• DHA seeks an integrated TTD testing solution for blood-donor screening at Landstuhl Regional Medical Center, Germany.
• This RFI is open to all capable sources, with no stated set-aside or competition constraints.
• Solution must include three complementary testing platforms for full suite of FDA-required blood-donor screening assays, with approximately 6,000 whole-blood units annually.
• Responses are not due by a specified date, as this is a Request for Information for market research and planning purposes only.
Description
Purpose The Defense Health Agency (DHA) is conducting market research to identify capable sources that can provide a complete, integrated multi-modality Transfusion-Transmitted Disease (TTD) testing solution for the Armed Services Blood Bank Center-Europe (ASBBC-EUR) located at Landstuhl Regional Medical Center (LRMC), Germany. This is a Request for Information (RFI) for market research and planning purposes only. It does not constitute a Request for Proposals (RFP), Request for Quotations (RFQ), or an invitation for bids. 2. Requirement Overview The Government requires the supply, installation, validation, training, ongoing maintenance, software support and upgrades, technical support, and reagent/consumable support for three complementary testing platforms capable of performing the full suite of U.S. Food and Drug Administration (FDA) required blood-donor screening assays: Immunohematology / ABO-Rh, Syphilis, Cytomegalovirus (CMV), Antibody Titer (example platform class: Beckman Coulter PK7400 or equivalent) Serology (example platform class: Abbott Alinity s or equivalent) – Human Immunodeficiency Virus (HIV) Antigen/Antibody Combo, Anti-Hepatitis C Virus (Anti-HCV), Hepatitis B Surface Antigen (HBsAg), Human T-lymphotropic Virus (HTLV) I/II, Anti-Hepatitis B Core (Anti-HBc), Chagas Nucleic Acid Testing (NAT) (example platform class: Grifols Procleix Panther / Ultrio Elite or equivalent) – HIV, Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), West Nile Virus (WNV), Babesia Approximate annual volume is 6,000 whole-blood units (plus residual plasma and platelets as needed). All systems must be FDA Center for Biologics Evaluation and Research (CBER)-cleared/licensed for blood-donor screening. Dual-marked (FDA + CE) systems are preferred. FDA-only systems are acceptable provided they operate directly on German power sources (single-phase 230 V / 50 Hz) with no transformer required. Preferred approach : A single integrated multi-modality solution from one prime contractor (or formal teaming arrangement). If responding as a team, joint venture, or prime-subcontractor arrangement, clearly identify the lead entity, proposed roles, and commercial distribution authority for each platform. If market research demonstrates that a viable single-source or single-team solution is not reasonably available, the Government reserves the right to pursue separate Requests for Quotation (RFQs) / Requests for Proposal (RFPs) for individual modalities. 3. Site and Utility Constraints (Critical) Performance location is a basement laboratory at LRMC, Germany, with approximately 585 usable square feet available after existing laboratory functions remain in place. Key constraints that must be addressed in any response: Power : Single-phase 230 V / 50 Hz. Schuko connectors preferred. Respondents shall provide the potential continuous and peak power demand (amps and kilovolt-amperes) for every analyzer and any supporting equipment (uninterruptible power supply, water-tre…
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