SSJ 36C248-26-AP-1635p_Redacted.pdf

Effective Date: 12/30/2025 Page 2 of 5

REVISION: 02

Acquisition ID#: 36C248-26-AP-1635

Xpert-Cdifficile/Epi GXCDIFF/EPI-10 10 On demand PCR test to detect and differentiate the epidemic strain of C difficile (027/NAP1/BI).

Xpert Xpress Strep A XPRSTREPA-10 80

On demand PCR test that accurately diagnose GAS. Supports antimicrobial stewardship and may reduce the amount of patient inappropriately prescribed antibiotics.

Xpert Carba-R GXCARBAR-10 20 On demand PCR test that can detect and differentiate the most prevalent carbapenemase gene families in just 48 minutes.

Xpert CT/NG GXCT/NG-10 500 On demand PCR test to detect the presence of chlamydia and gonorrhea, the most prevalent of all reportable STDs.

Xpert Xpress MVP XPRSMVP-10 100 On demand PCR test to aid in the diagnosis of vaginal infections in symptomatic women within an hour.

Xpert Xpress COVID PLUS XPRS-COV2-10 260

On-demand PCR test designed to detect SARS- CoV-2 (COVID-19) RNA in upper respiratory specimens. The PLUS version includes additional targets to improve detection of emerging variants and provides results in approximately 30 minutes.

Xpert Xpress COV-

2/FLU/RSV PLUS XPRS4PLEX-10 460

On-demand PCR test that simultaneously detects and differentiates SARS-CoV-2, Influenza A, Influenza B, and Respiratory Syncytial Virus (RSV) from a single patient sample. Results are available in about 36 minutes, supporting rapid diagnosis of respiratory infections with overlapping symptoms.

3. Statutory Authority Permitting Restricted Competition:

Revolutionary FAR Overhaul Part 12 - Acquisition of Commercial Products and Commercial Services.

The statutory authority for applying the Simplified Procedures for Commercial Items is 41 U.S.C. § 1901 and is implemented by RFO 12.102(b) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(X) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

Effective Date: 12/30/2025 Page 3 of 5

Acquisition ID#: 36C248-26-AP-1635

4. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): The supplies required are proprietary for a highly specialized analyzer that was previously purchased for the medical center.

The requested test types/ consumables approved by the Food & Drug Administration (FDA) for use for patient infectious disease testing and surveillance are specific to the GeneXpert equipment previously purchased and currently in place and are being used with the Pathology and Laboratory Departments at C.W. Bill Young Department of Veterans Affairs Medical Center and Lee County Community-Based Outpatient Clinics (CBOC). The requesting activity owns and will continue to operate the Cepheid GeneXperts to complete patient testing. The requested Cepheid multi-drug resistant organisms (MDRO) reagents are only compatible with this instrument. To guarantee the reagents quality and integrity is maintained, Cepheid does not use distributors. This allows for the replacement of any consumables directly and expeditiously if performance is not maintained at 100% acceptability. Additionally, use of any other consumables may result in standardization errors and misdiagnosis of patient testing samples. Use of any other type of consumables would also void all equipments warranties and product liability regulations. Additionally, procuring the Cepheid reagents prevents a duplication of cost that would occur if multiple testing platforms were purchased.

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

5. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

Sources Sought Synopsis: A notice of intent to sole source was issued on December 18, 2025 through January 09, 2026 at 1:00PM EST under 36C24826Q0193 for Cepheid MDRO reagents used in the Cepheid GeneXpert Infinity analyzer for the Bay Pines VA Healthcare System. No relevant responses were received.

6. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated cost to the Government will be considered fair and reasonable utilizing the information based on a comparison of proposed prices with prices found reasonable on previous purchases. The final contract price will be fair and reasonable as a comparison will be made with current VA contracts.

7. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted: A query on SBA Small Business Search (SBS) website was made on NAICS code 325413, In-Vitro Diagnostic Substance Manufacturing, resulting in 131 Service- Disabled Veteran Owned Small Business (SDVOSB)/ 139 Veteran Owned Small Business (VOSB) vendors that can possibly fulfill this requirement. This is a sole source requirement due to the compatibility of reagents and supplies with the analyzer, GeneXpert Infinity that has been previously procured for the facility with a remaining life expectancy of four years.

The GSA eLibrary catalog was queried with the vendor name “Cepheid”. There was one record found, GS-07F-0597T. A review of the terms and conditions show that the scope of the GSA contract is for the analyzers that the facility already owns. It does not appear that a Cost Per Test or Cost Per Reportable Result Agreement is within scope of the contract.

Effective Date: 12/30/2025 Page 4 of 5

Acquisition ID#: 36C248-26-AP-1635

Federal Procurement Data System (FPDS) was queried using the keyword “Cepheid” and filtering down to the Deparment of Veterans Affairs. The most recent procurements have been either purchase orders or delivery orders off of internal VA Indefinite Delivery Indefinite Quantity Contracts (open market). According to FPDS historical information, the most recent award made for internal Indefinite Delivery Indefinite Quantity (IDIQ) contracts was 36C26325D0005. This was awarded to Cepheid on 10/01/2024 for Network Contracting Office (NCO) 23 as a single award IDIQ in the procurement value of $7,489,000.00 for a period of five years. According to the record, this was non-competitive.

A notice of intent to sole source was issued on December 18, 2025, through January 09, 2026, at 1:00PM EST under 36C24826Q0193 for Cepheid MDRO reagents used in the Cepheid GeneXpert Infinity analyzer for the Bay Pines VA Healthcare System. No relevant responses were received.

Based on emails with the subject matter expert in the lab, the remaining life of the Government owned analyzers is 3.5 years. According to their records, GeneXpert Infinity-48S was acquired on 9/27/2019. It is due to be replaced approximately 09/27/2029 There is reason to believe that a 3.5 year IDIQ would be beneficial to the Government.

As described in Section 6 above, market research, in accordance with RFO Part 10, was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties.

8. Any Other Facts Supporting the Use of Other than Full and Open Competition: Specifications, statements of work, and purchase descriptions suitable for full and open competition are not available due to the proprietary nature of reagents being particular to the molecular analyzer.

Cepheid’s GeneXpert Infinity has already been purchased for the facility. Cepheid is the only distributor and sole manufacturer of the MDRO reagents compatible with the current equipment.

9. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: No relevant responses were received on the Notice of Intent to Sole Source 36C24826Q0193 posted on Contract Opportunities on December 18, 2025.

10. 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:

The Government will track the life expectancy of the analyzer. When it is time to procure a new analyzer, the procurement for the analyzer and reagents will be competed to the maximum extent practicable. In the future, if another vendor supplies a suitable alternative, their qualifications will be evaluated. The market will be continually assessed to determine if other vendors can provide the required supplies.

Approval is being sought for more than one year, as this is a recurring requirement. A sole source effort is required for the planned time duration for continuity of patient care.

11. 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, Effective Date: 12/30/2025 Page 5 of 5

Acquisition ID#: 36C248-26-AP-1635 which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Date Supervisory Clinical Laboratory Scientist – Hematology Pathology and Laboratory Medicine Service Bay Pines VA Healthcare System

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

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

Contracting Officer Network Contracting Office (NCO) 08

b. One Level Above the Contracting Officer (Required over $350K but not exceeding $900K): I certify the justification meets requirements for other than full and open competition.

Branch Chief

Network Contracting Office (NCO) 08

c. VHA Advocate for Competition and 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 approve ($900K to $9 million for other than full and open competition.)

Head of Contracting Activity, East

01/23/2026

01/23/2026

1/27/2026

2/2/2026