NOI to Sole Source to Precision for Medicine for repository services

The National Institutes of Health (NIH) plans to award a firm fixed price sole-source purchase order to Precision for Medicine for biorepository processing and storage services supporting the Department of Transfusion Medicine. This acquisition aims to maintain and monitor government-owned biological specimen freezers, including 10 units (2 chest and 8 upright freezers), within a controlled environment. Precision for Medicine, a College of American Pathologists (CAP)-certified biorepository located in Frederick, MD, provides specialized and regulated storage, processing, inventory management, and sample retrieval services. The contract emphasizes continuity and preservation of sample integrity, leveraging Precision’s established infrastructure with 24/7 environmental controls, redundant HVAC systems, backup power, and web-based reporting to ensure secure and temperature-monitored off-site specimen storage. The acquisition, conducted under FAR Part 13 Simplified Acquisition Procedures, justifies sole-source award due to the unique capabilities and CAP-certified status of the contractor, mitigating risk to long-term specimen viability amassed over more than 30 years. This presolicitation notice, posted in March 2026, does not include detailed contract clauses, pricing data, or formal competitive evaluation criteria, as it serves only as a notice of intent rather than a full solicitation. The contract is to be performed in Bethesda, Maryland, where the repository services will be delivered and inspected, with NIH maintaining final acceptance and oversight. Compliance with regulatory standards including ISO 9001:2008, ISO 13485:2003, 21 CFR Part 11, and CAP accreditation is mandated to uphold quality management and data integrity. No explicit packaging, labeling, or barcoding standards beyond internal system controls are outlined, reflecting the medical research context. Contract administration details such as payment offices and accounting codes are limited, with Huda Malik identified as the NIH point of contact. The sole-source justification highlights the critical need for uninterrupted biorepository services to prevent degradation or compromise of valuable specimens, underscoring the specialized nature and non-competitive sourcing of this procurement.