Molecular Diagnostic Laboratory Services

The U.S. Department of State, Bureau of Global Health Security and Diplomacy (GHSD), is issuing this Request for Information (RFI) in conjunction with the attached DRAFT Performance Work Statement (PWS) for the All-Inclusive Molecular Diagnostic Laboratory Services procurement. The new activity, if awarded, will cover molecular diagnostic laboratory testing and services across Sub-Saharan African and potentially other countries as part of the America First Global Health Security (AFGHS) strategy. The Contractor will provide continuous, fully managed molecular diagnostic goods and services in support of three primary program areas: HIV viral load (VL) and early infant diagnosis (EID) testing for treatment monitoring and epidemic control, tuberculosis (TB) diagnosis and drug resistant TB testing in support of national TB control programs; and pre-positioned testing capacity for global health security (GHS) pathogens including Ebola, Marburg, Lassa fever, and other high-consequence infectious disease threats. • The Contractor shall deliver a fully integrated all-inclusive molecular diagnostic service under this contract. • The all-inclusive molecular diagnostic per-test price has two components: the Global Goods Price and the Country-Specific Services Price. • The Contractor shall provide, deliver, and maintain all molecular diagnostic instruments required to perform the contracted test menu at all designated program sites. • The Contractor shall supply all reagents, assay kits, and consumables required to perform all tests in the contracted test menu. • The Contractor shall maintain a forward stock of critical spare parts and field-replaceable units (FRUs) at an approved in-country or regional logistics hub for each contracted country. • The Contractor shall conduct a site readiness assessment before instrument delivery at each site and decommission all equipment upon contract expiry or termination. • The Contractor shall provide initial hands-on training per site for all designated laboratory operators and conduct regular competency refresher visits at each site. • The Contractor shall obtain and maintain all regulatory approvals required to import, distribute, and operate all instruments, assays, and consumables in each contracted country.