-14014.pdf

OFOC SOP Revision 06 Page 1 of 3 Original Date: 03/22/11 Revision 06 Date: 08/30/2017

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A)

For

Other Than Full and Open Competition (>$150K)

Acquisition Plan Action ID: VA261-18-AP-5843

1. Contracting Activity: The U.S. Department of Veterans Affairs, VISN 21, Network Contracting

Office at the 3230 Dudley Blvd, McClellan, CA 95652 proposes to enter into a fixed price contract on the basis of justification for other than full and open competition for the Palo A lot VAMC located at

3801 Miranda Ave. Palo Alto, CA 94304. The Purchase Request number is 640-18-3-024-0024.

2. Nature and/or Description of the Action Being Processed: Justification and Approval for Other

Than Full and Open Competition for onsite image guidance using the Medtronic StealStation Imaging

System for the VA Palo Alto Health Care Systems, Surgical Services. This procurement will proceed on a sole source basis withMedtronic USA, Inc. This request will result in the issuance of a new firm fixed price contract for a base period of one year with 4, 12-month, option periods.

This procurement is for a contractor to provide onsite support services for all Neurosurgery cases requiring imaging guidance using the Medtronic StealthStation Treatment Guidance System and the

O-ARM Imaging System when needed 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.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The VAPAHCS requires a contractor to provide onsite support services for all Neurosurgery cases requiring imaging guidance using the Medtronic StealthStation Treatment Guidance System and the O-ARM Imaging System.

The StealthStation surgical navigation 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 total estimated contract price for base and all option periods is $ 591,400.0.

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

(X) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy

Agency Requirements per FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per FAR 6.302-3;

( ) (4) International Agreement per FAR 6.302-4

( ) (5) Authorized or Required by Statute FAR 6.302-5;

( ) (6) National Security per FAR 6.302-6;

( ) (7) Public Interest per FAR 6.302-7;

OFOC SOP Revision 06 Page 2 of 3

Revision 06 Date: 08/30/2017

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 authority cited in para 4 above must be used because no other vendor is capable of providing the services required.

Medtonic USA, Inc. is the exclusive equipment manufacturer of the Medtronic StealthStation

Treatment Guidance Systme and the O-arm Imaging System. Medtronics holds many patents on the system to include the software that runs the system. The maintenance and service of this system requires access to these specialized parts and software. Medtronic does not authorize the servie of its products nor sell parts to thir party service/repair companies.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Medtronic USA, Inc. was contacted to confirm that the guidance system support could not be provided through any third party and it was confrmed that no other vendor could provide the services required. A search of historical contracts was conducted and these services were once procured via open market competitive procedures to Medtronics in FY16. In FY17, the same services were procured via sole source.

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

Reasonable: The Independent Government Cost Estimate was submitted

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted: As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties.

Market Research was conducted by the Contracting Officer and the technical expert that will be utilizing the services to determine if there were any other local firms that could potentially provide the services required. Currently, there are no other firms that are authorized to provide support for this imaging system.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: 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 on an as needed basis.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: To date, no other sources have written to express an interest in the Medtronic StealthStation Imaging System including

O-arm support services required for the VAPAHCS.

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:

Every effort will be made to obtain competition. When another firm is able to meet the requirements needed by the using service, we will consider them.

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.

12. 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.

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

OFOC SOP Revision 06 Page 3 of 3

Revision 06 Date: 08/30/2017

March 21, 2018

Nandini C. Johnson Date

Contracting Officer

Network Contracting Office 21

b. One Level Above the Contracting Officer (Required over$150K but not exceeding $700K):

I certify the justification meets requirements for other than full and open competition.

Claire Ursino Date

Chief, Medical Sharing Branch I

Network contracting Office 21