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MAKING SAFE BLOOD AVAILABLE IN AFRICA

HEARING AND BRIEFING

BEFORE THE

SUBCOMMITTEE ON AFRICA, GLOBAL HUMAN 

RIGHTS AND INTERNATIONAL OPERATIONS

OF THE

COMMITTEE ON 

INTERNATIONAL RELATIONS 

HOUSE OF REPRESENTATIVES

ONE HUNDRED NINTH CONGRESS

SECOND SESSION

JUNE 27, 2006

Serial No. 109–200

Printed for the use of the Committee on International Relations

(

Available via the World Wide Web: http://www.house.gov/international—relations 

(II)

COMMITTEE ON INTERNATIONAL RELATIONS 

HENRY J. HYDE, Illinois, Chairman 

JAMES A. LEACH, Iowa 

CHRISTOPHER H. SMITH, New Jersey, 

Vice Chairman 

DAN BURTON, Indiana 

ELTON GALLEGLY, California 

ILEANA ROS-LEHTINEN, Florida 

DANA ROHRABACHER, California 

EDWARD R. ROYCE, California 

PETER T. KING, New York 

STEVE CHABOT, Ohio 

THOMAS G. TANCREDO, Colorado 

RON PAUL, Texas 

DARRELL ISSA, California 

JEFF FLAKE, Arizona 

JO ANN DAVIS, Virginia 

MARK GREEN, Wisconsin 

JERRY WELLER, Illinois 

MIKE PENCE, Indiana 

THADDEUS G. MCCOTTER, Michigan 

KATHERINE HARRIS, Florida 

JOE WILSON, South Carolina 

JOHN BOOZMAN, Arkansas 

J. GRESHAM BARRETT, South Carolina 

CONNIE MACK, Florida 

JEFF FORTENBERRY, Nebraska 

MICHAEL MCCAUL, Texas 

TED POE, Texas 

TOM LANTOS, California 

HOWARD L. BERMAN, California 

GARY L. ACKERMAN, New York 

ENI F.H. FALEOMAVAEGA, American 

Samoa 

DONALD M. PAYNE, New Jersey 

SHERROD BROWN, Ohio 

BRAD SHERMAN, California 

ROBERT WEXLER, Florida 

ELIOT L. ENGEL, New York 

WILLIAM D. DELAHUNT, Massachusetts 

GREGORY W. MEEKS, New York 

BARBARA LEE, California 

JOSEPH CROWLEY, New York 

EARL BLUMENAUER, Oregon 

SHELLEY BERKLEY, Nevada 

GRACE F. NAPOLITANO, California 

ADAM B. SCHIFF, California 

DIANE E. WATSON, California 

ADAM SMITH, Washington 

BETTY MCCOLLUM, Minnesota 

BEN CHANDLER, Kentucky 

DENNIS A. CARDOZA, California 

RUSS CARNAHAN, Missouri 

THOMAS E. MOONEY, SR., Staff Director/General Counsel 

ROBERT R. KING, Democratic Staff Director 

SUBCOMMITTEE ON AFRICA, GLOBAL HUMAN RIGHTS AND INTERNATIONAL

OPERATIONS

CHRISTOPHER H. SMITH, New Jersey, Chairman 

THOMAS G. TANCREDO, Colorado 

JEFF FLAKE, Arizona 

MARK GREEN, Wisconsin 

JOHN BOOZMAN, Arkansas 

JEFF FORTENBERRY, Nebraska 

EDWARD R. ROYCE, California, 

Vice Chairman 

DONALD M. PAYNE, New Jersey 

GREGORY W. MEEKS, New York 

BARBARA LEE, California 

DIANE E. WATSON, California 

BETTY MCCOLLUM, Minnesota 

EARL BLUMENAUER, Oregon 

MARY M. NOONAN, Subcommittee Staff Director 

GREG SIMPKINS, Subcommittee Professional Staff Member 

NOELLE LUSANE, Democratic Professional Staff Member 

SHERI A. RICKERT, Subcommittee Professional Staff Member and Counsel 

LINDSEY M. PLUMLEY, Staff Associate 

(III)

C O N T E N T S 

Page

WITNESSES 

The Honorable Chakah Fattah, a Representative in Congress from the State 

of Pennsylvania .................................................................................................... 5

Caroline Ryan, M.D., Sr. Technical Advisor, Deputy Directory for Program 

Services, Office of the Global AIDS Coordinator, U.S. Department of State .. 16

Robert E. Ferris, M.D., Medical Officer, Bureau for Global Health, U.S. Agency for International Development ....................................................................... 20

Jerry A. Holmberg, Ph.D., Senior Advisor for Blood Policy, Office of Public 

Health and Science, U.S. Department of Health and Human Services .......... 25

Ms. Karen Shoos Lipton, Chief Executive Officer, AABB (formerly the American Association of Blood Banks) ........................................................................ 38

Edward C. Green, Ph.D., Member of the Presidential Advisory Council on 

HIV/AIDS .............................................................................................................. 44

BRIEFING BY 

Neelam Dhingra, M.D., Coordinator, Blood Transfusion Safety, Essential 

Health Technologies, World Health Organization ............................................. 56

LETTERS, STATEMENTS, ETC., SUBMITTED FOR THE HEARING 

The Honorable Christopher H. Smith, a Representative in Congress from 

the State of New Jersey, and Chairman, Subcommittee on Africa, Global 

Human Rights and International Operations: Prepared statement ................ 3

The Honorable Chakah Fattah: Prepared statement ........................................... 7

Caroline Ryan, M.D.: Prepared statement ............................................................ 18

Robert E. Ferris, M.D.: Prepared statement ......................................................... 23

Jerry A. Holmberg, Ph.D.: Prepared statement .................................................... 26

Ms. Karen Shoos Lipton: Prepared statement ...................................................... 41

Edward C. Green, Ph.D.: Prepared statement ...................................................... 46

Neelam Dhingra, M.D.: Prepared statement ......................................................... 58

APPENDIX 

Material Submitted for the Hearing Record .......................................................... 73

(1)

MAKING SAFE BLOOD AVAILABLE IN AFRICA 

TUESDAY, JUNE 27, 2006

HOUSE OF REPRESENTATIVES,

SUBCOMMITTEE ON AFRICA, GLOBAL HUMAN RIGHTS

AND INTERNATIONAL OPERATIONS,

COMMITTEE ON INTERNATIONAL RELATIONS, 

Washington, DC. 

The Subcommittee met, pursuant to notice, at 3 o’clock p.m. in 

room 2172, Rayburn House Office Building, Hon. Christopher 

Smith (Chairman of the Subcommittee) presiding. 

Mr. SMITH. The Subcommittee will come to order. Good afternoon 

everyone, and welcome to the Subcommittee on Africa, Global 

Human Rights and International Operations, and I do apologize to 

our witnesses for the hour delay. We did, as you know, have a 

markup on an important resolution dealing with India, which, because of several amendments that were considered, carried into the 

early afternoon. Again, I apologize for that delay. 

It is my pleasure to convene this hearing of the Subcommittee. 

Today the Subcommittee is examining the important issue of the 

availability of safe blood within the medical systems of sub-Saharan Africa. I want to thank Chakah Fattah for originally suggesting that the Subcommittee convene this hearing. He brought to 

the Subcommittee a great deal, a wealth of information that all of 

us on the Committee found to be very, very useful, informative, 

provocative and more importantly demanding of our action. So I 

want to thank him for his leadership both on the Appropriations 

Committee in the Congress and for helping this Subcommittee as 

well. 

From my extensive travels to Africa, which have included visits 

to HIV/AIDS clinics and other healthcare facilities, I too have long 

been concerned about global health issues including HIV/AIDS, malaria and maternal health. It is disturbing, to say the least, to visit 

a district hospital in remote areas of Africa that only have one or 

two pints of blood in their refrigerators and to see rooms filled with 

expectant mothers and emaciated children experiencing an emergency. 

One also has to experience a long drive on the narrow, sub-Saharan two-lane highways to appreciate the significant danger of serious road accidents and resulting need for blood to save the injured. 

One dodges past overloaded trucks broken down in the middle of 

the road and passes within feet of adults and children walking on 

the road’s edge intermingled with goats and other livestock. 

The increased dangers and health crises in Africa call for increased means to address them, including adequate and safe supVerDate Mar 21 2002 14:49 Oct 11, 2006 Jkt 000000 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 F:\WORK\AGI\062706\28424.000 HINTREL1 PsN: SHIRL
2

plies of blood. A medical benefit related to safe blood that I have 

long promoted is the use of umbilical cord blood stem cells. On December 20, 2005, the Stem Cell Therapeutic and Research Act of 

2005—which I sponsored and my good friend and colleague was one 

of the principle cosponsors—that legislation provides $265 million 

for life-saving stem cell therapy, cord blood and bone marrow 

transplant, and it was signed into law by the President. 

Today in America, umbilical cord blood stem cells and adult stem 

cells are curing people of a myriad of terrible conditions and diseases. One of my greatest hopes is that these current day miracles 

will become common medical practice and available to tens of thousands of patients, including, one day, to the peoples of sub-Saharan 

Africa. 

This hope is inspired by people who have overcome incredible 

odds, thanks to cord blood stem cell transplants, like Keone Penn. 

He was born with severe sickle cell anemia, which afflicts more 

than 70,000 Americans, about one out of every 500 in America, and 

a disproportionate number of others. It is also a serious problem 

in Africa. According to a WHO report on sickle cell anemia, in 2005 

over 200,000 infants are born each year with sickle cell disease on 

the subcontinent of Africa. 

After years of suffering when no other treatments worked, Keone 

Penn’s doctors decided as a measure of last resort to perform a 

transplant with cord blood from an unrelated donor. This was the 

first time such a transplant had been tried for sickle cell disease, 

and it proved successful. One year after the transplant, Keone’s 

doctors pronounced him cured. 

Cord blood stem cells hold enormous promise, and have already 

been used to treat thousands of patients of more than 67 diseases. 

This potential should not be limited to the developing world but 

also for those in Africa and in other parts of the world where it has 

great utility. 

Again, I want to thank my good friend and colleague, Congressman Chakah Fattah, who knows of my interest and the interest of 

other Members of this Committee in Africa and health issues. I 

know that he shares my related interest in cord blood, and he 

helped to move the legislation, particularly when it was 

bottlenecked over on the Senate side. 

Therefore, again, I am happy to take his suggestion of having 

this hearing to propel the Subcommittee into this debate. We have 

not done all that much in the past on the availability of blood in 

Africa. I can assure you, my friend and colleague, that we will now 

really focus on this. 

In its recent report for 2007, it bears noting, the House Appropriations Committee expressed its concern about the existence of 

unsafe blood as a source of HIV infection in the developing world. 

The report notes that contaminated blood is of particular concern 

for women who require a blood transfusion to address complications from pregnancy and childbirth and for children whose lives 

are threatened by anemia. 

Based on these concerns, the Committee requested that the Office of the U.S. Global AIDS Coordinator together with the Agency 

for International Development, the Department of Health and 

Human Services and other relevant parties develop a comprehenVerDate Mar 21 2002 14:49 Oct 11, 2006 Jkt 000000 PO 00000 Frm 00006 Fmt 6633 Sfmt 6633 F:\WORK\AGI\062706\28424.000 HINTREL1 PsN: SHIRL
3

sive multi-year strategy for the PEPFAR focus countries. The strategy should aim to achieve a sufficient supply of blood for each 

country’s needs, the recruitment of voluntary non-remunerated 

blood donors, universal testing of donated blood for infectious diseases and the reduction of unnecessary transfusions. 

A separate strategy is requested for non-focus countries that 

would provide for the standardized operation and control of blood 

collection, adequate training, documentation and assessment measures. 

This hearing provides the opportunity to examine the extent of 

the current need in sub-Saharan Africa for an adequate supply of 

safe blood. We look forward to hearing from our distinguished witnesses about the challenges as well as the opportunities that this 

region faces in providing this essential medical service. 

We also hope to learn about what we need to do to overcome the 

difficulties and the best means to accomplish our common goal: A 

safe and adequate supply of blood to meet the needs of the people 

of Africa. 

I would like to yield to my friend and colleague, Mr. Payne, for 

his opening comments. 

[The prepared statement of Mr. Smith follows:]

PREPARED STATEMENT OF THE HONORABLE CHRISTOPHER H. SMITH, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY AND CHAIRMAN, SUBCOMMITTEE ON AFRICA, GLOBAL HUMAN RIGHTS AND INTERNATIONAL OPERATIONS

It is my pleasure to convene this hearing of the Subcommittee on Africa, Global 

Human Rights and International Operations. Today, the Subcommittee is examining 

the important issue of the availability of safe blood within the medical systems of 

sub-Saharan Africa. 

My extensive travels to Africa have included visits to HIV/AIDS clinics and other 

health care facilities, and I have long been concerned about global health issues including HIV/AIDS, malaria, and maternal health. It is disturbing, to say the least, 

to visit district hospitals in remote areas of Africa that have only one or two pints 

of blood in their refrigerators and to see rooms filled with expectant mothers and 

emaciated children experiencing an emergency. One also has to experience a long 

drive on the narrow, sub-Saharan two-lane highways to appreciate the significant 

danger of serious road accidents and the resulting need for blood to save the injured. 

One dodges past overloaded trucks broken down in the middle of the road and 

passes within feet of adults and children walking on the road’s edge, intermingled 

with goats and other livestock. The increased dangers and health crises in Africa 

call for increased means to address them, including adequate and safe supplies of 

blood. 

A medical benefit related to safe blood that I have long promoted is umbilical 

cord-blood stem cells. On December 20, 2005, the Stem Cell Therapeutic and Research Act of 2005, which I sponsored, was signed into law. This law provides $265 

million for life saving stem cell therapy, cord blood and bone marrow transplant. 

Today, in America, umbilical cord-blood stem cells and adult stem cells are curing 

people of a myriad of terrible conditions and diseases. 

One of my greatest hopes is that these current-day miracles will become common 

medical practice and available to tens of thousands of patients, including one day 

to the peoples of sub-Saharan Africa. This hope is inspired by people who have overcome incredible odds thanks to cord-blood stem cells transplants, like Keone Penn 

who was born with severe sickle cell anemia. Sickle cell anemia afflicts more than 

70,000 Americans and a disproportionate number of African-Americans. It is also a 

serious problem in Africa. According to a WHO report on sickle cell anemia, in 2005 

over 200,000 infants are born each year with sickle cell disease in Africa. 

After years of suffering, when no other treatments worked, Keone’s doctors decided as a measure of last resort to perform a transplant with cord blood from an 

unrelated donor. This was the first time such a transplant had been tried for sickle 

cell disease, and it proved successful. One year after the transplant, Keone’s doctors 

pronounced him cured. 

4

Cord blood stem cells hold enormous promise, and have already been used to treat 

thousands of patients of more than 67 diseases. This potential should not be limited 

to the developed world, but should also be explored for the benefit of the peoples 

in Africa and around the world. 

My good friend and colleague Congressman Chakah Fattah knows of my interest 

in health issues in Africa, and shares my related interest in cord blood stem cell 

research and medical treatments. Therefore, I was happy to take up his suggestion 

that the sub-committee conduct this hearing on the availability of safe blood transfusions in Africa. 

In its recent report for FY 2007, the House Appropriations Committee expressed 

its continued concern about the existence of unsafe blood as a source of HIV infection in the developing world. The report notes that contaminated blood is of particular concern for women who require a blood transfusion to address complications 

from pregnancy and childbirth and for children whose lives are threatened by anemia. 

Based on these concerns, the Committee requested that the Office of the Global 

AIDS Coordinator, together with the Agency for International Development, the Department of Health and Human Services and other relevant parties, develop a comprehensive multi-year strategy for the PEPFAR focus countries. The strategy should 

aim at achieving a sufficient supply of blood for each country’s needs, the recruitment of voluntary, non-remunerated blood donors, universal testing of donated blood 

for infectious diseases, and the reduction of unnecessary transfusions. A separate 

strategy is requested for non-focus countries that would provide for the standardized 

operation and control of blood collection, adequate training, documentation and assessment measures. 

This hearing is providing the opportunity to examine the extent of the current 

need in sub-Saharan Africa for an adequate and safe supply of blood. We look forward to hearing from our distinguished witnesses about the challenges as well as 

the opportunities that this region faces in providing this essential medical service. 

We also hope to learn about what we need to do to overcome the difficulties and 

the best means to accomplish our common goal: a safe and adequate supply of blood 

to meet the needs of the people of Africa.

Mr. PAYNE. Thank you very much, Mr. Chairman. I do not think 

there is anything more important than what our hearing is on 

today, making safe blood available in Africa. I commend you for 

calling this important hearing and of course to acknowledge my 

good friend and colleague, the Honorable Chakah Fattah, who early 

on a year or 2 ago talked about his idea of making safe blood available in Africa. I commend him for steadfastness. 

There are many, many programs that are important and necessary and needed. However, the appropriators have a very difficult time venturing into new programs. It is with a great deal of 

persistence that we could see a new program come in that we are 

talking about. I would like to actually commend you for your persistence and concern. 

As we will be hearing from our witnesses, there is a need for our 

immediate assistance concerning the urgent problem of blood storage and unsafe blood particularly in Africa. Unsafe blood only contributes to the enormous burden of HIV and AIDS. The risks of 

HIV infections through unsafe blood and blood products is exceptionally high, 95 to 100 percent compared to other routes of HIV 

exposure such as mother to child which is 11 to 32 percent and for 

other sexual contacts. 

In an era where HIV and AIDS has and still is devastating and 

killing millions, the importance of making safe blood available in 

Africa is very, very crucial. The problem of blood storage is another 

issue especially because the primary people affected are women 

and children. We must not ignore that we face many challenges 

such as limited resources and inadequate infrastructures that will 

greatly slow efforts. 

5

However, we must still take immediate steps to prevent further 

crises, and strive for improved health conditions. For example, organizations such as the World Health Organization along with others have advocated a strategy to achieve effective, cost efficient and 

safe national blood supply systems with the aim of increasing voluntary blood donations, screening blood for infections and 

prioritizing blood transfusions. 

I would like to hear about U.S. support for these efforts and innovative strategies that the international community can collaborate on. I hope that we can work together to strengthen the system 

for blood safety and availability. I was very pleased at the announcement yesterday where the Buffet and the Gates group would 

be coming together, and this may be that, an area where we could 

even make an inquiry into that new expanded foundation to even 

assist in some of the Federal dollars that we are looking at putting 

into this. 

I certainly would like to thank all of our witnesses for their efforts and progress in ensuring universal access to safe blood, and 

look forward to hearing the testimony of our witnesses. Thank you. 

Mr. SMITH. Thank you very much, Mr. Payne. Mr. Tancredo? If 

not, then I would like to welcome the Honorable Chakah Fattah, 

an experienced lawmaker serving in his sixth term in the U.S. 

House. He represents the Second Congressional District of Pennsylvania, which includes parts of Philadelphia and Cheltenham Township. Congressman Fattah has been a leader and a strong and powerful advocate on the issue of safe blood for Africa for a number 

of years in his position on the House Appropriations Committee. 

Congressman, the floor is yours. 

STATEMENT OF THE HONORABLE CHAKAH FATTAH, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF PENNSYLVANIA 

Mr. FATTAH. Thank you, Mr. Chairman. Let me first of all commend you in your leadership on this Subcommittee and the Ranking Member for your interest in this matter, and for convening this 

hearing today on a subject that I think has gotten far too little attention, and also it is exceptionally unique in our chamber that you 

would have a collaboration between appropriators and authorizers 

on a matter. 

I want to indicate my appreciation for your willingness to hear 

from an appropriator on a policy matter but this is something of 

extreme importance. I have had long conversations with you and 

the Ranking Member, and I want to thank you. 

Before I get into the substance of my abbreviated remarks I want 

to also add into the record letters from the Secretary General of the 

UN in support of this initiative, and also the Ambassador for the 

European Union, and also from Prime Minister Tony Blair, all indicating in sum and substance the same points that you made which 

is that this issue has gotten far too little attention. 

There have been billions assembled to combat the problem of 

AIDS, particularly in sub-Saharan Africa. We have had a long debate between abstinence and condoms and the whole focus on the 

ABC approach but too little attention has been focused on this particular problem. 

6

We have in these 45 countries something less than 10 percent of 

the world’s population but 60 percent of the cases of people living 

with HIV and some 15,000 people dying everyday. It is clear that 

a significant number of people have gotten through blood transfusions diseases that are transmitted through the blood supply including HIV, and the World Health Organization in an executive 

summary of a report that I will also provide for the Committee’s 

records, says that, ‘Unsafe blood transfusions have significantly 

contributed to the burden of new HIV infections in Africa. The risk 

of transfusion associated transmissions of HIV infection is exceptionally high, 95 to 100 percent, compared to other routes of HIV 

exposure.‘

Now, in our own country we recall not too long ago when we had 

problems in our blood supply, and we had to create new routines 

for testing blood and making sure that the blood supply was safe 

in terms of for transfusion purposes from HIV, and we accomplished that in the early 1980s. We actually know how to do this. 

It is not something that we have not accomplished. We know how 

to do it. We know how to train others to do it, and it is something 

that we could accomplish and save many, many lives in sub-Saharan Africa. 

This is a problem in other parts of the world also, in developing 

countries, and it is critically important I think that we focus some 

of our efforts in areas where we can demonstrate a result, and we 

know for certain that just because a child has malaria does not 

mean they have to have a death sentence through a blood transfusion that gives them a disease that will be fatal like HIV. There 

would also be the benefits of being able to screen for other diseases 

that would be transmitted through the blood supply. 

I come today first of all to say that we have asked for a study 

and a review of this matter. You are going to hear from officials 

with a variety of agencies, the Global AIDS Coordinating Office, 

the CDC, the World Health Organization and others about their review of this matter but clearly it is an area where we can have an 

impact. We are today having an impact in terms of some of the pediatric cases through efforts through USAID and through entities 

here in America and around the world working on this problem. 

I believe that we can have a major impact on this if we would 

make it a major part of our policy focus in terms of the HIV epidemic in Africa, that we can save many, many lives and the cost 

benefit ratio compared to other dollars spent I think would bear 

out well. I also think that there are plenty of others who want to 

be helpful, and I met with the Ambassador from the European 

Union, and they provide substantial aid sub-Saharan Africa. 

They indicate in the communications that I am putting in the 

record that they would like to see this as a major part of their 

thrust. I think there are partnerships that can be developed. 

I have also met with officials from the Gates Foundation because 

you do point out correctly that there are a number of entities, including some Mr. Chairman that you have mentioned associated 

with the Catholic Charities Organization that is doing work there 

and others that we could involve in a way to substantially respond 

to this problem. 

7

I appreciate the fact that you are holding this hearing, and resting on our decisionmaking we could impact perhaps millions of 

lives that otherwise would be lost to a disease that we do not have 

a cure for, we do not have a vaccine for but we could make certain 

that when people have a blood transfusion that they in fact do not 

have to be infected with this disease. That is one route that we can 

cut off. We know how to do it, and the resources are available to 

do it. 

It is just a matter of us coming together, and we have found a 

bipartisan support for this on the Appropriations Committee, 

Chairman Jerry Lewis, and the Chairman of my Subcommittee on 

Foreign Operations, Chairman Kolbe, and others are quite supportive of this effort, and we would like to find a way after this 

hearing for us to go down this road together and make a dynamic 

difference in terms of the chances of people, particularly women 

and children—19 of the 20 countries in this world in which women 

die through post pregnancy hemorrhages and in need of safe transfusions are in sub-Saharan Africa. 

We can make a difference. This is I think a signal that we can 

work together and find concrete routes to solve some of the more 

intractable problems that we face in this world. It is not just Warren Buffet and Bill Gates who have gotten together but if appropriators and authorizers can find a way to join hands on this I think 

we can make a significant difference. I thank you, Mr. Chairman, 

and I thank the Committee. I also thank the Ranking Member. 

[The prepared statement of Mr. Fattah follows:]

PREPARED STATEMENT OF THE HONORABLE CHAKAH FATTAH, A REPRESENTATIVE IN

CONGRESS FROM THE STATE OF PENNSYLVANIA

Thank you, Chairman Smith, Ranking Member Payne, and distinguished members of this committee. I appreciate the opportunity to appear before you today, and 

would like to thank this committee, particularly the Chairman and the Ranking 

Member, for your continued interest in matters of social justice and human rights. 

Mr. Chairman, much of the current discussion pertaining to the fight against 

global HIV/AIDS involves advocating for the implementation of one of three possible 

options. One possible option is to demand increased funding to the United States’ 

contribution to the Global Fund, which was established to provide funding to mostly 

developing countries to combat HIV/AIDS, tuberculosis, malaria, and other infectious diseases. Another frequently advocated option is to place continued pressure 

on pharmaceutical manufactures to provide low cost antiretroviral drugs to developing countries. Antiretroviral medicines prevent HIV from replicating and causing 

further damage to a compromised immune system, but many of these drugs require 

funds that are far beyond the means of most people residing in developing countries. 

The third option involves either the aggressive promotion of abstinence from all sexual activity, or encouraging the use of condoms to drastically reduce the possibility 

of transmission of HIV/AIDS due to unprotected sex. 

Mr. Chairman, I suggest to you a different focus that does not involve battling 

over the relative size of the U.S. contribution to internationally funded programs as 

compared to other donor nations, evoking the invariably passionate debate on the 

merits of whether abstinence is an effective strategy, or weighing the morality of 

potentially promoting sexual promiscuity of providing condoms to adults and sexually active children. Rather, more must be done to ensure the availability of a safe, 

clean, blood supply in Sub-Saharan Africa and other parts of the developing world, 

where preventable contamination from numerous infectious diseases such as HIV, 

hepatitis B, and hepatitis C occurs at unacceptable levels. 

The transmission of infectious diseases such as HIV due to an unsafe blood supply 

is completely preventable. Ensuring a clean blood supply is the only HIV/AIDS preventative measure that is virtually 100 percent effective. In the United States, for 

example, the blood supply has never been safer than it is today. Techniques for 

screening and testing blood donors have dramatically reduced the risk of transfusion 

transmitted viral infection. The risk of infection from HIV or AIDS from contamiVerDate Mar 21 2002 14:49 Oct 11, 2006 Jkt 000000 PO 00000 Frm 00011 Fmt 6633 Sfmt 6621 F:\WORK\AGI\062706\28424.000 HINTREL1 PsN: SHIRL
8

nated blood has decreased from as high as 1 in 100 units in some U.S. cities in the 

early 1980s to currently 1 in 1 billion units. The safety and integrity of the blood 

supply is maintained in the U.S. by mandating all collected and donated blood must 

comply with the Food and Drug Administration’s (FDA) blood safety regulations, 

which consist of five layers of overlapping safeguards. The regulations address:

• Donor Screening: Potential donors are screened by questioning them about 

their health, medical history, and risk factors for infectious diseases. Individuals whose blood may pose a health hazard are deferred

• Deferral Registries: Independent blood centers maintain a list, or registry, of 

all deferred donors and check all potential donors against that list. The American Red Cross has established a national registry that covers all its regional 

blood centers. Donors who are deferred on a temporary basis may resume donating once the deferral period has ended and provided the reason for the deferral no longer exists.

• Blood Testing: Donated blood is tested for infectious disease, including HIV, 

HBV, and HCV. Positive tests are discarded and the donors are deferred.

• Blood Quarantining: Blood donations are quarantined until they have been 

tested and the donation records verified.

• Correcting System Deficiencies: Blood centers must investigate any breaches 

of these safeguards and correct deficiencies that are identified by themselves 

or during FDA inspections.

With HIV-positive rates approaching or exceeding 20 percent in Sub-Saharan Africa, blood transfusions account for an ever-growing percentage of new HIV/AIDS 

cases. Of the estimated 6 million blood transfusions performed each year in sub-Saharan Africa, as many as half are improperly or untested for infectious diseases. 

Less than half of all African countries have adopted standard national blood transfusion policies that would limit HIV infections. More disturbingly, less than onethird of all African countries have some type of policy that attempts to limit HIV 

infection through blood transfusion. 

The global AIDS pandemic is well documented. Sub-Saharan Africa has just over 

10 percent of the world’s population, but is home to more than 60 percent of all people living with HIV, which is approximately 25.8 million. In 2005, an estimated 3.2 

million people in the region became newly infected, while 2.4 million adults and 

children died of AIDS. Worldwide, there will be an estimated 45 million new cases 

of infections due to HIV/AIDS by 2010 if efforts to fight the pandemic are not aggressively increased. 

The World Health Organization (WHO) estimates that approximately 120 countries lack proper blood supplies and offer inadequate screening. Out of the total population of HIV/AIDS infected persons, the WHO estimates that up to 10 percent of 

infections are from corrupted blood supplies and tainted blood transfusions. As I 

previously noted, these infections are 100 percent preventable. Understand, over 

300,000 people in Sub-Saharan Africa alone would be saved from enduring unbearable hardship and pain due to HIV/AIDS each year. 

There are many moving examples of personal tragedy throughout the world due 

to blood transfusions from unsafe blood supplies. Five years ago, a gentleman by the 

name of Raj Shekhar received a blood transfusion after an accident at a time when 

blood harvesting programs in India had few safeguards. Nearly a year later, he tested positive for HIV after being hospitalized for severe chest pain. Instead of being 

admitted to the operating room, his doctor refused to perform the necessary surgery 

due to fears of infection. Soon after learning Raj was infected with HIV, his wife 

left him. 

In a similar instance, the wife of a couple living in the Philippines in a squatter 

camp near Manila’s financial district required a blood transfusion due to a serious 

illness. Hospital officials gave the wife six units of blood, some of which were infected by HIV. Before her own contraction of the disease, she believed the virus to 

be a disease that afflicted homosexual men. Fearing her husband’s reaction, she 

chose not to tell him of her infection. The wife and her husband continued to engage 

in unprotected sex despite the wife’s knowledge she would probably infect her husband with HIV. The wife later became pregnant and gave birth to a baby girl. 

Though the couple’s daughter did not contract the disease, both parents developed 

the AIDS virus to their exposure to HIV. 

Assuring the existence of a safe and clean blood supply is the most cost effective 

and commonsensical approach to reducing the number of newly reported HIV cases 

each year. Recognizing more needs to be done to ensure the safety of the blood supply in Africa, last year I successfully appealed to my colleagues on the Foreign Operations Subcommittee on Appropriations to direct the Centers for Disease Control, 

9

the Office of the Global AIDS Coordinator, USAID, and the World Health Organization (WHO) to jointly issue a report detailing the severity of the impact contaminated blood has on the global fight against HIV/AIDS, as well as providing specific 

policy recommendations for immediate implementation. To ensure the safety of each 

blood unit, the following key activities were identified: (1) establishment of systems 

for the supply of test kits and reagents for blood screening and good laboratory practice; (2) recruitment of safe blood donors; (3) implementation of quality systems in 

blood transfusion services, and; (4) safe and appropriate use of blood to reduce unnecessary transfusions. 

Acknowledging the importance of the need to provide safe blood, the Foreign Operations Subcommittee on Appropriations has recently indicated in the Foreign Operations Committee Report for Fiscal Year 2007 that:

The Committee remains concerned about the problem of unsafe or contaminated blood as a source of HIV infection in the developing world. According to 

the March 2006 Report on Blood Safety, submitted by the Office of the Global 

AIDS Coordinator, ‘‘substantial problems have been documented’’ across all components of safe blood programs in developing countries. Many hospitals in the 

developing world do not have effective or complete screening of blood, and as a 

result, there can be a risk of transfusion-transmitted infectious diseases. The 

prevalence of contaminated blood acutely impacts women requiring blood transfusions due to complications from pregnancy and childbirth, as well as children 

with life-threatening illnesses such as anemia. 

Worldwide the major risk is hepatitis followed by HIV, malaria and syphilis. 

The Committee recognizes that there are a wide array of challenges in order to 

achieve adequate capacity and sustainability to support blood transfusion services in developing countries, including adequate infrastructure (such as reliable 

electricity for refrigeration), staff recruitment and training, laboratory equipment, effective legislation/policy, and financial/management systems to support 

blood services. 

The Committee understands that the Emergency Plan currently supports the 

Ministries of Health or the government’s National Blood Transfusion Service 

(NBTS) in fourteen of the fifteen focus countries for the purpose of developing 

nationally directed regionalized blood systems. The Committee strongly supports 

these activities and the Emergency Plan’s goal of establishing high-quality, sustainable blood transfusion-safety programs in each country. The Committee notes 

that the bill includes an over 40 percent increase in bilateral funding for focus 

countries and urges the Coordinator to increase significantly funding for safe 

blood programs over fiscal year 2006 levels. 

The Committee also recognizes that capacity building and infrastructure development are processes that require a period of years which realistically must be 

approached incrementally. In the Committee’s view, to achieve success in advancing blood safety requires a comprehensive and coordinated strategy among Ministries of Health, local communities, donors, and experts in blood transfusion. 

Therefore, the Committee requests that the Office of the United States Global 

AIDS Coordinator, working in coordination with other health sectors in USAID 

and HHS, and in consultation with WHO, other blood safety experts, and private 

foundations active in global health, develop and submit to the Committee a comprehensive, integrated multi-year strategic plan for PEPFAR focus countries to 

achieve the following:

(1) A sufficient supply of safe blood to meet the needs of the country; 

(2) A continuous and adequate supply of voluntary non-remunerated blood 

donation from the safest possible donors from low risk populations; 

(3) The universal testing of donated blood, including quality assured screening of all donated blood for infectious diseases; and 

(4) The reduction of unnecessary transfusions; safe and rational blood utilization, and the use of alternatives to transfusions whenever possible.

The pace and resource requirements of the plan should consider the other medical (e.g. mother-to-child transmission and safe medical injections) and non-medical prevention activities in PEPFAR countries and the impact of the strategic 

plan on maintaining a diversified prevention portfolio. The Committee further 

requests the Office of the Global AIDS Coordinator, working in coordination 

with the aforementioned agencies and non-governmental organizations, develop 

and submit to the Committee a comprehensive implementation strategy for nonfocus countries that achieves standardized operation and controls of blood collection, adequate training, documentation, and assessment measures. The strategic 

plans for both focus and non-focus countries shall be submitted to the Committee 

no later than 180 days of enactment. Finally, the plan also should examine exVerDate Mar 21 2002 14:49 Oct 11, 2006 Jkt 000000 PO 00000 Frm 00013 Fmt 6633 Sfmt 6621 F:\WORK\AGI\062706\28424.000 HINTREL1 PsN: SHIRL
10

penditure rates and factor them into the recommendations in order to ensure the 

timely obligation and expenditure of funds.

Through the relentless efforts of myself and my staff, I continue to garner enthusiastic support for my call to ensure the availability of a safe and clean blood supply 

in Africa from numerous countries, international governmental organizations, and 

non-governmental organizations. Many of these NGOs provide the tactical support 

necessary for carrying out aid programs and will be an integral part of ensuring Africa’s safe blood supply. Africare, U.S. Doctors for Africa, the Global AIDS Interfaith 

Alliance and the Global Impact Foundation have all enthusiastically endorsed my 

program. Julius Coles, the President of Africare, has acknowledged that this program is a ‘‘necessary component of HIV/AIDS prevention that has gotten too little 

attention up to now.’’ The support I have received from various NGOs reinforces my 

conviction that the problem of contaminated blood in Africa is one that we must rectify as quickly as possible. 

I am also heartened by the enthusiastic international support for my call for a 

clean blood supply. English Prime Minister Tony Blair indicates safe blood is an integral part of the development of a health care infrastructure within African nations. Similarly, the Head of the European Union Delegation in Washington, DC, 

Mr. John Bruton, believes that my fight to secure a safe blood supply will have a 

lasting effect on the impact of infectious disease in Africa, indicated that, ‘‘Blood 

safety should be an integral part of any national strategy for HIV/AIDS prevention, 

as well as a standard component of national health policies.’’ Lastly, Secretary General Kofi Annan has also endorsed my efforts, stating that my Safe Blood Initiative 

‘‘will play an invaluable role in benefiting the lives of millions of Africans.’’ I am 

humbled by the international support of my initiative, and I look forward to working 

with these countries and agencies as we work to help improve the lives of Africans 

now and in the future. 

A problem of such magnitude demands an unequivocal commitment from Congress to combat all aspects of the HIV/AIDS scourge. I believe with the leadership 

of the distinguished Chairman and the Ranking Member, substantive measures can 

be implemented to ensure significant improvements to blood and transfusion services that will result in a clean and reliable blood supply in Africa. I thank the distinguished members of this committee, and I will gladly answer any questions.

Mr. SMITH. Thank you very much, my friend. First of all, I have 

read the report that was submitted pursuant to your request, and 

I think it is a very good report in many ways. It does point out that 

the integrated strategy for blood safety adopted by the Emergency 

Plan and endorsed by focus countries includes a sufficient supply 

of blood, voluntary non-remunerated blood donation, universal testing and I think we all will agree, especially in light of the number 

you pointed out from the report by the WHO. If some contamination is in the blood, the recipient is going to get it. With 95 to 100 

percent probability, if it is in the blood you are going to get infected, and I think that point—as opposed to sexual transfer or 

some other means, while a baby is being born or whatever—no 

other means of transmission comes close. 

The WHO report did say that 5 to 10 percent of new HIV infections are transmitted through unsafe blood amounting to between 

160,000 and 320,000 new infections per year as a result of unsafe 

blood in sub-Saharan Africa. I will be asking our other witnesses 

if they agree with that number but that is a staggering number of, 

again, preventable diseases. 

I think you make another good point that other diseases, as well, 

are transmitted through the blood or contaminated blood: Hepatitis 

B and C, syphilis, malaria, and West Nile virus to name a few. As 

the blood is cleaned, certainly there are other positive outcomes 

from other diseases not contracted, as well. 

Your testimony was very comprehensive, so I thank you for that. 

I basically have one question. Do you think we are spending 

enough? The Administration, I believe, went from $25 million to 

11

$50 million to $32 million. Their argument, I think, is that there 

is money in the pipeline, an enormous amount of it, and it is building up an infrastructure and trying to encourage countries to develop that infrastructure. Are we spending that money fast enough 

in your view? Is there sufficient funding available? 

Mr. FATTAH. I would say a couple of things, Mr. Chairman. One 

is I think there is a tremendous amount of effort being extended 

but I think that there is too much passivity in terms of the urgency. That is that if you have 15,000 people dying each day in 

sub-Saharan Africa, and we have billions sitting in a global AIDS 

fund, if we have billions in the Millennium Challenge Account. 

There are reasons why we have not spent down large amounts of 

these dollars but this particular issue has not really been at the 

forefront. 

I question and there is a record of Ambassador Tobias before he 

took his new position in his old position as focus in terms of the 

Global AIDS Coordinator, and this really was not at the front and 

center of their work. I just want to see us move this further. 

I was in Nigeria and spoke to the health minister there. It was 

indicated to me that over 22 percent at that time of the new HIV 

cases were related to blood transfusions, and some of what is being 

said once you pull back the envelope is not as accurate as we might 

want it to be. That is that countries report that they have been 100 

percent testing but there is no one that is actually knowledgeable 

about this that believes that there is actually 100 percent testing 

of the blood before it is being made available for transfusions. I 

would invite you to question other witnesses on that. 

Secondly, they have a waiver for testing in most of these countries when they say that it is a family contribution, and they 

produce someone in which many experts believe are remunerated 

individuals and who then say that they are a family member and 

provide the blood, and therefore they move around the testing requirement. When I began this effort a year and a half ago, I called 

up into my office experts from CRS, who know as much as we can 

know about Africa. I asked them one simple question. These are 

our own experts here in the Congress. I asked, if I were traveling 

in Africa and I needed to get a blood transfusion, what country 

would I want to be in at the time that I needed that transfusion? 

The CRS experts that work for the Congress said that there would 

be no place that they would think that I would want to get a blood 

transfusion. In fact, there would be other circumstances that would 

be provided for me because there really was not a safe system to 

control and make sure that the blood supply is free of diseases in 

much of the continent. 

We spend about $357 per unit of blood in the United States to 

make sure that if we get a transfusion it is safe. Less than a dollar 

and a half is being spent in sub-Saharan Africa in any system at 

all to deal with the availability of safe blood. 

Mr. SMITH. You make a good point about whether or not we are 

getting accurate information. I noted again in the UA Working 

Group documents they claim, based on their statistics, that 10 percent of the total are from paid donors, 32 percent from family replacement donors, and voluntary unpaid donors make up 57 perVerDate Mar 21 2002 14:49 Oct 11, 2006 Jkt 000000 PO 00000 Frm 00015 Fmt 6633 Sfmt 6601 F:\WORK\AGI\062706\28424.000 HINTREL1 PsN: SHIRL
12

cent, which sounds pretty positive unless it is inaccurate. I think 

your point was well taken. Mr. Payne. 

Mr. PAYNE. Once again as I have indicated, Congressman Fattah, 

I commend you for spearheading this initiative in the Appropriations Committee. We certainly, as an authorizing Committee, here 

will attempt certainly to work closely with you to move this forward. I wonder if in your research has the question about needles 

come up? The fact that healthcare providers in many instances are 

themselves being infected by their work around the blood, and in 

particular needles and sometimes being pricked themselves by mistake? In your talk about clean blood, has there been any conversation regarding needles in general? 

Mr. FATTAH. One of the things that I think you are going to hear 

from future witnesses today is that there is a tremendous need for 

training and for a laboratory environment in which we can avoid 

some of that. One of your colleagues, Steve Rothman, there is an 

expert in New Jersey, a doctor who specializes in helping train doctors in what are called bloodless surgeries but really is a way to 

limit the need for large amounts of transfusions. 

There are a range of ways that we can go about this issue but 

clearly—and I said this to the Chairman—that if we are going to 

clean up the blood supply it will require some effort. It will require 

the ability to store blood, to recruit voluntary healthy donors, to 

test blood, to train African doctors and healthcare professionals. 

The African Union has now set up an entity to focus in on—and 

you and I have discussed that—the healthcare infrastructure. 

Clearly some part of the challenges on the continent relate to the 

whole issue of health and the infrastructure not just on this question but on many questions related to the healthcare infrastructure 

is weak up to an including creating electricity to rural villages and 

other places so that you can have an ability to store blood and 

blood products safely. 

Mr. PAYNE. I certainly appreciate and there is no question that 

the healthcare system is weak in many of the developing countries. 

As a matter of fact, that was one of the questions that President 

Tobleman Becky in South Africa was talking about when he was 

sort of misunderstood to some degree on his question about HIV 

and AIDS being just equal to other diseases. I think he was really 

trying to make the point that unless you get a healthcare system 

that can provide safe health in general that you are bound to fail. 

I think you certainly reiterate the fact that we really have to work 

on a system to assist developing countries to have a sustainable energy, have various equipment, refrigeration, things that they need 

in order to try to get the job done. 

Once again, let me commend you for this. With that, Mr. Chairman, I will yield back the balance of my time. 

Mr. SMITH. Ms. Lee. 

Ms. LEE. Thank you, Mr. Chairman. Let me also thank you for 

this hearing, and thank you for your leadership. I also visited Nigeria several years ago and met with the ministry of health, the 

President and others—I believe it was Mr. Gadenson when he was 

our Ranking Member—and learned of this very critical need and 

aspect of the whole HIV/AIDS pandemic. 

13

For the life of me, I still cannot figure out why understanding 

that a large percentage of HIV and AIDS transmission are related 

to unsafe blood transfusions, here in America we have been able 

to solve that crisis, that problem. Why in the world—and this is 

one thing that I tried to figure out when we were there—on a country-by-country basis as we look at PEPFAR and the Global Fund 

and all of these initiatives that this is not a specific requirement, 

and that we do not find? 

Certainly here in the United States we have the Red Cross. We 

have other partners who could take a country, go over to that country, set up shop and help them within a year’s time develop the infrastructure and develop what is needed to be able to begin to turn 

this around. 

You know I cannot figure out why that has not happened or why 

it is not happening now. I wondered if you had any insights since 

you have been working so hard on this, Mr. Fattah, and your leadership has been so vital in bringing this to this point? No one has 

been able to answer that question. 

Mr. FATTAH. I think that there is a tendency when you look at 

the question of the HIV epidemic on the continent and in sub-Saharan Africa to think that it is just so enormous that almost nothing 

can be done. Then we have through President Bush’s leadership 

created a multibillion dollars initiative that will be scaled up to $15 

billion over a few short years in the global AIDS fund are focused 

at HIV, malaria and TB. 

Now, we have children—it is estimated by one of the State Department vendors that provide safe blood for Americans if they are 

in need of a transfusion anywhere in Africa—that there are at least 

2 million of these 25 million victims of HIV are children who have 

gotten malaria through mosquito bites and which could have been 

prevented or could have been treated in other ways but at some 

point absent that treatment those children are in need of blood 

transfusions. So you solve one problem by giving almost a death 

sentence to a young person through an unsafe contaminated blood 

transfusion. 

I think the point that I would make is I think there is obvious 

benefits in the ABC approach, and I think there are good hearted 

people working on this. This is an area in which this is an absolute 

way to prevent transmission through this method, and that is 

through investing in a safe blood supply and all of the elements 

that would be needed to do that. That is that you would need laboratories and training and electricity and so on to get this done. 

If you think about what we can do when we are compelled to do 

it, I mean we can transport anything almost anywhere in the 

world. We just funded a new blood bank in Nigeria through USAID 

but we could literally put hundreds of new blood banks in sub-Saharan Africa if we decided that we wanted to do it, and we could 

do it not in 5 year’s time. We could literally do it in less than 1 

year because we as a nation and especially if we unite with other 

partners, if we decided that the lives that could be saved were 

worth saving then we could kind of have a different sense of urgency about this challenge. 

Ms. LEE. Mr. Chairman, I think that is the point. This is so 

clear, and I guess I am asking you from your perspective why have 

14

we not made this a priority, understanding that the Global Fund 

is there to fund initiatives to prevent and treat HIV and AIDS. We 

have PEPFAR. We have USAID. We have several initiatives, and 

we should be going to the world community to say we can reduce 

the incidence of transmission if in fact we have safe blood supply. 

It just seems like a no-brainer to me. We have done it here in 

America. Other countries have done it. Why can we not do it on 

the continent of Africa? 

Mr. FATTAH. I think where we are now is that we have arrived 

at a consensus that we are going to do it. I have talked to officials 

in the Bush Administration. We got this study that you are going 

to hear about, and we have new language in the Foreign Ops bill 

this year to move this matter forward. I think that the attention 

that the International Affairs Committee has now brought to this 

matter and the dialogue that will follow me, will be immensely 

helpful in having all of the various entities that are involved understand that the Congress in a bipartisan way wants to see some 

progress made on this matter, and wants to see it as a very high 

priority. 

Ms. LEE. Thank you, Mr. Chairman. This is very important this 

development in this hearing today because many of us have tried 

to figure out how to move this forward, and thank you again for 

your leadership. 

Mr. SMITH. Thank you. Let me just conclude with a question and 

something to take back—something I will be asking of our other 

witnesses, as well. In the report, Mr. Fattah, which you asked to 

be produced, there was a discussion on incremental versus nonincremental approaches, and the conclusion is that only the incremental approach is realistic for establishing blood services in developing countries, including in sub-Saharan Africa, and then they 

give their reasons for that conclusion. 

I wonder if there can be accelerated incremental approach, given 

the fact that so many people are dead or dying. One of our witnesses later on, Dr. Jerry Holmberg, will point out that an estimated 14 million blood units are needed. He cites in 2004 that only 

3.6 million units were collected. 

The issue, I think, is two-fold. It is one of safe blood, so you do 

not get infected when you get a transfusion, and the other issue is 

having capacity, because all these others folks who will get sick 

and are in need of a transfer of blood who will not get it. You and 

I have both talked about how we have been to hospitals, particularly in the rural setting, where you open up a refrigerator and 

there is one pint of blood just sitting there, and you wonder how 

long it has been sitting there. That is a very discouraging thing to 

see. 

If you wanted to comment on that issue. 

Mr. FATTAH. Fortunately, I was a student at one point in my life 

at the Kennedy School, and they had a whole theory on this whole 

question of nonincremental versus incremental policy initiatives, 

and we have seen them and various renditions of them in which 

the urgency and which we want to accomplish something dictates 

what we do and how fast we try to do it. 

There are several pieces to this obviously. If we want to create 

a system of voluntary donations in a cultural environment in which 

15

donating blood has not been yet seen as something that people generally do, then that is a matter of public education but we do not 

have to wait 3 years to design a public education campaign and encourage healthy people in Africa to give blood. We could even have 

people in other parts of the world donate blood. 

You could have African-Americans encouraged here to give blood 

that can go. I mean we can deal with this in a much more urgent 

way than I think that the study lays out. Again, I think that even 

though there are some very good and helpful points that are made, 

I think that part of the discussion is about how many lives can be 

saved? If it is just 10 percent of 25 million, and what does that 

mean yearly and how many lives, and therefore how much resources? 

I think that the point that you will see in both Kofi Annan’s comment here where he says that the HIV/AIDS pandemic poses an 

unprecedented threat to human security and development in the 

continent. The epidemic demands an exceptional response, and that 

this initiative on safe blood will play an invaluable role in benefitting lives of millions of Africans. 

You see the European Union which says that they provide a substantial share of the worldwide package of aid that goes to sub-Saharan Africa. Their Ambassador said they are willing to make this 

their number one priority. If we would I think find ways to partner 

with others and if we could have help, since we are politicians, designing a program that actually could work I think we could get 

at this a little bit sooner but I do think we have to give weight to 

their viewpoints but I do think that they should be questioned on 

it because we should have a sense of urgency when we have a 

chance to save lives. 

Mr. SMITH. Chakah, thank you so much for your tremendous 

leadership and for helping us today to better understand this issue. 

Mr. FATTAH. Thank you, Mr. Chairman. Let me thank your staff 

for all of their assistance and thank my staff for their work on this 

matter. Thank you. 

Mr. SMITH. Thank you. I would like to now invite to the witness 

table our second panel, beginning with Dr. Caroline Ryan who 

since October 2004 has been detailed to the Office of the U.S. Global AIDS Coordinator where she serves as senior technical advisor 

for the prevention and technical team lead. Previously, Dr. Ryan 

served as the Associate Director for International Activities in the 

Division of STD Prevention, and subsequently served as chief of 

the Prevention Branch in CDC’s Global AIDS Program. 

We will then hear from Dr. Robert E. Ferris. Dr. Ferris has 

served since 2005 as medical transmission manager at the Office 

of HIV/AIDS at USAID, Division of Technical Leadership and Research. Dr. Ferris completed his residency in 2003 at Internal Medicine/Pediatrics Program at Saint Vincent’s Hospital in New York, 

New York. 

We will then hear from Dr. Jerry Holmberg, who has served 

since 2003 as Senior Advisor for Blood Policy in the Office of Public 

Health and Science at the U.S. Department of Health and Human 

Services. Between 1980 and 2000, Dr. Holmberg served in the U.S. 

Navy, achieving the rank of Commander. During that period, he 

16

held various positions directing blood banks, blood donor centers 

and frozen blood bank deposits. 

Dr. Ryan, if you could begin with your testimony. 

STATEMENT OF CAROLINE RYAN, M.D., SR. TECHNICAL ADVISOR, DEPUTY DIRECTORY FOR PROGRAM SERVICES, OFFICE 

OF THE GLOBAL AIDS COORDINATOR, U.S. DEPARTMENT OF 

STATE 

Dr. RYAN. Mr. Chairman and Members of the Subcommittee, 

thank you for this opportunity to discuss President Bush’s Emergency Plan for AIDS Relief and the successes and challenges of providing safe blood in the developing world, primarily sub-Saharan 

Africa. This testimony will be a summary of my written remarks. 

We greatly appreciate the partnership between PEPFAR and the 

International Relations Committee, especially the Subcommittee on 

Africa, and we would like to thank all the Members of the Subcommittee for your commitment to the U.S. leadership in the fight 

against this tragic pandemic. 

The President and the Congress made a strategic decision to direct the activities of the Emergency Plan to focus on the prevention, care and treatment of HIV and AIDS. A focus of the Emergency Plan is to build local capacity, to provide long-term, sustainable programs in the countries with which we partner. Ensuring 

the availability of safe blood is one component of a multi prong HIV 

prevention strategy that includes prevention of sexual transmission, prevention of mother to child transmission and prevention 

of medical transmission. 

For the developing countries in which the Emergency Plan 

works, there are significant challenges to developing and maintaining an adequate, sustainable supply of safe blood. These include a 

lack of strong healthcare systems, a lack of or inadequate policy 

around blood safety and clinical use of blood, a lack of basic infrastructure such as consistent electricity for refrigeration and a lack 

of available and sufficiently trained health personnel. 

These conditions are pervasive in sub-Saharan Africa and are 

part of a larger and more complex development challenge. The 

Emergency Plan with its clear mandate to prevention, treatment 

and care for those infected with and affected by HIV/AIDS cannot 

alone address the infrastructure, policy and capacity challenges 

faced by developing countries. 

At the request of Representative Fattah and the House Appropriations Subcommittee for Foreign Operations, the Office of the 

Global AIDS Coordinator has prepared a report on blood safety as 

a component of the HIV/AIDS prevention strategy. Together with 

our colleagues from the Department of Health and Human Services, the U.S. Agency for International Development and the World 

Health Organization, we invited a group of technical consultants 

with expertise in blood safety to discuss the magnitude of the problem posed by unsafe blood products, the level of resources required 

to address the problem, the feasibility of a nonincremental approach to expanding transfusion services and the cost effectiveness 

of implementing a safe blood program in reducing rates of infection. 

17

The group’s consensus was presented in the report findings provided to this Committee. Let me first discuss the HIV transmission 

risk from unsafe blood and program components needed to assure 

its safety. Actual data from PEPFAR focus countries blood programs show an average of 3.2 percent of donors are HIV positive. 

Several studies have documented that blood transfusions are not 

the major cause of HIV transmission in most countries, especially 

those with generalized epidemics where most new infections are a 

result of heterosexual contact. 

There are challenges to providing safe blood at a national level, 

and these include assuring that a sufficient amount of blood is collected in the country, assuring the implementation of a system to 

recruit low risk donors, assuring that quality screening of donated 

blood is occurring and assuring that national policies and oversights to reduce unnecessary transfusions are in place. Without 

these components in place, there is a higher risk of transfusion 

transmitted diseases, and these include viral hepatitis, malaria in 

addition to HIV and AIDS. 

To reduce HIV and AIDS transmission risks prevented by blood 

transfusions, the Emergency Plan supports national programs to 

improve the quality of blood supplies through improved policies, 

the establishment of laboratory facilities and commodity procurement and healthcare worker training and management. The Emergency Plan in the focus countries supports national blood transfusion services, and provides technical assistance to them by 

partnering them with international blood safety organizations. 

The goal of the technical assistance is to increase blood supply 

through donor recruitment, to ensure blood safety through proper 

screening of donors and donated blood and to support the development of an improved national blood service in each country. 

I would like to discuss the issues on focus countries. In 2004, 

PEPFAR partners obligated a total of $24.4 million in funds to 

blood safety activities in the focus countries. In 2005, that amount 

was increased to $50 million. For fiscal year 2006, the current 

planned amount for blood safety activities is $32.3 million. 

During the first 2 years of the program, countries only spent onethird of the Emergency Plan funds allocated to ministries of health 

and national blood transfusion services. At the end of fiscal year 

2005, approximately $50 million was still in the pipeline and available in addition to the $32 million in funding plan for fiscal year 

2006. 

This is largely due to the infrastructure, human capacity and policy constraints. These countries cannot effectively spend funding 

until another layer of infrastructure is in place to allow for sustainable expansion of services. Additionally, most blood safety related 

activities supported by the Emergency Plan are implemented 

through partnerships with focus country government organizations 

such as ministries of health. These structures are traditionally 

slower to act in applying interventions at the national level. 

Assuming that those funds currently in the pipeline are appropriately out laid, the planned funding for blood activities in fiscal 

year 2007 will increase. The current funding level for blood safety 

activities does strike a reasonable balance between the absorptive 

capacity of the host country to develop national blood services and 

18

the continuation of a comprehensive and effective prevention program that focuses prevention efforts where new infections are occurring. 

The Emergency Plan must continue to be strategic in choosing 

where each prevention dollar is spent in support of this full portfolio of prevention interventions. Blood safety activities continue to 

be supported as a necessary element of this portfolio. At current 

levels we feel this both meets the capacity needs of the focus countries and fits a comprehensive and cost effective prevention strategy consistent with the epidemiology of where new infections are 

occurring. 

Mr. Chairman, the Emergency Plan is experiencing success in 

supporting HIV strategies in our host nations. Providing safe blood 

in Africa is a broad issue addressing the risks from all transfusion 

transmissible diseases including HIV/AIDS, hepatitis and malaria. 

We at the Office of the Global AIDS Coordinator will continue to 

work with our colleagues at the Department of Health and Human 

Services and USAID to support the ongoing blood safety programs 

as part of the Emergency Plans efforts to focus on HIV and AIDS. 

As countries continue to develop their basic infrastructure and 

strengthen their systems that they can maintain over the longterm, safe blood will begin to expand for national coverage. The 

large scale programs implemented as part of the Emergency Plan 

have begun to address this need through a thorough and comprehensive approach that will produce immediate results, longterm improvement and the likelihood of sustainability. 

The results of this strategy are already visible. The Emergency 

Plan supports approximately 600 blood safety service outlets or 

programs in the focus countries, and South Africa and Botswana 

now have safe blood supplies at the national level. In Kenya, there 

are 150,000 more units of safe blood up from 40,000 in 2004. 

This Subcommittee can be proud that through the President’s 

Emergency Plan the American people are partners with families, 

communities and nations that are reclaiming their future. Thank 

you for the opportunity to speak with you today, and I would be 

happy to address your questions. 

[The prepared statement of Dr. Ryan follows:]

PREPARED STATEMENT OF CAROLINE RYAN, M.D., SR. TECHNICAL ADVISOR, DEPUTY

DIRECTORY FOR PROGRAM SERVICES, OFFICE OF THE GLOBAL AIDS COORDINATOR, 

U.S. DEPARTMENT OF STATE

Mr. Chairman and Members of the Subcommittee: 

Thank you for this opportunity to discuss President Bush’s Emergency Plan for 

AIDS Relief (PEPFAR/Emergency Plan) and the successes and challenges of providing safe blood in the developing world, primarily Sub-Saharan Africa. 

We have greatly appreciated the partnership between PEPFAR and the International Relations Committee, especially the Subcommittee on Africa. We would like 

to thank all the members of the Subcommittee, and your commitment to the U.S. 

leadership in the fight against this tragic pandemic. 

The President and the Congress made a strategic decision to direct the activities 

of the Emergency Plan for global HIV/AIDS, and particularly on interventions designed for its prevention, care, and treatment. Of course, HIV/AIDS in the developing world is closely related to numerous other issues: economic development, food 

security, conflict, gender issues, and many more. 

A focus of the Emergency Plan is to build local capacity to provide long-term, sustainable HIV/AIDS prevention, care and treatment programs in the countries with 

which we partner. Ensuring the availability of safe blood is one component of a 

multi-prong strategy to prevent HIV transmission. And the results of this strategy 

19

are already visible: South Africa and Botswana now have safe or nearly safe blood 

supplies available at the national levels. In Kenya, there are 150,000 more units of 

safe blood, up from 40,000 in 2004. 

For the developing countries in which the Emergency Plan works, there are significant challenges to developing and maintaining an adequate sustainable supply 

of safe blood. These include:

• A lack of basic infrastructure which includes such things as consistent electricity, refrigeration, physical structures, laboratory equipment;

• Inadequate administrative procedures in place to allow for the purchase and 

management of blood-related commodities;

• A lack of or inadequate policy around blood safety and the clinical use of 

blood;

• And, A lack of strong health care systems.

These issues are pervasive in Sub-Saharan Africa, and remain part of a larger 

and more complex development challenge. The Emergency Plan, with its clear mandate to the prevention, treatment, and care for those infected with and affected by 

HIV/AIDS, cannot alone address the infrastructure, policy and capacity challenges 

faced by developing countries. 

At the request of Representative Fattah and the House Appropriations Sub-Committee for Foreign Operations, the Office of the Global AIDS Coordinator has prepared a report on blood safety as a component of the HIV/AIDS prevention strategy. 

Together with our colleagues from the Center for Disease Control (HHS/CDC), the 

U.S. Agency for International Development (USAID), and the World Health Organization (WHO), we invited a group of technical consultants with expertise in blood 

safety to discuss the magnitude of the problem posed by unsafe blood supplies, the 

level of resources required to address the problem, the feasibility of a non-incremental approach, and the cost effectiveness of implementing a safe blood program 

in reducing rates of infection. The group’s consensus was presented in the report 

findings provided to this committee. 

Let me first discuss the HIV transmission risk from unsafe blood in the Emergency Plan focus countries. Actual data collected from PEPFAR focus country blood 

safety programs show an average of 3.19% of donors were HIV positive. Several 

studies have documented that blood transfusions are not the major cause of HIV 

transmission in most countries. Among young women, for instance, the risk associated with transfusions appears low compared to the proportions infected by heterosexual transmission. This data reflects the prevalence of HIV/AIDS only. 

Even though transmission risk of HIV/AIDS through blood transfusions may be 

low, we have documented challenges in each of the following components of providing safe blood at the national level:

• Assuring that a sufficient amount of blood is collected in the country;

• Assuring the implementation of a system to recruit low risk donors;

• Assuring that quality screening of donated blood is occurring;

• And assuring that national policies and oversight to reduce unnecessary 

transfusions are in place.

These issues contribute to the higher risk of transfusion-transmitted diseases, including viral hepatitis and malaria, in addition to HIV/AIDS, in Africa. 

To reduce the HIV/AIDS transmission risks presented by blood transfusions, the 

Emergency Plan supports

• National programs to improve the quality of blood supplies through improved 

policies;

• The establishment of laboratory facilities and commodity procurement;

• Healthcare worker training and management.

The Emergency Plan also provides technical assistance to aid countries in implementing the foundational components of effective national blood transfusion services. 

PEPFAR promotes international blood safety organizations to partner with each 

of the focus countries to help in the development of a comprehensive system that 

includes low-risk blood donor selection, blood banking, and blood safety training. 

The goal of these programs is to increase blood supply through donor recruitment. 

The programs also work to ensure blood safety through proper screening of donors 

and donated blood. They support the development or improvement of a national 

blood service in each country. 

20

In fiscal year 2005, the Emergency Plan supported approximately 600 blood safety 

service outlets or programs in the focus countries. In 2004, PEPFAR partners obligated a total of $24.4 million in funds to blood safety activities in the focus countries. In 2005, that amount increased to $50 million. For fiscal year 2006, the current planned amount for blood safety activities is $32.3 million. 

During the first 20 months of funding, countries spent only one-third of the Emergency Plan funds allocated to Ministries of Health and National Blood Transfusion 

Services (MOH/NBTS) to establish safe blood systems. Two-thirds of funding remains in the pipeline. At the end of fiscal year 2005, approximately $50 million was 

still in the pipeline and available, in addition to the $32 million in funding planned 

for FY 2006. This is largely due to the infrastructure, human capacity, policy, and 

economic constraints experienced by the focus countries. These countries cannot effectively spend funding until another layer of infrastructure is in place to allow for 

sustainable expansion of services. Additionally, most blood safety-related activities 

supported by the Emergency Plan are implemented through partnerships with focus 

country government organizations such as the MOH. These structures are traditionally slower to act in applying interventions at the national level and often create 

an excess in available unused funding. Assuming that those funds currently in the 

pipeline are appropriately outlayed, the planned funding for blood safety activities 

will increase proportionately in FY 07. 

Now I would like to briefly discuss a baseline for assuming the cost effectiveness 

of safe blood as a means to avert HIV-transmission. Utilizing the simple WHO resource model of a cost of $45 to produce a unit of safe blood, the cost per HIV-infection averted can be extrapolated. Using a HIV prevalence rate of 3%, Testing 33 

units of blood at $45 a unit equals $1500 per unit identified. As the potential for 

contracting HIV from tainted blood is 80%, the approximate cost per infection averted is $2000 per infection (assuming all units of blood are used). I would point out 

that the WHO resource model assumes that basic infrastructure components such 

as functioning roadways, consistent supply of electricity, and sufficiently trained 

and available healthcare workers are in place and accessible. As I have mentioned, 

we know this is not the case, and that these development issues still pose a significant challenge in the countries the Emergency Plan supports. In reality, the cost 

per infection averted would be much more than $2000 when including the infrastructure costs necessary. 

The current levels of funding for blood safety activities strike a reasonable balance 

between the absorptive capacity of host countries to develop national blood services, 

and the continuation of a comprehensive and effective prevention program. The 

Emergency Plan must continue to be strategic in choosing where each prevention 

dollar is spent in support of this full portfolio of interventions. Blood safety activities 

continue to be supported as a necessary element of this portfolio. At current levels, 

we feel this both meets the capacity needs of the focus countries, and fits a comprehensive and cost effective prevention strategy. 

Mr. Chairman, the Emergency Plan is experiencing success in supporting the 

HIV/AIDS strategies of our host nations. Providing safe blood in Africa is a broad 

issue, addressing the risk from all transfusion-transmissible diseases, including 

HIV/AIDS, hepatitis, and malaria. We at the Office of the Global AIDS Coordinator 

will continue to work with our colleagues at the Department of Health and Human 

Services to support the ongoing blood safety programs as part of the Emergency 

Plan efforts focusing on HIV/AIDS. 

As countries continue to develop basic infrastructure and strengthening systems 

that they can maintain over the long-term, safe blood services will begin to expand 

for national coverage. The large-scale programs implemented as part of the Emergency Plan have begun to address this need with a thorough and comprehensive approach that will produce immediate results, long-term improvement, and the likelihood of sustainability. This Subcommittee can be proud that through the President’s 

Emergency Plan, the American people are partners with families, communities, and 

nations that are reclaiming their future. 

Thank you for the opportunity to speak with you today, and I would be happy 

to now address your questions.

Mr. SMITH. Doctor, thank you very much. Dr. Ferris. 

STATEMENT OF ROBERT E. FERRIS, M.D., MEDICAL OFFICER, 

BUREAU FOR GLOBAL HEALTH, U.S. AGENCY FOR INTERNATIONAL DEVELOPMENT 

Dr. FERRIS. Mr. Chairman, Members of the Subcommittee, good 

afternoon and thank you for the opportunity to testify on the imVerDate Mar 21 2002 14:49 Oct 11, 2006 Jkt 000000 PO 00000 Frm 00024 Fmt 6633 Sfmt 6601 F:\WORK\AGI\062706\28424.000 HINTREL1 PsN: SHIRL
21

portant topic of safe blood in Africa. The U.S. Agency for International Development works with its partners to improve blood 

transfusion practices, obstetrical delivery practices and health systems to create a safer blood supply. 

USAID and other U.S. Government partners recognize that safe 

blood saves lives. The medical knowledge and technical expertise 

exists. Implementing and sustaining safe blood supply systems in 

developing countries is the challenge today. 

Women and children are likely to be the greatest beneficiaries of 

safe blood supply in Africa. Women often require blood during a life 

threatening complication of childbirth. Children often require blood 

when their own blood levels are dangerously low from diseases 

such as malaria. During these not uncommon medical emergencies, 

access to safe blood is lifesaving. 

Blood and blood products are not risk free. HIV, hepatitis B, hepatitis C and malaria are just a few of the harmful factors transmissible during blood transfusions. Up to 5 percent of HIV infections in the developing world are estimated to result from transfusion of contaminated blood. 

USAID has directly worked to create a safer blood supply in several countries, including Nigeria and Egypt. Through the Safe 

Blood for Africa project, funded under the President’s Emergency 

Plan for AIDS Relief, USAID, with other Safe Blood for Africa partners, is developing a blood collection and distribution center in 

Abuja, Nigeria, where blood services historically have been understaffed and underfunded. USAID efforts in this initiative have contributed to the long range goal of sustaining a national blood policy 

and establishing a Nigerian national blood transfusion service. 

Through the help of Safe Blood for Africa, 18 national blood transfusion services are now working to safeguard blood supply in developing countries. 

In Egypt, USAID worked with public and private partners to enhance the blood banking enterprise. This project has developed a 

framework to increase voluntary blood donations. The project includes recordkeeping and data management systems to enable the 

retention of safe blood donors, a course in basic principles of safe 

blood collection and universal precaution guidelines, policies and 

procedures. 

USAID has had a long history of strengthening health systems 

and improving the quality and safety of healthcare in developing 

countries. USAID’s health programs in Africa have improved the 

safety of medical practices through technological innovations in 

clinical training, through improved governance, policy guidance, 

strengthened management and logistic systems, better health financing and improvements in service quality. 

USAID helps ensure proper blood safety procedures that can reduce the risk of HIV transmission from transfusions and contaminated needles. We do this by supporting education and behavior 

change among providers and patients, effective supply use by providers, improve distribution systems, improved supply forecasting 

ability and enhanced waste management practices. 

USAID also helps to reduce the need for blood transfusions 

through better medical management and prevention of transfusioncausing conditions in our child survival, infectious disease and maVerDate Mar 21 2002 14:49 Oct 11, 2006 Jkt 000000 PO 00000 Frm 00025 Fmt 6633 Sfmt 6601 F:\WORK\AGI\062706\28424.000 HINTREL1 PsN: SHIRL
22

ternal health programs. While most of these programs are currently funded from our non-HIV/AIDS child survival budget, they 

make substantial contributions to preventing HIV in medical settings. 

Two notable examples are the promotion of safe obstetrical delivery practices and combatting malaria. USAID promotes safe obstetrical delivery and care in its safe motherhood programs. For example, postpartum hemorrhage is a serious complication of childbirth 

that often requires blood transfusion. Our programs aim to reduce 

the need for transfusion by developing programs to prevent 

postpartum hemorrhage as well as protocols to manage hemorrhage appropriately when it occurs. 

Also, USAID funded the Program for Appropriate Technology 

and Health to test the feasibility of putting the drug oxytocin in 

Uniject prefilled, auto-disable injection devices. Oxytocin is a medication that effectively reduces bleeding following childbirth. The 

use of the Uniject device to deliver Oxytocin would make this lifesaving intervention even safer for patients and providers while decreasing the potential need for blood transfusion. 

The USAID-funded maternal and neonatal health program works 

in 10 countries in Africa on infection prevention practices, for safe 

motherhood and newborn health. These programs work at the national level on policies and standards which are then reflected in 

the curricula for preservice and inservice training of healthcare 

workers, preparation of training sites, the development of job aids 

and supportive supervision systems. 

We emphasize several key infection prevention behaviors: Injection safety, universal precautions, avoiding unnecessary medical 

procedures, proper sterilization of instruments, proper disposal of 

hazardous waste as well as newborn umbilical cord care. 

USAID is also a partner with the White Ribbon Alliance, an 

international coalition that increases public awareness about the 

need to make pregnancy and childbirth safe for all women and 

newborns. Optimizing a pregnant woman’s health is likely to prevent the need for some transfusions and reduce the strain on an 

already stretched supply of safe blood. 

Severe anemia from malaria is also a frequent cause for blood 

transfusion in Africa especially for young children. USAID has 

been committed to saving lives from malaria since the 1950s. 

USAID works closely with national governments to build their capacity to prevent and treat this disease. USAID also advances the 

discovery and development of new anti-malarial drugs and malaria 

vaccines. 

In addition to its ongoing malaria programs, USAID also manages programs through the President’s Malaria Initiative, a $1.2 

billion, 5-year initiative to control malaria in Africa. PMI is a collaborative U.S. Government effort led by USAID in conjunction 

with the Department of Health and Human Services, the Department of State, the White House and others. The goal of the initiative is to reduce malaria deaths by half in 15 target countries by 

reaching 85 percent of the most vulnerable groups, children under 

5 years of age and pregnant women with proven and effective malaria prevention and control measures. 

23

Clearly in reducing malaria by improved treatment and prevention of malarial infections fewer transfusions will be required to 

save those severely infected. 

Mr. Chairman and Committee Members, directly strengthening 

blood supply systems ultimately can make safe blood available 

throughout Africa. In the meantime, efforts that strengthen overall 

health systems and prevent medical emergencies like postpartum 

hemorrhage and severe anemia from malaria are critical to reduce 

the burden on currently fragile blood supply systems. 

I would like to assure the Committee that USAID, in partnership 

with HHS and the President’s Emergency Plan for AIDS Relief, 

will continue to work to strengthen systems to improve the delivery 

of safe blood in Africa. Thank you again for inviting me to speak 

on this important topic, and I am happy to take your questions. 

[The prepared statement of Dr. Ferris follows:]

PREPARED STATEMENT OF ROBERT E. FERRIS, M.D., MEDICAL OFFICER, BUREAU FOR

GLOBAL HEALTH, U.S. AGENCY FOR INTERNATIONAL DEVELOPMENT

Mr. Chairman and Members of the Subcommittee: 

Good morning and thank you for the opportunity to testify on the important topic 

of safe blood in Africa. The U.S. Agency for International Development (USAID) 

works with its partners to improve blood transfusion practices, obstetrical delivery 

practices and health systems to create a safer blood supply. 

USAID and other U.S. Government partners recognize that safe blood saves lives. 

The medical knowledge and technical expertise exists. Implementing and sustaining 

safe blood supply systems in developing countries is the challenge today. 

Women and children are likely to be the greatest beneficiaries of a safe blood supply in Africa. Women often require blood during a life threatening complication of 

childbirth. Children often require blood when their own blood levels are dangerously 

low from diseases such as malaria. During these not uncommon medical emergencies, access to a safe blood supply can be life saving. 

Blood and blood products are not risk-free. Human immunodeficiency virus (HIV), 

hepatitis B, hepatitis C, and malaria are some of the harmful factors transmissible 

during blood transfusions. Up to five percent of HIV infections in the developing 

world are estimated to result from transfusion of contaminated blood. 

USAID has directly worked to create a safer blood supply in several countries including Nigeria and Egypt. Through the Safe Blood for Africa project, USAID with 

the ExxonMobil Foundation, the Bill & Melinda Gates Foundation, Merck Pharmaceuticals, the Centers for Disease Control and Prevention (CDC) and Becton Dickson 

is developing a blood collection and distribution center in Abuja, Nigeria to prevent 

HIV transmission through blood transfusion. In Abuja, blood services historically 

had been understaffed and under funded. USAID’s efforts in this initiative have contributed to the long range goal of sustaining a National Blood Policy and establishing a Nigerian National Blood Transfusion Service. Through Safe Blood for Africa, 18 national blood transfusion services are now safeguarding the blood supply. 

In Egypt, USAID worked with public and private partners to enhance the blood 

banking enterprise. This project has developed a framework to increase voluntary 

blood donations. The project includes record-keeping and data-management systems 

to enable retention of safe donors; a course in basic principles of safe blood collection; and universal-precaution guidelines, policies, and procedures. 

HEALTH SYSTEMS

USAID has a long history of strengthening health systems and improving the 

quality and safety of health care in developing countries. USAID’s health programs 

in Africa have improved the safety of medical practices through technological innovations and clinical training and through improved governance, policy guidance, 

strengthened management, information and logistics systems; better health financing and improvements in service quality. 

USAID helps ensure proper blood safety procedures that can reduce the risk of 

HIV transmission from transfusions and contaminated needles. We do this by supporting education and behavior change among providers and patients, effective supply chain management, effective supply use by providers, improved distribution sysVerDate Mar 21 2002 14:49 Oct 11, 2006 Jkt 000000 PO 00000 Frm 00027 Fmt 6633 Sfmt 6621 F:\WORK\AGI\062706\28424.000 HINTREL1 PsN: SHIRL
24

tems, improved supply forecasting ability, and enhanced waste management practices. 

USAID also helps to reduce the need for blood transfusions through better medical management and prevention of transfusion-causing conditions in our child survival, infectious disease and maternal health programs. While most of these programs are currently funded from of our non-HIV/AIDS child survival budget, they 

make substantial contributions to preventing HIV in medical settings. Two notable 

examples are the promotion of safe obstetrical delivery practices and combating malaria. 

SAFE OBSTETRICAL DELIVERY PRACTICES

USAID promotes safe obstetrical delivery and care in its safe motherhood programs. For example, postpartum hemorrhage is a serious complication of childbirth 

that often requires blood transfusions. Our programs aim to reduce the need for 

transfusions by developing programs to prevent postpartum hemorrhage as well as 

protocols to manage hemorrhage appropriately when it occurs. 

Also,USAID funded the Program for Appropriate Technology in Health to test the 

feasibility of putting the drug oxytocin in Uniject pre-filled, auto-disable injection 

devices. Oxytocin is a medication that effectively reduces bleeding following birth, 

the biggest cause of maternal deaths. The use of the Uniject device to deliver oxytocin would make this life-saving intervention even safer for patients and providers 

while decreasing the potential need for blood transfusion. 

The USAID-funded Maternal and Neonatal Health Program works in 10 countries 

in Africa on infection prevention practices for safe motherhood and newborn health. 

These programs work at the national level on policies and standards which are then 

reflected in curricula for pre-service and in-service training of health care workers, 

preparation of training sites, the development of job aids and supportive supervision 

systems. In addition, we emphasize several key infection prevention behaviors: injection safety, universal precautions, hand-washing, avoiding of unnecessary medical 

procedures, proper sterilization of instruments, proper disposal of hazardous waste, 

and newborn umbilical cord care. 

USAID is also a partner in the White Ribbon Alliance, an international coalition 

that increases public awareness about the need to make pregnancy and childbirth 

safe for all women and newborns. The Alliance disseminates technical information 

on safe delivery practices, mobilizes communities, and calls attention to the needs 

of HIV positive mothers. 

MALARIA

USAID has been committed to saving lives from malaria since the 1950s. The 

Agency works closely with national governments to build their capacity to prevent 

and treat the disease. USAID also invests in the discovery and development of new 

antimalarial drugs and malaria vaccines. 

In addition to its ongoing malaria programs, the Agency also manages programs through the President’s Malaria Initiative (PMI), a $1.2 billion, five-year initiative 

to control malaria in Africa announced by President Bush in June 2005. PMI is a 

collaborative U.S. Government effort led by USAID, in conjunction with the Department of Health and Human Services (Centers for Disease Control and Prevention), 

the Department of State, the White House, and others. 

The goal of the Initiative is to reduce malaria deaths by half in 15 target countries in Africa by reaching 85 percent of the most vulnerable groups—children under 

5 years of age and pregnant women—with proven and effective malaria prevention 

and treatment control measures. PMI supports control measures including insecticide-treated bed nets, spraying with insecticides in communities, lifesaving antimalarial drugs, and treatment to prevent women from getting malaria. Clearly, in 

reducing the toll of malaria by improved treatment and prevention of malarial infections, fewer transfusions will be required to save those severely infected. 

CONCLUSION

Directly strengthening blood supply systems ultimately can make safe blood available throughout Africa. In the meantime, efforts that strengthen overall health systems and prevent medical emergencies like postpartum hemorrhage and severe anemia from malaria are critical to reduce the burden on currently fragile blood supply 

systems. 

I would like to assure the Committee that USAID, in partnership with HHS and 

the President’s Emergency Plan for AIDS Relief, will continue to work to strengthen 

systems to improve the delivery of safe blood in Africa. Thank you again for inviting 

me to speak on this important topic and I am happy to take your questions.

25

Mr. SMITH. Thank you so very much. And now, Dr. Holmberg. 

STATEMENT OF JERRY A. HOLMBERG, PH.D., SENIOR ADVISOR 

FOR BLOOD POLICY, OFFICE OF PUBLIC HEALTH AND 

SCIENCE, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 

Mr. HOLMBERG. Good afternoon, Mr. Chairman. I am Dr. Jerry 

Holmberg, Senior Advisor for Blood Policy and the Executive Secretary to the Advisory Committee on Blood Safety and Availability 

for the Department of Health and Human Services. Sitting behind 

me today is my colleague from the Center for Disease Control and 

Prevention, Dr. Matthew Kuehnert. I have asked Dr. Kuehnert to 

be present at the hearing to collaborate with me on some of the 

questions you may ask. 

In the healthcare setting, HIV, the hepatitis viruses, hepatitis B 

and C and the parasites that cause malaria are easily transmitted 

through exposure to blood caused by unsafe injections, poor infection control practices and contaminated blood yet at present fewer 

than 30 percent of countries worldwide have fully functional national blood services. 

The problem is especially acute in Africa where an estimated 14 

million blood units are needed while only 3.6 million units were 

collected for distribution in 39 countries in 2004. Screening in general remains a challenge in many resource constrained countries. 

One-third of the 90 million units of blood transfused worldwide in 

2000 were not screened for one of the three most serious transfusion transmitted viruses, that being HIV, hepatitis B virus and 

hepatitis C virus. 

In 2005, AIDS killed 3 million people, with 80 percent of these 

deaths in sub-Saharan Africa. In addition, there were almost 5 million new HIV infections worldwide, more than 11,000 new infections each day. Around the world the vast majority of these infections are sexually transmitted. Intravenous drug use and perinatal 

transmission also accounts for significant numbers of infections. 

Although blood transfusion accounts for a minority of new infections in countries with generalized epidemics where most infections 

are the result of heterosexual contact, contaminated blood remains 

the most efficient method for transmitting HIV from one person to 

another. Transfusions are estimated as the cause of 5 percent of 

HIV infections in developing countries. 

Much of the worldwide viral hepatitis burden, which includes 

acute infections, chronic hepatitis, cirrhosis and liver cancer, is due 

to hepatitis B virus. Hepatitis B virus kills about 620,000 persons 

worldwide annually. Approximately 350 million persons, 5 percent 

of the world population, live with chronic hepatitis B virus infection, with the highest rates of transmission and chronic infection 

primarily in parts of Africa and Asia. 

Young children who become infected with hepatitis B virus are 

more likely to develop chronic infection. The risk of death from 

hepatitis B virus related liver cancer or cirrhosis is approximately 

25 percent for persons who become chronically infected during 

childhood. 

While less common than hepatitis B virus as the cause of acute 

hepatitis, hepatitis C is estimated to have infected about 170 milVerDate Mar 21 2002 14:49 Oct 11, 2006 Jkt 000000 PO 00000 Frm 00029 Fmt 6633 Sfmt 6601 F:\WORK\AGI\062706\28424.000 HINTREL1 PsN: SHIRL
26

lion people, some 3 percent of the world’s population, 130 million 

of whom are chronic carriers. Disease prevalence is high in many 

countries in Africa, Latin America, Central and Southeastern Asia. 

In these countries, prevalence rates range from 5 to 10 percent. 

Malaria causes 300 to 500 million acute illnesses annually, and 

kills as many as 1 million people, mostly children under the age 

of five. Almost half the world’s population lives in areas where malaria is endemic. In Africa alone, malaria is responsible for an estimated 25 to 35 percent of all outpatient visits and 20 to 45 percent 

of all hospital admissions. 

Although malaria can be transmitted by blood, mosquitos are the 

primary vector of infection. However, blood transfusions play a critical role in sustaining the lives of children suffering from malaria 

induced anemia. In severe cases these children require blood transfusions to survive, the transfusions that are frequently unavailable 

due to a lack of blood. 

HHS supports the development of a long-term, sustainable blood 

safety program in Africa and Asia through the Emergency Plan 

and other initiatives. The creation of a blood safety program requires that attention be paid to issues of sustainability. Strategies 

must ensure that each new service is supported by adequate infrastructure such as laboratories and reliable power, the staff is recruited, trained and retained, the laboratory equipment and reagents are appropriate and available, and that processing procedures are properly managed. 

It is important to ensure that the blood safety strategies are not 

only comprehensive but integrated in or linked into other U.S. Government funded public health activities in a country. HHS works 

with its U.S. Government partners and with other international 

health organizations to ensure the programs funded through various mechanisms like the Emergency Plan, the Global Fund or private foundations do not duplicate efforts. 

HHS and its agencies look forward to continuing its collaboration 

with U.S. and international partners to incrementally strengthen 

the current blood safety program as part of a diverse portfolio of 

global disease prevention strategies. Thank you for the opportunity 

to testify. I am happy to answer any questions. 

[The prepared statement of Mr. Holmberg follows:]

PREPARED STATEMENT OF JERRY A. HOLMBERG, PH.D., SENIOR ADVISOR FOR BLOOD

POLICY, OFFICE OF PUBLIC HEALTH AND SCIENCE, U.S. DEPARTMENT OF HEALTH

AND HUMAN SERVICES

Good morning, I am Dr. Jerry Holmberg, Senior Advisor for Blood Policy and Executive Secretary of the Advisory Committee on Blood Safety and Availability within 

the Office of Public Health and Science of the Department of Health and Human 

Services (HHS). I am pleased to be here today to discuss blood safety and transfusion-transmitted diseases, including HIV/AIDS, viral hepatitis, and malaria in Africa. I have over 35 years of experience, primarily in clinical laboratory science, and 

have been involved in the blood community since the early 1970s, and I take blood 

safety and the availability of blood products seriously. 

Sitting behind me today is my colleague from the Centers for Disease Control and 

Prevention (CDC), Dr. Matthew Kuehnert. Dr. Kuehnert is the Assistant Director 

for Blood Safety, Division of Viral and Rickettsial Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention in Atlanta. I have 

asked Dr. Kuehnert to be present at this hearing to collaborate with me on questions you may ask. 

Please permit me to state that in my official capacity, I participate internationally 

with the Global Collaboration for Blood Safety (GCBS). Recognition of the need for 

27

1Global Database on Blood Safety, World Health Organization 

a GCBS was first endorsed by 41 countries represented during the Paris AIDS Summit in 1994 and adopted by the Forty-Eighth World Health Assembly (WHA) as 

WHA resolution 48.27 (1995), by all 191 World Health Organization (WHO) Member 

States in order to prioritize the need for global collaboration to improve blood safety. 

WHO is a participant of GCBS and also provides its secretariat. 

The GCBS participants agree to collaborate in facilitating progress in the following areas:

• international consensus on essential principles of global blood safety;

• encouraging the recognition and establishment of national blood programs;

• identifying priorities for the prevention of transfusion-related disease;

• implementation of appropriate and recognized transfusion practices, which 

ensure donor and recipient safety and are free from discrimination;

• effective recruitment of safe donors through the use of appropriate selection 

criteria;

• assuring quality and safety in the preparation of blood and blood products;

• safe international practices for the collection, storage, and transport of plasma 

and the preparation and distribution of its derivatives;

• the bi-directional traceability of blood products between donor and recipient 

whether in-country or across national borders; and

• promote evidence-based use of blood and blood products

• the exchange and use of information by encouraging data collection, management and dissemination.

The GCBS represents some of shared concerns that the Committee has in regards 

to improving blood safety and the medical infrastructure in Africa. 

In my remarks today, I will be addressing the overall burden of disease of HIV/

AIDS, viral hepatitis, and malaria in sub-Saharan Africa, and the role that unsafe 

blood transfusions play in the transmission of these diseases. I also will discuss the 

barriers and challenges related to implementing a long-term, sustainable blood safety program in the developing world, and will conclude by discussing some of the Department’s efforts to improve blood safety and address the burden of disease in subSaharan Africa. 

HIV, VIRAL HEPATITIS, AND MALARIA IN SUB-SAHARAN AFRICA

In the health care setting, HIV, the hepatitis viruses (hepatitis B virus (HBV) and 

hepatitis C virus (HCV)), and the parasites that cause malaria are easily transmitted through exposures to blood caused by unsafe injections, poor infection control 

practices, and contaminated blood. Yet, at present fewer than 30% of countries 

worldwide have fully functioning national blood transfusion services. The problem 

is especially acute in Africa, where an estimated 14 million blood units are needed, 

while only 3.6 million units were collected for distribution in 39 countries in 2004.1

Improving access to safe blood in the developing world is a daunting challenge requiring development of sustainable infrastructure which is complex and resourceand time-intensive. I will address the barriers faced by many countries and the Department’s response to them later in my testimony. 

HIV/AIDS 

Since 1981, AIDS has killed more than 25 million people, making it one of the 

most devastating epidemics in history. In 2005, AIDS killed three million people, 

with 80% of these deaths in sub-Saharan Africa. In addition, there were almost 5 

million new HIV infections worldwide—more than 11,000 new infections every 

day—bringing the number of people living with HIV to more than 40 million 

(UNAIDS, 2005). Around the world, the vast majority of these infections are sexually transmitted. Intravenous drug use and perinatal transmission also account for 

significant numbers of infections. The cost in human lives lost is staggering. And 

there are important subsequent costs that accompany each new infection and each 

death. Persistent stigma and discrimination in much of the developing world mean 

infected people remain at risk of losing jobs, friends, and family support. AIDS has 

torn apart families, orphaned children, and put new stresses on developing economies. For example, countries with an HIV prevalence of 15%, as is the case in a 

28

2Pavon B (2004). AIDS Slashes Life Expectancy in 23 African Countries. UN Chronicle Online 

Edition, Issue 3. 3WHO. Blood Safety and Clinical Technology Progress 2000–2001, 2002. 

4 Rapita, E. Dhingra N, Hutin Y, and Lloyd D. 11th International Symposium on Viral Hepatitis and Liver Disease. Syndey, Austraila, 2003. 

number of sub-Saharan African countries, are estimated to lose 1% Gross Domestic 

Product (GDP) every year2. 

Although blood transfusions account for a minority of new infections in countries 

with generalized epidemics (where most new infections are the result of heterosexual contact), contaminated blood remains the most efficient method of transmitting HIV from one person to another. According to WHO, transfusions are estimated 

as the cause of 5% of HIV infections in developing countries.3 I must say that the 

prevalence may be higher since reporting, documentation, and investigation into 

causes of the HIV infection may be non-existent in these developing countries. Factors that contribute to transfusion-related transmission in sub-Saharan Africa and 

other parts of the developing world include: high rates of transfusion in some groups 

of patients (particularly women and children); a higher prevalence of HIV in the 

general and blood donor populations; inadequate HIV antibody screening in some 

countries; and a high residual risk of contamination in blood supplies despite antibody screenings. 

Viral Hepatitis 

Much of the worldwide viral hepatitis burden, which includes acute infections, 

chronic hepatitis, cirrhosis and liver cancer, is due to HBV. HBV kills about 620,000 

persons worldwide annually. Approximately 350 million persons—5% of the world’s 

population—live with chronic HBV infection, with the highest rates of transmission 

and chronic infection primarily in parts of Africa and Asia. 

In sub-Saharan Africa, most of Asia, and the Pacific, most people become infected 

with HBV during childhood, and 8% to 10% of the general population is chronically 

infected. Young children who become infected with HBV are more likely to develop 

chronic infection. The risk of death from HBV-related liver cancer or cirrhosis is approximately 25% for persons who become chronically infected during childhood. 

While less common than HBV as a cause of acute hepatitis, HCV is estimated to 

have infected about 170 million people, some 3% of the world’s population, 130 million of whom are chronic carriers, according to WHO. Disease prevalence is high in 

many countries in Africa, Latin America and Central and South-Eastern Asia. In 

these countries, prevalence rates range from 5% to 10% (WHO). 

Screening in general remains a challenge in many resource constrained countries. 

According to WHO estimates based on country reports, one-third of the 90 million 

units of blood transfused worldwide in 2000 were not screened for one of the three 

most serious transfusion transmitted viruses, HIV, HBV and HCV.4 This gap in 

screening directly contributed to 78,000 HBV infections and more than half a million HCV infections. 

In sub-Saharan Africa in 2000, more than 70% of blood donations were screened 

for HBV, but only about 10% were screened for HCV. The total number of infections 

attributed to unsafe blood donations was 30,000 for HBV and 52,000 for HCV, leading to 80 deaths from HBV infection and 440 deaths from HCV. 

Although the overall proportion of new infections attributed to transfusion-transmitted HIV and viral hepatitis may be relatively low, because blood safety interventions are likely to be effective once they are implemented, they can be a potentially 

attractive preventive strategy. This, however, strongly depends on available resources and infrastructure for the interventions to be feasible. 

Malaria 

Malaria causes 300–500 million acute illnesses annually and kills as many as 1 

million people, mostly children under five years of age, according to WHO. Almost 

half of the world’s population lives in areas where malaria is endemic. In Africa 

alone, malaria is responsible for an estimated 25% to 35% of all outpatient visits 

and 20% to 45% of all hospita1 admissions. The economic impact associated with 

lost work days due to malaria has been estimated to reduce the GDP of heavily burdened countries by between 1% and 4%. The cost of these losses may be as high 

as US$12 billion per year. 

In the case of malaria, mosquitoes, not blood transfusions, are the primary vector 

of infection. However, blood transfusions play a critical role in sustaining the lives 

of children suffering from malaria-induced anemia. Anemic children lack sufficient 

red blood cells to carry oxygen to their organs. In severe cases, these children reVerDate Mar 21 2002 14:49 Oct 11, 2006 Jkt 000000 PO 00000 Frm 00032 Fmt 6633 Sfmt 6621 F:\WORK\AGI\062706\28424.000 HINTREL1 PsN: SHIRL
29

5 Clark, KA. Pediatric Transfusion in Developing Countries. In: Hillyer, Strauss and Luban, 

editor. Handbook of Pediatric Transfusion Medicine. San Diego, CA: Elsevier Academic Press; 

2004. p. 149–157. 

quire blood transfusion to survive—transfusions that are frequently unavailable due 

to a lack of blood. 

Screening donors for malaria has not been a priority activity in the African context because:

• the overwhelming source of exposure to malaria in Africa is from infected 

mosquitoes rather than transfused blood;

• screening tests are not sufficiently sensitive to effectively identify and defer 

donors to prevent them from transmitting infection; and

• many children receiving blood transfusions in this setting are already being 

treated for malaria as the underlying cause of their severe anemia.

• in many countries where malaria has high prevalence, standard protocol is 

to treat all transfusion recipients for malaria.

Additionally, because of high rates of malaria among potential donors, screening 

would further diminish an already inadequate blood supply. 

ISSUES RELATED TO BLOOD SAFETY IN DEVELOPING COUNTRIES

In the United States, the blood supply is considered very safe. The risks of infection with known blood-borne pathogens are low because of extensive donor exclusion 

guidelines, including laboratory screening. The medical transfusion community 

maintains continuously improved efforts to collect blood only from the safest donors 

and to screen all donated blood for blood-borne pathogens. The safety of the blood 

supply in the developing world, however, is markedly different than that in the 

United States. 

Barriers to maintaining an adequate, safe blood supply in developing countries 

exist on many levels. In many sub-Saharan Africa countries, blood services are either non-existent or significantly under-resourced or lacking the infrastructure and 

capacity to ensure sustainable operations. Infrastructure challenges include problems with electricity to ensure the consistent refrigeration needed to store donated 

blood. Additionally, funding is frequently inadequate to purchase blood-banking 

equipment and test kits, especially in countries faced with extreme poverty, political 

instability, and armed conflict. Also, in these same countries, salaries and training 

for blood-banking and transfusion personnel may not be supported by the national 

budget.5 This is particularly true in countries lacking policies and legislation for 

blood safety. In addition, many hospitals do not have effective laboratories to ensure 

the complete screening of blood. In countries with a high prevalence of HIV, HBV, 

and HCV among blood donors, this risk is especially high. Consequently, an incremental and time-phased approach that establishes the political, medical, and 

logistical frameworks for transfusion services is recommended. 

Regular, unpaid voluntary blood donors are needed for high-quality blood services 

worldwide—but identifying and targeting low-risk volunteers for blood donations 

can be difficult in areas with high disease prevalence. Currently, volunteer donors 

provide less than half of the blood supply in developing countries, and few countries 

have mobilized efforts to encourage unpaid, voluntary blood donation. In many countries where cultural attitudes may limit the acceptance of blood donation activities, 

governments and other institutions are beginning to counteract these attitudes with 

educational outreach programs. 

Still, many countries are forced to rely on emergency blood donations from paid 

donors or family members. These so-called ‘‘replacement’’ donors carry an increased 

risk of transmitting disease. Based on findings that unpaid donors have the lowest 

risk of transfusion-transmitted viruses, the WHA adopted Resolution WHA 28.72 in 

1975 and WHA 58.13 in 2005, which urged all WHO member states to base national 

transfusion services on non-remunerated volunteer blood donors. 

Limited amounts of safe and volunteer-donated blood, poor infrastructure (including a lack of clean water and constant electricity), and structural limitations in the 

healthcare system all contribute to the need for an integrated health and development strategy to ensure blood safety. Achieving a high quality, sustainable public 

health response will require implementing and strengthening multiple systems, including clinical quality assurance systems; health care infrastructure; human resource development; and procurement and logistics systems. 

30

6 Botswana, Coˆte d’Ivoire, Ethiopia, Guyana, Haiti, Kenya, Mozambique, Namibia, Nigeria, 

Rwanda, South Africa, Tanzania, Uganda, and Zambia. Vietnam was recently added as the 15th 

country. 7 American Association of Blood Banks (AABB), Safe Blood for Africa Foundation, Sanquin 

Consulting Services, Social and Scientific Systems, Inc. (SSSI), and World Health Organization 

(WHO/PAHO).

CURRENT HHS/CDC ACTIVITIES RELEVANT TO BLOOD SAFETY AND PREVENTION

There are a group of activities at HHS/CDC that impact the safety of blood in 

Africa. I want to highlight a few of these, including three of the most relevant programs. 

As part of the President’s Emergency Plan for AIDS Relief (Emergency Plan), 

HHS/CDC actively supports the development of integrated strategies for blood safety in 14 of the 15 focus countries,6 12 of which are in sub-Saharan Africa. HHS/

CDC’s Emergency Plan-funded initiative pairs the National Blood Transfusion Services with one of five non-governmental organizations7 that are recognized leaders in 

blood safety. This approach allows local blood services to obtain world class expertise and provides their personnel to the latest training. At the same time, it ensures 

that ideas, policies, and strategies are developed at the local level, with national 

staff serving in key leadership roles. This approach has four elements: 

1. Enhancing local laboratories’ capacity to test all donated blood for transfusion transmitted infections, with an emphasis on quality-assured screening 

of all donated blood for HIV.

2. Promoting voluntary non-remunerated blood donations—the collection of 

blood from, regular, unpaid blood donors from low risk populations.

3. Providing training and education for local medical personnel to reduce the 

number of unnecessary transfusions, promote safe and rational blood utilization, and increase the use of alternatives to transfusions.

4. Identifying the amount of blood needed each year to ensure a sufficient supply in each country.

HHS/CDC’s experience in 14 countries has demonstrated that most countries cannot effectively utilize large increases in financial resources for blood safety, and that 

moderate increases which enable incremental scale-up are most appropriate. 

HHS/CDC also provides subject matter expertise in the prevention of hepatitis B 

and C infection to community organizations, government agencies, and blood banks 

responsible for blood safety. It also develops evaluation panels for use internationally to determine the performance of test kits manufactured in other countries for 

laboratory screening of blood donations for HBV and HCV infections. Additionally, 

HHS/CDC provides financial support and technical assistance to the WHO for blood 

safety and the prevention of HBV and HCV transmission in health care settings. 

HHS/CDC is also involved in malaria prevention activities through the Presidential Malaria Initiative (PMI). The PMI is focused on expanding access to proven 

intervention methods like insecticide-treated bednets and indoor residual spraying, 

as well as scaling up access to effective care and treatment, especially for children 

and pregnant women. 

These efforts help prevent cases and decrease the need for transfusions related 

to malarial anemia. As such, HHS/CDC is currently focused on making progress in 

reducing the enormous background rate of infection. Once this is achieved, blood 

safety activities as they relate to malaria could become more feasible and cost effective. 

The National Heart, Lung, and Blood Institute (NHLBI) at HHS’s National Institutes of Health supports epidemiological studies at international demonstration 

sites addressing important blood safety and availability issues to ensure a safe and 

adequate blood supply. NHLBI is in the process of expanding the study to several 

sites in developing countries, where researchers will investigate critical scientific 

issues related to transfusion-transmitted HIV and other established and emerging 

transfusion-transmitted agents. 

NEXT STEPS

To summarize, for persons with HIV, viral hepatitis, or malaria in Africa, transfusion-associated transmissions represent a small proportion of the total number of 

new infections each year, but the number of these transmissions is substantial nonetheless, and efforts to address these causes are an important component of a comprehensive prevention strategy. The creation of a blood safety program requires that 

attention be paid to issues of sustainability. Strategies must ensure that each new 

31

service is supported by adequate infrastructure such as laboratories and reliable 

power; that staff is recruited, trained, and retained; that laboratory equipment and 

reagents are appropriate and available; and that processing procedures are properly 

managed. 

These are huge challenges. Yet despite these barriers, US Government support for 

blood safety programs is worthwhile for three reasons:

• First, proven interventions are available to dramatically reduce or virtually 

eliminate transfusion-related transmission of these infections.

• Secondly, blood safety programs protect vulnerable populations. Persons in 

need of transfusion cannot take personal action to reduce their risk.

• Third, blood safety programs build public health capacity by raising standards of care and building technical capacity among laboratory workers, 

nurses, and physicians. In addition, education, risk assessment, and laboratory screening can be used to support prevention interventions to other atrisk populations and the general public.

CDC has had a leadership role in global blood safety since the early years of the 

AIDS epidemic, with extensive expertise in epidemiology, laboratory development 

and management, and scientific and technical training. CDC also has experience in 

developing and implementing infectious disease control programs domestically and 

internationally. In addition, CDC has conducted landmark epidemiologic investigations in a number of settings to establish the risk for transfusion-associated infections; CDC scientists have devised and assessed new tests to protect the blood supply and have developed panels of specimens for blood banks to evaluate the quality 

of their screening of blood donations. 

HHS supports the development of long-term, sustainable blood safety programs in 

Africa and Asia through the Emergency Plan and other initiatives. HHS and its 

agencies, such as CDC and the Food and Drug Administration, also have long standing relationships with WHO and other international organizations committed to 

blood safety. 

Responding to the need to produce an adequate and safe blood supply in developing countries requires a comprehensive and coordinated effort among Ministries 

of Health and experts in blood transfusion throughout the world. Efforts implemented as part of the Emergency Plan have begun to address this need with a thorough and comprehensive approach that will produce immediate results, long-term 

improvement, and the likelihood of sustainability. 

It is important to ensure that blood safety strategies are not only comprehensive, 

but integrated in or linked to other US Government-funded public health activities 

in a country. HHS works with its US Government partners and with other international health organizations to ensure that programs funded through various 

mechanisms, like the Emergency Plan, the Global Fund or private foundations, do 

not duplicate efforts. HHS/CDC country offices are actively engaged in seeking ways 

to partner with these external donors and designing projects to complement each 

organization’s inherent strengths. 

HHS and its agencies looks forward to continuing its collaborations with U.S. and 

international partners to incrementally strengthen the current blood safety program 

as part of a diverse portfolio of global disease prevention strategies. 

Thank for you the opportunity to testify today. I am happy to answer any questions you may have.

Mr. SMITH. Dr. Holmberg, thank you very much for your work 

and for your testimony today. Let me ask a few opening questions. 

In OGAC’s report on blood safety and HIV/AIDS, your agency indicates that significant—and this is to Dr. Ryan—significant 

amounts of money have been awarded to focus countries for blood 

safety activities but these funds have not yet been expended. 

I looked at the table from August 2004 to 2005 and noted that 

some of the countries—for example, Nigeria has spent 61 percent 

of the $2.7 million that was given. Ethiopia spent zero. Cote 

d’Ivoire spent 52 percent. Uganda is at 50 percent. I think some 

of the reasons are obvious: Infrastructure, a lack of trained individuals to implement the program. 

I wonder if you might expound for a moment on the kind of resistance or the kind of cooperation you are, or were receiving in the 

32

field because obviously it is a two way street. There has to be that 

earnest desire to do this on the part of the countries where there 

is such an acute need. 

I would note that going back to 2001 the World Health Assembly 

Regional Committee for Africa established those goals, what hopefully were doable and will be doable goals by the year 2012, and 

it looks like we are not going to reach those unless there is some 

additional hurry-up offense. What can be done? The money is 

there. It is in a pot, presumably. It has been awarded, and it is not 

being spent. What could we do to help move that along? 

Dr. RYAN. Thank you very much, Mr. Chairman. I think the fact 

that we did a pipeline analysis assisted us in trying to identify 

where were the blocks in expenditure, and as a result of that identifying where there were difficulties in expending the funding we 

were able to accelerate the amount of technical assistance from the 

collaborating TA provider as well as making sure that the Centers 

for Disease Control who manages this grant was aggressively monitoring both the expenditures at the national transfusion center 

level and also by the TA provider. 

I think the answer is one, identify the problem and figure out 

where the blocks are, and two, bring in the technical assistance to 

help them figure out how to problem solve around those blockages. 

Mr. SMITH. Can I ask you, is there a sense of urgency on the part 

of the parliamentarians, the prime minister, the President, and the 

ministers of health to get at this? It seems to me that if you have 

got blood right, you are a long way in ensuring a healthier population. 

Dr. RYAN. I think there is a lot of urgency, and certainly that urgency is tempered a little bit by what are the conflicting urgencies 

that they deal with. When we look at the national AIDS control 

programs, they definitely want to have safe blood but they are also 

having to look at how do the prevent 90 percent of the other infections that are occurring. 

There are also the issues of how do they deal with the infrastructure challenges. Certainly there is an urgency but they are constantly faced with several conflicting urgencies at the same time. 

Mr. SMITH. Could you just, any one of our panelists, speak to 

how well or poorly the UN Global Fund is focusing on this particular issue of safe blood? Mention was made, and I listened, as 

I am sure many others did, to the press conference yesterday when 

Bill and Melinda Gates accepted that very sizable contribution of 

about $30 billion, and I noted that I think it was Melinda who said 

that this will go not toward new initiatives but expanding and 

building more capacity to existing ones. 

I know that the Gates Foundation has been very helpful in the 

area of safe blood. I am wondering if we will be making an overture 

to them to expand that effort in Africa. 

Dr. RYAN. I will take a stab at it. I think that one of the things 

we have done in the Emergency Plan is try to create successful 

models, and we have seen that in treatment. We have seen that in 

care. We have seen that in other prevention modalities, and what 

we hope to do is by providing successful models of scaling up safe 

blood programs that then the Global Fund can come in and either 

33

continue sustainable support of those models or implement those 

models in other countries. 

Mr. SMITH. The Global Fund? Anybody want to comment on 

that? Have they made this a priority? 

Dr. RYAN. I think that in some countries. I cannot tell you which 

countries but I know that as part of a comprehensive prevention 

portfolio the Global Fund I would assume would be addressing 

some of those issues on blood safety. 

Mr. SMITH. If you could, you and perhaps our panel of three witnesses, could you get back to us with some of the information about 

what the Global Fund is doing? Because it would be very helpful 

to know. Let me ask just a couple of final questions on the issue 

of blood testing supply kits. The two countries, the Democratic Republic of Congo and Kenya, reported using blood without testing for 

transfusion-transmitted infections due to the non availability of 

kits. 

We hear that there have been disruptions in the supply. They 

would love to do it but the kits are not available. How much priority do we give to ensuring that a blood testing kit is readily available for testing? 

Mr. HOLMBERG. Sir, are you talking about available to countries 

in Africa? 

Mr. SMITH. Yes, the countries in Africa. 

Mr. HOLMBERG. I cannot answer that question directly as far as 

the release of products from the United States over to Africa but 

I would like to make a statement that this is really part of the infrastructure that I think Dr. Ryan is talking about is really to try 

to have a sustainable model where we really work the systems out 

so that the supplies can get into the countries so that there will 

not be a disruption of services. 

Mr. SMITH. Are we working that problem, in your opinion, sufficient to meet the need? 

Dr. FERRIS. I think it is not. I think commodities in general are 

very difficult to get into certain regions, and there is a lot of work 

with supply chain management and improving those logistic systems throughout Africa. 

Mr. SMITH. Very briefly, I have a question on the voluntary blood 

donation rate per country from non-remunerated blood donors. The 

WHO report suggests wildly high numbers of countries that have 

achieved 100 percent. Does that comport with our experience as 

well? At least 12 countries are at 100 percent, three at 95 and then 

it drops down to the worst, which is more attaining at 1 percent. 

What has been our experience? As Chakah Fattah indicated earlier, there could be a concern here that we are not getting true voluntary donors who are not being paid. 

Dr. RYAN. The WHO report—and I am assuming that is from the 

2004 blood safety data management report—that is based on a passive reporting system. Any type of passive reporting system you 

know does have its flaws. That is why we have aggressively put in 

monitoring and evaluation components into the PEPFAR countries 

so that we can have our own database that we look at to make sure 

that we follow that prospectively so we can get what we hope will 

either be substantial data that will confirm the 2004 report or give 

us better insight into what is really happening. 

34

Mr. SMITH. WHO suggested in one of their reports that the cost 

of a unit of blood—and this was not just in Africa, but also other 

countries—was $55. Do we have a sense as to what it costs to ensure that a pint of blood is indeed clean in Africa? Is there a number? 

Dr. RYAN. We have made some rough calculations. We consider 

that if there is a 3 percent transfusion HIV prevalence rate then 

you would have to test one in 33 units to find the unit that is positive. At $45 that would give us a rate of about $1,800 per transfusion infection averted. That is not looking into what are the infrastructure costs, the electricity, the roads, et cetera. What we 

have to consider is how does that relate to what other prevention 

modalities there are. 

For example, prevention of mother to child transmission which 

accounts for in the focus countries we figure 14 to 20 percent, that 

costs us including the cost for infrastructure, we estimate that cost 

to be anywhere from $1,000 to $1,800. In terms of cost infection 

averted, the expenditure for PMTCT included the infrastructure 

costs is less effective and it has a greater proportion of infections 

are due to maternal to child transmission. 

Mr. SMITH. Finally, Dr. Holmberg, you mentioned 14 million 

blood units are missing or short in Africa. Obviously, reducing unnecessary transfusions would be one way of mitigating that. Even 

though you want to build up supply, stopping those that are not 

necessary would be an important goal. How much progress are the 

African nations making on trying to stop those unnecessary transfusions? Finally, if one of you might answer this: WHO says 5 to 

10 percent of the HIV infections are attributable to bad blood. The 

number you gave was 3.2 percent. Is that because of better calculations or is it that the programs are beginning to work? 

Dr. FERRIS. Regarding other means for reducing unnecessary 

transfusions, a lot of the focus there is on training physicians, 

other clinicians, and other healthcare workers on the proper indications and timing to transfuse a patient. It is difficult. Protocols are 

being developed and are already out there, and clinicians often 

have to compare the protocol to what they are seeing in front of 

them in terms of the patient’s conditions but those protocols are 

out there, and are being developed. With other preventative measures, hopefully we can reduce the need for blood transfusions. 

Mr. SMITH. Mr. Payne. 

Mr. PAYNE. Thank you very much. As it is indicated, we see that 

there is a logjam in getting the funds down to the root and out. I 

wonder in the PEPFAR program has there been very much set 

aside for medical training? Any one of you could answer. Any way 

to increase the medical infrastructure at the grassroots level? 

Dr. RYAN. All of those are very important parts of the strategy, 

and in each country we try to deal with all of them concurrently 

so that we can accelerate the process. What we see for example in 

Kenya is a very interesting thing where the first thing they wanted 

to do was make sure that there was universal testing of blood, and 

the second thing to do was to set up in hospitals transfusion committees so that you could train the hospitals and the doctor in 

those hospitals to say what is appropriate transfusion, and then 

monitor how well that is working, and a hospital will not be accredVerDate Mar 21 2002 14:49 Oct 11, 2006 Jkt 000000 PO 00000 Frm 00038 Fmt 6633 Sfmt 6601 F:\WORK\AGI\062706\28424.000 HINTREL1 PsN: SHIRL
35

ited unless 80 percent of its transfusions are appropriate and the 

doctors have been trained. 

So, it is a gradual process but I think that they all occur concurrently, and depending on the needs at different stages. 

Mr. PAYNE. Have there been any new tests created for screening 

blood or is there any basic improvements in that technique? 

Mr. HOLMBERG. Specifically for HIV? 

Mr. PAYNE. Just in general. Just the screening process of blood. 

Someone said that CDC has created new tests for screening donated blood, and I was wondering how effective these tests have 

been in protecting the blood supply, and to what extent are the 

tests being administered. 

Mr. HOLMBERG. As far as HIV and hepatitis C virus here in the 

United States and in most countries in Europe, there has been a 

migration to an advanced nucleic acid testing which has reduced 

the risk down to about one in 2 million for transmission of HIV or 

hepatitis C. I think what is being seen in the African countries is 

that the various equipment that is needed to do some of the comprehensive tests requires some of the older technology, and some 

of these countries are not ready to migrate to the more advanced 

technology because it does require more equipment and also highly 

trained individuals. 

Mr. PAYNE. Just aside from HIV, with malaria is malaria still a 

bigger killer than HIV and AIDS? 

Dr. RYAN. From transfusion or in general? 

Mr. PAYNE. Just in general. 

Dr. RYAN. I guess it would depend on sub-Saharan Africa. 

Mr. PAYNE. Yes, that is what I am speaking about. 

Dr. RYAN. I actually do not know how many deaths there are due 

to malaria. 

Mr. PAYNE. There has been little attention given to malaria over 

the years. I think that perhaps it has been because where malaria 

exists poor people live, and in a lot of instances it is not an incentive for pharmaceutical corporations to invest in those areas because the question comes up who is going to pay for it? As we 

know, the cost of providing an effective drug, according to the drug 

companies, there are so many failures until you get one, and therefore it seems that although we are dealing with safe blood and 

HIV, there has not been the attention given to malaria over the 

years. 

I do know that now there seems to be some move toward nets 

and some of the other programs. Even with the President’s initiative it is HIV/AIDS, malaria and tuberculosis and so malaria has 

kicked in over the past few years but it has been an area that 

seemed to have been neglected. I just wonder if any of you have 

any comment on that and then I will end my questioning because 

we are under time constraint. 

Mr. HOLMBERG. Yes, sir. If I can just respond back as far as the 

prevalence in healthy donors. Once again we have very sketchy 

data as far as malaria primarily because the testing for malaria is 

not that refined. Most of the studies that have been done and reported are based on a blood smear in which you actually have to 

see one of the parasites and the various forms of the parasite but 

in Benin, the rate is 33.5 percent in their donor population. In NiVerDate Mar 21 2002 14:49 Oct 11, 2006 Jkt 000000 PO 00000 Frm 00039 Fmt 6633 Sfmt 6601 F:\WORK\AGI\062706\28424.000 HINTREL1 PsN: SHIRL
36

geria, there has been reports anywhere from 4 percent all the way 

up to 40 percent. 

It depends on the geographic locations, and what you are hitting 

upon right now as far as even the attention primarily is because 

we have not been able to have sophisticated testing to be able to 

detect the malaria, and also various attempts that have happened 

over the years such as vaccinations has been not as successful as 

we had hoped they would be. I remember I think yesterday even 

with the Gates Foundation was talking about pursuing some of the 

activities with malaria. I heard that on the press release. 

That is a real area of concern and study because we have not 

been able to produce a vaccine to the malarias because there are 

four different types of malarias that undergo different structures in 

their development. 

Mr. PAYNE. Thank you very much. I will yield. 

Mr. SMITH. Ms. McCollum. 

Ms. MCCOLLUM. Thank you. I want to thank the Congressman 

from Pennsylvania for his work on this area because I did get to 

see, when I was in Tanzania CDC clinic in a hospital, and where 

there were, as Chairman Smith pointed out, very few units of blood 

available. I do not even know if the refrigerator was quite working 

at the right temperature but the awareness was being created and 

opportunities were hopeful. 

They also had a clinic where they had a group of I would call 

them junior high, high school students volunteering to give blood 

much like you would see at our high schools, and a couple of things 

were happening at the same time. They were talking about 

HIV/AIDS prevention. They were being role modeled as leaders in 

their community. 

I went in and talked to all of them about what a great gift of 

life that they were giving but that is only going to work in a very 

few hospitals in the cities but the work needs to start somewhere, 

and it does need to move forward. My understanding in Africa for 

the most part they do not even test for malaria because just about 

everybody in Africa has malaria. 

In the maternal child health clinics I was out in, I ran into a couple of places where some doctors, clinicians and nurses had great 

microscopes to look at blood but they did not have a generator operating to plug in the electric microscope to look at it. Here is 

where I would like to go kind of with my questioning. PEPFAR was 

supposed to be all new money, and it was not. 

I know that I could get all the numbers from my office but we 

did not bring them over with me. Maternal child health to the best 

of the ability of people who are on the Appropriations Committee 

money has been juggled around. It has been shifted out of one area 

into another area. PEPFAR seems like I hear there is a little bit 

of a shift. PEPFAR was first going to kind of have all these freestanding independent this is the PEPFAR clinic and they only do 

HIV AIDS there. 

My understanding now is PEPFAR has come to the conclusion 

that everything needs to be more integrated because of the limited 

number of health facilities and the limited number of people available to provide assistance in those health facilities because of the 

brain drain and other things going on. Can you tell me what part 

37

of the PEPFAR budget is going toward blood versus what part is 

going toward for example abstinence? The CDC funds that are in 

here, is that also coming out of PEPFAR or is that funded separate? 

Dr. RYAN. The funding is PEPFAR funding to CDC for CDC to 

be the implementor of the safe blood programs through what is 

called a track one central. There is also some USAID money that 

is PEPFAR money but it is coming at the program level from 

USAID. You are correct in saying that the PEPFAR model is one 

of integration because what we are really focused on is sustainability, and we work very closely under the three ones, the 

UNAIDS three ones to make sure that the programs that we put 

in place are under the country’s policies and operations so that 

they go on to be sustainable over time. 

That is a really important piece of the blood safety program too, 

and it accounts for some of the delay perhaps in funding is that 

where we are using national transfusion services because most 

countries rely on their government to supply safe blood, and after 

PEPFAR or whatever we need to make sure that those governments are empowered to continue supplying safe blood. That has 

been a very important part of the program. 

Ms. MCCOLLUM. Mr. Chair, if I may. Dr. Ryan, you are saying 

all of the PEPFAR programs are fully integrated? If I go into a 

PEPFAR area where the President’s initiative has been set up and 

there is HIV, tuberculosis clinic nearby it is all under one roof 

now? We are not taking healthcare workers from one area to go to 

another? 

Dr. RYAN. No. What I am saying is that we work under the auspices of the national AIDS control program. So the strategies that 

we have put in place and the programs that we have put in place 

are in full coordination with the national government. So that government essentially would try to coordinate under their policies 

and their framework how the PEPFAR programs would be implemented. 

Mr. SMITH. I deeply regret that we have four votes on the Floor. 

I have a number of questions I would like to submit for the record. 

I will leave as soon as you are done answering. The hearing will 

be in recess and then we will convene with panel three. On that 

whole issue of incremental approach, could you elaborate on that 

for the Committee? I read the report, and it does make a case, but 

as I said to Chakah Fattah earlier, there is incremental and there 

is enhanced incremental. It depends on how fast. You cannot build 

infrastructure in a day but you can build it faster if there is a will. 

I say this with a clear understanding of your points about money 

in the pipeline, and the graph certainly makes a compelling case 

that the money is there just waiting to be utilized, and hopefully 

utilized effectively. But if you could speak to that I will look at it 

as soon as we get back on the record and then we stand in recess. 

Dr. RYAN. The question is is it better to supply money for multiple years over time versus one large amount of money. Because 

of the absorptive capacity and some of the issues that I already 

raised, in order to get full blood safety program because of the 

manpower issues, the infrastructure issues, we felt that it was better and the examples of both Nigeria and Malawi I think provide 

38

very good examples of how sustained funding over time led to a 

much more successful, sustainable program than just one large 

bolus of funding. 

Staff. Thank you. We will now adjourn until the Chairman returns. Thank you. 

[Recess.] 

Mr. SMITH. The Subcommittee will resume its hearing. I would 

like to invite to the witness table our third panel, beginning first 

with Karen Shoos Lipton, who has served as the Chief Executive 

Officer for AABB since October 1994. Prior to joining AABB, Ms. 

Lipton was with the American Red Cross for 10 years. During her 

tenure with the American Red Cross, she served as acting senior 

vice president of biomedical services from November 1993 to September 1994, where she was responsible for the operations of this 

$1 billion revenue division engaged in the collection, processing and 

distribution of blood and tissues and blood components. 

We will then hear from Dr. Edward Green, who is an applied 

medical anthropologist with 30 years of experience in developing 

countries, including numerous countries in sub-Saharan Africa. Dr. 

Green’s sectoral experience includes AIDS and sexually transmitted diseases, primary healthcare, maternal and child health, 

child nutrition, water and sanitation. He has authored five books 

and over 350 peer-reviewed journal articles or book chapters, conference papers or commissioned technical reports. 

Ms. Lipton, if you could begin. 

STATEMENT OF MS. KAREN SHOOS LIPTON, CHIEF EXECUTIVE 

OFFICER, AABB (FORMERLY THE AMERICAN ASSOCIATION 

OF BLOOD BANKS) 

Ms. LIPTON. Good afternoon, Chairman Smith and the other 

Members of the Subcommittee who might come in. On behalf of our 

members we thank you for the opportunity to testify on the critical 

role of the President’s Emergency Plan for AIDS Relief and improving blood safety in sub-Saharan Africa and the Caribbean. 

AABB is a professional society with over 8,000 individual professionals in the fields of blood banking, transfusion medicine, cellular 

therapies and cord blood, and 1,800 institutions including blood 

centers, hospital based blood banks and transfusion services. Twenty percent of our members are located outside of the United States 

in 80 countries around the world. 

For over 50 years AABB has set voluntary standards for blood 

centers and transfusion services, and we have accredited those institutions against those standards. AABB standards are based on 

universally accepted quality principles, and they contain detailed 

technical requirements applicable to blood donor recruitment and 

evaluation, blood collection, blood processing, blood testing, blood 

storage and blood transfusion. 

AABB was the original developer and author of what we call 

quality system essentials which are now used as the basis for many 

laboratory standards and accreditation programs. AABB has had 

significant experience globally in improving transfusion medicine. 

Our written testimony contains a list of our activities but for purposes of today’s hearing I would like to tell you that AABB is the 

technical assistance provider for blood safety in 6 of the 14 

39

PEPFAR focus countries, Guyana, Kenya, Mozambique, Rwanda, 

South Africa and Tanzania. 

Written and oral testimony from other presenters has described 

the scope of the PEPFAR blood safety initiatives. From the technical assistance provider perspective all of us are engaged in the 

same activities, assessments, work plan development, training in 

all aspects of blood collection, processing and administration, advice on equipment purchase and rentals and assistance with the 

development of standard operating procedures and quality systems. 

I know that we all believe that the need to improve blood safety 

and availability in all of the PEPFAR countries and in all of Africa 

is urgent and demands a powerful response. Today I would like to 

focus my comments on several critical issues that I hope might 

shape Congress’ response to this tremendous need. 

First, the acute shortage of human resources and by that I mean 

appropriately educated and trained healthcare professionals, specifically physicians and medical technologists, is a serious threat to 

real progress. In each country there are at best a handful of individuals who are qualified to manage a national blood program, and 

these individuals often have multiple responsibilities within the 

ministries of health, working with dozens of relief providers, governmental and nongovernmental. 

In many cases, these individuals are so busy attending meetings 

that it is difficult to achieve the real work of operating and changing the system at the same time. The sad truth is that providing 

greater level of fundings without dealing with this serious limitation of capacity is simply not responsible. Outside the PEPFAR 

countries there is also a serious limitation globally of individuals 

who are truly qualified and competent to provide the necessary assistance. 

Today in the U.S. there is a serious shortage of medical technologists, nurses and physicians in transfusion medicine making 

recruitment for PEPFAR a challenging task. Globally each of the 

technical assistance providers runs the risk of destabilizing another 

fragile blood system when we recruit trained professionals from the 

ranks of blood transfusion services in other African countries. 

Second, sustainable blood safety and availability, unlike some of 

the other PEPFAR tracks, relies on infrastructures that do not 

exist or are at best weak. Poor roads, unreliable electricity and 

water and seasonal flooding that makes some parts of our countries 

inaccessible at certain times of the year are a serious threat to 

keeping blood, a perishable and temperature sensitive biologic, safe 

for transfusion. 

The lack of appropriate curricula, qualified teachers and equipment in medical and technical schools threatens our ability to bring 

qualified workers into the blood centers, and the cumbersome tender procurement and hiring systems that slow the ability to access 

PEPFAR funds, that slow the ability to acquire the necessary 

equipment and reagents and vehicles and that slow the ability to 

recruit and retain qualified staff are barriers to real and sustainable change. 

These barriers cannot be removed by throwing money at the 

problem. Removing them requires a long-term commitment of 

qualified technical assistants who work within the country to 

40

change these systems. PEPFAR funding for improvements to the 

safety and availability of blood has saved countless lives mostly in 

vulnerable populations such as children and pregnant and 

postpartum women. 

These improvements made under the mantle of HIV prevention 

have the added benefit of reducing the risk of many other transfusion transmitted diseases and the biggest risk of blood transfusion in Africa, the unit that is not there when it is needed. 

Improvements to capability testing and transfusion practices are 

also improving clinical outcomes and reductions in the risk of 

transfusions related complications including death that far exceed 

the benefits of reducing the risk of HIV alone. For this reason, 

AABB supports the expansion of the Federal Government’s efforts 

to improve the safety and supply of blood in Africa with the caveat 

that this expansion must be accomplished in a well-organized and 

deliberately phased approach that recognizes the capacity building 

nature of the programs that we are involved in, and the real limitations in the infrastructure and healthcare systems of these countries. 

Providing massive funding to the countries’ governments and the 

national blood transfusion services without recognizing a country’s 

capacity to properly utilize the funds, without recognizing the country’s ability to appropriately use blood and blood components and 

without strengthening supporting infrastructure will result in a 

failed effort in the long term. Moreover, if PEPFAR’s blood safety 

program is expanded to cover additional African countries, careful 

consideration must be given to assuring that technical experts do 

not destabilize existing blood services in an attempt to find qualified individuals. 

Existing national education and training systems must be 

strengthened in country to ensure a continual stream of properly 

trained healthcare professionals if these programs are to be sustainable. Finally, in order to fully benefit all patients, attention 

must be given to improving transfusion from what we call vein-tovein, from the collection of the unit to the transfusion into the individual. 

It is not enough that we improve infectious disease testing of 

blood. We must also work to ensure that the units are appropriately stored until the time of transfusion, and that each patient 

gets the right unit of blood. The wrong unit to the wrong patient 

or hemolysis of a unit of blood that is not stored in an appropriate 

temperature can kill more swiftly than any disease. 

Blood transfusions are a significant therapy in the treatment of 

complications related to childbirth, pediatric anemia related to malaria and victims of trauma but absent the necessary improvements 

in every aspect of blood—donor recruitment, blood collection and 

processing, testing and blood administration—we will not achieve 

our goal of making blood safe and available for those patients in 

need. 

AABB urges this Committee and Congress to support the development of a well-organized plan for the expansion of the blood safety program in three ways. One, incrementally expand funding to 

technical assistance providers in the 14 PEPFAR focus countries 

41

based on realistic estimates of human resource capacity, and the 

country’s ability to absorb the increased funding effectively. 

Two, add nonfocus countries into an organized blood safety improvement program again in an incremental, organized and sustainable manner. Three, recognition of the current status of the 

blood safety programs and the substantial work that remains to be 

done in these countries, extend PEPFAR blood safety funding beyond the current March 10, 2010, deadline for development of sustainable blood programs. Thank you. 

[The prepared statement of Ms. Lipton follows:]

PREPARED STATEMENT OF MS. KAREN SHOOS LIPTON, CHIEF EXECUTIVE OFFICER, AABB (FORMERLY THE AMERICAN ASSOCIATION OF BLOOD BANKS) 

Good morning Chairman Smith and members of the Subcommittee. My name is 

Karen Shoos Lipton and I am Chief Executive Officer of AABB. On behalf of AABB’s 

members we thank you for the opportunity to testify on the important role of the 

Presidents’ Emergency Plan for AIDS Relief (PEPFAR) in improving blood safety in 

Sub-Sahara Africa and the Caribbean. 

AABB is a professional society at its core, representing approximately 8,000 individual professionals in the fields of blood banking, transfusion medicine and cellular 

therapies and 1,800 institutions, including blood centers, hospital-based blood banks 

and transfusion services. Approximately 20 percent of our members are located outside of the United States in 80 countries around the world. 

For over 50 years, AABB has set voluntary standards for and accredited blood 

centers and transfusion services. In addition, we promote quality care for patients 

through our standard-setting and accreditation of cord blood and hematopoietic stem 

cell collection and storage facilities, immunohematology reference laboratories, and 

relationship testing laboratories. In fact, AABB, was the original developer and author of quality system essentials, which are now used by a number of organizations 

as the basis for their standards and accreditation programs. 

Globally, in addition to our role as a blood safety ‘‘Technical Assistance’’ provider 

under the PEPFAR program, AABB has formal and informal liaison relationships 

with many organizations around the world and has been involved in numerous blood 

safety projects. For example, we are a founding and active member in the World 

Health Organization’s Global Collaboration for Blood Safety. Jointly with the Pan 

American Health Organization, AABB assisted in the development of regional 

standards and implementation guidance for blood banks and transfusion services in 

the Caribbean region and delivered initial training on those standards to representatives from 22 countries. In 2004, we developed and delivered training for the Canadian government’s blood bank regulatory inspectors. Through our voluntary accreditation program we perform assessments and accredit 49 blood collection and transfusion facilities in 16 countries. 

More recently we signed two memoranda of understanding with the Chinese Society of Blood Transfusion and Shanghai Blood Center to develop professional education and technical programs in China and were selected as a subcontracting organization for a United States Agency for International Development (USAID) grant 

to improve blood safety in the country of Moldova. 

AABB’S EXPERIENCE AS A TECHNICAL ASSISTANCE PROVIDER IN AFRICA

Under the President’s Emergency Plan for AIDS Relief, AABB is the Technical 

Assistance provider to six of the 14 focus countries, Guyana, Kenya, Mozambique, 

Rwanda, South Africa and Tanzania. 

As a Technical Assistance provider, AABB’s role is to work with each country’s 

Ministry of Health and National Blood Transfusion Service (NBTS) to strengthen 

the blood supply and address safety systems. The seven key areas identified by the 

Office of the Global AIDS Coordinator (OGAC) and the Centers for Disease Control 

and Prevention (CDC) as meriting attention include:

1. Infrastructure

2. Blood Collection

3. Blood Testing and Processing

4. Transfusion and Blood Utilization

5. Training

6. Monitoring and Evaluation

42

7. Sustainability

AABB’s approach is, first, to conduct a complete assessment of the existing situation in each country. We perform a detailed ‘‘vertical’’ assessment of the country’s 

infrastructures that impact blood transfusion, including:

• enabling legislation;

• regulatory systems;

• government policies;

• NBTS policies and organizational structure;

• financial support for the blood program;

• educational systems; and

• infrastructure (e.g., roads, electricity).

Concurrently, we assess horizontally the NBTS management, operational systems, 

and infrastructure, including:

• staff training;

• donor recruitment;

• donor evaluation and screening;

• blood testing and processing;

• storage and distribution; and

• transfusion practices and blood utilization.

Once the assessment is completed, it is shared with the Ministry of Health and 

the NBTS in each country and, together, we develop a customized five-year work 

plan targeted at each area requiring improvement. From our decades of experience 

in the United States, and more recently in other regions of the world, we believe 

a key to advancing transfusion medicine and blood safety is assisting each country 

in establishing national standards that are based on universally accepted quality 

principles, but tailored to the individual public health needs and resources of each 

country. Such standards allow the countries to implement their own quality systems 

that can be sustainable into the future, even with the inevitable transition of personnel in the country and after U.S. partners in this program have departed. 

At this time, AABB is actively engaged in each of its six countries, working under 

organized and coordinated work plans for each. Each country, of course, is unique, 

but there are common problems that create significant challenges. 

To provide some perspective about the complicating factors that need to be addressed, we would like to provide you with a few real examples from our experiences:

• Standardized Testing and Collections:‘ As a general goal, AABB and others involved with PEPFAR’s blood safety program are all working toward standardizing the collection and testing of blood and, in general, reducing the number 

of locations where these activities are performed. We have all witnessed, firsthand, some of the deplorable conditions—non-functioning or non-existent 

equipment, no standard operating procedures and barely trained staff—that 

exist in some of the blood collection and testing sites. In some countries, centralization of some of the activities, particularly of testing, can serve to increase the quality of practice. As a practical matter, however, this is not a solution that works in every country. The very real problems of lack of roads and 

transportation, including in some places, whole areas of the country that are 

inaccessible during the rainy season, and the difficulties of maintaining an effective cold chain for this perishable material, require that additional sites be 

established and maintained, if we are to ensure the availability of blood for 

all patients in need. The very basic challenge of providing this service in areas 

that have unreliable electricity and water is daunting.

• Rapidly Expanded Funding: Often, even the simple process of accepting and 

disbursing funds becomes a roadblock to success. As an example, in one of our 

countries, it took nearly 10 months to open a bank account to receive 

PEPFAR funds and establish the requisite authority to access the funds. Even 

more common is the concentration of signature authority for the disbursement of funds in one person who must approve every purchase, from equipment, to reagents, to pencils. Further complicating the situation in most countries is that the NBTS is generally required to utilize the tender and procurement system that typically resides in the Ministry of Finance, and which is 

often cumbersome and based solely on a principle of lowest bid, without regard to technical compatibility or quality.

43

• Limited Senior Staff: In most countries there is only one or, at best, a few 

senior staff with the education and experience necessary to manage the NBTS 

operations. And, many of the individuals in these countries hold several positions, including Ministry of Health or public health laboratory responsibilities. Their schedules are further complicated by the sheer number of foreign 

government and non-governmental organizations (NGOs) operating in many 

of these countries. It is not uncommon for these individuals to spend entire 

days and weeks just attending meetings with these funding organizations, 

leaving little, if any, time to actually implement the changes or manage the 

day-to-day activity. This very real problem limits the capacity of the country 

to effectively deal with funding opportunities.

• Sustainability: The ability to sustain the improvements in blood safety into 

the future beyond the PEPFAR funding period is dependent on recognizing 

many inter-related factors, some of which are outside of the control of the 

NBTS. Several examples include:

1. Need for sustainable financial systems for blood programs. Most countries have a limited understanding of the costs required to maintain a 

safe and adequate blood supply. One solution may be to establish a perunit cost recovery system whereby the per unit charges can be passed 

on to the patient, insurance and/or into the hospital budget on a rationale usage. This solution, however, will be extremely difficult to implement and may have the effect of undermining efforts to create a voluntary blood supply as donors question why patients must pay for something that is given for free.

2. Need for educational and training systems that properly prepare individuals for jobs and careers in the blood bank, transfusion medicine and/

or laboratory fields. In most NBTS’s, the collection and laboratory staff 

are almost completely trained in an ‘‘on the job training’’ format, with 

minimal, if any formal education in the medical or laboratory field. Physicians often have had no, or very limited, instruction in transfusion 

medicine and proper blood utilization and administration. Even in those 

countries where training programs exist, the technical schools are often 

challenged by a lack of textbooks, materials and equipment required to 

teach the necessary skills.

3. Need for total systems and strategic approach. On a day-to-day basis, the 

NBTS’s are continually operating in a crisis-management mode, requiring them to focus their attention narrowly on solving each isolated, immediate problem, rather than looking at the overall systems and putting 

in place a more permanent system-wide solution. For example, if a facility runs out of test kits, it will most often ‘‘beg, borrow and steal’’ from 

another lab or facility, rather than focusing on improving the inventory 

and procurement process to avoid repeating the situation the following 

month. 

AABB SUPPORTS GRADUAL EXPANSION OF THE BLOOD SAFETY PROGRAM

PEPFAR funding for improvements to the safety and supply of blood for transfusion has saved the lives of countless people, mostly children and women of child 

bearing age, in the 14 focus countries. Congress should also be aware that the improvements to blood safety and availability made under the name of AIDS/HIV prevention have the added benefit of reducing the risk of many other transfusion-transmitted diseases, most notably hepatitis B, and in reducing the biggest risk of blood 

transfusion—the lack of blood when it is needed. Additionally, improvements to 

compatibility testing and transfusion practices are providing significant improvements to the clinical outcomes and reductions in the risk of transfusion-related complications, including the potential for death, that far exceed the benefits of reducing 

the risk of AIDS/HIV alone. Finally, it is important to recognize that blood is a critical health care infrastructure. Without improvements to the safety and availability 

of blood, further improvements to health care, including treatment for cancer, malaria and surgeries, will not be possible. 

AABB supports the expansion of the federal government’s efforts to improve the 

safety and supply of blood in Africa but we need to also emphasize the need for a 

well organized and deliberately phased approach to such expansion that recognizes 

the real limitations in the infrastructure and healthcare systems of these countries. 

Specifically, we would like to make three key points. First, in our experience, each 

country’s ability to make improvements is based on several limiting factors, most notably the lack of properly educated/trained human resources; limited existing 

44

healthcare delivery systems; and basic, often insufficient, infrastructures. Funding 

massive improvements to the NBTS without recognizing each country’s capacity 

properly to utilize the funds, appropriately to utilize blood and blood components, 

or to build supporting infrastructure, will result in a failed effort in the long term. 

PEPFAR Technical Assistance providers and NBTS’s work plans need to take a 

‘‘complete systems’’ approach, and not an ‘‘emergency’’ or crisis management approach to addressing all of these substantial barriers. Moreover, the work plans 

need to address the blood supply needs of the entire country, which often requires 

time-consuming and deliberate efforts. 

Second, the number of technical experts in the field of blood banking and transfusion medicine available globally to provide the necessary assistance is limited.

There are a limited number of individuals from high human index development 

countries who are available to spend the time necessary to provide real assistance. 

Attempts to attract qualified individuals from other African countries with better 

blood systems only serves to de-stabilize those blood programs. Within the focus 

countries themselves, there are few qualified professionals who can extend that 

knowledge to the next generation of blood providers. If PEPFAR’s blood safety program is expanded to cover additional African countries, careful consideration must 

be given to assuring that technical experts do not ‘‘desert’’ one country still in need 

in an effort to help another. Systems must be put in place to begin training sufficient numbers of blood banking and transfusion medicine providers. 

Third, in order to fully benefit African patients, attention must be given to improving transfusion medicine ‘‘vein to vein’’—from the collection of blood from volunteer 

donors, to the safe testing and processing of the blood components, to the act of 

transfusing these products into patients. It is not enough that we improve infectious 

disease testing of blood; we must also work to ensure that the units are appropriately stored until the time of transfusion and that each patient gets the right 

unit of blood. The wrong unit to the wrong patient or hemolysis of a unit of blood 

that is not stored at an appropriate temperature can kill as effectively as any disease. Blood transfusions are a significant therapy in the treatment of complications 

relating to childbirth, pediatric anemia related to malaria, and victims of trauma. 

Absent the necessary improvements in all aspects of blood—donor recruitment, 

blood collection and processing, testing and blood administration—we will not 

achieve our goal of making blood safe and available for these patients in need. 

AABB urges this Committee and Congress to support the development of a well 

organized plan for the expansion of the blood safety program in three ways:

1. Incrementally expand funding to technical assistance providers and the 14 

PEPFAR focus countries based on realistic estimates of human resource capacity and the countries’ ability to absorb the increased funding effectively.

2. Add non-focus countries into an organized blood safety improvement program, 

again in an incremental, organized and sustainable manner.

3. In light of the current status of blood safety programs and the substantial 

work to be done, extend PEPFAR blood safety funding beyond the current 

March 2010 deadline for development of a sustainable blood safety program.

AABB would welcome the opportunity to work with Congress, OGAC, CDC and 

other interested parties to develop a comprehensive plan for blood safety in the 

PEPFAR focus and non-focus countries. Thank you for the opportunity to express 

our opinions and share our experiences in the development and implementation of 

blood safety programs globally.

Mr. SMITH. Ms. Lipton, thank you so very much. Dr. Green. 

STATEMENT OF EDWARD C. GREEN, PH.D., MEMBER OF THE 

PRESIDENTIAL ADVISORY COUNCIL ON HIV/AIDS 

Mr. GREEN. Mr. Chairman, thank you for inviting me to participate in this important hearing on the issue of blood safety in Africa. I am a Senior Research Scientist at the Harvard Center for 

Population Development and Studies, which has the mission to promote cross-disciplinary research on critical issues of population 

health and development that will advance the well-being of the 

global poor. 

For most of my professional career I have not been an academic. 

I have worked in less developed countries, mostly in Africa, as an 

45

applied behavioral science researcher, a designer and evaluator of 

public health programs mostly under the funding of USAID. 

I have worked extensively in Africa and other resource-poor parts 

of the world. I have served as an in-country advisor to the ministries of health in both Mozambique and Swaziland, and I served 

on the advisory boards of several AIDS organizations, including the 

Presidential Advisory Council on HIV/AIDS. 

I have worked on AIDS prevention since the mid 1980s, and I appreciate the attention that you are bringing to the issue of safe 

blood and prevention efforts. It is difficult to believe that in populations with extraordinarily high HIV prevalence rates, as high as 

35 percent or more in some African countries, national policies, 

trained personnel and infrastructure are lacking or absent to ensure the blood collected and used for blood transfusions does not 

put the patient at risk for contracting HIV, hepatitis, malaria, et 

cetera. 

I am aware of the limited resources that are available to address 

this overwhelming health crisis, and I am aware that it will take 

a considerable time before numerous infrastructural inadequacies, 

healthcare worker shortages and other long-term development 

challenges inherent in a safe blood solution can be achieved. However, I would submit that there are means to address this crisis 

that could be undertaken immediately that do not require significant resources, and that would have measurable impact. 

Two such means to which I would like to draw your attention 

would require little more than a determination to put appropriate 

national policies into place, and to implement a follow-up strategy 

to ensure their proper and continued implementation. One is the 

importance of the screening and treatment of blood donors. Reports 

from the World Health Organization clearly demonstrate that donors who are unpaid volunteers and who donate regularly are the 

least likely to donate blood tainted with HIV and other life threatening pathogens. 

The likely reason behind this phenomenon is that such donors 

are motivated purely by altruism, and have no reason to hide their 

HIV status or other conditions that might affect blood safety. Paid 

donors and relatives of the patient, on the other hand, could have 

such motives for obvious reasons. 

One often overlooked factor in the recruitment and retention of 

voluntary blood donors is the treatment of donors within the medical system. Here in the United States we take for granted that 

when we go to give blood we will be greeted by a competent medical professional who has received adequate training for the proper 

taking of blood. We take for granted that the needle is sterile, and 

that being at the health facility will not threaten our own health, 

and we are relatively certain that if something goes wrong as a result of the blood donation, medical personnel are on hand to address the problem. 

Our blood donor programs are also set up to make the processes 

as easy and efficient as possible. These are all assumptions that do 

not necessarily apply in Africa. Administrators of safe blood programs in Africa need to give attention in ensuring that competent, 

polite medical personnel draw blood from donors in a sanitary, welcome environment, and that any necessary follow-up is provided 

46

immediately and within close proximity to the donor station. Such 

services also need to be consistent, since the volunteer blood donor 

station relies on its reputation to retain current donors and to attract additional ones. 

Finally, I would emphasize the need for national policies and 

training to reduce the number of unnecessary transfusions. Several 

studies of African health facilities in the 1990s indicate that between 13 and 47 percent of all pediatric transfusions are unnecessary. According to one study in Kenya, almost half of all pediatric 

transfusions could have been avoided if prescribing practices had 

followed standard transfusion guidelines. Such guidelines and policies are readily available, for example, from international health 

organizations. 

Transfusions could also be reduced significantly if increased attention and resources were directed to preventing maternal hemorrhaging and reducing the overall prevalence of malaria yet only 

half of the PEPFAR focus countries report having national guidelines that govern the clinical use of blood. I would therefore encourage U.S. agencies and organizations involved in blood safety to 

focus on these fundamental and essential elements that could be 

implemented now and at relatively little cost. 

Thank you once again, Mr. Chairman and Members of the Subcommittee for focusing attention on safe blood in Africa, and particularly on means to prevent the transmission of HIV through 

blood transfusions. 

[The prepared statement of Mr. Green follows:]

PREPARED STATEMENT OF EDWARD C. GREEN, PH.D., MEMBER OF THE PRESIDENTIAL

ADVISORY COUNCIL ON HIV/AIDS 

Mr. Chairman, thank you for inviting me to participate in this important hearing 

on the issue of blood safety in Africa. I am a Senior Research Scientist at the Harvard Center for Population and Development Studies, which has the mission to promote cross-disciplinary research on critical issues of population, health and development that will advance the well-being of the global poor. For most of my professional career, I have not been an academic. I have worked in less developed countries as an applied behavioral science researcher and as designer and evaluator of 

public health programs, mostly under funding of the US Agency for International 

Development. I have worked extensively in Africa and other resource-poor parts of 

the world. I served as an in-country advisor to the ministries of health in both Mozambique (1994–5) and Swaziland (1981–83), and I serve on the advisory boards of 

several AIDS organizations, including the Presidential Advisory Council for HIV/

AIDS (2003–), the Office of AIDS Research Advisory Council, National Institutes of 

Health (until 2006), and AIDS.org. Internet portal for AIDS information. I have 

worked in HIV/AIDS prevention since the mid-1980s, and I appreciate the attention 

that you are bringing to the issue of safe blood in prevention efforts. 

It is difficult to believe that in populations with extraordinarily high HIV prevalence rates—as high as 35% or more in some African countries—policies, trained 

personnel and infrastructure are lacking or absent to ensure that blood collected 

and used for blood transfusions does not put the patient at risk of contracting the 

disease. I am aware of the limited resources that are available to address this overwhelming health crisis, and I am aware that it will take considerable time before 

numerous infrastructure inadequacies, health care worker shortage, and other longterm development challenges inherent in a safe blood solution can be achieved. 

However, I would submit that there are means to address this crisis that could be 

undertaken immediately, that do not require significant resources, and that would 

have a measurable impact. Two such means to which I would like to draw your attention would require little more than a determination to put appropriate national 

policies into place and to implement a follow-up strategy to ensure their proper and 

continued implementation. 

One is the importance of the screening and treatment of blood donors. Reports 

from the World Health Organization clearly demonstrate that donors who are unVerDate Mar 21 2002 14:49 Oct 11, 2006 Jkt 000000 PO 00000 Frm 00050 Fmt 6633 Sfmt 6621 F:\WORK\AGI\062706\28424.000 HINTREL1 PsN: SHIRL
47

paid volunteers and who donate regularly are the least likely to donate blood tainted with HIV and other life-threatening pathogens. The likely reason behind this 

phenomenon is that such donors are motivated purely by altruism and have no reason to hide their HIV status or other conditions that may affect blood safety. Paid 

donors and relatives of the patient, on the other hand, could have such motives for 

obvious reasons. 

One often-overlooked factor in the recruitment and retention of voluntary blood 

donors is the treatment of donors within the medical system. Here in the United 

States, we take for granted that when we go to give blood, we will be greeted by 

a competent medical professional who has received adequate training for the proper 

taking of blood. We take for granted that the needle is sterile and that being in a 

health facility will not threaten our own health. And we are relatively certain that 

if something goes wrong as a result of the blood donation, medical personnel are 

on hand to address the problem. Our blood donor programs are also set up to make 

the process as easy and efficient as possible. These are all assumptions that do not 

necessarily apply in Africa. Administrators of safe blood programs in Africa need to 

give attention to ensuring that competent, polite medical personnel draw blood from 

donors in a sanitary, welcome environment, and that any necessary follow-up is provided immediately and within close proximity to the donor station. Such services 

also need to be consistent, since a volunteer blood donor station relies on its reputation to retain current donors and to attract additional ones. 

Finally, I would emphasize the need for national policies and training to reduce 

the number of unnecessary transfusions. Several studies of African health care facilities in the 1990s indicate that between 13–47 per cent of all pediatric transfusions are unnecessary. According to one study in Kenya, almost half of pediatric 

transfusions could have been avoided if prescribing practices had followed standard 

transfusion guidelines. Such guidelines and policies are readily available, for example from international health organizations. Transfusions could also be reduced significantly if increased attention and resources were directed to preventing maternal 

hemorrhaging and reducing the overall prevalence of malaria. Yet only half of the 

PEPFAR focus countries report having national guidelines that govern the clinical 

use of blood. 

I would therefore encourage U.S. agencies and organizations involved in blood 

safety to focus on these fundamental and essential elements that can be implemented now and at relatively little cost. Thank you once again, Mr. Chairman and 

Members of the subcommittee, for focusing attention on safe blood in Africa and 

particularly on means to prevent the transmission of HIV through blood transfusions.

Mr. SMITH. Dr. Green, thank you very much for your testimony 

as well. I would like to hear from Chakah Fattah if he has any 

questions. 

Mr. FATTAH. Dr. Green, let me ask you first, do you think that 

given the 45 countries in sub-Saharan Africa and given the problems with HIV that there would be resistance to some type of collaborative federation effort instead of going through each national 

health ministry in each country? Do you think that perhaps there 

could be a more area wide focus that would cross-fertilize a program? 

Mr. GREEN. I think that would be feasible, yes. 

Mr. FATTAH. Let me ask you another question. Do you think that 

an effort to make the public aware of the utility and the civic minded nature of blood donations over a period of time could penetrate 

African society in sub-Saharan Africa to encourage people who are 

healthy to voluntarily donate blood? As you have indicated here, 

that is something that we could start sooner rather than later. 

Mr. GREEN. In principle, yes. There are some indigenous theories 

of disease where you might have to address some people’s concerns 

about what might be done with their blood, but in principle, yes. 

Mr. FATTAH. We have thousands of United States Peace Corps 

volunteers in Africa. Do you think that they could be utilized in 

some constructive way in terms of educating people and encourVerDate Mar 21 2002 14:49 Oct 11, 2006 Jkt 000000 PO 00000 Frm 00051 Fmt 6633 Sfmt 6601 F:\WORK\AGI\062706\28424.000 HINTREL1 PsN: SHIRL
48

aging, particularly in communities where they are now working, 

building schools, doing other things, that they could be a part of 

an effort? 

Mr. GREEN. I think that is a good idea, and as a matter of fact, 

it is my understanding that all Peace Corps volunteers working in 

sub-Saharan Africa have to do something related to AIDS. They 

may have some other job but they are all doing something related 

to AIDS. I did some training of Peace Corps volunteers in AIDS 

prevention in Swaziland a couple of years ago, and that is my understanding. I think that would work. 

Mr. FATTAH. One last question. We have a few billion dollars 

that are sitting in the global AIDS fund and billions more sitting 

in the Millennium Challenge Account. Members of Congress who 

support these efforts—and I do too—have complained about the inability to get these dollars obligated more quickly and spent more 

quickly. Part of what we are talking about here is this particular 

effort and whether or not some additional resources focused at this. 

Now, we heard some testimony earlier from Dr. Ryan that there 

was a problem at the country level, and as I would understand it, 

that has something to do with the requirements. We have required 

countries to come up with one strategy, and there is a sort of procedure bureaucracy that has been created. Are you aware of whether 

or not there have been any evaluations of whether or not there are 

alternative ways to utilize some of these dollars to proceed in terms 

of improving the blood supply? 

Mr. GREEN. Well, sir, that is a broad and rather difficult question. There are bureaucratic realities that affect what we call the 

absorptive capacity. That is true. I think on the issue of ensuring 

safe blood and getting national safe blood policies and policies regarding transfusions in place I think that is an area where we 

could move relatively quickly but there are some problems with bureaucracies and national policies. 

Mr. FATTAH. One last question, Mr. Chair. You state in your testimony that we could literally save lives doing this given your extensive experience. I do not know if you heard the earlier testimony. I believe you did. Some say it is 3 percent. Others say it is 

5 percent. Health and Human Services say it could be 5 to 10 percent. Do you have any judgment about the data that is being used 

to make these judgments? 

I have a lot of concerns about the empirical nature of the data 

that is being used as to the question of how many donors now. I 

mean how many units of blood that are being used for transfusion 

purposes in sub-Saharan Africa are tested at all or may be contaminated with HIV, given your experience. 

Mr. GREEN. There are several questions there. I did actually notice that one of the questions that was asked—I do not think it was 

answered—the Chairman asked about the 3.2 percent. It is actually 3.19 percent of blood donors in all the PEPFAR focus countries 

except for Vietnam and Haiti. The average HIV prevalence rate 

was 3.19 percent. That was not the question. That 3.19 percent 

should not be confused with what percentage of the overall contribution to HIV infection comes from transfusions. I just want to 

clear that up. 

49

I think what we heard from PEPFAR figures as WHO figures 

was 5 percent. That sounds reasonable, but there is no more efficient way to infect many people than with infected blood. It is 

something where a little effort could have a large impact. 

Mr. FATTAH. Thank you. Ms. Lipton, you are a technical advisor 

in six of the countries you said? 

Ms. LIPTON. That is correct. 

Mr. FATTAH. Could you tell us whether or not you believe that 

the testing regime that is being reported by those countries is 

something we should rely on? 

Ms. LIPTON. I think as Dr. Ryan earlier said it is a voluntary reporting system right now through the ministry of health. 

Mr. FATTAH. I am familiar with what she said. 

Ms. LIPTON. Right. 

Mr. FATTAH. I am trying to ask you given your technical expertise whether you think we should rely on that data. 

Ms. LIPTON. No. When we walk into a country, what we recognize is that most of what is being reported is being reported out 

of the public system, and in many places there is actually a private 

system that nobody knows what is happening with. I do think it 

would be very important for us to begin to collect data, and in fact, 

there will be data collected now by the technical assistance providers to try to get a better reality on what actually is going on in 

the countries. 

Mr. FATTAH. You said a lot about infrastructure challenges, roads 

and difficulties to reach places. Where there are roads in the urban 

cities, where there is infrastructure in sub-Saharan Africa, are you 

suggesting that there is safer blood available? 

Ms. LIPTON. I think there is no doubt. 

Mr. FATTAH. Are the two related? I mean the infrastructure challenge and the safe blood challenge? 

Ms. LIPTON. I think they absolutely are but it is not just infrastructure in terms of roads and electricity which is critically important too and water but also when I talk about infrastructure I 

mean training systems and education systems in the countries that 

help to develop experts in the country. 

One of the things that happens to us in many situations is we 

train in on-the-job training and we get someone up to a certain 

competence level and they leave. If you do not have a system that 

continually feeds new people into a blood center or a hospital, you 

are correcting a problem for a day. You are not creating a system 

that allows it to be sustainable once we leave the country. 

Mr. FATTAH. Is the biggest challenge the human capital infrastructure? 

Ms. LIPTON. Absolutely. 

Mr. FATTAH. How long, in your estimation, would it take us to 

create a system that could self perpetuate itself to train thousands 

and thousands of people repeatedly to be able to participate in a 

systematic delivery of safe blood? 

Ms. LIPTON. I think you are realistically looking at a 5-year period. We have to go back and look at the medical schools and getting people trained in transfusion medicine in the medical schools, 

get their curriculum changed. 

50

I cannot tell you how sad it is to go into the medical technical 

colleges even in a place like Kenya. We reviewed their curriculum 

because we were concerned about this and wanted them to help us. 

They have a wonderful curriculum. They have no books. They have 

no equipment to teach people. So essentially they are teaching 

medical technologists in a classroom, and then they are coming into 

the blood center expecting them to be able to do technical work. 

Mr. FATTAH. If we had started 5 years ago, today we could have 

a system that could perpetually train people to provide for part of 

the system? 

Ms. LIPTON. Yes. I think what it most important about this and 

you know everyone wants to do something on an emergency basis 

and I think we could move faster but if a country does not feel the 

problem themselves, and if they do not own it at the end it is just 

going to go away when we leave. A lot of what we do is I guess 

you might call it job owning if you will. We spend a lot of time in 

the ministries of health and the ministry of finance and the ministry of education really convincing them about the critical importance of blood, and that they need to set up policies, and they need 

to set up these clinical guidelines. 

In most of our countries we have gotten them to adopt clinical 

transfusion guidelines. That is one step. That is 10 percent of the 

problem. Ninety percent is then educating the physicians on appropriate use. I think these are all very long-term efforts. We are in 

this for the long haul, and I really hope that when we talk about 

funding this we want and recognize we need to be. 

Mr. FATTAH. But you agree we need to do it? 

Ms. LIPTON. Absolutely. 

Mr. FATTAH. Have we started doing it yet? 

Ms. LIPTON. I think we have started. I think in many countries 

it has been a painful start up only because, an example, sometimes 

it took a long time for the governments to even set up the funding 

mechanisms. Every time we want to buy a piece of equipment, we 

have to go through the tender process in a country and not only 

go to the ministry of health but to the ministry of finance. One of 

the other things we are trying to do in these countries is gain a 

little bit of autonomy for the national blood transfusion service so 

that they have some control over their future and their sustainability. 

These policies that we talk about that sound so simple and so realistic to us really take quite a bit of politicking to get through at 

that national level in the countries. I think the more visibility and 

the more we have countries talk to each other and recognize the 

success of other programs, I think we can gain some advantage. It 

is remarkable to me how little cross fertilization there has been in 

a lot of the African countries in the blood transfusion services, and 

that is something that from our perspective we are fortunate to 

have six countries. 

We are really trying to build bridges and bonds, and actually get 

countries to partner one with the other. I think in the end that is 

what we need to do. 

Mr. FATTAH. Let me thank you, and let me thank the Chairman. 

Mr. SMITH. Thank you, Mr. Fattah. Ms. McCollum. 

51

Ms. MCCOLLUM. Following along, it has been my observation 

that we need to train more birth attendants to identify high risk 

pregnancies to move people along quicker if there is even access to 

a regional hospital or someplace. I mean in some areas that we 

have traveled the access is limited. 

You mentioned the shortage of some of the supplies in the room. 

When I am starting to hear of is the shortage of teachers, especially in nursing as more and more of the nurses leave and the 

nurses are not staying there to retire because they have either 

gone to England or to France or to Australia, wherever they are in 

high demand. 

If you could maybe address the teaching shortage, and what you 

think we need to do. If you have any ideas of how we keep technicians and teachers in-country, and then about if you had the electricity, reliable electricity what would it cost to set up a blood 

bank? A minimal operational blood bank not in one of the larger 

district hospitals but the smaller hospital, referral hospital like in 

Tanzania. What would be the start up cost just in the equipment 

to do that if the electricity was reliable? 

Ms. LIPTON. Let me address your first question first which is a 

real issue, the lack of teachers, the lack of individuals who remain 

in the country, and nurses in every country we have seen, if they 

are trained they leave because they can get better jobs. I think that 

is a very important issue. 

One of the things that we struggle with is trying to make sure 

that the pay scale for people in the public sector who are working 

in the national blood transfusion services is sufficiently high to 

keep them working there so that when we train them they do not 

leave to get a better paying job in a private sector or elsewhere. 

I think again a lot of that is going to have to be talking to the 

governments and getting them to understand that they need to invest in their own people and to make them stay in the system. 

Other than that, I am really not an expert in this area. I could only 

observe what I have seen. 

What does it cost to set up a blood center? You know from top 

to bottom I guess in terms of American dollars it is not very much 

money. In terms of what is in their budgets, it would be huge. I 

think the problem is you could build a center, you could get the 

equipment in there but if that is all you are doing, and you have 

not fixed the rest of the problems, you have solved the problem for 

a day, and you have not ensured that when you walk out they are 

going to continue ordering the test kits, that they are going to continue training. 

So that is why so much what we focus on is putting in place 

training systems and materials and training trainers so that when 

we depart there is a system that can carry forward, and is not dependent on one person leaving. 

If I could just ask, do you have a sense—if I could ask my colleague, Mr. Riley—a sense of the dollar? I was going to say probably I mean I would think between $500,000 and $600,000 you 

could have. Now, that is assuming again that you are not trying 

to fix electrical problems which are significant. 

Just as an example in Rwanda one of the places is so remote we 

are trying to do solar panels for electricity but the cost was just 

52

prohibitive. So now we are just focusing on can we get one solar 

panel for the laboratory that would allow our refrigerator and some 

of the test equipment to run. You know I would love to see that 

as a solution that we could develop, and that is certainly something 

I think the U.S. could help in but that would require more funding 

efforts like that. 

Mr. SMITH. Let me just ask some questions as well. I mentioned 

earlier the 2001 World Health Assembly Regional Committee and 

its targets and goals. Do you think that by 2012 at the current pace 

we are likely to reach—Ms. Lipton, this question would be for 

you—the goals that were articulated in that document? I mean it 

is obviously 11 years after bringing to the attention of the world 

that we have a plan. Is it being implemented? 

Ms. LIPTON. I think if all the stars aligned correctly possibly but 

you also have to recognize that in some of the countries we are 

dealing with there is political unrest, and so when that happens I 

know in some of the countries our colleagues are working in they 

have to keep starting and stopping. I think by 2012 I think we 

should clearly be on a good start. 

Mr. SMITH. Let me just ask you, you mentioned that we are in 

this for the long haul. What timeframe would you estimate is necessary to devise and implement a well-organized and deliberately 

phased approach? I understand the idea that capacity and infrastructure cannot be built overnight. You mentioned a moment ago 

the concern you have for the lack of books and the lack of machines 

and whatever is necessary. So you train up some motivated young 

men and women who then get sent out to the field and do not have 

the wherewithal to do what they have been trained to do. 

How much faster do you think we could push this? We heard earlier and the submission as a result of Congressman Fattah’s inquiry, the report that was written clearly shows that there is 

money just sitting there assumingly idle that needs to be put to 

good use so that more money can follow it. The question really is: 

How can we accelerate this timeframe without doing damage to infrastructure so we build it right but do it as quickly as possible? 

Ms. LIPTON. I suppose the first thing I would say is that coordination of all the efforts that are going on in these countries is very, 

very important. You cannot have 20 different NGOs running 

around in a country not coordinating their efforts because everyone 

is working at cross purposes, and again there is no one there left 

to go and do the real work. I think we need to somewhat discipline 

ourselves when we go into countries, the U.S. and we need to work 

with the European Union and others to understand who is doing 

what, and that we all need to sort of work in a plan together. 

I think that would actually speed things up as opposed to what 

is happening now when we are putting money in and getting people over there, and it is really very difficult to keep people on track 

and focused. Every time we have to pull somebody off in one of our 

countries we have planned training sessions that go for 2 weeks, 

every time we come in and they say, well we cannot do it that week 

because so and so is coming in here to do another project, we come 

to a dead halt. I do think coordination is important. 

In terms of what would it take, I mean honestly and truly if I 

think about this I think it is going to take 10 years in each country 

53

just to get us really so that we have the systems in place to sustain 

it, and I would really hope that this country could make that commitment and say, we will be there, and we will be there until we 

have put the system in place, until it is sustainable, and you know 

the thing that is so important about blood and everybody says this 

but it is so true, it is a critical healthcare infrastructure, and you 

cannot really improve a lot over the rest of the healthcare in a 

country. 

You know you talk about cancer. Treating cancer victims, surgery. You cannot do that without a safe and reliable blood supply. 

This is a cornerstone of improved healthcare in African countries 

just as it was in the U.S. 

Mr. SMITH. As you know there are an estimated 200,000 children 

who are born with sickle cell anemia every year in Africa, and 

those kids will require blood transfusions to lessen the impacts of 

sickle cell. It is a treatment which, each time, puts them at risk 

of one or the other blood-borne disease, including HIV/AIDS. 

Given the fact that AABB has experience in standards setting in 

the area of cord blood accreditation in storage, collection, from deriving it from the placenta or the umbilical cord to actual transplantation, what is your sense as to when we might be able to 

begin to see cord blood being used to lessen or even cure sickle cell 

anemia? As I mentioned earlier, Keone Penn was perhaps the first 

to benefit. We are now creating in the United States a totally coordinated effort to collect and to make available this transplantation. 

I have met with a number of health ministers, including most recently in Uganda with the health minister and gave them information about what we are trying to do here, and when we might be 

able to partner with that country, at least on a pilot basis. What 

would be your sense as to how we might get that off the ground? 

Ms. LIPTON. Honestly and truly I do not think it is in the very 

near future. I think that what you have to recognize in the cord 

blood is when you go in to do the collections the conditions that you 

have to have and they have to be very controlled to get as you 

know good collections that are viable and that can really engraft. 

It is a much more technical exercise. That does not mean that 

we could not assist with some cord blood units that we could even 

collect and could help with some of these pediatric patients but my 

experience in many of these countries is that the level of care for 

neonates really is not even at that level yet. That you know it really would be unusual for a child to be able to be whisked off to a 

setting where they could get a cord blood transplant. It is not to 

say we should not say that this is our goal but I do think it is perhaps a little bit further off than being able to get a safe and adequate blood supply. 

Mr. SMITH. I understand your point about providing U.S. produced cord blood. Certainly, generated cord blood offers some hope 

for those who are suffering because it is very transportable, as you 

know. Let me just ask you with regards to women who are dying 

as a result of anemia and other problems. Obviously transfers of 

blood can save their lives as well. 

My understanding is—and this is a WHO number—that 20 percent of all maternal deaths are attributable to anemia in pregVerDate Mar 21 2002 14:49 Oct 11, 2006 Jkt 000000 PO 00000 Frm 00057 Fmt 6633 Sfmt 6601 F:\WORK\AGI\062706\28424.000 HINTREL1 PsN: SHIRL
54

nancy. Again, without supply those women are more likely to die 

as a result of it. We have heard from a number of health ministers 

in Africa that what is lacking in all of Africa when you talk infrastructure—and there are many things lacking—are midwives and 

mostly women who would be available to help with an obstructed 

delivery, but also to help with the maintenance of a long protracted 

pregnancy that needs care. 

In the six countries in which you operate, what has been your 

experience with the partnership of midwives and skilled nursing, 

birth attendants and the like with the blood side of the equation? 

Ms. LIPTON. We really have not had much interaction with midwives. In most of the areas we work in would be what you call district hospitals, and so the patients who are lucky enough to have 

some kind of prenatal care get to the district hospitals. I can tell 

you that their concern although we talk about safety there is no 

doubt that when you are in every hospital the biggest issue they 

talk to us is not about safety. It is about availability. That they 

would be transfusing and saving some of these patients but they 

do not have the blood there. 

I think that again whereas we focus on safety and that is very 

important, the other side of this equation is clearly availability and 

motivating the volunteer donors and really getting them the safest 

people out to donate. 

Mr. SMITH. Finally, I just asked earlier about the blood testing 

kits or the lack of those kits. In the six countries that you operate 

in, has that been a problem? 

Ms. LIPTON. Yes. We have several issues that are going on. Right 

now most of our countries the purchases have to be approved 

through a tender process through the ministry of finance. The 

blood center up through the ministry of health will submit their 

purchasing order to the ministry of finance. The ministry of finance 

has a whole tender process where they might submit, you know 

they will put it out for an RFP and in some countries you may end 

up getting back a kit that first of all is not well integrated so you 

do not even know if the parts are working, and second you do not 

know when the tender process is going to go through. 

I think that that is something that we absolutely need to fix. We 

need to bring greater autonomy to these blood transfusion services 

so that they can actually select the test kits and reagents that they 

need and buy them. 

The other thing that we deal with is that we have a relatively 

unskilled group of people running a blood center who frankly do 

not really have a clue about inventory management. So one of the 

things we teach them is to talk about here is the test kits, and you 

need to remember to order them, and you need to think ahead. 

These are all skills that need to be imparted but yes, we have had 

difficulties. 

Mr. SMITH. Finally, in the six countries that you operate in, what 

has been your experience with the UN Global Fund? One of the 

concerns we have had vis-a`-vis PEPFAR, is that PEPFAR seems to 

get the money out of the door with a great deal of technical expertise much more swiftly. That is not to say the Global Fund will 

catch up at some point but even this year when the fiscal year 

2007 appropriations bill came up, the Administration had asked for 

55

$300 million for the Global Fund. During the markup, $245 million 

additional dollars were added to that but it was not like it was free 

money coming from nowhere. It was derived from the PEPFAR program and I believe from the maternal health account. 

Those accounts had less to deal with these problems. Global 

Fund had more. But I was wondering what the situation was in 

your experience. Did you see or experience a focus on clean blood 

from the Global Fund? 

Ms. LIPTON. I think any answer I would give you would just be 

terribly uninformed. I really focus primarily on technical assistance. I do not think I could give you a good answer. 

Mr. SMITH. If upon reflection you do have some thoughts—because one of the points that this Subcommittee is dedicated to is 

oversight. We all want to get the money into the spigots and into 

these organizations, but if it is not being spent with the efficacy we 

believe it should be, we either want to know why and try to fix it 

or move it over to another pot. If you have any thoughts on that. 

Finally, Dr. Green, if I could ask you: Are there studies to show 

what percentage of African blood donors are HIV positive? If so, 

what do they show? What percentage of donors in Africa are volunteers from your experience as opposed to those who are family 

members or paid donors in an emergency? 

Mr. GREEN. I will address the first question. I have seen some 

data compiled by the Centers for Disease Control that show that—

in fact, we have data from almost all the PEPFAR focus countries—and as I was commenting earlier, HIV prevalence is lower 

than we would expect. Let us round it off to 3.2 percent. Average 

HIV prevalence for sub-Saharan Africa is 7.2 percent, and that is 

down incrementally from a little bit higher. 

In fact, in the last 3 or 4 years we have seen an incremental decline in the average prevalence rate in Africa, which is good news, 

but the average rate of blood donors is 3.2 percent. In no country 

do we see a higher HIV infection rate among blood donors than 

what the estimate is for the population as a whole, which is good 

news. It suggests that there is not some underclass of sick people, 

like injecting drug users that we might find in a country with an 

IDU-driven epidemic like Ukraine or Russia, who are selling blood 

and are more likely to be infected. That is basically good news. 

As to what percentage of blood donors are volunteers, from the 

evidence I have seen from PEPFAR, less than half. This means, for 

reasons that have already emerged, that we need to get more voluntary donors and fewer who are donating or selling blood or who 

are family members. 

One way to do that is to decrease demand by eliminating unnecessary transfusions. Another way is to make blood donation more 

confidence-inspiring. 

Mr. SMITH. Thank you. Anything else any of our panelists would 

like to add? If not, I want to thank you for your testimony, especially for your extraordinary work. I apologize for these breaks as 

we have gone over to vote. It has been a long day for you, and we 

certainly do appreciate your patience. Thank you. 

I would like to now just officially say that the hearing ends but 

that we now begin a briefing pursuant to a protocol that is necessary with our friends at the United Nations. I want to just say 

56

that frequently during the last 2 years especially the UN has accommodated this Subcommittee and the Full Committee as well by 

providing expert witnesses to give us insight so that we can do our 

job better. I am very, very pleased and grateful to welcome Dr. 

Neelam Dhingra, who has been working in the field of transfusion 

medicine for the last 20 years. 

Since 2000, Dr. Dhingra has been working at the World Health 

Organization, headquarters in Geneva, Switzerland, and leads the 

WHO blood safety program as coordinator of blood transfusion safety. We are privileged to have you here, and thank you especially 

for your patience. I want to assure you and our previous witnesses 

that the information you do provide will be provided to other Members. 

It will be used in our deliberations, and I know my friend, Congressman Fattah and I, and Mr. Payne and others will take what 

you give us. I have already read your testimony. It was excellent. 

But I again want to thank you for again your patience in waiting 

and for your work. You are recognized. 

STATEMENT OF NEELAM DHINGRA, M.D., COORDINATOR, 

BLOOD TRANSFUSION SAFETY, ESSENTIAL HEALTH TECHNOLOGIES, WORLD HEALTH ORGANIZATION 

Dr. DHINGRA. Good afternoon, Chairman Smith, Congressman 

Chakah Fattah and Members of the Subcommittee. My name is Dr. 

Neelam Dhingra, and I am coordinator of the blood transfusion 

safety program at the World Health Organization. I thank you for 

this opportunity to brief the Committee on the needs and strategies 

for making safe blood available in Africa, and I will be summarizing my prepared statement during my presentation. 

There are two crucial issues which affect blood transfusion in Africa, and these are blood shortages and unsafe blood. In most of the 

African region today, access to safe blood when and where needed 

simply cannot be assured. Blood shortages have a particular serious impact on women and children. 

As was mentioned earlier, 19 of the 20 countries with the highest 

maternal death rates in the whole of the world are in Africa where 

the risk of death is 1 in 16 mothers as compared to 1 in approximately 3,000 in rich countries. The most common cause of maternal 

death is severe bleeding which can kill even a healthy woman within 2 hours if not attended to. This contributes to almost half of the 

maternal deaths in Africa. Hundreds of thousands of these deaths 

could be prevented through access to safe blood. 

Children are also particularly vulnerable to blood shortages because of the requirement of transfusion arising from life-threatening anemia caused by malaria or malnutrition. About 800,000 

deaths occur each year in Africa due to malaria, the majority of 

them in children under 5 years, and up to half of the transfusions 

given to children are related to severe anemia due to malaria. Sufficient safe blood supplies could contribute to saving about half a 

million of these young lives. 

Serious blood shortages also contribute to an increased risk of 

HIV and hepatitis by forcing a reliance on unsafe donors and increased pressure to issue blood without testing. Only 12 countries 

in Africa collect all their blood from voluntary unpaid blood donors 

57

which presents much lower risk of transmitting HIV and hepatitis 

than family or paid donors. 

The blood supply in Africa is currently very low, and less than 

3 million units of blood are collected for the population of more 

than 700 million people, and only about half of these are collected 

from voluntary unpaid blood donors. 

As far as testing is concerned, complete and accurate data on 

testing are simply not available, particularly in countries where 

blood services are fragmented. The majority of countries do not 

have reliable systems for testing due to shortages of trained staff, 

unreliable supply of test kits and lack of a basic quality system. 

In Africa, almost 9 out of 10 units of blood are not tested for HIV 

in a way that meets quality requirements. The risk of HIV infection through unsafe blood is exceptionally high. Almost everyone 

who receives HIV contaminated blood will get HIV infection. The 

good news is that the transmission of HIV through unsafe blood is 

preventable and is the only approach to HIV prevention that is almost 100 percent effective. 

The strategy for blood safety is well defined and has been successfully implemented even in resource-limited countries. It has 

three main components. First, collect blood only from the safest 

possible blood donors. Second, test all donated blood in accordance 

with basic quality requirements. Third, reduce unnecessary transfusions. 

This strategy can only be effectively implemented with firm political commitment and support through national policies and plans, 

clear roles and responsibilities between different national stakeholders such as the ministry of health, the nongovernmental organizations such as Red Cross and the hospitals, and also through 

appropriate blood supply structures. In addition, quality systems 

governing all activities related to blood transfusion and an adequate number of trained staff are also required for effective implementation of this strategy. 

The positive impact of this strategy has been seen in developing 

countries in all regions of the world including some countries in Africa. In Malawi for example after the establishment of the national 

blood service in 2003 a 60 percent decrease in deaths among seriously ill children and a 50 percent decrease in deaths in pregnant 

women with severe blood loss was recorded in the main hospital. 

In addition, South Africa has demonstrated how in a country 

with HIV prevalence of 21 percent in the general population it has 

been possible to reduce the HIV prevalence to 0.03 percent in their 

blood donors. WHO works with U.S. Government support in three 

PEPFAR focus countries, two in Africa, these are Ethiopia and Namibia, to improve the safety and availability of national blood supplies. 

Challenges are institutional as well as technical. That is: A fragmentation of blood transfusion services, poor institutional coordination and a lack of clarity of the roles and responsibilities amongst 

various stakeholders. The lack of sufficient trained staff is consistently cited as one of the main constraints faced by blood services. 

This year’s World Health Report of 2006 which is ‘‘Working Together for Health,’’ also recognizes the same shortage of trained 

manpower in the developing world. Positive improvements in these 

58

national blood systems have resulted from availability of funds and 

the development of trust and good working relations among ministries of health, national stakeholders and technical assistance 

agencies. Enhanced levels of commitment and support from governments demonstrated by the adoption of national policies and longterm strategic plans have paved the way for sustainable blood services. 

WHO works with ministries of health, the blood services, with 

nongovernmental organizations and other international agencies to 

strengthen overall national health systems through evidence-based 

technical advice. I would like to highlight six strategies that WHO 

has learned are important for making safe blood available in Africa. 

These are: Increased political commitment; institutional and 

technical capacity building; collaborations between national blood 

services and other programs at national level to reduce the need 

for blood transfusions; increase and sustain resources for blood 

safety and availability, recognizing that future requirements will 

be higher than current needs; resources for international technical 

assistance; and, last but not least, research and development to 

identify and implement innovative methodologies and appropriate 

technologies for blood safety in low-resource settings. 

In conclusion, least developed countries and transitional countries in Africa do need technical and financial support in our experience for at least 5 years to develop sustainable systems which can 

meet the transfusion needs of their patient population. 

Africa is in desperate need of a significant scaling up of efforts 

to make safe blood available to all patients whose survival and well 

being depends on this intervention. This is technically feasible in 

sub-Saharan Africa, lacking only the political commitment and the 

financial resources. Some countries are committed, but they also 

lack technical expertise and financial resources. 

Considering the high effectiveness of HIV prevention through 

safe blood there should be a zero tolerance to any transmission of 

HIV or any other blood borne pathogen within the healthcare system. 

I would like to leave all of you with this thought: That safe blood 

is a strategy which is truly cross cutting, from preventing deadly 

infections such as HIV and hepatitis, and promoting healthy lifestyle in blood donors to saving lives of people whose survival depends on timely access to safe blood. It is not rocket science. It is 

a simple strategy which can be easily implemented and is well integrated within the healthcare system. 

Investments in making safe blood available in Africa will make 

tremendous difference by saving millions of lives. WHO appreciates 

this opportunity to brief the Committee on this important issue. I 

thank you for your attention, and will be happy to answer questions which you may have on this subject. Thank you very much. 

[The prepared statement of Dr. Dhingra follows:]

PREPARED STATEMENT OF NEELAM DHINGRA, M.D., COORDINATOR, BLOOD TRANSFUSION SAFETY, ESSENTIAL HEALTH TECHNOLOGIES, WORLD HEALTH ORGANIZATION

Mr Chairman and members of the Subcommittee, on behalf of the World Health 

Organization (WHO), I thank you for the opportunity to brief the Committee on the 

59

1WHO Global Database on Blood Safety, 2004. Geneva, World Health Organization, 2006. 

needs and strategies for making safe blood available in Africa. The two crucial 

issues related to blood transfusion in the developing world, particularly Africa, are 

blood shortages and unsafe blood, which all too frequently lead to serious health 

consequences such as death from postpartum hemorrhage or the transmission of 

life-threatening infections such as HIV and hepatitis. These deaths and serious sideeffects are preventable through actions to improve blood safety and availability. 

With the goal of ensuring universal access to safe blood, WHO has been at the 

forefront of the movement to improve blood safety as mandated by successive World 

Health Assembly resolutions, the earliest dating from 1975. WHO strongly advocates the implementation of its global strategy for blood safety and provides ongoing 

policy guidance and technical support to Member States on its implementation. The 

US Government has made a major contribution to the realization of this goal, especially through the President’s Emergency Plan for HIV/AIDS Relief under which 

WHO is proud to be providing technical assistance in the strengthening of blood 

transfusion services in Ethiopia, Haiti and Namibia, three of the PEPFAR-focus 

countries. 

WHO also convenes and provides the secretariat for a unique forum, the Global 

Collaboration for Blood Safety, which is a network of about 60 internationally recognized organizations, institutions, associations, agencies and experts from developing 

and developed countries for sharing expertise, identifying problems, seeking solutions and working towards the common goal of global blood safety and availability. 

This goal has never been more important than in the era of HIV/AIDS. 

UNSAFE BLOOD TRANSFUSIONS AND HIV/AIDS IN AFRICA

Globally, AIDS has been responsible for more than 25 million deaths since 1981; 

an estimated 40.3 million people are currently living with HIV. Sub-Saharan Africa, 

with just over 10% of the world’s population, is home to more than 60% of all people 

living with HIV—25.8 million in 2005. With an estimated 3.2 million new infections 

in sub-Saharan Africa in 2005 (65% of all new infections globally), prevention is the 

mainstay of controlling the pandemic. 

Unsafe blood transfusions have contributed to the enormous burden of HIV infections in sub-Saharan Africa and still continue to add to this burden. The risk of HIV 

infection through unsafe blood and blood products is exceptionally high (95–100%) 

compared to other common routes of HIV exposure: for example, 11–32% for motherto-child transmission and 0.1%–10% for sexual contact. Sub-Saharan Africa has a 

particularly high level of transfusion-associated HIV compared with other regions 

due to a higher risk of infected blood being transfused. This results from a combination of factors: high rates of transfusion in some groups of patients (particularly 

women and children), a higher incidence and prevalence of HIV infection, dependence on unsafe blood donors and inadequate testing of blood for HIV in some countries. Women and children account for a disproportionate number of HIV infections 

through unsafe blood because they are the main groups of patients receiving blood 

transfusion. 

The safety and availability of blood transfusion is particularly under threat 

among refugee populations and in emergency situations where health systems have 

collapsed or have been weakened as a result of armed conflict, displacement of populations, natural disasters and other complex emergencies. In these extreme circumstances, making safe blood available to all patients needing transfusion is currently impossible. 

BLOOD SHORTAGES IN AFRICA

Blood donation rates in Africa are generally very low (about 5 per 1000 population) compared with developed countries (for example, 47 per 1000 population in 

the United States). In its most recent global survey1 on blood safety and availability, WHO collected data from 40 of the 48 countries in sub-Saharan Africa. 

These data indicate that 35 (87.5%) countries collect less than half of the blood 

needed to meet the transfusion requirements of their populations. In 2004, only 

about 2.8 million units of blood were collected for a population of around 720 million 

people (11% of the world’s population). 

Severe anemia occurs more frequently in Africa than in most other parts of the 

world. This results from the high number of patients with pregnancy-related complications, malaria, worm infestations, malnutrition and sickle cell disease. Blood 

transfusion is frequently central to the management of life-threatening anemia, but 

blood shortages are experienced throughout Africa. These have a particular impact 

on women and children. Globally, more than half a million women die each year as 

60

2The World Health Report, 2005. Make every mother and child count. Geneva, World Health 

Organization, 2005. 3WHO analysis of causes of maternal death:a systematic review. Lancet, 367, April 1, 2006: 

1066–1074. 4World Malaria Report. Geneva, UNICEF/World Health Organization, 2005. 

5 Botswana, Burundi, Central African Republic, Coˆte d’Ivoire, Malawi, Namibia, Rwanda, Senegal, South Africa, Swaziland, Togo and Zimbabwe. 6World Health Assembly Resolution WHA58.13: Proposal to establish World Blood Donor Day. 7 Blood Safety: Strategy for the African Region. Brazzaville, WHO Regional Office for Africa. 

2002.

a result of complications of pregnancy and childbirth 2. Of the 20 countries with the 

highest maternal death rates, 19 are in sub-Saharan Africa where the risk of maternal death is 1 in 16, compared with 1 in 2800 in rich countries. The most common 

cause of maternal death is severe bleeding, which can kill even a healthy woman 

within two hours, if unattended; in Africa, severe bleeding during delivery or after 

childbirth contributes to up to 44% of maternal deaths3. Many of these deaths could 

be prevented through access to safe blood. 

Children are also particularly vulnerable to shortages of blood in Africa because 

of their high requirement for transfusion arising from severe life-threatening anemia caused by malaria or malnutrition. Falciparum malaria causes more than 1 

million deaths each year worldwide4. It also contributes indirectly to many additional deaths, mainly in young children, through synergy with other infections and 

illnesses. Around 60% of the cases of clinical malaria and over 80% of malarial 

deaths occur in sub-Saharan Africa where 9 out of 10 malarial deaths occur in children under five years of age. Studies report that up to 50% of transfusions given 

to children are related to malaria-induced anemia. 

Paradoxically, despite a severely inadequate supply of blood in African countries, 

blood is often transfused unnecessarily. This needlessly exposes patients to the risk 

of HIV, hepatitis and other serious side-effects. This poor quality clinical care also 

reduces the availability of blood for patients for whom transfusion is essential and 

is a waste of scarce resources. 

UNSAFE BLOOD IN AFRICA

Serious blood shortages also contribute to an increased risk of HIV and hepatitis 

because an inadequate stock of blood forces a reliance on unsafe family or paid donors and increased pressure to issue blood without testing. In 2004, about 1.2 million units of blood were collected from family or paid donors who are considered at 

high risk for transmitting HIV, hepatitis B or hepatitis C. Only 12 sub-Saharan 

countries5 have achieved 100 per cent voluntary unpaid blood donation, which is the 

cornerstone of a safe blood supply. 

Every African country has a policy to test donated blood for HIV; most also aim 

to test blood for hepatitis B and syphilis and, increasingly, for hepatitis C. Data 

from 30 African countries indicate that, in 2004, transfusion-transmissible infections 

were detected in 183,000 units of blood (9.8%) which were subsequently discarded. 

Countries with a predominance of family or paid donors had higher rates of infected 

blood units than countries with voluntary unpaid blood donors. 

In countries where blood collection and testing systems are fragmented and hospital-based, complete and accurate data on testing are simply not available. This indicates that some countries are unable to fully implement their national policies on 

testing and that universal testing cannot be assured. The risk of disease transmission through unsafe blood is further increased when poor quality test kits are 

used or blood has to be issued without testing due to interrupted or unreliable supplies of test kits. The risk is compounded by poor testing procedures resulting from 

shortages of trained staff and a lack of quality systems. Thirty-three (83%) of the 

40 sub-Saharan African countries which provided data to WHO reported that they 

do not have fully operational quality systems in the blood transfusion service, including HIV testing. Around 2.7 million units of blood were collected in these 40 

countries in 2004; 88.5% of these were not tested for HIV in a quality-assured manner. 

STRATEGY FOR BLOOD SAFETY AND AVAILABILITY IN AFRICA

The good news is that the transmission of HIV through unsafe blood transfusion 

is preventable—and is, in fact, the only approach to HIV prevention that is almost 

100% effective. Blood safety is therefore one of the most cost-effective strategies for 

reducing the burden of HIV infection in Africa. The strategy advocated by WHO to 

achieve effective, cost-efficient and safe national blood supply systems6,7 has been 

61

8Transfusion medicine: looking to the future. Goodnough L, Shander A, Brecher M. Lancet, 

January 11 2003; 361: 161–169. 

endorsed by all governments through successive World Health Assembly resolutions 

and has also been adopted by the PEPFAR initiative. It has three main components:

• Voluntary unpaid blood donation: the first line of defense is the donation of 

blood only by regular, voluntary unpaid blood donors from low-risk populations, who are the safest possible blood donors, and a careful assessment 

of their suitability to donate blood.

• Universal testing of donated blood: the second line of defense is the screening 

of all donated blood in accordance with quality requirements for, at minimum, 

HIV, hepatitis B, hepatitis C and syphilis.

• Reducing unnecessary transfusions: the third line of defense is the appropriate use of transfusion only when medically indicated for patient survival 

and wellbeing, minimizing the loss of blood during surgery, and the use of 

suitable alternative treatment.

The successful implementation of this strategy is dependent on the national coordination of services, clear roles and responsibilities between different national 

stakeholders, a suitable infrastructure and proper organization and management. 

Uniform standards of performance and economies of scale can be achieved only 

where the key functions of the blood service are centralized or regionalized in main 

centers. Also required are quality systems covering all activities related to blood 

transfusion and an adequate number of trained staff. 

The impact of blood safety measures is demonstrated by the virtual elimination 

of transfusion-transmitted infections in the United States (estimated risk of HIV infection of 1 in 1,800,000 per blood unit 8). Importantly, improved blood donor selection techniques contributed to a dramatic reduction in the risk of transmission of 

infection, even before specific laboratory screening tests were available. 

The implementation of this strategy for blood safety, through the development of 

efficient systems, has also resulted in improved access to safe blood in developing 

countries in all regions of the world, including some countries in sub-Saharan Africa. In Malawi, for example, following the establishment of the National Blood Transfusion Service in 2003, a 60% decrease in mortality among seriously ill children and 

a 50% decrease in mortality in pregnant women with severe blood loss was recorded 

in patients admitted to the Queen Elizabeth Hospital in Blantyre. These reductions 

were directly attributable to the availability of safe blood. In addition, South Africa 

has demonstrated how, in a country with an HIV prevalence of 21.5% in the general 

population, it has been possible to reduce the HIV prevalence to 0.46% among firsttime blood donors and to 0.03% among regular blood donors. 

It can be cautiously estimated that nearly 500,000 HIV infections through blood 

transfusion are already being averted each year in sub-Saharan Africa through the 

adoption of simple blood safety measures in voluntary blood donation, blood donor 

selection and quality-assured testing of donated blood. 

Advanced technologies such as nucleic acid testing and pathogen inactivation have 

been introduced in the US and other developed countries to reduce the risk of disease transmission. In developing countries, priority has to be given to the implementation of more basic, proven strategies for blood safety before incorporating sophisticated new technologies for blood testing and processing which are not cost-effective 

or feasible in the absence of a nationally-coordinated, sustainable and effective blood 

transfusion service. Significant efforts are also being put into the development of 

blood substitutes, but their widescale use cannot be anticipated for another decade 

or two, even in developed countries. Artificial blood will certainly not be widely 

available in developing countries within the foreseeable future. 

THE WAY FORWARD

The experience of working in PEPFAR focus countries has demonstrated that the 

major challenges in improving the safety and availability of national blood supplies 

in Africa are institutional as well as technical. Key issues that have had to be addressed include the fragmentation of blood transfusion services, poor institutional 

coordination and a lack of clarity of roles and responsibilities among various stakeholders, including ministries of health. In addition, there are acute shortages of 

trained and dedicated manpower to support safe national blood programs. The lack 

of sufficient trained staff is consistently cited as one of the main constraints faced 

by fragmented blood transfusion services in many sub-Saharan countries. 

The main factors facilitating positive change in national blood transfusion systems 

have been the availability of funds; the development of trust and good working relaVerDate Mar 21 2002 14:49 Oct 11, 2006 Jkt 000000 PO 00000 Frm 00065 Fmt 6633 Sfmt 6621 F:\WORK\AGI\062706\28424.000 HINTREL1 PsN: SHIRL
62

tions between ministries of health, other national stakeholders and technical assistance agencies; and enhanced levels of commitment and support from governments, 

demonstrated by the adoption of national blood policies and long-term strategic 

plans, paving the way for sustainable blood transfusion services. 

This experience indicates that the following key interventions will be needed to 

strengthen systems for blood safety and availability throughout sub-Saharan Africa:

• Policy and program development: nationwide situation analysis of existing 

blood services and assessment of current and future needs, development of 

national blood policy and strategic plan, establishment of legislative framework and regulatory mechanism, national coordination of blood transfusion 

services and establishment of systems for financial sustainability.

• Infrastructure development: to ensure adequate and suitable facilities for 

blood collection, testing, processing, storage and distribution.

• National data collection and information management system: to ensure the 

traceability of donors, donated blood and transfusion recipients.

• Strengthening of blood donor programs: to increase the total number of donations by voluntary blood donors, reduce family and paid donation and implement strict criteria for assessing the suitability of donors.

• Testing and processing: centralized/regionalized testing of all donated blood in 

accordance with quality standards.

• Quality systems: in blood transfusion services and at the clinical interface.

• Training: of all staff in blood transfusion services and hospital staff involved 

in the clinical transfusion process.

• Blood utilization: prescribing of blood in accordance with national transfusion 

guidelines and the safe clinical transfusion procedures.

• Monitoring and evaluation: of all activities related to blood transfusion to assess progress, monitor trends and impact, and replan, as necessary. 

PRIORITIES

First, global advocacy and coordinated efforts by governments, donor agencies, 

technical agencies and other stakeholders are urgently needed in Africa. Progress 

depends on raising the need for safe blood on health and development agendas, and 

mobilizing increased political commitment and funding among African countries. 

Second, increased support is required for building institutional and technical capacity as well as the strengthening of national blood transfusion services within 

health care systems. This requires increased staffing, specific measures to retain 

staff once recruited and a huge increase in training. 

Third, close collaboration is required between national blood programs and other 

programs at national level, including national AIDS control programs, maternal and 

child health, malaria and anemia management. A commitment is needed by national health authorities, health care providers and clinicians to the prevention, 

early diagnosis and treatment of conditions that could otherwise lead to the need 

for transfusion by strengthening public health and primary health care programs. 

Fourth, the resources available for blood safety and availability should be increased and sustained at country level. A systematic approach is required to assess 

the level of resources needed, based on the clinical requirements for blood and blood 

products, the current capacity of blood transfusion services to meet these needs and 

the level of access of the population to health care services. With the strengthening 

of health care systems and improvements in diagnostic and treatment options, there 

will be increased clinical demands for blood and blood products. Measures to reduce 

transfusion-associated HIV infection must therefore address future requirements as 

well as current needs. 

Fifth, resources will need to be allocated specifically for international technical assistance in the strengthening of national blood transfusion services. 

Sixth, investment is also needed for research and development to enable developing countries to identify and implement innovative methodologies and appropriate 

technologies for blood safety. 

CONCLUSION

It is clear that least developed countries and transitional countries in Africa will 

need long-term technical and financial support to develop sustainable systems which 

can meet the transfusion needs of their patient populations. The development and 

implementation of a road map for blood safety throughout Africa can ultimately result in a safe, high quality blood supply for all patients requiring blood transfusion 

and the elimination of unsafe transfusion as a route of HIV transmission. 

63

In conclusion, Africa is in desperate need of a significant scaling-up of efforts to 

make safe blood available to all patients, whose survival and wellbeing depends on 

this treatment intervention. It is technically feasible, lacking only the political commitment and the financial resources. Considering the high effectiveness of HIV prevention through safe blood, there should be zero tolerance of any transmission of 

HIV and other infections within the health care system. 

WHO appreciates the opportunity to brief the Committee on this important issue. 

I thank you for your attention.

Mr. SMITH. Thank you so very much. Mr. Fattah. 

Mr. FATTAH. Thank you. Doctor, you have been at this for 20 

years. Over the last 10 years in terms of the United States’ efforts 

and other efforts in Africa in particular, where has safe blood and 

the safety of the blood supply ranked in the priority of our resources from where you sit? 

Dr. DHINGRA. I would say in many countries, not only in Africa, 

HIV/AIDS brought the problems of blood safety to the forefront. Before that, blood banks were you know the shops sitting in a corner 

of a hospital which were included as ‘‘laundry.’’ Literally blood 

banks were really not given any attention, and they were not seen 

as a source of so much of infection being transmitted through unsafe blood before HIV/AIDS came in the picture. 

So in a way, HIV has been a driver for change for blood transfusion services across the world. However, if you see the other 

strategies for preventing HIV, it has been always a struggle in the 

countries to find suitable resources to invest in preventing sexual 

transmission or transmission through blood and other routes for 

prevention. 

I think the U.S. Government initiatives have really been very important and drivers for major change in many developing countries, 

particularly in Africa, where, whether through global funds or 

through USAID or through CDC and the PEPFAR initiative, several of these initiatives have been able to bring forward the problem of blood safety, and have been able to get political commitment. 

However, what is lacking even now is institutional coordination. 

There is a total lack of clarity in the roles and responsibilities 

amongst several stakeholders who are working at the country level. 

With my experience of Ethiopia and Namibia in the African region, 

these were the fundamental problems we had. We have been there 

for 20 months already, and the major achievement we have had is 

developing this coordination between different stakeholders because there are ministries of health who have not recognized that 

at all so far. They have not taken their leadership position and the 

ownership of the blood program as part of the healthcare system. 

In some countries it has been delegated to the Red Cross or other 

NGOs, and they have not been supported adequately. So it is the 

lack of clarity of roles and responsibility which has led to this slow 

start in several of these countries including Ethiopia. 

Mr. FATTAH. You said in your testimony that you thought over 

a 5-year period of time you could take a country from nowhere to 

a safe sustainable blood supply in Africa. 

Dr. DHINGRA. This has been seen in several countries in Africa 

and other regions where international assistance was provided and 

political commitment was there. There had been significant improvements in 5 years. I cited Malawi as an example where in 2000 

64

when the funding was available through another international 

agency. For the first 2 years it was a very slow start because of 

all these institutional problems but after that with committed technical support provided by technical assistance there has been really 

a good improvement in blood safety. 

However, the improvements have to be seen after 5 years, whether they are sustainable or not. Up to the time there is a system 

of sustainable finances and human resource it is difficult for the 

international assistance to pull out. So at least 5 years. It could be 

up to 10 years. 

Mr. FATTAH. Let me ask the Chairman’s question from earlier. 

He asked Dr. Ryan about the cost of creating a safe unit of blood 

in sub-Saharan Africa. He talked about $55. Dr. Ryan says it 

would be about $45 per unit. You would have to go through 33 

units to find the one that was contaminated and so forth and so 

on. 

It was somewhat confusing as to what the actual answer to this 

question was. If we were trying to create the number of units needed which is somewhere around 12 million units or so in sub-Saharan Africa per year, what would the cost per unit be given your expertise? 

Dr. DHINGRA. WHO had undertaken an exercise to cost the blood 

transfusion services, and some of the developing countries were 

also included in this. This was done about 5 years back. At that 

time, on an average the cost of a unit of blood was about $40 including the infrastructure costs. However, with the changes time 

and with inflation in our countries and changing economic situation, the recent costing would be approximately $50 to $60 with 

basic minimal strategies implemented which is volunteer blood donation and testing by simple serology tests. 

If you introduce more and more technological advances, then the 

cost of unit goes higher but with the simple strategies for blood 

safety which includes voluntary blood donation and testing by simple serological testing it will be about $50 to $60 per unit of blood, 

and that does not include the processing of blood into different 

components. That is only a whole blood unit. 

But when the future developments occur in medical care, there 

will be need for blood components and then it has to be relooked 

into how the component facility has to be developed and what more 

resources have to be invested in that. 

Mr. FATTAH. If we were trying to get 14 million units, then at 

$50 per unit we are talking about $7 billion? 

Dr. DHINGRA. The whole blood. Just for the whole blood units. 

Mr. FATTAH. Right. $7 billion. 

Dr. DHINGRA. That is right. 

Mr. FATTAH. Thank you, Mr. Chairman. We are spending $9 billion a month in Iraq. It is probably give or take a dollar here or 

there. It might be doable. Thank you. 

Mr. SMITH. Thank you, Mr. Fattah. Dr. Dhingra, you point out 

that 35 countries collect less than half the blood needed to meet the 

transfusion requirements of their populations. I am wondering 

what impact does the malnourishment issue have, the fact that so 

many people are sick themselves? It makes it even harder, I would 

think, to find even if you were able to motivate people to donate. 

65

Does that account for a lot of the loss in addition to lack of infrastructure? Is that quantifiable as to what portion of the population 

base are candidates for donating blood? 

Dr. DHINGRA. It has to be seen you know in the age of the population donating blood and the country demographics. The malnutrition currently seen in younger population and the population which 

is giving blood is usually 18 to 60 or 65 years. It has been seen in 

several developing countries where anemias and malnutrition and 

other infections and parasites are present that by selecting the population of potential donors who are healthy it is possible to develop 

good donor bases even in developing countries. 

So, we have to just focus onto the population which is the least 

risk and the most suitable to give blood, and it is possible to get 

donors. In countries like Malawi, there are 100 percent volunteer 

donors, and they are youth clubs and they are all young donors 

who are giving blood. They are not anemic, and they are actually 

even promoting healthy lifestyle in the peer groups. In a way investing in volunteer blood donation programs again has a far 

reaching consequences on prevention of HIV through other routes 

also. 

Mr. SMITH. Thank you. Let me just ask you: You quote in your 

testimony a WHO analysis of the cause of maternal death that was 

contained in Lancet on April 1 of this year that many of the deaths 

could be prevented through access to safe blood. You point out that 

in Africa severe bleeding during delivery or after childbirth contributes to up to 40 percent of the maternal deaths, which is a staggering number but it also gives hope that with resources and real 

political and medical will these deaths could be averted. 

When you say many, how much of that? I know I may be asking 

a question that has no answer, but are we talking about most if 

they had access to a transfusion? 

Dr. DHINGRA. Yes, I would say most, and there are two crucial 

factors to save lives of pregnant mothers who are having complications. One is attended by a trained midwife, and then access to safe 

blood. It would be most death could be prevented if there is safe 

blood supply available. 

Mr. SMITH. Could you just explain to us what your sense is as 

to what the Global Fund is doing with regards to safe blood? Obviously they have a large pot of money. Have they, to your judgment, 

adequately integrated the mission of providing safe blood into their 

work? 

Dr. DHINGRA. As far as I understand global fund in the countries, 

it is based on country requirements. 

Mr. SMITH. Which they all have. 

Dr. DHINGRA. In some countries they have identified blood safety 

as a priority over and above other requirements of the HIV program, and I know countries like Ethiopia has a program on global 

funds and the Philippines is now doing a proposal which has blood 

safety as part of it. Cambodia did a project in which blood safety 

was included. So there are several countries. I have not got the detail with me right now but there are countries which are asking for 

blood safety as part of the global fund also. 

Mr. SMITH. Would it be possible for the record to get that kind 

of a breakout? 

66

Dr. DHINGRA. Maybe. 

Mr. SMITH. It would be very useful to see, especially since the 

U.S. is the major donor providing about one-third of that funding. 

I think Mr. Fattah and I and many others would love to see this 

money so well utilized especially as we put our arms around even 

further just how lifesaving this is. Your points about maternal 

deaths—I had heard about the mitigating factor of blood on maternal deaths. I never knew it was so dramatic. I do thank you for 

sharing that with us. 

Mr. FATTAH. Mr. Chairman, could I ask one? 

Mr. SMITH. Yes. 

Mr. FATTAH. We heard a lot of comments earlier about the absorptive capacity which is a bigger question today I guess than the 

day before Warren Buffet gave the Gates Foundation $32 billion. 

The inference is that we cannot with money do any more about this 

problem right now. What would be your comment to that? 

Dr. DHINGRA. I mean I am not sure that I understand your question. 

Mr. FATTAH. If Congress wanted to supply more resources to the 

question of safe blood in the world or in Africa or in sub-Saharan 

Africa, is there the absorptive capacity, this is the term of art that 

I have heard today, available so that something useful could be 

done with it so they could save some of the lives of these women 

or of these children or others whose lives are not being saved because of the absence of a safe, healthy blood supply or do we have 

so much money in the system and it is just a matter of kind of 

working out the politics and working out the stakeholders that 

money itself is not useful in this effort? 

Dr. DHINGRA. I think PEPFAR is a very good example. The 

PEPFAR focus countries in initial 20 months have shown what are 

the problems and what needs to be done to address these problems. 

In WHO’s experience of supporting the three countries, two of 

which are in Africa, Ethiopia and Namibia, it has really led to significant improvements in working situations. 

I have got the key achievements with me. It is the infrastructure 

is strengthening and blood donation and collection has significantly 

improved. Blood testing and processing has improved, and in addition the emphasis has also been given to improving the transfusion 

practices, and more than 600 people have been trained, and also 

there are systems for national data collection within the country. 

Until those resources are available to the country, within the 

country and also for technical assistance, this change would have 

never happened, and I think it is extremely important to support 

these countries by providing the required financial assistance and 

also technical assistance so that whatever changes happen is sustainable, and the countries can then take over the changes. 

Mr. FATTAH. I guess through PEPFAR, Doctor, I think the number was $32 million 2 years ago, $50 million last year, about $32 

million or so this year to safe blood supply in Africa which is beyond the two countries you are working in but in all of Africa. Is 

it your impression that that is enough or that more resources 

would be useful? Do you have a sense of that? 

Dr. DHINGRA. I think initial resources are required for a longer 

period of time in these countries. It is not only that these countries 

67

because it has taken time to start the activities ongoing. It will 

take much more than 5 years, maybe total 10 years period to actually develop sustainable systems in these countries and definitely 

financial resources are going to be required. Initial resources are 

required for these countries as well as even non-PEPFAR countries 

in sub-Saharan region to bring about any change from the existing 

situation. 

Mr. FATTAH. Do you think that either through the AU or through 

some other entity, that we could approach this problem as a subSaharan regional issue versus trying to deal with it country-bycountry? Is it your sense that there may be some ability to create 

some federation of states in sub-Saharan Africa to address this one 

problem and kind of cut through the red tape of the individual nation-by-nation blood transfusion systems that have been set up? 

Dr. DHINGRA. There are institutions existing. African Union is 

one of the existing system which could be utilized for this purpose. 

However, the requirements of each country are very specific, and 

it has to be addressed even if there are systems to coordinate the 

activities at the regional level. There is a great need to have national support for national systems and national coordination. 

Mr. FATTAH. Thank you. 

Mr. SMITH. Doctor, in your sixth recommendation you say there 

needs to be investment for research and development to enable developing countries to identify innovative methodology and appropriate technologies for blood safety. Are there innovative technologies that are being crafted that are specific to Africa where refrigeration may be a problem that you could speak to? Who is 

working on that? Who is providing the money for that? 

Dr. DHINGRA. This is one area which needs to be further investment in this area but there is a lot of potential for this, and I 

would like to mention that there have been several lessons learned 

even in the developed world when the blood transfusion services 

have been set up. So developing countries do not have to go 

through the whole process of those lessons learned, and these lessons learned in the developed world should be applied to the developing countries. They should not take 30 years to reach a level 

where the developed countries have reached in 30 years. They 

should do it in maybe 5 to 10 years. 

There are several methodologies and innovative technologies 

which could be explored and are available which are being used. In 

some countries, for example, where the refrigerator system is not 

working the big truck batteries have been used to create a system 

of refrigeration for transportation of blood and transportation of 

test kits. So similarly there is a need to look into those technologies 

which could be developed at the local level in these countries and 

investment needs to be done for this research and development in 

these areas. 

Mr. SMITH. As far as transfusion-transmitted infections, I just 

share this because my father had malaria. He got it when he was 

a combat soldier in infantry in New Guinea during the Second 

World War, and he was barred from ever donating blood, and yet 

obviously some of the individuals who will donate blood have malaria. How threatening is that in modern day? Are there any other 

diseases, blood-borne, that are not on the list now like hepatitis B 

68

and C and the like that could be a problem that might be caught 

with some additional detection? 

Dr. DHINGRA. If we look into the diseases which are transmitted 

through blood and the severity, there are four infections which 

WHO recommends that each unit should be tested for, and that is 

HIV, hepatitis B, hepatitis C and syphilis. There are other regional 

infections like Chagas disease and HTLV which the countries 

screen for also. 

Coming to malaria. Firstly, there are no good screening tests 

available for malaria particularly in the endemic countries where 

everybody would have had malaria at some stage or the other. 

Antibody tests are really not good and even antigen tests are not 

very cost effective to introduce for the screening of blood. 

So what is currently done in the developing countries is a sort 

of donor selection procedure to test for the donors who have had 

history of malaria in the last 6 months or 3 months for example 

just to remove the possibility of acute anemia being transmitted 

through blood. However, the transmission introduced malaria does 

happen, and in many developing countries including India, Ghana 

and several other countries any fever after transfusion is considered as malaria and treated as fever and malaria. In some countries even prophylactic malarial treatment is being given. 

It is a problem. However, it is not as serious a problem as HIV, 

hepatitis B is, and because of lack of good quality test kits which 

could be used as screening level for malaria in the endemic countries, screening of malaria is not recommended by WHO. But several countries are introducing antigen testing for malaria, and in 

non endemic countries antibody testing also is used and it is very 

useful. 

Mr. SMITH. Let me just ask in terms of getting the word out that 

prospective donors are in great need as the system gets established. It was my experience in the early 1980s, when the child 

survival fund and Jim Grant from UNICEF was doing his great 

work, that travel to countries like El Salvador and Nicaragua, but 

especially El Salvador, and it was the church that provided the infrastructure to get the message out but also to provide volunteers. 

We all know, and I have given blood many times, churches often 

have blood banks and when a pastor or whatever the denomination 

may be gets behind the pulpit and says, this is a national need or 

a local need, people line up and they give blood. 

Do you feel that in sub-Saharan Africa or anywhere else, but especially there, that the churches have been brought into the planning and implementation sufficiently? We were recently in Uganda, 

for example, and saw at Our Lady of Africa Church, there were 70 

HIV positive people taking part in the PEPFAR program who were 

disseminating antiretroviral medicines. The reach of that ministry/

health intervention was enormous, multiplied many times over by 

the church involvement. Are the churches involved as far as you 

know? 

Dr. DHINGRA. I would like to take a step back here and just talk 

two issues, two big issues which are affecting the blood donating 

recruitment program particularly for volunteer donation. One is a 

lack of donor education and campaign which reaches the potential 

69

donors, and the other is quality donor care which was also pointed 

out by other witnesses. 

There is a need to develop customized messages for the prospective donors, and once we know a population—what are their current attitudes and behaviors and what are the myths and misconception in that community to give blood—the messages can be 

customized to go to the donor population, and there definitely 

churches and other organizations definitely play a role at different 

level in different countries but this is some approach which can be 

adopted at a much larger level in other countries, and I appreciate 

your comment. 

Mr. SMITH. I appreciate that. It occurred to me that in El Salvador in 1984 they were admonishing the congregation, the mothers to bring their children in to get the MMR shots and to get the 

polio drops, and they were telling them up front, your child may 

develop a short fever but you have got to come back for the second 

one. So the reassuring statement from the pastor got most of those 

people, most of those moms to bring back their children. 

There is credibility, I think, when the message is conveyed 

through a faith-based approach, which may expand the ability of 

WHO and all of us that are concerned about it to get that message 

out. I just would encourage that. 

Dr. DHINGRA. Thank you. 

Mr. SMITH. You point out that in Malawi the establishment of 

the national blood transfusion service in 2003 has led to a 60 percent decrease in mortality among seriously ill children and a 50 

percent decrease in mortality in pregnant women with severe blood 

loss, recorded at the Queen Elizabeth Hospital. How did Malawi do 

it? Are they being looked up to by other ministries of health and 

other governments around Africa as well? 

Dr. DHINGRA. Malawi also went through the same phase which 

other countries are going through in sub-Saharan Africa, and it 

was through the support of another international agency, the EU, 

provided support but for initial 3 years nothing much happened because of again the lack of clarity in roles and responsibility, poor 

institutional coordination but once with the technical assistance 

from outside those systems were established and the government 

commitment was sustained and stabilized, the things have really 

improved. This is the main teaching hospital where significant improvements and the impact of a strategy have been seen in a developing country. 

Mr. SMITH. I just have two final questions. You point out cautiously that nearly 500,000 HIV infections through blood transfusion have already been averted each year in sub-Saharan Africa. 

That is great news, encouraging news. If you want to touch on 

that, that would be appreciated. 

Finally, I will give you some background on this, but I mentioned 

this to some of our earlier witnesses, the cord blood effort which 

may be down the road a bit but I do not think it should be discounted as a possible way of helping to cure sickle cell anemia and 

other blood related diseases like leukemia. It does cure leukemia. 

There have been many instances where that has been recorded. It 

seems to me that this is ready-made, maybe somewhat in the future, but I think we ought to be thinking about how that might 

70

look some years down the line and for some maybe right now. If 

you wanted to comment on that as well. 

Dr. DHINGRA. The first about the infections averted I think that 

is a very important aspect which has been seen with the blood safety strategies. If we see the HIV prevalence in general population 

in some of these sub-Saharan countries and we see the HIV prevalence in donor population with the support of the technical assistance or even their own programs there is a significant difference 

and the HIV prevalence in blood donors is much lower than the 

general population. 

So that is where infections are averted. If those strategies for volunteer blood donation were not implemented, all those infections 

for the general population would have passed through the blood 

supply, and even more infections would have occurred. 

The second level is when the testing is done, and from there it 

further brings down and removes the units which are positive. So 

it is just through those donors who have been rejected from this, 

taken away from the system by good quality blood donor program 

and the blood which is being tested currently that 500,000 infections are being averted. 

However, if you compare the risk of disease transmission in U.S. 

and in the countries in sub-Saharan Africa and the prevalence in 

the donor population, South Africa has brought it down from 21 

percent to 0.03 percent in blood donors but even that is very high. 

If you see in the U.S., for example, it is even less than 1 in 

10,000, 20,000 donors, and the risk of transmission is 1 in 1.8 million or even less than that, maybe 1 in 2.5 million today risk of infection transmission of HIV through blood. There is need to even 

further avoid these infections which are passing through unsafe 

blood, and in many countries these systems have not been fully introduced to volunteer donation and proper testing. 

A question on testing was asked earlier. No reliable data is available as mentioned in my statement. However, when we ask countries they say 100 percent is tested. Except two countries, everybody says 100 percent blood is tested but when we ask them about 

the quality systems, 33 countries out of these 46 countries said 

they have no quality systems. 

So that is what gives us the figure. We have you know calculated 

the 90 percent of blood units are not actually tested in a quality 

assured manner, even of the countries say that they are testing 100 

percent. However, there are no systems to collect the data so the 

reliability of this data is questionable. That is just one question. 

The other question about the cord banking, I think it is a very 

good new technology which is emerging which will definitely give 

opportunities for treatment for leukemia and for sickle cell anemia 

and other conditions to cure the diseases. However, firstly whichever country has developed cord banking they will have built upon 

a good blood transfusion service. So first we have to look into establishing a sustainable blood transfusion service which addresses 

at least the proper testing and storage and transportation of blood 

because cord banking is going to require a good testing system and 

a good storage and transportation system. 

Secondly, if we are going to treat patients in leukemias, we have 

to look into that the other blood components which are required for 

71

leukemia management also available, that this country has the capacity to produce platelets and other blood products which are required to treat leukemia. So there is definitely a possibility of incorporating these new technologies even into the developing world 

particularly in the cord blood banking side. 

Mr. FATTAH. Thank you very much for your testimony and your 

work. 

Mr. SMITH. Thank you so much for your testimony, for your insights, and your recommendations. The Subcommittee will really 

pour over your testimony. I have read it now twice. You have given 

us much to go on. I thank you for your exemplary work and look 

forward to working with you in the future. 

Dr. DHINGRA. Thank you very much. Could I just clarify one 

thing? 

Mr. SMITH. Sure. 

Dr. DHINGRA. I did quickly calculate when we were talking about 

the——

Mr. SMITH. Would you hit the button please? 

Mr. FATTAH. The cost, yes. Did we do the math wrong? 

Dr. DHINGRA. I did not calculate properly that time. My mental 

math was not that good. It is $50 times $15 million is $750 million, 

not $7 billion. 

Mr. FATTAH. Okay. 

Dr. DHINGRA. $750 million. 

Mr. FATTAH. It is even cheaper. 

Dr. DHINGRA. Yes. That is achievable. 

Mr. FATTAH. All right. This is good. Thank you. 

Dr. DHINGRA. Thank you very much. 

Mr. SMITH. The briefing is adjourned. 

[Whereupon, at 6:35 p.m., the Subcommittee was adjourned.] 

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A P P E N D I X 

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RESPONSES FROM JERRY A. HOLMBERG, PH.D., SENIOR ADVISOR FOR BLOOD POLICY, 

OFFICE OF PUBLIC HEALTH AND SCIENCE, U.S. DEPARTMENT OF HEALTH AND

HUMAN SERVICES, TO QUESTIONS SUBMITTED FOR THE RECORD BY THE HONORABLE

CHRISTOPHER H. SMITH, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF

NEW JERSEY AND CHAIRMAN, SUBCOMMITTEE ON AFRICA, GLOBAL HUMAN RIGHTS

AND INTERNATIONAL OPERATIONS

Question: 

In your testimony, you state that blood safety activities as they relate to malaria 

could become more feasible and cost effective as the background rate of the infection 

is reduced. Could you explain in more detail the inverse relationship between the two 

efforts (reduced malaria rates and increased efficacy of safe blood activities)? 

Response: 

If the background rate of malaria infection were greatly reduced to very low levels 

(i.e., approaching the levels seen in developed countries), it may become feasible and 

cost effective to consider donor screening as a way to reduce malaria transmitted 

by transfusion, as is done now in developed countries. However, most malaria-endemic countries in sub-Saharan Africa have a long way to go before reaching low 

levels of malaria infection. In these countries the high background prevalence of infection and disease overwhelmingly results from vector borne (mosquito) transmission. Limited resources must be focused on reducing the burden of malaria from 

this source. For now, blood safety efforts in sub-Saharan Africa will benefit from reducing cases of malaria-associated anemia and thus the overall number of transfusions needed to treat anemic malaria patients. 

Question: 

You also note the collateral benefits of blood safety programs in terms of education, 

risk assessment and laboratory screening. Could you elaborate and perhaps provide 

examples of how HHS/CDC has achieved these benefits? 

Response: 

In the course of blood collection, a national blood transfusion service (NBTS) puts 

a number of measures in place which can confer ancillary benefits to public health. 

First, all donors are given educational materials informing them of the clinical signs 

and symptoms associated with HIV infection and AIDS, high-risk activities for 

transmission, and the importance of refraining from donating blood if they have engaged in these activities or experienced associated signs and symptoms. 

Donors are counseled on any abnormal test results, given information about alternative sites or other mechanisms to obtain HIV tests, and told where donors can 

seek further follow-up care. 

A collateral benefit in most countries is the installation of incinerators at blood 

banks and blood processing labs. These incinerators prevent biohazardous waste 

from reaching local landfills. In Guyana, for instance, unused blood is simply 

trucked to the local dump and dropped off. There are no controls to prevent reuse 

of disposal items or prevention of exposure of biohazards to landfill workers, scavengers or the water table. 

Some other examples of public health benefits include:

• Education: NBTS blood donor outreach activities can be integrated with other 

disease control and health promotion activities. Examples include:

— In Rwanda, garden tools (nutrition), insecticide treated bed nets (malaria control) and bicycles (cardiovascular health) are offered as incentives to repeat donors. These incentives are accompanied with educational materials about the associated health benefits (e.g., malaria 

control).

— In some sub-Saharan countries, donor groups such as Club 25 have 

great outreach to the community and its younger population. Club 25

is a youthful concept, promoting the value of saving lives by giving 

blood. Through Club 25 young people are encouraged to attend a blood 

center, learn about healthy lifestyles and to give blood regularly, aiming 

for about 20 blood donations by age of 25 years. They also share what 

they have learned with their communities through health promotion activities to prevent HIV/AIDS, substance abuse and other health risk behaviors; in addition there are opportunities to be active in promoting 

first aid, good nutrition, physical exercise and road safety.

• Risk Assessment: The World Health Organization opines that repeat blood 

donors are less likely to engage in risky behaviors that can lead to HIV infecVerDate Mar 21 2002 14:49 Oct 11, 2006 Jkt 000000 PO 00000 Frm 00082 Fmt 6601 Sfmt 6621 F:\WORK\AGI\062706\28424.000 HINTREL1 PsN: SHIRL
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1http://www.southafrica.info/doinglbusiness/economy/fiscallpolicies/budget2005-peoplesguide.htm

tion. As the pool of regular blood donors grows, the risk of contaminated blood 

entering the blood supply (i.e., HIV infected blood that is not detected by antibody testing due to the window period in early HIV infections) is reduced. 

Likewise, regular blood donors also have a lower risk profile for other sexually transmitted infections, e.g., syphilis or hepatitis B.

• Laboratory screening: Many focus countries do not have a dedicated laboratory for the NBTS or the reference lab. In many countries, one central laboratory performs both functions. In these settings, training laboratory technicians through a blood safety program will have a positive impact on these 

technicians’ overall competency in the laboratory. 

Question: 

The PEPFAR inter-agency report on Blood Safety and HIV/AIDS notes that in 

South Africa, a highly-infected country, the National Blood Service did not find any 

evidence of HIV transmission by blood transfusion among the over 880,000 transfusions provided in 2000. What explains this successful record, and can it be replicated in other African countries? 

Response: 

South Africa is the richest and most developed country in sub-Saharan Africa. In 

FY06/07, the South African government committed $8 billion to the health sector 

(36% of the national budget 1 or $175 per capita). This level of public funding is supplemented by massive foreign aid, including $190 million in PEPFAR funds in 

FY06. South Africa’s success in protecting its blood supply is rooted, in part, in a 

steady stream of domestic funding to the South African National Blood Service 

(SANBS) over several decades. As a result, SANBS oversees a well-organized national blood program based on a national blood policy. Some of the successful activities implemented by SANBS include: 

• In 1999, the SANBS adopted a standardized blood safety policy that included 

the closure of donation sites with high HIV prevalence, implementation of direct oral questioning using a stringent self-exclusion questionnaire that incorporates questions about heterosexual and homosexual contacts, intravenous 

drug abuse, and HIV risk behaviors, and a product triage system based on 

donation risk profiling. Prevalence of HIV in the donor population declined 

progressively.

• The development of effective strategies to recruit and retain voluntary, nonremunerated blood donors.

• The establishment of high-quality laboratories to ensure that every unit of 

blood donated has been screened for HIV, hepatitis, and syphilis. Negotiations 

between SANBS and the Minister of Health led to the implementation in October 2005 of a new Donor Status Risk Management Policy. This included the 

implementation of individual donation nucleic acid (ID–NAT) testing. This 

policy continues to use stringent donor selection, universal testing, and product triage to ensure blood safety. Note: This level of technology enabling use 

of ID–NAT is not available in most developing countries.

• The creation of educational and media-based initiatives to combat fears and 

rumors about blood donation and promote a culture of regular blood donation. 

These activities build public confidence and ensure a committed and low-risk 

pool of blood donors for the future.

While the reasons for South Africa’s success are unique in sub-Saharan Africa, 

PEPFAR support has allowed several other African countries to rapidly strengthen 

their blood services and substantially increase the production of safe blood units. In 

Kenya, Zambia, and Cote d’Ivoire, for instance, Emergency Plan funds were directly 

responsible for a doubling of the number of safe blood units produced during the 

first 18 months of the initiative. These improvements were made possible by Emergency Plan funding for:

• New equipment and training to automate laboratory screening procedures.

• Enhanced outreach and donor mobilization efforts, particularly the use of mobile blood collection units.

• Continuing medical education for physicians to reduce the number of unnecessary blood transfusion orders.

80

• World-class technical assistance to develop strategic plans, national blood 

policies and regulations, and training curricula.

• Procurement of consumables and other supplies (e.g., blood bags, reagents)

Other Emergency Plan countries in Africa face more significant challenges, including a lack of basic infrastructure (electricity, roads), poorly defined legislative and 

legal frameworks to enforce safe blood policies and regulations; and a scarcity of 

human capacity to fill key technical and administrative positions. Some of these barriers are being addressed with Emergency Plan funds. For example:

• Human resource capacity is being developed through training and educational 

programs.

• Best practices and ideas from countries with functioning policies and legal 

frameworks are shared with countries just beginning the process.

• Work is underway to identify blood banks, laboratories and transfusion centers that could benefit from solar electrification.

Because many infrastructure issues are not unique to blood safety, HHS/CDC and 

its U.S. Government (USG) partners work to integrate specific Emergency Plan objectives and activities with broader USG development assistance for each country. 

Question: 

The same PEPFAR report (see above question) states that Haiti has 95% voluntary 

unpaid donation for blood as opposed to only 5% in Uganda. What is the explanation 

for this extreme difference? 

Response: 

[PLEASE NOTE: The PEPFAR report states: ‘‘Of the 15 Emergency Plan focus 

countries, five countries reported 100% voluntary unpaid blood donation in 2004 

while the remainder of the countries continue to rely on replacement family blood 

donors (from 5% in Uganda to 95% in Haiti).’’ The figures cited in this passage refer 

to donation rates from family/replacement donors, not voluntary, non-remunerated 

donors. Uganda receives 95% of its blood from voluntary unpaid donors and 5% from 

replacement family donors; while in Haiti the inverse is true, with 95% of the blood 

supply coming from replacement family donors and 5% coming from voluntary unpaid donors. We hope this note clears up any confusion caused by the wording of 

the report. We would also like to take this opportunity to explain why some countries, like Haiti, have not yet met the 100% voluntary, non-remunerated donor goal.] 

The recruitment and retention of blood donors who are at low-risk of infection 

with HIV or other blood-borne pathogens is a critical part of any successful blood 

safety program. Evidence demonstrates that voluntary, non-remunerated (unpaid) 

donors have a lower risk profile than donors who give blood for financial gain. As 

a result, PEPFAR supports national blood transfusion services to increase the identification and participation of volunteer blood donors, particularly those who donate 

more than once per year. 

Of the 14 Emergency Plan focus countries receiving blood safety funds, five reported in 2004 that 100% of the blood collected by the national blood service was 

donated by voluntary, non-remunerated donors. The proportion of donations from 

voluntary, non-remunerated donors in the remaining 9 countries covered a wide 

range, from a high of 95% in Uganda to a low of 5% in Haiti. 

The extreme difference in the use of paid or family/replacement donors versus volunteer, non-remunerated donors can be attributed to several factors, including:

• A lack of personnel (e.g., nurses, phlebotomists, administrators) to conduct 

blood drives or staff fixed-site blood centers.

• Social or cultural anxieties about blood donation.

• Weak central controls over satellite blood collection centers in rural areas or 

cities outside of the capital.

In Haiti, political instability played a significant role in dissuading the public 

from volunteering to donate blood. In the Haitian capital, Port-au-Prince, the central blood collection center is located in an area that saw intense street violence and 

was considered off-limits by many potential donors. We are pleased to report that 

Haiti’s numbers have improved steadily in 2006, following the successful presidential election and the introduction of new mobile collection units in the capital. 

In May 2006, the Haitian National Blood Transfusion Service reported 27% of donations were collected from voluntary, non-remunerated donors, up from 14% at the 

end of 2005 and 5% in 2004. 

HHS/CDC and its USG/Emergency Plan partners remain committed to increasing 

the participation of voluntary donors in Haiti and are actively supporting the NaVerDate Mar 21 2002 14:49 Oct 11, 2006 Jkt 000000 PO 00000 Frm 00084 Fmt 6601 Sfmt 6621 F:\WORK\AGI\062706\28424.000 HINTREL1 PsN: SHIRL
81

tional Blood Transfusion Service and its Haitian Red Cross partners in the following 

activities:

• Developing public awareness tools for blood safety.

• Organizing training sessions for donor recruitment in Port-au-Prince and Les 

Cayes.

• Introducing new legislation to return supervision of the blood transfusion system to the Ministry of Health.

• Planning for the renovation of 5 blood centers.

• Improving lab capacity to ensure 100% screening for HIV and hepatitis B and 

C.

• Training 172 clinicians and nurses in the clinical use of blood.

Collaborating with USAID to conduct solar power needs assessments on blood 

banks and clinics requiring reliable energy to support the cold chain. 

RESPONSES FROM MS. KAREN SHOOS LIPTON, CHIEF EXECUTIVE OFFICER, AABB 

(FORMERLY THE AMERICAN ASSOCIATION OF BLOOD BANKS), TO QUESTIONS SUBMITTED FOR THE RECORD BY THE HONORABLE CHRISTOPHER H. SMITH, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY AND CHAIRMAN, SUBCOMMITTEE ON AFRICA, GLOBAL HUMAN RIGHTS AND INTERNATIONAL OPERATIONS

Question: 

It has been asserted that cultural attitudes pose an obstacle to establishing voluntary blood donations in parts of Africa. Has your organization encountered this 

problem, and if so, could you describe those attitudes and any efforts that have been 

made to overcome them? Do government health officials share these attitudes? 

Response: 

Yes, we have encountered this problem in varying degrees in multiple countries. 

In most countries around the world, blood has a very important cultural meaning. 

It is sometimes viewed as a life force or a symbol of family and kinship ties. It may 

even be equated with personality and appearance. Several myths still remain regarding blood donation, including the belief that donating blood makes a person 

weak, infertile, or more susceptible to contracting AIDS or malaria. In addition, individuals with strong religious beliefs or racial/tribal ties may only wish to donate 

blood for individuals of the same religion/race/tribe, which is not consistent with a 

voluntary, non-remunerated blood program. Some cultures and religions require 

women to obtain consent from their husbands before donating blood, and oftentimes 

will not allow the woman to be interviewed for risk behaviors without the husband 

being present. A voluntary blood program requires a confidential interview to effectively screen for risk behaviors. 

In general, volunteerism is not common practice in many African countries. In addition, in countries where family replacement donation is still practiced, family 

members may feel the need to ‘‘save their blood’’ in the event that a family member 

or friend should need blood, preventing them from donating as a volunteer for the 

general public. 

In an attempt to overcome these obstacles, AABB is working with the National 

Blood Transfusion Services (NBTS) to gain a better understanding of the beliefs 

within each country regarding blood donation by conducting a Knowledge, Attitudes, 

and Practices (KAP) survey. Information obtained from this survey will be used to 

develop appropriate educational and public awareness information to promote the 

importance of voluntary blood donation. In addition, assistance will be provided to 

facilitate donations to accommodate specific cultural beliefs whenever possible (e.g., 

health history and interviews conducted by staff of the same gender). AABB is also 

working with the NBTS to educate government officials and hospital physicians and 

others about the importance of voluntary blood donation. 

Question: 

Are there other barriers unique to Africa that must be considered in the implementation of blood safety programs? If so, please include suggestions as to how these barriers can be overcome. 

Response: 

Financial sustainability is always a significant concern in Africa. Cost recovery 

systems, where a per-blood-unit transfused fee is passed on to the patient or insurer, are an option frequently considered. However, this solution may undermine 

82

efforts to create a voluntary blood supply. A long-term strategy for funding is required. 

An additional challenge is posed by a lack of knowledge, understanding, and/or 

sensitivity of the staff to openly discuss issues relating to sexual risk factors to effectively screen potential blood donors to ensure the safety of the blood supply. 

The NBTS has a direct link to the national health system in each country, as the 

blood collected, tested and distributed by the NBTS is ultimately transfused into patients in public and private hospitals. As such, the inherent weaknesses of the national health scheme within each country have a direct impact on the financial sustainability of the NBTS. In addition, poor road conditions make it difficult both to 

collect blood within the rural communities and distribute blood to rural hospitals. 

Inconsistent electrical supplies also create challenges in maintaining consistent temperature of blood and blood components. 

Question: 

In your testimony, you refer to the problem of National Blood Transfusion Services 

being unable to examine and implement system-wide solutions because they are continually in crisis mode. What solution would you propose for this problem? 

Response: 

AABB is working closely with each country to develop country-specific national 

standards for blood transfusion. Following approval of the national standards, country-specific trainings will be conducted to assist the country in implementation of 

the national standards. This standards-based approach facilitates the development 

of processes and systems rather than stand-alone activities, thus building long-term 

capacity of the NBTS to manage the operations in a consistent, standardized manner rather than falling into crisis mode. 

RESPONSES FROM EDWARD C. GREEN, PH.D., MEMBER OF THE PRESIDENTIAL ADVISORY COUNCIL ON HIV/AIDS, TO QUESTIONS SUBMITTED FOR THE RECORD BY THE

HONORABLE CHRISTOPHER H. SMITH, A REPRESENTATIVE IN CONGRESS FROM THE

STATE OF NEW JERSEY AND CHAIRMAN, SUBCOMMITTEE ON AFRICA, GLOBAL

HUMAN RIGHTS AND INTERNATIONAL OPERATIONS

Question: 

You lived for a considerable amount of time in Africa and worked with the health 

care systems. Did you have any personal experience with blood safety programs? If 

so, please describe. 

Response: 

I did once have some personal experience with being asked to donate blood in Africa. Two nurses I knew had set up a table at the entrance of a hotel, with the idea 

of catching people when they left the hotel or bar. Somehow, the setup did not seem 

very professional or confidence inspiring. The nurses were treating their efforts as 

something as a joke and they showed me the vials of blood that I would need to 

fill up. Since it was the AIDS era and it was southern Africa, I did not feel completely certain that the needle would be sterile, and I felt that the amount of blood 

being requested was excessive. So even though I knew the nurses, I declined. 

I later thought: if someone who knew the nurses was unwilling to give blood—

in fact, someone who works in the same field of public health—then think of what 

the average African would think. This underscores what I said in my Congressional 

testimony that the setting for blood donations must inspire trust and confidence. We 

Americans take for granted that the needle used in such donations is sterile. Africans often do not assume that. 

Question: 

Blood safety is one area of focus for prevention of HIV/AIDS transmission under 

the President’s Emergency Plan for AIDS Relief, together with needle injection safety, 

mother-to-child transmission and sexual transmission. The United States Leadership 

Against HIV/AIDS, Tuberculosis and Malaria Act of 2003 requires that 33 percent 

of PEPFAR prevention funds be spent on abstinence-until-marriage programs, which 

the Office of the Global AIDS Coordinator has interpreted to include ‘‘be faithful’’ 

programs. Some Members of Congress are advocating the elimination of this percentage spending requirement. Based on available evidence as to what prevention measures are resulting in reduced HIV/AIDS prevalence rates, would you support this effort to eliminate the abstinence-until-marriage spending requirement? 

83

1Office of the United States Global Aids Coordinator for AIDS Relief. The President’s Emergency Plan for AIDS Relief: U.S. Five-Year Global HIV/AIDS Strategy. Washington, DC, Feb 

2004. 2Office of the United States Global AIDS Coordinator for AIDS Relief. ABC Guidance for 

United States Government In-Country Staff and Implementing Partners Applying the ABC Approach to Preventing Sexually Transmitted HIV Infections within The President’s Emergency 

Plan for AIDS Relief. Washington, DC, Mar 2005. 3 Bessinger, R., Akwara, P., and Halperin, D. (2003). Sexual behavior, HIV and fertility trends: 

A comparative analysis of six countries; Phase I of the ABC study. Measure Evaluation; USAID. 

(www.cpc.unc.edu/measure/publications/special/); Green, Edward C., Vinand Nantulya, Yaa 

Oppong (2003)., ‘‘Literature Review and Preliminary Analysis of ‘‘ABC’’ factors in Six Developing 

Countries.’’ Cambridge: Harvard Center for Population and Development Studies. July 2003. 4 Buve, A., Carael, M., Hayes, R., Auvert, B., Ferry, B., Robinson, N., et al. (2001). Multicentre 

study on factors determining differences in rate of spread of HIV in sub-Saharan Africa: methods and prevalence of HIV infection. AIDS, 15(Suppl.), S5–S14. White, R., Cleland, J., Carael, 

M. (2000). Links between premarital sexual behavior and extramarital intercourse: multi-site 

analysis. AIDS, 14, 2323–2331. 5 Hearst N, Chen S. Condom Promotion for AIDS Prevention in the Developing World: Is it 

Working? Studies in Family Planning 2004; 35(1): 39–47. 6Shelton, James D, Daniel T Halperin,Vinand Nantulya, Malcolm Potts, Helene D Gayle, 

King K Holmes, ‘‘Partner reduction is crucial for balanced ‘‘ABC ‘‘approach to HIV prevention. 

BMJ 328(10) April 2004; Stoneburner RL, Low-Beer D. Population-level HIV declines and behavioral risk avoidance in Uganda. Science 2004; 304: 714–18; Halperin, DH, and Helen Epstein, ‘‘Concurrent sexual partnerships help to explain Africa’s high HIV prevalence: implications for prevention.’’ The Lancet Vol 364 July 3, 2004, pp. 4–6; Hearst, Norman and Sanny 

Chen, Condom Promotion for AIDS Prevention in the Developing World: Is It Working? Studies 

In Family Planning 2004;35 [1 ]:39–47).

Response: 

In January 2003, the United States pledged $15 billion to global AIDS under the 

President’s Emergency Plan for AIDS Relief (PEPFAR). The U.S. Agency for International Development (USAID) had recently adopted the ABC approach as the 

model of HIV prevention for generalized epidemics, using Uganda’s success as a 

model. In 2003, PEPFAR also adopted the ABC approach. The first PEPFAR prevention strategy document to be released announced that ‘‘risk elimination’’ would 

be the ‘‘cornerstone’’ of prevention.1 Risk elimination, also called risk avoidance, refers to sexual abstinence and to mutual fidelity between two uninfected sex partners. Risk reduction, on the other hand, refers to strategies such as condom usage 

that reduce but do not eliminate the risk of sexual transmission. PEPFAR, through 

the ABC approach, proposed to combat AIDS both ways, rather than only one way. 

The Office of the U.S. Global AIDS Coordinator (OGAC) later released further 

guidance on the ABC approach.2 Although this guidance has clarified the prevention 

approach to be followed by programs under PEPFAR, considerable confusion and 

controversy remain. Part of the reason for this seems to be the backlash coming 

from family planning and contraceptive-oriented organizations—and agencies including UNFPA and UNAIDS—which fear received smaller allocations of resources 

if some resources go to behavioral programs. In extreme forms, fear that condom 

programs might lose money have even led to formal proposals to eliminate primary 

prevention, behavioral programs altogether. 

Amending the 2003 Act that requires that 33% of PEPFAR prevention funds be 

spent on abstinence and fidelity programs in a way that would remove this ‘‘earmark,’’ would be an extremely bad move. It would return AIDS prevention to the 

era when HIV prevalence continued to rise in every country in Africa, with the exception of Uganda and Senegal, the first two countries in Africa to implement ABC 

programs, that is, programs that promote a balanced and targeted set of interventions that include Abstinence, Being faithful, and Condoms for whose who cannot 

or will not follow A or B behaviors. 

Since PEPFAR is implemented in countries with generalized epidemics (with the 

exception of Vietnam), its approach to AIDS prevention must be one that works with 

generalized epidemics. Risk reduction-only programs (condom promotion, treating 

STIs, and promotion of VCT) have been found to have little or no overall impact 

on generalized epidemics, if this is measured by declines in national HIV prevalence. This was the conclusion of the USAID ABC Study 2003,3 as well as two studies of UNAIDS: the multi-site African study (published in a special issue of Journal 

AIDS, 2001) 4 and the 2003 Condom Effectiveness Review.5

By 2004, analyses of Uganda data were published in leading scientific journals 

concluding that decline in casual sex (the B of ABC) was the major factor associated 

with HIV prevalence decline in Uganda.6 Since then, evidence for a pivotal role for 

partner reduction has emerged for more recent HIV declines in Kenya and 

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7Gregson, Simon, Geoffrey P. Garnett, Constance A. Nyamukapa, Timothy B. Hallett, James 

J. C. Lewis, Peter R. Mason, Stephen K. Chandiwana, Roy M. Anderson, ‘‘HIV Decline Associated with Behavior Change in Eastern Zimbabwe’’ Science 311, 664 (2006); Cheluget B, Baltazar 

G, Orege P, Ibrahim M, Marum LH, Stover J. (2006). ‘‘Evidence for population level declines 

in adult HIV prevalence in Kenya.’’ Sex Transmitted Infections Apr;82 Suppl 1:i21–6; Hayes, 

Richard and Helen Weiss, ‘‘Enhanced: Understanding HIV Epidemic Trends in Africa.’’

http://www.sciencemag.org/cgi/content/full/311/5761/

620?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=zimbabwe&searchid-

=1138923040026l15772&FIRSTINDEX=0&journalcode=sci 8Weller S, Davis K. Condom effectiveness in reducing heterosexual HIV transmission. 

Cochrane database Systematic Review 2002; (1): CD003255; Gardner, R., Blackburn, R. D., & 

Upadhyay, U. D. (1999). Closing the condom gap. (Population Reports, Series H). Baltimore: 

Johns Hopkins University. 9Green, E.C., ‘‘HIV/AIDS, TB, and Malaria: Combating a Global Pandemic.’’ Testimony on 

AIDS in Africa, for Committee Hearing, The House Committee on Energy and Commerce, U.S. 

House of Representatives, March 20, 2003. http://energycommerce.house.gov/108/Hearings/

03202003hearing832/Green1379.htm 10 Halperin DT, Steiner MJ, Cassell MM et al. The Time Has Come for Common Ground on 

Preventing Sexual Transmission of HIV. The Lancet 2004; 364: 1913–1915. 

Zimbabwe.7 This should not be surprising, considering that condoms are estimated 

to be between 80% and 85% effective against HIV when used consistently—that is, 

to reduce HIV transmission by 80% to 90% compared to non-use.8 Yet consistent use 

of condoms is rare and with ‘‘typical use’’ of condoms, risk reduction at the population level is in minimal. In fact, there is a very disturbing association (whether 

or not causation can be established) in Africa between higher condom use and higher levels of HIV infection. This can easily been seen by simply looking at levels of 

both condom use and HIV prevalence in a list of African nations. It is noteworthy 

that while this disturbing association is widely recognized among AIDS professionals, such a table has never been published to my knowledge. Such a table showing condom availability and national HIV infection levels were presented in my testimony 9 (Fig. 4). Consistent with this association, the first countries for which we 

have DHS behavioral data plus blood samples showing HIV status (Kenya, Tanzania, Ghana, Uganda) we see that condom users are almost always found to have 

higher HIV prevalence than non-users. 

A ‘‘consensus statement’’ published for the 2004 World AIDS Day in The Lancet 10

which was endorsed by over 150 global AIDS experts, including representatives of 

five UN agencies, WHO, World Bank, etc., as well as President Museveni of Uganda 

and various religious leaders including Archbishop Desmond Tutu, proposed that 

mutual faithfulness with an uninfected partner should be the primary behavioral 

approach promoted for sexually active adults in generalized epidemics. And abstinence or delay of age of ‘‘sexual debut’’ should be the primary behavioral approach 

promoted for youth. This represented a fairly marked departure from many previous 

prevention approaches, which emphasized risk reduction almost exclusively as the 

first line of defense for sexually active adults in all types of epidemics. A growing 

number of public and international health professionals including PEPFAR recognize that, before Uganda and Senegal, AIDS prevention lacked an essential primary 

prevention component. They see the AB components as logical, sensible, cost-effective, sustainable, culturally appropriate interventions for general, as distinct from 

high-risk, populations. Moreover, the evidence is clear that these components work 

and that risk reduction has not led to a single success in generalized epidemics. 

Critics of ABC, if they work in AIDS or reproductive health fields, are invariably 

critics of these same AB interventions while favoring condoms. They point to rape, 

coerced sex, the powerlessness and lack of choice of African women, and they argue 

that promoting AB behaviors is quixotic, doomed to failure, or simply ‘‘irrelevant to 

women’s lives.’’ The logic seems to be: if not every woman is in a position to practice 

abstinence of fidelity, then we should not promote these risk elimination behaviors 

at all. But this makes no logical or public health sense, moreover we know from decades of experience that a great many women are not in a position to insist on 

condom use. 

Another point of bitterness and contention are PEPFAR’s allocation guidelines, 

which specify that certain proportions of sexually transmitted HIV prevention funds 

must be spent on AB programs. This is unfortunate, since it appears to support a 

‘‘one size fits all’’ approach. AB proponents argue with some justification that unless 

there is political pressure, few if any funds would be allocated to AB programs, since 

almost no funds were so allocated, prior to the US policy shift. 

Still, any coerced allocations create a zero-sum game atmosphere, making AB critics feel that funds are being shifted away from familiar condom programs and perhaps away from organizations whose skills and experience center around contraceptives and who have been fighting the AIDS pandemic from the earliest years. Yet 

85

11Data available at: http://www.measuredhs.com/

the last few years have seen an almost exponential growth in funds available for 

condoms and for AIDS programs in general. There should be enough resources for 

both sides. And viewed objectively, both sides of this debate are right, depending on 

whether high-risk or general populations are targeted. Both approaches are needed 

and both population segments need coverage. The condom intervention works best 

in concentrated epidemics with small, identifiable groups of core transmission where 

it is possible to achieve high rates of condom use, while AB is the approach that, 

when backed up by C, has had proven impact in generalized epidemics. 

Who and how many are considered at high risk is also a point of contention. One 

side holds that ‘‘we are all at high risk; anyone can be infected.’’ Others point to 

DHS data that show higher levels of AB behaviors than many people assume, including those who ought to be familiar with the data:

1 23% of African men and 3% of African women reported multiple sexual partners in the last year

2 Among unmarried youth 15–24, 41% of young men and 32% of young women 

reported pre-marital sex in the past year

This means that most African men and women practice B behaviors (or do not 

have outside sexual partners) and most African teens do not report sexual intercourse in the past year. Moreover, the trend in Africa is towards higher levels of 

A and B behaviors and towards incrementally lower HIV prevalence (7.2% in 2005 

compared to 7.5% in 2003).11

What has been missing in this debate is a calm, even-handed, balanced viewpoint 

that recognizes that some resources clearly must be targeted to high-risk groups, 

while some must be directed to what survey and epidemiological evidence show are 

the majority of people. To target only those at high-risk is to effectively ignore the 

majority of any population. Targeting both minority (high-risk) and majority populations need not result in diminished quality or even quantity of prevention resources going to either group. If Uganda, with relatively few resources could design 

and implement a balanced and targeted ABC program, surely PEPFAR, with billions of dollars, can do as much. 

In sum, it would be a tragic mistake to remove earmarks for fidelity and abstinence programs, one that would result in massive loss of lives. We would be removing the two interventions that have worked better than any others in generalized 

epidemics. American AIDS activists tend to think of AIDS patterns and challenges 

in New York and San Francisco when they make their demands, even if they shift 

the rhetoric to sound as if they are talking about Africa. These activists, who no 

doubt mean well for Africa and less developed countries, need to look carefully at 

the AIDS-related evidence from less developed countries. 

Please do not undercut the one major donor agency in the world that is conducting effective AIDS prevention. 

RESPONSES FROM NEELAM DHINGRA, M.D., COORDINATOR, BLOOD TRANSFUSION

SAFETY, ESSENTIAL HEALTH TECHNOLOGIES, WORLD HEALTH ORGANIZATION, TO

QUESTIONS SUBMITTED FOR THE RECORD BY THE HONORABLE CHRISTOPHER H. 

SMITH, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY AND

CHAIRMAN, SUBCOMMITTEE ON AFRICA, GLOBAL HUMAN RIGHTS AND INTER- NATIONAL OPERATIONS

Question: 

Are you aware of countries that have continued blood safety programs with their 

own resources or have discontinued such programs once outside resources have been 

withdrawn? Do you perceive that this could be a problem in the future? If so, how 

can governments be convinced of the importance of continued support for blood safety 

programs? 

Response: 

The capacity of a country to maintain an effective blood safety program at the 

conclusion of a period of international assistance (financial and technical) is dependent on a sustainable infrastructure and systems being established during the project 

period. In all regions of the world, there are examples of developing countries (such 

as Chile) which, with the support of international donor and technical assistance 

agencies, have successfully established well-organized national blood programs with 

sustainable financial systems based on budget allocation, full or partial cost recovery or health insurance systems. There are also examples of countries which have 

86

failed to establish sustainable systems and which consequently are either unable to 

ensure the safety or availability of the national blood supply or which remain precariously dependent on external financial support. 

In the developing world, the major challenges to sustainability are the lack of tangible government support in the form of well-formulated national blood policies and 

plans with appropriate legislative frameworks, coupled with the fragmentation of 

blood transfusion services, a lack of clarity of roles and responsibilities between national stakeholders, poor institutional coordination and a lack of integration of blood 

programs within national healthcare systems. 

An ongoing focus on systems development, good institutional coordination and the 

consolidation of key activities in major centers is crucial for the effective coordination and management of blood services and the efficient utilization of resources. The 

early stages of funding and technical assistance should focus on the development of 

national blood policies, capacity building, risk management and the development of 

systems for the sustainable financing of national blood programs as critical components of the health care systems and infrastructure. Depending on the existing situation, building a sustainable blood safety program in a country with a less-developed blood transfusion service will require a long-term commitment to international 

assistance for at least 5–10 years. 

There are also countries such as Sri Lanka which have built up well-organized 

systems based on international financial and technical assistance and in 2006 are 

just reaching the point of transitioning to national support; sustainability of these 

programs will take several years to assess. The governments of the WHO Member 

States have expressed their commitment to blood safety in successive resolutions of 

the World Health Assembly, the annual policy-making meeting of ministers of 

health, and of WHO Regional Committees/Councils. However, there is a pressing 

need for ongoing advocacy by global partners in promoting wider understanding of 

the role of ‘Blood Safety and Availability’ in preventing the transmission of 

bloodborne infections. The urgency of the need for improved blood safety is highlighted by the response of governments to current lawsuits resulting from the transfusion of contaminated blood products. The recognition that it is more cost-effective 

to invest in developing safe blood programs than to face costly litigation is spurring 

on other countries to review and strengthen their blood safety programs. Advocacy 

is also required to call greater attention to safe blood as a core requirement in the 

health care system and its impact on other healthcare programs, including HIV/

AIDS, safe motherhood, child health, malaria, surgical and medical care, and also 

in the management of patients with cancer, blood disorders and trauma. 

Question: 

How does WHO’s work in the area of blood safety impact or how is it coordinated 

with WHO’s work in other areas of global health? 

Response: 

The specific mandate of WHO is to support its 192 WHO Member States in the 

implementation of policies defined by the World Health Assembly and the achievement of their specific health goals. It works with ministries of health, nongovernmental organizations (NGOs) and other international agencies through its organizational structure and network at global, regional and national levels, each with distinctive, complementary roles and areas of expertise. WHO headquarters is responsible for developing global strategies, guidelines and tools and establishing mechanisms to support their implementation at regional and country level through advocacy, capacity building and technical cooperation. WHO regional offices adapt these 

strategies, guidelines and tools to meet specific country needs and provide direct 

support in their implementation through WHO country offices. Country offices, 

which have intimate knowledge of national health programmes, work with national 

health authorities in the context of the overall strengthening of national health systems. They also provide leadership in the coordination and monitoring of related activities, including HIV/AIDS prevention, treatment and care, by governments, bilateral and multilateral agencies and nongovernmental organizations. WHO also hosts 

and acts as the secretariat for the Global Collaboration for Blood Safety, a forum 

for about 60 internationally recognized organizations, institutions, associations, 

agencies and experts from developing and developed countries concerned with global 

blood safety and availability. This forum provides a platform for sharing expertise, 

identifying problems, seeking solutions and working towards the common goal of 

global blood safety and availability. 

Within the United Nations family, the WHO Blood Transfusion Safety program 

takes the lead role in relation to blood safety and availability, working in collaboration with other WHO programs and initiatives, including HIV/AIDS prevention, 

87

health action in crises, making pregnancy safer, communicable diseases, injuries 

and violence prevention, malaria, family and community health, healthcare waste 

management, evidence and information for policy, health systems and the Health 

Metrics Network. Blood safety is identified as one of the five elements of the Global 

Patient Safety Challenge by the WHO-hosted World Alliance of Patient Safety. 

WHO also provides technical assistance to a number of country projects (Azerbaijan, Bangladesh, Burkina Faso, Cambodia, Ethiopia, Haiti, Namibia, Sri Lanka, 

Pakistan, Viet Nam) supported by other international development agencies, including the Asian Development Bank, Office of the U.S. Global AIDS Coordinator, U.S. 

Centers for Disease Control and Prevention, Global Fund, Gates Foundation, Japan 

Bank for International Cooperation, Japan International Cooperation Agency and 

the World Bank. 

RESPONSE FROM ROBERT E. FERRIS, M.D., MEDICAL OFFICER, BUREAU FOR GLOBAL

HEALTH, U.S. AGENCY FOR INTERNATIONAL DEVELOPMENT, TO QUESTION SUBMITTED FOR THE RECORD BY THE HONORABLE CHRISTOPHER H. SMITH, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY AND CHAIRMAN, SUBCOMMITTEE ON AFRICA, GLOBAL HUMAN RIGHTS AND INTERNATIONAL OPERATIONS

Question: 

USAID is to be commended for its efforts to make child birth safer and to reduce 

the incidence of malaria. What is the cost-effectiveness of such measures as compared 

to ensuring a safe blood supply? How do you think the two could best be coordinated 

in a single strategy to address maternal health, malaria and safe blood? 

Response: 

Low cost, high impact interventions exist to make child birth safer for pregnant 

women. For instance, external uterine message, controlled umbilical cord traction, 

and the administration of medications like oxytocin to contract the uterus are widely accepted, inexpensive interventions that can prevent 50–60% of postpartum hemorrhages. A dose of oxytocin in a Uniject syringe costs approximately US$0.50. 

Several low cost, high impact interventions to reduce the incidence of malaria also 

exist. These include insecticide-treated bed nets (ITNs) which cost an estimated 

US$5.00 each. Children are often the most vulnerable to the life threatening anemia 

caused by malaria. ITNs are highly effective in reducing childhood mortality and 

can cut the incidence of malaria by 50% in high prevalence areas. Approximately 

5.5 lives per 1,000 children can be saved through the use of ITNs. 

USAID is not aware of a direct cost-effectiveness analysis comparing these interventions with a safe blood supply. However, in the continuum of care, there are potentially significant synergies between prevention measures for the leading causes 

of blood transfusion (postpartum hemorrhage and severe anemia from malaria infection) and a safe blood supply. Maximizing prevention activities minimizes demand 

on already burdened blood supply systems. Theoretically, less demand would save 

scarce blood resources for severe cases that could not be prevented. More research 

is needed. 

Investing in health systems is likely to be the best single strategy to address 

issues of safe blood, maternal health, and malaria. The critical infrastructures needed for a successful health system, like trained healthcare staff, reliable electricity, 

and secure supply chain, would allow a safe blood system to thrive. Maternal health 

and the treatment of malaria would also significantly benefit. 

RESPONSES FROM CAROLINE RYAN, M.D., SR. TECHNICAL ADVISOR, DEPUTY DIREC- TORY FOR PROGRAM SERVICES, OFFICE OF THE GLOBAL AIDS COORDINATOR, U.S. 

DEPARTMENT OF STATE, TO QUESTIONS SUBMITTED FOR THE RECORD BY THE HONORABLE CHRISTOPHER H. SMITH, A REPRESENTATIVE IN CONGRESS FROM THE STATE

OF NEW JERSEY AND CHAIRMAN, SUBCOMMITTEE ON AFRICA, GLOBAL HUMAN

RIGHTS AND INTERNATIONAL OPERATIONS

Question: 

Please describe the nature, location and grant level for programs funded by the 

Global Fund that address blood safety. 

Response: 

The Office of the Global AIDS Coordinator (OGAC) requested information regarding the nature, location and grant level of Global Fund programs that address blood 

safety from the Global Fund Secretariat. The information provided follows: 

88

Experience has shown that Global Fund recipient countries include blood safety 

issues as part of general health systems strengthening activities and thus may fall 

outside the specific activities and selected indicators that are used to track progress 

for purposes of disbursement decisions in a number of grants.

• To date the Global Fund supports 36 grants which include indicators that relate to blood safety. The total amount signed for these grants is USD $453 

million, of which USD $316 million have already been disbursed.

• Their geographical distribution is as follows: 20 in Sub-Saharan Africa and 

the Middle East, 7 in Eastern Europe & Central Asia, 6 in East and South 

Asia & the Pacific, and 3 Latin America & the Caribbean. Those countries 

are:

— Jordan 

— Moldova 

— Tajikistan 

— Benin 

— Jamaica 

— Croatia 

— Kyrgyzstan 

— Haiti 

— Sudan 

— Swaziland 

— Sierra Leone 

— Azerbaijan 

— Guinea-Bissau 

— Eritrea 

— Chad 

— Mongolia 

— Zambia 

— Lao PDR 

— Afghanistan 

— Liberia 

— Pakistan 

— Georgia 

— Ethiopia 

— Armenia 

— Equatorial Guinea 

— Guinea 

— Togo 

— Mali 

— Multi-country Western Pacific 

— Niger 

— Papua New Guinea 

— Somalia 

— Yemen

• The 36 grants include a number of different specific targets related to blood 

safety. All 36 grants do have targets on ‘‘blood units screened’’ and additional 

targets refer to training of health personal in this area. Targets are formulated inconsistently throughout the grants, including ‘‘percentage of units 

screened’’ and ‘‘total numbers’’, so that it is difficult at this stage to provide 

concrete results achieved to date (in terms of specific numbers). 

Question: 

The June 2006 PEPFAR Report on Blood Safety and HIV/AIDS indicates that ‘‘an 

incremental approach is the only realistic approach for establishing blood services in 

developing countries including sub-Saharan Africa.’’ However, would you not agree 

that incremental funding could be substantially increased over current levels to 

achieve the goal of a fully-implemented blood safety system in a shorter period of 

time? Please explain your response. 

Response: 

Because of the absorption issues noted in the 2006 PEPFAR report, the size of 

any increase should be carefully calibrated to ensure that countries can make effective use of the additional funds in a rapid timeframe. During the FY04–FY05 funding cycle, the 14 ministries of health (MOHs) receiving blood safety funds ($60.2 

million) absorbed these funds with different levels of success. On average, 55% of 

the Emergency Plan funds obligated for blood safety during this period were actually used by the grantees. However, this figure masks the dramatically higher abVerDate Mar 21 2002 14:49 Oct 11, 2006 Jkt 000000 PO 00000 Frm 00092 Fmt 6601 Sfmt 6621 F:\WORK\AGI\062706\28424.000 HINTREL1 PsN: SHIRL
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sorptive capacity of some MOHs (e.g., Zambia, 97%; Nigeria 90%; Cote d’Ivoire, 85%) 

and the lower capacity of others (e.g., Ethiopia, 0%; Botswana, 8%; Guyana 30%). 

Several factors may limit a country’s ability to absorb funds:

• Lack of trained personnel to implement activities on a national scale.

• Limited or poorly managed administrative structures within the Ministry of 

Health and/or other national government agencies/ministries.

• Complex internal procurement mechanisms and restrictions. On this note at 

least one country (Cote d’Ivoire) has also experienced problems obtaining a 

duty-free exemption for equipment and materials imported with Emergency 

Plan funds.

• A lack of suitable structures to renovate and the HHS prohibition on constructing new facilities. This has been a significant hurdle in Ethiopia, Botswana and Guyana.

In contrast, key factors contributing to a successful absorption of Emergency Plan 

funds in other nations include:

• Strong administrative systems in the Ministry of Health and the National 

Blood Transfusion Service.

• Adequate personnel to perform Emergency Plan-funded activities.

• Streamlined procurement policies.

• Adequate existing facilities with less need to build or renovate.

Based on these factors and the experience of the last three fiscal years, we believe 

it is wise that decisions to increase funding for blood safety be made on an incremental, country-by-country basis. 

Question: 

What is PEPFAR doing to ensure the regular monitoring of the blood safety programs in focus countries (and non-focus countries to the extent they exist)? What obstacles have focus countries encountered in monitoring the proper use of blood products? 

Response: 

The Emergency Plan uses a number of mechanisms to conduct routine and issue/

site-specific monitoring of the 14 Emergency Plan-funded blood safety programs. 

These include:

• Most of the 14 focus countries have a program specialist on staff to ‘‘champion’’ blood safety issues and to interact with National Blood Transfusion 

Service (NBTS) partners on a daily basis.

• Emergency Plan-supported, nongovernmental technical assistance (TA) partners are increasingly basing staff members in the countries they serve. These 

in-country TA providers are often co-located with the Ministry of Health 

(MOH)/NBTS partners and provide daily program monitoring and guidance.

• Headquarters staff conducts routine site visits to blood safety programs in the 

14 countries. Since the beginning of calendar year 2006, all 14 countries have 

received at least one monitoring, oversight and/or TA visit. During these support and supervision site visits, HQ staff use a standardized protocol to inspect all aspects of a program. Staff supplements and adapts this protocol as 

needed, based on their own subject-matter expertise and the country context.

• In April 2006, the Department of Health and Human Services Centers for 

Disease Control and Prevention (HHS/CDC) coordinated a meeting of the five 

TA providers and representatives from two of the 14 focus countries to develop a comprehensive list of program indicators covering the following seven 

key program areas:

1. Infrastructure 

2. Blood Collection 

3. Blood Testing and Collection 

4. Transfusion and Blood Utilization 

5. Training 

6. Monitoring and Evaluation 

7. Sustainability

The indicator list includes contextual questions (i.e., items whose status is not expected to change year-to-year, such as number of hospital beds or whether a country 

has a Strategic Plan) and dynamic questions (i.e., items whose status would be expected to evolve over time, such as number of blood units collected). These indicaVerDate Mar 21 2002 14:49 Oct 11, 2006 Jkt 000000 PO 00000 Frm 00093 Fmt 6601 Sfmt 6621 F:\WORK\AGI\062706\28424.000 HINTREL1 PsN: SHIRL
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tors will be deployed in a user-friendly Access database and will be collected and 

analyzed bi-annually. 

Obstacles to monitoring the proper use of blood products include:

• A lack of trained local staff to oversee laboratory activities and clinical decisions on the use of blood.

• Few hospitals have functioning transfusion committees to monitor blood use, 

counsel/train physicians on the appropriate use of blood, and conduct 

hemovigilence activities.

• Weak enforcement of national policies and regulations.

• Limited data on the actual need for blood products. Example: An Emergency 

Plan-funded survey in Cote d’Ivoire in 2005 determined that significant wastage was occurring during the height of the malaria season when small 

amounts of blood from adult-sized blood bags were transfused into children 

suffering from anemia. Once these bags were opened, any remaining blood 

was discarded. Based on these findings, the Cote d’Ivoire blood service has 

increased the availability of pediatric-sized blood bags to reduce wastage during the rainy season.

• Private sector blood banks exist in all 14 focus countries. These banks often 

do not follow the national blood guidelines and do not submit blood they collect to the national screening program.

• War and civil unrest. Haiti, Cote d’Ivoire, Zimbabwe and Nigeria have all experienced disruptions to their blood services due to war and civil unrest. 

Question: 

According to WHO, about 40% of surveyed African countries have no line-item for 

blood transfusion services. Are there indications that the governments in the focus 

countries consider blood safety a priority? What exit strategies is PEPFAR planning 

ton ensure the sustainability of blood safety efforts within focus countries? 

Response: 

By their actions over the last three years, all of the 14 focus countries receiving 

blood safety funds have indicated a significant commitment to maintaining and improving on the advances made possible through the Emergency Plan. A list of activities indicating this commitment follows:

• All 14 focus countries have developed and enacted national blood policies. 

These countries have also enacted (or are working with their legislatures to 

enact) legislation to support these policies.

• National Blood Transfusion Services have been established. In several focus 

countries (e.g., Haiti), blood services were historically managed exclusively by 

the national Red Cross. Emergency Plan funds have allowed governments in 

these situations to regain control over and consolidate administration of their 

national blood supplies.

• National Blood Transfusion Services in all 14 countries have published or are 

writing 10 year strategic plans for safe blood.

• Efforts are underway in all 14 focus countries to determine the cost of producing a unit of safe blood and to develop/enhance mechanisms to recovering 

some of these costs.

Ensuring the sustainability of these programs and activities is a priority for all 

USG agencies contributing technical and administrative support to the Emergency 

Plan’s blood safety initiative. Emergency Plan exit strategies will need to be tailored 

to each country. These strategies will also, by necessity, need to be integrated into 

the USG’s long-term development strategies and objectives for each country. Substantial thought will also need to be given to ways in which Emergency Plan-funded 

activities which still require external support may be supplemented by other sources 

of funding. For blood safety, Emergency Plan partners are working in the following 

areas to build administrative and technical capacity in the focus countries:

• Significant work is underway to identify and train energetic physicians, 

nurses, laboratory technicians, administrators, logisticians, and other allied 

healthcare workers to manage the scale-up during the Emergency Plan period 

and execute the strategic plans under development for the post-Emergency 

Plan era.

• Significant efforts are made to ensure that blood safety activities are effectively linked to other prevention, care and treatment programs. Staff also 

work to develop strong relationships with other funding partners and to faciliVerDate Mar 21 2002 14:49 Oct 11, 2006 Jkt 000000 PO 00000 Frm 00094 Fmt 6601 Sfmt 6621 F:\WORK\AGI\062706\28424.000 HINTREL1 PsN: SHIRL
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tate new relationships between these partners and the ministries of health. 

For example, PEPFAR is working with ExxonMobil, Abbott and Safe Blood 

for Africa Foundation through a Public Private Partnership to implement a 

blood safety project with two major components, a National Blood Transfusion 

Service Training Laboratory and a Center of Excellence Blood Bank Facility 

in Nigeria’s Federal Capital Territory. Additionally, support is provided for 

several regional blood banking centers throughout the country.

• PEPFAR has supported ministries of health, where appropriate, to leverage 

economies of scale. In countries with functioning procurement systems, this 

support includes technology upgrades and training.

• The Emergency Plan is also supporting coordination with Internews to create 

a blood safety training module for journalists and other media workers. The 

objective of this project is to leverage the media’s existing communications 

networks to distribute blood donor education and mobilization information to 

the public without the costs associated with printed hand-outs and banners. 

Efforts are also underway to develop targeted messages using social marketing techniques. These activities are important for building the sense of 

local ownership so essential to sustainability. 

Question: 

As you know, the GAO recently submitted a report to Congress in early April regarding the impact of the 33% abstinence-until-marriage earmark for our Global 

AIDS prevention programs (Global Health: Spending Requirement Presents Challenges for Allocating Prevention Funding under the President’s Emergency Plan for 

AIDS Relief, GAO–06–395, April 4, 2006). 

Apart from finding that implementing the abstinence-until-marriage earmark 

challenged the ability of country teams to develop interventions that are responsive 

to local epidemiology and social norms, the GAO also found that one country team 

feared the earmark would force cuts in medical and blood safety activities and had 

sought an exemption from meeting the spending requirement. 

Given the GAO report and some of the other associated challenges presented by 

the abstinence-until-marriage earmark, wouldn’t eliminating the earmark give 

OGAC greater flexibility in spending our limited HIV prevention resources, so that 

we can put more money into blood safety and other areas, depending on local needs? 

Response: 

The legislation’s emphasis on Abstinence and Be Faithful (AB) activities has been 

an important factor in the fundamental and needed shift in U.S. Government (USG) 

prevention strategy from a primarily condoms ( C) approach prior to PEPFAR to the 

balanced ABC strategy. The Emergency Plan has developed a more holistic and equitable strategy, one that reflects the growing body of data that validate ABC behavior change. PEPFAR has followed Congress’ mandate that it is possible and necessary to strongly emphasize A, B, and C, while also seeking to support prevention 

of medical transmission through programs to ensure a safe blood supply and safe 

medical injections, programs to prevent mother to child transmission and other critical prevention interventions. 

At a recent briefing for Congressional staff and others, the Kenya director for a 

large program was asked if the 33% directive impacted his ability to program effectively. His answer, in paraphrase, was that ABC is the African approach and should 

be supported, that the directive had no adverse impact and in fact the enhanced emphasis on AB was beneficial in focusing programs on effective prevention. In a letter 

to the editor of Lancet the Minister of Health of Namibia and the CDC and USAID 

country directors presented opinions similar to the gentleman from Kenya. This 

joint letter reflects the reality that effective prevention programs must support national strategies; as long as the balanced ABC approach remains central to the 

strategies of host nations, it will necessarily be central to USG support for those 

nations.

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