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.*