0117 - SSJ MPT to SAT - Robertson.doc

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source

Attachment 1: Single Source Justification for SAP under the SAT

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: 36C250-24-AP-1999

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO) 10 located at 260 E University Avenue, Cincinnati, OH 45219-2356, in support of VISN 10, Richard L. Roudebush (RLR) VA Medical Center (VAMC), 1481 West 10th Street, Indianapolis, IN 46202-2803. 2237 #: 583-24-2-997-0117.

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The RLR is requesting a new firm fixed price contract to replace its current cardiac mapping system with the brand name Ensite X EP System. The replacement system includes:

· EnSite X EP System / ENSITE X-SYS – Qty of 1

· Advanced Mapping Software License / ENSITE-AM-2.0 – Qty of 1

· AutoMark Distance Software License / ENSITE-AMD-01 – Qty of 1

· Averaged Impedance Drop Software License / ENSITE-IMP-01

· EnSite Contact Force Module / CFK3000 – Qty of 1

· Ampere Generator Kit / H700494 – Qty of 1

· Ampere Remote Control / H700490– Qty of 1

· Cool Point Irrigation Pump / 89003 – Qty of 1 FOB Destination. Delivery date is 60 Days ARO. Period of Performance is 12 Months. The total estimated value is $233,750.00.

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

The EnSite X EP System is a catheter navigation and mapping system capable of displaying the 3-dimentional (3-D) position of conventional and sensor-enabled electrophysiology catheters, displaying cardiac electrical activity as waveform traces, and as a dynamic 3-D isopotential maps of the cardiac chamber. The contoured surfaces of these 3-D maps are based on the anatomy of the patient’s own cardiac chamber.

The system is compatible and integrated with the current Cardiac Electrophysiology Recording System, and GE Cardio Lab, including integration with the system server hardware. The system has: an open-ended platform feature that allows for the use of almost any ablation catheter (flexibility); provides contact and noncontact mapping; has intelligent automation tools with auto-map capabilities to reduce mapping time and produce high-reliability anatomic maps; Turbo Map feature that allows the operator to rapidly map secondary arrhythmias; time detection algorithms that include last deflection fraction and score mapping guided auto-marking features for procedural consistency; customizable dashboards to guide lesion marking; stability monitor alerts that sense changes in heart rate, rhythm, respiratory changes and anatomy movement; ability to create 3-D models with a high level (CT Scan-like) detail and auto field scaling; provides fast, real-time contact force measurements of the ablation catheter; auto-map and one-map tools that provides simultaneous collection of anatomic and electrical points from multiple electrodes; and provides catheter cooling technology with ablative therapy

The requested brand name system offers highly specialized tools that provides information about the heart’s electrical activity and catheter locations within the heart to physicians during electrophysiological procedures to treat patients with heart arrhythmias. During their market research, the end users found this system to be the only system capable of meeting the Government need for compatibility within the existing cardiac environment at the RLR VAMC.

The marketplace for this type of high-resolution aortic chamber mapping and display is very competitive and expensive. As such, there are few entities offering this type of system. The end user was unable to find any small or disadvantage businesses that could meet the governments need. The OEM is a large business and reports there are no authorized small business resellers available. The VA and SBA Rules of Two could not be obtained.

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

Market research queries were made using, VetCert, DSBS, GSA Advantage, FPDS-NG, VA NAC databases and other resources. The OEM (large business) reports there are no authorized small business resellers available. Based on market research, the CO has no reasonable expectation that offers/quotes will be received from at least two capable SD/VOSB (nor other types of small businesses) concerns. The VA and SBA Rules of Two cannot be obtained. Additionally, the CO does have a reasonable expectation that award can be made at a fair and reasonable price, offering the best value to the Government from the OEM (LB).

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.

_04/11/2024 ______ Name: Lillie Grey Date

Title: Contracting Officer Last Updated: 02/01/22