-13686.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: VA246-17-AP-8949

1. Contracting Activity: Department of Veterans Affairs, VISN 6, Fayetteville VA Medical Center.

ReqID# 565-18-3-090-0104.

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

The Fayetteville VA Medical Center, Radiology department has a need for a Thoracic Electromedical and Electrotherapeutic Apparatus. The SPiN Thoracic Navigation System is diagnostic bronchoscopy apparatus that uses a 3D road map and respiratory Gating technology to navigate Thoracic Needle aspiration using electromagnetic instrumentation. Moreover, this device proffers early lung cancer diagnosis and screening resultant of a computerized tomography (CT) screening.

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

The functional characteristics sought by the requiring agency listed below are essential to the

Government’s requirements. The SPiN Thoracic Navigation System demonstrates unique capabilities with functions available from only one supplier. Inclusive to these capabilities are:

Essential functional characteristics:

Access: Endobronchial a. Bronchoscope i. Therapeutic (6.0-6.3mm) Extended Working Channel

Steerable Catheter Access (View Peripheral Catheter) 1. 3.2mm OD, 2.0mm WC

2. 3.8mm OD, 2.5MM WC

Access: Transthoracic

Navigated Sampling

Real Time Confirmation i. View Peripheral Catheter 1. 3.2mm OD, 2.0mm WC

2. 3.8mm OD, 2.5mm WC

System Portability i. Must be able to transport and usable in any room of hospital without room “mapping”

Accuracy i. Airway Map 1. 3D road map based on both inspiration and expiration CT scans https://www.acquisition.gov/?q=/browse/far/13

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

System compatible with referral scans, low resolution and inspiration-only scans

Mean registration error: 2.6-5.0mm

Automatic registration

Respiratory Gating During Navigation

Fiducial placement i.e. Bronchoscopy and percutaneous placement of localization

Must allow percutaneous injections in the Operating Room or brunch suite when a wedge resection is required

Localization

Moreover, market research identified that there is only two commercially available sources on the market capable of providing Thoracic navigational System and based on the functionality needed sought, only one supplier possesses the predominant capabilities sought.

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

MR research was performed by the Contracting Officer (CO) IAW FAR part 10. A VIP search using NAICS 334510 returned One hundred and sixty-two (162) capable vendors (137-SDVOSB/25-VOSB). A secondary search using NAICS code 334510 and key word “ultrasound” returned eight (8) SDVOSB/ Zero

(0) VOSB registered for this product. The manufacturer of requested ultrasound equipment is Veran Medical Technologies Inc. and Alliant Enterprise is their exclusive SDVOSB distributor for all products sold to federal government healthcare facilities. Accordingly the rule of two could not be met. Veran Medical does not sell commercially direct to the government.

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.

Paul O. Waite Date: 04-25-2018 Contracting Officer

NCO616L1-81239

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