P03-J and A - 640-20-3-163-0097-Ablation System-CO Signed.pdf

VHAPM Part 813.106 Page 1 of 1 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020

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: 36C261-20-AP-4425

1. Contracting Activity: Department of Veterans Affairs, VISN 21, VA Northern California Healthcare System, RPO-West, Network Contracting Office, NCO 21, Martinez, CA on behalf of the VA Palo Alto Health Care System in Palo Alto, CA. 2237 PR. NO. 640-20-3-163-0097.

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The VA Palo Alto Health Care System (VAPAHCS) is seeking to purchase a NeuWave Microwave Ablation System for use in their Interventional Radiology and Surgery Departments for liver, kidney, and lung cancer treatments.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

The NeuWave Ablation System is CO2 cooled and is the smallest gauge in the marketplace at 17 gauge. It also has ablation confirmation software that assists during procedures. The new Ablation

System must be FDA approved and must be compatible with the Certus line of microwave ablation probes (PR and LK probes) currently being used at the VA hospital. Palo Alto has a large stock of microwave ablation probes costing thousands of dollars, which will be rendered useless if we procure an ablation system from a different manufacturer. The new system must be up to date with all VA security information and must be able to provide imaging software that allows the user to estimate the ablation zone on CT scans and be compatible with the probes on hand.

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

Market research was conducted by searching and reviewing VIPBIZ, SBA, FPDS, GSA Advantage, eCMS and other websites. Market research determined that there are two verified SDVOSB distributors that are available to fulfill this requirement. And NAICS 334510 is on the NMR waiver list and this requirement meets the 4-prong test.

Strategy: Due to the proprietary nature of the NeuWave Microwave Ablation System I recommend issue a Service Disable Veteran Owned Small Business (SDVOSB) Set-Aside Brand Name Only combined synopsis solicitation on beta.SAM.gov as the method of procurement.

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.

Name Date

08/31/2020 https://www.acquisition.gov/?q=/browse/far/13 https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466