S02_JA_Q0085_CS_CO.pdf

36C77025Q0085 | 2 Line Med/Surg

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-0154

1. Contracting Activity: Department of Veterans Affairs, NCO 15, National Contracting Office. 2237 # 760-25-1-050-0227, VA CMOP Leavenworth CMOP Office. 5000 S. 13th Street, Leavenworth, KS 66048-5580.

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 two (2) Brand Name Specific, Med/Surg items (LifeScan, ONE TOUCH ULTRA (GLUCOSE) TEST STRIPS in 100CT & 50CT) 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:

Market Research Methods/Techniques/Sources: 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 11/21/2024.

Market research is being conducted on 12/11/2024 for the upcoming acquisition

Attachment 1: Single Source Justification for SAP under the SAT of two LifeScan- ONE TOUCH ULTRA (GLUCOSE) TEST STRIPS – in (100CT) & (50CT) - packaging multiples.

A sources sought notice was not posted for this acquisition because Med/Surg buys are routine, and the Contracting Officer is very knowledgeable about the Med/Surg 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 (LifeScan, ONE TOUCH ULTRA (GLUCOSE) TEST STRIPS in 100CT & 50CT) 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.

Therefore, the VA image library and the Manufacture websites were search for details regarding Country of Origin and products. The requested items (LifeScan, ONE TOUCH ULTRA (GLUCOSE) TEST STRIPS in 100CT & 50CT) are brand name only/ dispense as written product.

Per company website products – “Only Works With OneTouch Ultra 2 Meter:

These blood glucose test strips are compatible with the OneTouch Ultra 2 meter.

With a large, backlit display screen and readings in just five seconds, this blood glucose monitoring system is designed to help you manage blood glucose.”

https://shop.onetouch.com/onetouch-meters - product details The IMFN was then used within the VISTA database to review past procurements.

After reviewing the last procurement in VISTA and getting contract numbers;

FPDS was reviewed and determined that per the last procurement - the product is manufactured in the United Kingdom. Furthermore, a TAA procurement was considered as the TAA threshold of 174K is met but the requested item is a Brand Name only product and per FAR 25.401(a)(5) – Brand Name only is an exceptions to TAA, Therefore, BAA applies.

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 SD/VOSB manufacturers for the required medical surgical item. The

Attachment 1: Single Source Justification for SAP under the SAT requested product OEM, Lifescan, was searched within the VetCert database and this yielded no result.

Research was conducted via Dynamic Small Business search which resulted in 19 small businesses who identified as manufacturers, utilizing NAICS code 325413.

The requested product OEM, Lifescan, was searched within the SBA database and this yielded no result.

Based on procurement history of the requested Med/Surg item, it is anticipated that at least two or more of the SDVOSB businesses are authorized distributors and capable of fulfilling the VA’s requirement at a fair and reasonable price.

Furthermore, LifeScan provides an authorized distributors listing.

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: 2024.12.12 13:20:08 -06'00'

KELLEY

CUNNINGHAM

Digitally signed by

KELLEY CUNNINGHAM

Date: 2024.12.13 08:09:28 -06'00'