Sync template from atomicqms-style deployment

2025-12-27 11:24:10 -05:00
parent 3b379006d5
commit e3b6fb3da5
27 changed files with 2976 additions and 2 deletions
--- a/.gitea/workflows/atomicai.yml
+++ b/.gitea/workflows/atomicai.yml
@@ -0,0 +1,104 @@
+name: AtomicAI Developmental Pediatrics Assistant
+
+on:
+  issue_comment:
+    types: [created]
+  issues:
+    types: [opened, assigned]
+  pull_request:
+    types: [opened, synchronize, assigned]
+  pull_request_review_comment:
+    types: [created]
+
+jobs:
+  claude-assistant:
+    runs-on: ubuntu-latest
+    if: |
+      github.actor != 'atomicqms-service' &&
+      (
+      (github.event_name == 'issue_comment' && contains(github.event.comment.body, '@atomicai')) ||
+      (github.event_name == 'issues' && github.event.action == 'opened' && contains(github.event.issue.body, '@atomicai')) ||
+      (github.event_name == 'pull_request' && github.event.action == 'opened' && contains(github.event.pull_request.body, '@atomicai')) ||
+      (github.event_name == 'pull_request_review_comment' && contains(github.event.comment.body, '@atomicai')) ||
+      (github.event.action == 'assigned' && github.event.assignee.login == 'atomicai')
+      )
+
+    permissions:
+      contents: write
+      issues: write
+      pull-requests: write
+
+    steps:
+      - uses: actions/checkout@v4
+        with:
+          fetch-depth: 0
+
+      - name: Run AtomicAI Developmental Pediatrics Assistant
+        uses: https://beta.atomicqms.com/atomicqms-service/actions/claude-code-gitea-action-slim@main
+        with:
+          trigger_phrase: '@atomicai'
+          assignee_trigger: 'atomicai'
+          claude_git_name: 'AtomicAI'
+          claude_git_email: 'atomicai@atomicqms.local'
+          custom_instructions: |
+            You are AtomicAI, an AI assistant specialized in Developmental Pediatrics Quality Management.
+
+            ## Your Expertise
+            - Autism Spectrum Disorder (ASD) diagnostic evaluations
+            - ADOS-2 (Autism Diagnostic Observation Schedule) administration protocols
+            - ADI-R (Autism Diagnostic Interview-Revised) standardization
+            - Developmental screening tools (ASQ-3, M-CHAT-R/F, PEDS)
+            - Intellectual disability assessments (WISC-V, Bayley-4, Stanford-Binet)
+            - ADHD evaluations (Conners, Vanderbilt, BASC-3)
+            - Learning disability assessments (WIAT-4, WJ-IV)
+            - Early intervention programs (Part C Birth-to-Three, Part B Preschool)
+            - IEP (Individualized Education Program) documentation
+            - Section 504 plan development and monitoring
+            - School liaison and educational advocacy
+            - Behavioral intervention planning (ABA, PBS)
+            - Feeding and swallowing evaluations (clinical feeding assessments)
+            - Sensory processing assessments (Sensory Profile, SPM)
+            - Multidisciplinary team coordination (OT, PT, SLP, Psychology, Social Work)
+            - Developmental milestones and surveillance
+            - Family-centered care and psychoeducation
+
+            ## Document Creation Guidelines
+            - Place Diagnostic Evaluation SOPs in SOPs/Diagnostic-Evaluations/
+            - Place Screening SOPs in SOPs/Screening/
+            - Place School Liaison SOPs in SOPs/School-Liaison/
+            - Place Clinical SOPs in SOPs/Clinical/
+            - Place Administrative SOPs in SOPs/Administrative/
+            - Place Safety SOPs in SOPs/Safety/
+            - Place Screening Result Forms in Forms/Screening-Results/
+            - Place School Report Forms in Forms/School-Reports/
+            - Place Assessment Tool Forms in Forms/Assessment-Tools/
+            - Place Case Management Forms in Forms/Case-Management/
+            - Place Policies in Policies/
+
+            ## Numbering Convention
+            - SOP-DE-XXX for Diagnostic Evaluation SOPs
+            - SOP-SCR-XXX for Screening SOPs
+            - SOP-SCH-XXX for School Liaison SOPs
+            - SOP-CLI-XXX for Clinical SOPs
+            - SOP-ADM-XXX for Administrative SOPs
+            - SOP-SAF-XXX for Safety SOPs
+            - POL-XXX for Policies
+            - FRM-XXX for Forms
+            - WI-XXX for Work Instructions
+
+            ## Regulatory and Professional Standards
+            - IDEA (Individuals with Disabilities Education Act)
+            - Section 504 of the Rehabilitation Act
+            - ADA (Americans with Disabilities Act)
+            - HIPAA compliance for developmental health information
+            - AAP (American Academy of Pediatrics) developmental surveillance guidelines
+            - CDC developmental milestone recommendations
+            - Evidence-based practice in autism diagnosis (DSM-5-TR criteria)
+            - Standardized assessment administration and scoring protocols
+            - Multidisciplinary evaluation team (MET) requirements
+            - Family Educational Rights and Privacy Act (FERPA)
+
+            Always create branches and submit changes as Pull Requests for review.
+            Focus on evidence-based developmental assessments, family-centered care, and interdisciplinary collaboration.
+          allowed_tools: 'Read,Edit,Grep,Glob,Write'
+          disallowed_tools: 'Bash,WebSearch'
--- a/Forms/Assessment-Tools/.gitkeep
+++ b/Forms/Assessment-Tools/.gitkeep
--- a/Forms/Assessment-Tools/FRM-ADOS-001-ADOS-2-Administration-Checklist.md
+++ b/Forms/Assessment-Tools/FRM-ADOS-001-ADOS-2-Administration-Checklist.md
@@ -0,0 +1,312 @@
+# ADOS-2 Administration Fidelity Checklist
+
+| Form ID | FRM-ADOS-001 | Revision | 1.0 |
+|---------|--------------|----------|-----|
+
+---
+
+## Section 1: Assessment Information
+
+| Field | Entry |
+|-------|-------|
+| Child Name | |
+| Date of Birth | |
+| Chronological Age | |
+| Assessment Date | |
+| Examiner Name | |
+| Observer Name (if applicable) | |
+| Medical Record Number | |
+
+## Section 2: Module Selection
+
+### Module Selected
+- [ ] Toddler Module (12-30 months)
+- [ ] Module 1 (31+ months, minimal expressive language)
+- [ ] Module 2 (any age, phrase speech)
+- [ ] Module 3 (fluent speech, child/adolescent)
+- [ ] Module 4 (fluent speech, older adolescent/adult)
+
+### Module Selection Criteria Met
+- [ ] Age appropriate
+- [ ] Expressive language level appropriate
+- [ ] Module selection documented in report
+
+### Justification for Module Selection
+
+
+
+
+## Section 3: Pre-Assessment Preparation
+
+### Materials and Setup
+- [ ] All required materials prepared and available
+- [ ] Testing room appropriate (minimal distractions)
+- [ ] Video recording equipment functional (if recording)
+- [ ] Scoring forms and manual available
+- [ ] Toys/materials in good condition
+- [ ] Backup materials available
+
+### Examiner Preparation
+- [ ] Reviewed child's background information
+- [ ] Reviewed previous assessments (if available)
+- [ ] Confirmed module selection
+- [ ] Prepared parent/caregiver for observation
+- [ ] Scheduled adequate time (45-60 minutes typical)
+
+## Section 4: Administration Fidelity
+
+### General Administration Principles
+
+| Item | Met | Notes |
+|------|-----|-------|
+| Rapport established with child | ☐ Yes ☐ No ☐ N/A | |
+| Standardized procedures followed | ☐ Yes ☐ No ☐ N/A | |
+| Flexibility applied appropriately | ☐ Yes ☐ No ☐ N/A | |
+| Presses administered correctly | ☐ Yes ☐ No ☐ N/A | |
+| Natural, playful interaction maintained | ☐ Yes ☐ No ☐ N/A | |
+| Appropriate pacing maintained | ☐ Yes ☐ No ☐ N/A | |
+| Child engaged throughout | ☐ Yes ☐ No ☐ N/A | |
+
+### Activity-Specific Fidelity
+
+#### Activities Administered (check all that apply)
+
+**Toddler Module:**
+- [ ] Free Play
+- [ ] Response to Name
+- [ ] Response to Joint Attention
+- [ ] Bubble Play
+- [ ] Anticipation of a Social Routine
+- [ ] Responsive Social Smile
+- [ ] Anticipation of a Social Routine with Objects
+- [ ] Functional Play
+- [ ] Birthday Party
+- [ ] Snack
+
+**Module 1:**
+- [ ] Free Play
+- [ ] Response to Name
+- [ ] Response to Joint Attention
+- [ ] Bubble Play
+- [ ] Anticipation of a Routine with Objects
+- [ ] Responsive Social Smile
+- [ ] Functional and Symbolic Imitation
+- [ ] Birthday Party
+- [ ] Snack
+
+**Module 2:**
+- [ ] Free Play
+- [ ] Response to Name Called
+- [ ] Birthday Party
+- [ ] Snack
+- [ ] Bubble Play
+- [ ] Construction Task
+- [ ] Make-Believe Play
+- [ ] Joint Interactive Play
+- [ ] Description of a Picture
+- [ ] Telling a Story from a Book
+- [ ] Conversation and Reporting
+
+**Module 3:**
+- [ ] Construction Task
+- [ ] Make-Believe Play
+- [ ] Joint Interactive Play
+- [ ] Demonstration Task
+- [ ] Description of a Picture
+- [ ] Telling a Story from a Book
+- [ ] Cartoons
+- [ ] Conversation and Reporting
+- [ ] Break (if needed)
+- [ ] Creating a Story
+- [ ] Social Difficulties and Annoyance
+- [ ] Emotions
+- [ ] Friends and Relationships
+- [ ] Loneliness
+
+**Module 4:**
+- [ ] Construction Task (if appropriate)
+- [ ] Current Work or School
+- [ ] Description of a Picture
+- [ ] Telling a Story from a Book
+- [ ] Cartoons
+- [ ] Break
+- [ ] Demonstration Task
+- [ ] Creating a Story
+- [ ] Social Difficulties and Annoyance
+- [ ] Emotions
+- [ ] Friends, Relationships, and Marriage
+- [ ] Loneliness
+
+### Standardization Issues
+
+**Were there any deviations from standardized administration?**
+- [ ] No deviations
+- [ ] Minor deviations (describe):
+- [ ] Major deviations affecting validity (describe):
+
+**Deviations Description:**
+
+
+
+
+### Child Factors Affecting Administration
+- [ ] Attention difficulties
+- [ ] Behavioral challenges
+- [ ] Fatigue
+- [ ] Illness
+- [ ] Anxiety/shyness
+- [ ] Language barriers
+- [ ] Sensory sensitivities
+- [ ] Other: _______________
+
+**Impact on Assessment:**
+
+
+
+
+## Section 5: Scoring Fidelity
+
+### Real-Time Scoring
+- [ ] Codes recorded during administration
+- [ ] Behavioral notes documented
+- [ ] Unclear items flagged for review
+
+### Post-Administration Scoring
+- [ ] All items scored within 24 hours
+- [ ] Video review conducted (if recorded)
+- [ ] Scoring manual consulted for unclear items
+- [ ] All required items completed
+
+### Algorithm and Classification
+- [ ] Algorithm scores calculated correctly
+- [ ] Social Affect (SA) total calculated
+- [ ] Restricted/Repetitive Behavior (RRB) total calculated
+- [ ] Overall Total calculated
+- [ ] Comparison score determined (if applicable)
+- [ ] Classification range determined
+
+### Classification Result
+- [ ] Autism
+- [ ] Autism Spectrum
+- [ ] Non-Spectrum
+
+**Overall Total:** _____
+**Comparison Score (if applicable):** _____
+
+## Section 6: Integration with Other Data
+
+### ADOS-2 Results Considered Alongside
+- [ ] ADI-R (Autism Diagnostic Interview-Revised)
+- [ ] Developmental history
+- [ ] Cognitive assessment
+- [ ] Adaptive behavior assessment
+- [ ] Language evaluation
+- [ ] Parent/caregiver report measures
+- [ ] Teacher/school observations
+- [ ] DSM-5-TR diagnostic criteria
+
+### Clinical Judgment Applied
+- [ ] ADOS-2 results interpreted in context
+- [ ] Limitations of ADOS-2 acknowledged
+- [ ] Best estimate clinical diagnosis made
+
+## Section 7: Quality Assurance
+
+### Examiner Qualifications
+- [ ] Research-reliable training completed (or equivalent)
+- [ ] Module-specific training completed
+- [ ] Adequate supervised experience
+- [ ] Annual competency check completed
+
+### Inter-Rater Reliability (if applicable)
+- [ ] Second scorer reviewed video
+- [ ] Agreement calculated
+- [ ] Agreement ≥80% achieved
+
+**Agreement Percentage:** _____%
+
+### Supervision/Consultation
+- [ ] Case reviewed with supervisor (if trainee)
+- [ ] Consultation obtained for complex case
+- [ ] Scoring reviewed with experienced colleague
+
+## Section 8: Documentation
+
+### Required Documentation Complete
+- [ ] ADOS-2 protocol form completed
+- [ ] Algorithm and classification documented
+- [ ] Behavioral observations recorded
+- [ ] Integration with other data documented
+- [ ] Diagnostic impression documented
+- [ ] Recommendations documented
+
+### Video Recording (if applicable)
+- [ ] Consent for recording obtained
+- [ ] Video quality adequate for review
+- [ ] Video stored securely per HIPAA
+- [ ] Video retention per policy
+
+## Section 9: Issues and Concerns
+
+### Administration Issues Encountered
+
+
+
+
+### Validity Concerns
+- [ ] No concerns - results considered valid
+- [ ] Minor concerns (specify):
+- [ ] Major concerns affecting validity (specify):
+
+### Follow-Up Needed
+- [ ] No follow-up needed
+- [ ] Repeat assessment recommended
+- [ ] Additional assessment needed
+- [ ] Consultation recommended
+
+## Section 10: Competency Verification
+
+*(To be completed by supervisor or reviewer)*
+
+### Fidelity Rating
+- [ ] Excellent - All procedures followed correctly
+- [ ] Adequate - Minor deviations, results valid
+- [ ] Inadequate - Significant issues, retraining needed
+
+### Reviewer Comments
+
+
+
+
+### Reviewer Signature | | Date | |
+
+---
+
+## Section 11: Examiner Self-Reflection
+
+### Self-Assessment of Administration
+
+
+
+
+### Areas for Improvement
+
+
+
+
+### Training Needs Identified
+
+
+
+
+## Section 12: Signatures
+
+| Examiner Signature | | Date | |
+|-------------------|---|------|---|
+| Supervisor Review (if applicable) | | Date | |
+
+---
+
+*Form FRM-ADOS-001 Rev 1.0*
+
+**Note:** This checklist is intended to support standardized ADOS-2 administration and quality assurance. It does not replace the official ADOS-2 manual or required training. Examiners must complete research-reliable training or equivalent before administering the ADOS-2 independently.
--- a/Forms/Case-Management/.gitkeep
+++ b/Forms/Case-Management/.gitkeep
--- a/Forms/FRM-001-Document-Change-Request.md
+++ b/Forms/FRM-001-Document-Change-Request.md
@@ -0,0 +1,66 @@
+# Document Change Request Form
+
+| Form ID | FRM-001 | Revision | 1.0 |
+|---------|---------|----------|-----|
+
+---
+
+## Section 1: Request Information
+
+| Field | Entry |
+|-------|-------|
+| Request Date | |
+| Requested By | |
+| Department | |
+
+## Section 2: Document Information
+
+| Field | Entry |
+|-------|-------|
+| Document Number | |
+| Document Title | |
+| Current Revision | |
+
+## Section 3: Change Description
+
+### Type of Change
+- [ ] New Document
+- [ ] Revision to Existing Document
+- [ ] Document Obsolescence
+
+### Description of Change
+*(Describe the proposed change in detail)*
+
+
+
+
+### Reason for Change
+*(Explain why this change is needed)*
+
+
+
+
+## Section 4: Impact Assessment
+
+### Affected Areas
+- [ ] Training Required
+- [ ] Other Documents Affected
+- [ ] Process Changes Required
+- [ ] Assessment Protocol Impact
+- [ ] Clinical Competency Impact
+
+### List Affected Documents
+
+
+## Section 5: Approvals
+
+| Role | Name | Signature | Date |
+|------|------|-----------|------|
+| Requester | | | |
+| Document Owner | | | |
+| Clinical Director (if clinical) | | | |
+| Quality Assurance | | | |
+
+---
+
+*Form FRM-001 Rev 1.0*
--- a/Forms/FRM-003-CAPA-Form.md
+++ b/Forms/FRM-003-CAPA-Form.md
@@ -0,0 +1,157 @@
+# Corrective and Preventive Action (CAPA) Form
+
+| Form ID | FRM-003 | Revision | 1.0 |
+|---------|---------|----------|-----|
+
+---
+
+## Section 1: CAPA Identification
+
+| Field | Entry |
+|-------|-------|
+| CAPA Number | |
+| Date Initiated | |
+| Initiated By | |
+| Department | |
+| CAPA Owner | |
+
+## Section 2: Problem Description
+
+### Source of CAPA
+- [ ] Internal Audit
+- [ ] External Audit
+- [ ] Management Review
+- [ ] Clinical Incident
+- [ ] Family Complaint
+- [ ] Assessment Protocol Deviation
+- [ ] Documentation Error
+- [ ] Staff Observation
+- [ ] Other: _______________
+
+### Severity Level
+- [ ] Critical (affects patient safety or diagnostic accuracy)
+- [ ] Major (significant quality impact)
+- [ ] Minor (limited impact)
+
+### Description of Nonconformity or Issue
+*(Provide detailed description including what happened, when, where, and who was involved)*
+
+
+
+
+### Affected Processes/Areas
+- [ ] Diagnostic Evaluations
+- [ ] Screening Programs
+- [ ] School Liaison
+- [ ] Documentation
+- [ ] Assessment Administration
+- [ ] Clinical Protocols
+- [ ] Training/Competency
+- [ ] Other: _______________
+
+## Section 3: Immediate Action (if applicable)
+
+### Immediate Containment Actions Taken
+*(Actions to prevent immediate recurrence or mitigate impact)*
+
+
+
+
+## Section 4: Root Cause Analysis
+
+### Investigation Method
+- [ ] 5 Whys
+- [ ] Fishbone Diagram
+- [ ] Timeline Analysis
+- [ ] Other: _______________
+
+### Root Cause Findings
+*(Document the fundamental cause of the problem)*
+
+
+
+
+### Contributing Factors
+- [ ] Training inadequacy
+- [ ] Protocol unclear
+- [ ] Communication breakdown
+- [ ] Assessment tool issue
+- [ ] Workload/scheduling
+- [ ] Documentation system
+- [ ] Equipment/materials
+- [ ] Other: _______________
+
+## Section 5: Corrective/Preventive Actions
+
+### Action Plan
+
+| Action # | Description | Responsible Person | Target Date | Status |
+|----------|-------------|-------------------|-------------|--------|
+| 1 | | | | |
+| 2 | | | | |
+| 3 | | | | |
+| 4 | | | | |
+
+### Type of Action
+- [ ] Corrective (address detected issue)
+- [ ] Preventive (prevent potential issue)
+
+### Affected Documents/Procedures
+*(List SOPs, protocols, or forms that need updating)*
+
+
+
+
+### Training Required
+- [ ] Yes
+- [ ] No
+
+If yes, describe:
+
+
+
+## Section 6: Implementation
+
+### Implementation Notes
+*(Document actions taken)*
+
+
+
+
+### Implementation Date | |
+### Implemented By | |
+
+## Section 7: Effectiveness Check
+
+### Verification Method
+- [ ] Follow-up audit
+- [ ] Metric monitoring
+- [ ] Process observation
+- [ ] Record review
+- [ ] Other: _______________
+
+### Verification Period
+- Start Date: _______________
+- End Date: _______________
+
+### Effectiveness Results
+*(Describe results of monitoring - has the issue been resolved?)*
+
+
+
+
+### Effectiveness Verified By | |
+### Verification Date | |
+
+## Section 8: CAPA Closure
+
+- [ ] All actions completed
+- [ ] Effectiveness demonstrated
+- [ ] Records complete
+
+### Closed By | |
+### Closure Date | |
+
+---
+
+*Form FRM-003 Rev 1.0*
--- a/Forms/FRM-004-Training-Record.md
+++ b/Forms/FRM-004-Training-Record.md
@@ -0,0 +1,156 @@
+# Training Record Form
+
+| Form ID | FRM-004 | Revision | 1.0 |
+|---------|---------|----------|-----|
+
+---
+
+## Section 1: Employee Information
+
+| Field | Entry |
+|-------|-------|
+| Employee Name | |
+| Employee ID | |
+| Position/Title | |
+| Department | |
+| Hire Date | |
+
+## Section 2: Training Information
+
+| Field | Entry |
+|-------|-------|
+| Training Topic/Course Title | |
+| Training Date | |
+| Training Duration (hours) | |
+| Training Type | ☐ Classroom ☐ Online ☐ On-the-job ☐ Self-study ☐ Conference |
+| Trainer/Instructor Name | |
+| Training Provider | |
+
+## Section 3: Training Category
+
+- [ ] New Employee Onboarding
+- [ ] QMS/Quality Policy
+- [ ] Regulatory Compliance (HIPAA, IDEA, etc.)
+- [ ] Assessment Tool Training
+- [ ] Clinical Protocol
+- [ ] Safety and Emergency Procedures
+- [ ] Software/Systems Training
+- [ ] Professional Development
+- [ ] Continuing Education
+- [ ] Annual Refresher
+- [ ] Other: _______________
+
+## Section 4: Assessment Tool Specific Training (if applicable)
+
+### Assessment Tool
+- [ ] ADOS-2 (specify modules): _______________
+- [ ] ADI-R
+- [ ] Bayley-4
+- [ ] WISC-V
+- [ ] Stanford-Binet 5
+- [ ] Vineland-3
+- [ ] ASQ-3
+- [ ] M-CHAT-R/F
+- [ ] WIAT-4
+- [ ] Conners Rating Scales
+- [ ] Other: _______________
+
+### Training Level
+- [ ] Initial training
+- [ ] Research-reliable certification
+- [ ] Refresher training
+- [ ] Inter-rater reliability check
+
+### Certification/Reliability Status
+- [ ] Certified
+- [ ] Reliability achieved (specify %): _______________
+- [ ] Certification expiration date: _______________
+
+## Section 5: Training Objectives
+
+*(List key learning objectives or competencies covered)*
+
+1.
+2.
+3.
+
+## Section 6: Assessment of Learning
+
+### Assessment Method
+- [ ] Written test (score: _______%)
+- [ ] Practical demonstration
+- [ ] Case review
+- [ ] Direct observation
+- [ ] Simulation/role-play
+- [ ] Attendance only
+- [ ] Other: _______________
+
+### Assessment Result
+- [ ] Competent (passed)
+- [ ] Not yet competent (requires retraining)
+
+### Comments
+
+
+
+
+## Section 7: Competency Documentation
+
+### Initial Competency Verified
+- [ ] Yes
+- [ ] No
+- [ ] N/A
+
+### Competency Verification Method
+- [ ] Observation by supervisor
+- [ ] Case audit
+- [ ] Fidelity checklist
+- [ ] Inter-rater reliability
+- [ ] Other: _______________
+
+### Competency Verified By | |
+### Verification Date | |
+
+## Section 8: Training Effectiveness
+
+*(To be completed 30-90 days post-training)*
+
+### Effectiveness Evaluation
+- [ ] Employee applying skills correctly
+- [ ] Additional support needed
+- [ ] Retraining required
+
+### Evaluated By | |
+### Evaluation Date | |
+### Comments | |
+
+## Section 9: Continuing Education (if applicable)
+
+| CE Credits | |
+|------------|---|
+| Licensing Board | |
+| License Number | |
+
+## Section 10: Signatures
+
+| Employee Signature | | Date | |
+|-------------------|---|------|---|
+| Trainer Signature | | Date | |
+| Supervisor Signature | | Date | |
+
+---
+
+## Training History Summary
+
+*(Use this section to track ongoing training - attach additional pages as needed)*
+
+| Date | Training Topic | Hours | Trainer | Assessment Result |
+|------|---------------|-------|---------|-------------------|
+| | | | | |
+| | | | | |
+| | | | | |
+| | | | | |
+
+---
+
+*Form FRM-004 Rev 1.0*
--- a/Forms/FRM-006-Audit-Checklist.md
+++ b/Forms/FRM-006-Audit-Checklist.md
@@ -0,0 +1,154 @@
+# Internal Audit Checklist
+
+| Form ID | FRM-006 | Revision | 1.0 |
+|---------|---------|----------|-----|
+
+---
+
+## Section 1: Audit Information
+
+| Field | Entry |
+|-------|-------|
+| Audit Date | |
+| Auditor Name(s) | |
+| Auditee (Department/Area) | |
+| Audit Scope | |
+| Audit Criteria (SOPs, Standards) | |
+
+## Section 2: Audit Criteria and Findings
+
+### Instructions
+- **C** = Conformity (requirement met)
+- **NC** = Nonconformity (requirement not met)
+- **OBS** = Observation (potential issue or improvement opportunity)
+- **N/A** = Not Applicable
+
+---
+
+## Section 3: Document Control (SOP-001)
+
+| Requirement | Status | Evidence Reviewed | Findings/Comments |
+|-------------|--------|-------------------|-------------------|
+| Documents have proper identification (ID, rev, date) | ☐C ☐NC ☐OBS ☐N/A | | |
+| Current versions are available and accessible | ☐C ☐NC ☐OBS ☐N/A | | |
+| Obsolete documents are removed from use | ☐C ☐NC ☐OBS ☐N/A | | |
+| Revision history is maintained | ☐C ☐NC ☐OBS ☐N/A | | |
+| Document reviews conducted per schedule | ☐C ☐NC ☐OBS ☐N/A | | |
+
+## Section 4: Training and Competency (SOP-003)
+
+| Requirement | Status | Evidence Reviewed | Findings/Comments |
+|-------------|--------|-------------------|-------------------|
+| Training records maintained for all staff | ☐C ☐NC ☐OBS ☐N/A | | |
+| New employee onboarding completed | ☐C ☐NC ☐OBS ☐N/A | | |
+| Competency assessments documented | ☐C ☐NC ☐OBS ☐N/A | | |
+| Assessment tool certifications current | ☐C ☐NC ☐OBS ☐N/A | | |
+| Annual training requirements met | ☐C ☐NC ☐OBS ☐N/A | | |
+| Inter-rater reliability checks conducted | ☐C ☐NC ☐OBS ☐N/A | | |
+
+## Section 5: Clinical Assessment Procedures
+
+| Requirement | Status | Evidence Reviewed | Findings/Comments |
+|-------------|--------|-------------------|-------------------|
+| Assessment protocols followed correctly | ☐C ☐NC ☐OBS ☐N/A | | |
+| Standardized administration maintained | ☐C ☐NC ☐OBS ☐N/A | | |
+| Scoring accuracy verified | ☐C ☐NC ☐OBS ☐N/A | | |
+| DSM-5-TR criteria applied appropriately | ☐C ☐NC ☐OBS ☐N/A | | |
+| Assessment materials properly maintained | ☐C ☐NC ☐OBS ☐N/A | | |
+| ADOS-2/ADI-R fidelity maintained (if applicable) | ☐C ☐NC ☐OBS ☐N/A | | |
+
+## Section 6: Documentation and Records
+
+| Requirement | Status | Evidence Reviewed | Findings/Comments |
+|-------------|--------|-------------------|-------------------|
+| Clinical records complete and accurate | ☐C ☐NC ☐OBS ☐N/A | | |
+| Informed consent documented | ☐C ☐NC ☐OBS ☐N/A | | |
+| Reports completed within timeframes | ☐C ☐NC ☐OBS ☐N/A | | |
+| Required elements included in reports | ☐C ☐NC ☐OBS ☐N/A | | |
+| Records stored securely (HIPAA) | ☐C ☐NC ☐OBS ☐N/A | | |
+
+## Section 7: Screening Programs (if applicable)
+
+| Requirement | Status | Evidence Reviewed | Findings/Comments |
+|-------------|--------|-------------------|-------------------|
+| Screening tools administered correctly | ☐C ☐NC ☐OBS ☐N/A | | |
+| Follow-up protocols followed | ☐C ☐NC ☐OBS ☐N/A | | |
+| Parent communication documented | ☐C ☐NC ☐OBS ☐N/A | | |
+| Referral pathways established | ☐C ☐NC ☐OBS ☐N/A | | |
+
+## Section 8: School Liaison (if applicable)
+
+| Requirement | Status | Evidence Reviewed | Findings/Comments |
+|-------------|--------|-------------------|-------------------|
+| IEP documentation complete | ☐C ☐NC ☐OBS ☐N/A | | |
+| 504 plans properly documented | ☐C ☐NC ☐OBS ☐N/A | | |
+| IDEA requirements met | ☐C ☐NC ☐OBS ☐N/A | | |
+| School communication timely | ☐C ☐NC ☐OBS ☐N/A | | |
+
+## Section 9: CAPA Process (SOP-002)
+
+| Requirement | Status | Evidence Reviewed | Findings/Comments |
+|-------------|--------|-------------------|-------------------|
+| Nonconformities documented | ☐C ☐NC ☐OBS ☐N/A | | |
+| Root cause analysis performed | ☐C ☐NC ☐OBS ☐N/A | | |
+| Corrective actions implemented | ☐C ☐NC ☐OBS ☐N/A | | |
+| Effectiveness verified | ☐C ☐NC ☐OBS ☐N/A | | |
+| CAPA records maintained | ☐C ☐NC ☐OBS ☐N/A | | |
+
+## Section 10: Safety and Incidents
+
+| Requirement | Status | Evidence Reviewed | Findings/Comments |
+|-------------|--------|-------------------|-------------------|
+| Safety procedures followed | ☐C ☐NC ☐OBS ☐N/A | | |
+| Incidents documented and investigated | ☐C ☐NC ☐OBS ☐N/A | | |
+| Staff aware of emergency procedures | ☐C ☐NC ☐OBS ☐N/A | | |
+
+## Section 11: Summary of Findings
+
+### Conformities (Positive Findings)
+
+
+
+
+### Nonconformities
+
+| NC # | Type | Description | Objective Evidence |
+|------|------|-------------|-------------------|
+| | ☐Major ☐Minor | | |
+| | ☐Major ☐Minor | | |
+| | ☐Major ☐Minor | | |
+
+### Observations/Opportunities for Improvement
+
+
+
+
+## Section 12: Audit Conclusion
+
+### Overall Assessment
+- [ ] Satisfactory - minor or no issues identified
+- [ ] Needs improvement - nonconformities require corrective action
+- [ ] Unsatisfactory - major nonconformities requiring immediate action
+
+### Recommended Follow-Up Actions
+
+
+
+
+## Section 13: Closing Meeting
+
+| Attendees | |
+|-----------|---|
+| Date | |
+| Audit findings presented | ☐ Yes |
+| Questions addressed | ☐ Yes |
+
+## Section 14: Signatures
+
+| Auditor Signature | | Date | |
+|------------------|---|------|---|
+| Auditee Signature | | Date | |
+
+---
+
+*Form FRM-006 Rev 1.0*
--- a/Forms/School-Reports/.gitkeep
+++ b/Forms/School-Reports/.gitkeep
--- a/Forms/School-Reports/FRM-SCH-001-IEP-Documentation-Form.md
+++ b/Forms/School-Reports/FRM-SCH-001-IEP-Documentation-Form.md
@@ -0,0 +1,393 @@
+# IEP Documentation and Liaison Form
+
+| Form ID | FRM-SCH-001 | Revision | 1.0 |
+|---------|-------------|----------|-----|
+
+---
+
+## Section 1: Student Information
+
+| Field | Entry |
+|-------|-------|
+| Student Name | |
+| Date of Birth | |
+| Current Age/Grade | |
+| School District | |
+| School Building | |
+| Medical Record Number | |
+
+## Section 2: Parent/Guardian Information
+
+| Field | Entry |
+|-------|-------|
+| Parent/Guardian 1 Name | |
+| Phone | |
+| Email | |
+| Parent/Guardian 2 Name | |
+| Phone | |
+| Email | |
+
+## Section 3: IEP Meeting Information
+
+| Field | Entry |
+|-------|-------|
+| IEP Meeting Type | ☐ Initial ☐ Annual ☐ Triennial ☐ Amendment ☐ Other: _____ |
+| Meeting Date | |
+| Meeting Location | |
+| Our Practice Participation | ☐ In-person ☐ Virtual ☐ By phone ☐ Written input only |
+| Practice Representative | |
+
+### IEP Team Members Present
+
+| Role | Name | Present |
+|------|------|---------|
+| Parent/Guardian | | ☐ |
+| Special Education Teacher | | ☐ |
+| General Education Teacher | | ☐ |
+| School Administrator/LEA Rep | | ☐ |
+| School Psychologist | | ☐ |
+| Speech-Language Pathologist | | ☐ |
+| Occupational Therapist | | ☐ |
+| Physical Therapist | | ☐ |
+| Developmental Pediatrician | | ☐ |
+| Student (age-appropriate) | | ☐ |
+| Other: _____________ | | ☐ |
+
+## Section 4: Eligibility Determination
+
+### IDEA Eligibility Category (Primary)
+- [ ] Autism
+- [ ] Developmental Delay (ages 3-9)
+- [ ] Emotional Disturbance
+- [ ] Intellectual Disability
+- [ ] Multiple Disabilities
+- [ ] Other Health Impairment
+- [ ] Specific Learning Disability
+- [ ] Speech or Language Impairment
+- [ ] Other: _______________
+
+### Additional Eligibility Categories (if applicable)
+
+
+
+
+### Evaluation Data Reviewed
+- [ ] Cognitive assessment
+- [ ] Autism diagnostic evaluation (ADOS-2, ADI-R)
+- [ ] Academic achievement testing
+- [ ] Speech-language evaluation
+- [ ] Occupational therapy evaluation
+- [ ] Physical therapy evaluation
+- [ ] Behavioral assessment
+- [ ] Medical information
+- [ ] Classroom observations
+- [ ] Parent input
+- [ ] Other: _______________
+
+## Section 5: Present Levels of Performance
+
+### Academic Performance Summary
+*(Strengths and areas of need)*
+
+
+
+
+### Functional Performance Summary
+*(Daily living skills, social-emotional, behavior, communication)*
+
+
+
+
+### How Disability Affects Educational Progress
+
+
+
+
+## Section 6: IEP Goals and Objectives
+
+### Goal #1
+**Area:** _______________
+
+**Goal Statement:**
+
+
+
+
+**Measurable Objectives:**
+1.
+2.
+3.
+
+**Progress Monitoring Method:**
+
+**Progress Reporting Schedule:**
+
+---
+
+### Goal #2
+**Area:** _______________
+
+**Goal Statement:**
+
+
+
+
+**Measurable Objectives:**
+1.
+2.
+3.
+
+**Progress Monitoring Method:**
+
+**Progress Reporting Schedule:**
+
+---
+
+*(Attach additional goals as needed)*
+
+## Section 7: Special Education Services
+
+| Service | Provider | Frequency | Duration | Location | Start Date |
+|---------|----------|-----------|----------|----------|------------|
+| | | | | | |
+| | | | | | |
+
+### Service Delivery Models
+- [ ] Co-teaching/Push-in
+- [ ] Pull-out (resource room)
+- [ ] Self-contained classroom
+- [ ] Related services in general education
+- [ ] Community-based instruction
+- [ ] Other: _______________
+
+## Section 8: Related Services
+
+| Service | Provider | Frequency | Duration | Location | Start Date |
+|---------|----------|-----------|----------|----------|------------|
+| Speech-Language Therapy | | | | | |
+| Occupational Therapy | | | | | |
+| Physical Therapy | | | | | |
+| Counseling | | | | | |
+| Behavioral Support | | | | | |
+| Social Work Services | | | | | |
+| Assistive Technology | | | | | |
+| Other: ____________ | | | | | |
+
+## Section 9: Accommodations and Modifications
+
+### Instructional Accommodations
+- [ ] Extended time
+- [ ] Reduced distractions
+- [ ] Preferential seating
+- [ ] Visual supports/schedules
+- [ ] Chunking of assignments
+- [ ] Repeated/simplified directions
+- [ ] Use of assistive technology
+- [ ] Sensory breaks
+- [ ] Other: _______________
+
+### Testing Accommodations
+- [ ] Extended time (specify: _____%)
+- [ ] Breaks during testing
+- [ ] Small group or separate setting
+- [ ] Read-aloud
+- [ ] Scribe
+- [ ] Use of calculator
+- [ ] Simplified language
+- [ ] Assistive technology
+- [ ] Other: _______________
+
+### Modifications to Curriculum
+- [ ] Modified assignments
+- [ ] Alternate assessments
+- [ ] Reduced workload
+- [ ] Simplified content
+- [ ] Other: _______________
+
+## Section 10: Behavioral Intervention Plan (BIP)
+
+### BIP Status
+- [ ] BIP in place
+- [ ] BIP not required
+- [ ] FBA (Functional Behavioral Assessment) needed
+
+### Target Behaviors (if BIP in place)
+
+
+
+
+### Behavioral Supports and Interventions
+
+
+
+
+## Section 11: Participation in General Education
+
+### Percentage of Day in General Education
+- [ ] 80% or more (inclusive)
+- [ ] 40-79%
+- [ ] Less than 40%
+- [ ] Separate setting
+
+### Justification for Removal from General Education (if applicable)
+
+
+
+
+## Section 12: Transition Planning (for students age 14+)
+
+### Post-Secondary Goals
+**Education/Training:**
+
+
+
+
+**Employment:**
+
+
+
+
+**Independent Living:**
+
+
+
+
+### Transition Services Needed
+- [ ] Instruction
+- [ ] Related services
+- [ ] Community experiences
+- [ ] Employment and post-school objectives
+- [ ] Daily living skills (if appropriate)
+- [ ] Functional vocational evaluation
+
+### Transition Service Providers
+
+| Service | Provider/Agency | Contact |
+|---------|----------------|---------|
+| | | |
+
+## Section 13: Extended School Year (ESY) Services
+
+### ESY Determination
+- [ ] ESY services recommended
+- [ ] ESY services not needed
+
+### ESY Services (if applicable)
+
+| Service | Frequency | Duration |
+|---------|-----------|----------|
+| | | |
+
+### Justification for ESY
+
+
+
+
+## Section 14: Assessment Participation
+
+### State/District Assessments
+- [ ] Regular assessment without accommodations
+- [ ] Regular assessment with accommodations
+- [ ] Alternate assessment
+
+### Alternate Assessment Justification (if applicable)
+
+
+
+
+## Section 15: Medical/Clinical Recommendations from Our Practice
+
+### Key Clinical Findings Relevant to Education
+
+
+
+
+### Recommendations for School-Based Supports
+1.
+2.
+3.
+
+### Suggested Accommodations Based on Diagnosis
+
+
+
+
+### Coordination with Medical/Therapeutic Services
+
+
+
+
+## Section 16: Parent Concerns and Input
+
+### Parent-Stated Priorities for IEP
+
+
+
+
+### Parent Concerns
+
+
+
+
+### Parent Agreement with IEP
+- [ ] Parent agrees with IEP
+- [ ] Parent has concerns (documented above)
+- [ ] Parent does not consent to IEP
+- [ ] Parent requests mediation/due process
+
+## Section 17: Follow-Up and Coordination
+
+### Our Practice Follow-Up Actions
+
+| Action | Responsible | Target Date | Status |
+|--------|-------------|-------------|--------|
+| | | | |
+| | | | |
+
+### Next IEP Review Date
+| Annual Review Due | |
+|-------------------|---|
+| Triennial Evaluation Due | |
+
+### Coordination Notes
+*(Communication with school, therapy coordination, etc.)*
+
+
+
+
+## Section 18: Documentation and Records
+
+### Records Provided to School
+- [ ] Diagnostic evaluation report
+- [ ] Cognitive assessment report
+- [ ] Medical documentation
+- [ ] Treatment recommendations
+- [ ] Progress notes
+- [ ] Other: _______________
+
+### Records Received from School
+- [ ] Current IEP
+- [ ] Progress reports
+- [ ] Teacher observations
+- [ ] School-based evaluation reports
+- [ ] Other: _______________
+
+## Section 19: Signatures and Approvals
+
+| Completed By | | Date | |
+|--------------|---|------|---|
+| Reviewed By (Provider) | | Date | |
+
+---
+
+## Section 20: Communication Log
+
+| Date | Contact Person | Topic | Method | Notes |
+|------|---------------|-------|--------|-------|
+| | | | ☐ Phone ☐ Email ☐ Meeting ☐ Letter | |
+| | | | ☐ Phone ☐ Email ☐ Meeting ☐ Letter | |
+| | | | ☐ Phone ☐ Email ☐ Meeting ☐ Letter | |
+
+---
+
+*Form FRM-SCH-001 Rev 1.0*
--- a/Forms/Screening-Results/.gitkeep
+++ b/Forms/Screening-Results/.gitkeep
--- a/Forms/Screening-Results/FRM-SCR-001-Developmental-Screening-Summary.md
+++ b/Forms/Screening-Results/FRM-SCR-001-Developmental-Screening-Summary.md
@@ -0,0 +1,212 @@
+# Developmental Screening Summary Form
+
+| Form ID | FRM-SCR-001 | Revision | 1.0 |
+|---------|-------------|----------|-----|
+
+---
+
+## Section 1: Child Information
+
+| Field | Entry |
+|-------|-------|
+| Child Name | |
+| Date of Birth | |
+| Age at Screening | |
+| Medical Record Number | |
+| Screening Date | |
+| Screened By | |
+
+## Section 2: Parent/Guardian Information
+
+| Field | Entry |
+|-------|-------|
+| Parent/Guardian Name | |
+| Relationship to Child | |
+| Contact Phone | |
+| Email | |
+
+## Section 3: Screening Tool(s) Administered
+
+### Primary Screening Tool
+- [ ] ASQ-3 (Ages & Stages Questionnaires, 3rd Edition)
+- [ ] M-CHAT-R/F (Modified Checklist for Autism in Toddlers, Revised with Follow-Up)
+- [ ] PEDS (Parents' Evaluation of Developmental Status)
+- [ ] SWYC (Survey of Wellbeing of Young Children)
+- [ ] BRIGANCE Early Childhood Screens
+- [ ] Other: _______________
+
+### Screening Tool Version/Age Range
+| Tool | Version | Age Range |
+|------|---------|-----------|
+| | | |
+
+## Section 4: ASQ-3 Results (if applicable)
+
+| Domain | Raw Score | Cutoff Score | Status |
+|--------|-----------|--------------|--------|
+| Communication | | | ☐ Above ☐ Monitoring ☐ Referral |
+| Gross Motor | | | ☐ Above ☐ Monitoring ☐ Referral |
+| Fine Motor | | | ☐ Above ☐ Monitoring ☐ Referral |
+| Problem Solving | | | ☐ Above ☐ Monitoring ☐ Referral |
+| Personal-Social | | | ☐ Above ☐ Monitoring ☐ Referral |
+
+### Overall Concerns Section Results
+- [ ] No concerns indicated
+- [ ] Concerns noted: _______________
+
+## Section 5: M-CHAT-R/F Results (if applicable)
+
+### M-CHAT-R Initial Screening
+- Total Risk Items: _____ / 20
+- Critical Items: _____ / 6
+
+### Initial Risk Level
+- [ ] Low Risk (0-2 total)
+- [ ] Medium Risk (3-7 total)
+- [ ] High Risk (8-20 total)
+
+### Follow-Up Interview Conducted
+- [ ] Yes
+- [ ] No (not indicated)
+- [ ] Declined by family
+
+### Follow-Up Results (if conducted)
+- Final Score after Follow-Up: _____
+- [ ] Passed screening
+- [ ] Failed screening - referral recommended
+
+## Section 6: PEDS Results (if applicable)
+
+### Concerns Identified
+- [ ] No concerns
+- [ ] Predictive concerns (Path A)
+- [ ] Non-predictive concerns (Path B)
+- [ ] Low concerns (Path C)
+- [ ] No concerns but parent comment/question (Path D)
+- [ ] No concerns, no questions (Path E)
+
+### Recommended Path
+- [ ] Path A: Refer for diagnostic assessment
+- [ ] Path B: Screen further with developmental screening tool
+- [ ] Path C: Age-appropriate anticipatory guidance
+- [ ] Path D: Address specific question/concern
+- [ ] Path E: Continue routine surveillance
+
+## Section 7: Developmental Domains Assessed
+
+| Domain | Status | Notes |
+|--------|--------|-------|
+| Expressive Language | ☐ Typical ☐ Concern ☐ Delay | |
+| Receptive Language | ☐ Typical ☐ Concern ☐ Delay | |
+| Gross Motor | ☐ Typical ☐ Concern ☐ Delay | |
+| Fine Motor | ☐ Typical ☐ Concern ☐ Delay | |
+| Social-Emotional | ☐ Typical ☐ Concern ☐ Delay | |
+| Cognitive | ☐ Typical ☐ Concern ☐ Delay | |
+| Adaptive/Self-Help | ☐ Typical ☐ Concern ☐ Delay | |
+
+## Section 8: Red Flags Observed
+
+### Autism-Specific Red Flags
+- [ ] Limited eye contact
+- [ ] No response to name
+- [ ] Limited or no pointing
+- [ ] Limited social smiling
+- [ ] Unusual sensory interests
+- [ ] Repetitive behaviors
+- [ ] Other: _______________
+
+### General Developmental Red Flags
+- [ ] Loss of previously acquired skills
+- [ ] Significant delay in milestones
+- [ ] Concerns about hearing or vision
+- [ ] Asymmetric movements
+- [ ] Parental intuition of concern
+- [ ] Other: _______________
+
+## Section 9: Risk Factors
+
+- [ ] Prematurity (<37 weeks gestation: _____ weeks)
+- [ ] Low birth weight (<2500g: _____ g)
+- [ ] NICU admission
+- [ ] Family history of developmental disorders
+- [ ] Environmental risk factors (poverty, exposure)
+- [ ] Medical conditions affecting development
+- [ ] Other: _______________
+
+## Section 10: Overall Screening Result
+
+### Summary Result
+- [ ] Passed - Development appears typical
+- [ ] Monitoring - Some concerns, rescreening recommended
+- [ ] Failed - Referral for comprehensive evaluation recommended
+
+### Domains of Concern (if any)
+
+
+
+
+## Section 11: Recommendations and Referrals
+
+### Immediate Actions
+- [ ] Routine developmental surveillance at next well-child visit
+- [ ] Rescreening in _____ months
+- [ ] Referral for comprehensive developmental evaluation
+- [ ] Referral to Early Intervention (Part C Birth-to-Three)
+- [ ] Referral to Preschool Special Education (Part B)
+- [ ] Referral to specific services:
+  - [ ] Speech-Language Therapy
+  - [ ] Occupational Therapy
+  - [ ] Physical Therapy
+  - [ ] Audiology
+  - [ ] Ophthalmology
+  - [ ] Other: _______________
+
+### Referrals Made
+
+| Service/Provider | Referral Date | Contact Information |
+|-----------------|---------------|---------------------|
+| | | |
+| | | |
+
+### Parent Education Provided
+- [ ] Age-appropriate developmental milestones discussed
+- [ ] Activities to promote development reviewed
+- [ ] Resources provided (handouts, websites, community programs)
+- [ ] Follow-up plan explained
+
+## Section 12: Parent Communication
+
+### Discussion with Parent/Guardian
+- Screening results explained: ☐ Yes
+- Questions answered: ☐ Yes
+- Recommendations discussed: ☐ Yes
+- Written summary provided: ☐ Yes
+
+### Parent Response
+- [ ] Agrees with recommendations
+- [ ] Has questions (documented below)
+- [ ] Declines recommendations
+- [ ] Requests additional information
+
+### Notes
+
+
+
+
+## Section 13: Follow-Up Plan
+
+| Follow-Up Action | Responsible Person | Target Date |
+|------------------|-------------------|-------------|
+| | | |
+| | | |
+
+## Section 14: Signatures
+
+| Screener Signature | | Date | |
+|-------------------|---|------|---|
+| Reviewed By (Provider) | | Date | |
+| Parent Acknowledgment | | Date | |
+
+---
+
+*Form FRM-SCR-001 Rev 1.0*
--- a/Policies/POL-001-Quality-Policy.md
+++ b/Policies/POL-001-Quality-Policy.md
@@ -0,0 +1,84 @@
+# Quality Policy
+
+| Document ID | POL-001 |
+|-------------|---------|
+| Title | Quality Policy |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+
+---
+
+## 1. Policy Statement
+
+[ORGANIZATION NAME] is committed to providing high-quality, evidence-based developmental and behavioral pediatric services that meet the unique needs of children and families. We strive for excellence in neurodevelopmental assessment, diagnosis, and care coordination while maintaining compliance with all applicable professional standards and regulatory requirements.
+
+## 2. Quality Objectives
+
+Our organization commits to:
+
+1. **Family-Centered Care**: Partnering with families to understand their concerns, priorities, and goals for their child's development
+2. **Evidence-Based Practice**: Utilizing standardized, validated assessment tools and evidence-based diagnostic protocols
+3. **Multidisciplinary Excellence**: Coordinating comprehensive evaluations with speech-language pathology, occupational therapy, physical therapy, psychology, and social work professionals
+4. **Timely Access**: Minimizing wait times for developmental screening and diagnostic evaluations
+5. **Assessment Fidelity**: Ensuring standardized administration and interpretation of diagnostic instruments (ADOS-2, ADI-R, cognitive assessments)
+6. **Educational Advocacy**: Supporting families in navigating early intervention and school-based services
+7. **Continuous Improvement**: Regularly evaluating clinical protocols, assessment tools, and service delivery models
+8. **Cultural Competency**: Providing developmentally and culturally responsive services to diverse populations
+9. **Regulatory Compliance**: Maintaining compliance with HIPAA, IDEA, Section 504, ADA, and professional practice standards
+10. **Staff Competency**: Ensuring clinical staff maintain required certifications and training in specialized assessment protocols
+
+## 3. Management Commitment
+
+Top management demonstrates commitment to the QMS by:
+
+- Ensuring the quality policy is appropriate to the organization's mission of serving children with developmental differences
+- Establishing measurable quality objectives (e.g., wait time metrics, assessment completion rates, family satisfaction)
+- Ensuring integration of QMS requirements into clinical workflows and assessment protocols
+- Promoting evidence-based practice and fidelity to standardized assessment administration
+- Ensuring resources needed for the QMS are available (trained staff, validated assessment tools, appropriate facilities)
+- Communicating the importance of quality developmental evaluations and family-centered care
+- Ensuring the QMS achieves its intended results (accurate diagnoses, timely reports, appropriate referrals)
+- Supporting staff professional development in specialized assessment techniques
+- Engaging with interdisciplinary team members to optimize collaborative care
+
+## 4. Scope
+
+This policy applies to all clinical staff, administrative personnel, trainees, and contractors involved in:
+- Developmental screening and surveillance
+- Comprehensive neurodevelopmental evaluations
+- Autism spectrum disorder diagnostic assessments
+- Intellectual disability evaluations
+- ADHD and learning disability assessments
+- School-based service coordination
+- Early intervention program liaison
+- Multidisciplinary team evaluations
+- Family counseling and psychoeducation
+
+## 5. Professional Standards
+
+Our practice adheres to:
+- **American Academy of Pediatrics (AAP)** guidelines for developmental surveillance and screening
+- **CDC Developmental Milestones** recommendations
+- **DSM-5-TR** diagnostic criteria for neurodevelopmental disorders
+- **IDEA** requirements for educational evaluations and IEP development
+- **Section 504** accommodation planning standards
+- **ADOS-2/ADI-R** research-validated administration and scoring protocols
+- **Ethical guidelines** of relevant professional organizations (AAP, APA, ASHA, AOTA, APTA)
+
+## 6. Communication
+
+This policy shall be:
+- Communicated to and understood by all clinical and administrative staff
+- Available to families as appropriate
+- Reviewed annually for continuing suitability
+- Updated to reflect changes in professional standards and regulatory requirements
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |
--- a/README.md
+++ b/README.md
@@ -1,3 +1,133 @@
-# developmental-pediatrics
+# Developmental Pediatrics Quality Management System

 This repository contains template documents for implementing a Quality Management System (QMS) specifically designed for **Developmental Pediatrics** practices, neurodevelopmental clinics, and interdisciplinary evaluation teams.
+
+## Purpose
+
+Designed for clinical practices that provide:
+- Autism spectrum disorder (ASD) diagnostic evaluations
+- Developmental delay assessments
+- Intellectual disability evaluations
+- ADHD and learning disability testing
+- Early intervention coordination
+- School-based service planning and advocacy
+
+## Designed For
+
+- Developmental-Behavioral Pediatric Practices
+- Neurodevelopmental Evaluation Clinics
+- University-Based Child Development Centers
+- Hospital-Based Developmental Pediatrics Departments
+- Multidisciplinary Assessment Teams
+- Early Intervention Programs
+
+## Repository Structure
+
+```
+developmental-pediatrics/
+├── Policies/                     # Quality policies and management commitment
+├── SOPs/                         # Standard Operating Procedures
+│   ├── Diagnostic-Evaluations/   # ASD, ID, ADHD evaluation protocols
+│   ├── Screening/                # ASQ, M-CHAT, developmental surveillance
+│   ├── School-Liaison/           # IEP, 504 plans, educational coordination
+│   ├── Clinical/                 # Clinical operations and protocols
+│   ├── Administrative/           # Scheduling, billing, records management
+│   └── Safety/                   # Safety protocols and incident reporting
+├── Work Instructions/            # Detailed work instructions for assessments
+├── Forms/                        # Record forms and templates
+│   ├── Screening-Results/        # Screening documentation templates
+│   ├── School-Reports/           # IEP, 504, school liaison forms
+│   ├── Assessment-Tools/         # Score sheets and data collection forms
+│   └── Case-Management/          # Care coordination and referral tracking
+└── Templates/                    # Document templates
+```
+
+## Document Numbering Convention
+
+- **POL-XXX**: Policies
+- **SOP-DE-XXX**: Diagnostic Evaluation SOPs
+- **SOP-SCR-XXX**: Screening SOPs
+- **SOP-SCH-XXX**: School Liaison SOPs
+- **SOP-CLI-XXX**: Clinical SOPs
+- **SOP-ADM-XXX**: Administrative SOPs
+- **SOP-SAF-XXX**: Safety SOPs
+- **WI-XXX**: Work Instructions
+- **FRM-XXX**: Forms and Records
+
+## AI-Powered Document Creation
+
+This template includes **AtomicAI** integration. Simply create an issue and mention `@atomicai` to:
+- Generate standardized assessment protocols
+- Create screening and evaluation forms
+- Draft IEP and school liaison documentation
+- Develop behavioral intervention procedures
+- Update existing clinical protocols
+
+## Getting Started
+
+1. Create a new repository using this template
+2. Customize documents with your practice's information
+3. Create issues with `@atomicai` to generate new documents
+4. Review and approve AI-generated content via Pull Requests
+
+## Key Clinical Protocols
+
+This template supports documentation for:
+
+### Diagnostic Evaluations
+- **Autism Spectrum Disorder (ASD)**: ADOS-2, ADI-R, DSM-5-TR criteria
+- **Intellectual Disability**: Standardized cognitive and adaptive assessments
+- **ADHD**: Comprehensive multimodal evaluations
+- **Learning Disabilities**: Psychoeducational testing and differential diagnosis
+
+### Screening Programs
+- **Ages & Stages Questionnaires (ASQ-3)**
+- **M-CHAT-R/F** (Modified Checklist for Autism in Toddlers)
+- **PEDS** (Parents' Evaluation of Developmental Status)
+- **Developmental milestone surveillance**
+
+### School-Based Services
+- **IEP Development**: Individualized Education Program documentation
+- **Section 504 Plans**: Accommodation planning and monitoring
+- **Educational Advocacy**: School liaison and communication protocols
+- **Transition Planning**: Early intervention to school-age services
+
+### Multidisciplinary Coordination
+- Team evaluations with OT, PT, SLP, Psychology
+- Integrated care planning
+- Family-centered care delivery
+- Referral management
+
+## Regulatory Compliance
+
+These templates support compliance with:
+- **IDEA** - Individuals with Disabilities Education Act
+- **Section 504** - Rehabilitation Act accommodations
+- **ADA** - Americans with Disabilities Act
+- **HIPAA** - Health Information Privacy and Security
+- **FERPA** - Family Educational Rights and Privacy Act
+- **21 CFR Part 11** - Electronic Records (if applicable)
+- **AAP Guidelines** - American Academy of Pediatrics developmental surveillance
+- **CDC Milestones** - Developmental milestone recommendations
+- **DSM-5-TR** - Diagnostic criteria for neurodevelopmental disorders
+
+## Assessment Standardization
+
+Protocols ensure:
+- Standardized administration of diagnostic tools
+- Fidelity to published assessment protocols
+- Inter-rater reliability for team evaluations
+- Evidence-based diagnostic decision-making
+- Cultural and linguistic competency
+
+## Family-Centered Care
+
+Documentation supports:
+- Shared decision-making with families
+- Culturally responsive service delivery
+- Family psychoeducation and support
+- Collaborative treatment planning
+- Care coordination across providers and systems
+
+---
+*Powered by AtomicQMS - AI-Enhanced Developmental Pediatrics Quality Management*
--- a/SOPs/Administrative/.gitkeep
+++ b/SOPs/Administrative/.gitkeep
--- a/SOPs/Clinical/.gitkeep
+++ b/SOPs/Clinical/.gitkeep
--- a/SOPs/Diagnostic-Evaluations/.gitkeep
+++ b/SOPs/Diagnostic-Evaluations/.gitkeep
--- a/SOPs/SOP-001-Document-Control.md
+++ b/SOPs/SOP-001-Document-Control.md
@@ -0,0 +1,138 @@
+# 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] |
--- a/SOPs/SOP-002-CAPA.md
+++ b/SOPs/SOP-002-CAPA.md
@@ -0,0 +1,190 @@
+# 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] |
--- a/SOPs/SOP-003-Training.md
+++ b/SOPs/SOP-003-Training.md
@@ -0,0 +1,239 @@
+# 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] |
--- a/SOPs/SOP-004-Internal-Audit.md
+++ b/SOPs/SOP-004-Internal-Audit.md
@@ -0,0 +1,248 @@
+# 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] |
--- a/SOPs/SOP-005-Management-Review.md
+++ b/SOPs/SOP-005-Management-Review.md
@@ -0,0 +1,249 @@
+# 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] |
--- a/SOPs/Safety/.gitkeep
+++ b/SOPs/Safety/.gitkeep
--- a/SOPs/School-Liaison/.gitkeep
+++ b/SOPs/School-Liaison/.gitkeep
--- a/SOPs/Screening/.gitkeep
+++ b/SOPs/Screening/.gitkeep
--- a/Templates/SOP-Template.md
+++ b/Templates/SOP-Template.md
@@ -0,0 +1,63 @@
+# Standard Operating Procedure: [Title]
+
+| Document ID | SOP-XXX |
+|-------------|---------|
+| Title | [Title] |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | [DEPARTMENT] |
+
+---
+
+## 1. Purpose
+
+[State the purpose of this procedure]
+
+## 2. Scope
+
+[Define the scope and applicability]
+
+## 3. Responsibilities
+
+### 3.1 [Role 1]
+- [Responsibility]
+- [Responsibility]
+
+### 3.2 [Role 2]
+- [Responsibility]
+- [Responsibility]
+
+## 4. Definitions
+
+| Term | Definition |
+|------|------------|
+| | |
+
+## 5. Procedure
+
+### 5.1 [Section Title]
+
+[Procedure steps]
+
+### 5.2 [Section Title]
+
+[Procedure steps]
+
+## 6. Related Documents
+
+- [List related procedures, forms, etc.]
+
+## 7. References
+
+- [External standards, regulations, etc.]
+- [Professional guidelines (AAP, DSM-5-TR, IDEA, etc.)]
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |
--- a/Instructions/WI-001-Template.md
+++ b/Instructions/WI-001-Template.md
@@ -0,0 +1,79 @@
+# Work Instruction: [Title]
+
+| Document ID | WI-001 |
+|-------------|--------|
+| Title | [Title] |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | [DEPARTMENT] |
+
+---
+
+## 1. Purpose
+
+[Describe the purpose of this work instruction]
+
+## 2. Scope
+
+[Define what activities this instruction covers]
+
+## 3. Safety Precautions
+
+- [List any safety requirements]
+- [Personal protective equipment needed]
+- [Hazards to be aware of]
+
+## 4. Equipment/Materials Required
+
+| Item | Specification |
+|------|---------------|
+| | |
+| | |
+
+## 5. Prerequisites
+
+- [Required training or certifications]
+- [Prerequisite knowledge or skills]
+
+## 6. Procedure
+
+### Step 1: [Title]
+[Detailed instructions]
+
+### Step 2: [Title]
+[Detailed instructions]
+
+### Step 3: [Title]
+[Detailed instructions]
+
+## 7. Acceptance Criteria
+
+[Define what constitutes successful completion]
+
+## 8. Troubleshooting
+
+| Issue | Solution |
+|-------|----------|
+| | |
+
+## 9. Records
+
+| Record | Location | Retention |
+|--------|----------|-----------|
+| | | |
+
+## 10. References
+
+- [Related SOPs]
+- [Assessment manuals]
+- [Professional guidelines]
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |