S02_JA_Q0200_Redacted.pdf

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

Revision: 01 Effective Date: 11/15/2024 Acquisition ID#

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: 36C770-25-AP-0472

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

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

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 for the supplies

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.

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

In accordance with FAR Part 10, VAAR 810, and VAAM M810 market research has been conducted for this acquisition. The procurement packet was received on March 17, 2025.

Market research was conducted beginning April 3,2025, for the upcoming acquisition.

Revision: 01 Effective Date: 11/15/2024 Acquisition ID#

A sources sought notice was posted to SAM.gov from 3/28/25-4/2/25 resulting in 3 responses from 2-SB, and 1-SDVOSB. All appear likely to be able to fulfill the requirement as distributors based on responses to sources sought notice.

Additional market research confirmed that MPN # 44677-0204-70 BREAST MILK STORAGE BAG was recently awarded from an open market purchase. RFQ 36C77025Q0133 provided 5 compliant quotes for MPN # 44677-0204-70 BREAST MILK STORAGE BAG. From the RFQ, contract 36C77025P0134 was awarded on 3/17/25 in the amount of for MPN# 44677-0204-70.

There was ample competition, and the awarded price was below the IGCE, and the lowest compliant quote received. All compliant vendors were either SDVOSB or Small Business concerns; however, they were distributors as the manufacturer is a large business. 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.

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 items were searched, and no results were found.

The CMOP Medication Image Library along with the manufacturer’s website was searched and it was determined that Lansinoh Laboratories Inc., a large business, is the manufacturer of the breast milk storage bags and Nursing Pads.

The Contracting Officer conducted searches in VetCert to determine if there are service-disabled, veteran-owned business (SDVOSB) or a veteran owned, small business (VOSB) who identify as manufacturers of utilizing NAICS code 325413 and yielded a total of 90 SDVOSB/VOSBs who identified as manufacturers; however, these SDVOSB/VOSBs are distributors for large businesses. There are no known SDVOSB/VOSBs manufacturers for the required products.

Market research was conducted via Dynamic Small Business search which resulted in 18 small businesses who identified as authorized distributors.

Based on procurement history of other med/surg products, it is anticipated that at least two or more of the small businesses are authorized distributors

Revision: 01 Effective Date: 11/15/2024 Acquisition ID# capable of fulfilling VA’s requirement at a fair and reasonable price

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 (nonsocioeconomic 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 med/surg products, take ownership or possession of the med/surg 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 items.

The CO has confirmed there is no class waiver associated for these med/surg products 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. This does not preclude a SD/VOSB from quoting and/or receiving an award as a small business.

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.

Sarah Fry Larry Zaritz Contract Specialist Contracting Officer

SARAH FRY

Digitally signed by

SARAH FRY

Date: 2025.04.03 15:52:16 -05'00'

LARRY

ZARITZ

Digitally signed by

LARRY ZARITZ

Date: 2025.04.03 21:07:44 -05'00'