Sync template from atomicqms-style deployment

SOPs/SOP-001-Document-Control.md

@@ -0,0 +1,120 @@
+# 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 Quality Management System.
+
+## 2. Scope
+
+This procedure applies to all controlled documents including:
+- Policies
+- Standard Operating Procedures (SOPs)
+- Work Instructions
+- Forms and Templates
+- Clinical Protocols
+- Emergency Procedures
+- 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
+
+### 3.2 Quality Assurance
+- Maintains the document control system
+- Assigns document numbers
+- Manages document distribution
+- Archives obsolete documents
+
+### 3.3 Approvers
+- Review and approve documents before release
+- Ensure documents are adequate for intended purpose
+
+## 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. 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. Final approval by designated approver
+5. Quality Assurance releases document
+
+### 4.3 Document Numbering
+
+Documents shall be numbered according to the following convention:
+
+| Type | Prefix | Example |
+|------|--------|---------|
+| Policy | POL | POL-001 |
+| General SOP | SOP | SOP-001 |
+| Ventilator SOP | SOP-VENT | SOP-VENT-001 |
+| Sedation SOP | SOP-SED | SOP-SED-001 |
+| Nutrition SOP | SOP-NUT | SOP-NUT-001 |
+| Transport SOP | SOP-TRN | SOP-TRN-001 |
+| Emergency SOP | SOP-EMR | SOP-EMR-001 |
+| Infection Control SOP | SOP-INF | SOP-INF-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
+
+### 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
+
+### 4.6 Periodic Review
+
+1. Clinical protocols reviewed at least annually
+2. Standard SOPs reviewed at least every 2 years
+3. Review documented even if no changes made
+4. Reviews may result in revision or reaffirmation
+
+## 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 |
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |

SOPs/SOP-002-CAPA.md

@@ -0,0 +1,150 @@
+# Standard Operating Procedure: Corrective and Preventive Action (CAPA)
+
+| Document ID | SOP-002 |
+|-------------|---------|
+| Title | Corrective and Preventive Action |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | Quality Assurance |
+
+---
+
+## 1. Purpose
+
+To establish a systematic process for identifying, investigating, correcting, and preventing nonconformities and potential nonconformities that affect patient care quality and safety in the NICU/PICU.
+
+## 2. Scope
+
+This procedure applies to:
+- Patient safety events and near-misses
+- Healthcare-associated infections
+- Medication errors and adverse drug events
+- Equipment failures
+- Process deviations
+- Audit findings
+- Regulatory findings
+- Potential nonconformities identified through risk analysis
+
+## 3. Definitions
+
+| Term | Definition |
+|------|------------|
+| 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 a nonconformity |
+| Effectiveness Check | Verification that implemented actions achieved desired results |
+| Sentinel Event | Unexpected occurrence involving death or serious physical/psychological injury |
+
+## 4. Responsibilities
+
+### 4.1 CAPA Owner
+- Investigates the issue
+- Identifies root cause
+- Develops and implements corrective/preventive actions
+- Verifies effectiveness
+
+### 4.2 Quality Assurance
+- Manages CAPA system
+- Assigns CAPA numbers
+- Tracks CAPA status
+- Reviews and approves CAPAs
+- Reports CAPA metrics to management
+
+### 4.3 Unit Leadership
+- Provides resources for CAPA implementation
+- Reviews CAPA trends
+- Ensures timely closure
+- Communicates serious events to appropriate parties
+
+## 5. Procedure
+
+### 5.1 CAPA Initiation
+
+1. Identify nonconformity or potential nonconformity
+2. Document issue on CAPA Form (FRM-003)
+3. Classify severity and priority:
+   - Critical (patient harm or high risk)
+   - Major (potential for patient harm)
+   - Minor (process deviation, no patient impact)
+4. Assign CAPA owner
+5. Notify Risk Management if patient safety event
+
+### 5.2 Investigation
+
+1. Gather relevant data and evidence
+2. Interview personnel involved
+3. Review related documents and records
+4. Review patient chart if applicable
+5. Use appropriate investigation tools:
+   - Root Cause Analysis (RCA)
+   - Failure Mode and Effects Analysis (FMEA)
+   - 5 Whys
+   - Fishbone Diagram
+
+### 5.3 Root Cause Analysis
+
+1. Identify potential root causes
+2. Verify root cause through evidence
+3. Document root cause determination
+4. Consider systemic implications
+5. Identify contributing factors
+
+### 5.4 Action Development
+
+1. Develop corrective/preventive actions
+2. Assign responsibilities and due dates
+3. Assess actions for:
+   - Appropriateness to problem severity
+   - Impact on other processes
+   - Resource requirements
+   - Sustainability
+
+### 5.5 Implementation
+
+1. Execute approved actions
+2. Document implementation evidence
+3. Update affected documents/processes
+4. Provide staff training as needed
+5. Communicate changes to all affected personnel
+
+### 5.6 Effectiveness Verification
+
+1. Define effectiveness criteria (measurable outcomes)
+2. Allow sufficient time for actions to take effect
+3. Collect and analyze data
+4. Document verification results
+5. If ineffective, reopen CAPA for further action
+
+### 5.7 Closure
+
+1. Review all CAPA documentation
+2. Verify all actions completed
+3. Confirm effectiveness verified
+4. Obtain approval for closure
+5. Share lessons learned with team
+
+## 6. CAPA Metrics
+
+Quality Assurance shall track and report:
+- Number of open CAPAs by category
+- CAPA aging
+- On-time closure rate
+- Effectiveness rate
+- CAPAs by source (safety event, infection, medication error, etc.)
+- Repeat events
+
+## 7. Related Documents
+
+- FRM-003 CAPA Form
+- SOP-005 Patient Safety Event Reporting
+- Risk Management Policies
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |

SOPs/SOP-003-Training.md

@@ -0,0 +1,163 @@
+# Standard Operating Procedure: Training and Competence
+
+| Document ID | SOP-003 |
+|-------------|---------|
+| Title | Training and Competence - NICU/PICU |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | Nursing Education / Quality |
+
+---
+
+## 1. Purpose
+
+To ensure personnel caring for critically ill neonates and children are competent based on appropriate education, training, skills, and experience.
+
+## 2. Scope
+
+This procedure applies to:
+- All NICU/PICU clinical staff (nurses, physicians, NPs, PAs, RTs)
+- Support staff (pharmacists, social workers, child life specialists)
+- Contract and temporary personnel
+- Students and trainees
+
+## 3. Responsibilities
+
+### 3.1 Unit Leadership/Managers
+- Identify training needs for NICU/PICU personnel
+- Ensure training is completed before independent practice
+- Evaluate competence of personnel
+- Maintain department training records
+
+### 3.2 Nursing Education
+- Coordinate NICU/PICU orientation programs
+- Maintain central training database
+- Track training compliance
+- Archive training records
+
+### 3.3 Quality Assurance
+- Develop QMS-related training
+- Approve clinical training curricula
+- Audit training compliance
+
+### 3.4 Clinical Staff
+- Complete assigned training on time
+- Maintain current certifications (NRP, PALS, ACLS)
+- Report training needs to supervisor
+- Participate in annual competency validation
+
+## 4. Required Certifications
+
+### 4.1 NICU Staff
+- Neonatal Resuscitation Program (NRP) - every 2 years
+- STABLE Program (post-resuscitation care)
+- Electronic Fetal Monitoring (OB/NICU)
+
+### 4.2 PICU Staff
+- Pediatric Advanced Life Support (PALS) - every 2 years
+- Advanced Cardiovascular Life Support (ACLS) if applicable
+
+### 4.3 All ICU Staff
+- Critical care orientation
+- High-risk medication administration
+- Ventilator management competency
+- Central line care
+- Sedation assessment
+- Pain assessment tools
+
+## 5. Procedure
+
+### 5.1 Training Needs Assessment
+
+1. Identify competence requirements for each role
+2. Document requirements in job descriptions
+3. Assess current competence of personnel
+4. Identify training gaps
+5. Consider regulatory and accreditation requirements
+
+### 5.2 New Employee Orientation
+
+All new NICU/PICU staff shall complete:
+
+1. **General Orientation** (1-2 days)
+   - Hospital policies
+   - Safety and emergency procedures
+   - Quality system overview
+
+2. **Unit Orientation** (4-12 weeks depending on role)
+   - Unit tour and equipment
+   - Documentation systems
+   - Communication protocols
+   - Family-centered care principles
+
+3. **Clinical Competencies** (validated during orientation)
+   - Patient assessment
+   - Medication administration
+   - Respiratory support
+   - IV access and management
+   - Emergency response
+
+4. **Required Certifications**
+   - NRP or PALS (must be current before start)
+   - Unit-specific competencies
+
+### 5.3 Annual Competency Validation
+
+All staff shall demonstrate competency annually in:
+1. Code/emergency response
+2. High-alert medication administration
+3. Sedation scoring
+4. Pain assessment
+5. Equipment operation (vents, infusion pumps)
+6. Documentation requirements
+7. Infection prevention practices
+
+### 5.4 Training Documentation
+
+Training records shall include:
+- Employee name and ID
+- Training title and date
+- Trainer name and qualifications
+- Assessment results (minimum 80% passing for written tests)
+- Practical demonstration verification
+- Signatures
+
+### 5.5 Retraining Requirements
+
+Retraining is required when:
+- Significant protocol revisions occur
+- Performance deficiencies identified
+- Extended absence from unit (>6 months)
+- New equipment or technology introduced
+- Sentinel event or serious safety concern
+
+### 5.6 Preceptor Qualification
+
+Preceptors must:
+- Have minimum 1 year ICU experience
+- Complete preceptor training program
+- Demonstrate teaching ability
+- Maintain current certifications
+
+## 6. Training Records Retention
+
+- Training records maintained for duration of employment
+- Records retained 7 years after employee departure
+- Records available for Joint Commission and regulatory inspection
+
+## 7. Related Documents
+
+- FRM-004 Training Record Form
+- FRM-005 Clinical Competency Checklist
+- Job Descriptions
+- Preceptor Manual
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |

SOPs/SOP-004-Internal-Audit.md

@@ -0,0 +1,169 @@
+# 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 to verify compliance with the Quality Management System and regulatory requirements.
+
+## 2. Scope
+
+This procedure applies to:
+- All NICU/PICU processes and procedures
+- Clinical documentation
+- Equipment maintenance and calibration
+- Staff competency and training
+- Medication safety practices
+- Infection prevention practices
+- Patient safety processes
+
+## 3. Responsibilities
+
+### 3.1 Quality Assurance
+- Develops annual audit schedule
+- Selects and trains auditors
+- Ensures audits are conducted
+- Tracks audit findings to closure
+- Reports audit results to management
+
+### 3.2 Auditors
+- Conduct audits per schedule
+- Document findings objectively
+- Submit audit reports on time
+- Follow up on corrective actions
+
+### 3.3 Auditees
+- Provide information and access
+- Respond to findings
+- Implement corrective actions
+- Verify effectiveness
+
+## 4. Audit Types
+
+### 4.1 Process Audits
+- Review specific processes for compliance
+- Conducted quarterly
+
+### 4.2 Document Audits
+- Review documentation for completeness and compliance
+- Conducted monthly (sampling approach)
+
+### 4.3 Compliance Audits
+- Verify compliance with regulatory requirements
+- Conducted annually or as needed
+
+### 4.4 Mock Surveys
+- Simulate Joint Commission survey
+- Conducted annually
+
+## 5. Procedure
+
+### 5.1 Audit Planning
+
+1. Develop annual audit schedule
+2. Identify audit scope and criteria
+3. Select auditor(s) - must be independent of area audited
+4. Review previous audit findings
+5. Notify auditee at least 2 weeks in advance
+
+### 5.2 Audit Preparation
+
+1. Review applicable documents and standards
+2. Develop audit checklist (FRM-006)
+3. Prepare opening meeting agenda
+
+### 5.3 Audit Execution
+
+1. **Opening Meeting**
+   - Confirm audit scope
+   - Review audit process
+   - Identify key personnel
+
+2. **Evidence Gathering**
+   - Review documents and records
+   - Observe processes
+   - Interview personnel
+   - Take notes and document evidence
+
+3. **Finding Classification**
+   - **Critical**: Immediate patient safety risk or major non-compliance
+   - **Major**: Significant deviation from requirements
+   - **Minor**: Documentation or procedural deviation
+   - **Observation**: Opportunity for improvement
+
+4. **Closing Meeting**
+   - Present findings
+   - Clarify any questions
+   - Agree on corrective action timeline
+
+### 5.4 Audit Reporting
+
+1. Complete audit report within 5 business days
+2. Report includes:
+   - Executive summary
+   - Scope and methodology
+   - List of findings
+   - Positive observations
+   - Recommendations
+3. Distribute to auditee and management
+
+### 5.5 Corrective Action
+
+1. Auditee develops corrective action plan
+2. Submit plan within 10 business days
+3. Quality Assurance reviews and approves plan
+4. Implement actions per timeline
+5. Document completion
+
+### 5.6 Follow-up
+
+1. Verify corrective actions implemented
+2. Assess effectiveness
+3. Close findings or escalate if inadequate
+4. Schedule re-audit if needed
+
+## 6. Auditor Qualification
+
+Auditors must:
+- Complete internal auditor training
+- Have knowledge of QMS requirements
+- Have clinical background (for clinical audits)
+- Maintain objectivity and independence
+
+## 7. Audit Metrics
+
+Quality shall track and report:
+- Number of audits completed vs. scheduled
+- Findings by type and area
+- Average time to close findings
+- Repeat findings
+- Audit effectiveness
+
+## 8. Related Documents
+
+- FRM-006 Audit Checklist
+- FRM-007 Audit Report Template
+- SOP-002 CAPA
+
+## 9. References
+
+- Joint Commission Standards
+- CMS Conditions of Participation
+- ISO 9001:2015 (if applicable)
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |

SOPs/SOP-005-Management-Review.md

@@ -0,0 +1,199 @@
+# 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 NICU/PICU Quality Management System to ensure its continuing suitability, adequacy, and effectiveness.
+
+## 2. Scope
+
+This procedure applies to the periodic review of all aspects of the Quality Management System by NICU/PICU leadership.
+
+## 3. Responsibilities
+
+### 3.1 Unit Medical Director / Nurse Manager
+- Chairs management review meetings
+- Reviews QMS performance
+- Makes decisions on resource allocation
+- Ensures actions are implemented
+
+### 3.2 Quality Assurance
+- Schedules management review meetings
+- Prepares meeting materials and data
+- Documents meeting minutes
+- Tracks action items to completion
+
+### 3.3 Department Heads
+- Provide input on their areas
+- Participate in meetings
+- Implement assigned actions
+
+## 4. Frequency
+
+Management review meetings shall be conducted:
+- At minimum, quarterly
+- More frequently if significant issues arise
+- In response to sentinel events
+
+## 5. Review Inputs
+
+The management review shall consider:
+
+### 5.1 Quality Metrics
+- Mortality rates (observed vs. expected)
+- Infection rates (CLABSI, VAE, CAUTI)
+- Medication errors and adverse drug events
+- Unplanned extubations
+- Pressure injuries
+- Family satisfaction scores
+- Length of stay
+- Readmission rates
+
+### 5.2 Performance Against Benchmarks
+- Vermont Oxford Network (NICU)
+- NACHRI/Children's Hospital Association benchmarks
+- State or national databases
+
+### 5.3 Internal Audit Results
+- Number and status of audit findings
+- Trends in non-conformances
+- Areas of concern
+
+### 5.4 External Audit/Survey Results
+- Joint Commission survey findings
+- State Department of Health findings
+- Regulatory agency findings
+
+### 5.5 Patient Safety Events
+- Sentinel events
+- Serious safety events
+- Near-miss reports
+- Root cause analysis results
+
+### 5.6 CAPA Status
+- Open CAPAs
+- Overdue CAPAs
+- Effectiveness of corrective actions
+- Repeat issues
+
+### 5.7 Training and Competency
+- NRP/PALS compliance rates
+- Orientation completion
+- Competency validation results
+- Staffing competency mix
+
+### 5.8 Resource Adequacy
+- Staffing levels and ratios
+- Equipment functionality
+- Budget performance
+- Technology needs
+
+### 5.9 Changes Affecting QMS
+- New regulations or standards
+- New equipment or technology
+- Process changes
+- Organizational changes
+
+### 5.10 Opportunities for Improvement
+- Staff suggestions
+- Quality improvement initiatives
+- Best practice adoption
+
+## 6. Review Outputs
+
+The management review shall produce:
+
+1. **Decisions on**:
+   - QMS improvements needed
+   - Resource allocation
+   - Quality objectives and targets
+   - Policy changes
+
+2. **Action Items** with:
+   - Specific actions to be taken
+   - Responsible parties
+   - Target completion dates
+
+3. **Communication Plan**:
+   - Key messages for staff
+   - Changes to be implemented
+
+## 7. Procedure
+
+### 7.1 Meeting Preparation
+
+1. Quality Assurance prepares:
+   - Data summaries and trending reports
+   - Status updates on previous action items
+   - Meeting agenda
+2. Distribute materials 1 week before meeting
+
+### 7.2 Meeting Conduct
+
+1. Review previous action items
+2. Present and discuss each input category
+3. Identify trends and systemic issues
+4. Discuss resource needs
+5. Make decisions and assign actions
+6. Set priorities
+
+### 7.3 Documentation
+
+1. Document meeting minutes including:
+   - Attendees
+   - Data reviewed
+   - Decisions made
+   - Action items with owners and dates
+2. Distribute minutes within 1 week
+3. Post on quality board
+
+### 7.4 Follow-up
+
+1. Quality Assurance tracks action items
+2. Report status at next meeting
+3. Escalate overdue items
+4. Communicate outcomes to staff
+
+## 8. Meeting Attendees
+
+Required:
+- Unit Medical Director
+- Nurse Manager
+- Quality Coordinator
+- Infection Control Representative
+
+As needed:
+- Pharmacy Representative
+- Respiratory Therapy Manager
+- Risk Management
+- Social Work/Child Life Leadership
+
+## 9. Related Documents
+
+- Quality Metrics Dashboard
+- Audit Reports
+- CAPA Log
+- FRM-008 Management Review Meeting Minutes Template
+
+## 10. References
+
+- Joint Commission Leadership Standards
+- ISO 9001:2015 Clause 9.3 (if applicable)
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |