nicu-picu/SOPs/SOP-005-Management-Review.md

# 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 |

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## 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)

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## Revision History

| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |