SAM #12408682

Sources sought for reagents and consumables for blood compatibility testing at Naval Medical Center Camp Lejeune

The Defense Health Agency (DHA), through the Defense Health Agency Contracting Activity (DHACA), is seeking sources for reagents and consumables to support blood compatibility testing at the Blood Donor Center, Naval Medical Center Camp Lejeune, North Carolina. - Government Buyer: - Defense Health Agency (DHA) - Defense Health Agency Contracting Activity (DHACA) - Naval Medical Center Camp Lejeune, Blood Donor Center - OEMs and Vendors: - Werfen USA, LLC (highlighted as the intended sole source if no other capable sources are identified) - Products/Services Requested: - Reagents and consumables for blood compatibility testing - Must be compatible with existing tube testing platform and Werfen USA instrumentation - No specific part numbers or quantities provided - Unique or Notable Requirements: - All products must comply with FDA, AABB, and CAP standards - ISO 13485:2003 and ISO 9001:2008 certification required - Compatibility with Werfen USA instrumentation is mandatory - If no other sources are found, a sole source contract will be awarded to Werfen USA, LLC

Description

The Defense Health Agency Contracting Activity (DHACA) is seeking sources to provide a supply of reagents and consumables essential for blood compatibility testing in support of the Blood Donor Center at Naval Medical Center Camp Lejeune (NMCCL), NC. The Government is seeking sources that can meet all the following requirements:

All reagents and consumables must be manufactured in strict adherence to the standards mandated by the following regulatory and accreditation bodies: Food and Drug Administration (FDA), Association for the Advancement of Blood and Biotherapies (AABB), and College of American Pathologists (CAP). The reagents must be compatible with the site’s existing tube testing operational platform suitable for utilization on a Werfen USA instrumentation. Reagents must be capable of accurately identifying patient blood types and detecting both expected and unexpected antibodies. Products must be certified to ISO 13485:2003 and ISO 9001:2008

If capable sources are not identified, DHACA intends to award one sole source contract under authority FAR Part 6.103-1 to Werfen USA, LLC to provide the described requirement to the NMCCL

This sources sought is not a request for competitive proposals and no solicitation document exists for the requirement. Sources interested in responding to this notice are required to submit a capability statement that includes technical data, and pricing information, in sufficient detail and with convincing evidence that clearly demonstrates the capability to provide the required products.  Capability statements shall not exceed three (8.5 x 11 inch) pages using a font size no smaller than 10-point.  All capability statements received by the due date of this notice will be considered by the Government.  A request for documentation or additional information will not be considered as an affirmative response.  A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government.  Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement or to proceed with the sole source contract.

Capability statements are due by 10:00 AM Eastern Time, 24 September 2026.  Capability statements shall be submitted by email ONLY as a Microsoft Word or Adobe PDF attachment to the following email address:  felicia.w.smith.civ@health.mil             

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