Key Takeaways
- Quality Assurance (QA) focuses on preventing defects; Quality Control (QC) focuses on detecting defects.
- Continuous Quality Improvement (CQI) uses ongoing data analysis to systematically improve processes.
- The pharmacist verification step is the final safety check before medication reaches the patient.
- Proper storage conditions (temperature, light, humidity) are critical for medication stability and safety.
- Infection control includes proper hand hygiene, PPE use, and aseptic technique for sterile compounding.
Quality Assurance and Continuous Quality Improvement
Quick Answer: Quality Assurance (QA) programs ensure medications are dispensed safely and accurately. CQI involves ongoing analysis and improvement of pharmacy processes. Key elements include pharmacist verification, proper storage, infection control, and systematic error tracking.
Quality Assurance vs. Quality Control
| Term | Definition | Focus |
|---|---|---|
| Quality Assurance (QA) | Proactive system to prevent errors | Prevention |
| Quality Control (QC) | Reactive testing to detect problems | Detection |
| Continuous Quality Improvement (CQI) | Ongoing process to improve quality | Improvement |
Quality Assurance Program Components
- Standard Operating Procedures (SOPs) - Written procedures for all tasks
- Staff Training - Initial and ongoing competency verification
- Environmental Monitoring - Temperature, humidity, cleanliness
- Equipment Maintenance - Calibration and preventive maintenance
- Documentation - Records of all quality-related activities
Continuous Quality Improvement (CQI)
CQI is a systematic approach to improving pharmacy operations through:
The Plan-Do-Study-Act (PDSA) Cycle
| Phase | Activity |
|---|---|
| Plan | Identify problem; develop intervention |
| Do | Implement the change on small scale |
| Study | Analyze results; compare to predictions |
| Act | Adopt, modify, or abandon the change |
Common CQI Metrics in Pharmacy
| Metric | Purpose |
|---|---|
| Prescription error rate | Track dispensing accuracy |
| Wait times | Measure efficiency |
| Intervention rate | Track pharmacist clinical activities |
| Patient satisfaction | Assess service quality |
| Refill adherence | Monitor patient medication compliance |
| Near-miss reports | Identify potential safety issues |
Pharmacist Verification Requirements
The final verification by a pharmacist is a critical safety checkpoint. Pharmacists must verify:
| Verification Element | Description |
|---|---|
| Drug-Utilization Review (DUR) | Check for interactions, allergies, duplications |
| Correct medication | Right drug, strength, dosage form |
| Accurate quantity | Correct count or volume |
| Proper labeling | Patient name, directions, warnings |
| Appropriate packaging | Child-resistant containers; special storage |
Key Point: Pharmacy technicians assist with preparation, but the pharmacist is legally responsible for final verification. Technicians should NEVER bypass this step.
Tech-Check-Tech (TCT) Programs
Some states allow trained technicians to verify the work of other technicians for certain tasks:
- Only permitted in specific settings (usually hospital/institutional)
- Technician must have special certification
- Does NOT replace pharmacist review for clinical decisions
- Requires state board approval
Proper Medication Storage
Temperature Requirements
| Storage Condition | Temperature Range |
|---|---|
| Room temperature | 68-77°F (20-25°C) |
| Controlled room temperature | 59-86°F (15-30°C) |
| Refrigerated | 36-46°F (2-8°C) |
| Frozen | -13 to 14°F (-25 to -10°C) |
Storage Monitoring
| Requirement | Purpose |
|---|---|
| Daily temperature logs | Document proper storage conditions |
| Calibrated thermometers | Ensure accurate readings |
| Alarm systems | Alert staff to temperature excursions |
| Light protection | Some drugs degrade in light |
| Humidity control | Prevent moisture damage |
Beyond-Use Dating
| Product Type | Typical Beyond-Use Date |
|---|---|
| Repackaged solids | 6 months or 25% of expiration (whichever is shorter) |
| Non-sterile liquids | 14-30 days depending on formulation |
| Sterile preparations | Per USP <797> based on risk level |
Infection Control
Hand Hygiene
| Situation | Requirement |
|---|---|
| Before compounding | Wash hands; use alcohol-based sanitizer |
| After handling contaminated items | Wash with soap and water |
| Between patients | Hand hygiene required |
| Minimum washing time | 20 seconds with soap and water |
Personal Protective Equipment (PPE)
| PPE Item | When Required |
|---|---|
| Gloves | Handling medications; compounding; hazardous drugs |
| Gown | Sterile compounding; hazardous drug handling |
| Mask | Sterile compounding; respiratory protection |
| Eye protection | Hazardous drug handling; splash risk |
| Shoe covers/hair covers | Cleanroom environments |
Aseptic Technique
For sterile compounding, technicians must:
- Work in a laminar airflow hood (LAFW) or biological safety cabinet
- Use proper garbing procedures
- Maintain first air principles (nothing between HEPA filter and critical site)
- Perform media fill testing to verify technique
- Follow USP <797> guidelines
Equipment Maintenance
| Equipment | Maintenance Requirement |
|---|---|
| Balances | Daily verification; annual calibration |
| Laminar airflow hoods | Certify every 6 months |
| Refrigerators/freezers | Daily temperature monitoring |
| Automated dispensing cabinets | Regular calibration and cleaning |
| Counting trays | Clean between uses; dedicated trays for hazardous drugs |
Exam Tip: Know temperature ranges for storage, hand hygiene requirements, and the difference between QA and CQI. Also understand why pharmacist verification cannot be skipped.
What is the primary difference between Quality Assurance (QA) and Quality Control (QC)?
Medications labeled "refrigerate" should be stored at which temperature range?
The Plan-Do-Study-Act (PDSA) cycle is a tool used in which quality program?