S02_JnA_Q0418_allsigned_Final_.pdf

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: 36C770-23-AP-0938

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

2237 # 763-23-4-021-1393, Lancaster CMOP, Lancaster, TX

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

Item Number IMFN

CMOP

Location Description NDC

MANUFACTURER PART

NUMBER (MPN) Quantity

Unit of Measure

Packaging Multiple

OEM

NAME Special Notes

0001 S0860 VA CMOP Lancaster - 763

SKIN PROTECTANT,CAVILON

ADVANCED 3M#5050 17158-5050-20 3M #5050 320 CS 20 3M

Delivery: 80 per Month over 4 moths

This is an individual brand name justification to support the procurement of the one (1) Brand Name Specific pharmaceutical (SKIN PROTECTANT,CAVILON ADVANCED 3M#5050) in the above table. The proposed procurement action will be a firm-fixed-priced contract.

Original Equipment Manufacturer (OEM) website: “3M Healthcare” - Reviewed Product details

Per the OEM, Advance Skin Protectant #5050 Protective coating creates an environment that repels irritants and supports healing and comfort.

Provides an effective barrier, which has been shown to reduce the pain of managing IAD¹.

Single-use applicator reduces the potential for cross-contamination.

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 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:

The Consolidated Mail Outpatient Pharmacy (CMOP) has identified that this pharmaceutical is not available from mandatory sources (e.g., prime vendor) and, therefore, has submitted the acquisition to Network Contracting Office (NCO 15) which provides acquisition support to CMOP. This acquisition is for medication/pharmaceuticals that have been specifically identified using National Drug Codes (NDCs) which is a unique, 3-segment numeric identifier assigned to each medication listed under Section 510 of the U.S. Federal Food, Drug and Cosmetic Act.

Since the NDC identifies the medication prescribed for the individual patient, market research must utilize NDCs as the primary search criteria to ensure the correct product (i.e., pharmaceutical) is purchased.

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 Market place.

NDC:17158-5050-20 was searched. However, the product is not listed on DailyMeds.

In In lieu of DailyMeds, search began by utilizing the VA image library – where the brand name, requested product manufacturer/ Original Equipment Manufacturer (OEM) was confirmed.

Once the OEM was confirmed, (OEM: 3M) searches continue in VetCert and SBA’s

DSBS databases. First using the NAICS Code: 325412 and then more specifically, searching for the manufacturer/ OEM (3m Healthcare).

VetCert, generated 132 SD/VOSB businesses using NAICS code: 325412.

SBA’s DSBS, generated 70 Small businesses using NAICS code: 325412.

Both databases were checked for the manufacture/ OEM (3M Healthcare) and the two searches yielded no results. Confirming that the manufacture, 3M is not registered with VetCert or the SBA.

The business that did generate are distributors of large wholesalers.

SAM.gov was then searched to confirm the OEM/ manufacturer business size. 3M Healthcare, is registered within sam.gov and confirms they’re a large corporation, under the Certs and Reps section of their registration.

Original Equipment Manufacturer (OEM) website: “3M Healthcare” - Reviewed Product details https://www.3m.com/3M/en_LB/p/d/v000255128

Per the OEM, Advance Skin Protectant #5050

Per the OEM website: “3M™ Cavilon™ Advanced Skin Protectant is a breakthrough technology for skin protection. It protects patients’ skin even under the most challenging conditions. Use this revolutionary, no-removal barrier solution to stop, reverse and even prevent IAD. Long lasting barrier, only requires application 2x per week. 3M™ Cavilon™ Advanced Skin Protectant is designed to help manage moderate to severe skin damage and protect at-risk skin. The ultra-thin yet highly durable barrier is able to attach to wet, weepy surfaces and create a protective environment that repels irritants and supports healing.”

Cross-referencing SAM.gov, the Small Business Administration’s VetCert, and/or other search engines (e.g., Google, U.S. Securities and Exchange Commission’s EDGAR), the manufacturer of the requested pharmaceutical has been determined to be a large business concerns.

The Contracting Officer reviewed the Non-Manufacturer Rule and its applicability to the procurement action. The non-manufacturer 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 pharmaceutical 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 pharmaceutical. The CO has confirmed there is no class waiver associated for pharmaceuticals under NAICS Code: 325412. 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 FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Jennifer Knight Contract Specialist

J. Braden Smith Contracting Officer

JENNIFER

KNIGHT

Digitally signed by

JENNIFER KNIGHT

Date: 2023.09.12 11:56:23 -05'00'

JUSTIN

SMITH

Digitally signed by

JUSTIN SMITH

Date: 2023.09.12 12:55:31 -05'00'