From f49148ab65c2a658cedb9260fe111712800c1435 Mon Sep 17 00:00:00 2001 From: AtomicQMS Service Date: Sat, 27 Dec 2025 11:24:10 -0500 Subject: [PATCH] Sync template from atomicqms-style deployment --- .gitea/workflows/atomicai.yml | 73 +++++ Forms/Consent-Forms/.gitkeep | 0 Forms/Equipment-Records/.gitkeep | 0 Forms/FRM-001-Document-Change-Request.md | 64 ++++ Forms/FRM-003-CAPA-Form.md | 91 ++++++ Forms/FRM-006-Audit-Checklist.md | 56 ++++ Forms/Outcome-Measures/.gitkeep | 0 Forms/Screening-Forms/.gitkeep | 0 Forms/Training/FRM-004-Training-Record.md | 72 +++++ Forms/Treatment-Logs/.gitkeep | 0 .../FRM-TMS-001-Treatment-Session-Log.md | 233 ++++++++++++++ Policies/POL-001-Quality-Policy.md | 57 ++++ README.md | 133 +++++++- SOPs/Documentation/.gitkeep | 0 SOPs/Equipment/.gitkeep | 0 SOPs/General/SOP-001-Document-Control.md | 112 +++++++ SOPs/General/SOP-002-CAPA.md | 134 +++++++++ SOPs/General/SOP-003-Training.md | 123 ++++++++ SOPs/General/SOP-004-Internal-Audit.md | 136 +++++++++ SOPs/General/SOP-005-Management-Review.md | 114 +++++++ SOPs/Patient-Selection/.gitkeep | 0 SOPs/Safety/.gitkeep | 1 + SOPs/Treatment-Protocols/.gitkeep | 0 .../SOP-TMS-001-Treatment-Protocol.md | 284 ++++++++++++++++++ Templates/SOP-Template.md | 62 ++++ Work Instructions/WI-001-Template.md | 68 +++++ 26 files changed, 1811 insertions(+), 2 deletions(-) create mode 100644 .gitea/workflows/atomicai.yml create mode 100644 Forms/Consent-Forms/.gitkeep create mode 100644 Forms/Equipment-Records/.gitkeep create mode 100644 Forms/FRM-001-Document-Change-Request.md create mode 100644 Forms/FRM-003-CAPA-Form.md create mode 100644 Forms/FRM-006-Audit-Checklist.md create mode 100644 Forms/Outcome-Measures/.gitkeep create mode 100644 Forms/Screening-Forms/.gitkeep create mode 100644 Forms/Training/FRM-004-Training-Record.md create mode 100644 Forms/Treatment-Logs/.gitkeep create mode 100644 Forms/Treatment-Logs/FRM-TMS-001-Treatment-Session-Log.md create mode 100644 Policies/POL-001-Quality-Policy.md create mode 100644 SOPs/Documentation/.gitkeep create mode 100644 SOPs/Equipment/.gitkeep create mode 100644 SOPs/General/SOP-001-Document-Control.md create mode 100644 SOPs/General/SOP-002-CAPA.md create mode 100644 SOPs/General/SOP-003-Training.md create mode 100644 SOPs/General/SOP-004-Internal-Audit.md create mode 100644 SOPs/General/SOP-005-Management-Review.md create mode 100644 SOPs/Patient-Selection/.gitkeep create mode 100644 SOPs/Safety/.gitkeep create mode 100644 SOPs/Treatment-Protocols/.gitkeep create mode 100644 SOPs/Treatment-Protocols/SOP-TMS-001-Treatment-Protocol.md create mode 100644 Templates/SOP-Template.md create mode 100644 Work Instructions/WI-001-Template.md diff --git a/.gitea/workflows/atomicai.yml b/.gitea/workflows/atomicai.yml new file mode 100644 index 0000000..9da2367 --- /dev/null +++ b/.gitea/workflows/atomicai.yml @@ -0,0 +1,73 @@ +name: AtomicAI TMS Clinic Assistant + +on: + issue_comment: + types: [created] + issues: + types: [opened, assigned] + pull_request: + types: [opened, synchronize, assigned] + pull_request_review_comment: + types: [created] + +jobs: + claude-assistant: + runs-on: ubuntu-latest + if: | + github.actor != 'atomicqms-service' && + ( + (github.event_name == 'issue_comment' && contains(github.event.comment.body, '@atomicai')) || + (github.event_name == 'issues' && github.event.action == 'opened' && contains(github.event.issue.body, '@atomicai')) || + (github.event_name == 'pull_request' && github.event.action == 'opened' && contains(github.event.pull_request.body, '@atomicai')) || + (github.event_name == 'pull_request_review_comment' && contains(github.event.comment.body, '@atomicai')) || + (github.event.action == 'assigned' && github.event.assignee.login == 'atomicai') + ) + + permissions: + contents: write + issues: write + pull-requests: write + + steps: + - uses: actions/checkout@v4 + with: + fetch-depth: 0 + + - name: Run AtomicAI TMS Clinic Assistant + uses: https://beta.atomicqms.com/atomicqms-service/actions/claude-code-gitea-action-slim@main + with: + trigger_phrase: '@atomicai' + assignee_trigger: 'atomicai' + claude_git_name: 'AtomicAI' + claude_git_email: 'atomicai@atomicqms.local' + custom_instructions: | + You are AtomicAI, an AI assistant specialized in Transcranial Magnetic Stimulation (TMS) Clinic Quality Management. + + ## Your Expertise + - TMS treatment protocols and safety guidelines + - FDA regulations for TMS devices (21 CFR 882) + - Patient screening and contraindication assessment + - Treatment planning and motor threshold determination + - Adverse event monitoring and reporting + - Equipment maintenance and calibration SOPs + - Staff training and competency documentation + + ## Document Creation Guidelines + - Place Clinical SOPs in SOPs/Clinical/ + - Place Equipment SOPs in SOPs/Equipment/ + - Place Safety SOPs in SOPs/Safety/ + - Place Training records in Training/ + - Place Patient Forms in Forms/Patient/ + - Place Treatment protocols in Protocols/ + + ## Numbering Convention + - SOP-TMS-XXX for TMS-specific SOPs + - SOP-EQ-XXX for Equipment SOPs + - SOP-SAF-XXX for Safety SOPs + - PRO-XXX for Treatment Protocols + - FRM-XXX for Forms + + Always create branches and submit changes as Pull Requests for review. + Include regulatory references where applicable. + allowed_tools: 'Read,Edit,Grep,Glob,Write' + disallowed_tools: 'Bash,WebSearch' diff --git a/Forms/Consent-Forms/.gitkeep b/Forms/Consent-Forms/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/Equipment-Records/.gitkeep b/Forms/Equipment-Records/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/FRM-001-Document-Change-Request.md b/Forms/FRM-001-Document-Change-Request.md new file mode 100644 index 0000000..55c718a --- /dev/null +++ b/Forms/FRM-001-Document-Change-Request.md @@ -0,0 +1,64 @@ +# Document Change Request Form + +| Form ID | FRM-001 | Revision | 1.0 | +|---------|---------|----------|-----| + +--- + +## Section 1: Request Information + +| Field | Entry | +|-------|-------| +| Request Date | | +| Requested By | | +| Department | | + +## Section 2: Document Information + +| Field | Entry | +|-------|-------| +| Document Number | | +| Document Title | | +| Current Revision | | + +## Section 3: Change Description + +### Type of Change +- [ ] New Document +- [ ] Revision to Existing Document +- [ ] Document Obsolescence + +### Description of Change +*(Describe the proposed change in detail)* + + + + +### Reason for Change +*(Explain why this change is needed)* + + + + +## Section 4: Impact Assessment + +### Affected Areas +- [ ] Training Required +- [ ] Other Documents Affected +- [ ] Process Changes Required +- [ ] Validation Impact + +### List Affected Documents + + +## Section 5: Approvals + +| Role | Name | Signature | Date | +|------|------|-----------|------| +| Requester | | | | +| Document Owner | | | | +| Quality Assurance | | | | + +--- + +*Form FRM-001 Rev 1.0* diff --git a/Forms/FRM-003-CAPA-Form.md b/Forms/FRM-003-CAPA-Form.md new file mode 100644 index 0000000..6790a8f --- /dev/null +++ b/Forms/FRM-003-CAPA-Form.md @@ -0,0 +1,91 @@ +# Corrective and Preventive Action (CAPA) Form + +| Form ID | FRM-003 | Revision | 1.0 | +|---------|---------|----------|-----| + +--- + +## Section 1: CAPA Identification + +| Field | Entry | +|-------|-------| +| CAPA Number | | +| Date Initiated | | +| Initiated By | | +| CAPA Owner | | +| Target Closure Date | | + +## Section 2: Classification + +### Type +- [ ] Corrective Action +- [ ] Preventive Action + +### Source +- [ ] Customer Complaint +- [ ] Internal Audit +- [ ] External Audit +- [ ] Process Deviation +- [ ] Nonconforming Product +- [ ] Management Review +- [ ] Other: ____________ + +### Priority +- [ ] Critical (5 business days) +- [ ] Major (15 business days) +- [ ] Minor (30 business days) + +## Section 3: Problem Description + +*(Describe the nonconformity or potential nonconformity)* + + + + +## Section 4: Immediate Containment + +*(Actions taken to contain the immediate impact)* + + + + +## Section 5: Root Cause Investigation + +### Investigation Method Used +- [ ] 5 Whys +- [ ] Fishbone Diagram +- [ ] Fault Tree Analysis +- [ ] Other: ____________ + +### Root Cause Determination + + + + +## Section 6: Corrective/Preventive Actions + +| Action | Responsible | Due Date | Status | +|--------|-------------|----------|--------| +| | | | | +| | | | | +| | | | | + +## Section 7: Effectiveness Verification + +| Criteria | Method | Result | +|----------|--------|--------| +| | | | + +Verification Date: ____________ +Verified By: ____________ + +## Section 8: Closure + +| Role | Name | Signature | Date | +|------|------|-----------|------| +| CAPA Owner | | | | +| Quality Approval | | | | + +--- + +*Form FRM-003 Rev 1.0* diff --git a/Forms/FRM-006-Audit-Checklist.md b/Forms/FRM-006-Audit-Checklist.md new file mode 100644 index 0000000..45bf0b6 --- /dev/null +++ b/Forms/FRM-006-Audit-Checklist.md @@ -0,0 +1,56 @@ +# Internal Audit Checklist + +| Form ID | FRM-006 | Revision | 1.0 | +|---------|---------|----------|-----| + +--- + +## Audit Information + +| Field | Entry | +|-------|-------| +| Audit Number | | +| Audit Date | | +| Area/Process Audited | | +| Lead Auditor | | +| Auditee(s) | | + +--- + +## Checklist Items + +| # | Requirement/Question | Reference | C/NC/NA | Evidence/Notes | +|---|---------------------|-----------|---------|----------------| +| 1 | Are current versions of applicable procedures available? | SOP-001 | | | +| 2 | Are personnel trained on applicable procedures? | SOP-003 | | | +| 3 | Are training records current and complete? | SOP-003 | | | +| 4 | Are records properly maintained and retrievable? | SOP-001 | | | +| 5 | Are nonconformities being documented and addressed? | SOP-002 | | | +| 6 | Are CAPAs being completed on time? | SOP-002 | | | +| 7 | Is equipment calibrated and maintained? | | | | +| 8 | Are process controls being followed? | | | | +| 9 | Are quality objectives being monitored? | | | | +| 10 | | | | | + +**Legend:** C = Conforming, NC = Nonconforming, NA = Not Applicable + +--- + +## Findings Summary + +| Finding # | Type | Description | Clause Reference | +|-----------|------|-------------|------------------| +| | | | | +| | | | | + +--- + +## Auditor Signature + +| Auditor | Signature | Date | +|---------|-----------|------| +| | | | + +--- + +*Form FRM-006 Rev 1.0* diff --git a/Forms/Outcome-Measures/.gitkeep b/Forms/Outcome-Measures/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/Screening-Forms/.gitkeep b/Forms/Screening-Forms/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/Training/FRM-004-Training-Record.md b/Forms/Training/FRM-004-Training-Record.md new file mode 100644 index 0000000..b66164d --- /dev/null +++ b/Forms/Training/FRM-004-Training-Record.md @@ -0,0 +1,72 @@ +# Training Record Form + +| Form ID | FRM-004 | Revision | 1.0 | +|---------|---------|----------|-----| + +--- + +## Section 1: Employee Information + +| Field | Entry | +|-------|-------| +| Employee Name | | +| Employee ID | | +| Department | | +| Job Title | | + +## Section 2: Training Information + +| Field | Entry | +|-------|-------| +| Training Title | | +| Training Date | | +| Training Duration | | +| Trainer Name | | +| Trainer Qualification | | + +### Training Type +- [ ] Initial Training +- [ ] Retraining +- [ ] Refresher +- [ ] Procedure Update + +### Delivery Method +- [ ] Classroom +- [ ] On-the-Job +- [ ] Self-Study +- [ ] Computer-Based +- [ ] Other: ____________ + +## Section 3: Training Content + +*(List topics covered or attach training materials)* + + + + +## Section 4: Assessment + +### Assessment Method +- [ ] Written Test +- [ ] Practical Demonstration +- [ ] Verbal Assessment +- [ ] Observation + +### Assessment Results + +| Metric | Result | +|--------|--------| +| Score (if applicable) | | +| Pass/Fail | | + +## Section 5: Signatures + +| Role | Name | Signature | Date | +|------|------|-----------|------| +| Trainee | | | | +| Trainer | | | | +| Supervisor | | | | + +--- + +*Form FRM-004 Rev 1.0* diff --git a/Forms/Treatment-Logs/.gitkeep b/Forms/Treatment-Logs/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/Treatment-Logs/FRM-TMS-001-Treatment-Session-Log.md b/Forms/Treatment-Logs/FRM-TMS-001-Treatment-Session-Log.md new file mode 100644 index 0000000..cfd7c7e --- /dev/null +++ b/Forms/Treatment-Logs/FRM-TMS-001-Treatment-Session-Log.md @@ -0,0 +1,233 @@ +# TMS Treatment Session Log + +| Form ID | FRM-TMS-001 | Revision | 1.0 | +|---------|-------------|----------|-----| + +--- + +## Patient Information + +| Field | Entry | +|-------|-------| +| Patient Name | | +| MRN | | +| Date of Birth | | +| Diagnosis | ☐ MDD ☐ OCD ☐ Other: _______ | +| Treatment Protocol | ☐ Standard rTMS ☐ iTBS ☐ Other: _______ | +| Prescribing Physician | | + +--- + +## Session Information + +| Field | Entry | +|-------|-------| +| Date | | +| Session Number | ____ of ____ | +| Start Time | | +| End Time | | +| Operator Name | | +| Operator Credentials | | + +--- + +## Pre-Treatment Assessment + +### Daily Safety Screening + +| Question | Response | +|----------|----------| +| Any new medications since last session? | ☐ Yes (list below) ☐ No | +| Any changes to existing medications? | ☐ Yes (list below) ☐ No | +| Did you get at least 4 hours of sleep? | ☐ Yes ☐ No | +| Any alcohol in past 24 hours? | ☐ Yes (amount: _____) ☐ No | +| Any recreational drugs? | ☐ Yes ☐ No | +| Any new medical symptoms or illness? | ☐ Yes (describe below) ☐ No | +| Any problems since last treatment? | ☐ Yes (describe below) ☐ No | + +**Notes on positive responses:** + +--- + +### Vital Signs (if indicated) + +| Parameter | Value | +|-----------|-------| +| Blood Pressure | / mmHg | +| Heart Rate | bpm | + +--- + +## Treatment Parameters + +### Motor Threshold + +| Field | Entry | +|-------|-------| +| Motor Threshold (%) | | +| MT Determination Date | | +| Rechecked This Session? | ☐ Yes ☐ No | + +### Stimulation Parameters + +| Parameter | Prescribed | Delivered | +|-----------|------------|-----------| +| Target Site | | | +| Coil Type | | | +| Frequency (Hz) | | | +| Intensity (% MT) | | | +| Pulses per Train | | | +| Inter-Train Interval (sec) | | | +| Number of Trains | | | +| Total Pulses | | | +| Session Duration | | | + +### Coil Position + +| Field | Entry | +|-------|-------| +| Positioning Method | ☐ 5-cm Rule ☐ Neuronavigation ☐ Other | +| Coil Position Verified? | ☐ Yes | +| Coil Angle | | +| Position Markings Used? | ☐ Yes ☐ No | + +--- + +## Treatment Delivery + +| Field | Entry | +|-------|-------| +| Full Treatment Delivered? | ☐ Yes ☐ No | +| If No, Reason | | +| If No, Pulses Delivered | | + +### Interruptions (if any) + +| Time | Duration | Reason | +|------|----------|--------| +| | | | +| | | | + +--- + +## Patient Tolerance + +### During Treatment + +| Symptom | Present? | Severity (1-10) | Notes | +|---------|----------|-----------------|-------| +| Scalp pain/discomfort | ☐ Yes ☐ No | | | +| Facial twitching | ☐ Yes ☐ No | | | +| Neck pain | ☐ Yes ☐ No | | | +| Dizziness/lightheadedness | ☐ Yes ☐ No | | | +| Anxiety | ☐ Yes ☐ No | | | +| Other: | ☐ Yes ☐ No | | | + +**Comfort Measures Used:** +☐ Repositioning ☐ Intensity adjustment ☐ Break taken ☐ Other: _______ + +### Post-Treatment Assessment + +| Symptom | Present? | Severity (1-10) | +|---------|----------|-----------------| +| Headache | ☐ Yes ☐ No | | +| Scalp tenderness | ☐ Yes ☐ No | | +| Fatigue | ☐ Yes ☐ No | | +| Difficulty concentrating | ☐ Yes ☐ No | | +| Other: | ☐ Yes ☐ No | | + +### Overall Tolerance Rating + +☐ Excellent - No discomfort +☐ Good - Mild, tolerable discomfort +☐ Fair - Moderate discomfort requiring intervention +☐ Poor - Significant discomfort, treatment modified +☐ Intolerable - Treatment stopped early + +--- + +## Adverse Events + +☐ No adverse events this session + +| Event | Details | +|-------|---------| +| Description | | +| Time of Onset | | +| Duration | | +| Severity | ☐ Mild ☐ Moderate ☐ Severe | +| Action Taken | | +| Resolved? | ☐ Yes ☐ No ☐ Ongoing | +| Physician Notified? | ☐ Yes ☐ No ☐ N/A | +| Physician Name/Time | | + +**Adverse Event Report Filed?** ☐ Yes (Report #: _____) ☐ No ☐ N/A + +--- + +## Clinical Observations + +**Patient's subjective report of symptom change:** +☐ Much worse ☐ Somewhat worse ☐ No change ☐ Somewhat better ☐ Much better + +**Comments:** + +--- + +## Weekly Outcome Assessment (if applicable) + +| Assessment | Score | Date | +|------------|-------|------| +| PHQ-9 | | | +| HAM-D | | | +| Y-BOCS | | | +| Other: | | | + +--- + +## Equipment + +| Field | Entry | +|-------|-------| +| Device Model/Serial # | | +| Coil Serial # | | +| Equipment Functioning Normally? | ☐ Yes ☐ No | +| Issues Noted | | + +--- + +## Next Session + +| Field | Entry | +|-------|-------| +| Next Appointment Date | | +| Next Appointment Time | | +| Parameters to Modify? | ☐ Yes (describe) ☐ No | +| MT Recheck Needed? | ☐ Yes ☐ No | +| Physician Review Needed? | ☐ Yes ☐ No | + +--- + +## Signatures + +### Operator Attestation + +I certify that this treatment session was administered in accordance with the prescribed protocol and documented accurately. + +| Field | Entry | +|-------|-------| +| Operator Signature | | +| Date | | +| Time | | + +### Supervising Physician Review (if required) + +| Field | Entry | +|-------|-------| +| Physician Signature | | +| Date | | +| Comments | | + +--- + +*Form FRM-TMS-001 Rev 1.0 - TMS Treatment Session Log* diff --git a/Policies/POL-001-Quality-Policy.md b/Policies/POL-001-Quality-Policy.md new file mode 100644 index 0000000..ebd85dd --- /dev/null +++ b/Policies/POL-001-Quality-Policy.md @@ -0,0 +1,57 @@ +# Quality Policy + +| Document ID | POL-001 | +|-------------|---------| +| Title | Quality Policy | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | + +--- + +## 1. Policy Statement + +[ORGANIZATION NAME] is committed to providing products and services that consistently meet customer requirements and applicable regulatory requirements. We strive for continual improvement of our Quality Management System to enhance customer satisfaction. + +## 2. Quality Objectives + +Our organization commits to: + +1. **Customer Focus**: Understanding and meeting customer needs and expectations +2. **Regulatory Compliance**: Maintaining compliance with all applicable regulations and standards +3. **Continuous Improvement**: Continually improving the effectiveness of our QMS +4. **Employee Engagement**: Ensuring all employees understand their role in quality +5. **Risk-Based Thinking**: Identifying and addressing risks and opportunities + +## 3. Management Commitment + +Top management demonstrates commitment to the QMS by: + +- Ensuring the quality policy is appropriate to the organization's purpose +- Ensuring quality objectives are established and compatible with strategic direction +- Ensuring integration of QMS requirements into business processes +- Promoting the use of the process approach and risk-based thinking +- Ensuring resources needed for the QMS are available +- Communicating the importance of effective quality management +- Ensuring the QMS achieves its intended results +- Engaging, directing, and supporting persons to contribute to QMS effectiveness + +## 4. Scope + +This policy applies to all employees, contractors, and processes within the scope of our Quality Management System. + +## 5. Communication + +This policy shall be: +- Communicated and understood within the organization +- Available to relevant interested parties as appropriate +- Reviewed for continuing suitability + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] | diff --git a/README.md b/README.md index 88f4fc6..631cd54 100644 --- a/README.md +++ b/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. \ No newline at end of file +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.* diff --git a/SOPs/Documentation/.gitkeep b/SOPs/Documentation/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/SOPs/Equipment/.gitkeep b/SOPs/Equipment/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/SOPs/General/SOP-001-Document-Control.md b/SOPs/General/SOP-001-Document-Control.md new file mode 100644 index 0000000..b64ef52 --- /dev/null +++ b/SOPs/General/SOP-001-Document-Control.md @@ -0,0 +1,112 @@ +# Standard Operating Procedure: Document Control + +| Document ID | SOP-001 | +|-------------|---------| +| Title | Document Control | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | +| Department | Quality Assurance | + +--- + +## 1. Purpose + +To establish a procedure for the creation, review, approval, distribution, and control of documents within the Quality Management System. + +## 2. Scope + +This procedure applies to all controlled documents including: +- Policies +- Standard Operating Procedures (SOPs) +- Work Instructions +- Forms and Templates +- Specifications +- External documents of external origin + +## 3. Responsibilities + +### 3.1 Document Owner +- Responsible for document content and accuracy +- Initiates document creation and revision +- Ensures periodic review is performed + +### 3.2 Quality Assurance +- Maintains the document control system +- Assigns document numbers +- Manages document distribution +- Archives obsolete documents + +### 3.3 Approvers +- Review and approve documents before release +- Ensure documents are adequate for intended purpose + +## 4. Procedure + +### 4.1 Document Creation + +1. Identify the need for a new document +2. Request document number from Quality Assurance +3. Draft document using appropriate template +4. Include all required header information +5. Submit for review and approval + +### 4.2 Document Review and Approval + +1. Route document to appropriate reviewers +2. Reviewers provide comments within 5 business days +3. Author addresses all comments +4. Final approval by designated approver +5. Quality Assurance releases document + +### 4.3 Document Numbering + +Documents shall be numbered according to the following convention: + +| Type | Prefix | Example | +|------|--------|---------| +| Policy | POL | POL-001 | +| SOP | SOP | SOP-001 | +| Work Instruction | WI | WI-001 | +| Form | FRM | FRM-001 | + +### 4.4 Revision Control + +1. All changes require documented justification +2. Changes follow same review/approval process as new documents +3. Revision number increments with each approved change +4. Revision history maintained in document footer + +### 4.5 Document Distribution + +1. Current versions available in document control system +2. Obsolete versions marked and archived +3. Training on new/revised documents as needed + +### 4.6 Periodic Review + +1. Documents reviewed at least every 2 years +2. Review documented even if no changes made +3. Reviews may result in revision or reaffirmation + +## 5. Related Documents + +- FRM-001 Document Change Request Form +- FRM-002 Document Review Record + +## 6. Definitions + +| Term | Definition | +|------|------------| +| Controlled Document | Document managed under document control system | +| Obsolete | Document no longer valid for use | +| Revision | Updated version of a document | + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] | diff --git a/SOPs/General/SOP-002-CAPA.md b/SOPs/General/SOP-002-CAPA.md new file mode 100644 index 0000000..8dace85 --- /dev/null +++ b/SOPs/General/SOP-002-CAPA.md @@ -0,0 +1,134 @@ +# Standard Operating Procedure: Corrective and Preventive Action (CAPA) + +| Document ID | SOP-002 | +|-------------|---------| +| Title | Corrective and Preventive Action | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | +| Department | Quality Assurance | + +--- + +## 1. Purpose + +To establish a systematic process for identifying, investigating, correcting, and preventing nonconformities and potential nonconformities. + +## 2. Scope + +This procedure applies to: +- Product and process nonconformities +- Customer complaints +- Audit findings +- Process deviations +- Potential nonconformities identified through risk analysis + +## 3. Definitions + +| Term | Definition | +|------|------------| +| Corrective Action | Action to eliminate the cause of a detected nonconformity | +| Preventive Action | Action to eliminate the cause of a potential nonconformity | +| Root Cause | Fundamental reason for a nonconformity | +| Effectiveness Check | Verification that implemented actions achieved desired results | + +## 4. Responsibilities + +### 4.1 CAPA Owner +- Investigates the issue +- Identifies root cause +- Develops and implements corrective/preventive actions +- Verifies effectiveness + +### 4.2 Quality Assurance +- Manages CAPA system +- Assigns CAPA numbers +- Tracks CAPA status +- Reviews and approves CAPAs +- Reports CAPA metrics to management + +### 4.3 Management +- Provides resources for CAPA implementation +- Reviews CAPA trends +- Ensures timely closure + +## 5. Procedure + +### 5.1 CAPA Initiation + +1. Identify nonconformity or potential nonconformity +2. Document issue on CAPA Form (FRM-003) +3. Classify severity and priority +4. Assign CAPA owner + +### 5.2 Investigation + +1. Gather relevant data and evidence +2. Interview personnel involved +3. Review related documents and records +4. Use appropriate investigation tools: + - 5 Whys + - Fishbone Diagram + - Failure Mode Analysis + +### 5.3 Root Cause Analysis + +1. Identify potential root causes +2. Verify root cause through evidence +3. Document root cause determination +4. Consider systemic implications + +### 5.4 Action Development + +1. Develop corrective/preventive actions +2. Assign responsibilities and due dates +3. Assess actions for: + - Appropriateness to problem severity + - Impact on other processes + - Resource requirements + +### 5.5 Implementation + +1. Execute approved actions +2. Document implementation evidence +3. Update affected documents/processes +4. Provide training as needed + +### 5.6 Effectiveness Verification + +1. Define effectiveness criteria +2. Allow sufficient time for actions to take effect +3. Collect and analyze data +4. Document verification results +5. If ineffective, reopen CAPA for further action + +### 5.7 Closure + +1. Review all CAPA documentation +2. Verify all actions completed +3. Confirm effectiveness verified +4. Obtain approval for closure + +## 6. CAPA Metrics + +Quality Assurance shall track and report: +- Number of open CAPAs +- CAPA aging +- On-time closure rate +- Effectiveness rate +- CAPAs by category/source + +## 7. Related Documents + +- FRM-003 CAPA Form +- SOP-003 Nonconforming Product Control +- SOP-004 Customer Complaints + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] | diff --git a/SOPs/General/SOP-003-Training.md b/SOPs/General/SOP-003-Training.md new file mode 100644 index 0000000..22538c1 --- /dev/null +++ b/SOPs/General/SOP-003-Training.md @@ -0,0 +1,123 @@ +# Standard Operating Procedure: Training and Competence + +| Document ID | SOP-003 | +|-------------|---------| +| Title | Training and Competence | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | +| Department | Human Resources / Quality | + +--- + +## 1. Purpose + +To ensure personnel performing work affecting product quality are competent based on appropriate education, training, skills, and experience. + +## 2. Scope + +This procedure applies to: +- All employees performing quality-affecting activities +- Contractors and temporary personnel +- Personnel requiring GxP training + +## 3. Responsibilities + +### 3.1 Supervisors/Managers +- Identify training needs for their personnel +- Ensure training is completed before performing tasks +- Evaluate competence of personnel +- Maintain department training records + +### 3.2 Human Resources +- Coordinate training programs +- Maintain central training database +- Track training compliance +- Archive training records + +### 3.3 Quality Assurance +- Develop QMS-related training +- Approve training curricula for GxP activities +- Audit training compliance + +### 3.4 Employees +- Complete assigned training on time +- Maintain current qualifications +- Report training needs to supervisor + +## 4. Procedure + +### 4.1 Training Needs Assessment + +1. Identify competence requirements for each role +2. Document requirements in job descriptions +3. Assess current competence of personnel +4. Identify training gaps + +### 4.2 Training Curriculum Development + +1. Define learning objectives +2. Develop training materials +3. Identify delivery method: + - Classroom + - On-the-job + - Self-study + - Computer-based +4. Define assessment criteria +5. Obtain approval from Quality (for GxP training) + +### 4.3 Training Delivery + +1. Schedule training session +2. Document attendance +3. Deliver training per curriculum +4. Assess comprehension through: + - Written test (minimum 80% passing) + - Practical demonstration + - Supervisor observation + +### 4.4 Training Documentation + +Training records shall include: +- Employee name and ID +- Training title and date +- Trainer name and qualifications +- Assessment results +- Signatures + +### 4.5 Retraining Requirements + +Retraining is required when: +- Significant document revisions occur +- Performance deficiencies identified +- Extended absence from job function +- Periodic requalification due + +### 4.6 New Employee Orientation + +All new employees shall complete: +1. Company orientation +2. Quality system overview +3. Job-specific training +4. SOP read and understand for applicable procedures + +## 5. Training Records Retention + +- Training records maintained for duration of employment +- Records retained 3 years after employee departure +- Records available for regulatory inspection + +## 6. Related Documents + +- FRM-004 Training Record Form +- FRM-005 Training Assessment Form +- Job Descriptions + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] | diff --git a/SOPs/General/SOP-004-Internal-Audit.md b/SOPs/General/SOP-004-Internal-Audit.md new file mode 100644 index 0000000..749d6a5 --- /dev/null +++ b/SOPs/General/SOP-004-Internal-Audit.md @@ -0,0 +1,136 @@ +# Standard Operating Procedure: Internal Audit + +| Document ID | SOP-004 | +|-------------|---------| +| Title | Internal Audit | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | +| Department | Quality Assurance | + +--- + +## 1. Purpose + +To establish a systematic approach for conducting internal audits to verify the effectiveness of the Quality Management System. + +## 2. Scope + +This procedure covers: +- QMS process audits +- Compliance audits +- Product audits +- System audits + +## 3. Definitions + +| Term | Definition | +|------|------------| +| Audit | Systematic, independent examination to determine conformance | +| Auditor | Person qualified to perform audits | +| Finding | Observation of conformance or nonconformance | +| Observation | Noted item not rising to level of finding | + +## 4. Responsibilities + +### 4.1 Lead Auditor +- Plans and schedules audits +- Prepares audit checklists +- Conducts audit activities +- Reports audit findings + +### 4.2 Quality Manager +- Maintains audit program +- Qualifies auditors +- Reviews audit reports +- Reports to management + +### 4.3 Auditee +- Provides access to areas/records +- Responds to findings +- Implements corrective actions + +## 5. Procedure + +### 5.1 Annual Audit Schedule + +1. Develop annual audit schedule considering: + - Previous audit results + - Process criticality + - Regulatory requirements + - Changes to processes +2. Ensure all QMS processes audited at least annually +3. Obtain management approval +4. Communicate schedule to affected areas + +### 5.2 Auditor Qualification + +Auditors shall: +- Complete auditor training course +- Conduct at least 2 audits under supervision +- Be independent of area being audited +- Maintain competence through ongoing audits + +### 5.3 Audit Preparation + +1. Review applicable procedures and standards +2. Review previous audit reports +3. Prepare audit checklist +4. Notify auditee of audit scope and schedule +5. Confirm auditor availability + +### 5.4 Conducting the Audit + +1. Hold opening meeting with auditee +2. Execute audit checklist +3. Gather objective evidence: + - Document review + - Personnel interviews + - Process observation +4. Document findings with evidence +5. Classify findings: + - Major Nonconformance + - Minor Nonconformance + - Observation +6. Hold closing meeting + +### 5.5 Audit Reporting + +1. Complete audit report within 5 business days +2. Report shall include: + - Audit scope and criteria + - Personnel interviewed + - Findings with evidence + - Recommendations +3. Distribute report to auditee and management + +### 5.6 Finding Resolution + +1. Auditee responds with corrective action plan within 10 business days +2. Quality reviews and approves plan +3. Auditee implements corrective actions +4. Auditor verifies effectiveness +5. Close finding upon verification + +## 6. Audit Records + +Maintain for 5 years: +- Audit schedules +- Checklists +- Reports +- Corrective action records + +## 7. Related Documents + +- FRM-006 Audit Checklist Template +- FRM-007 Audit Report Template +- SOP-002 CAPA + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] | diff --git a/SOPs/General/SOP-005-Management-Review.md b/SOPs/General/SOP-005-Management-Review.md new file mode 100644 index 0000000..dd82006 --- /dev/null +++ b/SOPs/General/SOP-005-Management-Review.md @@ -0,0 +1,114 @@ +# Standard Operating Procedure: Management Review + +| Document ID | SOP-005 | +|-------------|---------| +| Title | Management Review | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | +| Department | Quality Assurance | + +--- + +## 1. Purpose + +To ensure top management reviews the Quality Management System at planned intervals to ensure its continuing suitability, adequacy, and effectiveness. + +## 2. Scope + +This procedure applies to the periodic management review of the QMS, including all processes and quality objectives. + +## 3. Frequency + +Management reviews shall be conducted: +- At least annually +- More frequently if significant changes occur +- As needed based on quality performance + +## 4. Responsibilities + +### 4.1 Quality Manager +- Prepares management review agenda and materials +- Facilitates the meeting +- Documents meeting minutes and action items +- Tracks completion of action items + +### 4.2 Top Management +- Attends management review meetings +- Reviews QMS performance data +- Makes decisions on QMS improvements +- Allocates resources as needed + +### 4.3 Department Managers +- Provides input data for their areas +- Attends management review +- Implements assigned action items + +## 5. Management Review Inputs + +The following shall be considered: + +### 5.1 Actions from Previous Reviews +- Status of action items +- Effectiveness of implemented actions + +### 5.2 Changes in Context +- Internal changes (organization, resources) +- External changes (regulations, market) + +### 5.3 QMS Performance +- Customer satisfaction and feedback +- Quality objectives achievement +- Process performance metrics +- Nonconformities and corrective actions +- Audit results +- Supplier performance + +### 5.4 Resource Adequacy +- Personnel +- Infrastructure +- Work environment + +### 5.5 Risk and Opportunities +- Risk assessment results +- Effectiveness of risk controls +- New opportunities identified + +### 5.6 Improvement Opportunities +- Process improvements +- Product improvements +- QMS enhancements + +## 6. Management Review Outputs + +Decisions and actions related to: +- Improvement of QMS and processes +- Product improvement +- Resource needs +- Changes to quality policy or objectives + +## 7. Documentation + +### 7.1 Meeting Minutes +- Date and attendees +- Items discussed +- Decisions made +- Action items with owners and due dates + +### 7.2 Record Retention +- Management review records retained for 5 years +- Available for regulatory inspection + +## 8. Related Documents + +- FRM-008 Management Review Agenda Template +- FRM-009 Management Review Minutes Template + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] | diff --git a/SOPs/Patient-Selection/.gitkeep b/SOPs/Patient-Selection/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/SOPs/Safety/.gitkeep b/SOPs/Safety/.gitkeep new file mode 100644 index 0000000..dcf2c80 --- /dev/null +++ b/SOPs/Safety/.gitkeep @@ -0,0 +1 @@ +# Placeholder diff --git a/SOPs/Treatment-Protocols/.gitkeep b/SOPs/Treatment-Protocols/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/SOPs/Treatment-Protocols/SOP-TMS-001-Treatment-Protocol.md b/SOPs/Treatment-Protocols/SOP-TMS-001-Treatment-Protocol.md new file mode 100644 index 0000000..076680e --- /dev/null +++ b/SOPs/Treatment-Protocols/SOP-TMS-001-Treatment-Protocol.md @@ -0,0 +1,284 @@ +# Standard Operating Procedure: TMS Treatment Protocol + +| Document ID | SOP-TMS-001 | +|-------------|-------------| +| Title | Transcranial Magnetic Stimulation Treatment Protocol | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | +| Department | TMS Clinic | + +--- + +## 1. Purpose + +To establish standardized procedures for the safe and effective administration of Transcranial Magnetic Stimulation (TMS) therapy in accordance with FDA clearances, manufacturer guidelines, and clinical best practices. + +## 2. Scope + +This procedure applies to all TMS treatments including: +- Repetitive TMS (rTMS) for Major Depressive Disorder +- rTMS for Obsessive-Compulsive Disorder +- Intermittent Theta Burst Stimulation (iTBS) +- Other FDA-cleared or investigational protocols + +## 3. Responsibilities + +### 3.1 TMS Technician/Operator +- Position patient and equipment +- Determine motor threshold +- Administer treatment per prescription +- Monitor patient during treatment +- Document treatment parameters + +### 3.2 Prescribing Physician +- Evaluate patient eligibility +- Prescribe treatment protocol +- Review progress and adjust treatment +- Manage adverse events +- Provide medical oversight + +### 3.3 Clinical Coordinator +- Schedule treatments +- Track treatment compliance +- Coordinate patient assessments +- Maintain equipment logs + +## 4. Definitions + +| Term | Definition | +|------|------------| +| MT | Motor Threshold - minimum intensity to produce MEP | +| MEP | Motor Evoked Potential - observable motor response | +| rTMS | Repetitive Transcranial Magnetic Stimulation | +| iTBS | Intermittent Theta Burst Stimulation | +| DLPFC | Dorsolateral Prefrontal Cortex - common target for depression | + +## 5. Equipment and Materials + +- TMS device (FDA-cleared) +- Treatment coil (figure-8 or appropriate for indication) +- Positioning chair or table +- Ear protection (ear plugs) +- Treatment cap or head marking system +- Motor threshold determination tools +- Emergency equipment (as per emergency SOP) + +## 6. Procedure + +### 6.1 Pre-Treatment Assessment + +#### 6.1.1 Initial Evaluation (First Treatment) +1. **Verify Prescription** + - Diagnosis confirmed + - Treatment protocol specified + - Contraindications reviewed + - Informed consent on file + +2. **Safety Screening** + Confirm absence of contraindications: + - [ ] No ferromagnetic metal in head/neck + - [ ] No implanted devices (pacemaker, cochlear implant, DBS) + - [ ] No history of seizures (unless per protocol) + - [ ] No unstable medical conditions + - [ ] Current medications reviewed for seizure threshold effects + - [ ] Pregnancy test negative (if applicable) + +3. **Baseline Assessments** + - PHQ-9 or HAM-D (depression) + - Y-BOCS (OCD, if applicable) + - Vital signs + - Cognitive baseline if indicated + +#### 6.1.2 Daily Pre-Treatment Check +Before each session: +- [ ] Patient identity verified +- [ ] Assess for new contraindications +- [ ] Confirm adequate sleep (>4 hours) +- [ ] Confirm no alcohol/illicit substances +- [ ] Confirm no significant medication changes +- [ ] Assess for current illness +- [ ] Review previous session tolerance + +### 6.2 Motor Threshold Determination + +**Required at:** +- First treatment session +- Any significant change in medications affecting neural excitability +- If treatment efficacy changes significantly +- Per physician order + +**Procedure:** +1. Position patient comfortably +2. Place coil over motor cortex (M1) contralateral to dominant hand +3. Begin at 30-40% machine output +4. Deliver single pulses at 10-second intervals +5. Observe for thumb/finger movement (APB) +6. Increase intensity by 5% increments +7. Record lowest intensity producing 5 MEPs in 10 trials +8. Document MT and method used + +| MT Parameter | Value | +|--------------|-------| +| Date | | +| Resting Motor Threshold (%) | | +| Target Muscle | | +| Number of Trials | | +| Determined By | | + +### 6.3 Treatment Coil Positioning + +#### 6.3.1 Left DLPFC Targeting (Standard Depression Protocol) +**5-cm Rule Method:** +1. Identify motor hotspot (from MT determination) +2. Measure 5 cm anteriorly along scalp surface +3. Mark position on treatment cap +4. Verify coil angle (45° to midline) + +**Neuronavigation Method (if available):** +1. Register patient to MRI +2. Identify target coordinates +3. Position coil using navigation system +4. Document coordinates and trajectory + +#### 6.3.2 Alternative Targets +- Right DLPFC (low-frequency protocol) +- Supplementary Motor Area (OCD) +- Other per protocol specification + +### 6.4 Treatment Administration + +1. **Patient Preparation** + - Seat in treatment chair + - Provide ear protection + - Position head comfortably + - Instruct patient on what to expect + +2. **Equipment Setup** + - Power on device and perform calibration + - Select prescribed protocol + - Set treatment parameters: + | Parameter | Value | + |-----------|-------| + | Frequency (Hz) | | + | Intensity (% MT) | | + | Pulses per train | | + | Inter-train interval | | + | Total pulses | | + | Duration | | + +3. **Treatment Delivery** + - Position coil at marked location + - Maintain consistent coil contact + - Begin treatment delivery + - Monitor patient continuously + - Pause if patient reports concerning symptoms + +4. **Patient Monitoring During Treatment** + Observe for: + - Facial twitching (may indicate coil drift) + - Signs of distress + - Seizure warning signs + - Excessive discomfort + +### 6.5 Standard Treatment Protocols + +#### Major Depressive Disorder - Standard rTMS +| Parameter | Left DLPFC | +|-----------|------------| +| Frequency | 10 Hz | +| Intensity | 120% MT | +| Train duration | 4 seconds | +| Inter-train interval | 26 seconds | +| Trains per session | 75 | +| Total pulses | 3,000 | +| Session duration | ~37.5 minutes | +| Total sessions | 30-36 | + +#### Major Depressive Disorder - iTBS +| Parameter | Left DLPFC | +|-----------|------------| +| Pattern | 50 Hz bursts at 5 Hz | +| Intensity | 120% MT | +| Bursts per train | 10 (30 pulses) | +| Inter-train interval | 8 seconds | +| Total pulses | 600 | +| Session duration | ~3 minutes | +| Total sessions | 30-36 | + +### 6.6 Post-Treatment + +1. **Immediate Assessment** + - Ask about side effects + - Assess for headache, scalp pain + - Evaluate mental status + - Confirm safe to leave + +2. **Documentation** + Complete FRM-TMS-001 Treatment Log: + - Date and session number + - Treatment parameters used + - Coil position + - Patient tolerance + - Any adverse effects + - Operator signature + +3. **Patient Instructions** + - Mild headache/scalp discomfort common + - OTC analgesics acceptable + - Report severe/persistent symptoms + - Confirm next appointment + +### 6.7 Adverse Event Management + +| Event | Severity | Action | +|-------|----------|--------| +| Scalp discomfort | Mild | Adjust position, OTC analgesic | +| Headache | Mild-Moderate | OTC analgesic, reduce intensity if persistent | +| Syncope | Moderate | Stop treatment, lie patient down, assess vitals | +| Seizure | Severe | Stop treatment, protect patient, follow seizure protocol | + +**Seizure Response:** +1. Stop stimulation immediately +2. Note time +3. Protect patient from injury +4. Do not restrain +5. Call for help / activate emergency protocol +6. Monitor airway and breathing +7. Time seizure duration +8. Notify physician immediately +9. Complete incident report + +## 7. Outcome Monitoring + +| Assessment | Timing | Tool | +|------------|--------|------| +| Depression severity | Weekly | PHQ-9 or HAM-D | +| OCD severity (if applicable) | Weekly | Y-BOCS | +| Side effects | Each session | TMS side effect checklist | +| Treatment response | Sessions 10, 20, 30 | Physician evaluation | +| Remission assessment | End of acute course | Full clinical evaluation | + +## 8. Documentation + +- FRM-TMS-001 TMS Treatment Log +- FRM-TMS-002 Motor Threshold Record +- FRM-TMS-003 Side Effect Checklist +- Outcome assessment forms +- Equipment maintenance logs + +## 9. References + +- FDA clearance documentation +- Manufacturer operating manual +- Clinical practice guidelines (APA, CANMAT) +- Peer-reviewed TMS literature + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] | diff --git a/Templates/SOP-Template.md b/Templates/SOP-Template.md new file mode 100644 index 0000000..2e9f35e --- /dev/null +++ b/Templates/SOP-Template.md @@ -0,0 +1,62 @@ +# Standard Operating Procedure: [Title] + +| Document ID | SOP-XXX | +|-------------|---------| +| Title | [Title] | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | +| Department | [DEPARTMENT] | + +--- + +## 1. Purpose + +[State the purpose of this procedure] + +## 2. Scope + +[Define the scope and applicability] + +## 3. Responsibilities + +### 3.1 [Role 1] +- [Responsibility] +- [Responsibility] + +### 3.2 [Role 2] +- [Responsibility] +- [Responsibility] + +## 4. Definitions + +| Term | Definition | +|------|------------| +| | | + +## 5. Procedure + +### 5.1 [Section Title] + +[Procedure steps] + +### 5.2 [Section Title] + +[Procedure steps] + +## 6. Related Documents + +- [List related procedures, forms, etc.] + +## 7. References + +- [External standards, regulations, etc.] + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] | diff --git a/Work Instructions/WI-001-Template.md b/Work Instructions/WI-001-Template.md new file mode 100644 index 0000000..68167f1 --- /dev/null +++ b/Work Instructions/WI-001-Template.md @@ -0,0 +1,68 @@ +# Work Instruction: [Title] + +| Document ID | WI-001 | +|-------------|--------| +| Title | [Title] | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | +| Department | [DEPARTMENT] | + +--- + +## 1. Purpose + +[Describe the purpose of this work instruction] + +## 2. Scope + +[Define what activities this instruction covers] + +## 3. Safety Precautions + +- [List any safety requirements] +- [Personal protective equipment needed] +- [Hazards to be aware of] + +## 4. Equipment/Materials Required + +| Item | Specification | +|------|---------------| +| | | +| | | + +## 5. Procedure + +### Step 1: [Title] +[Detailed instructions] + +### Step 2: [Title] +[Detailed instructions] + +### Step 3: [Title] +[Detailed instructions] + +## 6. Acceptance Criteria + +[Define what constitutes successful completion] + +## 7. Records + +| Record | Location | Retention | +|--------|----------|-----------| +| | | | + +## 8. References + +- [Related SOPs] +- [Specifications] +- [Standards] + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] |