36C25726C0087_2.docx

SUBJECT*

NEW - BioMerieux Biofire TORCH 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

AWARD INFORMATION

MODIFICATION NUMBER

LINE ITEM NUMBER

AWARDEE NAME*

CONTRACTOR’S UEI

BIOMERIEUX INC

HCNVCMEG9NL6

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) PreparedinAccordancewithFARSubpart6.3andtheRevolutionaryFAROverhaul(RFO)totheFAR

ContractingActivity:DepartmentofVeteransAffairs,NetworkContractingOffice17(NCO17),South Texas Veterans Health Care System (STVHCS) AcquisitionPlanActionID:36C257-26-AP-4185Requisition Number:671-26-4-121-2083JOFOC Log Number:FY26 - NCO 17 - 1915 RequirementTitle:BioMérieuxBiofireTORCHServices ContractType:Firm-Fixed-Price(FFP),CommercialService,processedinaccordancewithFARPart12 EstimatedTotalValue(Base+Options):$109,915.04

1. IDENTIFICATIONOFAGENCYANDCONTRACTINGACTIVITY

ThisisaJustificationforOtherThanFullandOpenCompetitionpreparedbytheDepartmentofVeterans 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.

2. NATUREANDDESCRIPTIONOFTHEACTIONBEINGAPPROVED

TheGovernmentintendstoawardasingle/solesource,Firm-Fixed-Pricecommercialservicecontractto 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.

3. DESCRIPTIONOFSUPPLIES/SERVICESANDESTIMATEDVALUE

The contractor service program shall include, at a minimum: onsite repair performed by a bioMérieux (BioFire)CertifiedDiagnosticServiceEngineer(FSE)orAuthorizedDistributor;allreplacementparts;

Page 1 of 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 applicableinstrumentshippingcharges;a24/7toll-freehotlinewithsame-dayresponse;emergencyrepair 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).

4. IDENTIFICATIONOFTHESTATUTORYAUTHORITY

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 SatisfyAgencyRequirements."ThisauthorityhasbeenretainedundertheRevolutionaryFAROverhaul (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.

5. DEMONSTRATIONOFCONTRACTOR'SUNIQUEQUALIFICATIONS

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,andjeopardizecompliancewithAmericanAssociationofBloodBanks(AABB)andCollege of American Pathologists (CAP) accreditation standards required under VHA Directive 1106.1, thereby directly impacting Microbiology Laboratory diagnostic testing capability for Veteran patient care.

6. EFFORTSMADETOENSUREOFFERSARESOLICITEDFROMASMANYPOTENTIAL SOURCES AS PRACTICABLE In accordance with FAR Subpart 5.2, a Notice of Intent (NOI) to Sole Source, Notice ID 36C25726Q0759,waspostedtoSAM.gov/ContractOpportunitiesonJuly9,2026,andremainedopenfor 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.

7. DETERMINATIONOFFAIRANDREASONABLECOST

Page 1 of TheContractingOfficerhasdeterminedthattheanticipatedcosttotheGovernmentof$109,915.04will 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.

8. DESCRIPTIONOFMARKETRESEARCHCONDUCTED

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 theAbilityOnedatabase,asearchofGSAeLibrary,areviewofSAM.govcontractawardhistory,andthe 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.

9. OTHERFACTSSUPPORTINGUSEOFOTHERTHANFULLANDOPENCOMPETITION

A technical data package, specification, or statement of work suitable for full and open competition has notbeendeveloped,astheinstrumentationisproprietarytobioMérieux,Inc.,andnoothermanufacturer producesfunctionallyinterchangeableTorchinstrumentationcompatiblewiththeGovernment'sexisting installed equipment. Development of an alternative technical data package is not practicable given the closed, proprietary architectureof theinstrumentation and therequirement for continued OEMwarranty and accreditation compliance.

10. LISTINGOFSOURCESEXPRESSINGWRITTENINTEREST

Nosources,otherthanbioMérieux,Inc.,expressedinterestinwritinginperformingthisrequirement.No capability statements or responses were received in response to the Notice of Intent to Sole Source described in Section 6 above.

11. ACTIONSTOREMOVEOROVERCOMEBARRIERSTOCOMPETITION

Given the proprietary nature of the BioFire Torch instrumentation and bioMérieux, Inc.'s exclusive controloverOEMcertification,technicaldata,andproprietarysoftware,therearenopracticableactions available to the Government at this time to remove barriers to competition for maintenance and repair

Page 1 of servicesonthecurrentlyinstalledinstrumentation.TheContractingOfficerwillcontinuetomonitorthe 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 this requirement.

12. TECHNICAL/REQUIREMENTSPERSONNELCERTIFICATION

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

KRISTEN

DELGADO-

DELGADO-

WILLIAMS

Digitally signed by

KRISTEN

WILLIAMS

Date: 2026.07.29 12:25:04 05'00' )Signature:

Name:KristenDelgado-Williams Date:7/29/2026 Technical/RequirementsPersonnel,Pathology&LaboratoryMedicineService

13. CONTRACTINGOFFICERCERTIFICATION

I certify that this justification is accurate and complete to the best of my knowledge and belief, and that theuseofotherthanfullandopencompetitionundertheauthorityofFAR6.302-1isrequiredtosatisfy the Government's minimum needs as described herein.

14. APPROVAL

In accordance with FAR 6.304(a)(1), because the estimated total value of this proposed contract ($109,915.04)doesnotexceed$340,000.00theContractingOfficer'scertificationbelowservesas approval of this justification, unless a higher approval level is established by agency procedure.

OGNIAN IVANOV

Digitally signed by

OGNIAN

IVANOV

Date: 2026.07.29 12:32:08 05'00' )Signature:

Name:OgnianD.Ivanov Date:7/29/2026 ContractingOfficer NetworkContractingOffice17(NCO17) Department of Veterans Affairs SouthTexasVeteransHealthCareSystem Page 1 of