P03_ SSJ Final 09_18_Redacted.pdf

Request for Limited Sources Justification Format >SAT

VHAPG Part 808.405-6 Limiting Sources Page 1 of 6 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C241-25-AP-1516

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C241-25-AP-1516

(1) Contracting Activity: Network Contracting Office 1, Regional Procurement Office East on behalf of the Department of Veterans Affairs, Veterans Integrated Services Networks (VISN) 1, West Haven Veteran Affairs Medical Center, 950 Campbell Avenue West Haven, CT 06516-2770. Funding 689-25-2- 7922-0012.

(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). This is a new, sole source, firm-fixed requirement with options for (840) WatchPAT ONE Devices with services per year for 60 Months. This action will be awarded as a new contract. The Contracting Activity is seeking to purchase (840) WatchPAT ONE Devices with WatchPAT ONE Direct services per year, manufactured by Original Equipment Manufacturer large business Itamar Medical, 3290 Cumberland Club Drive, Atlanta, GA, 30339, USA.

Order against: Federal Supply Schedule (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: 4707552515

(3) Description of Supplies or Services:

The estimated amount of the base year for this requirement is for 840 studies per year. The total estimated value of this requirement including options for all 5 years totals to . The WatchPAT ONE is a fully disposable, reliable and accurate device for home sleep apnea testing. It measures sleep stages, respiratory events, oxygen saturation, heart rate and body position with a smartphone app and a cloud-based solution. WatchPAT ONE is an aid to diagnose sleep apnea including obstructive and central sleep apnea. The WatchPAT ONE device provides home sleep apnea testing through smart phone app transmissions to the cloud. Once the sleep apnea study is completed, the clinician can review the automated study results.

Period of Performance, (1) Base Year plus (4) Option Years.

Base Year: 09/30/2025 � 09/29/2026 at � Quantity of 840 per year WatchPAT ONE Devices with Service Option Year 1: 09/30/2026 - 09/29/2027 at � Quantity of 840 per year WatchPAT ONE Devices with Service Option Year 2: 09/30/2027 - 09/29/2028 at � Quantity of 840 per year WatchPAT ONE Devices with Service

VHAPG Part 808.405-6 Limiting Sources Page 2 of 6 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C241-25-AP-1516

Option Year 3: 09/30/2028 - 09/29/2029 at � Quantity of 840 per year WatchPAT ONE Devices with Service Option Year 4: 09/30/2029 - 09/29/2030 at � Quantity of 840 per year 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.

FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

FAR 8.405-6(a)(1)(B): 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

VHAPG Part 808.405-6 Limiting Sources Page 3 of 6 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C241-25-AP-1516 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 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. Connecticut's VA Healthcare System currently utilizes 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 and NOX T3 are the only FEDRAMP-approved Somnoware interfaces 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.

FAR 8.405-6(a)(1)(C): 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.

FAR 8.405-6(b): Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition. The proprietary data is:

These are �direct replacements� parts/components for existing equipment.

The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing.

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(5) Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination: The Contracting Activity has reviewed historical prices on an existing contract for similar WatchPAT ONE devices with WatchPAT ONE Direct services under contract number 36C24123P0049. This existing contract 36C24123P0049 is currently for WatchPAT ONE Devices with WatchPAT ONE Direct services at Togus VA Medical Center, 1 VA Center Augusta, ME 04330-6796, awarded to Veterans Healthcare Supply Solutions on 10-28-2022 as a 5-year contract ending on 10-30-2027. The pricing for the WatchPAT ONE devices with WatchPAT ONE Direct services under existing contract�s (36C24123P0049) Option 2 which was priced at $219.00 per device with service. VHSS has submitted market research pricing aligning with similar pricing as contract 36C24123P0049 Option 2. Regardless, the contract specialist will ensure pricing is determined to be fair and reasonable.

(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 Connecticut�s Sleep Lab.

There are many VA�s that use this service. These services are critical to allow the running of Connecticut�s 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 Connecticut. The program is currently being used at over twenty other VAMC's across the country. Currently, Connecticut�s VA Healthcare System uses the WatchPAT 200/300 Devices with services, and WatchPAT software that were previously acquired under contract no. 36C24119P1042 through Veterans Healthcare Supply Solutions. Sources Sought Notice 36C24125Q0281 was published to Contract Opportunities in attempts of seeking a domestic source. Three companies responded stating they can provide home sleep study devices and, Sleep Rite dba The Sleep Clinic, Sleep Care, Sleep Associates of Florida Inc, however there isn�t another device with dropship services that can meet the need. All market research leads to these devices and services being solely available through Itamar Medical�s FSS contract 36F79723D0108. Since this equipment is being manufactured in Israel a FSS vehicle will be utilized as going this route will not require a Buy American Act (BAA) waiver because the FSS schedule is governed by different acquisition regulations and agreements.

(7) Any Other Facts Supporting the Justification: Currently, Connecticut�s VA Healthcare System is down 3-4 sleep technicians. Using this service would allow their current sleep technician to focus on technical aspects of the test. Without this help, they will not be able to keep up with the added workload vacated by staff who are no longer at the VA. Sources Sought Notice 36C24125Q0281 was published to Contract Opportunities in attempts to seek a domestic source. Three companies responded stating they can provide home sleep study devices and, Sleep Rite dba The Sleep Clinic, Sleep Care, Sleep Associates of