SOW - Brain Stimulator.docx

Salt Lake City VA Medical Center Salt Lake City, UT 84148 statement of work and GENERAL Specifications FOR VA SLC

1. Background: Procurement of Transcranial Magnetic Stimulation (TMS) machine with repetitive (rTMS) and Intermittent Theta Burst Stimulation (iTBS) capability and stim guide coil positioning system for accurate coil placement, currently not available at Salt Lake City VA.

Repetitive and iTBS TMS is a non-invasive brain stimulation treatment that has shown efficacy in treating major depressive disorder and other mental health conditions often experienced by veterans. Our current TMS machine does not have iTBS capability which is increasingly more common in the community and fast becoming the standard of care. Adding this technology to SLCVA Mental Health’s available treatments aligns with its mission to provide cutting-edge therapies that can significantly improve veterans' quality of life.

2. Project Scope:

Procurement: The contract includes the purchase and delivery of TMS machine with iTBS capability and stim guide.

Installation: The vendor is responsible for the installation and setup of the machines at SLC VA.

Training: The contract includes training for VA healthcare providers on the proper use and operation of the TMS machine.

Maintenance and Support: The vendor will provide ongoing maintenance and technical support to ensure the machine remains in optimal working condition.

Compliance:

Regulatory Standards: The machines must meet all FDA regulations and other applicable standards for medical devices.

Quality Assurance: The vendor must demonstrate robust quality assurance processes to ensure the safety and efficacy of the machines.

Financial Terms:

Payment Structure: Details include the cost of each machine, terms of payment, and any financing options if applicable.

Budget Considerations: The contract must be aligned with the VA’s budgetary allocations and receive necessary approvals.

Duration and Renewals:

Contract Period: The specified duration of the contract, including any initial term and options for renewal.

Renewal Terms: Conditions under which the contract may be renewed, including performance metrics and evaluation criteria.

Liability and Risk Management:

Warranty: Warranty terms for the machines, covering defects and performance issues.

Liability Provisions: Clauses related to vendor liability for machine malfunction or failure, and indemnification for the VA.

Confidentiality and Data Security:

Data Protection: Vendor obligations to protect sensitive data, including PHI and PII, in compliance with VA guidelines and federal regulations.

Confidentiality Clause: Provisions to ensure that any proprietary or sensitive information exchanged under the contract remains confidential.

Services Intended to Provide Enhanced Mental Health Treatment: TMS machine is intended to provide an advanced, non-invasive treatment option for veterans suffering from treatment-resistant mental health conditions such as major depressive disorder (MDD).

Improved Patient Outcomes: By offering cutting-edge therapeutic technology, the treatment delivered by the machine is expected to improve patient outcomes, reduce symptom severity, and enhance overall quality of life for veterans.

Non-Pharmacological Alternatives: These machines provide a valuable alternative to medication, reducing reliance on pharmaceuticals and their associated side effects.

Comprehensive Provider Training: Ensures that VA healthcare providers are well-equipped with the knowledge and skills to utilize the TMS machine effectively, leading to better patient care.

Ongoing Technical Support and Maintenance: Ensures the continuous, reliable operation of the TMS machine, minimizing downtime and ensuring consistent availability for patients in need.

3. General features:

Stimulator Unit:

Pulse Type: Biphasic waveform Stimulus Parameters: Adjustable stimulus intensity and frequency Output: High current pulses capable of inducing magnetic fields.

Must deliver consistent dosage with no pulse decay.

Coil:

Coil Types: Air-cooled coil, figure-of-eight coil for focused stimulation Cooling Mechanism: Built-in cooling for continuous operation and comfort. Must allow for treatments back to back.

User Interface:

Touchscreen Control: For adjustment of stimulation parameters Programmed Protocols: Pre-loaded clinical protocols for various therapeutic applications Customizability: Ability to create and save custom protocols.

Stim Guide System:

3D Navigation: For targeting accuracy using 3D tracking and neuronavigation Patient Positioning: Adjustable head positioning system for optimal comfort and precision Integration: Integration with stimulator Safety Features:

Software Safeguards: Includes safety features to prevent accidental over-stimulation Emergency Stop: Built-in emergency stop button for immediate cessation of stimulation Monitoring: Continuous monitoring of coil temperature and system performance

4. Delivery Location:

Building 7 warehouse ATTN: Byron Jensen, GC18A Building 3 George E Whalen Dept of veterans affairs medical Ctr.

500 Foothill drive, SLC UT 84148

5. Software Validation:

No security accreditation is required; the Contractor will not have any access to an VA sensitive information. This project does not require acquisition of service that involves storage, transmitting or exchange of VA sensitive information.