Blood donor testing and reference lab services

Added: Jul 20, 2015 9:47 am Blood Donor Testing and Blood Bank Reference Lab in support of Eisenhower Army Medical Center, Fort Gordon, Georgia and Martin Army Community Hospital, Fort Benning, Georgia All tests shall be executed at the Contractor's premises, or within the Contractor's network of laboratories (affiliate or qualified subcontractor). Contractor referrals to a secondary (subcontractor) laboratory shall be kept to a minimum for control and uniformity purposes. Contractor shall have a plan to ensure no delay or stoppage of service in case of a national emergency (example 9/11).

All testing shall be in accordance with the Food and Drug Administration (FDA) regulations for the manufacturing of transfusable blood products and for blood bank reference lab testing. The standard test panel shall include at least: ABO/Rh, Antibody screen, Antibody Identification , STS, HBsAg, HBcAb, HCV, HIV 1 and 2, HTLV 1 and 2, Chagas/ T.cruzi, and Cytommegalovirus (for Apheresis platelet and plasma testing). The Nucleic Acid Test (NAT) panel shall include at least: WNV NAT, HIV NAT, HCV NAT and HBV NAT. The confirmatory testing shall consist of individually run tests: HBsAg Neutralization, HCV confirmatory, HBV confirmatory, HIV 1 and HIV 2 confirmatory, HTLV I/II confirmatory, and Syphilis (TP-PA) confirmatory. All tests included in the standard blood donor testing and confirmation testing will be performed IAW Code of Federal Regulation, Title 21 (CFR) and applicable industrial standards.