Notice of Intent to Sole Source – American Association of Blood Banks Inc. for Specialized Blood Products 25-007921

Notice of Intent to Sole Source – American Association of Blood Banks Inc. for Specialized Blood Products - Product Service Code: 6505 - NAICS Code: 621991 - Place of Performance: Bethesda, MD 20892, USA - Posting Number (POTS): 25-007921 Description This is a Notice of Intent, not a request for quotation. No solicitation document will be issued, and quotations will not be accepted. The National Institutes of Health (NIH) intends to award a sole source, Indefinite Delivery/Indefinite Quantity (IDIQ) contract to the American Association of Blood Banks Inc. (AABB), Bethesda, MD 20814-3264, for the procurement of various specialized blood products. The contract will include a base year and four one-year option periods: - Base Year: August 1, 2025 – July 31, 2026 - Option Year 1: August 1, 2026 – July 31, 2027 - Option Year 2: August 1, 2027 – July 31, 2028 - Option Year 3: August 1, 2028 – July 31, 2029 - Option Year 4: August 1, 2029 – July 31, 2030 Annual ordering and funding will be executed via task orders. Background The NIH Department of Transfusion Medicine (DTM), located in Bethesda, MD, provides transfusion services to the NIH Clinical Center, a 200-bed hospital treating patients under research protocols. Many patients, such as those with sickle cell disease, severe aplastic anemia, or post-transplant conditions, require highly specific blood components, including rare red blood cell (RBC) phenotypes and HLA-matched platelet products. AABB’s National Blood Exchange (NBE) program is the only known source capable of meeting these specialized needs through a nationwide network of FDA-licensed blood centers. Scope of Work The contractor must: - Provide leukoreduced RBCs, AB plasma, cryoprecipitate, and single donor platelets, including rare and antigen-negative units. - Ensure all products comply with regulatory standards, including those from the FDA, CLIA, AABB, and CAP. - Supply units prepared according to validated testing procedures and documented for traceability and compliance. - Maintain a national network of donor centers capable of sourcing rare blood types from a diverse population. - Deliver products in approved shipping containers that are recyclable and meet transport regulations. - Ensure 24/7 availability with an electronic ordering and tracking system. - Be able to search and acquire blood products from multiple blood centers across the U.S. Estimated Annual Volume: - 300–400 antigen-negative leukoreduced RBC units (100–150 of which are negative for C, E, K, Fya, Jkb, S) - 50–100 units of Fresh Frozen AB plasma - 100–200 HLA-typed single donor platelets Contractor Qualifications The contractor must be accredited by the AABB and CLIA and licensed by the FDA. They must provide antigen-screened units for common and uncommon antigens including but not limited to: C, E, K, k, Fy(a), Fy(b), S, s, Jk(a), Jk(b), V/VS, Go(a), Js(a), and U. Additional testing must follow the AABB Manual and CMS regulations. Regulatory Compliance The contractor must comply with the following regulations and standards: - FDA 21 CFR 211, 606, 820, and 1271 - FDA Guidelines for Quality Assurance in Blood Establishments (July 1995) - HCFA 42 CFR 493 (CLIA) - AABB Standards for Blood Banks, Transfusion Services, and Immunohematology Reference Labs - Joint Commission Hospital Accreditation Standards Method of Ordering Orders may be placed by authorized Transfusion Services staff via phone, email, or fax, referencing the contract number. The contractor must maintain a system to track orders, identify the requestor, and record timestamps. Acquisition Method This acquisition is being conducted in accordance with FAR 13.501 for sole source procurements exceeding the Simplified Acquisition Threshold under Simplified Acquisition Procedures. As such, it is exempt from the competition requirements of FAR Part 6. Submission of Capability Statements Interested parties may express interest and submit capability statements referencing this posting. The Government reserves the right not to compete this requirement if it is determined that only one source can meet the agency's needs. Deadline for submission: July 10, 2025, 6:30 AM EST Submit to: Shasheshe Goolsby, Lead Contract Specialist Email: shasheshe.goolsby@nih.gov