<DOC>
[107th Congress House Hearings]
[From the U.S. Government Printing Office via GPO Access]
[DOCID: f:81958.wais]
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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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 <SUP>1</SUP> 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).<SUP>2</SUP> 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.<SUP>3</SUP> 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.<SUP>4</SUP> 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.<SUP>5</SUP> 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.<SUP>6</SUP>
---------------------------------------------------------------------------
\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.<SUP>7</SUP> 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.<SUP>8</SUP> (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.<SUP>9</SUP>
---------------------------------------------------------------------------
\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.<SUP>10</SUP> 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.<SUP>11</SUP> 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.<SUP>12</SUP> 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:
<bullet> An understanding that we must work collaboratively; and
<bullet> 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:
<bullet> Collaboration with our blood banking and public health
colleagues to prepare for future disasters;
<bullet> Consensus as to what constitutes an adequate inventory and
measures to effectively manage the inventory to meet existing
and projected patient needs; and
<bullet> 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:
<bullet> Assessing the need for blood donations following a mass
casualty event;
<bullet> Coordinating public messaging of the need for blood donations;
and
<bullet> 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:
<bullet> Planning the balance between units collected and units
distributed among the regions
<bullet> Managing the units in inventory at the regions
<bullet> 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:
<bullet> The total demand requirements provided by hospital customers;
<bullet> The lead time to increase collections, processing of units and
distribution to hospitals;
<bullet> Customer service levels;
<bullet> The day to day volatility of demand;
<bullet> The shelf life and expiration cycle for each blood component;
and
<bullet> 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\<SUP>,</SUP>\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\<SUP>,</SUP>\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\<SUP>,</SUP>\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\<SUP>,</SUP>\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\<SUP>,</SUP>\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\<SUP>-</SUP>\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\<SUP>,</SUP>\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:
<bullet> 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.
<bullet> 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:
<bullet> 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:
<bullet> Build partnerships with organizations representing all facets
of blood management care (ie. ARC, AABB, ASHE).
Need for Physician Advocates:
<bullet> 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):
<bullet> 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:
<bullet> Evidence-based: Limit exposure to allogeneic blood.
<bullet> Incorporate rationale transfusion guidelines: Document
physiological need.
Need for Universal Registry Tracking Patient Outcomes:
<bullet> Helps to move the concept from individual specialty to
standard or ``best practice''
<bullet> Facilitate cooperation among centers to share data.
Lack of algorithm-based guidelines that are evidence based,
Inconsistent Guidelines
<bullet> 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
<bullet> Many do not perceive problems (i.e., risk, cost, conservation)
with use of allogeneic blood.
Competitive Environment
<bullet> Requires a coalition of multiple organizations which may have
conflicting opinions/agendas.
<bullet> Many do not realize that promoting optimal blood management
will benefit all bloodless programs/centers not undermine them.
Perception of High Cost
<bullet> 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:
<bullet> Provide physician-led initiatives into rationale approaches to
blood management. The current ways of looking at alternatives
to transfusions needed to be changed.
<bullet> 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.
<bullet> 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.
References
1. Hutchinson AB, Fergusson D, Graham ID, Laupacis A, Herrin J,
Hillyer CD. Utilization of technologies to reduce allogeneic blood
transfusion in the United States. Transfusion Medicine 2001;11:79-85.
2. Goodnough LT, Monk TG, Andriole GL. Erythropoietin therapy. N.
Engl. J. Med 1997;336:933.
3. Goodnough LT, Brecher ME, Kanter MH, AuBuchon JP. Transfusion
Medicine, Part I: Blood Transfusion. N. Engl. J. Med. 1999:340:439-
447.;342:1666-1668.
4. Spahn DR, Casuutt M. Eliminating blood transfusions: new aspects
and perspectives. Anesthesiology 2000;93(1):242-255.
5. Goodnough LT, Shander A, Brecher ME. Transfusion Medicine:
Looking to the future. Lancet, in press.
6. Van der Linden P, De Hert S, Daper A, et al. A standardized
multidisciplinary approach reduces the use of allogeneic blood products
in patients undergoing cardiac surgery. Can J Anaesth 2001;48(9):894-
901.
7. Cartotto R, Musgrave MA, Beveridge M, et al. Minimizing blood
loss in burn surgery. J Trauma 2000;49(6):1034-9.
8. Wittmann PH, Wittmann FW. Total hip replacement surgery without
blood transfusion in Jehovah's Witnesses. Br J Anaesth 1992;68)3):306-
307.
9. Helm RE, Rosengart TK, Gomez M, et al. Comprehensive
multimodality blood conservation: 100 consecutive CABG operations
without transfusion. Ann Thorac Surg 1998;65(1):125-36.
10. Smoller BR, Kruskall MS. Phlebotomy for diagnostic laboratory
tests in adults. Pattern of use and effect on transfusion requirements.
N Engl J Med 1986;314(19):1233-1235.
11. Brecher ME, Goodnough LT. The rise and fall of preoperative
autologous blood donation. Transfusion 2001;41:1459-1462.
12. Goodnough LT, Brecher ME, Kanter MH, Aubuchon JP. Transfusion
Medicine Part II. Blood Conservation. N Engl J Med 1999;340:525-533.
13. Kurtz SB, Frost DB. A comparison of two surgical techniqueus
for performing mastectomy. Eur J Surg Oncol 1995;21(2)143-145.
14. Braswell C, Campos J, Spence RK. Reducing operative blood loss
during hepatic surgery: from the middle ages to the space age. Current
Surgery 2001;58(5);472-477.
15. Schmied H, Schiferer A, Sessler DI, Meznik C. The effects of
red-call scavenging, hemodilution, and active warming on allogenic
blood requirements in patients undergoing hip or knee arthroplasty.
Anesth Analg 1998;86(2):387-91.
16. Goodnough LT, Monk TG, Brecher ME. Acute normovolemic
hemodilution should replace the preoperative donation of autologous
blood as a method of autologous-blood procurement. Transfusion
1998;38(5):473-476.17. Monk TG, Goodnough LT, Birkmeyer JD, et al.
Acute normovolemic hemodilution is a cost-effective alternative to
preoperative autologous blood donation by patients undergoing radical
retropubic prostatectomy. Transfusion 1995;35(7);559-565.
18. Huet C, Salmi LR, Fergusson D, et al. A meta-analysis of the
effectiveness of cell salvage to minimize perioperative allogeneic
blood transfusion in cardiac and orthopedic surgery. International
Study of Perioperative Transfusion (ISPOT) Investigators. Anesth Analg
1999;89(4):861-869.
19. Goodnough LT, Monk TG, Sicard G, et al. Intraoperative salvage
in patients undergoing elective abdominal aneurism repair: an analysis
of costs and benefits. J Vasc Surg 1996;24:213-218.
20. Carson JL, Noveck H, Berlin JA, Gould SA. Mortality and
morbidity in patients with very low postoperative Hb levels who receive
blood transfusion. Transfusion 2002;42:812-818.
21. Hebert PC, Wells G, Blajchman MA, for the Transfusion
Requuirements in Critical Care Investigators and the Canadian Critical
Care Trials Group. A multicenter, randomized, controlled clinical trial
of transfusion requirements in critical care. N Engl J Med
1999;340(6);409-417.
22. Hebert PC, Yetisir E, Martin C, et al. Is a low transfusion
threshold safe in patients with cardiovascular disease? Crit Care Med
2001;29:227-234.
23. Goodnough LT, Skikne B, Brugnara C. Erythropoietin, iron, and
erythropoiesis. Blood 2000;96:823-833.
24. Goodnough LT, Brittenham G. Limitations of the erythropoietic
response to serial phlebotomy: implications for autologous blood donor
programs. J Lab Clin Med 1990;115:28-35.
25. Goodnough LT, Price TH, Rudnick S. Soegiarso RW. Preoperative
red blood cell production in patients undergoing aggressive autologous
blood phlebotomy with and without erythropoietin therapy. Transfusion
1992;32:441-445.
26. Muirhead M, Bargman J, Burgess E, Jindal KK, Levin A, Nolin L,
Parfrey P. Evidence-based recommendations for the clinical use of
recombinant human erythropoietin. Amer. J. Kidney Disease. 1995;26:S1.
27. Kaisi M, Ngwalle EWK, Runyoro DE, Rogers J. Evaluation and
tolerance of response to iron dextran (Imferon) administered by total
dose infusion to pregnant women with iron deficiency anemia. Int J
Gynecol. Obstet. 1988;26:235.
28. Mays T, Mays T. Intravenous iron dextran therapy in the
treatment of anemia occuring in surgical, gynecologic, and obstetric
patients. Surg, Gybn, Obstet 1976;143:381.
29. Winslow RM. Blood substitutes--a moving target. Nat Med 1995;
1:1212-1215.
30. Stowell CP, Levin J, Spiess BD, Winslow RM. Progress in the
development of RBC substitutes. Transfusion 2001;41:287-299.
31. Ma Z, Monk TG, Goodnough LT, McClellan A, Gawryl M, Clark T, et
al. Effect of hemoglobin- and perflubron-based oxygen carriers on
common clinical laboratory tests. Clin Chem 1997; 43:1732-1737.
32. Scott MG, Kucik DF, Goodnough LT, Monk TG. Blood substitutes:
evolution and future applications. Clin Chem 1997; 43:1724-1731.
33. Rioux F, Drapeau G, Marceau F. Recombinant human hemoglobin
selectively inhibits vasorelaxation elicited by nitric oxide donors in
rabbit isolated aorticrings. J Cardiovasc Pharmacol 1995;25:587-594.
34. Winslow RM. Blood substitutes. Curr Opinion Hematol 2002;9:146-
151.
35. Kasper SM, Grune F, Walter M, Amr N, Erasmi H, Buzello W. The
effects of increased doses of bovine hemoglobin on hemodynamics and
oxygen transport in patients undergoing preoperative hemodilution for
elective abdominal aortic surgery. Anesth Analg 1998;87:284-291.
36. Sloan EP, Koenigsberg M, Gens D, et al. Diaspirin cross-linked
hemoglobin (DCL-Hgb) in the treatment of severe traumatic hemorrhagic
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
<bullet> There is a need to develop educational curricula focused on
clinical aspects of transfusion practice and the use of
transfusion alternatives.
<bullet> The safety and effectiveness of lowering transfusion triggers
and acceptance of anemia as reasonable blood conservation
options needs reassessment.
<bullet> Red-cell and platelet ``substitutes,'' now in various stages
of clinical trials, hold out new therapeutic options.
<bullet> 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:
<bullet> a revised full length questionnaire for first time and
infrequent donors;
<bullet> an abbreviated questionnaire for frequent donors and proposed
guidelines for its use;
<bullet> a medication deferral list as a companion document to both the
full length and abbreviated questionnaires;
<bullet> new donor educational materials; and
<bullet> 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),<SUP>1</SUP> 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.'' <SUP>2</SUP>
---------------------------------------------------------------------------
\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:
<bullet> 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.
<bullet> 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.
<bullet> 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 <SUP>TM</SUP> 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 <SUP>TM</SUP> 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.
<bullet> Actions to protect the blood supply
<bullet> Actions to assure continued supply
<bullet> Actions to treat affected individuals
<bullet> 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:
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> CBER scientists are researching pathogen inactivation/removal
methods that could be used to protect blood and blood products
from bioweapons.
<bullet> 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:
<bullet> FDA is preparing a guidance document on the deferral of
donors who have been immunized to prevent smallpox.
<bullet> 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.
<bullet> There has been monthly monitoring of VIG supplies and
doses available
<bullet> Cooperative communication with VIG manufacturers, the
Department of Defense, and CDC concerning VIG potency and
availability, monitoring of VIG studies, and progress
towards licensure.
<bullet> 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.
<bullet> 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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