36C26119Q0392-001.pdf

VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

VHAPM Part 813.106 Page 1 of 2 Original Date: 08/30/17 Revision 01 Eff Date: 04/23/2018

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106‐1 For

Over Micro‐Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C261‐19‐AP‐2432

1. Contracting Activity: Department of Veterans Affairs, VISN 21, San Francisco VA Medical Center

PR#662‐19‐2‐296‐0014

2. Brief Description of Supplies/ Services required and the intended use:

CVX‐300 Excimer Laser for the treatment of peripheral and coronary arterial disease

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

A proprietary letter was also provided by Phillips stating that they are the sole manufacturer of the CVX‐300 Excimer Laser System and the associated disposable laser fiber sheaths, which is the only laser lead extraction system available in the world.

4. Description of market research conducted and results or statement why it was not conducted:

Phillips/ Spectranetics is the only responsible manufacturer and no other supplies or services will satisfy agency requirements. In accordance with FAR 6.302‐1,41 U.S.C 253 (c) (1), “When the supplies or services required by the agency are available from only one responsible source and no other type of supplies or services will satisfy agency requirements, full and open competition need not be provided for.” However, efforts were made to locate similar providers.

After reviewing the information and specifications of the excimer laser, it was found that this type of excimer laser is patented by Spectranetics. Spectranetics was recently merged under Phillips.

A sources sought was posted on FBO, and 1 response was received from an SDVOSB. Since there was only 1 other response aside from the large business, Phillips, this will be an unrestricted solicitation.

A proprietary letter was also provided by Phillips stating that they are the sole manufacturer of the CVX‐300 Excimer Laser System and the associated disposable laser fiber sheaths, which is the only laser lead extraction system available in the world.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106‐1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Note: COs are required to make a determination of price reasonableness IAW FAR 13.106‐3. See the

S19 Open Market (FAR13) Award Documentation Form with Abstract to document price reasonableness.

VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

VHAPM Part 813.106 Page 2 of 2 Original Date: 08/30/17 Revision 01 Eff Date: 04/23/2018

Carol Lam Date Contracting Officer

Philips

Philips, 9965 Federal Drive, Colorado Springs, Colorado 80921 USA www.philips.com/IGTdevices, Tel 719 447 2000, Fax 877 447 2022

February 1, 2018

Dear Valued Customer:

Please accept this letter as certification that The Spectranetics Corporation, now part of Philips Image Guided Therapy Devices, is the sole distributor and manufacturer of the CVX-300 Excimer Laser System and the associated disposable laser fiber sheaths, which is the only laser lead extraction system available in the world.

Sincerely, Christopher Duffie Segment Leader – Lead Management

Philips Image Guided Therapy Devices