P03 JA Cepheid HCA Signed.pdf

VHAPG Part 806.3 OFOC Page 1 of 4 Revision: 03 Effective Date: 04/15/24 Acquisition ID#: 36C249-25-AP-2552

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C249-25-AP-2552

Contracting Activity: Department of Veterans Affairs, V I S N 09, Network Contracting Office 9 (NCO9) 1639 Medical Center Pkwy Ste 204, Murfreesboro, TN 37129. The purchase request# is 486-25-3-3980-0007.

Nature and/or Description of the Action Being Processed: This multiple facility (VISN-wide) requirement is for a sole source indefinite delivery contract (IDC) with ten 1-year ordering periods.

Description of Supplies/Services Required to Meet the Agency’s Needs: The VISN 9 Pathology and Laboratory Medicine Service (P&LMS) laboratories own and use the Cepheid platform and accompanying reagents and supplies which are used for rapid syndromic infectious disease (i.e., influenza, COVID, SARS, etc.) diagnostic testing on veteran’s submitted test samples. Per the IGCE, the estimated value of this acquisition is $2 for a period of performance starting 1 /202 and ending 1 /2035 (10-year IDIQ with 10 ordering periods).

This proposed contract is not restricted to the 5 year limit outlined in the Federal Acquisition Regulation under the four specific instances. A Determinations and Findings has been uploaded by the CO.

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 FAR 6. -1

Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): The P&LMS with laboratories within VISN 9 has been providing infectious assays since 2018, and and the reagents are proprietary.

Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market research was conducted for this requirement which confirmed proprietary nature of this acquisition and procurement method. The original equipment manufacturer (OEM), Cepheid, Inc., does not authorize third party vendors to sell, repair, service its equipment, and it is designed to only use proprietary supplies, consumables, etc. There is no expectation to receive technically acceptable offers from any source that will be fair and reasonable.

Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Conducted market research using GSA eLibrary keyword: Cepheid; DSBS/SBA search using NAICS: 334516 and SD/VOSB parameters; VetCert using NAICS: 334516; and FPDS-NG using keyword: Cepheid with Dept of VA and 36C249 parameters. The results are as follows:

The GSA search resulted in an active Cepheid FSS, GS-07F-0597T, is available for use; however, all line items/requirements are not offered on schedule.

The VetCert and DSBS/SBA search resulted in 234 SD/VOSBs, 295 SDVOSBs, and 55 VOSBs that are registered under this NAICS.

The FPDS-NG showed 118 contracts/contract modifications within NCO 9/VISN area awarded between 02/05/2018-03/04/2025 to the OEM with a spend total of $8,928,582.11. The eCMS search of those contracts revealed all were awarded as a sole source (FAR Part 13) or limiting sources (FAR Part 8) to the OEM.

Due to the proprietary nature of this requirement, there is no expectation to receive 2 or more offers from SD/VOSBs, SBs, or any vendor other than the OEM that will be technically acceptable with fair and reasonable pricing.

Any Other Facts Supporting the Use of Other than Full and Open Competition: There are many analyzers and reagents available in the marketplace; each are proprietary to the manufacturer. The only equipment, supplies, etc. compatible with Cepheid GeneXpert are Cepheid’s. The current value of VISN 9’s fleet of Cepheid GeneXpert is $1,550,000.

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

OEM,

VHAPG Part 806.3 OFOC

Acquisition ID#: 36C249-25-AP-2552

VHAPG Part 806.3 OFOC Page 3 of 4

Acquisition ID#: 36C249-25-AP-2552

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:

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.

Debbie E. Thompson Date Health System Specialist Diagnostic ICCs VISN 9 Office of Chief Medical Officer

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.

Date

Harry R. Grambo III

Branch Chief N C O 09

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Date

Robert M. Kellner Division Chief N C O 09

DEBBIE

THOMPSON

Digitally signed by

DEBBIE THOMPSON

Date: 2025.08.26 08:50:05 -05'00'

HARRY GRAMBO Digitally signed by HARRY GRAMBO Date: 2025.11.20 12:54:14 -05'00'

ROBERT KELLNER

Digitally signed by ROBERT

KELLNER

Date: 2025.11.20 12:02:59 -06'00'

SUSAN

NAGEL

Digitally signed by SUSAN

NAGEL

Date: 2025.11.20 15:25:04 -06'00'

Attachment 1: Request for Sole Source Justification Format >SAT

VHAPG Part 806.3 OFOC Page 4 of 4

Acquisition ID#: 36C249-25-AP-2552

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 $75 million) or approve ($750K to $75 million) for other than full and open competition.

Date

Daryl A. Berg Executive Director, RPO Central Head of Contracting Activity

DARYL BERG

Digitally signed by

DARYL BERG

Date: 2025.12.12 12:13:21 -06'00'