36C24518Q9309-001.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:_____ 688-18-4-995-0125_________________

1. Contracting Activity: Department of Veterans Affairs, VISN 05, Washington DC VA Medical Center

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

Purchase of an image-guided navigational bronchoscopy system that is capable of percutaneous lung biopsies. System uses a CT image to plan and provide 3D navigation through the procedure. It is used to place fiducials to mark lesions for resection, for navigational bronchoscopy, and navigational percutaneous transthoracic needle aspiration.

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

There are three manufacturers of navigational bronchoscopy systems – Bronchus, Medtronic, and Veran. Bronchus and Medtronic systems are only able to be utilized to approach lesions endoscopically and transparenchymally. The Veran system allows for CT guided percutaneous transthoracic needle aspiration – which allows physicians to biopsy by entering through the chest which is especially helpful to mark or biopsy small peripheral lung lesion or when the lesion is on certain parts of the lung anatomy making it easier to get to the tumor percutaneously.

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

Market Research was conducted and three manufacturers were identified that make navigational bronchoscopy systems. Only of one of those three manufacturers, Veran, makes a system that is capable of percutaneous lung biopsy. The other two systems only support endoscopic approaches.

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.

Name: William A. Epps, Sr. Date 09/11/2018 Title: Contracting Officer https://www.acquisition.gov/?q=/browse/far/13 https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466 https://vaww.pclo.infoshare.va.gov/PMWeb/S19%20Open%20Market-FAR13%20Award%20Documentation%20Form.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 2 of 2 Original Date: 08/30/17 Revision 01 Eff Date: 04/23/2018