QuidelOrtho Reagents and Supplies Standing Order – FY 2027

Title: QuidelOrtho Reagents and Supplies Standing Order – FY 2027 Agency: Department of Health and Human Services (HHS), National Institutes of Health (NIH), Clinical Center (CC) Department: Department of Transfusion Medicine (DTM), Transfusion Services Laboratory (TSL) NAICS Code: 325413 – In-Vitro Diagnostic Substance Manufacturing PSC: 6550 – In Vitro Diagnostic Substances, Reagents, Test Kits and Sets Place of Performance: NIH Clinical Center 10 Center Drive Bethesda, MD 20892 Estimated Period of Performance: October 1, 2026 through September 30, 2027 Response Deadline: October 5, 2026, at 1:00 PM Eastern Time (ET) DESCRIPTION The National Institutes of Health (NIH), Clinical Center (CC), Department of Transfusion Medicine (DTM), Transfusion Services Laboratory (TSL), has a requirement for a FY 2027 standing order for QuidelOrtho reagents and supplies used in patient and blood-product testing. The Transfusion Services Laboratory operates 24 hours a day, seven days a week, providing blood products and testing in support of transfusion needs for patients at the NIH Clinical Center. The required reagents are essential for patient and donor testing and are used to identify potentially harmful antibodies directed against transfused red blood cells.

The use of these reagents supports the provision of compatible blood products and helps prevent severe or potentially fatal hemolytic transfusion reactions. The required QuidelOrtho reagents have unique red-cell antigen compositions and donor panels and have undergone validation for clinical testing within the TSL. These products are incorporated into the laboratory's standard operating procedures and are currently validated as the test of record.

The requirement includes, but is not limited to, QuidelOrtho blood-bank reagents, gel cards, antisera, quality-control kits, reagent red blood cells, diluents, and associated supplies necessary to support patient care and blood-product manufacturing activities. Due to the short expiration dates of certain reagents, the products are manufactured based on customer standing orders. Supplies will therefore be manufactured and shipped throughout the period of performance according to the manufacturer's production schedule to ensure that the TSL receives in-date reagents as required.

INTENDED SOURCE The Government intends to procure these supplies from: QuidelOrtho Sales Company, LLC The Government's market research indicates that QuidelOrtho is the only source capable of providing the required proprietary reagents and supplies. QuidelOrtho does not authorize third-party resellers or distributors for these products. The required reagents have already undergone large-scale validation studies and are currently validated for clinical use within the NIH Clinical Center's Transfusion Services Laboratory.

Use of alternative reagents would require additional validation studies before they could be introduced into clinical testing and could result in delays to essential transfusion services and patient care. RESPONSE REQUIREMENTS This notice is not a request for competitive quotations. However, all responsible sources that believe they can provide the required products may submit a capability statement demonstrating their ability to satisfy the Government's requirement.

Capability statements must provide sufficient information demonstrating the respondent's ability to provide all required reagents and supplies, including documentation establishing authorization to provide the required QuidelOrtho products, if applicable. Responses must include: Company name, address, UEI, and point of contact; Business size and socioeconomic status under NAICS 325413; Documentation demonstrating the ability to provide the required QuidelOrtho reagents and supplies; Evidence that the proposed products meet the Government's requirements and are compatible with the NIH Clinical Center's existing validated testing processes; and Any other information demonstrating the respondent's capability to satisfy the complete requirement. All capability statements must be received no later than October 5, 2026, at 1:00 PM Eastern Time (ET) and sent to [email on the source notice].

Telephone calls are not acceptable. Responses received by the stated deadline will be considered by the Government solely for the purpose of determining whether conducting a competitive procurement is appropriate. A determination by the Government not to compete this proposed acquisition based upon responses to this notice is solely within the discretion of the Government.