FAR 13.5 Sole Source Justification 35C242-25-AP-2218 signed_Redacted.pdf

This document is a Sole Source Justification for PCR Molecular Testing under FAR 13.5 for the Department of Veterans Affairs. The procurement is for Cepheid's Polymerase Chain Reaction (PCR) Molecular Diagnostic Testing platform, to be used across multiple VA medical facilities including James J. Peters VA Medical Center, East Orange VA Medical Center, Hudson Valley Healthcare System, and New York Harbor Healthcare System. The contract will provide molecular reagent kits for testing various pathogens including MRSA, Clostridium difficile, COVID-19, influenza, chlamydia, and others, with testing to be performed on primary and secondary analyzers during evening and night shifts.

The anticipated award date is April 1, 2025, with a one-year contract period. Cepheid is identified as the only source capable of providing these specialized testing services, with a proprietary single-use X-pert test cartridge system that offers rapid and accurate results. The VA conducted market research using SBA tools and found insufficient small business (SDVOSB/VOSB) sources to meet the requirement. The contract pricing was determined to be fair and competitive, with lease and preventative maintenance services priced 20% lower than comparable market rates. The participating VA medical centers are developing a long-term procurement strategy through a committee that will conduct a market survey to potentially introduce more competition in future acquisitions.