S02_JnA_Q0188_Allsigned.pdf

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

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DEPARTMENT OF VETERANS AFFAIRS

Justification for Brand Name Awards IAW FAR 13.106-1 For

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

Acquisition Plan Action ID: 36C770-24-AP-0257

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 15, CMOP Division. 2237# 760-24-1-050-0377, Leavenworth CMOP, Leavenworth, KS

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

Item Number

ITEM MASTER

FILE NUMBER CMOP Location Description OEM NAME

MANUFACTURER PART

NUMBER (MPN) Quantity

Unit of Measure

Packaging Multiple

0001 19927 VA CMOP Leavenworth - 760 RESERVOIR,T:SLIM X2 W/T:LOCK,3ML 10CT, XL551

TANDEM

DIABETES CARE 89152-2541-05 3180 BX 10

0002 13125 VA CMOP Leavenworth - 760 BREAST MILK STORAGE BAG 100CT, XI538

LANSINOH

LABORATORIES, INC. 44677-0204-70 3024 BX 100

This is an induvial brand name justification to support the procurement of the Med/Surg item 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 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.

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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:

A sources sought notice was not posted for this acquisition because pharmaceutical/med/surge buys are routine, and the Contracting Specialist and Officer are very knowledgeable about the marketplace. It is unlikely that a source’s 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.

The station provided approved (Manufacture Part Number) for each of the line items.

(MPN:89152-2541-05 & MPN: 44677-0204-70) The first query was conducted within the VA image library, in order to gather photos and confirm the manufacturers/OEMs names.

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, searches begin by utilizing the VA image library – where the requested product manufacture/ OEM was confirmed.

Once the OEMs were confirmed, (OEMs: Tandem Diabetes Care, Inc & LANSINOH LABORATORIES, INC.) searches continue in VetCert and SBA’s DSBS databases. First using the NAICS Code: 325413 and then more specifically, searching for the manufacturer/ OEMs (OEMs: Tandem Diabetes Care, Inc &

LANSINOH LABORATORIES, INC).

VetCert, generated 85 SD/VOSB doing businesses using NAICS code:

325413.

SBA’s DSBS, generated 22 Small businesses doing business using NAICS code: 325413.

a. Both databases were checked for the manufacture/ OEMs (OEMs: Tandem Diabetes Care, Inc & LANSINOH LABORATORIES, INC) and the two searches yielded no results. Confirming that the manufacturers/ OEMs are not registered with VetCert or the

SBA.

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

SAM.gov was then searched to confirm the OEMs/ manufacturers size. Tandem Diabetes Care, Inc. & Lansinoh Laboratories Inc., are not registered within sam.gov.

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 Med/Surg product have both been determined to be a large business concerns.

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Reviewed past procurements via VISTA History look up- using the Item

Master File Number.

Line Item: 1 - IMFN: 19927. Past procurement PO – 760-A40016 on 11/15/2023.

i. Past procurement showed the product as being made in

Mexico.

Line Item: 2 IMFN: 13125. Past procurement PO – 760-A40017 on 11/20/2023.

i. Past procurement shows the product was made in the

USA; therefore, BAA compliant.

Product was then reviewed on the Manufacturer/ OEM website:

https://www.tandemdiabetes.com/

Per the manufacture/OEM website, below are the details on the requested product.

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.

https://lansinoh.com/collections/breastmilk-storage Per the manufacture/OEM website, below are the details on the requested product.

Lansinoh Breastmilk Storage Bags are built super strong, featuring a double zipper seal and reinforced double sealed side seams for ultimate protection. Ideal for freezing and protecting breastmilk. Presterilized and BPA/BPS free.

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 two med/surg items. The CS has confirmed there is no class waiver associated for pharmaceuticals under NAICS Code:

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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: _______________________________ Contract Specialist

Name: _______________________________

Contracting Officer

Jennifer Knight Digitally signed by Jennifer Knight Date: 2024.03.04 15:15:45 -06'00'

KELLEY

CUNNINGHAM

Digitally signed by

KELLEY CUNNINGHAM

Date: 2024.03.05 13:33:03 -06'00'