P03 SSJ Excimer Laser Maintenance 36C241-24-AP-0390 1.pdf

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: 36C241-24-AP-0390

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 1, located at Bedford MA, in support of VISN 01, VA Health Care System at Boston Medical Center 2237 # 523-24- 1-7441-0003

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

The following equipment will be covered under a service agreement.

CVX-300 Excimer Laser System Serial Number 81093

The estimated value of the proposed action is $123,000.00

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

The only PMA approved excimer laser system and disposable catheters for the treatment of peripheral and coronary arterial disease. Photoablation is the use of light to break down, vaporize and remove matter. The CVX-300 excimer laser system facilitates photoablation via a variety of Philips laser catheters to remove binding arterial plaques.

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

Market Research did not reveal any potentially capable SD/VOSB that can provide this requirement.

VFCP cannot be applied. The VA Rule of Two cannot be met.

According to the OEM Philips Healthcare, they are the sole source service provider of the equipment listed on this requirement. No other concern can perform maintenance on this equipment without voiding the manufacturer’s warranty. No other qualified vendor responded to the intent to sole source posting.

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.

Manasés Cabrera Deborah Reardon Contracting Specialist Contracting Officer

NCO 1 NCO 1

MANASES

CABRERA

Digitally signed by

MANASES CABRERA

Date: 2023.10.31 09:25:06 -04'00'

Deborah L.

Reardon 350203

Digitally signed by Deborah L. Reardon 350203 Date: 2023.10.31 10:07:30 -04'00'

Philips Image Guided Therapy Devices

Spectranetics LLC, FKA The Spectranetics Corporation, 9965 Federal Drive, Colorado Springs, CO 80921 USA www.philips.com/IGTdevices, Tel 800 231-0978, Fax 719-447-2030

9/18/2023

To: All Laser Clients:

RE: CVX-300 Excimer Laser & PLS Nexcimer Laser System Philips/Spectranetics, Sole Source Provider

To Whom It May Concern:

The CVX-300 Laser & PLS Nexcimer Laser System and all associated laser catheters are manufactured solely by Philips/Spectranetics LLC, FKA The Spectranetics Corporation, now a part of Philips Image Guided Therapy Devices. Spectranetics manufactures, distributes and services the CVX-300 Laser & PLS Nexcimer Laser System. We provide fully trained and certified Field Service Engineers that can ensure the system receives proper maintenance and operates safely as approved by the FDA for specific indications for use. Spectranetics guarantees that all service completed on your system will be performed by our factory trained and certified Field Service Engineers utilizing only authorized and approved components. Our engineers are experts in their field and work daily with the CVX-300 Laser & PLS Nexcimer Laser System.

Philips/Spectranetics is the only authorized service group for the CVX-300 Laser & PLS Nexcimer Laser System. Philips/Spectranetics has not trained, certified or acknowledged any third party to service this Class III medical device. Philips/Spectranetics does not sell replacement parts, as the system has no user serviceable parts.

If you have questions, or need any additional information, please feel free to contact us.

Thank you!

Sincerely, Laser Services Philips Image Guided Therapy Devices