    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).

    *** End of document. ***