12300398-JA redacted.pdf

CUI//SP-PROCURE//FEDCON

Control Number:

JUNE 2025

FAR Part 13 Justification and Approval

Simplified Procedures for Certain Commercial Items

1. Requiring Activity: Department of Health Technology Management Services (HTM- S), Brooke Army Medical Center, JBSA Fort Sam Houston, TX

2. Contracting Activity: Medical Readiness Health Contracting Office – West, JBSA Fort Sam Houston, TX

3. Description of Action: Request approval to award a new base and two-year option Firm-Fixed-Price (FFP) service contract to Medtronic USA, Inc, 200 Medtronic Drive, Lafayette, CO, 80026. The contract will be fully funded using appropriate Fiscal Year 2025 (FY25) Operations and Maintenance Army (OMA) funds.

4. Description of Supplies/Services: Non-personal service contract for the repair and maintenance of two (2) Medtronic Stealth Station S8 Navigation Platforms in accordance with Original Equipment Manufacturer (OEM) specifications and quality control policies and procedures. The repair and maintenance support are for two (2) Medtronic Stealth Station S8 Navigation Platforms located at BAMC, Ft. Sam Houston, Texas. The services will consist of unlimited repairs, labor, travel and parts replacement as well as semi-annual and annual maintenance. All repairs shall be done by qualified / authorized technicians. All parts used to repair the Medtronic Stealth Station S8 Navigation Platforms shall be OEM manufactured parts that meet regulatory and quality standards. The service coverage shall include travel, labor, parts, and materials.

Period Period of Performance (POP) Estimated Value Base 01 Sept 2025 through 31 Aug 2026

Option 1 01 Sept 2026 through 31 Aug 2027 Option 2 01 Sept 2027 through 31 Aug 2028

Estimated Overall Total Price

5. Authority Cited: FAR 13.106-1(b)(1): For purchases not exceeding the simplified acquisition threshold (SAT), only one source reasonably available, urgency, exclusive licensing agreements, brand name, or industrial mobilization.

6. Reason for Authority Cited: Sole Source Procurement of Medtronic USA, Inc. for Stealth Station S8 Navigation Platform Maintenance, Repair, and Software Updates at Brooke Army Medical Center (BAMC).

JUNE 2025

a. Background: Medtronic USA, Inc. is the (OEM) of the Stealth Station S8 Navigation Platforms, a sophisticated image-guided surgery navigation platform. The Stealth Station S8 Navigation Platforms incorporates a complex interplay of patented hardware components, proprietary software algorithms (e.g., for image registration, surgical planning, and instrument tracking), and a unique system architecture developed and owned exclusively by Medtronic. These technologies are not openly available and cannot be reverse-engineered or replicated by third-party service providers.

1) Effective maintenance and repair of the Medtronic Stealth Station S8

Navigation Platforms require specialized expertise and training that is exclusively provided by Medtronic-certified technicians. Medtronic technicians undergo rigorous training programs that cover all aspects of the system's operation, maintenance, and repair. The use of non-Medtronic-trained technicians could compromise the Medtronic Stealth Station S8 Navigation Platforms 's performance, void warranties, and potentially create safety risks for patients.

2) Medtronic USA, Inc. is the OEM of the Medtronic Stealth Station S8

Navigation Platforms, a sophisticated image-guided surgery navigation platform.

b. Alternatives: This justification is based on Medtronic's proprietary control of the Medtronic Stealth Station S8 Navigation Platforms technology, their unique specialized expertise in maintaining these complex systems, and the critical regulatory requirements associated with ensuring their safe and effective operation in a surgical environment.

c. Impact if not approved: Should this request not be approved rejecting the contract for the Medtronic Stealth Station S8 Navigation Platform can have far-reaching consequences for the healthcare provider, patients, and surgeons. A thorough evaluation of the potential impacts is crucial before deciding.

7. Efforts to Obtain Competition: The Contracting Officer will publish the notices required by FAR 5.201 and any bids or proposals received shall be considered.

a. Effective competition: N/A

b. Subcontracting competition: No subcontracting plan required in accordance with FAR 19.702(a)(1).

8. Actions to Increase Competition: After contract award, this justification will be available at the Government-Wide Point of Entry (GPE), beta.SAM.gov. If in the future other products become available, market research will be performed to consider other sources that meet or exceed the current requirement.

9. Market Research: The Medtronic Stealth Station S8 Navigation Platform located at BAMC owned by the Government requires repair and semi-annual and annual

JUNE 2025

maintenance. A search of the internet using Medtronic Stealth Station S8 Navigation Platform did not reveal a commercial source. However, personal knowledge with the solicitation of prior contracts for the same type of equipment has shown that there are several commercial sources available that will satisfy the Government’s requirement.

10. Interested Sources: A Sources sought is currently posted on SAM.gov on 7 August 2025 which closes on 13 August 2025 to see if there are any interested sources who are capable of fulfill this requirement.

11. Other Facts: N/A

a. Procurement history. N/A

Contract Number Contractor Procurement Method

Amount (est.) Period of Performance

N/A N/A N/A N/A N/A

b. Other facts. N/A

JUNE 2025

12. Technical Certification: I certify 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.

13. Requirements Certification: I certify 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.

14. Fair and Reasonable Cost Determination: I hereby determine that the anticipated price/cost to the Government for this contract action will be fair and reasonable. This determination will be made using Independent Government Estimate and other pricing information gathered.

15. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.