J066--NEW – Roche Benchmark Ultra Services

es Contract Type: Firm-Fixed-Price (FFP), Commercial Service, processed in accordance with FAR Part 12 Estimated Total Value (Base + Options): $249,252.94 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 Department of Veterans Affairs (VA), Network Contracting Office 17 (NCO 17), proposes to award a new firm-fixed-price commercial services contract, using the procedures of FAR Part 12 as implemented by the Revolutionary FAR Overhaul (RFO), to Roche Diagnostics Corporation for service and maintenance support of three (3) Roche BenchMark Ultra automated Immunohistochemistry (IHC)/In Situ Hybridization (ISH) staining instruments located at the South Texas Veterans Health Care System (STVHCS), Pathology and Laboratory Medicine Service, Specialty Laboratory in San Antonio, Texas. The proposed action is a follow-on to incumbent sole source contract 36C25721P1359 and will be awarded as a new stand-alone contract. DESCRIPTION OF SUPPLIES/SERVICES AND ESTIMATED VALUE The STVHCS has a continued need for comprehensive, OEM-authorized service and maintenance support for three Roche BenchMark Ultra instruments (Serial Numbers 311977, 311975, and 316490) that perform critical IHC/ISH diagnostic testing for Veteran patients. Under the contemplated contract, the contractor shall provide: unlimited on-site service support by a Certified Roche Field Service Engineer (FSE) Monday through Friday, 8:00 a.m. to 5:00 p.m. local time (excluding Federal holidays); a 24/7 customer support line to report service issues; repair service dispatch within 48 hours of call receipt (same-day dispatch when two or more instruments are down); all repair and annual preventative maintenance (PM) parts and associated shipping costs; one annual PM service per instrument; on-site applications troubleshooting and up to five (5) days of applications support annually by a Certified Roche Field Applications Specialist (FAS); and installation of all manufacturer operational modifications by an FSE. The estimated total value of this acquisition, including a one-year base period and four (4) one-year option periods, is $249,252.94. Product Service Code (PSC): J065 -- Maintain, Repair, Rebuild of Equipment: Medical, Dental, and Veterinary Equipment and Supplies. NAICS Code: 811210 -- Electronic and Precision Equipment Repair and Maintenance (Size Standard $34M). 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 RFO FAR 6.103-1(b), "One Responsible Source" (formerly FAR 6.302-1, "Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements"). Under the Revolutionary FAR Overhaul (RFO) restructuring of FAR Part 6, the seven exceptions to full and open competition previously codified at FAR 6.302-1 through 6.302-7 have been renumbered and streamlined as RFO FAR 6.103-1 through 6.103-7, with the only-one-responsible-source authority now specifically located at RFO FAR 6.103-1(b). This action is justified under RFO FAR 6.103-1(b) because the supplies and services required are available from only one responsible source and no other supplies or services will satisfy the agency's requirements. DEMONSTRATION OF CONTRACTOR'S UNIQUE QUALIFICATIONS Roche Diagnostics Corporation is the sole manufacturer and distributor of the BenchMark Ultra automated workflow series and associated reagents, consumables, diagnostic software, and hardware, as documented in its sole-source letter. Roche has certified that it is the only manufacturer and distributor of the BenchMark Ultra platform and that service and maintenance of the instrument family must be performed exclusively by Roche Diagnostics-trained Field Service Engineers (FSEs), or the manufacturer warranty is rendered null and void. The proprietary nature of the technology contained within the instruments including closed-architecture diagnostic software, proprietary calibration procedures, and restricted access to OEM parts, firmware, and technical documentation requires that only Roche Diagnostics perform certain maintenance and service procedures. The operator's manual specifies that routine maintenance activities performed by end users are limited; all other maintenance and repair activities must be performed by Roche FSEs. No third-party service provider has access to the OEM-authorized parts, diagnostic tools, firmware updates, or manufacturer training necessary to safely and effectively service these instruments without compromising patient safety, College of American Pathologists (CAP) accreditation, or VHA Directive 1106 compliance. Each of the three BenchMark Ultra instruments at STVHCS performs a unique set of IHC/ISH assays that the other instruments cannot perform. Any prolonged downtime of one or more instruments would result in significant delay or inability to perform essential diagnostic testing, adversely affecting Veteran patient care. Only Roche Diagnostics can provide OEM-authorized service that maintains instrument performance within manufacturer specifications and preserves warranty and regulatory compliance. Accordingly, Roche Diagnostics Corporation is the only responsible source capable of satisfying the agency's requirements under RFO FAR 6.103-1(b). EFFORTS MADE TO ENSURE OFFERS ARE SOLICITED FROM AS MANY POTENTIAL SOURCES AS PRACTICABLE In accordance with RFO FAR Part 10 and VAAR 810, the Contracting Officer conducted extensive market research, as documented in Market Research Report MRR-36C257-26-AP-4408. Research included: Searching the SBA VetCert database using the keywords "BenchMark Ultra" and NAICS 811210 to identify certified capable SDVOSBs and VOSBs (no results). Reviewing prior market research and acquisition history for similar requirements, including sole source contract 36C25726P0473 for a BenchMark Ultra Plus instrument and incumbent service contract 36C25721P1359. Searching SAM.gov, SBA small business databases, Federal Prison Industries (UNICOR), AbilityOne, and GSA eLibrary (including Roche's GSA contract V797P-7347A, which covers cost-per-test arrangements rather than dedicated service contracts). Additionally, pursuant to RFO FAR 5.201 and 5.207, the Government posted a Notice of Intent (NOI) 36C25726Q0808 to SAM.gov on July 30, 2026, for ten (10) calendar days, inviting responses from any responsible sources capable of meeting the requirement. No responses or capability statements were received during the posting period. All market research efforts consistently support the conclusion that no other source, small business or otherwise, is capable of providing OEM-authorized BenchMark Ultra service and maintenance. Determination Regarding the VA Rule of Two and Use of Set-Asides. The VA Rule of Two requires that before using a non-competitive procedure, the Contracting Officer determine whether two or more VetCert-listed SDVOSBs