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Prompted by concerns with the transmission of the AIDS virus, FDA launched an intensive inspection program of all blood banks and plasma centers in 1988. Over eleven 11 percent of the facilities were found to have significant enough violations to prompt a regulatory response. These problems included the processing of blood suspected of contamination with the AIDS virus, although there were no cases where blood or products confirmed to be so contaminated were released. During this program inspections of American Red Cross (ARC) blood banks in Nashville and Washington, D. C. indicated operational errors leading to the release of unsuitable units of blood and blood products, errors that continued despite corrections. So, in 1988 FDA and ARC signed a voluntary agreement in which the latter would improve operations across the nation by establishing closer oversight of regional operations by national headquarters, standardizing operating procedures, and monitoring more closely computerized information to prevent release of unsuitable blood.

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