J066--NEW – Roche Benchmark Ultra Services

DEPARTMENT OF VETERANS AFFAIRS NETWORK CONTRACTING OFFICE 17 (NCO 17) South Texas Veterans Health Care System (STVHCS) JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION (Sole Source) Prepared in Accordance with RFO FAR 6.103-1(b) and the Revolutionary FAR Overhaul (RFO) to the FAR
Contracting Activity: Department of Veterans Affairs, Network Contracting Office 17 (NCO 17), South Texas Veterans Health Care System (STVHCS) Acquisition Plan Action ID: 36C257-26-AP-4408 Requisition Number: 671-26-4-121-2325 JOFOC Log Number: FY26 - NCO 17 - 2033 Requirement Title: Roche Benchmark Ultra Services 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 or VOSBs are capable of performing the work and likely to submit offers at fair and reasonable prices. Based on the market research summarized above and detailed in MRR-36C257-26-AP-4408, no VetCert-listed SDVOSB or VOSB, and no other small business concern, was identified as capable of providing OEM-authorized BenchMark Ultra service. Accordingly, the VA Rule of Two cannot be met for this requirement, and a set-aside for SDVOSBs or VOSBs is not appropriate. The acquisition will proceed as a sole source award to Roche Diagnostics Corporation under RFO FAR 6.103-1(b). DETERMINATION OF FAIR AND REASONABLE COST The estimated total value of $249,252.94 for the base period and four option years is considered fair and reasonable based on: Price analysis of incumbent contract 36C25721P1359 (total value $259,416.75 for a comparable base-plus-four-year term). Comparison to pricing under Roche's GSA cost-per-test contract V797P-7347A and Roche's commercial pricing. The proposed pricing is consistent with historical prices for BenchMark Ultra service and maintenance and reflects minor adjustments for inflation and applications support. A detailed price analysis will be documented in the contract file, including verification against Roche's current commercial catalog or pricing schedules and confirmation that discounts offered to the Government are at least equal to or better than those offered to Roche's most favored commercial customers. 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 ten-day Notice of Intent to Sole Source described in Section 6 above. These searches confirmed that Roche Diagnostics is the exclusive source capable of providing OEM-certified maintenance and repair services for the BenchMark Ultra 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 Service under this contract is required to maintain compliance with College of American Pathologists (CAP) accreditation standards, VHA Directive 1106, and manufacturer OEM specifications for diagnostic instrumentation. Use of non-authorized service providers would jeopardize CAP accreditation, potentially invalidate patient test results, and expose VA to unacceptable clinical risk. The instruments' proprietary design, combined with the absence of an alternate source identified through exhaustive market research and public posting, supports the conclusion that award to Roche Diagnostics Corporation on a sole source basis is in the best interest of the Government and Veteran patients. LISTING OF SOURCES EXPRESSING WRITTEN INTEREST No sources, other than Roche Diagnostics, 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 Because the BenchMark Ultra platform is proprietary and OEM-restricted, VA's ability to foster competition for this specific service is limited. However, the requiring activity will continue to monitor developments in the histology and IHC/ISH marketplace, including any emergence of open-architecture platforms or alternative technologies that could support future competitive acquisitions. As instruments reach end-of-life or are replaced, the requiring activity will consider competitive procurements that emphasize open architecture, interoperable platforms, and multiple-vendor service options to enhance future competition opportunities. TECHNICAL/REQUIREMENTS PERSONNEL CERTIFICATION
I certify that the supporting data contained herein, verifying the Government's minimum needs and the technical basis for other than full and open competition, is complete and accurate to the best of my knowledge and belief.
KRISTEN DELGADO- Digitally signed by KRISTEN DELGADO-WILLIAMS
Signature: _WILLIAMS Date: 2026.08.11 08:12:03 -05'00'
Name: Kristen Delgado-Williams Date: 8/10/2026 Technical/Requirements Personnel, Pathology & Laboratory Medicine Service CONTRACTING OFFICER CERTIFICATION I certify that this justification is accurate and complete to the best of my knowledge and belief, and that the use of other than full and open competition under the authority of RFO FAR 6.103-1(b) is required to satisfy the Government's minimum needs as described herein. APPROVAL In accordance with RFO FAR 6.104(a)(1) (formerly FAR 6.304(a)(1)), because the estimated total value of this proposed contract ($249,252.94) does not exceed $900,000.00, the Contracting Officer's certification below serves as approval of this justification, unless a higher approval level is established by agency procedure.

OGNIAN IVANOV IVANOV Digitally signed by OGNIAN Date: 2026.08.10 10:24:05 -05'00' Signature: Name: Ognian D. Ivanov Contracting Officer Network Contracting Office 17 (NCO 17) Department of Veterans Affairs
Date: 8/10/2026