# 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 Developmental Pediatrics Quality Management System to ensure its continuing suitability, adequacy, effectiveness, and alignment with organizational strategy.

## 2. Scope

This procedure applies to the periodic management review of all aspects of the QMS including clinical operations, assessment protocols, quality objectives, and regulatory compliance.

## 3. Responsibilities

### 3.1 Clinical Director / Top Management
- Chairs management review meetings
- Reviews QMS performance
- Makes decisions on QMS improvements
- Allocates resources for quality initiatives
- Approves quality objectives

### 3.2 Quality Assurance Manager
- Schedules management reviews
- Prepares review materials and data
- Documents meeting minutes and decisions
- Tracks action items
- Distributes meeting records

### 3.3 Department Managers
- Provide input on QMS performance
- Present departmental quality metrics
- Participate in review discussions
- Implement management decisions

## 4. Procedure

### 4.1 Meeting Frequency

Management reviews shall be conducted:
- Minimum twice per year (semi-annual)
- More frequently if needed based on:
  - Significant changes to services
  - Regulatory changes
  - Major nonconformities
  - Strategic planning needs

### 4.2 Review Inputs

Management review shall consider:

#### 4.2.1 Status of Previous Actions
- Action items from previous reviews
- Implementation status
- Effectiveness of completed actions

#### 4.2.2 Changes Affecting QMS
- **Internal changes**:
  - New assessment tools or protocols
  - Staff changes
  - Technology/EHR updates
  - Service expansion
- **External changes**:
  - DSM-5-TR updates
  - AAP guideline revisions
  - Regulatory changes (IDEA, HIPAA)
  - Professional standard updates

#### 4.2.3 Quality Objectives Performance
- Achievement of established quality objectives
- Metrics analysis:
  - Wait times for evaluations
  - Assessment completion rates
  - Report turnaround time
  - Family satisfaction scores
  - Referral conversion rates
  - No-show/cancellation rates

#### 4.2.4 Clinical Performance Indicators
- Diagnostic accuracy and consistency
- Assessment protocol adherence
- Inter-rater reliability results
- Multidisciplinary coordination effectiveness
- School liaison outcomes
- Early intervention referral outcomes

#### 4.2.5 Audit Results
- Internal audit findings
- External audit results (if applicable)
- Regulatory inspections
- Accreditation surveys
- Trends in nonconformities

#### 4.2.6 Customer Feedback
- Family satisfaction surveys
- Complaint analysis
- Compliment tracking
- Referring provider feedback
- School partner feedback

#### 4.2.7 Process Performance
- Screening program effectiveness
- Scheduling efficiency
- Documentation accuracy
- Billing/coding accuracy
- Records management

#### 4.2.8 CAPA Effectiveness
- Open CAPA status
- Closed CAPA summary
- Trending analysis
- Recurrence rates
- Effectiveness verification results

#### 4.2.9 Training and Competency
- Training completion rates
- Competency assessment results
- Certification status
- Continuing education compliance
- Staff development needs

#### 4.2.10 Risk and Opportunities
- Risk assessment updates
- New risks identified
- Opportunities for improvement
- Innovation opportunities

#### 4.2.11 Resource Adequacy
- Staffing levels
- Assessment tools and equipment
- Facility adequacy
- Technology systems
- Budget and financial resources

### 4.3 Review Outputs

Management review shall result in decisions and actions regarding:

#### 4.3.1 Opportunities for Improvement
- Process enhancements
- Clinical protocol updates
- Technology improvements
- Workflow optimization

#### 4.3.2 Need for Changes to QMS
- Policy updates
- Procedure revisions
- New SOPs needed
- Assessment protocol changes

#### 4.3.3 Resource Needs
- Staffing requirements
- Training needs
- Equipment/tool acquisition
- Facility modifications
- Budget allocations

#### 4.3.4 Quality Objectives
- Update existing objectives
- Establish new objectives
- Retire achieved objectives
- Adjust targets based on performance

### 4.4 Meeting Conduct

1. **Pre-Meeting**:
   - QA Manager prepares meeting package 1 week in advance
   - Package includes data, metrics, and analysis
   - Distribute to all attendees

2. **During Meeting**:
   - Review all required inputs
   - Discuss findings and trends
   - Identify improvement opportunities
   - Make decisions on actions needed
   - Assign responsibilities and due dates

3. **Post-Meeting**:
   - Document minutes including decisions and action items
   - Distribute minutes within 5 business days
   - Track action items
   - Communicate relevant decisions to staff

### 4.5 Documentation

Document management reviews including:
- Meeting agenda
- Data and metrics reviewed
- Discussion summary
- Decisions made
- Action items with responsibilities and due dates
- Attendees and date

Records retained for minimum 7 years.

### 4.6 Follow-Up

1. QA Manager tracks action items
2. Status updates provided to management
3. Completed actions reported at next review
4. Overdue actions escalated

## 5. Quality Objectives Examples

Examples of developmental pediatrics quality objectives:
- Reduce wait time for diagnostic evaluations to <8 weeks
- Achieve >95% family satisfaction rating
- Complete assessment reports within 2 weeks of evaluation
- Maintain ADOS-2 inter-rater reliability >80% agreement
- Achieve >90% attendance rate for scheduled evaluations
- Complete IEP documentation within 5 business days
- Provide developmental screening at 100% of well-child visits (for integrated clinics)

## 6. Communication of Results

Management review outcomes communicated to:
- All staff (relevant decisions and changes)
- Clinical teams (protocol updates)
- Administrative staff (process changes)
- Quality committee (if established)

## 7. Related Documents

- Management Review Meeting Template
- Quality Objectives Dashboard
- QMS Performance Metrics
- Audit Reports
- CAPA Summary Reports

## 8. References

- ISO 9001:2015 Clause 9.3 (Management Review)
- Clinical quality management best practices

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## Revision History

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