S02_JNA_Q0049_Allsigned_final.pdf

36C77026Q0049 | 4-Line-Items Med/Surg Acquisition Plans: 36C770-26-AP-0171 | 36C770-26-AP-0188

2237’s: 761-26-2-014-0037 | 762-26-1-040-0450

Last Updated: 02/01/22

DEPARTMENT OF VETERANS AFFAIRS

BRAND NAME JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR

CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 761-26-2-014-0037 | 762-26-1-040-0450

1. Contracting Activity: The Department of Veterans Affairs, NCO 15 – CMOP Division - Contracting Office will be procuring this acquisition for four (4) medical surgical products.

Contracting office will utilize 2237 #s 761-26-2-014-0037 | 762-26-1-040-04509 for the replenishment of low stock levels at the three CMOP locations.

2. Nature and/or Description of the Action Being Processed: This procurement is for four

(4) line items - medical surgical supplies. See chart below. 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 four (4) medical surgical items listed in the below table. The estimated value of the required med/surg supplies is $578,800.00. Delivery Schedule will be as followed.

Chelmsford CMOP requires one delivery for line items 1–3. The specific delivery schedule will be determined during the evaluation.

Tucson CMOP requires one delivery for line item 4. The specific delivery schedule will be determined during the evaluation.

4. Statutory Authority Permitting Restricted Competition:

The statutory authority for Commercial Items - 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 reason(s) below:

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

2237’s: 761-26-2-014-0037 | 762-26-1-040-0450

Last Updated: 02/01/22

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.

Line Item: 1 – ONE TOUCH VERIO (GLUCOSE) TEST STRIP 100CT.

2237’s: 761-26-2-014-0037 | 762-26-1-040-0450

Last Updated: 02/01/22

Line Item: 2 – SET,INFUSION AUTOSOFT XC TANDEM #1001680

Line Item: 3 – Hollister, CATH SET, INTERMIT 14FR H#96144.

2237’s: 761-26-2-014-0037 | 762-26-1-040-0450

Last Updated: 02/01/22

Line Item: 4 – SET, INFUSION AUTOSOFT XC TANDEM #1001729

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 eight (8) interested vendors. Therefore, a competitive solicitation will be posted to the Government point of entry at SAM.gov to provide public knowledge of VA’s requirement. Only qualified vendors will be able to submit quotes due to the Gray Market/Brand Name only, OEM requirements.

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.

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 810 market research was conducted. The procurement packages were received by the Contracting Office on 11/24/2025 & 12/01/2024. Market research was conducted on 12/5/2025 and again on 2/10/2026 for the upcoming acquisition of four med/surg items.

A sources sought notice was posted on 12/5/2026 until 12/9/2026 for the four medical surgical products. The sources sought ask about Country of Manufacture, OEM documentations, business side and GSA contracts….Eight vendors replied to the sources sought.

2237’s: 761-26-2-014-0037 | 762-26-1-040-0450

Last Updated: 02/01/22

Additional market research will be conducted to verify the country of manufacture. It was determined based on product labels that the all of the items are made non-domestically. Photos are shown above.

Medical Surgical items are generally not found on the National Institutes of Health (NIH) U.S. National Library of Medicine DailyMeds website. All four (4) line items were searched and yielded no results.

a. In lieu of DailyMeds, search continued by utilizing the VA image library – where all the requested products manufacturer/ Original Equipment Manufacturers (OEMs) were confirmed.

b. All Item Master File Number were then used to query VISTA – in order to review past procurement history.

c. Once the OEMs were confirmed, searches continue in VetCert database. First using the NAICS Code: 325413 and then more specifically, searching all the manufacturer/ OEMs.

SBA-VetCert, https://search.certifications.sba.gov/ - generated one (1) SD/VOSB businesses using NAICS code: 325413

The database was checked for all the brand specific OEMs and yielded no results. Confirming that the OEMs are not registered with SBA’s database.

The businesses that did generate are distributors of large wholesalers.

d. The following databases/websites were queried to identify manufacturers/packagers and domestic availability of the required Medical Surgical items.

SAM.gov – o All three (3) OEMs were searched on https://sam.gov/content/home Line Item 1: OEM - LifeScan/OneTouch (UEI:

PQGUFCG4CXQ1) is registered in SAM.gov. Per their reps and certs, they are a large business.

Line Item 3: OEM - Hollister INC (UEI:

GWFZJ24NX5Q3) is registered in SAM.gov. Per their reps and certs, they are a large business.

Line Item 2 & 4: OEM -Tandem Diabetes Care (UEI:

H8JBWTNHJKJ6) is registered in SAM.gov. Per their reps and certs, they are a small business.

2237’s: 761-26-2-014-0037 | 762-26-1-040-0450

Last Updated: 02/01/22

Federal Procurement Data System (FPDS) https://www.fpds.gov/fpdsng_cms/index o Past procurements were reviewed – Looked for last listed country of origin information as reported.

SBA – DSBS

o https://dsbs.sba.gov/search/dsp_dsbs.cfm o 5 Vendors generated as doing business with NAICS Code:

325413, with Keyword: Manufacturing o All three of the OEMs were searched & none of the UEI’s generated within the SBA/DSBS Database.

NAC – National Acquisition Center (CCST) o https://www.vendorportal.ecms.va.gov/NAC/Search o Searched all the requested items on the MedSurg Catalog.

This yielded no results.

Reviewed all the Original Equipment Manufacturer (OEMs) websites

Line Item: 1 – https://www. https://www.onetouch.com/ & https://www.lifescan.com/

Line Item: 2 – https://www.tandemdiabetes.com/ Line Item: 3 – https://www.hollister.com/en Line Item: 4 – https://www.tandemdiabetes.com/ o Direct from OEMs websites – what the product does.

Line Item: 1 – ONE TOUCH VERIO (GLUCOSE) TEST STRIP 100CT.

o Per the OEM - General Overview – Per the OEM – The item is a Blood glucose test strips used in conjunction with the OneTouch® Verio meter. Accurate Readings in 5 Seconds. VA patients already have the Verio Meter and need the corresponding test strips.

Line Item: 2 – SET, INFUSION AUTOSOFT XC TANDEM #1001680.

o Per the OEM - General Overview – the details on the requested product.

Per the OEM – “An infusion set is a complete tubing system, changed every 2-3 days, which delivers insulin from the insulin pump to your body.” The Autosoft XC Tandem Infusion Set 6mm 23 Inch 10 Count includes an infusion set with a build in needle cover. This product features a 90-degree soft cannula. This new t:lock technology will reduce fill time by up to 30 seconds. VA

2237’s: 761-26-2-014-0037 | 762-26-1-040-0450 patients are prescribed this product based on their medical conditions and cannot deviate.

Line Item: 3 – Hollister, CATHETER SET, INTERMIT 14FR H#96144.

Per the OEM --The Advance Plus™ touch free intermittent catheter system provides the right balance of ease of use and protection in the convenience of a closed system. Kit contains gloves, under pad drape, and benzalkonium swab sticks. This specific product is size 14Fr/CH 16’ – length – straight box of 100. VA patients are prescribed this product based on their medical conditions and cannot deviate. As catheter’s are prescribed specifically for the patient’s body – on sizing, curves and lengths etc.…

Line Item: 4 – SET, INFUSION AUTOSOFT XC TANDEM #1001729.

“An infusion set is a complete tubing system, changed every 2-3 days, which delivers insulin from the insulin pump to your body.” This box of 10 Tandem Autosoft XC Infusion Sets features a 9mm cannula and 43" tubing with a built-in needle cover and a 90-degree soft cannula. The t:lock technology from Tandem Diabetes significantly reduces fill times by 30%. VA patients are prescribed this product based on their medical conditions and cannot deviate.

e. The Nonmanufacturer Rule

13 CFR 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 only one small business manufacturer produces the Tandem product in the commercial marketplace; however, the product is not manufactured domestically. The other two OEMs—Hollister and OneTouch/Lifescan—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 items. As a result, this acquisition will be split:

o o The remaining items will be competed on a full and open basis because the OEMs are large businesses and the products are manufactured

2237’s: 761-26-2-014-0037 | 762-26-1-040-0450 small business manufacturers currently exist and that would allow compliance with the NMR.

8. Discuss consideration to BAATAA/Exception to BAA (See FAR Part 25) 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. All items are made non-domestically as shown in the above chart. A pre-award BAA waiver will be submitted.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition”:

Previous acquisition history with this VA contracting office has shown a mix of large and small businesses have met and fulfilled this product in the recent past.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Market research shows previous awardees have demonstrated an interest in this requirement via the posted sources sought.

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. There is plenty of competition expected based on the sources sought results.

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.

Signature:

Jennifer Knight Contract Specialist Network Contracting Office (NCO 15) – CMOP Division

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

Jennifer Knight Digitally signed by Jennifer Knight Date: 2026.02.26 09:28:33 -06'00'

2237’s: 761-26-2-014-0037 | 762-26-1-040-0450

Last Updated: 02/01/22

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Signature:

Kelley Cunningham Senior Contracting Officer Network Contracting Office 15 – CMOP Division

KELLEY

CUNNINGHAM

Digitally signed by

KELLEY CUNNINGHAM

Date: 2026.02.27 07:59:26 -06'00'