S02.JnA Q0310.pdf

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

Last Updated: 02/1/22 Page 1 of 3

DEPARTMENT OF VETERANS AFFAIRS

Justification for Brand Name Awards IAW FAR 13.106-1 For

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

Acquisition Plan Action ID: 36C770-24-AP-0573

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 15, CMOP

Division.

2237 #760-24-3-050-0936, Leavenworth CMOP, Leavenworth, KS.

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

Item Number Description MPN Qty Unit of

Measure Packaging Multiple Manufacture Origin

SET,INFUSION MINIMED #MMT-

381A 10CT, XV652 MMT-381A 300 BX 10 Medtronic Mexico

SET,IV ADMIN,INF,QUICK SET,L

32IN,9MM CANNULA MMT-386 SET,

10CT INFUSION MINIMED (XT791)

MMT-386A 360 BX 10 Medtronic Mexico

This is an individual brand name justification to support the procurement of the Medtronic MiniMed Infusion Sets in the table above. The proposed procurement action will be a firm-fixed-price contract award for the brand name line items.

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) 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.

https://www.acquisition.gov/?q=/browse/far/13

Last Updated: 02/1/22 Page 2 of 3

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

In accordance with FAR Part 10, VAAR 810, market research has been conducted for this acquisition.

A U.S. Small Business Administration (SBA) Veteran Small Business Certification (VetCert) search identified 90 potential SDVOSB and VOSB’s as capable vendors. An inquiry of the SBA Dynamic Small Business (DSBS) database produced 39 small businesses. These vendors are not manufacturers, but they are distributors for large business wholesalers. The Government is not allowed to do business using wholesale trade or retail trade NAICS codes, searches must be conducted using the manufacturer NAICS code 325413, in-vitro diagnostic substance manufacturing. Based on this research and policy, the rule of two cannot be met to set the procurement aside for a socioeconomic subcategory of small business; however, in accordance with 13 Code of Federal Regulations (CFR) § 121.406(c) the Nonmanufacturer Rule (NMR) and limitations on subcontracting, CFR § 125.6, do not apply for acquisitions under $250K; therefore, a small business set-aside is

Last Updated: 02/1/22 Page 3 of 3 feasible. This procurement will be solicited as a small business set-aside; and a pre-solicitation contracting opportunity was posted to SAM.gov.

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.

Kayla Powers Contracting Specialist

Kelley Cunningham Contracting Officer

KAYLA

POWERS

Digitally signed by KAYLA

POWERS

Date: 2024.05.30 14:46:09 -05'00'

KELLEY

CUNNINGHAM

Digitally signed by

KELLEY CUNNINGHAM

Date: 2024.05.30 14:56:16 -05'00'