S02_JnA_36C77024Q0024_Knight_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: 36C770-24-AP-0015

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

2237 # 760-24-1-021-0053, Lancaster CMOP, Lancaster, TX.

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

Item Number IMFN CMOP Description MPN Quantity

Unit of Measure

Packaging Multiple OEM NAME

0001 18784 VA CMOP Lancaster - 763 CATH SET,INTERMIT 14FR APOGEE H#B14FB (XU389) H#B14FB 360 CS 100 Hollister Incorporated

This is an individual brand name justification to support the procurement of the one (1) Brand Name Specific Med/Surg item (CATH SET,INTERMIT 14FR APOGEE H#B14FB (XU389)) in the above table. The proposed procurement action will be a firm-fixed-priced.

Per the OEM, Product is a Touch free, sterile, and self-contained, the Apogee Plus™ intermittent catheter system.

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 and or MPN 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 10/12/2023. Market research is being conducted on 10/26/2023 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 products are not available from typical contract vehicles or supply chains. All avenues have been exhausted by CMOP via searches on Prime Vendor, NAC, and FSS; an open market procurement is the only option that remains for purchasing the med/surg products. This requirement is not for lack of planning, but due to inventory not being available via normal supply chains.

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 marketplace). The item was searched, and no results were found.

The CMOP Medication Image Library along with the manufacturer’s website were searched and it was determined that Hollister Incorporated, a large business, is the manufacturer of the requested - CATH SET,INTERMIT 14FR

APOGEE H#B14FB.

The Contracting Specialist 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 code: 325413. This yielded a total of 84 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 (DSBS) which resulted in 33 small businesses who identified as authorized distributors.

The manufacture “Hollister Incorporated” was also specifically searched within the SBA database, this yielded no results.

The Contracting Officer 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 pharmaceutical. The CO has confirmed there is no class waiver associated for pharmaceuticals under NAICS Code: 325413. The Contracting Officer 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 Knight J. Braden Smith Contract Specialist Contracting Officer

JENNIFER KNIGHT

Digitally signed by JENNIFER

KNIGHT

Date: 2023.10.26 14:07:11 -05'00' JUSTIN SMITH

Digitally signed by JUSTIN

SMITH

Date: 2023.10.27 07:22:55 -05'00'