ssj_Redacted.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 Single Source Awards IAW FAR 13.106 1 For

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

Acquisition Plan Action ID: 36C250 25 AP 1755

1. Contracting Activity: The Department of Veterans Affairs, Veterans Integrated Service Network (VISN) 10, Louis Stokes Cleveland VAMC (CLE VAMC) Network Contracting Office

(NCO) 10.

Transaction: 541 25 2 250 0080

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

Network Contracting Office (NCO) 10 intends to award a new, firm fixed price, purchase order to Medtronic. This request is for Barrx HALO generators.

1 EA Barrx Capital Partnership Promo 1 EA Haloflex Energy GeneratorX1 1 EA Freight

ESTIMATED DOLLAR VALUE:

REQUIRED DELIVERY DATE: 30 Days ARO

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Medtronic is the Original Equipment Manufacturer (OEM) and the sole provider of the Barrx HALO Generator. No other manufacturer designs, produces, or distributes a system with the proprietary HALO radiofrequency ablation technology. The device's unique compatibility with Medtronic's HALO catheters, safety features, and proven clinical effectiveness further necessitate sourcing directly from the OEM or its authorized distributors. The Barrx HALO Generator has the following proprietary features that are not available from any other manufacturer:

Controlled radiofrequency energy delivery Multiple applicator compatibility Real time feedback and safety features Minimally invasive and outpatient use Proven clinical effectiveness

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4. Description of market research conducted and results or statement why it was not conducted:

Market research, as follows, was conducted by the Contracting Officer and the service to identify available domestic sources to meet the requirements:

VetCert was queried, as required, using NAICS 335312, with 146 results [Veteran Small Business Certification (sba.gov)]. Market research was unable to identify any SD/VOSBs that manufacture the product.

The OEM, Medtronic, a large business, was contacted to receive a list of authorized distributors, with a concentration on SDVOSB and VOSB authorized distributors. The OEM stated that they currently use Beacon Point Associates, Marathon Medical Corporation, and Veterans Healthcare Supply Solutions (VHHS), all SDVOSBs as their authorized distributors.

Search (DSBS) (SBA SBA Search Results) under NAICS CODE 335312 and key words “halo generator” with no results.

A search was conducted on the Interagency Contract Directory (Interagency Contract Directory Portal) with key words “halo generator” with no results.

A search was conducted on GSA eLibrary [(Search Results (gsaadvantage.gov)] with key words “halo generator” with no results.

A search was conducted on NAC [VA National Acquisition Center Contract Catalog Search Tool] with key words “halo generator” with no results.

A search was conducted in Federal Procurement Data System (FPDS) (FPDS NG ezSearch) with key words “halo generator” with the following results: for surface grinder from Reinen Machine Sales Inc., and for a jFno otherack, bottle, hydraulic hand 30 tone from Kipper Tool Company.

A search was conducted of the Defense Logistics Agency Electronic Catalog (ECAT) at dla.mil with key words “halo generator” with no results.

A search was conducted on MSPV DMMonline Home Page (dla.mil) with key words “halo generator” with no results.

A search was conducted on SCMC VA Supply Chain Master Catalog (sharepoint.com) with key words “halo generator” with no results.

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A search was conducted on DLA Troop MedPBD DMMonline Home Page (dla.mil) with no results.

IAW OMB MemorandumM 19 13 Category Management: Making Smarter Use of Common Contract Solutions and Practices, this requirement cannot be satisfied through Best in Class contracting (BIC).

A search was conducted of the U.S. Food & Drug Administration (FDA) website (www.fda.gov) with key words “halo generator” with no results.

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.

Rachelle J. Hamer Date Contracting Officer

RACHELLE HAMER Digitally signed by RACHELLE HAMER Date: 2025.02.05 11:33:31 -05'00'