S02_JnA_Q0001.pdf

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761-27-1-014-0001 -Chelmsford CMOP MED/SURGE -(VA-27-00005024)
Solicitation number
36C77027Q0001
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SOLE SOURCE JUSTIFICATION SUMMARY

This is a Department of Veterans Affairs (VA) Sole Source Justification document under Simplified Acquisition Procedures for Commercial Items (FAR 6.301). The procurement is for three medical-surgical products needed for the Chelmsford Consolidated Mail Outpatient Pharmacy (CMOP) as a one-time buy under Acquisition Plan Action ID 761-27-1-014-0001. The required items are: (1) Heat & Moisture Exchanger, PROVOX #8262 manufactured by Atos Medical (Switzerland) in quantity 720; (2) OneTouch Verio Glucose Test Strips (O0346) manufactured by OneTouch (United Kingdom) in quantity 2400; and (3) Catheter Set, Intermittent 14FR H#96144 manufactured by Hollister (India) in quantity 400. Competition is restricted based on the "Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements" exception, as the products have been prescribed by VA physicians and are identified by specific manufacturer part numbers with no permitted National Drug Code substitutions.

The justification demonstrates that a Sources Sought notice was posted from August 13-19, 2026, yielding two vendor responses; however, none of the proposed alternatives met the required compatibility, functional, and clinical-use specifications. Market research confirmed that all three original equipment manufacturers are large businesses with products manufactured outside the United States, and no domestic equivalents were identified. The acquisition will be split: the diabetic test strips will be solicited as a Service-Disabled Veteran-Owned Small Business (SDVOSB) set-aside, while the remaining two items will be competed on a full and open basis since no small business manufacturers exist for those products. The Contracting Officer has determined the anticipated cost will be fair and reasonable based on competition, the Independent Cost Government Estimate, and previous acquisition history. A pre-RFQ Buy American Act (BAA) waiver will be submitted for approval.

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File Type Posted
S02_NMR waiver_From_SBA_for_testStrips_Q0001.pdf PDF
S02_pricing Schedule Q0001_.xlsx XLSX spreadsheet
S02_RFQ_36C77027Q0001_Med_Surg_761_.pdf PDF

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Effective Date: 12/30/2025 Page 1 of 4 Revision: 02 Acquisition ID#: 36C77026Q0001

The Department of Veterans Affairs, NCO 15 – CMOP Division - Contracting Office will be procuring this acquisition for three (3) medical surgical products.

Contracting office will utilize 2237# 761-27-1-014-0001 for the replenishment of low stock at the Chelmsford CMOP.

This procurement is for three

(3) medical surgical supplies. 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 6.301. The proposed procurement action will be a new firm-fixed-price contract.

This is an individual brand name justification to support the procurement of three med/surg products below; for the Chelmsford CMOP. This will be a one-time buy.

The statutory authority for applying the Simplified Procedures for Commercial Items of RFO FAR 6.301 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.

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

Products have been prescribed for patients by VA physicians. Pharmacy employees do not have the training and/ or authority to countermand physician’s orders.

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

ITEM

NUMBER DESCRIPTION OEM

Country of Origin

MANUFACTURER

PART NUMBER

(MPN) QUANTITY

0001 HEAT & MOISTURE EXCHANGER,PROVOX #8262 Atos Medical Switzerland PROVOX 8262 720 0002 ONE TOUCH VERIO (GLUCOSE) TEST STRIP (O0346) OneTouch United Kingdom O0346 2400 0003 CATH SET, INTERMIT 14FR H#96144 (XV066) Hollister India 96144 400

Effective Date: 12/30/2025 Page 2 of 4

Acquisition ID#: 36C77026Q0001 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.

A Sources Sought notice was posted from August 13, 2026, through August 19, 2026, to identify domestic sources and evaluate potential equivalent products for the three requested medical/surgical line items.

Two Responses were received. The two vendors identified potential alternatives for each of the items; however, the market research, and subject matter experts determined that none of the proposed alternatives met the required compatibility, functional, and clinical-use specifications of the station-requested products.

Based on the results of the Sources Sought notice and technical evaluation of the responses received, no domestic equivalent products were identified that satisfy the requirements for the three requested items.

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.

The Consolidated Mail Outpatient Pharmacy (CMOP) determined that these medical-surgical items are 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 items identified by Manufacturer Product Number (MPN) and product names.

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 manufacturers/OEMs as , A sources sought was issued seeking domestic equivalents – to be reviewed by the pharmaceutical staff. Two vendors responded and none of the suggested products meet the technical requirements to be a suitable domestic substitute.

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

Effective Date: 12/30/2025 Page 3 of 4

Acquisition ID#: 36C77026Q0001

The three (3) OEMs were 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 other two items are not on any NAC/FSS/GSA contract.

121.406(b), at least two small businesses identify themselves as authorized distributors.

These firms have 500 or fewer employees, operate in the retail/wholesale trade for pharmaceuticals, and take ownership or possession of the products through their facilities or personnel.

Market research shows that all three OEMs—Altos Medical, OneTouch/ Lifescan and Hollister —are large businesses, and their products are also manufactured outside the United States.

The Contracting Officer confirmed there is a class waiver for diabetic test strips (Medical Surgical Supplies) under NAICS 325413, but no waiver applies to the remaining two (2) items. As a result, this acquisition will be split:

The remaining items will be competed on a full and open basis because the OEMs manufacturers currently exist and that would allow compliance with the NMR.

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-RFQ, BAA waiver will be submitted for approval.

Furthermore, the sources sought confirmed that there are presently no domestic equivalent product available.

Two Vendors responded to the sources sought and previous procurements of like items have generated between 3-20 responses. Therefore, it is expected that competition will be present.

: 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 contracted about adding the item to the current contract and the OEM is starting the process. The other two items are not on an NAC/FSS/GSA contract.

Effective Date: 12/30/2025 Page 4 of 4

Acquisition ID#: 36C77026Q0001

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

Charlene Nye Contract Specialist Network Contracting Office (NCO 15) – CMOP Division

Jennifer Knight Contract Specialist

Kelley Cunningham Contracting Officer

CHARLENE NYE (Affiliate) Digitally signed by CHARLENE NYE (Affiliate) Date: 2026.09.21 09:45:15 -07'00'

JENNIFER

KNIGHT

Digitally signed by JENNIFER

KNIGHT

Date: 2026.09.21 11:47:55 -05'00'

KELLEY

CUNNINGHAM

Digitally signed by

KELLEY CUNNINGHAM

Date: 2026.09.22 08:39:34 -05'00'

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