P03 JA AP 2745.pdf

Revision: 01 Effective Date: 11/15/2024 Page 1 of 2 Acquisition ID# 36C260-25-AP-2745

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: 36C260-25-AP-2745 JOFOC Tracking #: FY25 NCO 20 - 1287

1. Contracting Activity: Department of Veterans Affairs, VISN 20, Portland VA

Medical Center Research and Development Service. Funding to be provided via 2237 648-25-3-1391-0036.

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

10 SOMNOtouch RESP PSG devices are requested to be purchased for use in the ongoing VA clinical research study: Supplementation with Amino Acid Rehabilitative Therapy in TBI (SmARTTBI): A Randomized Placebo-Controlled Trial to Improve Sleep. Estimated total cost is $96,570.00.

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

SOMNOtouch RESP devices are modular PSG devices that can utilize up to 25 sensor channels, have an adjustable sample rate ranging from 4 to 512 seconds, and can collect data in one device that would normally require either multiple unique sensors, and/or an in-lab overnight sleep test. The devices are light weight and compact, and do not disrupt the ability to sleep while worn. They have a large internal memory storage and a long lasting, rechargeable battery, unique features compared to other sleep diagnostic devices. Devices are also equipped to conduct data analysis which features American Academy of Sleep Medicine (AASM) compliant sleep staging and allows devices to be reconfigured with different settings depending on the study needs. SOMNOtouch RESP devices are specifically configured to collect metrics of interest in regard to longitudinal sleep and intervention efficacy studies, and are used to record sleep, pulmonary, and cardiac activity from clinical subjects in their own home.

The SOMNOtouch RESP system is not used in isolation, but rather as part of a broader set of clinically and operationally vetted devices, including wristband passive monitors, bed sensor mats, and other biometric tools. These devices would be permanent equipment, with each device usable only by one research participant at a time. SOMNOtouch RESP devices are proprietary technology only available through SOMNOmedics America, Inc.

Alternate devices may have proprietary data structures, limited raw access, or require costly software to access collected metrics. Protocol amendments would be https://www.acquisition.gov/?q=/browse/far/13

Revision: 01 Effective Date: 11/15/2024 Page 2 of 2 Acquisition ID# 36C260-25-AP-2745 required to justify any device change. Institutional Review Board (IRB) processing timelines often range from 6–12 weeks, during which all data collection would be paused. Any gap in performance would directly threaten the study integrity, forcing new recruitment or protocol adjustments. New validation data would be required to establish that any alternate device meets clinical-grade standards for the targeted outcomes. Any new device would require extensive compatibility testing—not just to validate it individually, but to ensure its data can be synchronized with the current established system. Introducing a non-validated substitute would therefore not only disrupt one stream of data but undermine the integrity of the entire multi-device analysis process already in place.

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

Market research was conducted: in accordance with FAR Part 10, VAAR 810 and in the order of priority set forth in VAAR 819.7004. A query of the Small Business Administration’s Veteran Small Business Certification (VetCert), National Acquisition Center FSS schedules, Government-wide contract databases, General Services Administration FSS schedules, and a search of commercial databases were performed on 4/30/2025.

VetCert was searched using NAICS 334510 resulted in 322 SDVOSB/VOSBs.

A search on GSA Advantage using key words SOMNOmedics SOMNOtouch Respiratory PSG devices resulted in zero matches. A search on SAM using sleep disorder study devices resulted in 15 matches. A search of National Acquisition Center FSS schedules and Government-wide contract databases resulted in zero matches.

The conclusion of the market research report is that SOMNOmedics America, Inc.is the sole manufacturer and distributor of the SOMNOtouch RESP Respiratory Screening devices and these devices are not manufactured in the United States.

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.

Craig Ritchey Date Contracting Officer

07/18/2025 https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466