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Policies/POL-001-Quality-Policy.md

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+# Pediatric Pharmacy Quality Policy
+
+| Document ID | POL-001 |
+|-------------|---------|
+| Title | Pediatric Pharmacy Quality Policy |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+
+---
+
+## 1. Policy Statement
+
+[ORGANIZATION NAME] Pediatric Pharmacy is committed to providing safe, effective, and developmentally appropriate pharmaceutical care for infants, children, and adolescents. We strive for excellence in pediatric medication therapy through evidence-based practices, continuous quality improvement, and unwavering commitment to medication safety for our youngest patients.
+
+## 2. Quality Objectives
+
+Our pediatric pharmacy commits to:
+
+1. **Pediatric Patient Safety**: Ensuring accurate dosing calculations and age-appropriate formulations for all pediatric patients
+2. **Medication Error Prevention**: Implementing multiple verification systems to prevent calculation errors, wrong doses, and medication mix-ups
+3. **Regulatory Compliance**: Maintaining compliance with all applicable pharmacy regulations, USP standards, and pediatric-specific guidelines
+4. **Clinical Excellence**: Providing evidence-based pharmaceutical care appropriate to each developmental stage (neonate, infant, child, adolescent)
+5. **Family-Centered Care**: Engaging parents, guardians, and age-appropriate patients in medication education and counseling
+6. **Continuous Improvement**: Continually improving pediatric pharmacy processes through data analysis, error reporting, and quality initiatives
+7. **Staff Competency**: Ensuring all pharmacy personnel are trained and competent in pediatric-specific calculations, compounding, and safety protocols
+8. **Off-Label Use Management**: Documenting and monitoring off-label medication use with appropriate clinical justification
+
+## 3. Pediatric-Specific Commitments
+
+Top management and the pharmacy leadership demonstrate commitment to pediatric pharmaceutical care by:
+
+- Ensuring weight-based and BSA-based dosing verification for all pediatric orders
+- Implementing independent double-check systems for high-alert medications in children
+- Providing access to pediatric dosing references and calculation tools
+- Maintaining competency in pediatric compounding, including flavoring and age-appropriate formulations
+- Ensuring proper handling of neonatal medications, including dilutions and concentrations
+- Supporting pediatric medication safety initiatives and error prevention programs
+- Maintaining compliance with USP <795>, <797>, and <800> for pediatric preparations
+- Documenting and reviewing all pediatric medication errors and near-misses
+- Ensuring appropriate transition of care protocols from neonatal to pediatric to adult services
+
+## 4. Scope
+
+This policy applies to all personnel involved in:
+- Pediatric medication order verification
+- Dosing calculation and verification
+- Pediatric compounding (sterile and non-sterile)
+- Neonatal medication preparation
+- Pediatric chemotherapy preparation
+- TPN compounding for neonates and children
+- Vaccine storage and administration
+- Medication counseling for pediatric patients and families
+- Controlled substance management for minors
+
+This policy covers patients from birth through 18 years of age (or up to 21 years as defined by institutional policy).
+
+## 5. High-Alert Medications in Pediatrics
+
+We recognize that certain medications pose heightened risk in pediatric populations and require additional safeguards:
+
+- Concentrated electrolytes (potassium, sodium chloride >0.9%, calcium)
+- Insulin and hypoglycemic agents
+- Opioids and sedatives in neonates and infants
+- Chemotherapy agents
+- Anticoagulants (heparin, enoxaparin)
+- Neuromuscular blocking agents
+- IV medications requiring dilution or dose calculation
+- Medications with narrow therapeutic indices in children
+
+## 6. Dosing Safety
+
+All pediatric medication orders must include:
+- Patient's current weight (in kg)
+- Patient's age (or gestational age for neonates)
+- Indication for use (especially for off-label medications)
+- Dose expressed in appropriate units (mg/kg, mg/m², etc.)
+- Maximum dose limits verified
+- Calculation verification by independent pharmacist
+
+## 7. Communication
+
+This policy shall be:
+- Communicated to all pharmacy personnel and relevant clinical staff
+- Reviewed annually and updated as pediatric pharmacy practice standards evolve
+- Available to parents and guardians upon request
+- Integrated into new employee orientation and ongoing training
+
+## 8. Quality Monitoring
+
+Quality indicators for pediatric pharmacy include:
+- Pediatric medication error rates (by category)
+- Dosing calculation errors prevented
+- Compounding accuracy and sterility testing results
+- Time to preparation for stat neonatal/pediatric orders
+- Off-label use documentation compliance
+- Parent/guardian counseling completion rates
+- Staff competency assessment results
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |