P03 - SSJ - 36C259-24-AP-3499 - Carto 3 Maintenance - PDF_Redacted.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

Effective Date: 02/01/2022 Page 2 of 3 by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(x) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): The authority cited in paragraph 4 must be used because no other vendor is capable of providing maintenance or services to the Canto 3 system. In an email dated May 9, 2024, from Cody Curtis, Territory Manager – Denver Central at Biosense Webster it was conveyed that Biosense Webster has proprietary rights to the equipment and the repair of the equipment. Mr. Curtis stated that Biosense Webster has Field Service Engineers who provide all the required maintenance.

Due to the complexity of generator and irrigation pump equipment and the chance for harm to staff and patients, this must be maintained by factory trained staff and validated prior to use on a patient. Biosense Webster does not permit or train others to perform service or maintenance on these devices. Boston Scientific can perform maintenance to the required FDA and safety standards.

5. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market Research indicates that there are no other vendors capable of provide the service and maintenance of the current Carto 3 system. Biosense Webster was contacted about support options for this system, and if there were any other vendors, or authorized distributors capable of providing this service to the Government. Biosense Webster has confirmed that they have certified staff to maintain the equipment and that they do no train other parties to conduct this work. Further searches on VIP, VetCert, SBA, GSA Advantage, and SAM did not produce any other vendors capable of providing this service.

The contracting officer's determination to make a sole source award is a business decision wholly within the discretion of the contracting officer. To ensure that opportunities are available to the broadest number of verified SDVOSBs, this authority is to be used judiciously and only when in the best interest of the Government.

6. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The price will be analyzed in accordance with FAR 13.106-3(a)(2) to ensure it is fair and reasonable. The price will be compared to previous prices paid by the Government for comparable requirement. The price will also be compared to the Independent Government Cost Estimate (IGCE).

7. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted: Market research indicates there are no other vendors that can supply the required maintenance and services. Biosense Webster is the only source