Sync template from atomicqms-style deployment

.gitea/workflows/atomicai.yml

@@ -0,0 +1,75 @@
+name: AtomicAI Clinical Outpatient 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 Clinical Outpatient 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 Clinical Outpatient Quality Management.
+
+            ## Your Expertise
+            - Ambulatory care quality standards (AAAHC, NCQA)
+            - Patient flow and scheduling optimization
+            - Outpatient clinical protocols and pathways
+            - Patient safety and infection control
+            - Medication management and reconciliation
+            - Care coordination and referral processes
+            - Patient education and discharge planning
+            - HIPAA compliance and privacy regulations
+
+            ## Document Creation Guidelines
+            - Place Clinical SOPs in SOPs/Clinical/
+            - Place Administrative SOPs in SOPs/Administrative/
+            - Place Safety SOPs in SOPs/Safety/
+            - Place Patient Forms in Forms/Patient/
+            - Place Clinical Protocols in Protocols/
+            - Place Policies in Policies/
+
+            ## Numbering Convention
+            - SOP-OP-XXX for Outpatient SOPs
+            - SOP-ADM-XXX for Administrative SOPs
+            - SOP-SAF-XXX for Safety SOPs
+            - PRO-XXX for Clinical Protocols
+            - POL-XXX for Policies
+            - FRM-XXX for Forms
+
+            Always create branches and submit changes as Pull Requests for review.
+            Focus on patient-centered care and efficient clinic operations.
+          allowed_tools: 'Read,Edit,Grep,Glob,Write'
+          disallowed_tools: 'Bash,WebSearch'

Forms/FRM-001-Document-Change-Request.md

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+# 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*

Forms/FRM-003-CAPA-Form.md

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+# 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*

Forms/FRM-006-Audit-Checklist.md

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+# 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*

Forms/Intake-Forms/FRM-OPT-001-New-Patient-Registration.md

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+# New Patient Registration Form
+
+| Form ID | FRM-OPT-001 | Revision | 1.0 |
+|---------|-------------|----------|-----|
+
+---
+
+## Patient Information
+
+| Field | Entry |
+|-------|-------|
+| Last Name | |
+| First Name | |
+| Middle Name/Initial | |
+| Preferred Name | |
+| Date of Birth | |
+| Age | |
+| Sex | ☐ Male ☐ Female ☐ Other |
+| Social Security # (last 4) | XXX-XX-_____ |
+
+### Contact Information
+
+| Field | Entry |
+|-------|-------|
+| Street Address | |
+| Apartment/Unit | |
+| City | |
+| State | |
+| Zip Code | |
+| Home Phone | |
+| Cell Phone | |
+| Work Phone | |
+| Preferred Contact Method | ☐ Home ☐ Cell ☐ Work ☐ Email |
+| Email Address | |
+| OK to Leave Message? | ☐ Yes ☐ No |
+
+### Additional Information
+
+| Field | Entry |
+|-------|-------|
+| Marital Status | ☐ Single ☐ Married ☐ Divorced ☐ Widowed ☐ Partnered |
+| Race/Ethnicity (optional) | |
+| Preferred Language | |
+| Interpreter Needed? | ☐ Yes (Language: _______) ☐ No |
+| Employer | |
+| Occupation | |
+
+---
+
+## Emergency Contact
+
+| Field | Entry |
+|-------|-------|
+| Name | |
+| Relationship | |
+| Home Phone | |
+| Cell Phone | |
+| Work Phone | |
+
+---
+
+## Primary Care Information
+
+| Field | Entry |
+|-------|-------|
+| Primary Care Physician | |
+| Practice Name | |
+| Phone Number | |
+| Fax Number | |
+| Address | |
+| Date of Last Visit | |
+
+---
+
+## Referring Provider (if applicable)
+
+| Field | Entry |
+|-------|-------|
+| Referring Physician | |
+| Practice Name | |
+| Phone Number | |
+| Fax Number | |
+| Reason for Referral | |
+
+---
+
+## Insurance Information
+
+### Primary Insurance
+
+| Field | Entry |
+|-------|-------|
+| Insurance Company | |
+| Policy/ID Number | |
+| Group Number | |
+| Policy Holder Name | |
+| Policy Holder DOB | |
+| Relationship to Patient | ☐ Self ☐ Spouse ☐ Child ☐ Other: _______ |
+| Insurance Phone | |
+
+### Secondary Insurance (if applicable)
+
+| Field | Entry |
+|-------|-------|
+| Insurance Company | |
+| Policy/ID Number | |
+| Group Number | |
+| Policy Holder Name | |
+| Policy Holder DOB | |
+| Relationship to Patient | ☐ Self ☐ Spouse ☐ Child ☐ Other: _______ |
+| Insurance Phone | |
+
+---
+
+## Responsible Party (if different from patient)
+
+| Field | Entry |
+|-------|-------|
+| Name | |
+| Relationship to Patient | |
+| Date of Birth | |
+| Address (if different) | |
+| Phone Number | |
+| Email | |
+
+---
+
+## Pharmacy Information
+
+| Field | Entry |
+|-------|-------|
+| Preferred Pharmacy Name | |
+| Address | |
+| Phone Number | |
+| Cross Street/Location | |
+| Preferred Mail Order Pharmacy | |
+
+---
+
+## Medical History Summary
+
+### Current Medications
+*List all current medications including over-the-counter and supplements*
+
+| Medication Name | Dose | Frequency |
+|-----------------|------|-----------|
+| | | |
+| | | |
+| | | |
+| | | |
+| | | |
+| | | |
+
+### Allergies
+
+☐ No Known Allergies (NKA)
+
+| Allergen | Type | Reaction |
+|----------|------|----------|
+| | ☐ Drug ☐ Food ☐ Other | |
+| | ☐ Drug ☐ Food ☐ Other | |
+| | ☐ Drug ☐ Food ☐ Other | |
+
+### Medical Conditions
+*Check all that apply*
+
+| Condition | ☐ | Condition | ☐ |
+|-----------|---|-----------|---|
+| Arthritis | | Liver Disease | |
+| Asthma | | Lung Disease/COPD | |
+| Cancer | | Mental Health Condition | |
+| Diabetes | | Seizures/Epilepsy | |
+| Heart Disease | | Stroke/TIA | |
+| High Blood Pressure | | Thyroid Disease | |
+| High Cholesterol | | Other: _____________ | |
+| Kidney Disease | | Other: _____________ | |
+
+### Surgical History
+
+| Surgery/Procedure | Year |
+|-------------------|------|
+| | |
+| | |
+| | |
+
+---
+
+## Social History
+
+| Field | Entry |
+|-------|-------|
+| Tobacco Use | ☐ Never ☐ Current ☐ Former (Quit year: _____) |
+| If yes, type/amount | |
+| Alcohol Use | ☐ None ☐ Social ☐ Daily |
+| If yes, type/amount | |
+| Exercise | ☐ None ☐ Light ☐ Moderate ☐ Vigorous |
+| Frequency | times per week |
+
+---
+
+## How Did You Hear About Us?
+
+☐ Physician Referral: _________________
+☐ Insurance Directory
+☐ Internet Search
+☐ Social Media
+☐ Friend/Family Member
+☐ Other: _________________
+
+---
+
+## Acknowledgments
+
+### Financial Policy
+☐ I have read and understand the financial policy. I authorize payment directly to this practice of any insurance benefits otherwise payable to me. I understand that I am responsible for any amount not covered by insurance.
+
+### Privacy Practices
+☐ I have received a copy of the Notice of Privacy Practices and understand how my health information may be used and disclosed.
+
+### Release of Information
+☐ I authorize the release of medical information necessary to process insurance claims and for continuity of care with referring and consulting physicians.
+
+### Communication Authorization
+☐ I authorize communication via: ☐ Phone ☐ Email ☐ Text Message for appointment reminders and health information.
+
+### Assignment of Benefits
+☐ I authorize payment of medical benefits to this practice for services rendered.
+
+---
+
+## Patient Portal
+
+☐ I would like to enroll in the patient portal
+
+| Field | Entry |
+|-------|-------|
+| Preferred Email for Portal | |
+
+---
+
+## Signature
+
+| Field | Entry |
+|-------|-------|
+| Patient/Guardian Signature | |
+| Printed Name | |
+| Relationship (if not patient) | |
+| Date | |
+
+---
+
+## For Office Use Only
+
+| Field | Entry |
+|-------|-------|
+| Date Received | |
+| Entered By | |
+| Chart Number | |
+| Insurance Verified | ☐ Yes |
+| Copay Collected | $ |
+| Notes | |
+
+---
+
+*Form FRM-OPT-001 Rev 1.0 - New Patient Registration Form*

Forms/Training/FRM-004-Training-Record.md

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+# 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*

Policies/POL-001-Quality-Policy.md

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+# 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] |

README.md

@@ -1,3 +1,133 @@
-# clinical-outpatient
+# Clinical Outpatient Services Quality Management System
 
-A comprehensive QMS template designed for ambulatory care clinics, outpatient services, and specialty practices.
+A comprehensive QMS template designed for ambulatory care clinics, outpatient services, and specialty practices.
+
+## 🏢 Designed For
+
+- **Primary Care Clinics** - Family medicine, internal medicine, pediatrics
+- **Specialty Clinics** - Cardiology, neurology, oncology, etc.
+- **Ambulatory Surgery Centers** - Outpatient surgical procedures
+- **Urgent Care Centers** - Walk-in acute care services
+- **Diagnostic Centers** - Imaging, laboratory, testing facilities
+- **Infusion Centers** - Outpatient chemotherapy and infusion therapy
+- **Rehabilitation Clinics** - Physical therapy, occupational therapy
+
+## 📋 Regulatory Framework
+
+This template supports compliance with:
+
+- **The Joint Commission** - Ambulatory Care accreditation
+- **AAAHC** - Accreditation Association for Ambulatory Health Care
+- **CMS** - Medicare/Medicaid ambulatory requirements
+- **State Medical Board** - Physician practice regulations
+- **OSHA** - Workplace safety requirements
+- **HIPAA** - Patient privacy and security
+- **CLIA** - Laboratory testing requirements (if applicable)
+- **State Facility Licensing** - Ambulatory care facility regulations
+- **AMA Guidelines** - Medical practice standards
+- **PCMH** - Patient-Centered Medical Home standards
+
+## Repository Structure
+
+```
+├── SOPs/
+│   ├── Patient-Flow/          # Scheduling, check-in, rooming, discharge
+│   ├── Clinical-Care/         # Assessment, treatment, documentation
+│   ├── Medication-Management/ # Prescribing, dispensing, samples
+│   ├── Procedures/            # Office procedures, minor surgery
+│   ├── Infection-Control/     # Sterilization, injection safety
+│   └── General/               # Document control, training, CAPA
+├── Forms/
+│   ├── Patient-Intake/        # Registration, history, consent forms
+│   ├── Visit-Documentation/   # Progress notes, assessments, orders
+│   ├── Referral-Forms/        # Specialist referrals, authorizations
+│   ├── Procedure-Records/     # Procedure consent, logs, aftercare
+│   ├── QI-Records/            # Quality metrics, patient satisfaction
+│   └── Training/              # Competency assessments
+├── Policies/                  # Practice policies
+├── Work-Instructions/         # Step-by-step procedures
+└── Templates/                 # Document templates
+```
+
+## Document Numbering Convention
+
+- **POL-XXX**: Policies
+- **SOP-PF-XXX**: Patient Flow SOPs
+- **SOP-CC-XXX**: Clinical Care SOPs
+- **SOP-MED-XXX**: Medication Management SOPs
+- **SOP-PRC-XXX**: Procedure SOPs
+- **SOP-IC-XXX**: Infection Control SOPs
+- **WI-XXX**: Work Instructions
+- **FRM-XXX**: Forms and Records
+
+## 🤖 AI-Powered Assistance
+
+This repository includes **AtomicAI**, your outpatient QMS assistant. Mention `@atomicai` in any issue or pull request to:
+
+- Draft patient flow and scheduling procedures
+- Create clinical care protocols
+- Generate medication management procedures
+- Develop office procedure SOPs
+- Create infection control protocols
+- Review documents for AAAHC/Joint Commission compliance
+
+### Example Prompts
+
+- "@atomicai create an SOP for patient check-in and rooming workflow"
+- "@atomicai draft a chronic disease management protocol for diabetes"
+- "@atomicai write a medication prior authorization procedure"
+- "@atomicai create an in-office procedure consent process"
+- "@atomicai develop a referral management workflow"
+- "@atomicai create a sterilization procedure for reusable instruments"
+
+## Getting Started
+
+1. **Define Practice Workflows** - Map patient flow from arrival to discharge
+2. **Customize Clinical Protocols** - Adapt for your specialty and patient population
+3. **Set Up Quality Metrics** - Establish HEDIS or specialty-specific measures
+4. **Implement Medication Safety** - Configure prescribing and sample procedures
+5. **Train Staff** - Use competency assessment forms
+
+## Key Documents to Create First
+
+1. **Patient Check-In SOP** - Standardized intake process
+2. **Clinical Documentation Policy** - Charting standards and requirements
+3. **Medication Reconciliation SOP** - Accurate medication lists
+4. **Referral Management SOP** - Tracking referrals and follow-up
+5. **Infection Control Policy** - Hand hygiene, injection safety, sterilization
+6. **No-Show/Cancellation Policy** - Patient appointment compliance
+7. **After-Hours Coverage SOP** - Triage and on-call procedures
+
+## Special Considerations for Outpatient Care
+
+### Patient Access
+- Scheduling optimization and wait time management
+- Same-day/urgent appointment availability
+- Patient portal and communication
+- Reminder systems and no-show reduction
+- Insurance verification and authorization
+
+### Care Coordination
+- Referral tracking and follow-up
+- Care transitions between providers
+- Medication reconciliation at each visit
+- Chronic disease management programs
+- Population health initiatives
+
+### Quality Improvement
+- HEDIS measures and reporting
+- Patient satisfaction surveys
+- Clinical outcome tracking
+- Peer review and chart audits
+- Continuous quality improvement
+
+### Compliance
+- HIPAA privacy and security
+- Medical record retention
+- Prescription monitoring programs
+- Credentialing and privileging
+- Incident reporting
+
+---
+
+*This template is maintained by AtomicQMS. For questions, open an issue in this repository.*

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] |

SOPs/General/SOP-002-CAPA.md

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+# 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] |

SOPs/General/SOP-003-Training.md

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+# 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] |

SOPs/General/SOP-004-Internal-Audit.md

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+# 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] |

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] |

SOPs/Patient-Care/SOP-OPT-001-Appointment-Management.md

@@ -0,0 +1,276 @@
+# Standard Operating Procedure: Outpatient Appointment Management
+
+| Document ID | SOP-OPT-001 |
+|-------------|-------------|
+| Title | Outpatient Appointment Scheduling and Management |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | Outpatient Services |
+
+---
+
+## 1. Purpose
+
+To establish standardized procedures for scheduling, managing, and documenting outpatient appointments to ensure efficient clinic operations, optimize provider schedules, and enhance patient access to care.
+
+## 2. Scope
+
+This procedure applies to all outpatient appointment scheduling including:
+- New patient appointments
+- Follow-up appointments
+- Procedure appointments
+- Telehealth visits
+- Same-day/urgent appointments
+- Specialist referrals
+
+## 3. Responsibilities
+
+### 3.1 Scheduling Staff
+- Schedule appointments per protocols
+- Verify insurance and authorizations
+- Communicate appointment details to patients
+- Manage appointment reminders
+
+### 3.2 Front Desk Staff
+- Complete patient check-in/check-out
+- Collect copays and outstanding balances
+- Update patient demographics
+- Schedule follow-up appointments
+
+### 3.3 Clinical Staff
+- Prepare patients for encounters
+- Document clinical information
+- Communicate provider schedules
+
+### 3.4 Providers
+- Adhere to schedule templates
+- Communicate scheduling preferences
+- Approve schedule modifications
+
+## 4. Definitions
+
+| Term | Definition |
+|------|------------|
+| New Patient | Patient not seen by practice within past 3 years |
+| Established Patient | Patient seen within past 3 years |
+| Slot | Designated time block for specific appointment type |
+| Template | Schedule structure defining available appointment types |
+| No-Show | Patient who fails to appear for scheduled appointment |
+
+## 5. Procedure
+
+### 5.1 Appointment Scheduling
+
+#### 5.1.1 Information to Collect
+| Required Information | Check |
+|---------------------|-------|
+| Patient full legal name | ☐ |
+| Date of birth | ☐ |
+| Contact phone number(s) | ☐ |
+| Email address (optional) | ☐ |
+| Insurance information | ☐ |
+| Referring provider (if applicable) | ☐ |
+| Reason for visit | ☐ |
+| Preferred appointment times | ☐ |
+
+#### 5.1.2 Appointment Type Selection
+
+| Appointment Type | Duration | Notes |
+|-----------------|----------|-------|
+| New Patient Comprehensive | 60 min | Full history and physical |
+| New Patient Focused | 30-45 min | Single concern |
+| Established Patient Follow-up | 15-20 min | Routine follow-up |
+| Established Patient Extended | 30-40 min | Complex issues |
+| Procedure | Varies | Per procedure type |
+| Telehealth | 15-30 min | Virtual visit |
+| Same-Day/Urgent | 15-20 min | Acute concerns |
+
+#### 5.1.3 Scheduling Process
+1. **Verify Patient Status**
+   - New vs. established patient
+   - Check for alerts or special needs
+   - Review last visit date
+
+2. **Match Appointment Type**
+   - Assess reason for visit
+   - Select appropriate appointment type
+   - Confirm duration adequate for needs
+
+3. **Find Available Slot**
+   - Check provider availability
+   - Offer multiple date/time options
+   - Consider patient preferences
+
+4. **Complete Booking**
+   - Confirm appointment details
+   - Verify contact information
+   - Document special requests
+
+5. **Provide Appointment Information**
+   - Appointment date and time
+   - Location and parking information
+   - Pre-appointment instructions
+   - What to bring (insurance, ID, referral, etc.)
+   - Cancellation policy
+
+### 5.2 Appointment Reminders
+
+| Reminder Type | Timing | Method |
+|--------------|--------|--------|
+| Initial confirmation | At scheduling | Verbal + written |
+| First reminder | 7 days prior | Automated call/text/email |
+| Second reminder | 2-3 days prior | Automated call/text/email |
+| Final reminder | 1 day prior | Automated call/text/email |
+
+### 5.3 Check-In Process
+
+1. **Patient Arrival**
+   - Greet patient professionally
+   - Verify identity (photo ID)
+   - Confirm appointment details
+
+2. **Registration Update**
+   - Review and update demographics
+   - Verify insurance information
+   - Collect copies of cards if changed
+   - Verify emergency contact
+
+3. **Documentation Collection**
+   - Obtain referral authorization (if required)
+   - Collect completed forms
+   - Obtain signatures as needed
+
+4. **Financial**
+   - Verify insurance eligibility
+   - Collect copay
+   - Discuss outstanding balances
+   - Arrange payment plans if needed
+
+5. **Clinical Handoff**
+   - Note patient arrival in system
+   - Alert clinical staff
+   - Provide estimated wait time if delayed
+
+### 5.4 Check-Out Process
+
+1. **Schedule Follow-up**
+   - Review provider orders for follow-up timing
+   - Offer appointment options
+   - Provide written confirmation
+
+2. **Orders and Referrals**
+   - Provide lab/imaging orders
+   - Explain referral process
+   - Schedule procedures as indicated
+
+3. **Financial Close**
+   - Collect any additional payments
+   - Provide receipts
+   - Explain billing process
+
+4. **Patient Materials**
+   - After visit summary
+   - Educational materials
+   - Prescription information
+
+### 5.5 No-Show Management
+
+1. **Same-Day Follow-up**
+   - Attempt to contact patient
+   - Document contact attempts
+   - Offer rescheduling
+
+2. **Documentation**
+   - Mark appointment as no-show
+   - Document reason if known
+   - Note rescheduling attempts
+
+3. **Pattern Identification**
+   - Track chronic no-shows
+   - Implement interventions:
+     - Phone reminders
+     - Require confirmation
+     - Consider scheduling policies
+
+4. **Clinical Considerations**
+   - Flag urgent clinical needs
+   - Notify provider if clinically significant
+   - Send follow-up communication per policy
+
+### 5.6 Cancellations and Rescheduling
+
+#### Patient-Initiated
+1. Document reason for cancellation
+2. Offer alternative dates
+3. Update appointment status
+4. Fill vacated slot if possible
+
+#### Provider-Initiated
+1. Notify affected patients promptly
+2. Offer alternative dates/providers
+3. Document reason
+4. Prioritize by clinical urgency
+
+### 5.7 Wait List Management
+
+1. **Add to Wait List**
+   - Earlier date desired
+   - Specific provider requested
+   - Urgent clinical need
+
+2. **Work Wait List**
+   - Check daily for openings
+   - Contact patients in priority order
+   - Update list status
+
+## 6. Special Situations
+
+### 6.1 Same-Day Appointments
+- Reserve slots for urgent needs
+- Assess acuity to determine appropriateness
+- Document medical necessity
+
+### 6.2 Telehealth Appointments
+- Verify technology capability
+- Provide access instructions
+- Confirm consent for telehealth
+- Test connection before appointment
+
+### 6.3 Interpreter Services
+- Identify language needs at scheduling
+- Arrange interpreter services in advance
+- Allow additional appointment time
+- Document interpreter used
+
+## 7. Documentation
+
+- FRM-OPT-001 New Patient Registration
+- FRM-OPT-002 Insurance Verification
+- Appointment confirmation letter/text
+- Check-in/check-out log
+
+## 8. Quality Metrics
+
+| Metric | Target |
+|--------|--------|
+| Schedule utilization | >85% |
+| No-show rate | <10% |
+| Same-day cancellation rate | <5% |
+| Wait time to appointment (new patients) | Per specialty benchmark |
+| Patient satisfaction with scheduling | >90% |
+
+## 9. References
+
+- Practice management policies
+- Insurance contract requirements
+- State and federal regulations
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |

SOPs/Safety/.gitkeep

@@ -0,0 +1 @@
+# Placeholder

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] |

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] |