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

Revision: 01 Effective Date: 11/15/2024 Page 1 of 3 Acquisition ID# 36C250-25-AP-44211

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-4211

1. Contracting Activity: The Department of Veterans Affairs, Veterans Integrated Service

Network (VISN) 10, Dayton Veterans Affairs Medical Center (DAY VAMC) Network Contracting Office (NCO) 10.

Transaction: 552-25-3-325-0046

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, brand name purchase order to Mirion Medical (Capintec), Inc., 1st American Medical Distributors, Inc. or DGA Medical for dose calibrators.

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: Per FAR 11.105, "Items Peculiar to One Manufacturer," and FAR 12.302, "Tailoring of Provisions and Clauses for the Acquisition of Commercial Items," Varian, the OEM, through its sole authorized distributor Advanced Critical Devices, is uniquely qualified to provide the microwave ablation system based on the following:

Includes dual 2.45 GHz microwave generators, allowing for higher energy output and faster, more efficient ablations.

Supports both single-needle and dual-needle configurations to accommodate various clinical and anatomical requirements.

Dual generators can function independently or in a linked mode, providing procedural flexibility.

Proprietary myAblation Guide software is integrated, offering real-time procedural planning and guidance.

Software is deployed on the syngo.via View&Go platform, which is exclusive to this system and not compatible with third-party tools.

Includes Ximitry Probes in multiple lengths (15 cm, 20 cm, and 27 cm), allowing for targeted treatment in diverse patient populations.

Effective Date: 11/15/2024 Page 2 of 3 Acquisition ID# 36C250-25-AP-44211

Comes with an OEM-specific temperature sensor probe (18G x 20 cm) for real-time monitoring and safety.

Planning and confirmation software supports pre-procedure targeting and post-procedure verification, improving accuracy and patient outcomes.

Delivered with a mobile cart for clinical portability and ease of use in different departments or procedure rooms.

FDA-cleared system that must be used with proprietary probes and software to maintain regulatory compliance.

Requires specific OEM firmware and licenses, which are not available from third-party sources.

Advanced Critical Devices is the sole authorized distributor, as confirmed by the OEM (Varian); no other SDVOSBs or VOSBs currently offer this system.

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

The OEM, Varian (a large business), was contacted to obtain a list of authorized distributors, with a focus on SDVOSBs and VOSBs. The OEM stated that they currently only use Advanced Critical Devices, a small business.

GSA eLibrary, ECAT, SAM.gov, Interagency Contract Directories, NAC, SEWP, COP-CS, FPDS, SCMC, MSVP, BIC and FDA:

Keywords Used: "microwave ablation system" Results: None

DSBS:

NAICS Code Searched: 334510 (Other Computer Related Services) Keywords Used: "microwave ablation system" Results: None could provide the containers that met the specific technical and regulatory requirements besides Alvarez, LLC.

Based on these findings, no alternative vendors were identified that could fulfill the need without significant facility modifications, procurement delays, or operational disruptions.

The VA and SBA rule of two cannot be met, there is only one small business vendor, Advanced Critical Care.

Effective Date: 11/15/2024 Page 3 of 3 Acquisition ID# 36C250-25-AP-44211

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. Per FAR 13.106-3(a)(2)(ii), price reasonableness will be based on comparison of proposed prices with prices found reasonable on previous purchases using

FPDS.

Rachelle J. Hamer Contracting Officer

NCO 10

RACHELLE

HAMER

Digitally signed by

RACHELLE HAMER

Date: 2025.06.30 12:26:23 -04'00'