36C26126AP2174FY261753 JOFOC NCO21 Cepheid Test Kits HCA Approved_Redacted.pdf

VHAPG Part 806.3 OFOC Page 1 of 6 Revision: 04 Effective Date: 12/15/25 Acquisition ID#: 36C261-26-AP-2174

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C261-26-AP-2174 JOFOC Tracker ID: FY26 - NCO 21 - 750

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office

(NCO 21), Veteran Integrated Service Network (VISN) 21, VA Southern Nevada Healthcare Center (VASNHCS) at 6900 North Pecos Road, Las Vegas, NV 89086.

2237: 593-26-2-968-0024

2. Nature and/or Description of the Action Being Approved: This action is for the establishment of an Indefinite Delivery, Indefinite Quantity (IDIQ) contract for Cepheid test kits (reagents) to be used with the existing Cepheid GeneXpert DX instruments within laboratory in accordance with FAR 12.102. The test kits needed to perform the testing are only available through the Original Equipment Manufacturer (OEM), Cepheid Inc.

The action will not be competed and will be procured as a sole source. The contract will be a firm fixed price IDIQ contract with five (5) ordering periods. This is a new requirement.

3. :

VASNHCS currently owns the Cepheid GeneXpert Infinity 48 module analyzer outright. At this time, the VA uses this instrument to run several different test kits.

The items being procured are as follows:

GXCARBAR-10 (detection and differentiation of carbapenem resistance of KPC, NDM, VIM, OXA-48, and IMP)

GXCDIFF/EPI-10 (detection of Clostridium difficile) GXMRSA-NXG-10 (detects methicillin-resistant Staphylococcus aureus) GXCT/NG-10 (detects Chlamydia trachomatis) XPRSTREPA-10 (detects Strep A) XPRS4PLEX-10 (detects SARS-CoV-2, influenza A, influenza B, and/or RSV) XPRSMVP-10 (detection of DNA from BV organisms, Candida species, and Trichomonas vaginalis) 900-0370 (Nasal Swabs) SWAB/G-50 (endocervical, vaginal, pharyngeal, and rectal swab) URINE/A-50 (urine collection kit for detecting sexually transmitted infections)

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Acquisition ID#: 36C261-26-AP-2174

3C057N (transport medium for stabilization and transport of unprocessed upper respiratory specimens)

SDPS-120 (Specimen Collection Swab) 480CFA (liquid based collection and transport swab) CARBAR-BU1 (detection of carbapenemase producing Enterobacterales)

This is a Food and Drug Administration (FDA) approved method with a fast, accurate Polymerase chain reaction (PCR) test that is needed for veteran care and the facility has the instrument that tests for several different organisms and conditions. These are the test kits that are used with the instrument no other testing material will work.

The anticipated period of performance for the IDIQ is from 06/01/2026- 09/30/2030.

Clause FAR 52.217-8 will be included in the solicitation, an option to extend the period of performance up to an additional 6 months.

The independent Government estimate (IGE) is as follows:

Ordering Period 1: (06/01/2026- 09/30/2026) Ordering Period 2: (10/01/2026- 09/30/2027) Ordering Period 3: (10/01/2027- 09/30/2028) Ordering Period 4: (10/01/2028- 09/30/2029) Ordering Period 5: (10/01/2029- 09/30/2030)

Anticipated IDIQ ceiling is $6,300,000.00

4. Statutory Authority Permitting Other than Full and Open Competition: FAR 12.102-1 will be utilized under authority FAR 6.103-1. Competition is restricted on this procurement for the reason below.

( X ) (1) Only One Responsible Source and No Other Supplies or Services Will

Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by

RFO 6.103-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by RFO 6.103-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by RFO 6.103-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by RFO 6.103-4

( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by RFO 6.103-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by RFO 6.103-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by RFO 6.103-7;

5.

Acquisition Requires the Use of the Authority Cited Above (applicability of

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Acquisition ID#: 36C261-26-AP-2174 authority): The Cepheid GeneXpert Infinity 48 module analyzer is owned by VASNHCS, and there is no intention to replace it. If VA was to do so, it would be an significant cost for the VA and would put a strain on staffing. There is no other analyzer on the market that can perform this entire panel of testing. All staff are trained and competent on this instrument. Testing occurs 24/7 on a STAT basis, which means they need to perform testing and provide results within 60 minutes for the provider to treat the veteran. If alternative brand test kits are procured, a new analyzer would be needed to be procured, the calibration start up time period would be at least five months, and veteran s tests would not be able to be performed during that time period to include Clostridium difficile infection field.

This action was procured under 36C26124D0063 as a sole source previously (valued at $3,400,000.00), for the same needed test kits. The Government is establishing a new contract for the same OEM specific test kits that it procured in 2024.

Accordingly, the OEM is the only firm capable of providing the supplies described in Section 3 above due to proprietary rights and verified by a letter received from the OEM. No competition is viable, as these items are proprietary and performance can only be obtained from the OEM. To consider another manufacturer would be disadvantageous to the Government and its stakeholders.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as possible (including whether a notice was or will be publicized as required by RFO Part 5 and, if not, which exception under RFO Part 5 applies): Market research was conducted, and no other distributors of the Cepheid testing kits could be found. These are proprietary kits only manufactured by the OEM, it is not possible to procure the needed items from alternative sources.

7. Determination by the CO that the Anticipated Cost to the Government will be

Fair and Reasonable: Fair and reasonableness pricing will be compared to the Independent Government Cost Estimate, and historical pricing found on the Federal Procurement Data System and System for Award Management.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: The Contracting Officer (CO) reviewed the Federal Procurement Data System (FPDS), the System for Award Management (SAM.gov), General Services Administration (GSA) Advantage and eLibrary, the National Acquisition Center (NAC), and the Supply Chain Master Catalogue (SCMC). Additionally, the CO emailed the OEM on 02/25/2026 requesting information regarding the availability of authorized distributors and the place of manufacture. Also, the CO reviewed the Market Research Report (MRR) from contract 36C26124D0063 and reached out to a Contract Specialist (CS)

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Acquisition ID#: 36C261-26-AP-2174 who has an ongoing solicitation (36C25026Q0328) for an identical requirement in NCO 10 for VA Indianapolis.

North American Industry Classification System (NAICS) code 325413 (In-Vitro Diagnostic Substance Manufacturing) was utilized, which resulted in 137 Veteran Owned Small Businesses (VOSBs) and 129 Service-Disabled Veteran Owned Small Businesses (SDVOSBs). The CO reached out to the OEM for a list of authorized veteran distributors, the OEM responded by stating that they did not have any distributors.

FPDS was reviewed, order SPE2DE24D0013 SPE2D62F1M65 was found awarded to Cepheid on 03/06/2025 in the amount of for testing kits; no set-aside was used (full and open). Additionally, contract 36C26124D0063 was found awarded to Cepheid in the amount of $3,400,000.00 on 03/25/2024 for Cepheid testing kits;

no set-aside was used (sole sourced).

SAM.gov was reviewed, where a Notice of Intent to Sole Source was found under ID 36C25026Q0328; a notice stating that Cepheid is the only available vendor to provide testing kits to be used with a GeneXpert DX instrument. Additionally, a Notice of Intent to Sole Source was found under ID IHS1519531_IHS1505586;

another notice stating that Cepheid is the only available vendor to provide testing kits to be used with a GeneXpert DX instrument.

GSA was reviewed, where contract GS-07F-0597T was found, awarded to the OEM.

Upon review, the CO determined that this contract is explicitly for equipment, rather than the test kits being purchased in this requirement.

The NAC was reviewed, with no relevant results being found.

The SCMC was reviewed, several localized IDIQs (awarded to the OEM) were found, none are available for VASNHCS to order from.

The CO contacted the OEM on 02/25/2026 requesting information regarding the availability of authorized distributors and the place of manufacture. The OEM responded by stating that there are no authorized distributors and that the needed items are manufactured in the United States. The OEM also indicated that there are no available contracting vehicles for the needed items, and that any contract will need to be procured on the Open Market.

The CO reviewed the MRR from contract 36C26124D0063, which indicated that Cepheid was the only available source for the needed items.

The CO also reviewed the MRR and Sole Source Justification (SSJ) for the ongoing solicitation (36C25026Q0328) in NCO 10 for an identical requirement, after requesting documents from the CS procuring that requirement. That action is also

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Acquisition ID#: 36C261-26-AP-2174 being solicited as a sole source requirement, the MRR and SSJ both indicated that Cepheid is the only known provider of the needed items.

The Contracting Officer (CO) has awarded similar Cepheid test kit contracts previously (36C26124D0063) and has firsthand knowledge that the OEM is the only source, and that the VA has existing instruments on site that require OEM specific test kits.

Given these facts, the CO believes that a sole source IDIQ to the OEM on the Open Market is necessary in accordance with FAR Part 12.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

There are no known distributors of the needed items other than the OEM.

Additionally, the Contractor Performance Assessment Reporting System (CPARS) was reviewed and it was found that Cepheid has Satisfactory performance.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Cepheid (W6HQTMWB9Q28); 904 East Caribbean Drive, Sunnyvale CA 94089-

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: Market research will be conducted in the future as the need arises. Additionally, the Cepheid testing instrument will be reviewed during its lifecycle for any opportunity for change in manufacturers.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Leanne R. Swanson Date Program Analyst VA Southern Nevada Healthcare System

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

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Acquisition ID#: 36C261-26-AP-2174

Mathew B. Czeshinski Date Contracting Officer Network Contracting Office 21

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $900K): I certify the justification meets requirements for other than full and open competition.

Nicholas Kluch Date Director of Contracting

Network Contracting Office 21

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and recommend approval (if over $90 million) or approve ($900K to $90 million) for other than full and open competition.

Curtis M. Jordan Date Executive Director, Regional Procurement Office West Head of Contracting Activity (HCA)