S02_JA_Q0037_CO.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: 36C770-25-AP-0028

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

2237 # 761-25-1-014-0011, Chelmsford, CMOP – Chelmsford, MA.

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 one (1) Brand Name Specific, Med/Surg items (LifeScan, ONE TOUCH VERIO (GLUCOSE) TEST STRIP) 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:

The Consolidated Mail Outpatient Pharmacy (CMOP) has identified that this medical surgical item 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 a medical surgical supply that has been specifically identified using the manufacture part number (MPN) and name. Since the (MPN) identifies the medical surgical item prescribed for the individual patient, market research must utilize (MPN) as the primary search criteria to ensure the correct product (i.e., Med/Surg) is purchased.

Medical Surgical items are not found on the National Institutes of Health (NIH) U.S. National Library of Medicine DailyMeds website. In lieu of DailyMeds database, searches began by utilizing the VA image library – where the requested products manufacturer/ OEM and (IMFN) Item Master File Number was confirmed. The chart below shows item MPN with corresponding manufacturer.

Market research confirmed that the LifeScan, (ONE TOUCH VERIO (GLUCOSE) TEST STRIPT 100CT) are not available from typical contract vehicles or supply chains VIA The National Acquisition Center (CCST) Which displays PPV, FSS and GSA contracts. All Avenues have been exhausted by CMOP and contracting activities via searches on CCST; an open market procurement is the only option that remains for purchasing these pharmaceuticals

The IMFN was then used within the VISTA database to review past procurements.

After reviewing the last procurement in VISTA and getting the contract number; FPDS was reviewed and determined - per the last procurements

- the product is manufactured in the United Kingdom.

VetCert was searched using NAICS code: 325413, which generated 90 SD/VOSB doing business with NAICS code: 325413. OEM, LifeScan was then searched within the database and did not yield results.

SBA was searched using NAICS code: 325413, which generated 113 SD/VOSB doing business with NAICS code: 325413. OEM, LifeScan was then searched within the database and did not yield results.

SAM.gov was then searched to confirm the OEM/ manufacturer business size for the manufacture (Lifescan). Manufacturer is not registered within sam.gov.

DnB was then searched to determine the OEM business size. DnB shows the OEM as having 2000 employees, confirming they’re a large business.

OEM/Manufacturer website (https://www.onetouch.com/) was then reviewed for product detail.

The Contracting Officer reviewed the Non-Manufacturer Rule (NMR). In accordance with the NMR as defined in 13 CFR § 121.406, the requirement that a Non-Manufacturer supply the product of a small business concern is referred to as the NMR. In order to qualify as a small business concern for a small business set-aside, an offeror must either manufacture the item in accordance with the Limitations on Subcontracting (see FAR section 52.219-14, 52.219-27 and 13 C.F.R. § 125.6) or supply the product of a small business made in the United States. There is an existing NMR Class Waiver for NAICS 325413 that covers the diabetic test strips in this requirement. The Class waiver was posted to the Federal Register in 85 Fed. Reg. 43634 on July 17, 2020. The current list of NMR Class Waivers is maintained by the SBA and can be found at Non-manufacturer rule class waiver list | U.S. Small Business Administration (sba.gov). Based on the market research conducted, the CO determined there is a reasonable expectation that quotes would be received from two (2) or more SDVOSBs that can comply with the NMR.

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 Kelley Cunningham Contract Specialist Contracting Officer

Jennifer Knight Digitally signed by Jennifer Knight Date: 2024.10.23 10:20:10 -05'00'

KELLEY

CUNNINGHAM

Digitally signed by

KELLEY CUNNINGHAM

Date: 2024.10.23 14:01:38 -05'00'