0003-LSJ-Hamer.pdf

Attachment 1: Justification for Limiting Sources for Micro-Purchase Threshold up to the SAT

VHAPG Part 808.405-6 Limiting Sources Page 1 of 6 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C250-26-AP-1550

DEPARTMENT OF VETERANS AFFAIRS

FAR 8 – Justification for Limiting Sources (LSJ) For

Limiting Sources (<SAT)

Acquisition Plan Action ID: 36C250-26-AP-1550

1. Contracting Activity: he Department of Veterans Affairs, Veterans Integrated Service

Network (VISN) 10, Indianapolis Veterans Affairs Medical Center (INDY VAMC), Network Contracting Office (NCO) 10.

Transaction: 583-26-2-095-2475

2. Description of Action: Network Contracting Office (NCO) 10 intends to award a new firm fixed- price, one year Delivery Order (DO) to Itamar Medical, Inc. for sleep studies. The Department of Veterans Affairs requires WatchPAT devices, services, and related supplies to support sleep studies for Veterans at the INDY VAMC. The requirement includes WatchPAT devices and services, probes, and multi-night testing services. These FDA-cleared home sleep apnea testing devices accurately record sleep patterns and physiological data, enabling clinicians to diagnose and monitor sleep disorders remotely. This contract will provide a comprehensive testing solution that enhances diagnostic efficiency, increases access to sleep studies, and supports the VA’s mission to improve the health and well-being of Veterans.

Order against: FSS Contract Number: 36F79723D0108

Name of Proposed Contractor: Itamar Medical, Inc.

Street Address: 3290 Cumberland Club Drive, Suite 100 City, State, Zip: Atlanta, GA 30339-4914 Phone: (469) 617-0144

3. Description of Supplies or Services:

The Department of Veterans Affairs, INDY VAMC, requires a contract for the procurement of WatchPAT devices and services that includes the following:

1,100 CS2116045 WatchPATOne Direct 1,100 CS2116046 WatchPATOne Direct Services

The WatchPAT devices and services provide a turnkey testing solution that includes direct-to-patient shipping, return logistics, and the mailing of all required probes and consumable components to ensure proper device functionality and clinical accuracy. As part of this service, the vendor provides real-time patient troubleshooting and help desk support, assisting Veterans with device placement, activation, Bluetooth connection, and resolving

VHAPG Part 808.405-6 Limiting Sources Page 2 of 6

Acquisition ID#: 36C250-26-AP-1550 technical issues throughout the study period. These support functions are critical to ensuring data integrity, successful recording, and patient adherence.

These FDA-cleared home sleep apnea testing devices and their associated Direct Program services significantly enhance diagnostic efficiency, reduce scheduling constraints, and expand access to sleep disorder evaluations for Veterans. By leveraging the WatchPAT Direct Program’s mail-out logistics, Original Equipment Manufacturer (OEM)-certified consumables, patient support services, and secure data transmission, the VA can maintain uninterrupted, clinically validated, and cybersecurity-compliant HSAT operations. This contract directly supports the Department of Veterans Affairs’ mission to improve the health, well-being, and continuity of care for the Veteran population.

ESTIMATED DOLLAR VALUE: $240,900.00

REQUIRED DELIVERY DATE: February 25, 2026, through February 24, 2027

4. Authority:

Order Against FSS: Authority of the Multiple Award Schedule Program, Title III of the Federal Property and Administrative Services Act of 1949 (41 USC 251, et seq.); Title 40 USC 501, Services for Executive Agencies; and Section 803 of the National Defense Authorization Act of 2002 (PL 107-107) and implemented by FAR 8.405-6. Mark the applicable exception:

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;

(FAR 8.405-6(a)(1)(i)(B));

5. Rationale/explanation to support cited authority:

Itamar Medical, Inc. is uniquely qualified to provide the sleep study services and related WatchPAT devices required by the IND VAMC due to its status as the sole authorized distributor of the WatchPAT system in the United States. 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. 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

VHAPG Part 808.405-6 Limiting Sources Page 3 of 6

Acquisition ID#: 36C250-26-AP-1550 fulfilling this acquisition while maintaining clinical accuracy, patient accessibility, and operational efficiency.

Market research was conducted by the Contracting Officer and the Medicine Service to determine if there were other vendors capable of providing sleep studies that meet INDY VAMC's specific requirements. The following sources were reviewed:

Itamar Medical, Inc., the OEM, a large business was contacted on 10/17/2025 to provide a list of authorized distributors and details regarding the origin of the product, with a focus on distributors authorized as SDVOSB or VOSB. The OEM indicated that they have Veterans Healthcare Supply Solutions (VHSS) an SDVOSB, Panakeia, a small business, and IronBow (now Soldier One), a large business, for their authorized distributors. The OEM also confirmed that the WatchPAT device is manufactured in Israel.

A Sources Sought Notice, RFI 36C25026Q0068, was posted on SAM.gov, Contract Opportunities on October 23, 2025, with a response date of October 30, 2025, utilizing NAICS code 621999. Responses were received from the following companies:

Veterans Healthcare Supply Solutions (VHSS) - SDVOSB Chris Masters

(904) 638-5222 cmasters@vhss1.com VHHS and their ECAT Contract cannot be utilized due to services needed on the new internal contract.

Itamar Medical, Inc. – Large business Matthew C. Pummer

(888) 748-2627 matthew.plummer@zoll.com Has a NAC Contract, 36F79723D0108 for the commodities.

Aerobodies, Inc. – Small Business Michael Daniel

(703) 820-0217 michaeld@aerobodies.com Aerobodies, Inc. is not an authorized reseller of the WatchPAT system but has indicated efforts to contact the OEM for potential authorization. However, due to the immediate clinical need and the proprietary nature of the WatchPAT platform—supported exclusively by Itamar Medical, Inc. and its authorized distributor—the Government cannot consider vendors without existing, verifiable distributor rights. The INDY VAMC relies on the WatchPAT Cloud environment, and any non-authorized source would cause interoperability and clinical workflow failures. Therefore, procurement must remain limited to the OEM or its authorized distributors to maintain system compatibility, patient care continuity, and compliance with VA standards.

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Acquisition ID#: 36C250-26-AP-1550

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 INDY VAMC. Because the required WatchPAT devices and consumables are proprietary and available only through Itamar Medical, Inc. or 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.

Metro Medical Equipment & Supply Darla “DJ” Halfacre

(314) 880-3515 Djhalfacre2@metromedicalequip.com The metro sleep testing devices is not the best option for our facility because they utilize a nasal cannula and chest belts to acquire data. Some patients can’t tolerate nasal cannulas and chests belts during their sleep. Metro provides less comfort and convenience for the patient which results in up to a 15% failure rate in testing compared to a 2% failure rate for the WatchPat One device. Metro is a standard device which excel at identifying airflow obstruction whereas the WatchPat measures sleep architecture and has a high accuracy in detecting central sleep apnea. Furthermore, the Indianapolis VAMC has been utilizing the WatchPat Cloud environment, and any other devices would cause interoperability and clinical workflow failures. Therefore, procurement must remain limited to the OEM or its authorized distributors to maintain system compatibility, patient care continuity, and

11/1/2025 GSA eLibrary, ECAT, SAM.gov, Interagency Contract Directories, NAC, SEWP, FPDS, SCMC, MSVP, BIC, FDA, MSVP, and ECAT were reviewed:

o Keywords Used: "sleep studies" o Results: Itamar Medical was identified as having a NAC contract, 36F79723D0108, for the commodities. ECAT cannot be utilized because services are involved. No other vendors or results were found across the remaining databases.

On 11/1/2025 SBS was reviewed:

o NAICS Code Searched: 621999 (All Other Miscellaneous Ambulatory Health

Care Services) o Keywords Used: "sleep studies" o Results: There were three results that could not provide the product needed.

An Intent to Sole Source Notice, RFI 36C25026Q0068, was posted on SAM.gov, Contract Opportunities on February 10, 2026, with a response date of February 17, 2026, utilizing NAICS code 62199. Responses were received from the following companies:

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Acquisition ID#: 36C250-26-AP-1550

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.

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 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 Care, Inc – Small Business Jennifer Brickner

(614) 774-6098 jennifer@sleepcareinc.com Sleep Care, Inc. did not demonstrate authorized distributor status for the WatchPAT

VHAPG Part 808.405-6 Limiting Sources Page 6 of 6

Acquisition ID#: 36C250-26-AP-1550 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 INDY 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.

Metro Medical Equipment and Supply – Small Business, Minority, and Women Owned Darla “DJ” Halfacre

(314) 383-2879 Djhalfacre2@metromedicalequip.com The metro sleep testing devices is not the best option for our facility because they utilize a nasal cannula and chest belts to acquire data. Some patients can’t tolerate nasal cannulas and chests belts during their sleep. Metro provides less comfort and convenience for the patient which results in up to a 15% failure rate in testing compared to a 2% failure rate for the WatchPat One device. Metro is a standard device which excel at identifying airflow obstruction whereas the WatchPat measures sleep architecture and has a high accuracy in detecting central sleep apnea. Furthermore, the Indianapolis VAMC has been utilizing the WatchPat Cloud environment, and any other devices would cause interoperability and clinical workflow failures. Therefore, procurement must remain limited to the OEM or its authorized distributors to maintain system compatibility, patient care continuity, and

The Nonmanufacturer Rule (NMR) does not apply to this procurement, as the award will be made directly to the manufacturer of the product. The VA and SBA Rule of Two cannot be met, there isn’t more than one distributor. Market research indicates that Itamar Medical, Inc. is the only responsible source capable of meeting the Government’s requirements on

FSS.

Rachelle J. Hamer Contracting Officer

NCO 10