RFQ - 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 2 Acquisition ID#: 583-25-1-997-0067

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-1407

1. Contracting Activity: Department of Veterans Affairs, NCO10, Richard L. Roudebush VA Medical

Center, Indianapolis IN, submitted 2237 #583-25-1-997-0067 for a AVVIGO Mobile Guidance System.

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The Cardiology Department requires an AVVIGO Mobile Guidance System to meet the demands of the VA. The Boston Scientific AVVIGO system is in current use at the VA. However, this system must be shared between both the surgery and cardiology departments to meet the needs of the VA. The surgery department can no longer afford to share their system. The AVVIGO System utilizes a high-definition intravascular ultrasound and invasive physiology to perform percutaneous coronary intervention in the Cath lab. Guidelines indicate the importance of using intravascular ultrasound (IVUS) and fractional flow reserve (FFR) in patients undergoing coronary stent implantation, especially in cases of complex coronary stenting. Complex coronary stenting makes up many of the procedures performed at the RLR VAMC Cardiology Department.

Necessary supplies are:

Item # Part# Description Qty

1 BSC H749249312010 AVVIGO + INT SYSTEM, US 1

Touch screen medical grade tablet with battery, Desktop docking station, power supply and Installation guide, Includes up t 5 FFR links (UPN H7495551000), 1 year standard manufacturer warranty 2 BSC H749393160100 Permanent Sled (Included) 1

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The Cardiology Department leadership determined that the Boston Scientific (OEM), AVVIGO Mobile Guidance System was the best equipment to meet the departments requirements. The Boston Scientific AVVIGO demonstrates significant advantages, particularly in the context of complex lesions. The AVVIGO's advanced imaging capabilities and navigation technology enable it to effectively cross and visualize challenging lesions that may hinder other systems. The AVVIGO's enhanced ability to manage intricate vascular conditions not only enhances diagnostic accuracy but also contributes to improved patient outcomes. Market Research found no other comprehensive options on the market to fulfill all Government requirements, particularly in the context of complex lesions. The specifications needed by the end-user could not

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 2 of 2 Acquisition ID#: 583-25-1-997-0067 be met or shown compatibility by any other product examined. Substituting a device other than that specifically prescribed is detrimental to the treatment of the Veteran patient.

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

DSBS queried using NAICS 334510 and keywords “AVVIGO” for SD/VOSB’s with 0 vendors found.

VetCert query by same NAICS with 320 results. Review of GSA Advantage! NAC, FPDS-NG, SAM, and industry professionals were conducted for potential vendors. Requested items were not found by any other contract vehicle. OEM confirmed equipment is proprietary. OEM confirmed Veterans Healthcare Supply Solutions (VHSS), LLC (SD/VOSB) as the only authorized resellers for these products which was quoted. Authorized sole reseller letter provided. No other product examined could satisfy VA requirements. Product is on NMR Class Waiver List. The VA and SBA Rule of Two cannot be met. Intends to compete between OEM and their only authorized SD/VOSB reseller, unrestricted, open market.

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 Title

DWIGHT

PETSCHE

Digitally signed by DWIGHT

PETSCHE

Date: 2025.02.21 07:25:35 -05'00'