Blood Supply: Transfusion-Associated Risks (Letter Report, 02/25/97,
GAO/PEMD-97-2).

The U.S. blood supply is safer today than at any time in recent history,
with risks from blood transfusions quite small compared with the
benefits of transfusion in saving lives. Improved donor screening and
education have removed from the donor many persons who are at high risk
for disease, and tests used to screen blood for viruses are considerably
more sensitive than earlier versions. However, risks remain. Eight of
every 10,000 donated units of blood carry a serious risk to the
recipient, including allergic reactions, bacteria, reactions to
incompatible blood transfusions, and viruses. GAO estimates that four
out of 1,000 patients who receive the average transfusion of five units
of blood are at risk of being exposed to contaminated blood that could
sicken or even kill them. On the other hand, as many as half of the
1,000 recipients would be at serious risk of dying immediately unless
they receive a transfusion. The risk that a surgery patient will require
blood and develop a chronic disease or die as a result of that blood is
estimated at five in 100,000. For the average person with no foreseeable
plans for surgery, the annual risk of developing a chronic disease or
dying from the transfusion is five in 1 million.

--------------------------- Indexing Terms -----------------------------

 REPORTNUM:  PEMD-97-2
     TITLE:  Blood Supply: Transfusion-Associated Risks
      DATE:  02/25/97
   SUBJECT:  Infectious diseases
             Health hazards
             Health statistics
             Product safety
             Quality control
             Medical supplies
             Testing
             Acquired immunodeficiency syndrome
IDENTIFIER:  AIDS
             
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Cover
================================================================ COVER


Report to the Ranking Minority Member, Committee on Commerce, House
of Representatives

February 1997

BLOOD SUPPLY -
TRANSFUSION-ASSOCIATED RISKS

GAO/PEMD-97-2

Blood Supply:  Transfusion-Associated Risks

(973439)


Abbreviations
=============================================================== ABBREV

  ABRA - American Blood Resources Association
  ARC - American Red Cross
  ATL - Adult T-cell leukemia and lymphoma
  CDC - Centers for Disease Control and Prevention
  CJD - Creutzfeldt-Jakob disease
  CMV - Cytomegalovirus
  FDA - Food and Drug Administration
  HAM/TSP - HTLV-I-associated myelopathy and tropical spastic
     paraparesis
  HAV - Hepatitis A virus
  HBc - Hepatitis B core
  HBV - Hepatitis B virus
  HBsAG - Hepatitis B surface antigen
  HCV - Hepatitis C virus
  HDV - Delta hepatitis
  HEV - Hepatitis E virus
  HGV - Hepatitis G virus
  HHS - Department of Health and Human Services
  HIV - Human immunodeficiency virus
  HTLV - Human T-lymphotropic virus
  IGIV - Immune Globulin Intravenous
  NIH - National Institutes of Health
  TRALI - Transfusion-related acute lung injury

Letter
=============================================================== LETTER


B-274942

February 25, 1997

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

Dear Mr.  Dingell: 

Widespread concern about the safety of the blood supply has led to
many changes in the way blood is collected, processed, and
transfused.  Consequently, the risks of contracting certain diseases,
such as AIDS and hepatitis, are lower today than they were in the
mid-1980s, when the public became increasingly aware that blood
transfusions are not risk free. 

You expressed concern about disparate estimates of
transfusion-associated AIDS and hepatitis cases and asked that we
determine the current risks, evaluating the content and quality of
data collected to assess these risks.  In this report, we address the
risks of contracting AIDS and hepatitis from blood as well as other
known risks of blood transfusion. 

You also asked us to evaluate the Food and Drug Administration's
(FDA's) layers of safety and its ability to ensure the safety of the
blood supply in light of changes in the blood industry.  We provide
that information in our report entitled Blood Supply:  FDA Oversight
and Remaining Issues of Safety.\1


--------------------
\1 U.S.  General Accounting Office, Blood Supply:  FDA Oversight and
Remaining Issues of Safety, GAO/PEMD-97-1 (Washington, D.C.:  1997). 


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