Lesson 1-9 Quality Assessment

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

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

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

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

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

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

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

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

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

Quality Control Chart

Accuracy versus Precision

Basic Statistics Mean, variance, and standard deviation

Basic Statistics Using the standard deviation Establish confidence limits Establish reference ranges

Normal Distribution Curve

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

Quality Control Charts

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.   This work is licensed under a Creative Commons Attribution 4.0 International License.