Sync template from atomicqms-style deployment

SOPs/SOP-005-Management-Review.md

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+# 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 establish a process for top management to review the NICU/PICU Quality Management System to ensure its continuing suitability, adequacy, and effectiveness.
+
+## 2. Scope
+
+This procedure applies to the periodic review of all aspects of the Quality Management System by NICU/PICU leadership.
+
+## 3. Responsibilities
+
+### 3.1 Unit Medical Director / Nurse Manager
+- Chairs management review meetings
+- Reviews QMS performance
+- Makes decisions on resource allocation
+- Ensures actions are implemented
+
+### 3.2 Quality Assurance
+- Schedules management review meetings
+- Prepares meeting materials and data
+- Documents meeting minutes
+- Tracks action items to completion
+
+### 3.3 Department Heads
+- Provide input on their areas
+- Participate in meetings
+- Implement assigned actions
+
+## 4. Frequency
+
+Management review meetings shall be conducted:
+- At minimum, quarterly
+- More frequently if significant issues arise
+- In response to sentinel events
+
+## 5. Review Inputs
+
+The management review shall consider:
+
+### 5.1 Quality Metrics
+- Mortality rates (observed vs. expected)
+- Infection rates (CLABSI, VAE, CAUTI)
+- Medication errors and adverse drug events
+- Unplanned extubations
+- Pressure injuries
+- Family satisfaction scores
+- Length of stay
+- Readmission rates
+
+### 5.2 Performance Against Benchmarks
+- Vermont Oxford Network (NICU)
+- NACHRI/Children's Hospital Association benchmarks
+- State or national databases
+
+### 5.3 Internal Audit Results
+- Number and status of audit findings
+- Trends in non-conformances
+- Areas of concern
+
+### 5.4 External Audit/Survey Results
+- Joint Commission survey findings
+- State Department of Health findings
+- Regulatory agency findings
+
+### 5.5 Patient Safety Events
+- Sentinel events
+- Serious safety events
+- Near-miss reports
+- Root cause analysis results
+
+### 5.6 CAPA Status
+- Open CAPAs
+- Overdue CAPAs
+- Effectiveness of corrective actions
+- Repeat issues
+
+### 5.7 Training and Competency
+- NRP/PALS compliance rates
+- Orientation completion
+- Competency validation results
+- Staffing competency mix
+
+### 5.8 Resource Adequacy
+- Staffing levels and ratios
+- Equipment functionality
+- Budget performance
+- Technology needs
+
+### 5.9 Changes Affecting QMS
+- New regulations or standards
+- New equipment or technology
+- Process changes
+- Organizational changes
+
+### 5.10 Opportunities for Improvement
+- Staff suggestions
+- Quality improvement initiatives
+- Best practice adoption
+
+## 6. Review Outputs
+
+The management review shall produce:
+
+1. **Decisions on**:
+   - QMS improvements needed
+   - Resource allocation
+   - Quality objectives and targets
+   - Policy changes
+
+2. **Action Items** with:
+   - Specific actions to be taken
+   - Responsible parties
+   - Target completion dates
+
+3. **Communication Plan**:
+   - Key messages for staff
+   - Changes to be implemented
+
+## 7. Procedure
+
+### 7.1 Meeting Preparation
+
+1. Quality Assurance prepares:
+   - Data summaries and trending reports
+   - Status updates on previous action items
+   - Meeting agenda
+2. Distribute materials 1 week before meeting
+
+### 7.2 Meeting Conduct
+
+1. Review previous action items
+2. Present and discuss each input category
+3. Identify trends and systemic issues
+4. Discuss resource needs
+5. Make decisions and assign actions
+6. Set priorities
+
+### 7.3 Documentation
+
+1. Document meeting minutes including:
+   - Attendees
+   - Data reviewed
+   - Decisions made
+   - Action items with owners and dates
+2. Distribute minutes within 1 week
+3. Post on quality board
+
+### 7.4 Follow-up
+
+1. Quality Assurance tracks action items
+2. Report status at next meeting
+3. Escalate overdue items
+4. Communicate outcomes to staff
+
+## 8. Meeting Attendees
+
+Required:
+- Unit Medical Director
+- Nurse Manager
+- Quality Coordinator
+- Infection Control Representative
+
+As needed:
+- Pharmacy Representative
+- Respiratory Therapy Manager
+- Risk Management
+- Social Work/Child Life Leadership
+
+## 9. Related Documents
+
+- Quality Metrics Dashboard
+- Audit Reports
+- CAPA Log
+- FRM-008 Management Review Meeting Minutes Template
+
+## 10. References
+
+- Joint Commission Leadership Standards
+- ISO 9001:2015 Clause 9.3 (if applicable)
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |