S02_JnA_Q0116_Signed.pdf

36C77025Q0115 | 1-Line Med/Surg

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

DEPARTMENT OF VETERANS AFFAIRS

Justification for “Brand Name” Single Source Awards IAW FAR 13.106-1

For Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C770-25-AP-0238

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

Contracting Office. 2237 #766-25-1-400-0288 for the VA CMOP – Charleston/ Ladson (766).

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

ITEM

NUMBER

ITEM

MASTER

FILE

NUMBER ADDRESS2 DESCRIPTION

LOCAL

STOCK

NUMBER QTY

UNIT OF

MEASURE

PACKAGING

MULTIPLE OEM

Place of

Manufacturer

0001 14021 VA CMOP Charleston - 766A

DRESSING,DRAWTEX

4IN X 4IN 10CT (XH825) 85138-3003-02 900 BX 10

Urgo

Medical South Africa

This is an individual brand name justification to support the procurement of the one

(1) Brand Name Specific, Med/Surg items listed in the above table. The proposed procurement action will be a firm-fixed-priced contract.

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

Product has 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 dispense 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 (PBM) has determined that CMOP IDs in the 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 or MPN but 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 or perform specific function 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: Market research began on 4/8/2025 for the upcoming acquisition for Medical Surgical supplies for the Charleston/ Ladson CMOPs.

Attachment 1: Single Source Justification for SAP under the SAT

A sources sought notice was not posted for this acquisition because pharmaceutical/ Med/Surg buys are routine, and the Contracting Officer is very knowledgeable about the marketplace. Market Research confirmed that the product was recently awarded from an open market purchase.

RFQ number 36C77024Q405 provided ten (10) compliant quotes that were able to supply the med/surg products. From this RFQ, contract:

36C77024P0412 was awarded to Alliant Enterprise on September 24, 2024. There was ample competition. All compliant vendors were either SDVOSB or Small Business concerns; however, they were distributors as the manufacturer is a large business. It is unlikely that a sources sought notice would produce significantly new information about the market.

Therefore, a competitive solicitation will be posted to the Government point of entry at SAM.gov to provide public knowledge of VA’s Requirement.

Medical Surgical items are not found on the National Institutes of Health (NIH)U.S. National Library of Medicine DailyMeds website. The station provided an approved (Manufacture Part Number/ local stock numbers) for the requested Med/ Surg items. (85138-3003-02) The first query was conducted within the VA image library, in order to gather photos and confirm the manufacturers/OEMs names.

Reviewed the National Acquisition Center (CCST) Searched for GSA/FSS/PV Contracts - using the station approved product name via the Med/Surg Catalog Search – The requested item wa searched by product name and yielded no results.

The Contracting Officer conducted three (3) searches in the SBA Dynamic

Small Business Search database looking for Small businesses & SDVOSB’s utilizing NAICS code: 325413 & a final search into the product OEM: Stead Med/ Urgo Medical. The first Search specifically looking for small businesses utilizing NAICS code: 325413 yielded a total of 20 small business. The second search specifically looking for SD/VOSB utilizing NAICS code: 325412 yielded a total of 2 SD/VOSB’s. Both Searches resulted in vendors who are authorized distributors. The final search into the OEM – Stead Med/ Urgo Medical resultedin no results within the SBA database.

Furthermore, OEM was searched in SAM.gov and yeidled no results.

Product was then reviewed on the brand specific Manufacturer/ OEM website:

Line Item: 1 (Drawtex Dressing 4X4) :

https://www.urgomedical.us/

Per the manufacture/OEM website, below are the details on the requested product.

Drawtex actively draws fluid away from the wound up to 150 cc/hour, retaining its integrity when moist.

Drawtex helps to remove debris from the wound by drawing out fibrin and slough, while leaving healthy granulation tissue in.

Draws and absorbs excessive wound exudate.

Draws bacteria from the wound.

a. i. A study that evaluated Drawtex in an infected burn model demonstrated that Drawtex can draw methicillin-resistant Staphylococcus aureus (MRSA) from either an inoculated broth or an experimental burn wound eschar.

Draws harmful MMP’s from the wound

a. i. Chronic wounds have excessive inflammation, increased pro-inflammatory cytokines, increased proteases such as MMPs, and decreased growth factors. Removing or decreasing the harmful MMPs is an important aspect of wound bed preparation.

The The Contract specialist 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, take ownership or possession of the product 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 item. The CS has confirmed there is no class waiver associated for pharmaceuticals under NAICS Code: 325413. 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

FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Jennifer Knight Contracting Officer

Jennifer Knight Digitally signed by Jennifer Knight Date: 2025.04.21 12:26:32 -05'00'