S02_JnA_Q0054_Allsigned_.pdf

Effective Date: 12/30/2025 Page 1 of 3 Revision: 02 Acquisition ID#: 36C77026Q0054

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR

CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 761-26-2-014-0044

1. Contracting Activity: The Department of Veterans Affairs, NCO 15 – CMOP Division - Contracting Office will be procuring this acquisition for one (1) medical surgical products.

Contracting office will utilize 2237# 761-26-2-014-0044 for the replenishment of low stock at the Chelmsford CMOP.

2. Nature and/or Description of the Action Being Processed: This procurement is for 400 - Atos - HEAT & MOISTURE EXCHANGER, PROVOX #8262; a medical surgical supply. In accordance with RFO FAR 12.102 Restricting competition and RFO FAR 12.202 Publishing Commercial Product where acquisitions conducted under RFO FAR 12.201-1 Simplified Acquisition Procedures require a justification using the format of RFO FAR 6.103-5. The proposed procurement action will be a new firm-fixed-price contract.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: This is an individual brand name justification to support the procurement of Atos - HEAT & MOISTURE EXCHANGER, PROVOX #8262. The contract will be a firm fixed. This will be a one-time buy.

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of RFO FAR 6.103-5 is 10 U.S.C.

§ 3204(a)(5) & 41 U.S.C. § 3204(a)(5) and is implemented by RFO FAR 12.102 for restricting competition on this procurement.

Competition is restricted on this procurement for the reasons below:

(X) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

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

Products have been prescribed for patients by VA physicians. Pharmacy employees do not have the training and/ or authority to countermand physician’s orders. “Brand Specific” products are the same thing as “dispense as written” on a physician’s prescription. No Manufacture Part Number (MPN) substitutions are permitted. In the VA, Pharmacy Benefits Management (PBM) has determined that CMOP IDs in the Manufacturer Part Number (MPN) will always identify “brand specific products in the “VA PRINT NAME” This is not always inclusive where a particular NDC has been determined to be “formulation specific” by clinical evaluation performed by the PBM or in the case where only one product in the marketplace has been identified to contain the specific ingredients to match the product code or work in coordination with brand name, medical surgical equipment.

Effective Date: 12/30/2025 Page 2 of 3

Acquisition ID#: 36C77026Q0054

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A Sources sought that was posted on SAM.gov - we received four interested vendors.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Contracting Officer anticipates cost of award will be fair and reasonable based on competition, the Independent Cost Government Estimate (IGCE), and previous acquisition cost history for the same requirements.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: The Consolidated Mail Outpatient Pharmacy (CMOP) determined that this medical-surgical item is not available through mandatory sources (e.g., prime vendor) and therefore submitted the requirement to Network Contracting Office (NCO 15) for acquisition support. The requirement is for a brand-specific Med/Surg item identified by Manufacturer Product Number (MPN) and product name:

ATOS Medical Provox – Heat & Moisture Exchanger, Provox Item #8262.

Medical-surgical items are not listed on the National Institutes of Health (NIH) U.S. National Library of Medicine DailyMed website. In lieu of DailyMed, the search began with the VA Image Library, which confirmed the manufacturer/OEM as ATOS Medical.

After confirming the OEM, additional searches were conducted in VetCert and SBA’s Dynamic Small Business Search (DSBS) databases. ATOS Medical does not appear in the SBA database, and only three vendors were identified under NAICS code 325413, none of which are SDVOSB.

ATOS Medical was searched in SAM.gov and found to be an active and registered as a large business manufacturer under NAICS code 325413.

The NAC was also searched – as Altos has a NAC contract. The requested item is not in the NAC contract and therefore must go open market. The NAC and OEM were both contacted about adding the item to the current contract and the OEM is starting the process.

The Contracting officer reviewed the applicability of the Non-Manufacturer Rule (NMR) to this procurement. The NMR applies to socioeconomic-specific small business set-asides for contracts above the micro-purchase threshold but does not apply to total small business set-asides below the Simplified Acquisition Threshold (SAT).

In accordance with 13 CFR 121.406(b), market research identified two or more small business concerns that are authorized distributors. These firms have 500 or fewer employees, operate in the retail/wholesale trade, typically sell medical surgical supplies, and take ownership or possession of the medical-surgical products through their facilities or personnel.

However, research confirms there are no domestic small business manufacturers for this item in the commercial marketplace.

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Acquisition ID#: 36C77026Q0054

The Contract Specialist verified that no class waiver exists for this medical surgical product under NAICS Code: 325413. While an individual waiver was considered, it is not feasible due to the urgent nature of this acquisition. Therefore, a socioeconomic-specific set-aside is not practical because vendors cannot comply with the NMR without a waiver of the fourth prong. Alternatively, a total small business set-aside is appropriate, as the NMR does not apply to total small business set-aside below the SAT.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: These items are Brand Name/ Dispense as written only. Per FAR 25.01(a)(5) the use of the sole source justification for brand name only - is an exception to the use of trade agreements.

Therefore, BAA applies. A pre-award, BAA waiver will be submitted for approval.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Per the Sources sought that was posted on SAM.gov - we received four interested vendors.

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: No action is being taken at this time due to the fact that no MPN substitutions are permitted based on physician’s specific orders.

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.

a. Contracting Officer: I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Contracting Officer Date

Jennifer Knight Digitally signed by Jennifer Knight Date: 2026.01.08 12:49:21 -06'00'