clinical-tms-clinic/README.md

TMS & Neuromodulation Clinic Quality Management System

A comprehensive QMS template designed for Transcranial Magnetic Stimulation (TMS) clinics and neuromodulation therapy centers.

🧠 Designed For

• TMS Treatment Centers - rTMS and dTMS therapy clinics
• Psychiatric Practices - TMS services for depression and anxiety
• Academic Medical Centers - Research and clinical TMS programs
• Neurology Practices - TMS for migraine and other neurological conditions
• Veterans Affairs Facilities - TMS for PTSD and depression
• Neuromodulation Centers - Multi-modality treatment facilities
• Research Programs - TMS clinical trials and studies

📋 Regulatory Framework

This template supports compliance with:

• FDA - TMS device clearances and labeling (510(k))
• CMS - Medicare coverage criteria for TMS
• The Joint Commission - Ambulatory care accreditation
• State Medical Board - Physician supervision requirements
• OSHA - Workplace safety (magnetic fields, noise)
• HIPAA - Patient privacy requirements
• Clinical TMS Society - Best practice guidelines
• APA Practice Guidelines - Treatment-resistant depression protocols
• State Facility Licensing - Outpatient treatment facility regulations

Repository Structure

├── SOPs/
│   ├── Patient-Selection/     # Screening, contraindications, consent
│   ├── Treatment-Protocols/   # Coil placement, dosing, parameters
│   ├── Safety/                # Seizure precautions, adverse events, emergencies
│   ├── Equipment/             # Maintenance, calibration, troubleshooting
│   ├── Documentation/         # Treatment records, outcome tracking
│   └── General/               # Document control, training, CAPA
├── Forms/
│   ├── Screening-Forms/       # TMS safety questionnaire, contraindication checklist
│   ├── Consent-Forms/         # Treatment consent, research consent (if applicable)
│   ├── Treatment-Logs/        # Daily treatment records, parameter documentation
│   ├── Outcome-Measures/      # PHQ-9, GAD-7, symptom rating scales
│   ├── Equipment-Records/     # Maintenance logs, calibration records
│   └── Training/              # Competency assessments, operator certification
├── Policies/                  # Clinic policies
├── Work-Instructions/         # Step-by-step procedures
└── Templates/                 # Document templates

Document Numbering Convention

• POL-XXX: Policies
• SOP-PS-XXX: Patient Selection SOPs
• SOP-TX-XXX: Treatment Protocol SOPs
• SOP-SAF-XXX: Safety SOPs
• SOP-EQ-XXX: Equipment SOPs
• SOP-DOC-XXX: Documentation SOPs
• WI-XXX: Work Instructions
• FRM-XXX: Forms and Records

🤖 AI-Powered Assistance

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

• Draft patient screening and selection protocols
• Create treatment parameter SOPs for different conditions
• Generate safety and emergency response procedures
• Develop equipment maintenance protocols
• Create outcome tracking documentation
• Review documents for regulatory compliance

Example Prompts

• "@atomicai create an SOP for TMS patient screening and contraindication assessment"
• "@atomicai draft a motor threshold determination procedure"
• "@atomicai write a seizure management emergency protocol"
• "@atomicai create a treatment protocol for treatment-resistant depression"
• "@atomicai develop a TMS coil maintenance and cleaning SOP"
• "@atomicai create a patient outcome tracking form with PHQ-9"

Getting Started

1. Establish Safety Protocols - Implement screening and emergency procedures
2. Define Treatment Protocols - Standardize parameters for each indication
3. Set Up Outcome Tracking - Configure depression/anxiety rating scales
4. Implement Equipment Maintenance - Schedule calibration and maintenance
5. Train Operators - Use competency assessment forms

Key Documents to Create First

1. TMS Safety Screening SOP - Contraindication assessment and clearance
2. Motor Threshold Determination SOP - Standardized MT procedure
3. Treatment-Resistant Depression Protocol - FDA-cleared parameters
4. Seizure Emergency Response - Critical safety procedure
5. Treatment Session Documentation - Daily treatment records
6. Outcome Measure Collection - PHQ-9/GAD-7 administration schedule
7. Coil Positioning SOP - Anatomical targeting procedures

Special Considerations for TMS Clinics

Patient Selection

• Comprehensive psychiatric evaluation
• Contraindication screening (implants, seizure history)
• Prior treatment history documentation
• Insurance authorization and coverage verification
• Informed consent with risk discussion

Treatment Delivery

• Motor threshold determination protocols
• Coil positioning and targeting methods
• Treatment parameter documentation
• Session duration and frequency
• Tapering and maintenance protocols

Safety Management

• Seizure precautions and response
• Syncope management
• Hearing protection requirements
• Staff magnetic field exposure limits
• Emergency equipment availability

Outcome Monitoring

• Baseline and ongoing depression scales
• Treatment response criteria
• Non-response protocols
• Adverse event documentation
• Long-term follow-up procedures

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