JOFOC 36C257-26-AP-1235 v4 Final Approved.pdf

Effective Date: 11/15/24 Page 1 of 6

REVISION: 01

Acquisition ID#: 36C257-26-AP-1235

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH RFO FAR 12.102(b) Restricting Competition

Acquisition Plan Action ID: 36C257-26-AP-1235 RPOW Tracking Number: FY26 - NCO 17 - 406

1. Contracting Activity:

Department of Veterans Affairs, Network Contracting Office 17, located at 5441 Babcock Rd., Ste. 302, San Antonio, TX 78240, in support of Veterans Integrated Service Networks (VISN) 17. VISN 17 locations are listed below.

a. VA Amarillo Healthcare System (AMA), 6010 Amarillo Blvd. W., Amarillo, TX 79106

b. VA Central Texas Healthcare System (CTX), 1901 Veterans Memorial Dr., Temple, TX 76504

c. VA El Paso Healthcare System (ELP), 5001 N. Piedras St., El Paso, TX 79930

d. South Texas Veterans Healthcare System (STX), 7400 Merton Minter Blvd., San Antonio, TX

78229

e. VA Texas Valley Coastal Bend Healthcare System (VCB), 2601 Veterans Dr., Harlingen, TX

78550

f. West Texas VA Healthcare System (WTX), 300 Veterans Blvd., Big Spring, TX 79720

Funding will be provided through separate task orders.

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

This procurement is for the consolidation of Cepheid GeneXpert maintenance and repair (M&R) services in accordance with RFO FAR 12.102 where acquisitions conducted under Simplified Acquisition Procedures require justification using the format of RFO FAR 6.104.

VISN 17 requires M&R services for VA-owned Cepheid GeneXpert analyzers used to test for infectious diseases, such as Methicillin-resistant Staphylococcus aureus (MRSA), COVID-19, Respiratory Syncytial Virus (RSV), and the flu. This requirement will be awarded as a new, firm fixed price, single award indefinite delivery, indefinite quantity (IDIQ).

This requirement is a consolidation of five (5) existing contracts for CTX, NTX, AMA, STX, and WTX, and a new contract for VCB. All existing contracts were awarded as sole source acquisitions to Cepheid. To comply with Executive Order 14271 (Ensuring Commercial, Cost-Effective Solutions in Federal Contracts), a consolidation of these contracts, with the addition of the VCB services, was determined to be appropriate as the consolidation would save the Government an estimated 259 days (6,216 hours) in Contracting Activity labor over a five-year period and would standardize the required commercial services for GeneXpert analyzers across VISN 17.

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

VISN 17 requires M&R services for the Cepheid GeneXpert analyzers, to include technical support, preventative maintenance, repairs, software updates, and new Original Equipment Manufacturer (OEM) replacement parts. See the table below for the services required under the proposed IDIQ.

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Acquisition ID#: 36C257-26-AP-1235

Description Quantity Unit of Measure

GeneXpert Infinity Service Agreement - El Paso 1 YR

GeneXpert Infinity Service Agreement - South Texas 1 YR

GX 16-16 Advantage Service Agreement - Central Texas (3 Analyzers) 3 YR

GeneXpert Advantage Service Agreement - Big Spring 1 YR

GeneXpert Advantage Service Agreement – Amarillo (4 Analyzers) 4 YR

GeneXpert Service Agreement - Valley Coastal Bend (3 Analyzers) 3 YR

Reinstatement Fee* 3 YR

*The reinstatement fee would only apply to ordering period 1 for VCB.

This requirement will be for five (5) one-year ordering periods:

a. Ordering Period 1: 7/1/2026-6/30/2027

b. Ordering Period 2: 7/1/2027-6/30/2028

c. Ordering Period 3: 7/1/2028-6/30/2029

d. Ordering Period 4: 7/1/2029-6/30/2030

e. Ordering Period 5: 7/1/2030-6/30/2031

The total estimated value of this proposed IDIQ is $1,250,000.00.

4. Statutory Authority Permitting Restricted Competition:

RFO FAR 12.102, Restricting Competition. The statutory authority for applying the Simplified

Acquisition Procedures RFO FAR 12.102 is 41 U.S.C. § 1901 and is implemented by RFO FAR 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

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

Based on the market research conducted detailed in Paragraph 8 below, M&R services for equipment manufactured by OEM, Cepheid, can only be provided by the OEM. Cepheid has stated that they are the only vendor that can provide services and have no authorized third parties certified as field service engineers (FSEs).

Due to the platform complexity for specialized testing, it is invaluable the VA acquires a service agreement contract to support the needs of service to maintain the analyzers in peak operating performance, ensuring continued patient testing. If the equipment were to be serviced by a third-party vendor that is not certified by the OEM, the equipment could be deemed inoperable and require the Government to replace the equipment. A new GeneXpert analyzer costs about $250,000.00 and each requires at least 30 days to install and validate. With some stations using as many as four (4) analyzers, the cost of replacing the inoperable equipment would exceed $1,000,000.00 and could delay in-house testing, and therefore patient care, by at least 90 days, including procurement times.

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Acquisition ID#: 36C257-26-AP-1235

Accordingly, Cepheid is the only firm capable of providing the supplies and services described in Paragraph 3 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.

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

Market research was conducted in accordance with RFO FAR part 10 and VAAR part 810 to determine if there are any SDVOSBs, VOSBs, or any other small businesses that appear capable of providing the required services at a fair and reasonable price. Market research results are detailed in Paragraph 8 below. Only one (1) large business vendor, Cepheid, was found to be able to provide the required services.

A Notice of Intent (NOI) to sole source was issued in place of a Sources Sought Notice. The NOI, 36C25726Q0147, was issued on 12/1/2025 and closed on 12/10/2025. Upon closure of the NOI, no responses were received.

Cepheid was contacted, via email, on 12/2/2025 requesting if there were any third parties authorized to provide the required M&R services. Cepheid responded on 12/10/2025, providing a sole source letter and stating that “… Cepheid does not work with third-party service distributors for the VA.”

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

The CO anticipates that pricing will be fair and reasonable. Pricing will be determined fair and reasonable based on the five (5) existing contracts in place in accordance with RFO FAR 12.204(a).

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

Market Research Was Not Conducted:

Market research was conducted in accordance with RFO FAR part 10 and VAAR part 810 between November and December 2025.

Searches were conducted on the Small Business Administration’s (SBA) Small Business Search Tool, General Services Administration (GSA) eLibrary, Ability One, Federal Prison Industries (UNICOR), System for Award Management (SAM), the Internet, a NOI, and contacting the GeneXpert OEM, Cepheid.

a. Small Business Search Tool (SDVOSB and VOSB searches):

i. A search of NAICS Code 811210 was conducted. This resulted in 831 SDVOSBs and

VOSBs.

ii. To narrow the results for the specific equipment requiring services, the search was updated to include keyword “GeneXpert.” This resulted in 0 SDVOSBs and VOSBs.

b. Small Business Search Tool (All Small Businesses):

i. A search of NAICS Code 811210 was conducted. This resulted in 6,226 small businesses.

ii. ii. To narrow the results for the specific equipment requiring services, the search was updated to include keyword “GeneXpert.” This resulted in 0 small businesses.

c. GSA eLibrary:

i. A search on GSA eLibrary for “GeneXpert” resulted in Schedule 334516. This schedule is for supplies only. No services are provided under this schedule.

d. Ability One:

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Acquisition ID#: 36C257-26-AP-1235

i. A search for “GeneXpert” resulted in 0 vendors.

e. UNICOR:

i. A search for PSC Code J066 resulted in 0 vendors.

f. SAM:

i. SAM was used to verify business sizes of vendors found that were not registered on the SBA Business Search Tool database. Vendor business size for small business vendor indicated in paragraph h below was verified using SAM.

g. NOI:

i. Notice of Intent, 36C25726Q0147, was issued on 12/1/2025, and closed on

12/10/2025. No vendors responded to the notice.

h. Internet Search:

i. A search for “GeneXpert analyzer maintenance services” resulted in one (1) large business vendor capable of providing the required services, Cepheid. One (1) small business vendor, Diamond Diagnostics, appeared in the search results, but the vendor only sells refurbished GeneXpert equipment. This requirement is for services, not equipment; Diamond Diagnostics does not appear to be able to provide services for Cepheid equipment.

i. Contacting the OEM:

i. Cepheid was contacted, via email, on 12/2/2025 requesting if there were any third parties authorized to provide the required M&R services. Cepheid responded on 12/10/2025, with a sole source letter and stating that “… Cepheid does not work with third-party service distributors for the VA.”

j. Buy American Act/ Trade Agreement Act:

i. This does not apply as this requirement is for services. The cost of supplies, if any, is anticipated to be below the micro-purchase threshold.

Based on the market research conducted above, only Cepheid appears to be capable of providing the required equipment and maintenance services for the existing Government-owned equipment.

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:

Cepheid 904 E. Caribbean Dr.

Sunnyvale, CA 94089 Rita Reis rita.reis@cepheid.com

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:

Prior to the award of any order, market research will be conducted to determine if the marketplace has changed and there are authorized distributors capable of providing the required services. If other vendors are found, and market research determines that a lower price can be obtained through competition, then a new solicitation will be issued in lieu of issuing new order(s).

Effective Date: 11/15/24 Page 5 of 6

Acquisition ID#: 36C257-26-AP-1235

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.

Sandra Austin Date Administrative Officer Pathology and Laboratory Medicine Service VA Texas Valley Coastal Bend Healthcare System

Effective Date: 11/15/24 Page 6 of 6

Acquisition ID#: 36C257-26-AP-1235

13. 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.

Delphia Schoenfeld Date Senior Contract Specialist/Contracting Officer Laboratory Services Support Network Contracting Office 17

b. One Level Above the Contracting Officer: I certify the justification meets requirements for other than full and open competition.

Michael J. Tusinger Date Branch Chief Laboratory Services Support

c. Director of Contracting: I certify the justification meets requirements for other than full and open competition.

Mark A. Layman Date Director of Contracting

d. 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 approve ($900K to $9 million or $15.0 million for acquisitions described in RFO FAR 12.001(c)) for other than full and open competition.

Curtis M. Jordan Date Executive Director, Regional Procurement Office West Head of Contracting Activity (HCA) https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx VHASTXSchoeD Typewritten Text 1/20/2026