FAR 12.201-1 Sole Source Justification Over SAT 36C242-26-AP-2203_Redacted.pdf

Acquisition ID#: 36C242-26-AP-2203

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 12.201-1

Acquisition Plan Action ID: 36C242-26-AP-2203

1. Contracting Activity: Department of Veterans Affairs, VISN 02, VA Hudson Valley Healthcare

System, Montrose campus, 2094 Albany Post Road, Montrose, New York 10548, seeks to procure as a sole source, firm-fixed price award Cepheid PCR molecular testing equipment, reagents, accessories, lease and maintenance service for 6 months for Organizational Activities: James J. Peters VAMC 130 W. Kingsbridge Road, Bronx, New York 10468, New York Harbor Healthcare System Margaret Cochran Corbin VAMC 423 East 23rd Street, New York, NY 10010, New York Harbor Healthcare system Brooklyn VAMC 800 Poly Place, Brooklyn, NY 11209, Hudson Valley Castle Point VAMC, 41 Castle Point Road, Wappinger Falls, NY 12590, New Jersey Healthcare system East Orange VAMC 385 East Tremont, New Jersey 07018, and Northport VAMC 79 Middleville Road, Northport, NY 11768 Molecular laboratory departments through transaction #s 526-26-3-145-0037,561-26-3-040-0040,620- 26-3-124-0044,630-26-3-035-0123,632-26-3-080-0076 funded actions.

2. Nature and/or Description of the Action Being Processed: The action under this justification is to award a sole-source, firm-fixed price contract for Cepheid brand Polymerase Chain Reaction (PCR) Molecular Testing equipment, reagents, accessories, and lease and preventative maintenance service for six (6) months until a new long-term contract can be established.

3. Description of Supplies/Services Required to Meet the Agency�s Needs: This requirement is for continued use of government-owned and contractor -provided Cepheid GeneXpert and Infinity instruments that provide Polymerase Chain Reaction (PCR) Molecular Diagnostic Testing. This will allow the facilities to continue testing until a new long-term contract can be established. The following VA medical facilities own their instruments: East Orange VAMC (secondary platform only), Castle Point VAMC (no secondary platform), FDR VA Hospital (no secondary platform), Margaret Cochran Corbin VAMC (primary platform only), and Brooklyn VAMC (no secondary platform). The following VA medical facilities have been provided with Contractor-owned instruments, payable on a monthly lease and preventative maintenance agreements: James J. Peters VAMC (primary and secondary platforms), East Orange VAMC (primary platform only), Margaret Cochran Corbin (primary platform only), and Northport VAMC (primary and secondary platforms). All of the equipment requires a lease and a preventative maintenance service. For maintenance, this includes regularly scheduled inspections, equipment servicing, and preemptive repairs should the equipment suffer any unexpected failures or downtime.

A contractor-provided secondary analyzer instrument is utilized at both James J. Peters and Northport VAMCs to facilitate testing of one or two assays during evening and night shifts when the Molecular department is closed.

All medical facilities on this contract require molecular reagent kits. The contractor is required to provide, according to the specification outlined below, testing supplies for MRSA, C.difficile (with or without epidemic strain 027), COVID-19, influenza, RSV, Chlamydia trachomatis/Neisseria gonorrhea. MTB and RIF resistance, strep group A, T.vaginalis, Carbapenemase producing organism identification, MRSA/S.aureus blood culture identification, MVP identification, and all necessary equipment, reagents, standards, controls, supplies, consumables/disposable items, parts, accessories, and cabinets to support or house the analyzer (if necessary). Additionally, the contractor must supply universal interface equipment and any other items required for the proper operation of PCR Molecular testing, facilitating the generation of Cost-Per-Kit (CPK) services.

The VA requires the molecular reagent kits for the following tests on a single platform on the primary analyzer:

a. Methicillin Resistant Staphylococcus Aureus (MRSA).

b. Clostridium difficile with identification of 027 strain.

c. Influenza A, B, RSV.

d. Chlamydia trachomatis/Neisseria gonorrhea.

e. Mycobacterium tuberculosis complex.

f. Streptococcus pyogenes.

g. Trichomonas Vaginalis.

h. Carbapenemase-producing organism identification with differentiation among the major families of resistant genes.

i. MRSA/SA Blood Culture identification.

The VA requires the molecular regent kits for the following test on a secondary analyzer:

a. Clostridium difficile with identification of the 027 strain.

b. Influenza A, B, RSV.

The period of performance for this contract action is from April 01, 2026, to September 30, 2026.

Estimated Value:

Anticipated award date is April 01, 2026.

4. Statutory Authority Permitting Restricted Competition:

FAR 12.101-1 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items is 41 U.S.C. § 1901 and is implemented by RFO FAR 12.201-1 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 per 41 U.S.C §1901 as implemented by RFO FAR 12.201-1.

( ) Unusual and Compelling Urgency per 41 U.S.C §1901 as implemented by RFO FAR 12.201-1.

( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 U.S.C. §1901 as implemented by RFO FAR 12.201-1.

( ) International Agreement per 41 U.S.C. §1901 as implemented by RFO FAR 12.201-1.

( ) Authorized or Required by Statute per 41 U.SC.§1901 as implemented by RFO FAR

12.201-1.

( ) National Security per 41 U.S.C §1901 as implemented by RFO FAR 12.201-1.

( ) Public Interest per 41 U.S.C.§1901 as implemented by RFO FAR 12.201-1.

5. Demonstration that the Contractor�s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Cepheid is currently the only company that can provide the supply/services outlined in section 3 above. The Polymerase Chain Reaction (PCR) Molecular Diagnostic testing platform uses a single-use X-pert test cartridge. This fully automated device handles sample extraction, PCR amplification, and detection, offering a simple workflow with minimal hands-on time and the ability to operate without constant supervision. It features an easy-to-use random-access system designed for on-demand testing. Results from PCR testing are fast and accurate, usually available in under an hour, and the system can interface with a Laboratory Information System (LIS) and electronic medical records (EMR).

The incumbent contractor, Cepheid, is already delivering these services, and a long-term contract is in the process of being established for continued use. This requirement will allow Cepheid to continue providing highly specialized patient care testing for the molecular laboratory department without any interruptions.

If this 6-month requirement is not approved, the molecular laboratory department will lose the ability to test and order supplies, which will cause interruption of laboratory department services at six (6) medical center facilities in VISN 2. The contractor has an active SAM registration, and their performance on the current contract is satisfactory or better. For these reasons, it is in the Government�s best interest to approve this requirement and ensure uninterrupted service from the incumbent contractor until a new contract is awarded.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: It is not feasible to obtain competition based on market research, as the criteria for the �Only one Responsible source� under FAR Acquisition Regulation (FAR) is met, as outlined in sections 2 and 5 of this justification. Based on this fact, the Contracting Officer conducted minimum market research outlined on line 8 below. For requirements after September 30, 2026, a procurement package is currently being developed that will incorporate findings from market research. That package will identify potential sources and determine an appropriate procurement strategy.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: In accordance with (IAW) FAR 12.201-1(e)(1), the Contracting Officer (CO) has determined that the proposed prices are fair and reasonable. This assessment was made by comparing the price for lease and preventative maintenance service for the NJ GeneXpert

Infinity 48-48 analyzer under Purchase order# 36C24225P0795, the current contract. The lease and one-month preventive maintenance service are priced at , and the same analyzer service is priced at , reflecting the same price.

Additionally, the CO compared the reagent catalog number# XPRS4PLEX-10 for Xpress COVID-2/FLU/RSV plus testing, listed in the same current contract for all sites, which costs per kit. This contract also has this reagent at the same price of . This indicates that the prices for lease and preventive maintenance, as well as reagents, are at current market rates, reinforcing that they are fair and reasonable.

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

Market Research Was Not Conducted: A quick search was conducted in the SBA Dynamics small business search tool (formerly DSBS) utilizing NAICS 334516 Keyword �PCR Molecular Testing�, as well as an intent to sole source posting to contract opportunities (SAM.gov).

The results of the search in the DSBS search tool revealed a potential of zero (0) SDVOSBs, zero (0) VOSBs, and zero (0) Small businesses that could be potential sources for the requirement. An intent to sole source was posted on Contract Opportunities from February 26, 2026, through March 12, 2026, which resulted in zero (0) responses. Cepheid is the Original Equipment Manufacturer (OEM) of the equipment and supplies and has supplied the Contracting Officer with a letter confirming that fact. The equipment is proprietary, and no other reagents, accessories, vendor-leased, or preventative maintenance service would be compatible with the equipment for this requirement. The Contracting Officer concludes, based on market research, that there are insufficient SDVOSB or VOSB with both interest and capability to meet the VA Rule of Two as defined by VAAR 819.70. Therefore, a set-aside for SDVOSB or VOSB providers is not a viable strategy at this time. It is determined that competition would not be appropriate for this need. Recent past performance was discussed with the Contracting Officer�s Representative (COR), and no issues were found.

Additionally, the Buy American Act (BAA) applies. A review of the vendor�s Trade Agreement Certificate under FAR 52.225-6 will be conducted to assess compliance with

BAA.

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

UEI: W6HQTMWB9Q28

904 East Caribbean Drive Sunnyvale, CA 94089

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: To remove or overcome barriers to competition, the participating station labs have established a committee to conduct a market survey, identify changes in their requirements, and create