Attach 05 Single Source Justification MPT to SAT_Redacted.pdf

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 3

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: 36C244-23-AP-1654

1. Contracting Activity: Department of Veterans Affairs, VISN 4, Pittsburgh VA Medical Center- University Drive, University Dr. C Pittsburgh, PA 15240-1003. PR: 646-23-2-233-0234

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

Line No. Part No. Description Qty

0001 NIMVITAL-WCART-2PI BUNDLE NIM VITAL SYSTEM W/CART 2PI 1

0002 NIM4CM01 CONSOLE NIM4CM01 NIM 4.0 1

0003 1897821 POWER CORD 1897821 6 METER IEC320 115V 1

0004 NIM4CPB1 PATIENT INTERFACE NIM4CPB1 NIM 4.0 2

0005 NIM4CPB2 CONN CABLE NIM4CPB2 PAT INTFC NIM 4.0 1

0006 NIM4CAM1 INTFC ADAPTOR NIM4CAM1 MUTE PROBE 1

0007 NIM4CC01 CART NIM4CC01 NIM 4.0 1

0008 8225825 PROBE 8225825 3PK INCREMT STD PRASS ROHS 1

0009 NIMCAD400 INTFC ADAPTOR NIMCAD400 NIM 4.0 INCREMT 2

0010 8220325 MUTING PROBE 8220325 NIM 1

The estimated value of the proposed action is .

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

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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 than ever.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.

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

Vendor Information Page (VIP); U.S. Small Business Administration Dynamic Small Business Search (SBA DSBS). A keyword search of Item Description Code SBS found zero (0) vendors.

NCO4 confirmed the Original Equipment Manufacturers listing of authorized distributors. All 4 Vendors are certified as follows: Affirmative Solutions (SDVOSB); Beacon Point Associates (SDVOSB);

Marathon Medical Corporation (SDVOSB); and Veterans Healthcare Supply Solutions (SDVOSB).

U.S. General Services Administration (GSA) Databases. Seeking Sources RFQ ID: RFQ1606962 was posted from 02-04-2023 to 02-09-2023 on GSA eBuy. This effort produced two (2) responses: Alliant Healthcare (SDVOSB) and Agiliti Health, Inc. (Large Business) both responded they do not carry this product or service. -WCART-and GSA eLibrary found zero (0) vendors.

Interagency Contract Directory (ICD); DLA Troop Support Medical Electronic Catalog (ECAT); VA National Acquisition Center (NAC) Contract Catalog Search Tool (CCST); VA Supply Chain Master Catalog (SCMC) -WCART- the ICDP, ECAT, VA NAC CCST, and VA SCMC found zero (0) vendors.

NCO4 correspondence with the Original Equipment Manufacturer. The Contract Specialist (CS) contacted OEM ( ) for authorized distributors (02-14-2023). The Vendor representative responded by identifying four (4) vendors: Affirmative Solutions (SDVOSB), Beacon Point Associates (SDVOSB), Marathon Medical Corporation (SDVOSB), and Veterans Healthcare Supply Solutions

(SDVOSB).

SBA Non-Manufacturer Rule (NMR) class waiver list.

the SBA Non-manufacturer rule (NMR) class waiver list and determined that there is a Class Waiver to the NMR.

Veterans Health Administration (VHA) Procurement Guide (PG) Nonmanufacturer Rule (NMR) Decision Tree. NCO4 used the VHAPG NMR Decision Tree and determined that the current NAICS Code permits an SDVOSB/VOSB Set-Aside.

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Market Research has indicated four (4) likely vendors: Affirmative Solutions (SDVOSB), Beacon Point Associates (SDVOSB), Marathon Medical Corporation (SDVOSB), and Veterans Healthcare Supply Solutions (SDVOSB) as the only vendors able to satisfy all requirements. SBA NMR waiver was found and Rule of Two has been met. Based on the above Market Research, the NCO4 recommends issuing a Service-Disabled Veteran-Owned Small Business Set-Aside Solicitation on the GSA eBuy.

This is Brand Name Only. This market research is less than 12 months old.

4. 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.