S02_JnA_Q0373.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: 02/01/22 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: 36C770-23-AP-0868

1. Contracting Activity: The Department of Veterans Affairs, Network Contracting Office (NCO) 15 – Consolidated Mail Outpatient Pharmacy (CMOP) Division on behalf of the Leavenworth CMOP.

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

Item Number

File Number

(IMF)

Description MPN Quantity Unit of Measure

Packaging Multiple

Local Stock Number

0001 19927 RESERVOIR,T:SLIM

W/T:LOCK,3ML

(XL551) 10CT

#1008621 2400 BX 10 89152-2541

-05

0002 16025 SET,INFUSION

AUTOSOFT 90

TANDEM

#1002817 10CT

XJ652

#1002817 2000 BX 10 99152-2817

-00

This is an individual brand name justification to support the procurement of the medical surgical (med/surg) items in the table above. The proposed procurement action will be a firm-fixed-price contract award.

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.

Last Updated: 02/01/22 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.

The procurement packet was received on July 14, 2023. Market research was conducted on August 10, 2023, for the upcoming acquisition.

A sources sought notice was not posted for this acquisition because medical surgical (med/surg) buys are routine, and the Contracting Officer is very knowledgeable about the marketplace. 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.

Market research confirmed that these 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 these med/surg products. This requirement is not for lack of planning, but due to inventory not being available via normal supply chains.

The Contracting Officer conducted further searches in VetCert utilizing NAICS code 325413 and yielded a total of 81 SD/VOSBs who identified as authorized distributors. Further market research was conducted via Dynamic Small Business search (DSBS) which resulted in 21 small businesses who identified as authorized distributors.

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.

The CMOP Medication Image Library along with the manufacturer’s website was searched and it was determined that Tandem Diabetes Care, a large business, is the manufacturer of both the Reservoir, T:slim X2 w/T:lock, 3ml cartridge and the Autosoft 90 Infusion set.

The Contracting Officer reviewed the Non-Manufacturer Rule (NMR). In accordance with the NMR as defined in 13 CFR 121.406(b), there are two or more SD/VOSB authorized distributors who can provide the med/surg products. However, the contracting officer could not identify a small business manufacturer that can provide the product as a domestic end product to set this requirement aside for SD/VOSB concerns. Furthermore, the NMR does not apply to specific set-asides when under the

Last Updated: 02/01/22 Page 3 of 3 simplified acquisition threshold (SAT). This acquisition is under the SAT and has been determined that a total small business set-aside is appropriate for this acquisition. The CO has determined that the NMR is not applicable for this requirement and that there are small business authorized distributors who will compete for the award.

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.

Kelley Cunningham Date Contracting Officer