P03_JA_Q0063_CS_CO_signed_Redacted.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP up to SAT

Revision: 02 Page 1 of 3 Effective Date: 12/30/2025 Acquisition ID# 36C770-26-AP-0191

DEPARTMENT OF VETERANS AFFAIRS

Justification for “Brand Name” Single Source Awards IAW FAR 12.102 For

Over Micro-Purchase Threshold but Not Exceeding the SAT

Acquisition Plan Action ID: 36C770-26-AP-0191

1. Contracting Activity: Department of Veterans Affairs, NCO 15, National

Contracting Office, Tucson CMOP, Tucson, AZ. 2237 #762-26-1-040-0448

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

ITEM

NUMBER IMFN

CMOP

FACILITY DESCRIPTION

PART NUMBER

(MPN) QTY

UNIT OF

MEASURE

PACKAGING

MULTIPLE

UNIT

PRICE

0001 15187 VA CMOP Tucson -762 ELECTRODE PAD,EARCLIP AS#EEP(XJ196) 00036-3335-00 3900 EA 256

This is an individual brand name justification to support the procurement of one (1) Brand Name Specific Med/Surg item (ELECTRODE PAD, EARCLIP AS#EEP(XJ196)) in the above table. The proposed procurement action will be a firm-fixed-price contract awarded for the supplies with an estimated cost of

Per the OEM, product is self-adhesive felt electrode pads for use with Alpha-Stim Ear clip Electrodes used with the Alpha-Stim M and Alpha-Stim AID stimulators.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

Products have been prescribed for patients by VA Physicians. Pharmacy employees do not have the training and/or authority to countermand physician orders. Brand Specific products are the same thing as dispensing as written on a physician’s prescription. No National Drug Code (NDC)/ or specific Manufacture Part Number (MPN) substitutions are permitted. In the VA, Pharmacy Benefits Management

Revision: 02 Page 2 of 3 Effective Date: 12/30/2025 Acquisition ID# 36C770-26-AP-0191

(PBM) has determined that CMOP National Drug File (NDF) will most always identify brand specific products in the VA PRINT NAME. This is not always inclusive where a particular NDC and or MPN 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.

4. Description of market research conducted and results or statement why it was not conducted:

Market Research Methods/Techniques/Sources: In accordance with FAR Part 10 and VAAR 810, market research has been conducted for this acquisition.

Sources sought notice posted on SAM.gov from 12/19/25 to 12/26/25. The results are as follows:

1) One (1) small business responded, stating that they are an authorized distributor who distribute the requested med/surg item and that the item is manufactured in the

USA.

2) One (1) SDVOSB responded stating that they are an authorized distributor who distribute the requested med/surg item and that the item is manufactured in the USA and China.

Market research confirmed that the med/surg products are not available from typical contract vehicles or supply chains. All avenues have been exhausted by CMOP via searches on Prime Vendor, NAC, and FSS; an open market procurement is the only option that remains for purchasing the med/surg products. This requirement is not for lack of planning, but due to inventory not being available.

A query was conducted via the National Institutes of Health (NIH) U.S. National Library of Medicine DailyMed website. The purpose of this search is to determine if there are any domestic sources available (both large and small business concerns in the marketplace). The item was searched, and no results were found. Generally, Medical Surgical items do not generate on the DailyMeds site.

The CMOP Medication Image Library along with the manufacturer’s website were searched and it was determined that Alpha-Stim, a large business, is the manufacturer of the requested - ELECTRODE PAD, EARCLIP AS#EEP(XJ196).

Past procurement history was reviewed using VISTA, via the IMFN. Products have only been purchased via government purchase card.

The Contracting Specialist conducted searches in SBA Dynamic Vet search to determine if there are service-disabled, veteran-owned small business (SDVOSB) or a veteran-owned, small business (VOSB) who identify as manufacturers utilizing NAICS code: 325413. This yielded a total of 2 SD/VOSBs who identified as manufacturers; however, these SD/VOSBs are distributors for large businesses.

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Furthermore, a search was conducted via SBA Dynamic Small Businesses (SB) who identify as manufacturers utilizing NAICS code 325413 and yielded a total of 12 SBs who identified as manufacturers. However, these SBs are distributors for large businesses. There are no SBs manufacturers for the required med/surg item. The manufacture Alpha-Stim was specifically searched within the SBA Dynamic Small Businesses database, this yielded no results.

A search was conducted via SAM.gov – which resulted in Alpha-Stim not being registered in SAM.gov.

The Contracting Officer reviewed the Non-Manufacturer Rule and its applicability to the procurement action. The nonmanufacturer rule applies to socioeconomic specific small business categories for contracts valued above the micro-purchase threshold, but does not apply to total (non-socioeconomic specific) small business set-asides below the SAT. In accordance with the Non-Manufacturer Rule as defined in 13 CFR 121.406(b), there are two or more small business concerns who identify themselves as authorized distributors. These small business concerns have 500 or less employees, engage in the retail wholesale trade and normally sell pharmaceuticals/Medical/Surgical items, take ownership or possession of the pharmaceuticals/Med/Surg items via its facilities or via its personnel. However, market research concludes that there are presently no domestic small business concern manufacturers that exist in the commercial marketplace for the Med/Surg Product. The CO has confirmed there is no class waiver associated for the Med/Surg item under NAICS Code: 325413. The Contracting Officer considered the use of an individual waiver, however, is not feasible due to the expedient nature of this acquisition. Given this information, a socioeconomic specific set-aside may not be feasible as vendors would not be able to comply with the NMR without a waiver of the fourth prong. Alternatively, a total small business set-aside is feasible as the NMR does not apply to total small business set-asides below the SAT.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR 1 . I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Sarah Fry Jennifer Knight Contract Specialist Contract Officer

SARAH FRY

Digitally signed by

SARAH FRY

Date: 2025.12.29 12:08:25 -06'00'

Jennifer Knight Digitally signed by Jennifer Knight Date: 2025.12.29 12:38:02 -06'00'