Summary

Transmission of the HIV virus by transfusion decreased dramatically after donor testing was introduced in 1995, and more and better tests for other diseases have also reduced transfusion risks. Although the blood supply is very safe, federal regulations cannot entirely eliminate all risk from transfusions because of human error, technological limitations of testing, and the biological nature of the product itself. The Food and Drug Administration (FDA) can strengthen the safety of the blood supply in some areas. For example, the lack of a uniform donor questionnaire allows variability in donor screening; lack of mandatory deferral notification allow some donors who have tested positive for viruses to unwittingly attempt to donate again; untested units donated for self-use may be mistakenly used for unintended recipients; and FDA has been slow to investigate error and accident reports that may warrant a recall. FDA does not require unlicensed facilities--those that do not sell or exchange blood products across state lines--to report errors and accidents. This is a significant problem because these unlicensed facilities constitute more than two thirds of all blood facilities that, together, produce 10 percent of the nation's blood. FDA inspections of both licensed and unlicensed blood facilities appear to be inconsistent in focus, scope, and documentation. Moreover, FDA does not maintain a central repository for inspection reports and, therefore, does not examine national trends. GAO also found confusion within the blood industry about how to interpret FDA regulations.

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 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.