S02_JA_Q0436_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: 36C770-23-AP-0963

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

2237 # 760-23-4-050-1511, Leavenworth CMOP, Leavenworth, KS

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

Item

Number IMFN CMOP Description Local Stock

Number Quantity Unit of

Measure Packaging Multiple OEM NAME

0001 6243 VA CMOP Leavenworth - 760 ONE TOUCH ULTRA (GLUCOSE) TEST STRIP 50CT (XZ173) 53885-0244-50 144 BX 50 LifeScan 0002 6247 VA CMOP Leavenworth - 760 ONE TOUCH ULTRA (GLUCOSE) TEST STRIP 100 XZ173 53885-0245-10 2160 BX 100 LifeScan

This is an individual brand name justification to support the procurement of the two (2) Brand Name Med/Surg test Strips item, listed in the above table. The proposed procurement action will be a firm-fixed-priced contract.

Original Equipment Manufacturer (OEM) website: “LifeScan” - Reviewed Product details Per the OEM, OneTouch Ultra Diabetic Test Strips provide fast and less painful testing of glucose levels.

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 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 and VAAR 810, market research has been conducted for this acquisition. The procurement package was received by the Contracting Office on 8/21/2023.

Market research is being conducted on 9/15/2023 for the upcoming acquisition.

A sources sought notice was not posted for this acquisition because pharmaceutical/med/surge 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 the med/surg items are not available from typical contract vehicles or supply chains, such as and not limited to Prime Vendor, NAC and FSS; an open market procurement is the only option that remains for purchasing this product.

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 Market place. The items were searched, and no results were found.

The CMOP Medication Image Library along with the manufacturer’s website were searched and it was determined that LifeScan, a large business is the manufacturer of One Touch Ultra glucose diabetic test strips 50CT and 100CT.

The Contracting Officer conducted searches in VetCert to determine if there are service-disabled, veteran-owned small business (SDVOSB) or a veteran-owned, small business (VOSB) who identify as manufacturers utilizing NAICS code325413. This yielded a total of 83 SD/VOSBs who identified as manufacturers; however, these SD/VOSBs are distributors for large businesses. There are no known SD/VOSB manufacturers for the required product.

Market research was conducted via Dynamic Small Business search which resulted in 39 small businesses who identified as authorized distributors.

The OEM, LifeScan was specifically searched in VetCert, SBA -DSBS, SAM.GOV and DnB to determine business size. The OEM “Lifescan” did not generate results in VetCert, SBA-DSBS or SAM.gov. The OEM business size was confirmed in the DnB database search. The OEM “LifeScan is in fact a large business concern.

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, 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). On June 16, 2016, the U.S. Supreme Court ruled that consistent with Public Law 109-461 (38 U.S.C. 8127 and 8128), the VA shall award contracts based upon competition restricted to SDVOSBs or VOSBs when a contracting officer has a reasonable expectation, based on market research, that two or more firms listed as certified in the SBA’s Veteran Small Business Certification (VetCert) database are likely to submit offers and an award can be made at a fair and reasonable price that offers best value to the United States. This is known as the “VA Rule of Two”. 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. As the VA strongly encourages maximum SDVOSB/VOSB participation in all requirements, this set-aside decision serves this purpose.

As such it was determined to be in the best interest of the Government to utilize other than competitive procedures to set-aside the requirement 100% for SDVOSB concerns to satisfy the VA’s Rule of Two.

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 Contract Specialist

J. Braden Smith Contracting Officer

JENNIFER

KNIGHT

Digitally signed by JENNIFER

KNIGHT

Date: 2023.09.15 11:13:55 -05'00'

JUSTIN SMITH Digitally signed by JUSTIN SMITH Date: 2023.09.15 11:35:52 -05'00'