Blood Safety:

Enhancing Safeguards Would Strengthen the Nation's Blood Supply

T-HEHS-97-143: Published: Jun 5, 1997. Publicly Released: Jun 5, 1997.

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GAO discussed its two reports on the safety of the nation's blood supply, focusing on: (1) the current risks of blood transfusion; (2) the content and quality of data collected to assess these risks; and (3) the Food and Drug Administration's (FDA) layers of safety and their ability to ensure the safety of the nation's blood supply.

GAO noted that: (1) its analysis of current risks from transfusion showed that, while the nation's blood supply is safer today than at any time in recent history, some risk remains, even if all the safeguards available work perfectly; (2) GAO also found several vulnerabilities and gaps in current procedures which, if eliminated, would provide greater assurance of safety for the nation's blood supply; (3) the most serious of these problems follow: (a) not all donors who test positive for certain viruses are notified, which means that they can attempt to donate again and also may go without treatment; (b) similarly, not all recipients of virally contaminated blood are notified, which may keep them from seeking treatment and also allow them to transmit the disease; (c) blood facilities are not required to remove from their inventory blood from donors who have subsequently tested positive for viral infections; (d) unlicensed blood facilities that, together, produce 10 percent of the nation's blood do not have to submit to FDA error and accident reports that may signal the need to recall potentially contaminated units of blood; (e) FDA's investigations of error and accident reports that warrant a recall take a long time and increase the risk that units will have been transfused before a recall is accomplished; and (f) finally, FDA's inspections of blood facilities are inconsistent in focus, scope, and documentation; and (4) GAO's reports contained a number of recommendations to the Secretary of Health and Human Services to eliminate these weaknesses in the quality assurance system for the blood supply.

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