developmental-pediatrics/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 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]