JFOC_Redacted _2.pdf

Acquisition ID#: 36C242-26-AP-1943 Page 2 of 5 isolate within an hour using mass spectrophotometry is required, as the improved turnaround time will be integral in improving the prognosis for numerous types of infectious diseases.

Additionally, a blood culture incubation and growth detection system (Bact/Alert Virtuo) is necessary to alert staff as soon as growth is detected, allowing critical results to be reported promptly to providers who can then adjust patient care accordingly. For this system, compatible collection containers (Bact/Alert aerobic and anaerobic blood culture bottles) are required.

Furthermore, an alert system is needed to notify staff in various clinical laboratory areas when growth in blood cultures is detected, enabling a 24/7 response during off-hours. A common middleware solution (Maestra) is also required to correlate patient results between different platforms and facilitate interfacing results into the patient record.

4. Statutory Authority Permitting Restricted Competition:

RFO FAR 12 Acquisition of Commercial Products and Commercial Services. The statutory authority for applying procedures for Commercial Items of FAR 12 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) (1) 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;

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

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

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

( ) (5) Authorized or Required by Statute per 41 U.S.C. § 1901 as implemented by RFO FAR 12.201-1;

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

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

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

Biomerieux is the only vendor capable of meeting all the needs listed above, including the identification of yeast species, which is a new VA requirement. They are able to provide bacterial identification, susceptibility testing, blood culture detection, a remote alert system, and middleware to all the VA facilities listed above. No other vendor is available to satisfy this requirement.

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

In accordance with FAR Part 10 and VAAR Part 810, market research was conducted from January 2026 through March 2026. A search in GSA and Veteran Small Business Certification (VetCert) using NAICS code 334516 and PSC 6550 yielded no results, including zero SDVOSB and zero VOSB that could potentially satisfy the requirement. The Contracting Officer also conducted a search in the Supply Chain Master Catalog (SCMC) and FPDS from SAM.gov for similar requirements over the past six months and found that multiple similar procurements were also awarded to Biomerieux. An intent to sole source (36C24226Q0333) was also published, and only Biomerieux Inc. responded.

Acquisition ID#: 36C242-26-AP-1943 Page 3 of 5 sections 2 and 5 of this justification. Based on these findings, the Contracting Officer has conducted the minimum required market research, detailed on line 8 below. The VISN 2 Downstate Bacterial ID/Susceptibility and Blood Culture acquisition committee and the CO will continue to identify potential sources and determine an appropriate procurement strategy for future acquisitions.

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 speaking with and comparing quotes received from the market research conducted, as well as discussions with , Federal Government Contract Lead from Biomerieux, regarding the pricing terms. The quoted pricing is subject to revision each calendar year, with at least one (1) month prior notice to the customer in the event of a price adjustment. The quoted pricing assumes the customer enables deployment of the software or software service within six (6) months of the effective date; failure to prices for reagents, excluding the RP2.1 Panel and GI Panel, will increase by 3% in Option Years 2 and 4, effective on the first anniversary of the effective date and each subsequent anniversary. Price increases will apply to all new orders placed after the applicable anniversary. The CO believes these terms are acceptable given current economic conditions and the rising costs of goods and services.

Furthermore, Biomerieux has been supporting the sites listed above (with the exception of the Bronx) for the past five years, and their prices have consistently been fair to the VA.

The CO also determined from the market research conducted including a comparison with the Independent Government Cost Estimate, the previous contract (36C24221D0066), and SCMC pricing ing shows only a slight increase compared to the past five years' long-term contract and SCMC pricing from 2025 and earlier. Although the vendor is proposing a 3% price increase in Option Years 2 and 4, the CO considers this reasonable given the prevailing economic climate and increasing costs of goods and services. This indicates that the prices are at current market rates, reinforcing that they are fair and reasonable.

Acquisition ID#: 36C242-26-AP-1943 Page 4 of 5

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

Market Research Was Not Conducted:

In accordance with FAR Part 10 and VAAR Part 810, a market research was conducted using the SBA was posted on Contract Opportunities (SAM.gov), and only Biomerieux Inc. responded. The search in the DSBS tool revealed zero (0) SDVOSBs, zero (0) VOSBs, and zero (0) small businesses that could potentially meet the requirement. The intent to sole source was posted on Contract Opportunities from February 06, 2026, through February 12, 2026, and received zero (0) responses.

Biomerieux is the Original Equipment Manufacturer (OEM) of the equipment and supplies and has provided a letter to the Contracting Officer confirming this. The equipment is proprietary, and no other reagents, accessories, vendor-leased, or preventive maintenance services would be compatible with the equipment for this requirement.

Based on market research, the Contracting Officer concludes that there are insufficient SDVOSB or VOSB firms 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, and competition would not be appropriate for this procurement. Recent past performance was also confirmed with the Original Equipment Manufacturer that they have no distributors or resellers authorized to serve the VA.

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:

The Bacterial Identification and Susceptibility Testing market is well-defined, with a finite number of vendors capable of providing these services. The potential vendor, BIOMERIEUX, INC, has been identified as the only one that can meet all the requirements, including identifying yeast species, which is a new VA requirement. The OEM providers have confirmed that they have no distributor or reseller that deals with the VA on their behalf, and this procurement has been awarded to the same vendor for the past five years.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: