P03. SSJ 36C248-26-AP-2988_Redacted.pdf

Revision: 02 Effective Date: 12/30/2025 Page 1 of 2 Acquisition ID#

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW Revolutionary FAR Overhaul (RFO) 12.102(a)

For Over Micro-Purchase Threshold but Not Exceeding the Simplified Acquisition

Threshold

Acquisition Plan Action ID:

1. Contracting Activity: Department of Veterans Affairs (VA), Veterans Health

Administration (VHA), Regional Procurement Office East, Network Contracting Office 08 (NCO 08) located at 8875 Hidden River Parkway, Suite 160, Tampa, Florida 33637, in support of VISN 08 Bay Pines VA Health Care System (BPVAHCS), C.W. Bill Young (CWBY) Department of Veterans Affairs Medical Center (VAMC) at 10,000 Bay Pines Blvd. Bay Pines, FL 33744.

2237:

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: Renewal of annual service coverage (Premier Care and Essential Care plans) for two GeneXpert diagnostic analyzers [Serial Number (SN)

]. Coverage includes Preventative Maintenance, repairs, parts, labor, module swaps, uptime guarantee, software updates, and loaner equipment per Original Equipment Manufacturer (OEM) terms. The estimated procurement value is .

Period of Performance:

Base Year: June 17, 2026 - June 16, 2027 Option Year 1: June 17, 2027 - June 16, 2028 Option Year 2: June 17, 2028 - June 16, 2029 Option Year 3: June 17, 2029 - June 16, 2030 Option Year 4: June 17, 2030 - June 16, 2031

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The GeneXpert Infinity 48S-32 (SN ) and GeneXpert GXIV-4 (SN ) are proprietary diagnostic systems manufactured exclusively by Cepheid. All preventative maintenance, repairs, module replacements, software updates, and uptime guarantee services are controlled solely by the OEM. The attached Cepheid service agreement specifies that all maintenance activities — including replacement of worn module ejectors, lubrication of moving parts, fan filter replacement, optics cleaning, automation battery replacement, and annual Xpert Check diagnostics — must be performed by Cepheid-certified field service engineers. No third parties are authorized or certified to perform these tasks. The required annual Xpert Check kit, performance

Revision: 02 Effective Date: 12/30/2025 Page 2 of 2 Acquisition ID# verification procedures, proprietary diagnostics, and software updates are supplied only by the OEM and cannot be procured independently or through any reseller.

Only Cepheid possesses the proprietary software, diagnostic tools, specialized components, and rights to perform module swaps, loaner system provisioning, and uphold the contractual 98% uptime guarantee for the GeneXpert Infinity system. Use of non-OEM service providers would void manufacturer support, jeopardize system certification, and violate the technical and regulatory requirements for these clinical diagnostic platforms. No alternative service vendor or aftermarket provider has legal access to the OEM parts, firmware, test cartridges, loaner systems, or calibration tools necessary to meet the required specifications. Therefore, Cepheid is the only responsible source capable of providing the mandatory maintenance and service coverage for these analyzers.

4. Description of market research conducted and results or statement why it was not conducted: An Small Business Administration (SBA) Small Business Search (SBS) search utilizing NAICS code 811210 yielded 753 Service-Disabled Veteran Owned Small Business (SDVOSB)/ 873 Veteran Owned Small Business (VOSB) vendors that can possibly fulfill this requirement. Market research was conducted through a review of SAM.gov, Analytics, Data, and Decision Support Unified Platform (ADDSUP), prior Government procurements, and available commercial service providers. This research confirmed that maintenance and repair services for the Government-owned Cepheid GeneXpert equipment can only be obtained directly from the Original Equipment Manufacturer (OEM), Cepheid. No third-party vendors are authorized or capable of providing OEM-compliant service, proprietary diagnostics, certified parts, or required software support. All previous federal purchases for GeneXpert service agreements have been awarded directly to Cepheid, and no alternate sources were identified. Based on these findings, the market research supports a sole-source acquisition to the OEM.

5. Contracting Officer's Certification: Purchase is approved in accordance with RFO

12.102(a). I certify that the foregoing justification is accurate and complete to the

Date

Contracting Officer