P03. SSJ 36C248-26-AP-4652_Redacted.pdf

Revision: 02 Effective Date: 12/30/2025 Page 1 of 2 Acquisition ID# 36C248-26-AP-4652

DEPARTMENT OF VETERANS AFFAIRS

Justification for Sole 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: 36C248-26-AP-4652

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), Lee County VA Clinic at 2489 Diplomat Parkway East, Cape Coral, FL 33909-5422.

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The Bay Pines VA Healthcare System requires the purchase, delivery, installation, testing, and onsite training for one (1) Rapid Antigen Testing System (Analyzer: Laboratory Molecular Assay – Infectious Organism) for the Lee County VA Clinic. The system shall include all components necessary for full operation, including a desktop computer with Windows 11 or later, monitor, printer, uninterruptible power supply (UPS), daisy chain kit, and all associated accessories required for installation and operation.

The contractor shall provide installation, system testing, operator training, operational manuals, and warranty support to ensure the equipment is fully operational and ready for clinical use upon acceptance. The requested equipment will support rapid molecular testing for infectious organisms and provide timely diagnostic results for Veterans receiving care at the Lee County VA Clinic. The estimated procurement value is .

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The Bay Pines VA Healthcare System currently uses Cepheid GeneXpert systems throughout its healthcare network. Buying another GeneXpert for the Lee County clinic keeps every laboratory using the same equipment and the same testing process/ methodology.

The requested instrument is required to maintain standardization of laboratory operations across the healthcare system. Utilizing the same instrumentation and testing methodology ensures consistency in laboratory workflows, quality control processes, test performance, staff training, and competency assessments.

Standardization minimizes the risk of user error, reduces staff confusion when

Revision: 02 Effective Date: 12/30/2025 Page 2 of 2 Acquisition ID# 36C248-26-AP-4652 rotating between facilities, and promotes consistent patient testing practices throughout the healthcare system.

Acquiring a different manufacturer's analyzer would require implementation of a separate testing methodology, additional staff training, revised standard operating procedures, validation of new testing processes, and maintenance of multiple platforms. This would increase operational complexity, create unnecessary inefficiencies, and increase the potential for errors in patient testing.

Because the Bay Pines VA Healthcare System has already standardized on this platform, procurement of the same manufacturer's instrument is in the Government's best interest to ensure continuity of operations, maintain consistent laboratory practices, and support safe and efficient patient care.

This justification is based on the need for compatibility, operational standardization, and continuity of clinical laboratory services rather than on a preference for a particular vendor.

4. Description of market research conducted and results or statement why it was not conducted: Market research was limited because the requiring activity identified the Cepheid GeneXpert platform as necessary to meet the Government's minimum needs for compatibility and standardization across the Bay Pines VA Healthcare System. The Contracting Officer contacted Cepheid to verify the availability of the required instrument and confirmed that Cepheid is the manufacturer of the GeneXpert platform. Manufacturer information, available product literature, and prior acquisition history were also reviewed.

Based on this market research, no other manufacturer was identified that could provide an instrument fully compatible with the existing GeneXpert platform and capable of meeting the Government's minimum requirements for standardized laboratory operations. Accordingly, additional market research was not expected to identify another manufacturer capable of satisfying the Government's minimum needs.

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 best of my knowledge and belief.

Date

Contracting Officer