Blood Donor Testing Services

Reportable Tests - Blood Donor Testing

Firm-Fixed-Price (FFP)

Non-Personal Services. Provide FDA licensed Blood Testing for Infectious Disease for the Standard Test Panel and Confirmatory Testing in accordance with the Performance Work Statement (PWS), Paragraph 5. The Government will only pay for Reportable Tests.

Contractor Manpower Reporting (CMR)

Period of Performance: 01 May 2020 - 30 Apr 2021 (Base Period)
Period of Performance: 01 May 2021 - 30 Apr 2022 (Option Period 1)
Period of Performance: 01 May 2022 - 30 Apr 2023 (Option Period 2)

GENERAL. This is a non-personal services contract to provide blood donor testing for the Armed Services Blood Bank Center - Europe (ASBBC-E). The Government will not exercise any supervision or control over the Contractor employees performing services herein. Such employees shall be accountable solely to the Contractor who, in turn, is responsible to the Government. This testing requirement fulfills guidance from the FDA requiring all DoD Blood Donor Centers (BDCs) to test samples from individual human donors, including donors of whole blood and blood components, and other living donors for blood type, occurrence of blood antibodies and infectious diseases.

SCOPE. The Contractor shall provide all required facilities, personnel, services, materials, equipment, and supplies required to meet the requirements outlined in this Performance Work Statement. 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 shall be a platform approved by the FDA (shall be performed in accordance with Code of Federal Regulation, Title 21 (CFR) and applicable industrial standards). Donor blood testing services will support the Armed Services Blood Bank Center - Europe (ASBBC-E) located at Landstuhl Regional Medical Center, Landstuhl (LRMC), Germany.

REQUIREMENTS. The Contactor shall provide the full range of donor blood diagnostic testing capabilities to execute required tests annotated in PWS paragraph 5. entitled “Description of Work”. Whole blood and platelet/plasma apheresis products from the ASBBC-E will require the routine individual donor blood testing panel and repeat testing, as well as confirmation testing. The Contractor shall provide any confirmatory testing and additional tests required by the FDA. All donor blood laboratory testing shall be executed in accordance with standard industry practices. All tests shall be executed at the Contractor's premises, or within the Contractor's network of laboratories (affiliate or qualified subcontractor). Contractor shall provide a Contingency Plan that describes in detail, how the Contractor intents to perform when an emergency/natural disaster is declared and there is a surge in units to be tested, to avoid any delay or stoppage of service.