S02_JA_36C77024Q0225_allsigned.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: 36C770-24-AP-0420

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

2237 # 766-24-2-400-0544, Charrleston/Ladson CMOP, Ladson, SC

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

Item Number IMFN CMOP Location Item Descriptions Local Stock #'s MPN's Quantity

Unit of Measure

Packaging Multiple

OEM

NAME

0001 15078 VA CMOP Charleston - 766A

CONTOUR NEXT (GLUCOSE)

TEST STRIP 50CT (XR423) 00193-7311-50 #7311 1440 BX 50 ASCENSIA DIABETES CARE

0002 15079 VA CMOP Charleston - 766A

CONTOUR NEXT (GLUCOSE)

TEST STRIP 100CT (XR423) 00193-7312-21 #7312 432 BX 100 ASCENSIA DIABETES CARE

This is an individual brand name justification to support the procurement of the two (2) Brand Name Specific, Med/Surg items (CONTOUR NEXT (GLUCOSE) TEST STRIP 50CT & 100CT) 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 Med/Surg item 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 two (2) medical surgical supplies that has been specifically identified using the manufacture part numbers (MPNs) and name. Since the (MPNs) identifies the medical surgical item prescribed for the individual patient, market research must utilize (MPNs) 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.

i. In lieu of DailyMeds, searches begin by utilizing the VA image library – where the requested products manufacture/ OEMs can be confirmed.

ii. Once the OEM was confirmed, (OEM: Ascencia) searches continue in VetCert and SBA’s DSBS databases. First using the NAICS Code: 325413 and then more specifically, searching for the manufacturer/ OEM (Ascensia).

1. VetCert, generated 86 SD/VOSB businesses using NAICS code: 325413.

2. SBA’s DSBS, generated 18 Small businesses using NAICS code: 325413.

a. Both databases (VetCert & SBA DSBS) were checked for the manufacturer/OEM (Ascensia) and the searches yielded no results.

Confirming that the manufactures are not registered with VetCert or the SBA.

b. The business that did generate are distributors of large wholesalers.

SAM.gov was searched to confirm the OEM business size. Ascensia is registered within SAM.gov and confirms they’re a large corporation, under the Certs and Reps section.

i. Cross-referencing the information with databases 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 manufacturers of the requested pharmaceutical(s) have been determined large business concerns.

OEM/Manufacturer website was reviewed for product information.

i. Line Item 1 & 2 : (CONTOUR NEXT (GLUCOSE) TEST STRIP 50CT & 100CT), MPNs 7311 & 7312 are used to measure Glucouse levels.

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.

Contract Specialist

Contracting Officer

Jennifer Knight Digitally signed by Jennifer Knight Date: 2024.03.15 09:30:06 -05'00'

KELLEY

CUNNINGHAM

Digitally signed by

KELLEY CUNNINGHAM

Date: 2024.03.15 10:29:16 -05'00'