P03 - PM_Part813 106_Atch1_SingleSourceJustification_MPT-SAT_EnSite X EP System.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 02 Eff Date: 03/31/2020

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:_ VA-21-00098601

1. Contracting Activity:

Department of Veterans Affairs, VISN 05 Department of Veterans Affairs/Veterans Health Administration Network Contracting Office 5 512-20-3-874-0092

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

Washington DC VAMC has an additional electrophysiologist to allow expansion of the ablation and cardiac implantable electronic device programs. Washington DC VAMC will be providing cryoablation to treat atrial fibrillation. Further expansion of ablation for other arrhythmias necessitates the procurement of a three dimensional catheter navigation and mapping system.

VISN 5 requires bio-decontamination systems for each facility. Due to the current COVID-19 pandemic the need to rapidly bio-decontaminate equipment and facilities has increased. Hydrogen Peroxide Vapor (HPV) technology has proven to kill over 98% of pathogens.

1 - 3D catheter navigation and mapping system

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

Abbott Laboratories EnSuite X EP System is a 3D catheter navigation and mapping system with the following unique characteristics:

• Ability to use the system with any catheter does not have to be a specific type

• Field Service personal to support installation and use of the system

• User controlled power or temperature modes

• Monitor real-time temperature and impedance data

• Presets available

• Ability to manage procedural needs through user-configured interface

• RF Output Power: 1 to 100 W adjustable in steps of 1 W

• Impedance Range: Measures 50 O to 300 O in steps of 1 O

• Target Temperature: 15° C to 80° C adjustable in steps of 1° C

• RF Delivery Time: 1 to 999 seconds adjustable in steps of 1 second

• Control Modes: Temperature; Power 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 02 Eff Date: 03/31/2020

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

There are other companies that have catheter navigation and mapping system however they require the use of specific catheters. The Abbott Laboratories EnSite X EP System will allow for the use of catheters already purchased and in use at the Washington DC VAMC to continue to be used.

Additionally, the past performance of Abbott Laboratories field service personal to support the installation and use of the system is an important factor and critical in providing the best quality of care to Veterans.

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.

Chantey Bost Date 09/14/2021

Contracting Officer https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466