1. Lesson 1-9
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 Standards and calibration
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
This project was funded at $3,000,000 (100% of its total cost) from a grant awarded under the Trade Adjustment Assistance Community College and Career Training Grants, as implemented by the U.S. Department of Labor’s Employment and Training Administration. Rogue Community College is an equal opportunity employer/program. Auxiliary aids and services, alternate form and language services are available to individuals with disabilities and limited English proficiency free of cost upon request.
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