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SOPs/SOP-003-Training.md
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SOPs/SOP-003-Training.md
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# Standard Operating Procedure: Training and Competency
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| Document ID | SOP-003 |
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| Title | Training and Competency |
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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 |
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---
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## 1. Purpose
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To ensure all pediatric pharmacy personnel are properly trained, competent, and maintain current knowledge in pediatric pharmaceutical care, medication safety, and specialized pediatric pharmacy practices.
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## 2. Scope
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This procedure applies to all personnel involved in pediatric pharmacy operations, including:
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- Pediatric pharmacists
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- Pharmacy technicians working with pediatric medications
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- Pharmacy students and residents in pediatric rotations
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- Compounding personnel preparing pediatric formulations
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- Quality and administrative staff
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## 3. Responsibilities
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### 3.1 Pharmacy Director
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- Ensures adequate training resources
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- Approves training program
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- Reviews competency trends
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- Ensures regulatory compliance
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### 3.2 Training Coordinator
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- Maintains training records
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- Schedules training sessions
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- Tracks competency assessments
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- Coordinates continuing education
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### 3.3 Department Managers/Preceptors
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- Identifies training needs
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- Provides on-the-job training
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- Conducts competency assessments
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- Documents training completion
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### 3.4 All Personnel
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- Complete required training
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- Demonstrate competency
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- Maintain continuing education
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- Report training needs
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## 4. Definitions
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| Term | Definition |
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|------|------------|
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| Competency | Demonstrated ability to perform job functions safely and accurately |
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| Initial Training | Training provided before independent practice |
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| Ongoing Training | Periodic training to maintain and update skills |
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| Competency Assessment | Evaluation of ability to perform specific tasks |
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| Preceptor | Licensed pharmacist qualified to train and assess others |
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## 5. Procedure
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### 5.1 Training Needs Assessment
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1. **New Hire Assessment**
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- Review job description and required competencies
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- Assess prior experience with pediatric pharmacy
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- Identify knowledge gaps
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- Develop individualized training plan
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2. **Ongoing Needs**
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- Annual competency reviews
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- New procedures or equipment
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- Quality events or errors
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- Regulatory changes
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- Expansion of services
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### 5.2 Initial Training Program
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#### 5.2.1 General Orientation (All Staff)
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- Facility tour and emergency procedures
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- Introduction to pediatric patient population
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- Quality Management System overview
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- Documentation requirements
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- HIPAA and patient privacy for minors
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- Medication error reporting
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#### 5.2.2 Pediatric Pharmacy Fundamentals (All Clinical Staff)
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- Pediatric developmental stages (neonate, infant, child, adolescent)
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- Weight-based and BSA-based dosing principles
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- Pediatric dosing references and resources
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- Common pediatric medications and indications
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- Off-label medication use in pediatrics
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- Pediatric high-alert medications
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- Age-appropriate counseling techniques
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- Parent/guardian communication
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#### 5.2.3 Dosing and Calculations (Pharmacists and Technicians)
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- Dosing calculation methods (mg/kg, mg/m²)
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- Maximum dose verification
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- Dilution calculations for neonates
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- BSA calculation methods (Mosteller, DuBois)
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- Use of dosing calculators and verification tools
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- Independent double-check procedures
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- Common calculation errors and prevention
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#### 5.2.4 Pediatric Compounding (Compounding Staff)
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- USP <795> pediatric applications
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- USP <797> for neonatal/pediatric sterile preparations
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- Suspension preparation from solids
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- Flavoring systems and palatability
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- Low-concentration formulations
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- Unit-dose preparation
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- Stability and beyond-use dating for pediatric formulations
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- Aseptic technique for small volumes
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#### 5.2.5 Specialized Areas (As Applicable)
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**Neonatal Pharmacy**
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- Prematurity and gestational age considerations
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- Neonatal dosing adjustments
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- TPN compounding for neonates
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- Medication administration in NICU
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- Drug concentrations for neonatal use
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**Pediatric Oncology**
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- Chemotherapy dosing (BSA-based)
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- USP <800> compliance
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- Pediatric chemotherapy protocols
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- Supportive care medications
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- Safe handling and disposal
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**Controlled Substances**
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- DEA requirements for minors
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- Opioid dosing in children
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- Controlled substance documentation
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- Prescription monitoring programs
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### 5.3 Competency Assessment
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#### 5.3.1 Initial Competency
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Must demonstrate competency before independent practice:
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**Written Assessment**
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- Pediatric pharmacy knowledge test (minimum 80%)
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- Dosing calculation test (100% accuracy required)
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- Medication safety scenarios
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**Practical Assessment**
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- Dosing calculation with verification
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- Prescription order processing
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- Compounding technique (if applicable)
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- Patient counseling simulation
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- Computer system use
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**Direct Observation**
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- Preceptor observes minimum 20 orders/preparations
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- Uses standardized competency checklist
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- Documents satisfactory performance
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#### 5.3.2 Ongoing Competency
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Assessed annually for all staff:
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**Annual Competencies**
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- Dosing calculations (5-10 scenarios, 100% required)
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- High-alert medication protocols
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- Medication error prevention
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- One specialty area relevant to role
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**Triggered Competencies**
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- After medication error (within 30 days)
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- New equipment or technology
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- New procedures or protocols
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- Return from extended leave (>6 months)
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### 5.4 Continuing Education
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#### 5.4.1 Requirements
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- Pharmacists: State board requirements + 5 hours pediatric-specific annually
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- Technicians: State board requirements + 3 hours pediatric-specific annually
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#### 5.4.2 Approved Activities
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- Pediatric pharmacy conferences (PPAG, ASHP)
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- Online CE with pediatric focus
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- Journal clubs on pediatric topics
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- In-service training programs
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- Specialty certification preparation (BCPPS)
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### 5.5 Documentation
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1. **Training Records**
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- Training date and topic
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- Trainer name
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- Training method (classroom, online, OJT)
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- Completion status
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2. **Competency Records**
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- Date of assessment
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- Assessor name
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- Competency demonstrated
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- Score/result
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- Remediation if needed
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3. **File Maintenance**
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- Individual training files for each employee
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- Accessible for inspections
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- Updated within 30 days of training
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- Retained per regulatory requirements
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### 5.6 Remediation
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If competency not demonstrated:
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1. Identify specific deficiency
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2. Provide additional training/practice
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3. Re-assess within 30 days
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4. Document remediation and outcome
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5. Escalate to Pharmacy Director if unsuccessful after second attempt
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### 5.7 Preceptor Qualification
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To serve as preceptor/trainer:
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- Licensed pharmacist with minimum 2 years pediatric pharmacy experience
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- Demonstrated competency in area of training
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- Completed preceptor training program
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- Annual review of preceptor performance
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## 6. Pediatric-Specific Competencies
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All pediatric pharmacy staff must demonstrate:
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- Accurate weight-based dosing calculations
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- Recognition of age-inappropriate doses
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- Identification of pediatric high-alert medications
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- Appropriate use of pediatric dosing references
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- Understanding of developmental considerations
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- Effective parent/guardian communication
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## 7. Records
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| Record | Location | Retention |
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|--------|----------|-----------|
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| Individual training files | HR/Pharmacy | Duration of employment + 3 years |
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| Competency assessments | Training files | 3 years |
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| Training attendance logs | Training coordinator | 3 years |
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| CE certificates | Individual files | Per state board requirements |
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## 8. Related Documents
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- FRM-004 Training Record
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- FRM-XXX Competency Assessment Checklists
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- Job Descriptions
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- Annual Competency Calendar
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## 9. References
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- State Board of Pharmacy CE requirements
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- USP <795>, <797>, <800> training requirements
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- ASHP Guidelines on Pharmacy Technician Training
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- PPAG Pediatric Pharmacy Practice Standards
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- Joint Commission HR standards
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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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