36C25726C0089_2.docx

SUBJECT*

NEW – Roche Benchmark Ultra Services

GENERAL INFORMATION

BASE NOTICE TYPE

Network Contracting Office 17

5441 Babcock Road Ste. 302 San Antonio TX 78240

POINT OF CONTACT*

Contracting Officer Ognian D. Ivanov ognian.ivanov@va.gov 210-694-6302

AWARD INFORMATION

MODIFICATION NUMBER

AWARDEE NAME*

CONTRACTOR’S UEI

ROCHE DIAGNOSTICS CORPORATION

JDMDFEZBYH36

AWARDEE ADDRESS LINE 1*

AWARDEE ADDRESS LINE 2*

AWARDEE ADDRESS LINE 4*

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

Justification and Approval Notice Justification and Approval Notice

DESCRIPTION

Justification and Approval Notice

DEPARTMENTOFVETERANSAFFAIRS

NETWORKCONTRACTINGOFFICE17(NCO17)

SouthTexasVeteransHealthCareSystem(STVHCS)

JUSTIFICATIONFOROTHERTHANFULLANDOPENCOMPETITION

(SoleSource) PreparedinAccordancewithRFOFAR6.103-1(b)andtheRevolutionaryFAROverhaul(RFO) to the FAR

ContractingActivity:DepartmentofVeteransAffairs,NetworkContractingOffice17 (NCO 17), South Texas Veterans Health Care System (STVHCS) AcquisitionPlanActionID:36C257-26-AP-4408Requisition Number:671-26-4-121-2325JOFOC Log Number:FY26 - NCO 17 - 2033 RequirementTitle:RocheBenchmarkUltraServices ContractType:Firm-Fixed-Price(FFP),CommercialService,processedinaccordance with FAR Part 12 EstimatedTotalValue(Base+Options):$249,252.94

1. IDENTIFICATIONOFAGENCYANDCONTRACTINGACTIVITY

This is a Justification for Other Than Full and Open Competition prepared by the DepartmentofVeteransAffairs,NetworkContractingOffice17(NCO17),insupportof arequirementoftheSouthTexasVeteransHealthCareSystem(STVHCS),Pathology& Laboratory Medicine Service.

2. NATUREANDDESCRIPTIONOFTHEACTIONBEINGAPPROVED

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), toRocheDiagnosticsCorporationforserviceandmaintenancesupportofthree(3)Roche BenchMark Ultra automated Immunohistochemistry (IHC)/In Situ Hybridization (ISH) staininginstrumentslocatedattheSouthTexasVeteransHealthCareSystem(STVHCS), Page 1 of PathologyandLaboratoryMedicineService,SpecialtyLaboratoryinSanAntonio, Texas. The proposed action is a follow-on to incumbent sole source contract 36C25721P1359 and will be awarded as a new stand-alone contract.

3. DESCRIPTIONOFSUPPLIES/SERVICESANDESTIMATEDVALUE

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 Veteranpatients.Underthecontemplatedcontract,thecontractorshallprovide: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 serviceper instrument; on-site applicationstroubleshooting and up tofive (5) days of applications support annually by a Certified Roche Field Applications Specialist (FAS); and installation of all manufacturer operational modifications by an FSE.

Theestimatedtotalvalueofthisacquisition,includingaone-yearbaseperiodandfour (4)one-yearoptionperiods,is$249,252.94.

ProductServiceCode(PSC):J065--Maintain,Repair,RebuildofEquipment:Medical, Dental, and Veterinary Equipment and Supplies.

NAICSCode:811210--ElectronicandPrecisionEquipmentRepairandMaintenance (Size Standard $34M).

ThisacquisitionisbeingprocessedasacommercialserviceunderFARPart12,as revised under the Revolutionary FAR Overhaul (RFO).

4. IDENTIFICATIONOFTHESTATUTORYAUTHORITY

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 streamlinedasRFOFAR6.103-1through6.103-7,withtheonly-one-responsible-source authority nowspecifically located atRFOFAR6.103-1(b). This action isjustified 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'srequirements.

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5. DEMONSTRATIONOFCONTRACTOR'SUNIQUEQUALIFICATIONS

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 andthatserviceandmaintenanceoftheinstrumentfamilymustbeperformedexclusively 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-architecturediagnosticsoftware,proprietarycalibrationprocedures,andrestricted access to OEM parts, firmware, and technical documentation—requires that only Roche Diagnostics perform certain maintenance and service procedures. The operator's manual specifiesthatroutinemaintenanceactivitiesperformedbyendusersarelimited;allother 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 oneormoreinstrumentswouldresultinsignificantdelayorinabilitytoperformessential 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,RocheDiagnosticsCorporationistheonlyresponsiblesourcecapableof satisfying the agency's requirements under RFO FAR 6.103-1(b).

6. EFFORTSMADETOENSUREOFFERSARESOLICITEDFROMASMANY POTENTIAL SOURCES AS PRACTICABLE InaccordancewithRFOFARPart10andVAAR810,theContractingOfficerconducted extensive market research, as documented in Market Research Report MRR-36C257-26-AP-4408. Research included:

SearchingtheSBAVetCertdatabaseusingthekeywords"BenchMarkUltra"andNAICS 811210 to identify certified capable SDVOSBs and VOSBs (no results).

Reviewing prior market research and acquisition history for similar requirements, includingsolesourcecontract36C25726P0473foraBenchMarkUltraPlusinstrument and incumbent service contract 36C25721P1359.

Page 1 of Searching SAM.gov, SBA small business databases, Federal Prison Industries (UNICOR), AbilityOne, and GSA eLibrary (including Roche's GSA contract V797P-7347A,whichcoverscost-per-testarrangementsratherthandedicatedservicecontracts).

Additionally,pursuanttoRFOFAR5.201and5.207,theGovernmentpostedaNoticeof 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 andmaintenance.

DeterminationRegardingtheVARuleofTwoandUseofSet-Asides.

The VA Rule of Two requires that before using a non-competitive procedure, the ContractingOfficer 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,noVetCert-listedSDVOSBorVOSB,andnoothersmallbusinessconcern, was identified as capable of providing OEM-authorized BenchMark Ultra service.

Accordingly,theVARuleofTwocannotbemetforthisrequirement,andaset-asidefor 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).

7. DETERMINATIONOFFAIRANDREASONABLECOST

Theestimatedtotalvalueof$249,252.94forthebaseperiodandfouroptionyearsis considered fair and reasonable based on:

· Priceanalysisofincumbentcontract36C25721P1359(totalvalue$259,416.75fora comparable base-plus-four-year term).

· ComparisontopricingunderRoche'sGSAcost-per-testcontractV797P-7347Aand Roche's commercial pricing.

TheproposedpricingisconsistentwithhistoricalpricesforBenchMarkUltraserviceand 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.

8. DESCRIPTIONOFMARKETRESEARCHCONDUCTED

Page 1 of Market research was conducted in accordance with FAR Part 10, VAAR 810, and VAAMM810,andisfullydocumentedintheaccompanyingMarketResearchReportfor 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 VARule of Two cannot be satisfiedfor thisrequirement.

9. OTHERFACTSSUPPORTINGUSEOFOTHERTHANFULLANDOPENCOMPETITION

ServiceunderthiscontractisrequiredtomaintaincompliancewithCollegeofAmerican 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 Veteranpatients.

10. LISTINGOFSOURCESEXPRESSINGWRITTENINTEREST

No sources, other than Roche Diagnostics, expressed interest in writing in performing thisrequirement.Nocapabilitystatementsorresponseswerereceivedinresponsetothe Notice of Intent to Sole Source described in Section 6 above.

11. ACTIONSTOREMOVEOROVERCOMEBARRIERSTOCOMPETITION

BecausetheBenchMarkUltraplatformisproprietaryandOEM-restricted,VA'sabilityto foster competition for this specific service is limited. However, the requiring activitywill 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.

12. TECHNICAL/REQUIREMENTSPERSONNELCERTIFICATION

Page 1 of Icertifythatthesupportingdatacontainedherein,verifyingtheGovernment'sminimum needs and the technical basis for other than full and open competition, is complete and accurate to the best of my knowledge and belief.

KRISTENDELGADO-DigitallysignedbyKRISTEN

DELGADO-WILLIAMS

Page 1 of Signature:_WILLIAMS

Date:2026.08.1108:12:03-05'00'

Page 1 of Page 1 of Name:Kristen Delgado-Williams Date: 8/10/2026 Technical/RequirementsPersonnel,Pathology&LaboratoryMedicineService

13. CONTRACTINGOFFICERCERTIFICATION

Icertifythatthisjustificationisaccurateandcompletetothebestofmyknowledgeand 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.

14. APPROVAL

InaccordancewithRFOFAR6.104(a)(1)(formerlyFAR6.304(a)(1)),becausethe estimated total value of this proposed contract ($249,252.94) does not exceed $900,000.00,theContractingOfficer'scertificationbelowservesasapprovalofthis justification, unless a higher approval level is established by agency procedure.

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OGNIAN

IVANOV

IVANOV

Digitally signed by

OGNIAN

Date:

2026.08.10 10:24:05 05'00' )Signature:

Name:OgnianD.Ivanov Contracting Officer NetworkContractingOffice17(NCO17) Department of Veterans Affairs

Date:8/10/2026