36C25626Q0852_Draft PWS.pdf

Performance Work Statement (PWS) – Robotic Transcranial Doppler (TCD) System

Title: Acquisition and Implementation of Robotic Transcranial Doppler (TCD) System (NeuroSignal)

1. Purpose

The purpose of this PWS is to outline the requirements for acquisition, installation, configuration, and implementation of a Robotic Transcranial Doppler (TCD) system to support advanced cerebrovascular monitoring, including detection and trending of vasospasm, evaluation of cerebral autoregulation, real-time assessment of hemodynamics, and microembolic signal (MES) surveillance across neurocritical care, stroke, and perioperative settings at the Michael E. DeBakey VA Medical Center

(MEDVAMC).

2. Scope

This PWS covers:

• Procurement of one (1) Robotic TCD system, including console, robotic headset(s), 2 MHz transducers, fixation mechanisms, mobile cart, cables, and required accessories.

• Software licenses/modules necessary for automated vessel search, probe actuation, continuous signal optimization, spectral Doppler/M-mode visualization, emboli detection, waveform trending, and data export/reporting.

• Integration with VA-approved hardware and network environments, including user authentication and secure storage on VA-controlled systems.

• Installation and configuration of the device, software, and network connectivity.

• Clinical training for physicians, technologists, and nursing staff.

• Initial technical support, warranty services, and implementation assistance.

3. Objectives

• Enable continuous, high-quality neuromonitoring for patients at risk of vasospasm, hypoperfusion, embolic phenomena, or autoregulatory failure.

• Standardize TCD acquisition quality and reduce operator dependency through robotic automation and autonomous signal optimization.

• Improve workflow efficiency and expand monitoring duration without sustained technologist presence.

• Integrate TCD data with clinical documentation workflows and case conferences (stroke, neuro-ICU).

• Ensure secure implementation within VA IT and cybersecurity standards and maintain all patient data on VA-controlled systems.

• Support quality improvement initiatives and research protocols that require uninterrupted, reproducible monitoring.

4. Requirements

4.1 System Specifications (Device & Software)

The contractor shall provide a Robotic TCD platform with the following capabilities:

• Robotic automation: Automated vessel search, probe alignment, and continuous signal optimization for bilateral monitoring (e.g., MCA) with minimal operator intervention.

• Autonomous reacquisition: Automatic probe adjustment/reacquisition after patient movement, with audible/visual alerts for signal loss and recovery.

• Continuous monitoring stability: Hands-free monitoring suitable for prolonged trending in neuro-ICU environments.

• Ultrasound modalities: Spectral Doppler and M-mode visualization, real-time hemodynamic measurements and beat-to-beat waveform capture.

• Advanced analytics:

o Microembolic signal (MES) detection and logging.

o Trend analysis and configurable alarms for vasospasm risk (user-defined thresholds).

o Optional autoregulation indices and physiologic correlation (if available from vendor).

• User workflows: Protocol-driven studies (vasospasm surveillance, emboli detection, autoregulation), configurable presets, and role-based user access.

• Data management:

o Export to secure formats (PDF, CSV, image files) for inclusion in CPRS/clinical documentation.

o HL7 or equivalent integration path if supported; otherwise secure file-based transfers to VA servers.

o Local storage on VA-approved workstation or network share; no offsite/cloud storage.

4.2 Hardware Requirements

The contractor shall provide:

• One (1) Robotic TCD console with medical-grade display, keyboard/mouse, and integrated control software.

• One (1) Robotic headset (adjustable for adult head sizes) with fixation and comfort accessories; optional pediatric accommodations if available.

• Two (2) 2 MHz transducers (primary use) and any required connectors/cables.

• Mobile cart (lockable) with cable management and footprint suitable for ICU rooms.

• Battery backup/UPS compatible with VA standards to protect against brief power interruptions.

• Printer (or VA-approved print workflow) for bedside summary reports as needed.

• Any necessary interface modules to capture or reference physiologic timing signals (if supported), provided they meet VA cybersecurity and biomedical standards.

4.3 Installation and Configuration

The contractor shall:

• Coordinate with VA IT and Biomedical Engineering for installation planning, network configuration, and device inspections.

• Perform onsite or remote installation of the system and software.

• Configure user roles, study protocols, and data export destinations on VA-controlled storage.

• Verify functionality via acceptance testing, including:

o Successful bilateral insonation and stable continuous monitoring on test subjects or approved phantom.

o Demonstration of automated search/alignment and autonomous reacquisition after controlled head movement.

o Generation and export of test reports to designated VA directories.

• Installation shall not proceed without VA IT and ISO approval.

4.4 Data Handling and Security

• All VA patient data shall remain on VA-controlled systems; no offsite or vendor cloud retention is authorized under this PWS.

• Contractor shall comply with VA Directive and Handbook 6500 series and HIPAA requirements.

• Contractor personnel shall complete required background checks if access to VA systems or facilities is needed.

• No cloud-based storage or remote data hosting is authorized unless expressly approved by VA in writing.

4.5 Training

The contractor shall provide clinical training for relevant staff, including:

• Device orientation and robotic headset application.

• Protocols for vasospasm surveillance, emboli detection, and autoregulation workflows.

• Best practices for study setup, artifact reduction, alarm configuration, and report generation.

• Training materials (manuals and digital documentation) and at least one (1) structured session plus Q&A support.

4.6 Support and Warranty

The contractor shall provide:

• One-year device and software warranty (minimum).

• Remote technical support and software updates during the warranty period.

• Onsite service when required; target response within 24 hours for critical issues (or per vendor standard terms).

• Preventive maintenance schedule aligned to Biomedical Engineering guidance.

5. Performance Standards

Performance shall be evaluated based on:

Standard Acceptable Performance

Delivery & Installation

Completed within agreed timeframe after PO issuance; all hardware/software installed and networked per VA requirements.

Functionality Successful bilateral insonation; continuous monitoring with autonomous reacquisition; MES detection features operational;

export/report functions verified.

Data Quality Stable, reproducible Doppler signals suitable for trending and clinical decision-making; minimal artifact during standard ICU conditions.

Training Completion of structured session(s); delivery of training materials;

users demonstrate proficiency in protocol setup and report generation.

Support Response to technical issues within 24 hours; escalation pathway defined; updates applied without disruption to clinical care.

Security Compliance

Full adherence to VA IT and security policies (VA Handbook 6500, HIPAA); no offsite data storage; access controls implemented. [1]

6. Deliverables

The contractor shall provide:

• Robotic TCD system hardware (console, headset, transducers, cart, accessories).

• Software licenses/modules and activation keys.

• Installation documentation, configuration notes, and acceptance test results.

• Training materials and schedule; attendance log and competency checklist.

• Warranty documentation and service contact information.

• Security compliance documentation required for VA IT/ISO review.

7. Period of Performance

• Delivery: Within 45–60 days ARO (or per vendor terms).

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• Installation: Within 30 days of equipment receipt.

• Training: Within 30 days of installation.

• Warranty: 12 months from installation date.

8. Security Requirements

The contractor shall:

• Comply with VA Handbook 6500 and associated directives.

• Ensure no offsite storage or external hosting of VA data.

• Coordinate with Information Security Officer (ISO) for cybersecurity review.

• Provide documentation required for VA IT approval, including network diagrams, software versioning, and patch/update procedures.

• Participate in security review or site visit if required.

(End of PWS)