P03. Attachment 1 Single Source Justification_OVER_SAT.pdf

Attachment 1: Request for Sole Source Justification Format >SAT

VHAPG Part 806.3 OFOC Page 1 of 3 Revision: 03 Effective Date: 04/15/24 Acquisition ID#: __________________

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID:

1. Contracting Activity: Department of Veterans Affairs, VISN 23, Sioux Falls Medical Center

PR# 636-25-4-2301-0279

2. Nature and/or Description of the Action Being Processed: Sole Source procurement of services to maintain the Medtronic O-ARM Navigation system located at the Omaha VA Medical Center, 4101 Woolworth Ave Omaha, NE 68105. Estimated value of contract: $367,625.00.

3. Description of Supplies/Services Required to Meet the Agency’s Needs The contractor will furnish all labor, transportation, parts, test equipment, tools, and expertise necessary to maintain the Medtronic O-ARM located at the Omaha VA Medical Center. The vendor shall provide the following coverages on the system. Corrective Maintenance: provide diagnostics, labor, and repair of the system should the product fail to function within Medtronic (the manufacturer of the system) published specifications. The vendor shall provide, at no cost to the government, all replacement parts necessary to return the covered unit to good working order. Standard overnight shipping will be used for replacement parts. Planned Maintenance: At a mutually agreed upon time during normal coverage hours, the vendor shall provide all necessary planned maintenance as defined in the system technical manual. Software Coverage: provide all software maintenance releases as deemed necessary by equipment manufacturer. Provide software upgrade releases when available at no charge. The vendor shall provide all coverages and benefits normally given in their commercial service and support agreements to include factory training opportunities for the clinicians. All work done by the vendor shall ensure the equipment maintains it Food and Drug Administration (FDA) certification.

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;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR

6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

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

VHAPG Part 806.3 OFOC Page 2 of 3 Revision: 03 Effective Date: 04/15/24 Acquisition ID#: __________________

Only Medtronic has rights to modify their proprietary software and therefore provide software fixes and updates as required by the government’s minimum requirement to keep the covered system’s software up to date and functional. The software is part of an FDA approved medical device and therefore must be maintained according to the manufacturer’s recommendations.

6. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Price comparisons were made to previously awarded service contract for the similar item and the price offered is equal to or better than other contracts issued.

7. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Performed internet searches for Medtronic O-ARM (maintenance, service, software) and could not find any other vendors that said they could provide the necessary services..

8. Any Other Facts Supporting the Use of Other than Full and Open Competition: None

9. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

MEDTRONIC USA, INC. ENT AND NAVIGATION PRODUCTS

Bridget Pence, Contract Coordinator 720-890-2118 bridget.pence@medtronic.com

10. 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: The government will again perform market research for maintenance services for the Medtronic O-ARM system if the service is required after contract end. Based on past experience, software support for medical devices such as this can only be provided by the manufacturer of the device that gained FDA 510K approval, so it is anticipated that competition will not be possible for future actions concerning this service

11. 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.

James Mazurek Date Supervisory BESS Omaha VA

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

VHAPG Part 806.3 OFOC Page 3 of 3 Revision: 03 Effective Date: 04/15/24 Acquisition ID#: __________________

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

Date

Jesse Sweesy Contracting Officer

NCO23

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.

Name Date NCO/PCO XX Duty Title

Facility

Date2_af_date: 4/14/25