Quality Control & Quality Assessment details

Quality assessment explained

1. Quality
Assessment

2. Quality Assessment (QA)
Changing terminology
Quality Control, Quality Assurance
Quality Assessment, Continuous Quality
Improvement, Total Quality Management
Quality Systems

3. Quality Assessment (QA)
QA programs required by Clinical Laboratory
Improvement Act ’88 (CLIA)
Goal
Ensure reliable test results
Improve patient care

4. Components of
Quality Systems Program
Personnel qualifications and training
Participation in proficiency testing
Blind samples
Results compared to those
from other laboratories

5. Components of
Quality Systems Program
Quality assessment (QA)
Preanalytical factors
Postanalytical factors
Analytical factors

6. Preanalytical Factors
Patient and specimen identification
Specimen collection
Selection of test method
Qualified testing personnel
Up-to-date procedure manual

7. Postanalytical Factors
Calculations
Reporting results
Charting results
Reduced errors
Computers
Bar-coded labels

8. Analytical Factors
Sample preparation
Instrument maintenance and calibration
Standards and controls
Test procedure

9. Analytical Factors
Operator technique
Interfering substances/conditions
Statistical analysis of control results

10. Quality Control
Safety precautions
Controls
External
Internal or equivalent
Standards and calibration
Reportable or linear range
Accuracy and precision
Random and systematic errors

11. Quality Control Chart

12. Accuracy versus Precision

13. Basic Statistics
Mean, variance, and standard deviation

14. Basic Statistics
Using the standard deviation
Establish confidence limits
Establish reference ranges

15. Normal Distribution Curve

16. Quality Control Charts
Levey-Jennings charts
Trend
Shift
Westgard’s rules

17. Quality Control Charts

18. Coefficient of Variation (CV)
Compares precision of methods
CV =s×100
mean