Justification and Approval Nexus Biofeedback_Redacted.pdf

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6515--Nexus Biofeedback System- Mind Media USA VAMC Las Vegas, NV
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36C26125Q0888
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This document is a Single Source Justification for Simplified Acquisition Procedures (SAP) from the Department of Veterans Affairs (VA) for the VA Southern Nevada Healthcare System (VASNHS). The procurement is for a NeXus-10 Biofeedback and Neurofeedback System, which offers comprehensive physiological monitoring capabilities including ECG, EMG, skin conductance, temperature, blood volume pulse, and respiration measurements. The system is uniquely positioned to support the VA's Integrative Health Coordinating Center and Whole Health Approach, with particular relevance to Veterans who experience conditions like chronic pain, hypertension, depression, and anxiety.

Market research confirmed that no existing government contracts (FSS, GSA, SAC, NAC) offer this specific brand, and no alternative equipment meets all acquisition requirements. Mind Media, USA, Inc. is the sole supplier, with the current hospital staff already trained on this device. The system provides significant medical testing capabilities in one unit, avoiding duplicate costs and multiple device purchases. The acquisition is valued under the Simplified Acquisition Threshold (SAT) of $250,000, with a transaction number of 593-25-4-136-01220, and is planned for implementation with an effective date of 11/15/2024. The justification is processed under Federal Acquisition Regulation (FAR) 13.106-1 for single-source awards.

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

Revision: 01 Effective Date: 11/15/2024 Page 1 of 2 Acquisition ID#: 36C261-25-AP-4211

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: 36C261-25-AP-4211 JOFOC Tracker Number: FY25 -NCO 21-1987

1. Contracting Activity: Department of Veterans Affairs, VA Sierra Pacific Network (VISN) 21, VA Southern Nevada Healthcare System (VASNHS), 6900 North Pecos Road, North Las Vegas, NV 89086.

The transaction number is 593-25-4-136-01220.

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

Biofeedback is supported by the VA�s Integrative Health Coordinating Center and aligned with the Whole Health Approach to care. Biofeedback offers an evidence-based process that uses one�s physiological signals, such as heart rate and body temperature, to develop feedback driven self-regulation that brings about healthy changes. Other physiological signals observed are respiration, skin conductance, muscle activity, blood volume pulse, and brain activity. Biofeedback has been shown to help with one�s management of stress, mental health, cognitive performance, sports optimization, and overall well-being.

Estimated amount is

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

The NeXus-10 Biofeedback and Neurofeedback System allows for a greater variety of physiological measurements than any other biofeedback and/or neurofeedback system. The system monitors and measures patients� ECGs, EMGs, skin conductances, temperatures, blood volume pulses, and respirations; and has four channels of bipolar ExG inputs and four auxiliary inputs and allows for simultaneous monitoring. The equipment is easy for patients to use because it has Bluetooth and is wearable. With this system, medical providers are able to help patients who experience problems with chronic pain, migraine and tension-type headaches, urinary incontinence and constipation, anxiety, depression, hypertension, attention deficit hyperactivity disorder, and other conditions.

This is especially relevant given the prevalence of these conditions in the Veteran population. For example, nearly 50 percent of Veterans are diagnosed with hypertension, approximately 27 percent of Veterans suffer from chronic pain, 18 percent experience symptoms of depression and 15percent have anxiety. The NeXus-10 Biofeedback and Neurofeedback System is the only system of its kind that is able to test for brain activity, muscle activity, and all peripheral signals like heart rate, relative blood flow, skin conductance, repiration, and temperature.The Nexus 10 Biofeedback System is currently at VASNHS.

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

Revision: 01 Effective Date: 11/15/2024 Page 2 of 2 Acquisition ID#: 36C261-25-AP-4211

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

The VASNHS Program Official's market research reveals that existing government contracts, including FSS, GSA, SAC, and NAC, do not offer the required brand. An extensive internet search confirmed that no other equipment meets all the acquisition requirements. Additionally, the research found that the equipment is a commercial item available on the open market and complies with Buy American Act (BAA) standards. Mind Media, USA, Inc. has previously supplied this product as a single-source requirement for VASNHS. The current hospital staff is trained on this device, and switching to a different product would necessitate additional training for clinical users and biomedical technicians, leading to a significant learning curve. The Nexus 10 Biofeedback is the only device that provides all necessary medical testing and information in one unit, benefiting the Government by avoiding duplicate costs and the need for multiple devices to perform the same services. Therefore, in accordance with Federal Acquisition Reglation (FAR) 13.106-1(b)(1)(i), there is only one responsible source, and no other supplies or services will satisfy the VA�s requirements in this case.

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.

Date

Title Contracting Officer

08/19/2025

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