36C24419Q0764-002.pdf

Revision 08 Date: 04/18/2018

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID:____36C244-19-AP-1877________

1. Contracting Activity: Department of Veterans Affairs, VISN 4, Wilkes-Barre VA Medical Center, 1111

East End Blvd. Wilkes-Barre, PA 18711. Purchase Request number: 693-19-2-179-0039.

2. Nature and/or Description of the Action Being Processed: VA intends to award a new Firm Fixed price contract for CorPath GRX Vascular Robotics, a vascular robotic system for percutaneous coronary intervention. The estimated value of the proposed action is $752,902.22.

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

The Wilkes-Barre VAMC has a Brand Name requirement for a Vascular Robot. This is the only FDA cleared vascular robotic system on the market. The CorPath GRX Vascular Robot is the global technology leader in robotic-assisted precision to percutaneous coronary interventions. Cor Path GRX is FDA cleared and delivers best-in class medical education and training programs to support the interventional teams including physicians, technologists, and nurses. A multicenter trial demonstrated the safety and feasibility of the CorPath system, meeting its clinical and technical endpoints with operators experiencing a significant reduction in radiation exposure. The CorPath GRX is currently operational in several VA Medical Centers across the nation.

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 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;

FAR13.5 Simplified Procedures for Certain Commercial Items: Vascular Robot

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 CorPath GRX is the first and only robotic assisted coronary system. Its specialized operations allow for controlled placement of coronary guidewires and stents. The robotic system lends itself to open architure that is compatible with standard catheterization laboratory hardware and imaging systems such as those employed at the Wilkes- Barre VA Medical Center. This system can be used with either the radial or femoral approach with high clinical and technical success. This aspect is critical to its integration into the workload at Wilkes- Barre VAMC since the laboratory performs the vast majority of catherization’s via the radial approach.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: CO conducted market research by posting a Sources Sought notice on FBO for 3 days from 3-12-19 to 3-15-19 under sources sought number 36C244-19-Q-0392. Results from this sources sought revealed 1 authorized SDVOSB distributor.

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

Reasonable: CO intents to post an Unrestricted Combined Synopsis to FBO for 5 days to compete this requirement and utilize Lowest Price Technically Accepted as an evaluation factor. Competitive pricing will be the main determination considered for Fair and Reasonable pricing along with Technical Capabilities/Evaluation against the salient features and the IGCE.

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

Market Research Was Not Conducted. Initial market research was conducted by utilizing the NAC, SAC and GSA with negative results. A sources sought was posted for 3 business days under solicitation 36C244-19-Q-0392. Positive results from this sources sought revealed 1 exclusive SDVOSB authorized distributor in addition to the manufacturer, Corindus.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: The vendor must be

FDA approved for this piece of equipment.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Alliant Healthcare is the exclusive SDVOSB authorized distributor along with the manufacturer, Corindus.

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:

Market research will be conducted for any subsequent acquisitions to locate prospective vendors or authorized distributors that may have entered the market for the vascular robot system.

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.

Kristina Griffiths Date Nurse Mgr., Cardiology VAMC Wilkes-Barre

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.

Ronald J. Kline Date Contracting Officer

NCO4

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.

Darlene Seminko Date Branch Chief, Commodities 2

NCO4

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