250 lines
6.4 KiB
Markdown
250 lines
6.4 KiB
Markdown
# Standard Operating Procedure: Management Review
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| Document ID | SOP-005 |
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| Title | Management Review |
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| Revision | 1.0 |
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| Effective Date | [DATE] |
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| Author | [AUTHOR] |
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| Approved By | [APPROVER] |
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| Department | Quality Assurance |
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---
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## 1. Purpose
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To establish a process for top management to review the Developmental Pediatrics Quality Management System to ensure its continuing suitability, adequacy, effectiveness, and alignment with organizational strategy.
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## 2. Scope
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This procedure applies to the periodic management review of all aspects of the QMS including clinical operations, assessment protocols, quality objectives, and regulatory compliance.
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## 3. Responsibilities
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### 3.1 Clinical Director / Top Management
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- Chairs management review meetings
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- Reviews QMS performance
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- Makes decisions on QMS improvements
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- Allocates resources for quality initiatives
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- Approves quality objectives
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### 3.2 Quality Assurance Manager
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- Schedules management reviews
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- Prepares review materials and data
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- Documents meeting minutes and decisions
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- Tracks action items
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- Distributes meeting records
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### 3.3 Department Managers
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- Provide input on QMS performance
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- Present departmental quality metrics
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- Participate in review discussions
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- Implement management decisions
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## 4. Procedure
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### 4.1 Meeting Frequency
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Management reviews shall be conducted:
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- Minimum twice per year (semi-annual)
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- More frequently if needed based on:
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- Significant changes to services
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- Regulatory changes
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- Major nonconformities
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- Strategic planning needs
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### 4.2 Review Inputs
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Management review shall consider:
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#### 4.2.1 Status of Previous Actions
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- Action items from previous reviews
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- Implementation status
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- Effectiveness of completed actions
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#### 4.2.2 Changes Affecting QMS
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- **Internal changes**:
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- New assessment tools or protocols
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- Staff changes
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- Technology/EHR updates
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- Service expansion
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- **External changes**:
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- DSM-5-TR updates
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- AAP guideline revisions
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- Regulatory changes (IDEA, HIPAA)
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- Professional standard updates
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#### 4.2.3 Quality Objectives Performance
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- Achievement of established quality objectives
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- Metrics analysis:
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- Wait times for evaluations
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- Assessment completion rates
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- Report turnaround time
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- Family satisfaction scores
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- Referral conversion rates
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- No-show/cancellation rates
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#### 4.2.4 Clinical Performance Indicators
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- Diagnostic accuracy and consistency
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- Assessment protocol adherence
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- Inter-rater reliability results
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- Multidisciplinary coordination effectiveness
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- School liaison outcomes
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- Early intervention referral outcomes
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#### 4.2.5 Audit Results
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- Internal audit findings
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- External audit results (if applicable)
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- Regulatory inspections
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- Accreditation surveys
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- Trends in nonconformities
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#### 4.2.6 Customer Feedback
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- Family satisfaction surveys
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- Complaint analysis
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- Compliment tracking
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- Referring provider feedback
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- School partner feedback
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#### 4.2.7 Process Performance
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- Screening program effectiveness
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- Scheduling efficiency
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- Documentation accuracy
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- Billing/coding accuracy
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- Records management
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#### 4.2.8 CAPA Effectiveness
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- Open CAPA status
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- Closed CAPA summary
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- Trending analysis
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- Recurrence rates
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- Effectiveness verification results
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#### 4.2.9 Training and Competency
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- Training completion rates
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- Competency assessment results
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- Certification status
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- Continuing education compliance
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- Staff development needs
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#### 4.2.10 Risk and Opportunities
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- Risk assessment updates
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- New risks identified
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- Opportunities for improvement
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- Innovation opportunities
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#### 4.2.11 Resource Adequacy
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- Staffing levels
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- Assessment tools and equipment
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- Facility adequacy
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- Technology systems
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- Budget and financial resources
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### 4.3 Review Outputs
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Management review shall result in decisions and actions regarding:
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#### 4.3.1 Opportunities for Improvement
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- Process enhancements
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- Clinical protocol updates
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- Technology improvements
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- Workflow optimization
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#### 4.3.2 Need for Changes to QMS
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- Policy updates
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- Procedure revisions
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- New SOPs needed
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- Assessment protocol changes
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#### 4.3.3 Resource Needs
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- Staffing requirements
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- Training needs
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- Equipment/tool acquisition
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- Facility modifications
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- Budget allocations
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#### 4.3.4 Quality Objectives
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- Update existing objectives
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- Establish new objectives
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- Retire achieved objectives
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- Adjust targets based on performance
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### 4.4 Meeting Conduct
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1. **Pre-Meeting**:
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- QA Manager prepares meeting package 1 week in advance
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- Package includes data, metrics, and analysis
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- Distribute to all attendees
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2. **During Meeting**:
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- Review all required inputs
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- Discuss findings and trends
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- Identify improvement opportunities
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- Make decisions on actions needed
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- Assign responsibilities and due dates
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3. **Post-Meeting**:
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- Document minutes including decisions and action items
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- Distribute minutes within 5 business days
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- Track action items
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- Communicate relevant decisions to staff
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### 4.5 Documentation
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Document management reviews including:
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- Meeting agenda
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- Data and metrics reviewed
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- Discussion summary
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- Decisions made
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- Action items with responsibilities and due dates
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- Attendees and date
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Records retained for minimum 7 years.
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### 4.6 Follow-Up
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1. QA Manager tracks action items
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2. Status updates provided to management
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3. Completed actions reported at next review
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4. Overdue actions escalated
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## 5. Quality Objectives Examples
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Examples of developmental pediatrics quality objectives:
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- Reduce wait time for diagnostic evaluations to <8 weeks
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- Achieve >95% family satisfaction rating
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- Complete assessment reports within 2 weeks of evaluation
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- Maintain ADOS-2 inter-rater reliability >80% agreement
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- Achieve >90% attendance rate for scheduled evaluations
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- Complete IEP documentation within 5 business days
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- Provide developmental screening at 100% of well-child visits (for integrated clinics)
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## 6. Communication of Results
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Management review outcomes communicated to:
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- All staff (relevant decisions and changes)
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- Clinical teams (protocol updates)
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- Administrative staff (process changes)
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- Quality committee (if established)
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## 7. Related Documents
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- Management Review Meeting Template
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- Quality Objectives Dashboard
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- QMS Performance Metrics
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- Audit Reports
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- CAPA Summary Reports
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## 8. References
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- ISO 9001:2015 Clause 9.3 (Management Review)
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- Clinical quality management best practices
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---
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## Revision History
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| Rev | Date | Description | Author |
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|-----|------|-------------|--------|
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| 1.0 | [DATE] | Initial release | [AUTHOR] |
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