220 lines
7.3 KiB
Markdown
220 lines
7.3 KiB
Markdown
# Standard Operating Procedure: Corrective and Preventive Action (CAPA)
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| Document ID | SOP-002 |
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| Title | Corrective and Preventive Action (CAPA) |
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| Revision | 1.0 |
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| Effective Date | [DATE] |
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| Author | [AUTHOR] |
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| Approved By | [APPROVER] |
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| Department | Pediatric Pharmacy - Quality |
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---
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## 1. Purpose
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To establish a systematic approach for identifying, investigating, and resolving quality issues in pediatric pharmacy operations, and for implementing preventive measures to minimize recurrence of pediatric medication errors and safety events.
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## 2. Scope
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This procedure applies to all quality events in pediatric pharmacy, including:
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- Pediatric medication errors (actual and potential)
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- Dosing calculation errors
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- Compounding deviations
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- Equipment failures affecting pediatric preparations
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- Process non-conformances
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- Patient/family complaints
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- Near-miss events specific to pediatric medications
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- Regulatory observations or deficiencies
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## 3. Responsibilities
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### 3.1 All Pharmacy Personnel
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- Report quality events immediately
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- Participate in investigations
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- Implement corrective actions as assigned
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### 3.2 Quality Manager
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- Oversees CAPA process
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- Assigns investigations
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- Tracks CAPA completion
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- Reviews effectiveness of actions
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### 3.3 Pediatric Pharmacy Manager
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- Approves corrective and preventive actions
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- Allocates resources for implementation
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- Reviews trends in pediatric medication events
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### 3.4 Investigation Team
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- Conducts root cause analysis
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- Develops action plans
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- Implements and verifies effectiveness
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## 4. Definitions
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| Term | Definition |
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|------|------------|
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| CAPA | Corrective and Preventive Action |
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| Corrective Action | Action to eliminate the cause of a detected nonconformity |
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| Preventive Action | Action to eliminate the cause of a potential nonconformity |
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| Root Cause | Fundamental reason for an event's occurrence |
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| Medication Error | Any preventable event that may cause or lead to inappropriate medication use or patient harm |
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| Near Miss | Event that could have resulted in harm but did not reach the patient |
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| Sentinel Event | Unexpected occurrence involving death or serious physical/psychological injury |
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## 5. Procedure
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### 5.1 Event Identification and Reporting
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1. **Immediate Response**
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- If patient safety is at risk, take immediate action to prevent harm
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- For pediatric medication errors reaching patient, notify prescriber and document
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- Notify supervisor and pharmacy manager immediately for serious events
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2. **Event Documentation**
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- Complete medication error report within 24 hours
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- Include patient age, weight, and calculated dose
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- Document all relevant facts without speculation
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- Classify severity using institutional scale
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- Report to external systems as required (state board, ISMP)
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3. **Initial Assessment**
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- Quality Manager reviews within 24 hours
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- Determine if CAPA is required
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- Assign severity and priority
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- Initiate CAPA form
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### 5.2 Investigation
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1. **Team Assignment**
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- Quality Manager assigns investigation team
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- Include pediatric pharmacist if dosing-related
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- Include compounding specialist if preparation-related
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- Team leader designated
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2. **Data Collection**
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- Gather all relevant information
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- Interview involved personnel
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- Review related documentation
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- Examine physical evidence (if applicable)
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- Calculate what dose was intended vs. what was prepared/dispensed
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3. **Root Cause Analysis**
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- Use appropriate tools (5 Whys, Fishbone diagram, etc.)
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- Identify all contributing factors:
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- Human factors (calculation error, distraction, fatigue)
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- Process factors (unclear protocols, verification gaps)
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- System factors (inadequate tools, staffing issues)
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- Environmental factors (interruptions, workspace design)
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- Document analysis in CAPA form
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- Avoid blame; focus on system improvements
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### 5.3 Action Planning
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1. **Develop Corrective Actions**
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- Address immediate issue
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- Prevent recurrence
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- Consider hierarchy of controls:
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- Elimination (remove the hazard)
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- Substitution (replace with safer alternative)
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- Engineering controls (equipment, software verification)
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- Administrative controls (policies, training)
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- PPE/other safeguards (alerts, forcing functions)
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2. **Develop Preventive Actions**
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- Identify similar risks in other processes
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- Implement preventive measures
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- Update procedures or protocols
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3. **Action Plan Documentation**
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- Assign responsibility for each action
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- Set target completion dates
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- Define success criteria
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- Identify required resources
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### 5.4 Implementation
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1. Execute action plan according to timeline
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2. Update SOPs, work instructions, or forms as needed
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3. Communicate changes to all affected staff
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4. Provide training if procedures changed
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5. Document completion of each action
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### 5.5 Effectiveness Check
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1. **Verification** (within 30 days of implementation)
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- Verify actions were implemented as planned
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- Confirm staff are following new procedures
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- Check for unintended consequences
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2. **Validation** (30-90 days after implementation)
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- Analyze data to confirm problem resolved
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- Monitor for recurrence
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- Review related metrics
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- For pediatric medication errors, review if similar errors have occurred
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3. **Documentation**
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- Document effectiveness check results
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- If ineffective, re-open CAPA and revise action plan
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- If effective, close CAPA with Quality Manager approval
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### 5.6 CAPA Closure
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1. Quality Manager reviews completed CAPA
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2. Verifies all actions completed
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3. Confirms effectiveness demonstrated
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4. Approves closure
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5. Files CAPA record
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### 5.7 Trending and Analysis
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1. Quality Manager reviews all CAPAs quarterly
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2. Identify trends:
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- Types of pediatric medication errors
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- Medications frequently involved
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- Time of day patterns
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- Staff training needs
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3. Report to management and pharmacy staff
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4. Initiate preventive actions for trends identified
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## 6. Pediatric-Specific Considerations
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- **Dosing Errors**: Analyze calculation methods, reference sources, verification processes
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- **Age-Appropriate Issues**: Review if formulation, concentration, or route was suitable for patient age
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- **Communication**: Consider if parent/guardian counseling could have prevented issue
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- **Off-Label Use**: Review documentation and clinical justification
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- **High-Alert Medications**: Ensure additional safeguards in place for pediatric use
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## 7. Records
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| Record | Location | Retention |
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|--------|----------|-----------|
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| CAPA Forms | Quality records | 5 years |
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| Medication error reports | Pharmacy records | 5 years |
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| Root cause analysis | CAPA file | 5 years |
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| Effectiveness checks | CAPA file | 5 years |
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| Trend reports | Quality records | 3 years |
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## 8. Related Documents
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- FRM-003 CAPA Form
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- Medication Error Reporting Policy
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- POL-001 Pediatric Pharmacy Quality Policy
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- SOP-SAF-XXX Medication Error Prevention
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## 9. References
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- ISMP Guidelines for Pediatric Medication Safety
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- FDA Guidance for Industry: CGMP for Drugs
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- Joint Commission Sentinel Event Policy
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- State Board of Pharmacy reporting requirements
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- ISO 9001:2015 Section 10.2 (Nonconformity and Corrective Action)
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---
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## Revision History
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| Rev | Date | Description | Author |
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|-----|------|-------------|--------|
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| 1.0 | [DATE] | Initial release | [AUTHOR] |
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