Notice of Intent to Sole Source to Cerus Corporation for Intercept Platelet Processing Sets 25-007944

Notice of Intent to Sole Source to Cerus Corporation for Intercept Platelet Processing Sets Product Service Code: 6640 NAICS Code: 334516 Place of Performance: Bethesda, MD 20892 USA Purchase Order Number: 25-007944 Description This is a Notice of Intent and NOT a request for quotation. No solicitation will be issued, and quotations will not be requested. The National Institutes of Health (NIH) intends to award a firm fixed-price purchase order on a sole source basis to Cerus Corporation, located at 1220 Concord Avenue Suite 600, Concord, California 94520-4906, for the purchase of Intercept Platelet Processing Sets (dual storage containers). Eight cases will be shipped monthly, starting July 15, 2025, through September 30, 2025. The Transfusion Services Laboratory (TSL) provides 24/7 support to patients requiring blood transfusions as part of NIH protocols at the Clinical Center (CC). Conditions such as anemia and thrombocytopenia, common side effects of treatments including transplantation, sickle cell disease, and myelodysplastic syndromes, necessitate platelet transfusions. This procurement is to obtain specific kits used in the pathogen reduction process. Pathogen Reduction Technology reduces the risk of transfusion-transmitted infections, including sepsis and transfusion-associated graft-versus-host disease, by inactivating pathogens and leukocyte contaminants in platelet components. This process is vital to protecting vulnerable patient populations receiving platelet transfusions at the CC. The contract will cover the base period from June 1, 2025, through September 30, 2025. Items Requested: Quantity Catalog # Description 768 kits INT2540B INTERCEPT Platelet Processing Set with Dual Storage Containers (Semi-Integrated Set) Cerus Corporation is the sole manufacturer of these Intercept Platelet Processing Sets, which are essential to rendering blood products safe for transfusion by reducing pathogen replication. Unavailability of these kits could expose patients to infectious diseases. Per internal procedure DTM SOP 0028, materials, supplies, equipment, or services impacting product quality are considered critical. This applies to patient care, blood product manufacturing, and clinical laboratory diagnostics where strict control ensures safety and quality. Documentation confirms this vendor meets all necessary regulatory and quality standards, including but not limited to: FDA 21 CFR 211 - Current Good Manufacturing Practice for Finished Pharmaceuticals FDA 21 CFR 606 - Current Good Manufacturing Practice for Blood and Blood Components FDA 21 CFR 820 - Quality System Regulation FDA 21 CFR 1271 - Current Good Tissue Practices FDA Guidelines for Quality Assurance in Blood Establishments (July 1995) HCFA 42 CFR 493 - Clinical Laboratory Improvement Act of 1988 AABB Standards for Blood Banks, Transfusion Services, Cellular Therapy, and Immunohematology ASHI Standards for Histocompatibility Testing JC Hospital Accreditation Standards AAHRPP Standards for Accrediting Human Research Protection Programs ACGME Common Program Requirements and CAAHEP Standards and Guidelines No other known vendors can meet these stringent requirements for this proprietary technology. This acquisition will follow Federal Acquisition Regulation (FAR) 13.501, which covers special documentation for sole source acquisitions above the Simplified Acquisition Threshold. Contracts awarded under FAR Part 13 (Simplified Acquisition Procedures) are exempt from FAR Part 6 (Competition Requirements). Interested parties may submit capability statements in response to this notice. The Government s decision not to compete the requirement is final and based solely on these responses. Please submit comments referencing this posting number to the Office of Purchasing and Contracts by July 11, 6:30 AM EST. Submit capability statements ONLY to: Shasheshe Goolsby, Lead Contract Specialist Email: shasheshe.goolsby@nih.gov