Award 36C26124P0840 -Medtronic Guided Imaging Surgery System.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 1 of 4

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN

ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C261-24-AP-0893. Justification for Other Than Full and Open Competition Tracker number: FY24-NCO 21-1137.

1. Contracting Activity: Department of Veterans Affairs, Veterans Integrated Service Network (VISN) 21, Regional Procurement Office (RPO) West, Network Contracting Office (NCO) 21, 711 Kapiolani Blvd., Honolulu, HI 96813. The purchase request number is 662-24-1-067-0032.

2. Nature and/or Description of the Action Being Processed: This procurement is for preventive maintenance service for Medtronic Guided Imaging Surgery System 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.

This requirement will result in the issuance of a new firm-fixed price contract for a one-year base period and four one-year option periods in accordance with FAR 52.217-9 Option to Extend the Term of the Contract. Additionally, the resulting contract will include FAR 52.217-8, Option to Extend Services which can be exercised in increments of one to six months, but for no more than a total of six months during the life of the contract. The cost for this option, if exercised, will be at the same rates as those in effect under the contract at the time the option is exercised.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The San Francisco Veterans Affairs Health Care System (SFVAHCS) requires a contractor to provide onsite support services for Medtronic Guided Imaging Surgery System. The system enables physicians to precisely track the location of surgical instruments throughout a procedure. The system is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures.

The contactor will be required to provide preventive maintenance services to the system in such condition that it maybe operated in accordance with its manufacturer’s specifications including the design and functionality. This may consist of calibration, cleaning, oiling, adjusting, replacing parts, and maintaining the equipment, including all intervening calls necessary between regular services and calibrations.

The estimated value is $180,825.00 for the base period and four options with a total of $904,125.00.

The estimated period-of-performance for this requirement is April 1, 2024 – March 31, 2025, base period with the ultimate completion date of March 31, 2029. The period -of-performance, description, and values are as follows:

Period -of-Performance Description Values Base period: April 1, 2024 – March 31, 2025 Preventive Maintenance

Medtronic Guided Imaging Surgery System

$180,825.00

Option period one: April 1, 2025 – March 31, 2026 Preventive Maintenance Medtronic Guided Imaging Surgery System

$180,825.00

Effective Date: 02/01/2022 Page 2 of 4

Option period two: April 1, 2026 – March 31, 2027 Preventive Maintenance Medtronic Guided Imaging Surgery System

$180,825.00

Option period three: April 1, 2027 – March 31, 2028 Preventive Maintenance Medtronic Guided Imaging Surgery System

$180,825.00

Option period four: April 1, 2028 – March 31, 2029 Preventive Maintenance Medtronic Guided Imaging Surgery System

$180,825.00

Total $904,125.00

4. Statutory Authority Permitting Restricted Competition: FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented 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

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Only one responsible source. The components of the preventive maintenance Medtronic Guided Imaging Surgery System are as follows:

• The intuitive StealthStation S8 System enables clear visualization and surgical navigation of every segment in the spine, streamline surgical flow for single degenerative deformity correction, lateral access or cervical procedures.

• Visualize the unique spinal anatomy of each patient and enjoy the flexibility to choose from a wide range of spinal instruments and implants for the procedure perform.

• The system seamlessly integrates with more than 200 Stealth-navigated instruments and implants — Medtronic’s unmatched portfolio includes everything from needles for percutaneous access and Stealth-Midas™ high speed drills, to drivers and inserters for spinal implant placement.

• Adopt advanced techniques for complex and minimally invasive cases with navigated instrumentation designed for each step of spinal procedure.

• Complex anatomy, View 3D, real time information when approaching the sacral ala, thoracic pedicles, deformed vertebrae, and the posterior cervical spine.

Effective Date: 02/01/2022 Page 3 of 4

Medtronic is the sole manufacturer and distributor of their products including their associated hardware components, applicable licensed software applications and surgical instrumentation. Medtronic products are complex, high-tech medical devices subject to the regulation by the Food and Drug Administration.

As such, Medtronic does not authorize the repairs and/or preventive maintenance services to these Medtronic systems by customers or third parties, including the loading or reloading of software.

Medtronic has been performing the services satisfactorily to the SFVAHCS.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market research was conducted, and it has been determined that the guidance system support could not be provided through any third party, and no other vendor could provide the services required. A search of historical contracts was conducted, and the same services was procured through open market in Fiscal Year (FY) 2022 via sole source to Medtronic.

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

The Independent Government Cost Estimate (IGCE) is based on historical prices paid for the same services. The CO will determine the pricing to be fair and reasonable based on the comparison of proposed pricing with the IGCE. The best possible pricing will be pursued by negotiating with the vendor prior to award.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Previous market research performed such as VetCert, General Services Administration (GSA) yielded no interest either from Service Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), and small business concerns.

Similarly, the Contracting Officer conducted market research and queried VetCert, GSA, and Small Business Dynamic Small Business Search (DSBS) using the NAICS Code 811210 Electronic and Precision Equipment Repair and Maintenance as well as Guided Imaging Surgery System and returned zero results. The market research was conducted in March and February 2024.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: Medtronic strongly recommends that only system product coordinators employed by the hospital or Medtronic representatives operate/maintain their products.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: To date, no other sources other than Medtronic have written to express an interest in the Medtronic Guided Imaging Surgery System preventive maintenance services required by the SFVAHCS. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55440.

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: Continuous market research will be conducted at the time options are exercised to determine the possibility of other firms that may be able to provide the services required.

Effective Date: 02/01/2022 Page 4 of 4

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.

Gabriella B. Orteza Date Chief, Biomedical Engineer San Francisco VA Health Care System

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.

Pablo S. Cunanan Date Contracting Officer Network Contracting Office (NCO) 21

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.

Nicholas J. Kluch Date Director of Contracting

Network Contracting Office (NCO) 21

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve ($750K to $7.5 million (or $15.0 million for acquisitions described in FAR 13.500(c)) for other than full and open competition.

Curtis M. Jordan Date Executive Director, Regional Procurement Office West Head of Contracting Activity (HCA) https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx