Department of Health and Human Services, Food and Drug Admnistration: Current Good Manufacturing Practice for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting Hepatis C Virus Infection ("Lookback")
GAO-07-1237R, Sep 20, 2007
GAO reviewed the Department of Health and Human Services, Public Health Service, Food and Drug Administration's (FDA) new rule on current good manufacturing practice for blood and blood components, notification of consignees and transfusion recipients receiving blood and blood components at increased risk of transmittng hepatis C virus infection ("lookback"). GAO found that (1) the final rule requires entities collecting blood or blood components to establish, maintain, and follow an appropriate "lookback" system for identifying prior blood and blood components previously donated by someone who later tests reactive for evidence of hepatitis C virus (HCV) infection, requires collection entities to quarantine blood and blood components from such a donor, to notify consignees, and to perform further testing on the donor. The rule also requires, as appropriate, consignees to notify transfusion recipients of blood or blood components donated by such a donor, and revises the human immunodeficiency (HIV) "lookback" requirements to be consistent with the HCV "lookback" requirements, and it extends the record retention period to 10 years; and (2) FDA complied with applicable requirements in promulgating the rule.