Reagents for Blood Compatibility Testing

Closed Pre-Solicitation Posted

Solicitation number
12408682
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

Place of performance
Camp Lejeune, North Carolina 28547, United States

Notice details come from SAM.gov. Updated .

About this opportunity

The Defense Health Agency Contracting Activity (DHACA) anticipates awarding a sole-source contract to Werfen USA, LLC for reagents and consumables to support blood compatibility testing at the Blood Donor Center, Naval Medical Center Camp Lejeune, North Carolina, unless capable alternative sources respond by September 24, 2026.

This sources-sought notice does not constitute a competitive solicitation. Interested vendors must submit capability statements (not to exceed three 8.5-by-11-inch pages, 10-point font minimum) demonstrating technical and pricing capability. The Government will consider all statements received by the due date; requests for additional documentation will not constitute affirmative responses, and the Government retains sole discretion whether to compete based on the replies received.

Reagents and consumables must meet FDA, AABB, and CAP regulatory and accreditation standards. Products must be compatible with Werfen USA instrumentation configured for tube testing and capable of accurately identifying patient blood types and detecting expected and unexpected antibodies. ISO 13485:2003 (medical devices) and ISO 9001:2008 (quality management) certification is required.

Work location is Naval Medical Center Camp Lejeune, North Carolina. If no qualified alternative sources are identified, DHACA intends to invoke FAR 6.103-1 (unavailability of qualified sources) to award sole-source to Werfen USA, LLC.

Notice text

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:

  1. 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).
  2. The reagents must be compatible with the site’s existing tube testing operational platform suitable for utilization on a Werfen USA instrumentation.
  3. Reagents must be capable of accurately identifying patient blood types and detecting both expected and unexpected antibodies.
  4. 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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