Intent to Sole Source - ORTHO Vision Equipment

The National Institute of Health, Clinical Center intends to award a sole-source firm-fixed-price task order to QuidelOrtho Sales Company, LLC for the procurement of an Ortho Vision Analyzer and associated accessories to support pretransfusion testing for blood grouping and antibody detection within the Department of Transfusion Medicine in Bethesda, Maryland. The acquisition, identified by solicitation number NOI-CC-OLAO-26-006399, is justified under 41 U.S.C. 253(c)(1) and FAR 6.302-1 due to the proprietary nature of the Ortho Vision system, which requires exclusive access to manufacturer-specific reagents, maintenance, and repairs, leaving no other responsible source capable of meeting the agency’s requirements. The contract value is estimated at $92,485.66, covering the analyzer, an Ortho Vision Table, a Lexmark printer, and a validation and competency kit, with a 12-month warranty included at no additional cost. The equipment must comply with FDA regulations including 21 CFR 211, 606, 820, and 1271, as well as AABB and HCFA standards, ensuring adherence to high-quality manufacturing and transfusion safety protocols. Delivery is required at Building 10, Room 2S217, NIH, Bethesda, MD, and payment terms adhere to FAR 52.212-4(g), with payment due 30 days after receipt of a proper invoice. Electronic payment information, including bank routing and account numbers, must be provided by the contractor. While this is not a request for proposal, responsible sources may submit a capability statement by email to valerie.gregorio@nih.gov by 12:00 PM Eastern Standard Time on May 29, 2026, with the subject line referencing the solicitation number; however, the Government retains sole discretion to proceed without competition based on responses received. The contractor’s unique entity ID is ZFXRG96JMJ39, CAGE code is 12B04, and the entity is located at 9975 Summers Ridge Road, San Diego, California. The project officer is Traci Paige and the contracting officer is Susan Nsangou, with administrative oversight provided by the NIH Purchasing and Contracts Department.