Integrated Multi-Modality Transfusion-Transmitted Disease (TTD) Testing Systems for Armed Services Blood Bank Center-Europe (ASBBC-EUR), Landstuhl Regional Medical Center (LRMC), Germany

1. 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.

1. 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-treatment system, etc.) under full operational load.

Water: All three platforms are assumed to require treated/purified water (reverse osmosis or equivalent, Clinical Laboratory Reagent Water or Type I preferred). Respondents must state exact water consumption footprint (gallons/liters per day) for each piece of equipment presented, purity specifications, estimated daily volume, and footprint of any required water-treatment system(s).

Footprint: Provide exact dimensions, weight, and clearance requirements for all proposed equipment and any water-treatment equipment.

Environmental: Ambient 1828 C, 2080 % relative humidity typical. Confirm compatibility.

Network & Data Infrastructure: Workstations will be equipped with standard RJ45 Ethernet network drops; all equipment data interfaces must operate within the existing DoD/DHA local area network environment, and no external commercial internet connections or vendor-installed wireless networks are permitted. 4. Contract Type Preferences Both lease (cost-per-test or cost-per-kit inclusive of reagents, ongoing maintenance, software support and upgrades, and technical support) and outright purchase solutions will be considered.

The Government states a preference for leased equipment, particularly given the potential relocation noted below. 5. Potential Facility Relocation ASBBC-EUR may relocate to a new facility within the next 25 years.

The new location will not exceed 50 km from the current site and, for planning purposes, should be treated as approximately 20 km. Respondents should address: How a lease structure would accommodate relocation or early termination. Residual value, buy-out, or transfer options for purchased equipment.

Any additional costs or logistics associated with de-installation, transport, and re-installation at a new German location within the distances noted above. 6. Performance Location and Legal Framework All performance will occur on a U.S. military installation in the Federal Republic of Germany under the North Atlantic Treaty Organization (NATO) Status of Forces Agreement (SOFA).

All applicable host-nation laws and U.S. laws and regulations will apply. Respondents must confirm ability to perform under these conditions and identify any existing in-country service capability, parts stocking locations, or technical personnel based in Germany or the European Union. 7.

Correlation / Validation and Start-Up Costs Respondents should note that correlation and validation requirements must satisfy applicable U.S./DHA blood-bank standards as well as host-nation (German) expectations that the laboratory must meet. All reagents, quality-control materials, and related consumables required for initial correlation and validation shall be treated as part of the initial setup / installation cost and are not included in the ongoing test quantities or reagent volumes under the contract. 8.

System for Award Management (SAM) Registration Interested parties must possess (or immediately begin obtaining) an active System for Award Management (SAM.gov) registration. Because this requirement is performed in Europe, respondents are specifically requested to state whether they currently maintain an active SAM registration with a European or NATO Commercial and Government Entity (CAGE) code. If not, parties that intend to respond to a future solicitation should begin the registration process now.

1. Information Requested Interested sources are requested to submit a brief capability statement (not to exceed 10 pages) addressing: a. Company name, CAGE code, Unique Entity Identifier (UEI), and point of contact, SAM registration status, including any European/NATO CAGE code. b.

Confirmation of FDA CBER clearance/license status for each proposed platform. c. Whether a single integrated multi-modality solution (or formal teaming arrangement) can be offered. d. Lease and/or purchase pricing constructs (rough-order-of-magnitude acceptable at this stage), inclusive of ongoing maintenance and software support/upgrades. e.

Potential continuous and peak power demand (amps and kilovolt-amperes) for the full proposed configuration. f. Water-treatment requirements, purity specifications, daily volume, and footprint (all three platforms assumed to require treated water). g. Equipment dimensions, weight, and site-preparation needs. h.

Current in-country (Germany/European Union) service, parts, and technical support capability. i. Experience installing the same or equivalent platforms in European military, blood-center, or hospital environments. j. Ability to meet a Not-Later-Than operational date of 27 September 2027. k.

Approach to ongoing maintenance, software support, and upgrades throughout the period of performance. l. Confirmation that reagents and quality-control materials for initial correlation/validation are included in start-up costs. m. Vendors shall detail all equipment IT and network requirements, including physical network connections, supported LIS/DBSS interface protocols (e.g., HL7, ASTM), any required middleware or server hardware, and whether remote diagnostics/internet connectivity is needed for system operation or vendor support. n.

Any other information the respondent believes relevant to the Government's acquisition planning. In addition to the capability information requested above, respondents are invited to offer brief observations or alternative solution concepts that could better address the site constraints, integrated multi-modality preference. Any such input is for market-research purposes only and will not be evaluated as a proposal.