Reagents for Blood Compatibility Testing

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.