United States Government Publishing Office publisher pbl distributor dst United States Government Accountability Office Program Evaluation and Methodology Division author aut Government Organization text government publication eng GAOREPORTS Legislative Agency Publications gao legislative 2010-08-12 U.S. Government Printing Office 1997-02-25 monographic deposited born digital 157 p. GA 1.13:PEMD-97-1 https://www.govinfo.gov/app/details/GAOREPORTS-PEMD-97-1 P0b002ee18039cf19 f:pe97001 DGPO 2010-08-12 2011-03-28 GAOREPORTS-PEMD-97-1 machine generated eng fdlp REPORT GAOREPORTS-PEMD-97-1 PEMD-97-1 Acquired immunodeficiency syndrome Infectious diseases Safety regulation Health hazards Inspection Testing Reporting requirements Product safety Medical supplies Quality control Medicare Program Medicaid Program AIDS FDA Program Oriented Data System FDA Error and Accident Reporting System Other Written Product PEMD Pursuant to a congressional request, GAO evaluated the Food and Drug Administration's (FDA) "layers of safety" that provide the framework for regulating and monitoring the U.S. blood industry, focusing on the actual and potential vulnerabilities in the layers of safety that may present a threat to the public health.<p/>GAO found that: (1) the transmission of human immunodeficiency virus (HIV) by transfusion decreased dramatically after HIV testing for donors was introduced in 1985, and more and better tests for other diseases also have reduced the the risks from blood transfusions; (2) while the blood supply is very safe, no amount of federal regulation can entirely eliminate blood-transfusion risks because of human error, technological limitations of state-of-the-art tests, and the biological nature of the product itself; (3) within the overlapping layers of safety, GAO found areas where FDA can take action that would further improve the safety of the blood supply: (a) the lack of a uniform donor questionnaire allows variability in donor screening; (b) the lack of mandatory deferral notification allows some donors who have tested positive for viruses to unwittingly attempt donation again; (c) untested units donated for self-use may inadvertently be used for unintended recipients; and (d) FDA has been slow to investigate error and accident reports that may warrant a recall; (4) FDA does not require unlicensed facilities, those that do not engage in the sale, barter, or exchange of blood products across state lines, to report errors and accidents; (5) because unlicensed facilities constitute more than two thirds of all blood facilities that, together, produce 10 percent of the nation's blood, FDA has not fully monitored the quality of this portion of blood products; (6) FDA's inspections for both licensed and unlicensed blood facilities appear to be inconsistent in focus, scope, and documentation; (7) in addition, these inspections are often not conducted within time periods set by FDA's own guidelines; (8) FDA does not maintain a central repository for inspection reports and, thus, does not examine national trends; and (9) GAO's survey results also indicated confusion within the blood industry regarding the interpretation for FDA policy guidance and regulations. https://www.govinfo.gov/content/pkg/GAOREPORTS-PEMD-97-1/html/GAOREPORTS-PEMD-97-1.htm https://www.govinfo.gov/content/pkg/GAOREPORTS-PEMD-97-1/pdf/GAOREPORTS-PEMD-97-1.pdf GAO/PEMD-97-1 https://www.govinfo.gov/app/details/GAOREPORTS-PEMD-97-1 Other Written Product GAO/PEMD-97-1; Blood Supply: FDA Oversight and Remaining Issues of Safety; Acquired immunodeficiency syndrome Infectious diseases Safety regulation Health hazards Inspection Testing Reporting requirements Product safety Medical supplies Quality control Medicare Program Medicaid Program AIDS FDA Program Oriented Data System FDA Error and Accident Reporting System Title 21 Part 610.40 21 CFR Part 610.40 Title 21 Part 640.3 21 CFR Part 640.3