Quality Control

Continuing Education Credits

• P.A.C.E.® Contact Hours: 2 hour(s)
• Florida Board of Clinical Laboratory Science CE Credit Hours -
  Supervision/Administration, Quality Control/Quality Assurance, and Safety: 2 hour(s)

Objectives

• Define terms associated with statistical quality control.
• Explain quality control graphical tools, including Gaussian curves, Levey-Jennings charts, CUSUM calculations, and Youden plots.
• Detail Westgard rules used to identify QC problems.
• Provide practical examples of QC in laboratory environments.
• Give suggestions for troubleshooting quality control errors.

Course Outline

• Definition of Quality Control
• What is Quality Control?
• Important Concepts in Quality Control
• Controls
• What is a Control?
• Safety and Handling of Controls
• Appearance of Controls
• Why Run Controls?
• Assayed and Unassayed Controls
• What is an unassayed control?
• Controls are tested (run) for all of the following reasons, except:
• Precision and Accuracy
• Aiming for the Target
• Closer, but not Quite
• Bullseye!
• An assayed glucose control produces the following results through 10 runs: 99, 99, 99, 98, 98, 98, 98, 97, 97, 97. The established range for this cont...
• Specificity
• Calculating Specificity
• Specificity Example
• Specificity Example: Test Results
• Specificity Example: Calculations (1)
• Specificity Example: Calculations (2)
• Specificity Example: Comparison
• Using the data and formula to the right, we can calculate specificity of the West Nile Virus test to be:
• Sensitivity
• Calculating Sensitivity
• Sensitivity Example: Calculations (1)
• Sensitivity Example: Calculations (2)
• Sensitivity Example: Comparison
• Using the data and formula to the right, we can calculate sensitivity of the West Nile Virus test to be:
• Specificity versus Sensitivity
• Sensitivity is the ability of a test to correctly identify individuals who indeed do have a particular disease or disorder. A test with high sensitivi...
• Predictive Value
• A Word on Positive and Negative Predictive Values
• How do predictive values relate to the prevalence of a disease?
• Random and Systematic Error
• Types of Error
• Random Error
• Systematic Error
• Indicate which of the factors in the list below are more likely to be random errors or systematic errors.
• Internal and External Quality Control
• Internal Quality Control
• External Quality Control
• External Quality Control, continued
• External Quality Control, continued
• Comparing Types of Quality Control Programs
• Match the type of quality control to the benefits it provides.
• Reference Ranges and X-barM
• The Importance of Monitoring Patient Results: Reference Ranges and X-barM
• Reference ranges should do all of the following, except:
• Quality Control Procedures, Documentation and Interpretation
• Basic Terms
• Mean
• Histograms
• Standard Deviation
• Acceptable Standard Deviation (SD)
• Establishing Quality Control Limits
• In a normal distribution, approximately what percent of data would be more than +/- 3 standard deviations (SD) from the mean?
• Levey-Jennings Chart
• Levey-Jennings Control Charts
• What is a Levey-Jennings Chart?
• On which day(s) did the control data fall at least one standard deviation (SD) from the mean?
• Westgard Rules
• Using Westgard Rules
• Westgard Rule 13S
• Westgard Rule 22S
• Westgard Rule 41s
• Westgard Rule R4s
• The Levey-Jennings charts on the right represent two levels of control for an analyte. Do they show acceptable quality control results?
• Does the Levey-Jennings chart to the right show acceptable quality control results?
• Trends
• Shifts
• Cumulative Summation Limit (CUSUM)
• What is a Cumulative Summation Limit?
• CUSUM Example: Plotting Control Data
• CUSUM Example: Calculating CUSUM
• CUSUM Example: Exceeding the CUSUM Limit
• CUSUM and Westgard Rules
• Youden Plot
• What is a Youden Plot?
• Using a Youden Plot
• In the accompanying Youden plot, what conclusions can be drawn about the data?
• Systematic Troubleshooting
• Troubleshooting
• Possible Corrective Actions
• Possible Corrective Actions, continued
• Possible Corrective Action, continued
• Possible Corrective Action, continued
• Possible Corrective Action, continued
• QC testing has failed. The instrument operator has checked control and reagent dates, as well as, storage conditions. These items were within acceptab...
• Establishment of Verification of Method Performance Specifications
• Verification of Performance Specifications for Nonwaived Testing
• Verification for Nonwaived Testing
• Summary
• Summary
• References
• References

Additional Information