P03 FAR13 SSJ 36C249-23-AP-3584 CryoConsole CO Signed.pdf

VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Single Source Justification for SAP under the SAT

VHAPM Part 813.106 Page 1 of 2 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: 36C249-23-AP-3584 (VA-24-00005115)

1. Contracting Activity: Department of Veterans Affairs, VISN 09, Lexington VA Healthcare System, NCO9, 2237#596-24-1-077-0026

Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The Lexington VA Healthcare System in Aug of 2021 purchased the CryoConsole Systems under the IDIQ 36C10G18D0105 NX EQ CRYOTHERAPY TISSUE ABLATION SYSTEMS contract. Currently the system is used in the Cath Lab for cryoablation and requires preventative and corrective/repair maintenance for optimum functionality. These services ensure the equipment functions as intended for patient safety during procedures. The estimated amount per year for this system is $15,750 for total value of $78,750.00 for a base + 4 option years.

Base Year: 10/1/2023-9/30/2024 $15,750.00 Option Year 1: 10/1/2024-9/30/2025 $15,750.00 Option Year 2: 10/1/2025-9/30/2026 $15,750.00 Option Year 3: 10/1/2026-9/30/2027 $15,750.00 Option Year 4: 10/1/2027-9/30/2028 $15,750.00

Total Anticipated Contract Value: $78,750.00

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

The CryoConsole is intended for use with compatible Medtronic cryoablation catheters. Only OEM-trained field service engineers (FSE’s) are able to work on this equipment due to its complexity and proprietary components. The OEM does not offer training and certification to distributor’s representatives or hospital biomedical engineers, leaving the OEM as the only available source for service and parts. Thus, this high-tech medical equipment used in the Cath Lab for cryoablation may only be serviced and maintained by Medtronic USA, Inc the original equipment manufacturer (OEM) or all associated warranties will be voided. Medtronic has provided proprietary letter stating they do not offer training or certification for distributors or hospital biomedical engineers.

https://www.acquisition.gov/?q=/browse/far/13

VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Single Source Justification for SAP under the SAT

VHAPM Part 813.106 Page 2 of 2 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020

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

VIP Search: utilizing search parameters NAICS code 811210 with key word “cryoConsole” provided zero (0) results.

FPDS Search: utilizing search parameters with key word “CryoConsole” resulted in a total of (65) results. To narrow the result field additional key words “cryoconsole maintenance service” were utilized that identified (2) vendors MEDTRONIC, INC. and REMI GROUP LLC.

SAM Search: utilizing search parameters with key word “CryoConsole” resulted in (47) inactive results of various procurements of supplies and services to Medtronic USA Inc GSA Advantage Search: utilizing search parameters NAICS Code 811210 with key words “cryoconsole” provided zero (0) results Dynamic Small Business Search (DSBS): utilizing search parameters NAICS Code 811210 with key words “cryoconsole” provided zero (0) results.

Intent to Sole Source Notice: 36C24924Q0005 was posted 08/11/2023 and closed 08/21/2023 at 10am CST which resulted in zero (0) responses from interested contractors.

Based on market research findings, there is not a reasonable expectation of receiving quotes from 2 or more SDVOSB/VOSB’s.

Medtronic USA, Inc has provided a proprietary letter stating they are the exclusive OEM manufacturer & proprietor of device allowing no other authorized trainers or distributors of this highly complex cardiac ablation system to perform maintenance or repair services without voiding in place warranties.

4. 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.

Shawn M. Hendricks Date

Contracting Officer https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466