Intent to Sole Source - Medical/Scientific Instruments for the Department of Transfusion Medicine, NIH Clinical Center

Intent to Sole Source - Medical/Scientific Instruments for the Department of Transfusion Medicine, NIH Clinical Center
This is a notice of intent, not a request for proposal. the national institute of health, clinical center (nih-cc) intends to negotiate on an other than full and open competition basis with the following vendor: fisher scientific.
acquisition description:
the nih clinical center, department of transfusion medicine (dtm), infectious diseases section requires acquisition of a 1) real-time pcr system, 2) an automated nucleic acid extractor and 3) a microvolume spectrophotometer to support clinical research and the development, optimization, and validation of diagnostic assays for hepatitis viruses and other transfusion-transmitted pathogens.
the required system must support generation of high-quality quantification data from clinical specimens, including viral rna/dna and host-derived nucleic acids. the instrument must enable applications such as targeted genome amplification, work with a wider dynamic detection range, support the library prep for viral genome sequencing, and assay development workflows necessary for evaluating test performance and refining diagnostic methods prior to implementation in a clinical testing environment.
the system must meet the following functional and operational requirements:
high data accuracy and reproducibility to ensure reliable detection of viral variants and evaluation of assay performance;
low- to moderate-throughput capability appropriate for assay development, pilot studies, and validation activities involving smaller sample sets;
rapid turnaround times to support iterative testing and optimization of clinical assays;
flexible run configurations that allow efficient processing of varying sample volumes without excess capacity;
cost-efficient operation, including the ability to minimize per-run and per-sample costs for pathogen detection;
integrated and streamlined workflows, including nucleic acid extraction, amplification, quantification and data analysis within a platform from the same vendor to reduce complexity and variability;
ease of use and standardized operation, supporting reproducibility and implementation in a clinical laboratory environment;
compatibility with established nucleic acid preparation and amplification methods and existing laboratory workflows.
the flexibility to be using the systems in a clia certified environment.
the statutory authority for this sole source requirement is 41 u.s.c. 253(c) (1) as implemented by far 6.302-1 only one responsible source and no other supply of service will satisfy agency requirements. this is not a request for proposal. all responsible sources that could provide the required may submit a capability statement that will be considered by email (subject line to reference noi-olao-cc-27-000121) by 12:00 pm eastern standard time on 10/23/2026 to: valerie.gregorio@nih.gov.
all responses received by the closing date of this synopsis will be considered by the government. a determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the government.