Sync template from atomicqms-style deployment

README.md

@@ -1,3 +1,132 @@
-# clinical-tms-clinic
+# TMS & Neuromodulation Clinic Quality Management System
 
-A comprehensive QMS template designed for Transcranial Magnetic Stimulation (TMS) clinics and neuromodulation therapy centers.
+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
+
+---
+
+*This template is maintained by AtomicQMS. For questions, open an issue in this repository.*