Attachment 1 Single Source Justification MPT to SAT NIM Vital 002_Redacted.pdf

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Attached to
6515--NIM VITAL SYSTEM Federal contract opportunity
Solicitation number
36C24823Q1971
Issued by
Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 8

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This single source justification document from the Department of Veterans Affairs Network Contracting Office 8 requests a brand name Medtronic NIM Vital intraoperative neuromonitoring system with cart for use at the Gainesville VA Medical Center. The proprietary NIM system provides continuous nerve monitoring and tracking of nerve condition through audible and visual alerts to help guide surgery and improve patient outcomes. As this system would replace an existing Medtronic NIM configuration already in use across surgical sites, obtaining a compatible system from another brand would not be cost effective. Market research found no other authorized distributors beyond the two identified Medtronic distributors. The contracting officer certified the single source purchase in accordance with FAR 13.1061(b).

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VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

Last Updated: 02/01/22 Page 1 of 2

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: __36C248‐23‐AP‐6358__________________

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 8 (NCO 8), Station

573 North Florida/South George Veterans Health System. 2237: 573‐24‐1‐030‐0015

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

Gainesville VAMC has a new Brand Name request for the Medtronic Bundle NIM Vital System w/ Cart. The NIM intraoperative neuromonitoring system is an electromyographic (EMG) monitor for use during various surgeries, including ENT and general surgical procedures in which a nerve may be at risk due to unintentional manipulation. NIM nerve monitoring electrodes are placed in the appropriate muscle locations in the patient for the procedure being performed. The NIM Vital system is an intraoperative EMG monitor that enables users to locate and confirm the integrity of nerves during surgical procedures. The system stimulates nerves (propagates an action potential) through a variety of stimulation probes that causes the muscle associated with the nerve to contract. The system then picks up these electric signals from the muscles through a variety of electrodes and converts this information into meaningful graphs and sounds that the system displays on the monitor. The system continuously monitors EMG activity from the muscles innervated by the nerve at risk.

Estimated cost:

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

Brand Name Medtronic NIM Vital system provides detailed intraoperative nerve condition information to inspire surgical strategy and help improve patient outcomes. Proprietary technology notifies you in real time of nerve condition visually and audibly. NIM Nervassure continuous monitoring technology provides real‐time feedback on nerve function so you can adjust course, if necessary, during thyroid surgery and other procedures affecting head and neck nerves. NIM NerveTrend EMG reporting enables nerve condition tracking throughout a procedure, even when using intermittent nerve monitoring. During both continuous and intermittent trending, green, yellow, and red status bars provide visual information, and their associated tones provide audible cues, making monitoring nerve function and interpreting EMG trends easier. NIM Vital nerve condition information can be captured in a single, meaningful snapshot. Proprietary technology enables monitoring nerve condition through Medtronic Advanced Energy device use. Clinically relevant audible cues alert you to nerve functional status. Intelligent noise reduction technology suppresses artifact events by 94.5%, for a quieter experience.

These are direct replacement parts/components for an existing system that is at end of life.

Due to continued improvements in technology and limited availability of replacement parts, the currently used NIM system is entering the final stages of serviceability.

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

Last Updated: 02/01/22 Page 2 of 2

The material/service must be compatible in all aspects (form, fit and function) with existing system presently installed/performing.

It would not be cost effective to the NF/SG VA Health System to completely replace an entire system with a different brand when NIM Medtronic configuration is already in place and compatible with the Surgical Services Sites. This request is for a replacement/upgrade to the existing configuration.

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

Market research was conducted, with the following results: A keyword search of Part Number” NIMVITAL‐WCART‐ 2PI” in the GSA Advantage and GSA eLibrary found zero (0) vendors.

A keyword search of Part Number” NIMVITAL‐WCART‐ 2PI” in VA National Acquisition Center (NAC) Contract Catalog Search Tool (CCST), and VA Supply Chain Master Catalog (SCMC) found zero (0) vendors.

Two (2) Medtronic authorized distributors were identified and confirmed: Beacon Point Associates (SDVOSB), and Veterans Healthcare Supply Solutions (SDVOSB).

A keyword search of NAICS “334510” in the SBA Non‐Manufacturer rule (NMR) class waiver list and determined that there is a Class Waiver to the NMR.

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.

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