P03 Medtronic 36C260-23-AP-4386_Redacted.pdf

VHAPG Part 806.3 OFOC Page 1 of 3 Revision: 01 Effective Date: 04/01/23

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C260-23-AP-4386

1. Contracting Activity: Department of Veterans Affairs, Veterans Healthcare Administration, Regional Procurement Office West, Network Contracting Office 20 1601 E.

Fourth Plain Blvd Vancouver WA 98661, on behalf of VISN 20, Portland VA Medical Center. 2237 #:648-24-1-105-0003

2. Nature and/or Description of the Action Being Processed: This request is for a sole source justification to Medtronic USA Inc, the manufacturer, as a new firm-fixed price contracts for a base + 4 option years for service of the Portland Surgery Services Medtronic O-Arm.

3. : This is a service -Arm used for image guidance in the OR. All parts, labor. software upgrades. and technical service are to be provided. This will insure the system will operate in accordance to manufacturer specifications and tolerances.

POP start Total

Base 10/1/2023-09/30/2024 Option year one 10/1/2024-09/30/2025 Option year two 10/1/2025-09/30/2026

Option year three 10/1/2026-09/30/2027

Option year four 10/1/2027-09/30/2028

Total

4. Statutory Authority Permitting Other than Full and Open Competition:

( X ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

5. Demonstration that the C Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

Medtronic Products are complex medical devices subject to regulation by the Food and Drug Administration. As such, Medtronic does not authorize the repair or service of these Medtronic Products by customers or third parties, including the loading or reloading of software, and does not authorize any third parties to perform service or repair. Medtronic does not sell or authorize the sale of parts to third party service/repair companies. Medtronic does not provide training or training manuals to any third parties. Medtronic representatives

VHAPG Part 806.3 OFOC Page 2 of 3

Effective Date: 04/01/23 and designated hospital staff, referred to as system product coordinators, are continually trained on new features, software, and next generation products to ensure they have the knowledge to operate these Medtronic Products properly and safely.

Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A sources sought synopsis was issued, on 8/28/2023, the 36C26023Q1007, Service contract for the Portland VAMC Medtronic O-Arm used for image guidance in the OR. No responses were received.

Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The price has been determined to be fair and reasonable the pricing is the same as the previous purchase order 36C26020P0004 for the Portland VAMC Medtronic O-ARM.

Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Do to the nature of this procurement limited market research was conducted. Mandatory and encouraged sources were searched but the services were not found. On 08/28/2023 a sources sought (36C26023Q1007 ) was published to SAM.gov, however no vendors to it. The manufacture of this equipment, Medtronic USA, Inc. was contacted to find if they had any authorized partners that were authorized to provide these services. The manufacturer replied these did not have any authorized partners that can provide these services. A proprietary rights letter was provided by

Any Other Facts Supporting the Use of Other than Full and Open Competition: The Medtronic O-Arm is owned by the Portland VAMC if any unauthorized service, repair or modification were to be performed, Medtronic reserves the right to refuse to service any adulterated Medtronic Products if they consider it to be not repairable according to Medtronic standards.

Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Medtronic USA Inc

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: Any subsequent endeavor will have the marketplace surveyed to see if there is availability of competition.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Gordon Hosoda Chief, Biomedical Engineering

VA Portland Health Care System

VHAPG Part 806.3 OFOC Page 3 of 3

Effective Date: 04/01/23

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: This part if filled out by Contracting Staff as part of the Justification

a. Contracting Officer Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Michael J. Allred Branch Chief (Medical Equipment)

Network Contracting Office 20

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Brian Corey ision 1 Network Contracting Office 20

Brian M. Corey 258998

Digitally signed by Brian M.

Corey 258998 Date: 2023.09.05 10:00:38 -06'00'