Neurophysiology & EEG Laboratory Quality Management System

A comprehensive QMS template designed for EEG laboratories, neurophysiology departments, and neurodiagnostic services.

🧠 Designed For

• Hospital EEG Laboratories - Inpatient and outpatient EEG services
• Epilepsy Monitoring Units (EMU) - Long-term video-EEG monitoring
• Sleep Laboratories - Polysomnography and sleep studies
• Intraoperative Monitoring (IOM) - Surgical neuromonitoring services
• Evoked Potential Labs - VEP, SSEP, BAEP testing
• Pediatric Neurophysiology - Neonatal and pediatric EEG
• Research Neurophysiology - Clinical research EEG programs

📋 Regulatory Framework

This template supports compliance with:

• ACNS - American Clinical Neurophysiology Society guidelines
• ASET - American Society of Electroneurodiagnostic Technologists standards
• ABRET - Neurodiagnostic credentialing requirements
• The Joint Commission - Hospital accreditation (if applicable)
• CMS - Medicare technical component requirements
• HIPAA - Patient privacy requirements
• AASM - American Academy of Sleep Medicine (for sleep labs)
• State Licensing - Technologist licensing requirements
• OSHA - Workplace safety requirements
• FDA - Medical device regulations for EEG equipment

Repository Structure

├── SOPs/
│   ├── Routine-EEG/           # Standard EEG, activation procedures, reporting
│   ├── Long-Term-Monitoring/  # Continuous EEG, video-EEG, EMU protocols
│   ├── Evoked-Potentials/     # VEP, SSEP, BAEP, motor EP procedures
│   ├── Sleep-Studies/         # PSG, MSLT, MWT protocols
│   ├── Equipment/             # Maintenance, calibration, electrode care
│   └── General/               # Document control, training, CAPA
├── Forms/
│   ├── Requisition-Forms/     # EEG orders, clinical history forms
│   ├── Technical-Logs/        # Recording logs, montage documentation
│   ├── Report-Templates/      # EEG interpretation report templates
│   ├── Equipment-Records/     # Maintenance logs, calibration records
│   ├── Infection-Control/     # Electrode cleaning, disinfection logs
│   └── Training/              # Competency assessments, credentialing
├── Policies/                  # Department policies
├── Work-Instructions/         # Step-by-step procedures
└── Templates/                 # Document templates

Document Numbering Convention

• POL-XXX: Policies
• SOP-EEG-XXX: Routine EEG SOPs
• SOP-LTM-XXX: Long-Term Monitoring SOPs
• SOP-EP-XXX: Evoked Potential SOPs
• SOP-SLP-XXX: Sleep Study SOPs
• SOP-EQ-XXX: Equipment SOPs
• WI-XXX: Work Instructions
• FRM-XXX: Forms and Records

🤖 AI-Powered Assistance

This repository includes AtomicAI, your neurophysiology QMS assistant. Mention @atomicai in any issue or pull request to:

• Draft EEG recording and reporting procedures
• Create long-term monitoring protocols
• Generate evoked potential testing SOPs
• Develop equipment maintenance procedures
• Create infection control protocols
• Review documents for ACNS compliance

Example Prompts

• "@atomicai create an SOP for routine EEG recording with activation procedures"
• "@atomicai draft an epilepsy monitoring unit admission protocol"
• "@atomicai write a somatosensory evoked potential (SSEP) testing procedure"
• "@atomicai create an electrode application and skin preparation SOP"
• "@atomicai develop an EEG interpretation and reporting workflow"
• "@atomicai create a neonatal EEG recording protocol"

Getting Started

1. Establish Technical Standards - Define recording parameters and montages
2. Implement Quality Metrics - Set up technical quality indicators
3. Define Reporting Standards - Standardize interpretation and reporting
4. Set Up Equipment Maintenance - Schedule calibration and maintenance
5. Train Technologists - Use competency assessment forms

Key Documents to Create First

1. Routine EEG Recording SOP - Standard 20-minute EEG procedure
2. Electrode Application SOP - 10-20 system placement, skin prep
3. Activation Procedures SOP - Hyperventilation, photic stimulation
4. EEG Report Template - Standardized interpretation format
5. Equipment Maintenance SOP - Daily, weekly, monthly checks
6. Infection Control Policy - Electrode cleaning and disinfection
7. Artifact Recognition Training - Technical quality standards

Special Considerations for Neurophysiology

Technical Quality

• 10-20 electrode placement accuracy
• Impedance requirements (<5 kΩ)
• Filter and sensitivity settings
• Montage standardization
• Artifact identification and reduction

Recording Protocols

• Routine EEG duration and components
• Activation procedure requirements
• Special montages (referential, bipolar)
• Pediatric and neonatal considerations
• ICU and portable EEG protocols

Equipment Management

• Amplifier calibration schedules
• Electrode inventory and testing
• Computer system maintenance
• Video synchronization testing
• Backup and archive procedures

Infection Control

• Single-use vs. reusable electrodes
• Electrode gel handling
• Skin preparation products
• Equipment surface cleaning
• High-level disinfection requirements

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This template is maintained by AtomicQMS. For questions, open an issue in this repository.