Department of HHS on consistent 
public messaging on the need for blood donations during natural and 
man-made disasters. This Task Force will provide an effective means for 
the blood banking organizations and federal government officials 
responsible for disaster preparedness and public health to coordinate 
efforts before and after disaster strikes. Through the Task Force, the 
entire blood banking and public health officials will have an effective 
means of assessing the need for blood donations following a mass 
casualty event, coordinating public messaging of the need for blood 
donations, and the transportation of blood components where needed.
    Question #9--On August 22, 2002, CBS News aired a report featuring 
Joe Szaller, a former mobile medical team manager at the Red Cross 
Chesapeake regional blood center. According to Mr. Szaller, blood was 
routinely collected without the required pre-check. He also said that 
Red Cross employees were put on bloodmobiles without the mandatory 
safety training and weren't asking donors the right screening questions 
to identify if they were high-risk donors. CBS News reported that a 
recent FDA inspection found a long list of safety violations at this 
blood center, including many of the same ones Szaller complained about. 
The Red Cross claimed that it was not given a full and fair opportunity 
to respond to the CBS report. Does the Red Cross want to respond to 
this report? What actions is the Red Cross taking to improve compliance 
at its facilities?
A. Background to Mr. Szaller's Employment
    The CBS report discussed a Hotline call that Mr. Szaller had made 
before the Red Cross suspended and terminated him for mismanagement. On 
February 22, 2001, Mr. Szaller placed an anonymous call to the Red 
Cross Hotline and reported a variety of perceived regulatory 
violations.
    The Hotline service forwarded this information to the Office of 
General Counsel on the same day for investigation. The Red Cross 
maintained the strict confidentiality of this information at all times. 
Only the Office of General Counsel, the Investigator and personnel 
essential to the investigation were made aware of the anonymous call. 
Importantly, all Hotline calls are strictly administered by the Office 
of General Counsel. The Region completed its investigation of the case 
on February 23, 2001, and returned its findings on March 2, 2001. A 
response was properly filed with the Hotline service on March 30, 2001.
    The CBS report stated that the Red Cross fired Mr. Szaller for 
mismanagement, despite stellar job reviews and commendations. Mr. 
Szaller was employed as a Team Manager in the collections department 
from March 30, 1998 to March 1, 2001. However, Mr. Szaller's employment 
at the Red Cross was not without incident. On February 20, 2001, his 
supervisor received a request from members of Mr. Szaller's team (all 
female) to have a private meeting to discuss their concerns about Mr. 
Szaller's work conduct. Mr. Szaller's supervisor notified Human 
Resources of the request by memo dated February 22, 2001. At the 
meeting, they conveyed their concern over his demeaning and overbearing 
behavior as their manager, alleging that he regularly misrepresented 
information, and generally created a very uncomfortable work 
environment. The Red Cross does not tolerate this type of behavior from 
personnel, and certainly not from its managers.
    On February 23, 2001, Mr. Szaller was suspended based on the 
investigation into the complaints made by his staff. Those who made the 
decision to suspend Mr. Szaller were never made aware of his anonymous 
Hotline call the previous day and, therefore, there is no connection 
between Mr. Szaller's call to the Hotline and the personnel decisions 
that were made regarding Mr. Szaller.
    On March 1, 2001, Mr. Szaller's supervisor and a human resources 
representative interviewed Mr. Szaller and some of his colleagues. Mr. 
Szaller was terminated by letter dated March 6, 2001, based on the 
complaints made by his staff regarding his unacceptable behavior.
B. Mr. Szaller's Allegations
Blood collected without the required pre-check
    Before every donation, the Red Cross carefully screens donors for 
eligibility in several ways. If the donor can present his or her Social 
Security Number (SSN) on the day of donation, the Red Cross may use a 
pre-check device that includes computerized information about 
ineligible donors based on their SSN. The pre-check device may indicate 
that the donor is ineligible for a variety of reasons, such as the 
donor has given blood during the last 56 days, which is the required 
waiting period between donations, or has tested positive for a viral 
marker.
    If the Red Cross determines that a donor is eligible using the pre-
check device, or if eligibility cannot be determined because the donor 
does not provide an SSN, the donor is given a health history 
questionnaire, called the Blood Donation Record (``BDR'') and is 
interviewed by a health historian. Based on the responses provided by 
the donor, the health historian determines if the donor may proceed to 
a physical health assessment. If the Red Cross permits a donor to 
proceed to this assessment, Red Cross staff evaluates the physical 
health of the donor using vital signs, the BDR, and an overall 
impression of the donor.
    If the Red Cross permits a donation, it takes the donated unit of 
blood, the information about the donor from the BDR, and sample test 
tubes from the unit o blood, and creates three separate, parallel 
processing tracks. On one track, the unit of blood is taken to a 
manufacturing area. On the second track, information from the BDR is 
entered into a national computer system to create an electronic 
donation record. On the third track, the sample test tubes are shipped 
to a national testing laboratory. The Red Cross will not label or 
distribute a unit of blood until the information from the BDR and the 
test results are entered into the system and are acceptable.
    It is important to note that the pre-check device is not the only 
means of determining donor eligibility. However, all donors must 
successfully proceed through the eligibility determination and health 
assessment process before the Red Cross permits them to donate. 
Accordingly, there are donors that are allowed to donate blood because 
their eligibility was determined, not solely by the use of the pre-
check device, but rather, through the BDR, health history interview, 
and physical health assessment process.
Red Cross employees put on bloodmobiles without mandatory safety 
        training
    Mr. Szaller alleged that Red Cross employees were placed on 
bloodmobiles without safety training. The Red Cross has always taken 
steps to ensure that donor suitability policies and procedures 
described above are followed, including training and supervisory 
reinforcement.
    The Red Cross is committed to ensuring the health and safety of its 
employees. Staff are trained according to FDA regulations and to ensure 
they can successfully perform their jobs. This training must be 
complete and documented before they are released to perform their 
functions. The Red Cross commitment to safety is also exemplified by 
the implementation of applicable Occupational Safety and Health 
Administration (OSHA) regulations, offering training programs in both 
OSHA and Department of Transportation (DOT) requirements, developing an 
annual national Red Cross safety meeting and, finally, by creating a 
Safety and Environment Division within Biomedical Services. The Safety 
and Environment Division staff act as internal consultants providing 
guidance to Red Cross facilities on various OSHA, DOT and EPA issues. 
With regard to meeting OSHA bloodborne pathogen requirements, staff who 
may have a potential for exposure to blood or other potentially 
infectious materials through their job functions are fully trained in 
universal precautions and the use of personal protective equipment. In 
addition, these staff are offered the hepatitis B vaccination series in 
accordance with OSHA regulations.
Red Cross employees not asking donors screening questions to identify 
        high risk donors
    There was also a concern expressed in the CBS report that Red Cross 
personnel were not asking the appropriate screening questions to 
identify ``high-risk'' donors. As explained above, during the donor 
eligibility determination process, the Red Cross manually creates and 
reviews a BDR for each blood donor. The BDR provides the primary means 
of recording and tracking donor suitability and consists of demographic 
information, physical findings relating to the donor, and a completed 
health history questionnaire.
    The health history section of the BDR is a series of yes/no 
questions that serve as the initial screening mechanism for purposes of 
determining donor suitability. The current FDA-approved questions 
regarding donor suitability are clearly printed on the BDR. 
Accordingly, whether the donor completes the BDR, or if Red Cross 
personnel assist the donor in completing the BDR, the appropriate donor 
suitability questions are presented to the donor. The Red Cross is 
moving with the rest of the industry toward adopting the new Uniform 
Donor Questionnaire. These new questions and format were developed by 
leaders in the blood industry, including the Red Cross and the 
government, to ensure questions that are being asked are validated and 
elicit accurate responses from the potential donor.
C. Improving Compliance and Upgrade Investments
    Since 1992, the Red Cross has invested millions of dollars into 
improvements and upgrades. The Red Cross invested approximately $191 
million to standardize processes and procedures, to train 12,000 field 
personnel, and to implement a new infrastructure. The Red Cross also 
implemented a National Blood Computer System (NBCS) and created a 
Quality Assurance function. The Red Cross has invested more than $290 
million to improve quality. In moving the organization toward a more 
national system in order to improve the effectiveness of it's 
operations and to ensure every region nationwide complied with all 
regulations, the Red Cross consolidated the National Testing System 
from 50 sub-scale regional laboratories to 9 state-of-the-art 
standardized testing laboratories.
    The Red Cross is focused on improving quality now and in the 
future. We intend to augment our improvements even further by 
increasing our Capital Improvement Program's annual operating expenses 
during the next five years. In addition, the Red Cross plans to upgrade 
and restructure its Information Technology by enhancing the computing 
technology platform to allow deployment of new application components 
and integration with the NBCS applications. We also plan investments to 
construct new processing facilities and to invest in supply chain 
infrastructure.
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