JOFOC for Biofire Spotfire signed by CO_Redacted.pdf

This is a Single Source Justification form for a procurement action not exceeding the Simplified Acquisition Threshold, submitted by the U.S. Department of State's Overseas Post Baghdad, Health Unit.

The contracting activity seeks to procure the BIOFIRE SPOTFIRE System (product number PR16268894 DOS Health Unit) through a brand-name justification under Federal Acquisition Regulation 13.106-1(b)(1). The BIOFIRE SPOTFIRE System is an advanced high-multiplex PCR diagnostic platform that delivers rapid, reliable diagnostic results with sample preparation and automated testing capabilities across up to four modules within a typical patient visit timeframe. This system enables clinicians to make faster treatment decisions at the point of care, enhancing the quality and timeliness of patient care. The Health Unit has formally identified this technology as meeting its clinical and operational requirements, supported by formal recommendation from the Bureau of Medical Services' Pharmaceutical and Therapeutic Committee for adoption across all U.S. Embassy Health Units worldwide to standardize diagnostic equipment and ensure consistency in clinical capability, technical support, and quality assurance globally. The justification notes that Health Unit staff have already completed training on the BIOFIRE SPOTFIRE System, ensuring immediate operational readiness and eliminating additional training or implementation delays. The Contracting Officer has determined that only one source is reasonably available based on the brand-name authority and has certified that the anticipated cost to the Government is fair and reasonable. The exact estimated value of the purchase is redacted from the document.