P03_ SSJ_Redacted.pdf

Request for Sole Source Format >SAT GSAM/R 538.7104-3(b) Sole Source Justifications - Federal Supply Schedule Ordering Procedures

36C241-26-AP-0376 Page 2 of 5

Option Year 4: 12/31/2029 - 12/30/2030 at – 500 WatchPAT ONE Devices with Service

Total Value Including All Options:

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. =

GSAM/R 538.7104-3(b)(1)(i): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

GSAM/R 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; 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; The WatchPAT ONE Direct Services process will allow the VA to test, diagnose and treat obstructive sleep apnea patients without the need to have them enter the medical facility. Prior to WatchPAT ONE, the patients would be required to come to the facility to be trained to use the equipment and then come back to return it. This program would eliminate any redundancies. The sleep apnea device being requested must be compatible with this program, which would need to be compatible with CPRS (Computerized Patient Record System). Deviating from the WatchPAT ONE brand would require purchasing, installing, and training on a different software program that is not FEDRAMP approved, which would also need to be compatible with CPRS. Unlike other sleep study devices, the WatchPAT ONE provides detailed information on sleep architecture, including sleep stages (wake, light sleep, deep sleep, and REM sleep). The WatchPAT ONE also uses an isosbestic wavelength to ensure that the Peripheral Arterial Tone (PAT) signal does not change through the course of oxygen status in the patient during the test. NO other single use, disposable testing modality uses this type of senor to accurately measure vascular changes. This comprehensive data helps clinicians better understand the patient's overall sleep quality and identify disturbances in sleep patterns which help with treatment accuracy. The WatchPAT ONE is disposable and is designed for single use unlike other devices that are reusable. Since the WatchPAT ONE is a pre-calibrated disposable device, this eliminates the need for patients to return the device after the sleep study, reducing logistical challenges and concerns over device hygiene. Unlike other sleep study devices, the WatchPAT ONE is designed to be worn like a wristwatch with an accompanying finger sensor. This setup is generally regarded as comfortable and non-intrusive, in contrast to devices that require placement on the forehead or other cumbersome areas. This user-friendly design seeks to minimize sleep disruption typically caused by more cumbersome testing methods. Additionally, opting for a reusable device introduces a range of complications, such as the need for thorough cleaning, maintenance, and reprocessing between uses, which can be both time-consuming and logistically challenging. This also raises concerns about hygiene and the potential for cross-contamination, especially if not properly sanitized. The WatchPAT ONE is also being chosen for its simplicity, unlike other sleep study devices, the WatchPAT ONE does not require patients to set up multiple sensors like nasal cannulas, effort sensors, effort belts, or oximeters. Obtaining a device with various sensors and belts can be uncomfortable for some patients, potentially affecting their sleep quality during the test night.

Discomfort can lead to difficulty in falling or staying asleep, which might impact the accuracy of the test results. With more sensors and components, there is also an increased risk of technical issues such as sensors becoming dislodged or malfunctioning during the night. This can result in incomplete or inaccurate data, necessitating a repeat of the sleep study which could be costly. The WatchPAT ONE is the only device with a uniform pressure field at the finger testing site that ensures

36C241-26-AP-0376 Page 3 of 5 correct measurement during the time of testing. This ensures that WatchPAT has a 98% first night test success rate. Unlike many other devices, the WatchPAT ONE is the only single use, disposable sleep apnea test device with FDA approval for the diagnosis of both Obstructive and Central sleep apnea without the use of referred data channels or additional AI based software for analysis. This device is also FDA approved for identification of atrial fibrillation and premature heart beats. The WatchPAT ONE direct services provides immediate study results available to the VA at time of test complete by a patient, no cost to a patient or VA if the device is lost or broken during testing, 24/7 tech support, complimentary support for patients and healthcare providers. The most crucial aspect of acquiring these devices is the WatchPAT ONE Direct service that accompanies the WatchPAT ONE which is one of only two devices compatible with the Somnoware interface adopted by the National VA Sleep Program. Federal Risk and Authorization Management Program (FedRAMP) approval is crucial for maintaining the confidentiality, integrity, and availability of government data when using cloud services and currently only the WatchPAT ONE by Itamar and NOX T3 by Nox Medical are the only FEDRAMP-approved Somnoware interfaces/companies for secure testing and data transmission within the VA. However, the NOX T3 is not a disposable device and must be returned to the hospital for processing. Moreover, no other companies are using a "dropship" method within Somnoware to securely transmit data (with FEDRAMP approval) for mailing out devices–a crucial service. Itamar Medical prepares the WatchPAT ONE for shipping and sends it directly to the veteran’s address, ensuring timely delivery through the use of tracking information. This drop shipping method allows for quicker delivery times since the product does not need to be transferred from a retailer to the hospital and then to the customer. Software used by the U.S. federal government must often be FedRAMP approved to ensure it meets rigorous security standards essential for protecting sensitive data and maintaining information security.

GSAM/R 538.7104-3(b)(1)(iii): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

GSAM/R 538.7104-3(b)(1)(iv): It is necessary to place the order with a particular FSS contractor to satisfy a minimum guarantee established in the FSS BPA; or

GSAM/R 538.7104-3(b)(1)(v): A law expressly authorizes or requires that the purchase be made from a specified source.

GSAM/R 538.7104-4: Items peculiar to one manufacturer:

5. Describe Why You Believe the Order Represents the Best Value consistent with GSAM/R 538.7102- 2(4) to aid the contracting officer in making this best value determination: Based on the analysis of these previous contracts, it can be asserted that the price is determined to be fair and reasonable because the pricing has been consistently set at $219.00 per study since 2022. This stability and consistency in pricing over multiple contract periods indicate that the price has been thoroughly

36C241-26-AP-0376 Page 4 of 5 evaluated and deemed appropriate in alignment with market rates for similar services. The sustained acceptance of per study by the VA underscores its fairness and reasonableness.

36C24123P0049 WatchPAT ONE Direct Program (Device & Service)

Period of Performance:

10/2022 – 10/2027

36F79723D0108 36C24125F0183

WatchPAT ONE Direct Program (Device & Service)

Period of Performance:

09/2025 – 09/2030

6. Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted. Government-wide database of contracts and other Government and commercial databases that provide information relevant to agency acquisitions such as SBADSBS (previously VETCERT), GSA e-Library, SBA DSBS, and FPDS were queried. The Contracting Activity conducted its first search was on SBA VETCERT using NAICS 334510 which yielded 321 total results. FPDS search using keyword “WatchPAT ONE” yielded 26 contract actions for similar devices with services, one of which was for Togus VA Medical Center in VISN 1 for the same exact device with services under contract no. 36C24123P0049. SBA DSBS search using NAICS 334510 along with keyword “ZOLL” yielded 2 profiles, SB PA Lifeservers and SB American Hospital Supply, who are not authorized to provide WatchPAT ONE Devices with Services. Last search was on GSA e-Library using keyword “ZOLL” which yielded 5 manufacturers, all subsidiaries of ZOLL, however none of which were their subsidiary ZOLL Itamar. OEM LB ZOLL Itamar Regional Sales Manager David Bean stated on Tue 1/7/2025 at 9:45 AM via email that SDVOSB VHSS is their sole source provider for the WatchPAT ONE Direct Program. There is no US manufactured sleep study equipment that satisfies the needs of White River Junction’s Sleep Lab. There are many VA’s that use this service. These services are critical to allow the running of White River Junctions very busy Sleep Lab. If they are not able to use these services, they run the risk of falling very behind in their ability to offer sleep services to veterans in Vermont. The program is currently being used at over twenty other VAMC's across the country. All market research leads to these devices and services being solely available through Itamar Medical’s FSS contract 36F79723D0108 due to the FEDRAMP authorization process. Since this equipment is being manufactured in Israel a FSS vehicle will be utilized.

7. Any Other Facts Supporting the Justification: Due to lack of staff and volume of need, all supplies provided by the vendor will reduce the number of units needing to be owned and tracked by the department. It will provide faster turnaround times from the time the study is requested to when the results can be read and relayed to the patient. Zoll customer service is available for patients 24/7 for both questions and education. The inability to acquire the necessary staffing and/or upgraded home sleep study equipment significantly impairs White River Junction’s ability to fulfill the agency’s mission of delivering timely, high-quality care to Veterans. Currently, patient demand for home sleep studies exceeds their capacity. They do not have sufficient staff to set up and manage these studies, and the current device lacks the capability to capture comprehensive sleep metrics, preventing providers from making evidence-based treatment recommendations. This compromises clinical decision-making and may lead to underdiagnosis or misdiagnosis.

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: No actions are currently planned at this time. However, the Sleep Lab Department at White River Junction’s VA Medical Center remains committed to staying at the forefront of sleep apnea monitoring technology. Our team is continuously researching and evaluating innovative methods and equipment that have the potential to significantly improve patient outcomes. As we identify

36C241-26-AP-0376 Page 5 of 5 promising advancements, we will consider these options for future procurement to ensure we provide the best possible care for our veterans. Our goal is to integrate cutting-edge technology to enhance diagnosis, treatment, and overall patient experience when the need arises.

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 sole source justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by GSAM/R 538.71 as directed by FAR 8.4.

SIGNATURE DATE

DAWN PERKINS

SUPERVISORY PROGRAM SPECIALIST

WHITE RIVER JUNCTION VA 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.

GAIL GRUNDY NCO 1/ RPO EAST

CONTRACTING OFFICER FACILITY/NCO 1

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.

CORY DIONNE NCO 1/ RPO EAST

BRANCH CHIEF FACILITY/NCO 1

DAWN

PERKINS

Digitally signed by

DAWN PERKINS

Date: 2025.12.16 07:46:03 -05'00'

GAIL

GRUNDY

Digitally signed by GAIL

GRUNDY

Date: 2025.12.18 10:52:38 -05'00'

CORY DIONNE Digitally signed by CORY DIONNE Date: 2025.12.18 14:39:34 -05'00'