SSJ.pdf

Request for Sole Source Justification Format >SAT

VHAPG Part 806.3 OFOC Page 1 of 4 Revision: 04 Effective Date: 12/15/25 Acquisition ID#: 36C250-26-AP-1359

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C250-26-AP-1359

1. Contracting Activity: Department of Veterans Affairs, VISN 10, Richard L.

Roudebush VA Medical Center, 1481 West 10th Street, Indianapolis, IN 46202, submitted 2237# 583-26-2-097-0328 for Cepheid Reagents.

2. Nature and/or Description of the Action Being Approved:

This contract is for Cepheid Reagent kits to be used with the existing Cepheid GeneXpert DX instruments within the microbiology laboratory. The reagents needed to perform the testing are only available through the manufacturer (OEM), Cepheid Inc. This is a firm fixed price contract.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

The estimated value of the proposed action for 1 year is $617,108.60.

Period of Performance is 3/1/2026 - 2/28/2027.

This contract is for the Xpert Xpress SARS-CoV-2 plus (XPRS-COV2-10), Xpress CoV-2/FLU/RSV plus (XPRS4PLEX-10), Xpert C. difficile/epi (GXCDIFF/EPI-10), Xpert Carba-R (GXCARBAR-10), Xpert MTB/RIF (GXMTB/RIF-US-10), Xpert MVP (XPRSMVP-10) and Xpert Factor II/V (GXFIIFV-10) reagents kits and Collection kits (SWAB/G-50-US) to be used with the existing Cepheid GeneXpert DX instruments within the microbiology laboratory. The reagents needed to perform the testing are only available through the OEM, Cepheid Inc.

4. Statutory Authority Permitting Other than Full and Open Competition:

(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;

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Acquisition ID#: 36C250-26-AP-1359

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

Cepheid is the sole manufacture of these kits which are necessary to continue testing offered by the microbiology department. These reagents are run on the existing Cepheid instruments already onsite. The kits are needed to continue Covid, Flu, and RSV respiratory testing, C. difficile testing, Carbapenemase producing organism testing, MTB/Rif testing, vaginal panel testing, and Factor II/V testing. These kits have all undergone verification on IQCP plans on the instruments within the RLR VAMC Microbiology department and are approved for testing.

Opening competition to other vendors would require procuring new instruments to run different reagents, and the cost would substantially offset any savings made from opening competition.

Accordingly, Cepheid Inc. is the only firm capable of providing the supplies and services described in Section IV above without the Veteran’s Health Administration experiencing substantial duplication of cost that could not be expected to be recovered through competition.

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):

FPDS reviewed for items that could possibly match. NAC, GSA, and Supply Chain Master Catalog also reviewed, along with ADDSUP. Notice of Intent to Sole Source was posted on GPE on February 19, 2026, with a response date of February 27, 2026. No responses have been received.

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

Fair and Reasonable:

We are proceeding with a sole source justification and the price is similar to other like items recently awarded. The price is determined to be fair and reasonable by reviewing market trends and ensuring the contractor's costs align with industry standards.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

Items are domestic end products and made in the USA.

SBA SBS queried using NAICS code 325413 and keywords “cepheid” with 0 SD/VOSB’s located. Conducted a SBA SBS query by same NAICS with 907 results.

The product is not on the Non-Manufacturer Rule Class Waiver list. Items not found on GSA Advantage nor NAC. Items can be procured by only one vendor, Cepheid Inc. (OEM), as they are the only supplier of the reagents. Neither the VA Rule of Two nor SBA Rule of Two can be satisfied.

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Acquisition ID#: 36C250-26-AP-1359

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

None

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

None

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 continue to be conducted to determine if other sources are available to satisfy the Government’s requirements.

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.

Amanda Reuille Date

Laboratory Manager

Richard L Roudebush VAMC

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.

Todd Cress Date

Contracting Officer

Services and Commodities Team 6

Network Contracting Office 10

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Acquisition ID#: 36C250-26-AP-1359

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.

Christopher Gundy Date

Branch Chief

Services and Commodities Team 6

Network Contracting Office 10