S02 - JA - Q0092 - CS - 2s copy_Redacted.pdf

36C77025Q0092 | 1 - 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-0164

1. Contracting Activity: Department of Veterans Affairs, NCO 15, National Contracting Office. 2237 # 766-25-1-400-0207 for the VA CMOP – Charleston/ Ladson (766).

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

Item

Number Description Stock

Number Quantity Unit of

Measure Packaging

Multiple Unit Price

Manufacturer Country of Origin

Usage

0001 RESERVOIR,T:SLIM

X2 W/T:LOCK,3ML

10CT, XL551

89152-2541-05 6250 BX 10 TANDEM

DIABETES

CARE

Mexico Insulin pump used to store and provide people living with diabetes their insulin.

This is an individual brand name justification to support the procurement of the one

(1) Brand Name Specific, Med/Surg item listed in the above table. The proposed procurement action will be a firm-fixed-priced contract awarded for the supplies with an estimated cost of

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 packages were received on 11/26/2024. Market research began on 12/11/2024 for the upcoming acquisition for Medical Surgical supplies for the Charleston/Ladson CMOP.

A sources sought notice was not posted for this acquisition because pharmaceutical/medical/surgical buys are routine, and the Contracting Officer is very knowledgeable about the marketplace. Market Research confirmed that product was recently awarded on 1/15/2025 from an open market unrestricted purchase. RFQ number 36C77025Q0061 provided four (4) compliant quotes that were able to supply the Reservoir T Slim. From this RFQ contract 36C77025P0074 was awarded to Regimed Medical in the amount of for this product. There was ample competition and the awarded price was below the IGCE. All complaint Vendors were either SDVOSB or Small Business concerns, however they were distributors as the manufacturer is a large business. 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 an approved (Manufacture Part Number) for the requested Med/Surg items. 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 via the Med/Surg Catalog Search – The requested item was searched by product name and yielded no results.

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 90 SDVOSB/VOSBs who are registered as doing business under NAICs code: 325413. The brand specific manufacturers/OEM (TANDEM DIABETES CARE) were searched within VetCert database and yielded no results.

Market research was conducted via the SBA within the Dynamic Small Business search - which resulted in 19 small businesses who are registered as doing business under NACICs Code: 325413. The three brand specific manufacturers/OEMs (TANDEM DIABETES CARE) were searched within the SBA database and yielded no results.

Products were then reviewed on the brand specific Manufacturers/ OEMs website:

Line Item: 1 (RESERVOIR,T:SLIM X2 W/T:LOCK,3ML 10CT, XL551): https://www.tandemdiabetes.com/products/insulin-pumps/t-slim-x2-insulin-pump

Per the OEM – “Product “The t:slim X2 insulin pump with interoperable technology is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in people requiring insulin..”

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.

Jennifer Coleman Kelley Cunningham Contract Specialist Contracting Officer