Company: Antelope Valley Healthcare District
Product: Blood and blood components
Date: 05/01/2003
Specifically, the procedure “Donor Registration and Medical Interview,” which includes instructions for entering deferral information into the computer system based on disqualifying information provided during the donor screening process, does not provide details concerning the documentation of information (such as exposure dates) so that an appropriate time-dependant deferral can be calculated. The attempted donation by C.S. on 5/20/02 documents skin piercing “5 weeks ago.” The attempted donation by P.S. on 6/6/02 only documents “skin piercing.” There are no instructions or a standardized method of documenting information so that the next eligibility date can be accurately determined
Specifically, at least three autologous donors that tested reactive for screening tests for hepatitis B or hepatitis C were not appropriately deferred from future allogeneic donation. While you did enter the donors’ deferral status in your manual index card system, the donors’ deferral status was not appropriately updated in your computer system. The manual index card system is only checked when the computer system flags the donor as deferred, therefore, the lack of deferral information in the computer system would prevent you from identifying the donors as deferred if they attempted an allogeneic donation
FDA District: Los Angeles District Office
