Sync template from atomicqms-style deployment

SOPs/SOP-001-Document-Control.md

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+# Standard Operating Procedure: Document Control
+
+| Document ID | SOP-001 |
+|-------------|---------|
+| Title | Document Control |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | Quality Assurance |
+
+---
+
+## 1. Purpose
+
+To establish a procedure for the creation, review, approval, distribution, and control of documents within the Developmental Pediatrics Quality Management System.
+
+## 2. Scope
+
+This procedure applies to all controlled documents including:
+- Policies
+- Standard Operating Procedures (SOPs)
+- Work Instructions
+- Assessment protocols
+- Forms and Templates
+- Clinical protocols
+- External documents of external origin
+
+## 3. Responsibilities
+
+### 3.1 Document Owner
+- Responsible for document content and accuracy
+- Initiates document creation and revision
+- Ensures periodic review is performed
+- Maintains clinical accuracy of assessment protocols
+
+### 3.2 Quality Assurance
+- Maintains the document control system
+- Assigns document numbers
+- Manages document distribution
+- Archives obsolete documents
+- Ensures version control
+
+### 3.3 Approvers
+- Review and approve documents before release
+- Ensure documents are adequate for intended purpose
+- Verify clinical protocols align with professional standards
+
+### 3.4 Clinical Director
+- Reviews and approves clinical assessment protocols
+- Ensures alignment with evidence-based practice
+- Verifies standardized assessment procedures
+
+## 4. Procedure
+
+### 4.1 Document Creation
+
+1. Identify the need for a new document
+2. Request document number from Quality Assurance
+3. Draft document using appropriate template
+4. Include all required header information
+5. Reference applicable professional standards (AAP, DSM-5-TR, IDEA, etc.)
+6. Submit for review and approval
+
+### 4.2 Document Review and Approval
+
+1. Route document to appropriate reviewers
+2. Reviewers provide comments within 5 business days
+3. Author addresses all comments
+4. Clinical protocols reviewed by Clinical Director
+5. Final approval by designated approver
+6. Quality Assurance releases document
+
+### 4.3 Document Numbering
+
+Documents shall be numbered according to the following convention:
+
+| Type | Prefix | Example |
+|------|--------|---------|
+| Policy | POL | POL-001 |
+| Diagnostic Evaluation SOP | SOP-DE | SOP-DE-001 |
+| Screening SOP | SOP-SCR | SOP-SCR-001 |
+| School Liaison SOP | SOP-SCH | SOP-SCH-001 |
+| Clinical SOP | SOP-CLI | SOP-CLI-001 |
+| Administrative SOP | SOP-ADM | SOP-ADM-001 |
+| Safety SOP | SOP-SAF | SOP-SAF-001 |
+| Work Instruction | WI | WI-001 |
+| Form | FRM | FRM-001 |
+
+### 4.4 Revision Control
+
+1. All changes require documented justification
+2. Changes follow same review/approval process as new documents
+3. Revision number increments with each approved change
+4. Revision history maintained in document footer
+5. Clinical protocol changes reviewed for impact on assessment standardization
+
+### 4.5 Document Distribution
+
+1. Current versions available in document control system
+2. Obsolete versions marked and archived
+3. Training on new/revised documents as needed
+4. Clinical staff notified of assessment protocol updates
+
+### 4.6 Periodic Review
+
+1. Documents reviewed at least every 2 years
+2. Clinical protocols reviewed annually to ensure alignment with current professional standards
+3. Review documented even if no changes made
+4. Reviews may result in revision or reaffirmation
+
+### 4.7 External Documents
+
+1. External standards (DSM-5-TR, ADOS-2 manual, AAP guidelines) maintained as reference
+2. Latest versions obtained and archived
+3. Changes to external standards trigger review of related internal documents
+
+## 5. Related Documents
+
+- FRM-001 Document Change Request Form
+- FRM-002 Document Review Record
+
+## 6. Definitions
+
+| Term | Definition |
+|------|------------|
+| Controlled Document | Document managed under document control system |
+| Obsolete | Document no longer valid for use |
+| Revision | Updated version of a document |
+| Clinical Protocol | Procedure for standardized assessment administration or clinical decision-making |
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |

SOPs/SOP-002-CAPA.md

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+# Standard Operating Procedure: Corrective and Preventive Action (CAPA)
+
+| Document ID | SOP-002 |
+|-------------|---------|
+| Title | Corrective and Preventive Action (CAPA) |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | Quality Assurance |
+
+---
+
+## 1. Purpose
+
+To establish a systematic approach for identifying, investigating, and addressing nonconformities, clinical errors, and opportunities for improvement in developmental pediatric services.
+
+## 2. Scope
+
+This procedure applies to all aspects of developmental pediatric services including:
+- Diagnostic assessment procedures
+- Screening programs
+- School liaison activities
+- Clinical operations
+- Documentation and reporting
+- Family communication
+- Multidisciplinary coordination
+- Safety incidents
+
+## 3. Responsibilities
+
+### 3.1 All Staff
+- Report nonconformities, incidents, and improvement opportunities
+- Participate in CAPA investigations
+- Implement assigned corrective actions
+
+### 3.2 Quality Assurance Manager
+- Coordinates CAPA process
+- Assigns CAPA owners
+- Tracks CAPA completion
+- Reports CAPA metrics to management
+
+### 3.3 CAPA Owner
+- Investigates root cause
+- Develops action plan
+- Implements corrective/preventive actions
+- Verifies effectiveness
+
+### 3.4 Clinical Director
+- Reviews clinical CAPAs
+- Approves clinical protocol changes
+- Ensures assessment standardization maintained
+
+## 4. Definitions
+
+| Term | Definition |
+|------|------------|
+| Nonconformity | Failure to meet specified requirements or standards |
+| Corrective Action | Action to eliminate the cause of a detected nonconformity |
+| Preventive Action | Action to eliminate the cause of a potential nonconformity |
+| Root Cause | Fundamental reason for occurrence of a problem |
+
+## 5. Procedure
+
+### 5.1 CAPA Initiation
+
+CAPAs may be initiated from:
+- Internal audits
+- Management reviews
+- Clinical incident reports
+- Family complaints
+- Assessment protocol deviations
+- Documentation errors
+- Diagnostic discrepancies
+- School liaison communication issues
+- Training gaps
+- Equipment/tool malfunctions
+
+### 5.2 CAPA Documentation
+
+1. Complete FRM-003 CAPA Form
+2. Describe the issue in detail
+3. Include relevant data (dates, affected cases, assessment tools involved)
+4. Assign severity level:
+   - **Critical**: Affects patient safety or diagnostic accuracy
+   - **Major**: Significant impact on service quality
+   - **Minor**: Limited impact, easily corrected
+
+### 5.3 Root Cause Analysis
+
+1. CAPA Owner assigned by QA Manager
+2. Gather facts and data
+3. Use appropriate analysis tools:
+   - 5 Whys
+   - Fishbone diagram
+   - Timeline analysis
+4. Consider contributing factors:
+   - Training adequacy
+   - Protocol clarity
+   - Assessment tool fidelity
+   - Communication breakdown
+   - Workload/scheduling
+   - Documentation systems
+5. Document root cause findings
+
+### 5.4 Action Plan Development
+
+1. Identify corrective actions to address root cause
+2. Identify preventive actions to prevent recurrence
+3. Assign responsibilities and target completion dates
+4. Consider impact on:
+   - Assessment standardization
+   - Clinical protocols
+   - Staff training
+   - Documentation systems
+   - Related processes
+
+### 5.5 Implementation
+
+1. Execute action plan
+2. Document implementation activities
+3. Update affected procedures/protocols
+4. Provide staff training if needed
+5. Communicate changes to relevant personnel
+
+### 5.6 Effectiveness Check
+
+1. Verify actions implemented as planned
+2. Monitor for recurrence (minimum 30 days)
+3. Review relevant metrics:
+   - Assessment completion rates
+   - Documentation accuracy
+   - Family satisfaction
+   - Protocol adherence
+4. Document effectiveness check results
+
+### 5.7 CAPA Closure
+
+1. QA Manager reviews for completeness
+2. Verify all actions completed
+3. Confirm effectiveness demonstrated
+4. Close CAPA in tracking system
+5. Archive CAPA records
+
+### 5.8 Trending and Analysis
+
+1. QA reviews CAPA data quarterly
+2. Identify trends and patterns
+3. Report findings to management
+4. Initiate preventive actions for recurring issues
+
+## 6. Special Considerations for Clinical CAPAs
+
+### 6.1 Assessment Protocol Deviations
+- Document impact on diagnostic validity
+- Review with Clinical Director
+- Consider need for case re-evaluation
+- Update assessment training
+
+### 6.2 Diagnostic Discrepancies
+- Review assessment data and scoring
+- Verify DSM-5-TR criteria application
+- Consider multidisciplinary team review
+- Document clinical reasoning
+
+### 6.3 School Liaison Issues
+- Review IEP/504 documentation accuracy
+- Verify IDEA compliance
+- Improve school communication protocols
+
+## 7. Related Documents
+
+- FRM-003 CAPA Form
+- SOP-001 Document Control
+- SOP-004 Internal Audit
+- Clinical Incident Report Form
+
+## 8. References
+
+- ISO 9001:2015 Clause 10.2 (Nonconformity and Corrective Action)
+- Clinical quality improvement methodologies
+- Patient safety best practices
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |

SOPs/SOP-003-Training.md

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+# Standard Operating Procedure: Training and Competency
+
+| Document ID | SOP-003 |
+|-------------|---------|
+| Title | Training and Competency |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | Quality Assurance |
+
+---
+
+## 1. Purpose
+
+To establish requirements for training and competency assessment of personnel involved in developmental pediatric services, ensuring standardized assessment administration and evidence-based clinical practices.
+
+## 2. Scope
+
+This procedure applies to all personnel involved in:
+- Clinical assessments and evaluations
+- Developmental screening
+- Administrative support
+- School liaison activities
+- Quality assurance functions
+
+## 3. Responsibilities
+
+### 3.1 Clinical Director
+- Identifies training needs
+- Develops clinical training curriculum
+- Assesses clinical competency
+- Maintains assessment tool certifications
+- Approves specialized assessment administrators
+
+### 3.2 Quality Assurance Manager
+- Maintains training records
+- Tracks training completion
+- Schedules required training
+- Documents competency assessments
+
+### 3.3 Supervisors
+- Ensure staff complete required training
+- Assess ongoing competency
+- Identify performance gaps
+- Support professional development
+
+### 3.4 Employees
+- Complete assigned training
+- Maintain required certifications
+- Participate in competency assessments
+- Seek additional training as needed
+
+## 4. Training Requirements
+
+### 4.1 New Employee Onboarding
+
+All new employees shall complete:
+
+1. **General Training** (within first week):
+   - Organization overview and mission
+   - Quality policy and QMS overview
+   - HIPAA and patient privacy
+   - Safety and emergency procedures
+   - Document control procedures
+   - Electronic health record system
+
+2. **Role-Specific Training** (within first 30 days):
+   - Position-specific SOPs and protocols
+   - Clinical workflows and procedures
+   - Assessment tools and protocols (if applicable)
+   - Multidisciplinary team coordination
+   - Family communication best practices
+
+### 4.2 Clinical Assessment Training
+
+Clinical staff shall complete specialized training in:
+
+#### 4.2.1 Autism Diagnostic Tools
+- **ADOS-2** (Autism Diagnostic Observation Schedule, 2nd Edition)
+  - Research-reliable training or equivalent
+  - Annual inter-rater reliability checks
+  - Module-specific training for each age/language level
+
+- **ADI-R** (Autism Diagnostic Interview-Revised)
+  - Standardized training in administration
+  - Scoring and interpretation protocols
+  - Annual reliability verification
+
+#### 4.2.2 Cognitive and Developmental Assessments
+- **Bayley-4** (Bayley Scales of Infant and Toddler Development)
+- **WISC-V** (Wechsler Intelligence Scale for Children)
+- **Stanford-Binet 5**
+- **Vineland Adaptive Behavior Scales-3**
+- **Leiter International Performance Scale-3**
+
+#### 4.2.3 ADHD and Behavior Rating Scales
+- Conners Rating Scales-4
+- Vanderbilt Assessment Scales
+- BASC-3 (Behavior Assessment System for Children)
+- CBCL (Child Behavior Checklist)
+
+#### 4.2.4 Learning Disability Assessments
+- WIAT-4 (Wechsler Individual Achievement Test)
+- WJ-IV (Woodcock-Johnson IV)
+- KTEA-3 (Kaufman Test of Educational Achievement)
+
+#### 4.2.5 Screening Tools
+- ASQ-3 (Ages & Stages Questionnaires)
+- M-CHAT-R/F (Modified Checklist for Autism in Toddlers)
+- PEDS (Parents' Evaluation of Developmental Status)
+
+### 4.3 Regulatory and Compliance Training
+
+All staff shall complete annual training in:
+- HIPAA and patient privacy
+- IDEA and special education law (for school liaison staff)
+- Section 504 and ADA requirements
+- Mandated reporter requirements
+- Cultural competency
+- Trauma-informed care
+
+### 4.4 Continuing Education
+
+Clinical staff shall maintain:
+- Professional licensure requirements
+- Continuing education credits per licensing board
+- Updated knowledge of DSM-5-TR criteria
+- Current AAP developmental surveillance guidelines
+- Evidence-based practice updates
+
+## 5. Competency Assessment
+
+### 5.1 Initial Competency
+
+Before independent practice, employees shall demonstrate competency through:
+
+1. **Observation**: Direct observation by supervisor/trainer
+2. **Testing**: Written or practical examination
+3. **Case Review**: Review of practice cases with feedback
+4. **Simulation**: Practice scenarios or role-play
+
+### 5.2 Assessment Tool Competency
+
+Clinical staff administering standardized assessments shall demonstrate:
+
+1. **Administration Fidelity**:
+   - Correct setup and materials
+   - Standardized instructions
+   - Accurate timing and prompting
+   - Appropriate rapport building
+
+2. **Scoring Accuracy**:
+   - Accurate real-time scoring
+   - Correct interpretation of responses
+   - Proper use of scoring criteria
+
+3. **Protocol Adherence**:
+   - Following published administration guidelines
+   - Proper documentation
+   - Recognizing when to discontinue or adapt
+
+### 5.3 Ongoing Competency
+
+Annual competency verification through:
+- Case audits and documentation review
+- Inter-rater reliability checks (for diagnostic tools)
+- Supervisor observations
+- Peer review
+- Outcome metrics (e.g., report timeliness, family satisfaction)
+
+### 5.4 Competency Documentation
+
+Document competency assessments using:
+- FRM-004 Training Record Form
+- Assessment tool fidelity checklists
+- Inter-rater reliability data
+- Competency assessment forms
+
+## 6. Training Records
+
+### 6.1 Record Contents
+
+Training records shall include:
+- Employee name and position
+- Training topic/course title
+- Date of training
+- Duration/credits
+- Trainer/instructor name
+- Competency assessment results
+- Certifications and expiration dates
+
+### 6.2 Record Retention
+
+- Active employee records: Maintained in personnel file
+- Former employee records: Retained for 7 years after separation
+- Assessment tool certifications: Maintained with current credentials
+
+## 7. Training Effectiveness
+
+Training effectiveness evaluated through:
+- Post-training assessments
+- Performance metrics
+- Error/incident rates
+- Family satisfaction feedback
+- Audit findings
+- Competency assessment results
+
+## 8. Retraining
+
+Retraining required when:
+- Competency assessment fails
+- Significant protocol deviations identified
+- New assessment tools implemented
+- Regulatory changes require updated knowledge
+- Annual refresher training due
+- Extended absence from clinical duties (>6 months)
+
+## 9. Related Documents
+
+- FRM-004 Training Record Form
+- Assessment tool administration manuals
+- Competency assessment checklists
+- Personnel files
+
+## 10. References
+
+- ADOS-2 Clinical Training Guidelines
+- Professional licensing board requirements
+- AAP developmental surveillance recommendations
+- IDEA regulations (34 CFR Part 300)
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |

SOPs/SOP-004-Internal-Audit.md

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+# Standard Operating Procedure: Internal Audit
+
+| Document ID | SOP-004 |
+|-------------|---------|
+| Title | Internal Audit |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | Quality Assurance |
+
+---
+
+## 1. Purpose
+
+To establish a systematic process for conducting internal audits of the Developmental Pediatrics Quality Management System to verify compliance with established procedures and identify opportunities for improvement.
+
+## 2. Scope
+
+This procedure applies to all processes, departments, and activities within the QMS including:
+- Clinical assessment procedures
+- Diagnostic evaluations
+- Screening programs
+- School liaison activities
+- Documentation and record keeping
+- Training and competency
+- Safety and incident management
+- Administrative processes
+
+## 3. Responsibilities
+
+### 3.1 Quality Assurance Manager
+- Develops annual audit schedule
+- Selects and trains auditors
+- Reviews audit findings
+- Tracks corrective actions
+- Reports audit results to management
+
+### 3.2 Internal Auditors
+- Conduct audits according to schedule
+- Document findings objectively
+- Maintain independence and objectivity
+- Follow audit procedures
+- Complete audit reports
+
+### 3.3 Auditee (Area Being Audited)
+- Provide access to records and personnel
+- Respond to audit findings
+- Implement corrective actions
+- Verify effectiveness of corrections
+
+### 3.4 Management
+- Review audit results
+- Allocate resources for corrective actions
+- Support audit process
+
+## 4. Definitions
+
+| Term | Definition |
+|------|------------|
+| Audit | Systematic, independent examination of activities and results |
+| Auditor | Person qualified to conduct audits |
+| Auditee | Person or department being audited |
+| Nonconformity | Failure to meet a specified requirement |
+| Observation | Potential issue or opportunity for improvement |
+| Objective Evidence | Data supporting existence or truth of something |
+
+## 5. Procedure
+
+### 5.1 Audit Planning
+
+1. **Annual Audit Schedule**:
+   - QA Manager develops schedule covering all QMS areas
+   - High-risk areas audited more frequently
+   - Clinical assessment procedures audited semi-annually
+   - Schedule reviewed and approved by management
+
+2. **Audit Frequency**:
+   - Core QMS processes: Annually minimum
+   - Clinical assessment protocols: Semi-annually
+   - High-risk areas: Quarterly
+   - New procedures: Within 3 months of implementation
+
+3. **Auditor Selection**:
+   - Auditors independent of area being audited
+   - Clinical audits conducted by qualified clinical personnel
+   - External auditors may be used for objectivity
+
+### 5.2 Audit Preparation
+
+1. **Define Audit Scope**:
+   - Identify processes/areas to audit
+   - Specify audit criteria (SOPs, regulations, standards)
+   - Determine audit timeframe
+
+2. **Review Documentation**:
+   - Current SOPs and protocols
+   - Previous audit reports
+   - Recent CAPA records
+   - Relevant regulations (HIPAA, IDEA, AAP guidelines)
+
+3. **Develop Audit Checklist**:
+   - Use FRM-006 Audit Checklist template
+   - Include key requirements to verify
+   - Prepare interview questions
+   - Plan document sampling strategy
+
+4. **Notify Auditee**:
+   - Provide 2-week advance notice
+   - Communicate audit scope and schedule
+   - Request access to records and personnel
+
+### 5.3 Audit Execution
+
+1. **Opening Meeting**:
+   - Confirm audit scope and schedule
+   - Explain audit process
+   - Answer questions
+
+2. **Evidence Gathering**:
+   - **Document Review**: Sample clinical records, assessment reports, training records
+   - **Interviews**: Discuss procedures with staff
+   - **Observations**: Observe assessment administration, clinical processes
+   - **Data Analysis**: Review metrics, completion rates, accuracy data
+
+3. **Clinical Audit Focus Areas**:
+   - Assessment tool administration fidelity
+   - Diagnostic criteria application (DSM-5-TR)
+   - Report completeness and accuracy
+   - Standardization of protocols
+   - Family communication documentation
+   - School liaison documentation (IEP/504)
+   - Screening program adherence
+   - Multidisciplinary coordination
+
+4. **Document Findings**:
+   - Record objective evidence
+   - Note conformities and nonconformities
+   - Identify opportunities for improvement
+   - Document findings on audit checklist
+
+5. **Closing Meeting**:
+   - Present findings to auditee
+   - Discuss nonconformities
+   - Answer questions
+   - Explain follow-up process
+
+### 5.4 Audit Reporting
+
+1. **Audit Report Contents**:
+   - Audit scope and criteria
+   - Audit date and participants
+   - Summary of findings
+   - Nonconformities identified
+   - Observations and recommendations
+   - Positive findings (conformities)
+
+2. **Classification of Findings**:
+   - **Major Nonconformity**: Significant failure affecting patient safety, diagnostic accuracy, or regulatory compliance
+   - **Minor Nonconformity**: Isolated failure with limited impact
+   - **Observation**: Potential issue or improvement opportunity
+
+3. **Report Distribution**:
+   - Auditee
+   - Department manager
+   - Clinical Director (for clinical audits)
+   - Quality Assurance Manager
+   - Senior management
+
+### 5.5 Corrective Action
+
+1. Auditee develops corrective action plan for nonconformities
+2. Actions documented using FRM-003 CAPA Form
+3. Target completion dates established
+4. QA Manager tracks action completion
+5. Follow-up audit conducted to verify effectiveness
+
+### 5.6 Audit Records
+
+Maintain audit records including:
+- Audit schedule
+- Audit checklists
+- Audit reports
+- Evidence reviewed
+- Corrective action documentation
+- Follow-up verification
+
+Records retained for minimum 7 years.
+
+## 6. Special Audit Types
+
+### 6.1 Clinical Assessment Audits
+
+Focus on:
+- ADOS-2/ADI-R administration fidelity
+- Cognitive assessment standardization
+- Scoring accuracy
+- Diagnostic criteria application
+- Report quality and timeliness
+- Informed consent documentation
+
+### 6.2 School Liaison Audits
+
+Focus on:
+- IEP documentation completeness
+- 504 plan adherence
+- IDEA compliance
+- School communication timeliness
+- Educational records management
+
+### 6.3 Screening Program Audits
+
+Focus on:
+- Screening tool administration
+- Follow-up protocols
+- Referral pathways
+- Parent communication
+- Data tracking and outcomes
+
+## 7. Auditor Qualifications
+
+Internal auditors shall:
+- Complete internal auditor training
+- Understand QMS requirements
+- Maintain objectivity
+- Clinical auditors: Hold appropriate clinical credentials
+- Demonstrate knowledge of audit techniques
+
+## 8. Related Documents
+
+- FRM-006 Audit Checklist
+- FRM-003 CAPA Form
+- SOP-002 Corrective and Preventive Action
+- Annual Audit Schedule
+
+## 9. References
+
+- ISO 19011:2018 Guidelines for Auditing Management Systems
+- Clinical quality audit methodologies
+- HIPAA audit protocols
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |

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 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
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |