# 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 | Pediatric Pharmacy |

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## 1. Purpose

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.

## 2. Scope

This procedure applies to all personnel involved in pediatric pharmacy operations, including:
- Pediatric pharmacists
- Pharmacy technicians working with pediatric medications
- Pharmacy students and residents in pediatric rotations
- Compounding personnel preparing pediatric formulations
- Quality and administrative staff

## 3. Responsibilities

### 3.1 Pharmacy Director
- Ensures adequate training resources
- Approves training program
- Reviews competency trends
- Ensures regulatory compliance

### 3.2 Training Coordinator
- Maintains training records
- Schedules training sessions
- Tracks competency assessments
- Coordinates continuing education

### 3.3 Department Managers/Preceptors
- Identifies training needs
- Provides on-the-job training
- Conducts competency assessments
- Documents training completion

### 3.4 All Personnel
- Complete required training
- Demonstrate competency
- Maintain continuing education
- Report training needs

## 4. Definitions

| Term | Definition |
|------|------------|
| Competency | Demonstrated ability to perform job functions safely and accurately |
| Initial Training | Training provided before independent practice |
| Ongoing Training | Periodic training to maintain and update skills |
| Competency Assessment | Evaluation of ability to perform specific tasks |
| Preceptor | Licensed pharmacist qualified to train and assess others |

## 5. Procedure

### 5.1 Training Needs Assessment

1. **New Hire Assessment**
   - Review job description and required competencies
   - Assess prior experience with pediatric pharmacy
   - Identify knowledge gaps
   - Develop individualized training plan

2. **Ongoing Needs**
   - Annual competency reviews
   - New procedures or equipment
   - Quality events or errors
   - Regulatory changes
   - Expansion of services

### 5.2 Initial Training Program

#### 5.2.1 General Orientation (All Staff)
- Facility tour and emergency procedures
- Introduction to pediatric patient population
- Quality Management System overview
- Documentation requirements
- HIPAA and patient privacy for minors
- Medication error reporting

#### 5.2.2 Pediatric Pharmacy Fundamentals (All Clinical Staff)
- Pediatric developmental stages (neonate, infant, child, adolescent)
- Weight-based and BSA-based dosing principles
- Pediatric dosing references and resources
- Common pediatric medications and indications
- Off-label medication use in pediatrics
- Pediatric high-alert medications
- Age-appropriate counseling techniques
- Parent/guardian communication

#### 5.2.3 Dosing and Calculations (Pharmacists and Technicians)
- Dosing calculation methods (mg/kg, mg/m²)
- Maximum dose verification
- Dilution calculations for neonates
- BSA calculation methods (Mosteller, DuBois)
- Use of dosing calculators and verification tools
- Independent double-check procedures
- Common calculation errors and prevention

#### 5.2.4 Pediatric Compounding (Compounding Staff)
- USP <795> pediatric applications
- USP <797> for neonatal/pediatric sterile preparations
- Suspension preparation from solids
- Flavoring systems and palatability
- Low-concentration formulations
- Unit-dose preparation
- Stability and beyond-use dating for pediatric formulations
- Aseptic technique for small volumes

#### 5.2.5 Specialized Areas (As Applicable)

**Neonatal Pharmacy**
- Prematurity and gestational age considerations
- Neonatal dosing adjustments
- TPN compounding for neonates
- Medication administration in NICU
- Drug concentrations for neonatal use

**Pediatric Oncology**
- Chemotherapy dosing (BSA-based)
- USP <800> compliance
- Pediatric chemotherapy protocols
- Supportive care medications
- Safe handling and disposal

**Controlled Substances**
- DEA requirements for minors
- Opioid dosing in children
- Controlled substance documentation
- Prescription monitoring programs

### 5.3 Competency Assessment

#### 5.3.1 Initial Competency
Must demonstrate competency before independent practice:

**Written Assessment**
- Pediatric pharmacy knowledge test (minimum 80%)
- Dosing calculation test (100% accuracy required)
- Medication safety scenarios

**Practical Assessment**
- Dosing calculation with verification
- Prescription order processing
- Compounding technique (if applicable)
- Patient counseling simulation
- Computer system use

**Direct Observation**
- Preceptor observes minimum 20 orders/preparations
- Uses standardized competency checklist
- Documents satisfactory performance

#### 5.3.2 Ongoing Competency
Assessed annually for all staff:

**Annual Competencies**
- Dosing calculations (5-10 scenarios, 100% required)
- High-alert medication protocols
- Medication error prevention
- One specialty area relevant to role

**Triggered Competencies**
- After medication error (within 30 days)
- New equipment or technology
- New procedures or protocols
- Return from extended leave (>6 months)

### 5.4 Continuing Education

#### 5.4.1 Requirements
- Pharmacists: State board requirements + 5 hours pediatric-specific annually
- Technicians: State board requirements + 3 hours pediatric-specific annually

#### 5.4.2 Approved Activities
- Pediatric pharmacy conferences (PPAG, ASHP)
- Online CE with pediatric focus
- Journal clubs on pediatric topics
- In-service training programs
- Specialty certification preparation (BCPPS)

### 5.5 Documentation

1. **Training Records**
   - Training date and topic
   - Trainer name
   - Training method (classroom, online, OJT)
   - Completion status

2. **Competency Records**
   - Date of assessment
   - Assessor name
   - Competency demonstrated
   - Score/result
   - Remediation if needed

3. **File Maintenance**
   - Individual training files for each employee
   - Accessible for inspections
   - Updated within 30 days of training
   - Retained per regulatory requirements

### 5.6 Remediation

If competency not demonstrated:
1. Identify specific deficiency
2. Provide additional training/practice
3. Re-assess within 30 days
4. Document remediation and outcome
5. Escalate to Pharmacy Director if unsuccessful after second attempt

### 5.7 Preceptor Qualification

To serve as preceptor/trainer:
- Licensed pharmacist with minimum 2 years pediatric pharmacy experience
- Demonstrated competency in area of training
- Completed preceptor training program
- Annual review of preceptor performance

## 6. Pediatric-Specific Competencies

All pediatric pharmacy staff must demonstrate:
- Accurate weight-based dosing calculations
- Recognition of age-inappropriate doses
- Identification of pediatric high-alert medications
- Appropriate use of pediatric dosing references
- Understanding of developmental considerations
- Effective parent/guardian communication

## 7. Records

| Record | Location | Retention |
|--------|----------|-----------|
| Individual training files | HR/Pharmacy | Duration of employment + 3 years |
| Competency assessments | Training files | 3 years |
| Training attendance logs | Training coordinator | 3 years |
| CE certificates | Individual files | Per state board requirements |

## 8. Related Documents

- FRM-004 Training Record
- FRM-XXX Competency Assessment Checklists
- Job Descriptions
- Annual Competency Calendar

## 9. References

- State Board of Pharmacy CE requirements
- USP <795>, <797>, <800> training requirements
- ASHP Guidelines on Pharmacy Technician Training
- PPAG Pediatric Pharmacy Practice Standards
- Joint Commission HR standards

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## Revision History

| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |