S02_BrandName_JnA_Q0398_allsigned.pdf

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

VHAPG Part 806.3 OFOC Page 1 of 4 Revision: 01 Effective Date: 04/01/23

DEPARTMENT OF VETERANS AFFAIRS

Justification for Brand Name Award IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C770-24-AP-0703

2237 Number: 762-24-3-040-2403

1. Contracting Activity: The Department of Veterans Affairs, Network Contracting Office (NCO) 15- Consolidated Mail Outpatient Pharmacy (CMOP) Division on behalf of the Tucson 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) item in the table above. The proposed procurement action will be a firm-fixed-price contract.

Item Number IMFN CMOP Description

MANUFACTURER

PART

NUMBER (MPN) Quantity Unit of

Measure Packaging Multiple OEM NAME

0001 19927 VA CMOP Tucson - 762 XL551: RESERVOIR,T:SLIM X2 W/T:LOCK,3ML 89152-2541-05 4200 BX 10 Tandem

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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, Market Research has been conducted for this acquisition.

Market Research Methods/Techniques/Sources:

Market Research Methods/Techniques/Sources: In accordance with FAR Part 10 and VAAR 810, market research has been conducted for this acquisition. Market research is being conducted on 8/15/2024 for the upcoming acquisition for TANDEM RESERVOIR, T: SLIM X2 W/T:

LOCK,3ML (MPN: 89152-2541-05).

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.

Medical Surgical items are not found on the National Institutes of Health (NIH) U.S. National Library of Medicine DailyMeds website. The station provided approved (Manufacture Part Number) for each of the requested item. (MPN:89152-2541-05) The first query was conducted within the VA image library, in order to gather photos and confirm the manufacturers/OEMs names.

Reviewed the National Acquisition Center (CCST) Searched for GSA/FSS/PV Contracts using the station approved product name was searched via the Med/Surg Catalog Search –

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The requested item was searched by product name and yielded no results.

Reviewed VISTA History for past acquisition information- Using the Item Master File number: (19927)

Past procurement shows the product being made in Mexico.

Line Item: 1 (Tandem RESERVOIR,T:SLIM X2

W/T:LOCK,3ML 10CT, XL551) – Past procurement at the Tucson CMOP –

a. PO – 762-A40017 | 36C77024P0159

FPDS was reviewed using the Contract number above (36C77024P0159)

- to see country of Origin information.

a. Country of Origin: Mexico

The contracting specialist 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 utilizing NAICs code: 325413 and this yielded a total of 89 SDVOSB/VOSBs who are registered as doing business under NAICs code: 325413. The brand specific manufacturers/OEM was searched and yielded no results.

Market research was conducted via Dynamic Small Business search which resulted in19 small businesses who are registered as doing business under NACICs Code: 325413. The brand specific manufacturers/OEM was searched and yielded no results.

A query was then conducted in SAM.gov on the Manufacturer/ OEM, this yielded no results for the compan (Tandem Diabetes Care).

A query was then conducted on Dun and Bradstreet to determine Business Size. Where it was confirmed that Tandem is a large business with 2400 employees. https://riskanalytics.dnb.com/en-US/dashboard

Products was then reviewed on the brand specific Manufacturer/ OEM website:

The t: slim Insulin Pump 3mL cartridge with t: lock is built around the latest insulin delivery technology. Using a pouch inside of the cartridge instead of a syringe and incorporating Tandem Diabetes Care's patent-pending Micro-Delivery Technology™, this cartridge allows maximum capacity in the smallest space. Designed to be used with the t: slim Insulin Pump System.

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The Contract specialist 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 (non-socioeconomic 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 pharmaceuticals, take ownership or possession of the pharmaceutical 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 item. The CS has confirmed there is no class waiver associated for pharmaceuticals under NAICS Code: 325413. The Contract specialist 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.

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.

Name: Jennifer Knight Title: Contract Specialist Facility: NCO 15, CMOP Division

Name: Kelley Cunningham Title: Contracting Officer Facility: NCO 15, CMOP Division

Jennifer Knight

Digitally signed by Jennifer Knight Date: 2024.08.16 07:19:25 -05'00'

KELLEY

CUNNINGHAM

Digitally signed by KELLEY

CUNNINGHAM

Date: 2024.08.16 13:50:05 -05'00'