C01 LSJOS.pdf

Request for Limited Sources Justification Format >SAT

VHAPG Part 808.405-6 Limiting Sources Page 1 of 7 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C250-26-AP-0440

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

GSAR 538.7104-3

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

(1) Contracting Activity: The Department of Veterans Affairs, Veterans Integrated Services Network (VISN) 10, Louis Stokes Veterans Affairs Medical Center, Cleveland, OH (CLE VAMC), Network Contracting Office (NCO) 10.

Transaction: 541-26-2-704-0014

(2) Description of Action: This acquisition is conducted under the authority of the Multiple- Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501). Network Contracting Office (NCO) 10 intends to award a new firm fixed- price, Base Year plus four 1-year option years, Blanket Purchase Agreement (BPA) 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 CLE 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, CLE VAMC, requires a contract for the procurement of WatchPAT devices and services that includes the following:

4800 EA Annually WatchPat One Direct Program CS21170020 100 EA Annually WatchPat One Direct Program CS2117001 100 EA Annually WatchPat Direct using, WPone-M for 2 Nights/CS2117007 100 EA Annually WPone Probe for WatchPat Direct Service

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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 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: $1,108,200.00 Base Year and $5,541,000.00 four 1-year option years

REQUIRED DELIVERY DATE: February 1, 2026, through January 31, 2031, Base

Year plus four 1-year option years

(4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

GSAR 538.7104-3(b)(1)(ii): 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 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

VHAPG Part 808.405-6 Limiting Sources Page 3 of 7 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C250-26-AP-0440 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) Describe Why You Believe the Order Represents the Best Value consistent with GSAR 538.7102- 2(b)(4) aid the contracting officer in making this best value determination: The WatchPAT One Direct Program provided by Itamar Medical, Inc. represents the best value to the Government because it combines clinical superiority, operational efficiency, and lifecycle cost-effectiveness under a pre-competed Schedule contract with fair and reasonable pricing.

Clinical and Technical Value:

FDA-cleared home sleep apnea testing (HSAT) technology clinically validated against in-lab polysomnography.

Uses proprietary Peripheral Arterial Tone (PAT) technology, oximetry, actigraphy, and heart rate variability to deliver accurate, non-invasive diagnosis of sleep-disordered breathing.

Integrates seamlessly with the WatchPAT Cloud environment already used by CLE VAMC, ensuring continuity of care, data integrity, and cybersecurity compliance.

Provides OEM-certified probes and consumables, ensuring device accuracy and patient safety.

Operational Efficiency and Access to Care:

Turnkey “Direct Program” model includes mail-out logistics, return shipping, patient support, and data upload, eliminating VA staffing and infrastructure burdens.

Real-time patient help desk support reduces failed studies, repeat testing, and clinical delays.

Expands access to sleep studies for Veterans who cannot easily attend in-lab appointments improving equity of care and reducing appointment backlogs.

Multi-night testing improves diagnostic yield and reduces the need for repeat evaluations.

Cost and Procurement Advantages:

Pricing for commodities is established under Itamar Medical’s NAC Contract #36F79723D0108 and has been pre-evaluated for fairness and reasonableness.

The integrated device-and-service model reduces total lifecycle cost by avoiding separate contracts, additional staffing, equipment maintenance, and in-lab testing expenses.

Ordering through the Schedule and open-market services streamlines acquisition, minimizes administrative burden, and ensures timely delivery of care.

Taken together, this order achieves best value by delivering clinically validated outcomes, reducing operational overhead, and leveraging pre-competed pricing. Alternative approaches

VHAPG Part 808.405-6 Limiting Sources Page 4 of 7 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C250-26-AP-0440 would require multiple vendors, additional labor, or in-lab testing capacity, resulting in higher overall costs, reduced standardization, and delayed care for Veterans.

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted. Market research was conducted by the Contracting Officer to determine if there were other vendors capable of providing sleep studies that meet CLE 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, 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 CLE 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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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 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.

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 GSA 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 no results.

The NMR does not apply to this procurement, since the contract will be awarded to the manufacturer of the product. The VA and SBA Rule of Two cannot be met, the requirement is over the SAT and a set-aside is not required. There is only one responsible source, this will be solicited on the NAC to Itamar Medical, Inc.’s NAC Contract # 36F79723D0108 for commodities and open market services.

The WatchPAT devices are manufactured in Israel and available on the NAC contract. Both the commodities and the related open market services will be awarded to Itamar Medical, Inc., utilizing NAC Contract #36F79723D0108 for the supply items and open-market procurement for the services. There is a waiver for the NAC contract.

(7) Any Other Facts Supporting the Justification: A FITARA review is not required for this procurement because the acquisition involves supplies/services and does not include the purchase or development of information technology hardware or software.

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(8) A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made: On-going research of the industry marketplace will be conducted to determine if there are new entrants into this product arena.

(9) Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by RFO Subpart 8.4. (This signature is the requestor’s supervisor, fund control point official, chief of service or someone with responsibility and accountability.)

Matthew Bussa Acting Administrative Officer, Medicine Service VISN 10, VA Northeast Ohio Healthcare System

(10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

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

STEPHANI

E TANNER

Digitally signed by

STEPHANIE TANNER

Date: 2026.01.15 15:13:36 -05'00'

RACHELL

E HAMER

Digitally signed by

RACHELLE HAMER

Date: 2026.01.15 15:48:27 -05'00'

VHAPG Part 808.405-6 Limiting Sources Page 7 of 7 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C250-26-AP-0440

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $900K): I certify the justification meets requirements for other than full and open competition.

Adam P. Weber Branch Chief – Supply Team 1

Toni Waggoner-Boykin Division Chief – Services and Commodities

Monae D. Heath Acting Director of Contracting (DoC) Network Contracting Office (NCO) 10

HIGHER LEVEL APPROVAL (Required over the SAT but not exceeding $900K):

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for restricting consideration of the Federal Supply Schedule contractors to fewer than the number required by

GSAR 538.71.

Daryl A. Berg Executive Director, RPO Central Head of Contracting Activity

ADAM

WEBER

Digitally signed by

ADAM WEBER

Date: 2026.01.15 16:47:05 -05'00'

TONI WAGGONER-

BOYKIN

Digitally signed by TONI

WAGGONER-BOYKIN

Date: 2026.01.20 09:00:13 -05'00'

MONAE HEATH

Digitally signed by MONAE

HEATH

Date: 2026.01.20 11:49:31 -05'00'

DARYL

BERG

Digitally signed by

DARYL BERG

Date: 2026.01.23 13:44:16 -06'00'