PM Part806.3 Atch2 FAR6 JA OVER SAT signed.pdf

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >SAT

OFOC SOP Revision 09 Page 1 of 4 Original Date: 03/22/11 Revision 09 Date: 04/17/2020

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C263-20-AP-2606

1. Contracting Activity:

Department of Veterans Affairs, VISN 23, Nebraska Western Iowa Health Care System (NWIHCS), Omaha NE Network Contract Office 23 (NCO 23), Sioux Falls Services Team

PR-IFCAP: 636-20-4-2301-0755

2. Nature and/or Description of the Action Being Processed:

This procurement is for Medtronic O-Arm O2 Service and Support Services to support the Nebraska Western Iowa Health Care System (NWIHCS) in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2.

Service to include Hardware Coverage, Software Coverage, Clinical and Professional Services, Ongoing Product Maintenance, Software License, and Remote Support at the Nebraska Western Iowa Health Care System (NWIHCS), Omaha NE, 4101 Woolworth Avenue, Omaha NE, 68105-1850.

Contract to include four (4), one-year option periods.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

Proposed Action: Firm Fixed Price procurement Total Estimated Value: $367,625.00 Annual Cost: $73,525.00 Period of Performance: 8/1/2020 to 7/31/2021 Option Periods: 4 Maximum Completion Date: 7/31/2025

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

FAR13.5 Simplified Procedures for Certain Commercial Items: The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(2).

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

The manufacturer’s warranty period is due to expire and the equipment is eligible for the extended period offered by Medtronic as the covered products have not been repaired or altered outside of

OFOC SOP Revision 09 Page 2 of 4 Original Date: 03/22/11 Revision 09 Date: 04/17/2020

MEDTRONIC’s supervision or by non-MEDTRONIC firms. Medtronic is the original equipment manufacturer (OEM) and sole distributor of the O-Arm Imaging System and does not provide third-parties access to licensed software applications.

These systems and instruments 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 cannot guarantee the proper performance or results of its systems following any unauthorized service, repair or modification to these Medtronic products, and any unauthorized service, repair or modification will void existing warranties and service agreements.

Additionally, Medtronic does not sell or authorize the sale of parts to third party service/repair companies. Medtronic cannot guarantee the proper performance or results of its systems if unauthorized or non-OEM parts have been used, and is not responsible for the cost to bring any adulterated equipment back to manufacturer's specifications. Medtronic reserves the right to refuse to service any adulterated equipment if we consider it to be not repairable according to Medtronic standards.

Further, Medtronic assumes no responsibility or liability for any resulting claims, costs, and expenses associated with the use of any systems, devices or instruments for which unauthorized service was performed or non-OEM parts have been used for repair or maintenance.

Accordingly, Medtronic is the only firm capable of providing the supplies and services described in Section III above without the Veteran’s Health Administration experiencing substantial duplication of cost that could not be expected to be recovered through competition and unacceptable delays in fulfilling its requirements.”

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

A Bet.SAM.gov Contract Opportunity, Notice of Intent to Sole Source, was published to potentially identify any possible sources. No responses were received.

Notice Number: 36C26320Q0461 Posted Date: 5/29/2020 Response Date: 6/12/2020 Results: No responses Synopsis Description: Notice of Intent to Sole Source

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable: The CO will evaluate the offeror to ensure the anticipated cost will be considered fair and reasonable. The price will be compared to similar contracts for similar services.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Posted Notice of Intent to Sole Source; no responses. The OEM has provided a memo to reflect that they do not use third party vendors for maintenance and repair and that acces to software updates is restricted.

OFOC SOP Revision 09 Page 3 of 4

Revision 09 Date: 04/17/2020

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

These systems and instruments 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 cannot guarantee the proper performance or results of its systems following any unauthorized service, repair or modification to these Medtronic products, and any unauthorized service, repair or modification will void existing warranties and service agreements. Medtronic does not sell or authorize the sale of parts to third party service/repair companies. Medtronic cannot guarantee the proper performance or results of its systems if unauthorized or non-OEM parts have been used, and is not responsible for the cost to bring any adulterated equipment back to manufacturer's specifications. Medtronic reserves the right to refuse to service any adulterated equipment if we consider it to be not repairable according to Medtronic standards.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Quote from the OEM, 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: No actions can be taken at this time to foster competition. However, consideration of competitive actions will be taken into account for future acquisitions of similar equipment.

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.

John Becker Contracting Officer

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

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

John Becker Contracting Officer Network Contract Office 23

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

http://vaww.pclo.infoshare.va.gov/PMWeb/VHAPM_Part_806.3.aspx

OFOC SOP Revision 09 Page 4 of 4

Revision 09 Date: 04/17/2020

Travis Johnson Branch Chief Network Contract Office 23

Medtronic Medtronic Neurosurgery

Restorative Therapies Group

826 Coal Creek Circle

Louisville, Colorado 80027 www.medtronic.com

April 13, 2020

Dear Valued Customer, As you are aware, Medtronic is the manufacturer and sole distributor of the StealthStation™ surgical systems (S7 and S8), ENT surgical systems (Fusion™ and SB ENT), Electromagnetic Navigation (AxiEM™), Powered ENT Systems (StraightshotTM M4 Microdebrider), 0-arm™ Imaging System, PoleStar™ Surgical

MR System, and Midas Rex™ drills and attachments, including the associated hardware components, applicable licensed software applications and surgical instrumentation.

These systems and instruments 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 cannot guarantee the proper performance or results of its systems following any unauthorized service, repair or modification to these Medtronic products, and any unauthorized service, repair or modification will void existing warranties and service agreements.

Additionally, Medtronic does not sell or authorize the sale of parts to third party service/repair companies. Medtronic cannot guarantee the proper performance or results of its systems if unauthorized or non-OEM parts have been used, and is not responsible for the cost to bring any adulterated equipment back to manufacturer's specifications. Medtronic reserves the right to refuse to service any adulterated equipment if we consider it to be not repairable according to Medtronic standards.

Further, Medtronic assumes no responsibility or liability for any resulting claims, costs, and expenses associated with the use of any systems, devices or instruments for which unauthorized service was performed or non-OEM parts have been used for repair or maintenance.

Medtronic is available to support you for troubleshooting, issue resolution, technical calibrations, system checks, system repairs, and planned maintenance inspections. For more information or to schedule maintenance of your system, please contact your Medtronic Sales Representative or technical support at

800-595-9709.

snru Rick Brandl

Senior Director of Service Operations

Medtronic Restorative Therapies Group