C01 MFR LSJOS AMED.pdf

Acquisition ID#: 36C250-26-AP-0440

MEMORANDUM FOR CONTRACT FILE

IN LIEU OF AMENDMENT TO LIMITED SOURCES JUSTIFICATION

ORDER >SAT

GSAR 538.7104-3

1. Contract/Requirement Information:

• Date: February 12, 2026

• Acquisition Plan Action ID: 36C250-26-AP-0440

• Title of Requirement: Sleep Studies CLE

2. Purpose of Amendment:

This amendment modifies the original Limited Sources Justification Order over the Simplified Acquisition Threshold to reflect that a Notice of Intent to Sole Source, RFQ 36C25026Q0154, was posted on SAM.gov, Contract Opportunities, from February 4, 2026 through February 11, 2026, under NAICS code 621999. Two responses were received. A technical review of the responses confirmed that neither vendor could provide the proprietary WatchPAT system required to meet the Government’s minimum needs.

The responding vendors were:

Sleep Care, Inc – Small Business Jennifer Brickner

(614) 774-6098 jennifer@sleepcareinc.com Sleep Care, Inc. did not demonstrate authorized distributor status for the WatchPAT system or provide sufficient technical details to meet the Government’s requirements.

The submission lacked evidence of product compatibility or interoperability with the existing WatchPAT Cloud infrastructure used by the CLE VAMC. Because the required WatchPAT devices and consumables are proprietary and available only through Itamar Medical, Inc. or its authorized distributor, procurement from unauthorized sources would disrupt interoperability and clinical workflows. Therefore, Sleep Care, Inc. cannot be considered a viable source for this requirement.

Sleep Rite PSG LLC d/b/a The Sleep Clinic Jawwad Cheema

(225) 766-5656 jawwad.cheema@thesleepclinicla.com Sleep Rite PSG LLC did not demonstrate authorized distributor status for the WatchPAT system or provide sufficient technical documentation to validate compliance with the Government’s requirements. The submission lacked verifiable evidence confirming compatibility with the mailto:jennifer@sleepcareinc.com mailto:jawwad.cheema@thesleepclinicla.com existing WatchPAT server-based environment currently operated by the VA Northeast Ohio Healthcare System (VANEOHS), which includes proprietary software, databases, licenses, and established clinical and cybersecurity interfaces supporting Home Sleep Apnea Testing (HSAT).

Because the required WatchPAT devices and associated consumables are proprietary and distributed exclusively through Itamar Medical, Inc. or its authorized distributors, procurement through an unauthorized source would require deployment of a separate, duplicative system environment and additional cybersecurity authorization, including issuance of a new Authority to Operate (ATO). Such action would disrupt interoperability, clinical workflow continuity, and established cybersecurity controls. Therefore, Sleep Rite PSG LLC cannot be considered a viable source for this requirement.

Sleep Reset Shimin Ooi

(646) 678-8596 shimin@thesleepreset.com Sleep Reset indicated within its submission that it has access to provide the required WatchPAT devices and associated Original Equipment Manufacturer (OEM) services; however, during market research and vendor verification activities, the OEM, Itamar Medical, Inc., provided a listing of authorized distributors and service providers permitted to supply the devices and perform OEM-supported services, and Sleep Reset was not identified as an authorized distributor. Sleep Reset did not provide sufficient documentation demonstrating an authorized relationship with the OEM or confirmed access to OEM-supported products, software, licenses, and services necessary to ensure compatibility with the existing WatchPAT platform environment operated by the VA Northeast Ohio Healthcare System (VANEOHS). Additionally, VirtuOx does not meet the Government’s requirement because it offers an alternate home sleep apnea testing (HSAT) platform rather than devices fully compatible with the established WatchPAT infrastructure currently in place. Because the requirement is limited to proprietary WatchPAT devices and manufacturer-supported services to maintain interoperability, clinical workflow continuity, and cybersecurity compliance, Sleep Reset and VirtuOx cannot be considered viable sources for this requirement.

3. Summary of Original Justification:

The original LSJOS authorized award to Itamar Medical, Inc. under the authority of GSAR 538.7104-3(b)(1)(ii), which permits limiting sources when only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized. Itamar Medical, Inc. is uniquely qualified to provide the sleep study services and related WatchPAT devices required by the CLE VAMC. The requirement entails a fully integrated solution, including the WatchPAT One Direct Program devices, patient probes, multi-night home sleep testing services, and cloud-based data upload for interpretation by qualified sleep specialists. This combination of device, service, and secure data integration cannot be replicated by any other vendor.

mailto:shimin@thesleepreset.com

The WatchPAT system is FDA-cleared and validated against full polysomnography, providing non-invasive, clinically accurate assessment of sleep-disordered breathing through peripheral arterial tone, oximetry, actigraphy, and heart rate variability. In addition, Itamar Medical has established experience working with VA facilities, ensuring compliance with VA-specific operational and clinical requirements, secure handling of patient data, and timely service delivery. No other vendor can provide the full scope of devices, multi-night services, and operational support necessary to meet this requirement without significant duplication of effort or cost to the VA. These factors demonstrate that Itamar Medical, Inc. is the only source capable of fulfilling this acquisition while maintaining clinical accuracy, patient accessibility, and operational efficiency.

5. Impact on Competition

Although the Notice of Intent to Sole Source was posted on SAM.gov and two responses were received, neither respondent is capable of providing the fully integrated WatchPAT One Direct Program solution required by the Cleveland VAMC. The requirement specifically necessitates the proprietary WatchPAT system, including FDA-cleared WatchPAT One devices, associated disposable probes, multi-night home sleep testing services, secure cloud-based data transmission, and interpretation infrastructure integrated with the manufacturer’s platform.

Itamar Medical, Inc. is the sole authorized distributor and provider of the WatchPAT system in the United States. The responding vendors do not have authorization to distribute or provide the proprietary WatchPAT devices or the associated integrated program required to meet clinical and operational needs. Use of an alternate vendor would require substitution of a different device platform, resulting in a material change to the requirement, potential clinical retraining, disruption to established workflows, and possible duplication of cost and effort.

Accordingly, the circumstances supporting the original Limited Sources Justification remain unchanged. The amendment does not create an opportunity for additional competition because only Itamar Medical, Inc. can provide the proprietary WatchPAT system and associated integrated services required to meet the Government’s minimum needs.

Rachelle J. Hamer Contracting Officer Network Contracting Office (NCO) 10