S02_JnA_Q0009_Allsigned_.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items

Attachment 1: Request for Sole Source Justification Template >SAT-$7.SM under FAR13.S the VA, Pharmacy Benefits Management (PBM) has determined that CMOP IDs in the National Drug

File (NDF) will mist 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.

AutoSoft 90 lnfusionS..O, Auto Soft· 90 Infusion Set � lit� @ 6 mm ® 23 in/ 60 cm l:l 2021-09-01

� �05705244018129 � 1002817 @5251554 /10x) i MiniMed· Micf Advance

IIIDIIIIIIIIIUIIIIIIIIII, 111.i

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A synopsis of this requirement will be posted to SAM.gov and the RFQ will be posted as Other than Full and Open Competition. Only qualified vendors will be able to submit quotes due to Gray Market/Name Brand only requirements.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

The anticipated cost will be fair and reasonable based off competition and or the IGCE.

8. Description of the Market Research Conducted and the Results. or a Statement of the Reasons

Market Research Was Not Conducted:

Market research, in accordance with FAR Part 10, was conducted. The NAC (National Acquisition

Center- Med-Surg Catalog) database was checked for existing contracts. No PV contracts were found for either item. The infusion set Tandem 1002817, has an FSS contract. Although, one FSS contract was identified, to promote competition this will be solicited open market. The infusion set

MMT-243A did not not have a FSS contract. Please refer to Briefcase document P02_NAC _MR.

Reviewed results from similar requirements. Checked VIP and SBA search results. The SBA search showed 86 small business doing business using NAICS code 325413 (In-vitro diagnostic substance manufacturing). The VIP database search concluded there are 45 SDVOSB or VOSB companies doing business using NAICS code 325413 (In-vitro diagnostic substance manufacturing); however, due to

Non-Manufacturer Rule (NMR) requirements, unable to set-aside for SDVOSB/VOSB suppliers without a waiver. VA Rule of Two requirements cannot be met based on this market research and the SBA's NMR as defined in FAR Part 19 and 13 CFR § 121.406. Furthermore, due to the time constraints of this acquisition, there is not sufficient time to request an individual waiver to the NMR.

Additionally, based on FAR 25.401(a)(5) Buy American Act applies to this procurement due to an exception to Trade Agreements.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: This will be an

Other than Full and Open competition RFQ due to Gray Market/ Brand Name only requirements.

Last Updated: 02/01/22