S02_JnA_Q0287.pdf

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

Last Updated: 02/01/22 Page 1 of 3

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-0578

1. Contracting Activity: The Department of Veterans Affairs, Network Contracting Office (NCO) 15 – Consolidated Mail Outpatient Pharmacy (CMOP) Division on behalf of the Chelmsford CMOP.

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

Item Number

File Number

(IMF)

Description Local Stock Number

Quantity Unit of Measure

Packaging Multiple

0001 19927 RESERVOIR,T:SLIM

X2 W/T:LOCK,3ML

10CT, XL551

89152-2541-

2000 BX 10

0002 761 BAG,LEG LATEX

REUSABLE UROCARE

#9532

99999-9532-

1200 EA 1

0003 12866 LANCET,ACCU-CHEK

FASTCLIX DRUM

(XH019)

65702-0288-

1200 EA 102

0004 15823 SET, INFUSION

AUTOSOFT 90

TANDEM #1002820,

XJ689

89152-2820-

480 BX 10

This is an individual brand name justification to support the procurement of the medical surgical (med/surg) items in the table above. The proposed procurement action will be a firm-fixed-price contract award for the supplies.

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.

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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.

The procurement packet was received on April 24, 2024. Market research was conducted beginning May 30, 2024, for the upcoming acquisition.

A sources sought notice was not posted for this acquisition because medical surgical (med/surg) 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 these 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 these med/surg products. This requirement is not for lack of planning, but due to inventory not being available via normal supply chains.

The Contracting Officer conducted further searches in VetCert utilizing NAICS code 325413, In-Vitro Diagnostic Substance Manufacturing, and yielded a total of 90 SD/VOSBs who identified as authorized distributors. Further market research was conducted via Dynamic Small Business search (DSBS) which resulted in 18 small businesses who identified as authorized distributors.

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 items were searched and no results were found.

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The CMOP Medication Image Library along with the manufacturer’s website was searched, the chart below shows the manufacturer and business size for each med/surg product.

Item Number

Description Manufacturer Country of Origin

0001 RESERVOIR,T:SLIM X2 W/T:LOCK,3ML 10CT,

XL551

Tandem Diabetes Care (Large Business)

Mexico

0002 BAG,LEG LATEX REUSABLE UROCARE #9532 Urocare Products (Small Business)

USA

0003 LANCET,ACCU-CHEK FASTCLIX DRUM

(XH019)

Roche Diagnostics (Large Business)

Germany

0004 SET, INFUSION AUTOSOFT 90 TANDEM

#1002820, XJ689

Tandem Diabetes Care (Large Business)

Mexico

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 is presently only one domestic small business manufacturers that exist in the commercial marketplace for line item 2. Reusable Latex Bag, Urocare, as noted in the above chart is manufactured domestically by a small business; however line items 1, 3, and 4 are manufactured by large businesses. The CO has confirmed there is no class waiver associated for these med/surg items under NAICS Code 325413. The Contracting Officer considered the use of an individual waiver;

however, it 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 for line items 1, 3, and 4. Alternatively, a total small business set-aside is feasible as the NMR does not apply to total small business set-asides below the SAT; furthermore, since the majority 58% of the procurement is manufactured by large businesses and there are not multiple small business manufacturers to promote competition this requirement will be solicited as a small business set-aside. This does not preclude a SD/VOSB from quoting and/or receiving an award as a small business.

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.

Kelley Cunningham Date Contracting Officer Network Contracting Office 15, CMOP Division