6515--36C262-23-AP-2865 phoenix natus sleep works (VA-23-00039419) (VA-23-00046750)

B.4 STATEMENT OF WORK

1.0 Background:

The sleep software is used for Veteran patients recognized as having signs and symptoms of a sleep disorder. Both equipment and software are needed for recognition of patient sleep patterns and sleep disorders such as sleep related breathing disorders, seizure disorders during sleep, as well as over 80 other possible sleep related disorders.

2.0 Description of how the equipment being requested operates:

The equipment operates by taking the electrical signal of brain, respiratory effort, and flow during a patient s sleep to determine sleep disorders. The equipment sends these signals to a computer for the technicians and providers to interpret.

3.0 Where will the equipment being requested be used:

Equipment and software will be used in the sleep lab for the diagnosis and treatment of sleep disorders.

4.0 Who will be using the equipment being requested:

Equipment and software will be used by Respiratory therapist, Registered sleep technologist and physicians.

5.0 Description of what specific requirements you have of the equipment:

Equipment needs to support inspire titrations, mandibular advancement devices, and all the latest modes of PAP therapy. Touchscreen base unit is needed to document while in patient room, work with current SQL server and 64 channels - 6 sensor inputs for extended sleep studies with generation of customizable reports.

PRODUCT SPECIFICATIONS:

The following aspects of the referenced equipment have been determined to be critically important to the deliverables procured products must meet the following specifications by name and description:

NDx Amplifier

AC Channels: 64 AC channels, 6 Sensor inputs

Referential Inputs.40 referential + 24 programmable (from differential to ref)

Differential Inputs: Programmable up to 12

Sensor Inputs: 6 (Chest, Abdomen, Snore, Airflow, Pressure, Position)

DC Channels (patient side):4 non-isolated

DC Channels (computer side): 12 isolated

Photic: Yes

Digital Trigger Input: 8-bit TTL

Pulse Oximetry: SpO2, Pulse Rate, PPG, Plethysmogram, Pulse Quality

Event Button: 2 (Breakout and Base)

Headcap Input: 25 Pin Connector

Integrated pulse oximeter and pressure sensor

Touchscreen Base Unit

Add Tech Notes / Bio-Calibrations from the patient bedside unit on a Touchscreen display

Critical for Hard of Hearing Veteran Patient Population

Real time interaction with ongoing studies

Server/Computer

Virtual machine compatible

Server runs on Windows Server 2019

Database uses SQL Server 2019

PCs run on Windows 10

Citrix compatible

SleepWorks 9.x Software

Stream data directly to a server and automatically switches to store to the local station if there is failure in the network connectivity

Ability to Monitor multiple patients on one station through the software

Automated power recovery Study is automatically restarts if there is a power failure

Real time analyzers - user selectable to define which ones to run.

Unlimited look back / Scoring by the PSG tech, with real time display of event counts & AHI

Titration of all PAP devices (plus other devices - MatrX dental devices / Inspire nerve stimulator)

Allows users to log off and another user to login without interrupting the recording.

Remote viewing of data, looking back to the start of the recording and up to real-time

User customizable personal workspaces

Built-in HIPAA compliance software for role-based operation with Active Directory

6.0 Justification:

Currently PVAHCS sleep system has components that are no longer supported by manufacture for repair, and the software will not be updated to accommodate changes in the diagnosing and treatment of sleep disorders. The request for new software and hardware will meet future needs of the medical center to be compliant with Windows 10 and newer security features. The new platform will also work with Somnoware interface platform that has already been implemented at PVAHCS.

7.0 Delivery and Shipping Information:

The contractor shall provide the following for shipment and delivery of equipment:

SleepWorks Sys w Ceiling Mounted Axis IP PTZ Video, NDx Amplifier, SleepWorks 9.x Quantity:4

Computer Provided with Encrypted Hard Drive Quantity:4

Prem Intercom Sys W/Recording Quantity: 4

SleepWorks 9.x Review Software PC 10pk for VA workstations Quantity: 1

SleepWorks 9.x Data Server Software Quantity:1

ADVANCE CARE SERVICE CONTRACT- 5YR Quantity 1

*NOTE: Installation Included*

*NOTE: Training Included*

All items shall be shipped to the following location: Polysomnogram Sleep Testing System 6

Department of Veterans Affairs

Phoenix VA Healthcare System

Carl T. Hayden VA Medical Center

650 E. Indian School Road

Phoenix, AZ 85012-1892

8.0 Confidentiality and nondisclosure:

This equipment does not connect to a VA network. Therefore, in accordance with Appendix A, Handbook 6500.6 Checklist, block 6, the C&A requirements do not apply to this requirement, and a Security Accreditation Package is not required. Device will not be connected to network to enable nurse call functionality.

This equipment is capable of storing patient information. But SD cards will not be used in equipment to store data. Therefore, in accordance with Appendix A, Handbook 6500.6 Checklist block 7, Appendix B and C provisions apply.

Appendix B: The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract.

Appendix C: VA will own this equipment. If vendor needs access during delivery, assembly, install or repair, the contractor shall be escorted by a VA employee to ensure there is no exposure to VA sensitive information. If the contractor is required to be on site for more than two consecutive days, VHA Privacy Training, TMS Course VA10203, is required and available at https://www.tms.va.gov/SecureAuth35/. The contractor will provide all consumable supplies necessary for training and competency assessment of hospital staff. Proof of training will be provided to the COR upon request.