SLEEP STUDIES CLE

Amendment / Modification

This document serves as an amendment to a Limited Sources Justification Order (LSJO) for "Sleep Studies CLE". It modifies the original LSJO to reflect that a Notice of Intent to Sole Source (RFQ 36C25026Q0154) was posted on SAM.gov from February 4, 2026, to February 11, 2026, under NAICS code 621999.

Two responses were received, but a technical review confirmed that neither vendor could provide the proprietary WatchPAT system required to meet the Government's minimum needs.

• Sleep Care, Inc: Did not demonstrate authorized distributor status for the WatchPAT system or provide sufficient technical details. Lacked evidence of product compatibility/interoperability with the existing WatchPAT Cloud infrastructure. Procurement from unauthorized sources would disrupt interoperability and clinical workflows.

• Sleep Rite PSG LLC: Did not demonstrate authorized distributor status or provide sufficient technical documentation. The required WatchPAT devices and consumables are proprietary and exclusively distributed through Itamar Medical, Inc. or its authorized distributors. Procurement from unauthorized sources would require a separate, duplicative system environment and additional cybersecurity authorization, disrupting interoperability, clinical workflow continuity, and cybersecurity controls.

• Sleep Reset: Indicated access to required WatchPAT devices and OEM services but was not identified as an authorized distributor by Itamar Medical, Inc. Did not provide sufficient documentation of an authorized relationship or confirmed access to OEM-supported products/software/licenses. VirtuOx, offered by Sleep Reset, is an alternate HSAT platform, not fully compatible with the established WatchPAT infrastructure.

• The amendment does not create an opportunity for additional competition as only Itamar Medical, Inc. can provide the proprietary WatchPAT system and associated integrated services required to meet the Government's minimum needs.

• The circumstances supporting the original Limited Sources Justification remain unchanged.

• Itamar Medical, Inc. is the sole authorized distributor and provider of the WatchPAT system in the United States. Use of an alternate vendor would require substitution of a different device platform, leading to potential clinical retraining, disruption to established workflows, and duplication of cost and effort.

Limited Sources Justification

This document justifies the procurement of sleep study devices and services for the Louis Stokes Veterans Affairs Medical Center (CLE VAMC) from Itamar Medical, Inc. under a firm-fixed-price Blanket Purchase Agreement (BPA). The acquisition is conducted under the Multiple-Award Schedule Program, utilizing authority GSAR 538.7104-3(b)(1)(ii) because only one source is capable of providing the unique and highly specialized supplies or services required.

• Procurement of WatchPAT devices and services for home sleep apnea testing.

• Includes WatchPAT One Direct Program devices, probes, multi-night testing services, and cloud-based data upload for interpretation.

• Turnkey solution includes direct-to-patient shipping, return logistics, and OEM-certified consumables.

• Real-time patient troubleshooting and help desk support.

• Contractor: Itamar Medical, Inc.

• Contract Type: Firm-fixed-price, Base Year plus four 1-year option years.

• Estimated Dollar Value: $1,108,200.00 (Base Year) and $5,541,000.00 (four option years).

• Period of Performance: February 1, 2026, through January 31, 2031.

• Contract Number: FSS Contract Number: 36F79723D0108

• This is a limited sources justification, not a solicitation for proposals.

• The justification cites Itamar Medical, Inc. as the sole authorized distributor of the WatchPAT system in the United States, making them uniquely qualified.

• Best value is determined by clinical superiority, operational efficiency, and lifecycle cost-effectiveness.

• Not applicable as this is a limited sources justification.

• Market research was conducted, including a Sources Sought/RFI, to identify other potential sources. Veterans Healthcare Supply Solutions (VHSS), Aerobodies, Inc., and Sleep Care, Inc. were reviewed but found not to meet the specific requirements due to lack of authorization, proprietary nature of the system, or interoperability concerns.

• The WatchPAT devices are manufactured in Israel.