J066--NEW - BioMerieux Biofire TORCH Services

es Contract Type: Firm-Fixed-Price (FFP), Commercial Service, processed in accordance with FAR Part 12 Estimated Total Value (Base + Options): $109,915.04 IDENTIFICATION OF AGENCY AND CONTRACTING ACTIVITY This is a Justification for Other Than Full and Open Competition prepared by the Department of Veterans Affairs, Network Contracting Office 17 (NCO 17), in support of a requirement of the South Texas Veterans Health Care System (STVHCS), Pathology & Laboratory Medicine Service. NATURE AND DESCRIPTION OF THE ACTION BEING APPROVED The Government intends to award a single/sole source, Firm-Fixed-Price commercial service contract to bioMérieux, Inc. (BioFire Diagnostics, LLC), 515 S. Colorow Dr., Salt Lake City, UT 84108, for an extended warranty period to include preventative service and maintenance for Government-owned BioMérieux (BioFire) Torch instrumentation located in the Microbiology Laboratory, Pathology & Laboratory Medicine Service, Audie L. Murphy VA Hospital, San Antonio, Texas. The contract will consist of a Base Year plus four (4) Option Years, as documented in the accompanying Justification to Include Options. DESCRIPTION OF SUPPLIES/SERVICES AND ESTIMATED VALUE The contractor service program shall include, at a minimum: onsite repair performed by a bioMérieux (BioFire) Certified Diagnostic Service Engineer (FSE) or Authorized Distributor; all replacement parts; all software upgrades and new releases; all labor, travel, and expenses for unscheduled visits; all replacement equipment necessary for repairs; one yearly scheduled preventative maintenance visit; all applicable instrument shipping charges; a 24/7 toll-free hotline with same-day response; emergency repair within 24 hours of request; same-day repair if both instruments are down; and repairs performed during normal business hours, 8:00 AM to 5:00 PM, Monday through Friday. The total estimated value for the Base Year and four Option Years combined is $109,915.04. This acquisition is being processed as a commercial service under FAR Part 12, as revised under the Revolutionary FAR Overhaul (RFO). IDENTIFICATION OF THE STATUTORY AUTHORITY The statutory authority permitting other than full and open competition is 41 U.S.C. § 3304(a)(1), as implemented by FAR 6.302-1, "Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements." This authority has been retained under the Revolutionary FAR Overhaul (RFO) revisions to FAR Part 6, which streamlined the noncompetitive procedures requirements while preserving the underlying statutory authorities for other than full and open competition, including the sole/only one responsible source exception. DEMONSTRATION OF CONTRACTOR'S UNIQUE QUALIFICATIONS The Government-owned BioFire Torch instrumentation is proprietary equipment manufactured exclusively by bioMérieux, Inc. (BioFire Diagnostics, LLC). Due to the proprietary nature of the instrumentation, only a bioMérieux (BioFire) Certified Diagnostic Service Engineer or an Authorized Distributor possessing manufacturer certification, proprietary technical data, and proprietary diagnostic software access may perform maintenance, repair, and software support on the instrumentation. No other source possesses the OEM certification, proprietary parts, or software access necessary to service this equipment. Use of an uncertified vendor would void manufacturer warranties, risk instrument malfunction, and jeopardize compliance with American Association of Blood Banks (AABB) and College of American Pathologists (CAP) accreditation standards required under VHA Directive 1106.1, thereby directly impacting Microbiology Laboratory diagnostic testing capability for Veteran patient care. EFFORTS MADE TO ENSURE OFFERS ARE SOLICITED FROM AS MANY POTENTIAL SOURCES AS PRACTICABLE In accordance with FAR Subpart 5.2, a Notice of Intent (NOI) to Sole Source, Notice ID 36C25726Q0759, was posted to SAM.gov/Contract Opportunities on July 9, 2026, and remained open for eleven (11) calendar days, closing July 20, 2026, to provide any other responsible source the opportunity to submit a capability statement demonstrating an ability to meet the Government's requirement. No capability statements, responses, or objections were received during the posting period. DETERMINATION OF FAIR AND REASONABLE COST The Contracting Officer has determined that the anticipated cost to the Government of $109,915.04 will be fair and reasonable. This determination is based on a comparison to the pricing paid under the predecessor sole source contract (36C25721P0467, total value $108,500.00, period of performance 09/01/2021 08/31/2026) for the same requirement and instrumentation, escalated appropriately for the current period of performance. A price analysis will be completed and documented in the contract file prior to award in accordance with FAR 15.404-1. DESCRIPTION OF MARKET RESEARCH CONDUCTED Market research was conducted in accordance with FAR Part 10, VAAR 810, and VAAM M810, and is fully documented in the accompanying Market Research Report for this requirement. Techniques employed included a search of the Veteran Small Business Certification (VetCert) database and SBA sources, a search of the SBA small business database, a search of the FPI/UNICOR database, a search of the AbilityOne database, a search of GSA eLibrary, a review of SAM.gov contract award history, and the eleven-day Notice of Intent to Sole Source described in Section 6 above. These searches confirmed that bioMérieux, Inc. is the exclusive source capable of providing OEM-certified maintenance and repair services for the Torch instrumentation, and that no SDVOSB, VOSB, or other small business source capable of performing this proprietary service exists. Accordingly, the VA Rule of Two cannot be satisfied for this requirement. OTHER FACTS SUPPORTING USE OF OTHER THAN FULL AND OPEN COMPETITION A technical data package, specification, or statement of work suitable for full and open competition has not been developed, as the instrumentation is proprietary to bioMérieux, Inc., and no other manufacturer produces functionally interchangeable Torch instrumentation compatible with the Government's existing installed equipment. Development of an alternative technical data package is not practicable given the closed, proprietary architecture of the instrumentation and the requirement for continued OEM warranty and accreditation compliance. LISTING OF SOURCES EXPRESSING WRITTEN INTEREST No sources, other than bioMérieux, Inc., expressed interest in writing in performing this requirement. No capability statements or responses were received in response to the Notice of Intent to Sole Source described in Section 6 above. ACTIONS TO REMOVE OR OVERCOME BARRIERS TO COMPETITION Given the proprietary nature of the BioFire Torch instrumentation and bioMérieux, Inc.'s exclusive control over OEM certification, technical data, and proprietary software, there are no practicable actions available to the Government at this time to remove barriers to competition for maintenance and repair services on the currently installed instrumentation. The Contracting Officer will continue to monitor the market and will re-evaluate the availability of competitive alternatives, including at the next instrument technology refresh or replacement cycle, prior to any future re-competition of th