Quality Control (Online CEU Course)
Garland E. Pendergraph, PhD, JD, MLScm, SM(ASCP), HCLD(ABB)
Quality Control is a comprehensive course in QC terminology, practices, statistics, and troubleshooting for the clinical laboratory. Designed for those who have little or no experience with quality control but need a firm grounding, this course will help all students quickly and easily identify and correct errors in quality control procedures. Concepts covered include: running assayed and unassayed controls, specificity, sensitivity, Westgard rules, Levey-Jennings charts, Youden plots, and CUSUM calculations. MediaLab also offers an "Introduction to Quality Control" course to complement the more detailed and thorough presentation in this course.
Continuing Education Credits
Objectives
- Introduce quality control terminology.
- Explain quality control graphical tools, including Gaussian curves, Levey-Jennings charts, CUSUM calculations, and Youden plots.
- Detail Westguard rules used to identify QC problems.
- Provide practical examples of QC in laboratory environments.
- Give suggestions for troubleshooting quality control errors.
Course Outline
Click on a link in the outline to view a sample page from this course.
- Definition of Quality Control
- Important Concepts in Quality Control
- Controls
- Precision and Accuracy
- Aiming for the Target
- Closer, but not Quite
- Bull's-eye!
- A lab tech is running an assayed glucose control. The manufacturer has determined the control to have a value of 95. The lab tech runs the g...
- Specificity
- Calculating Specificity
- Specificity Example
- Specificity Example: Test Results
- Specificity Example: Calculations (1)
- Specificity Example: Calculations (2)
- Specificity Example: Comparison
- Based on the data for the experimental and tried-and-true procedures, which test would produce fewer
- 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
- Specificity vs. Sensitivity
- Based on the data for the experimental and tried-and-true procedures, which test would produce fewer
- Using the data and formula to the right, we can calculate sensitivity of the West Nile Virus test to
- Standards and Calibrators
- What are Standards and Calibrators?
- Calibration Curve
- Linearity
- Linearity Example
- Non-linear Calibration Curves
- Which of the following meets the strict definition of linearity given by Plaut?
- Random and Systematic Error
- Types of Error
- Random Error
- Systematic Error
- Causes of Error
- Indicate which of the problems in the list below are more likely to be random errors or systematic e
- Internal and External Quality Control
- Internal Quality Control
- External Quality Control (1)
- External Quality Control (2)
- External Quality Control (3)
- Comparing Types of Quality Control
- Match the type of quality control to the benefits it provides.
- Reference Ranges
- Quality Control Procedures, Documentation and Interpretation
- Basic Terms
- Overview of Statistics
- Mean
- Histograms
- Standard Deviation
- Acceptable Standard Deviation
- In a normal distribution, what percent of data would be more than +/- 3 standard deviations from the
- Levey-Jennings Chart
- The Levey-Jennings Chart's Inventors
- What is a Levey-Jennings Chart?
- On which days did the control data fall at least one standard deviation from the mean?
- Westgard Rules
- Using Westgard Rules
- Westgard Rule 13S
- Westgard Rule 22S
- Westgard Rule 41s (1)
- Does the Levey-Jennings chart to the right show acceptable quality control results?
- Does the Levey-Jennings chart to the right show acceptable quality control results?
- Trends
- Shifts
- Cumulative Summation Limit
- 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 Action (1)
- Possible Corrective Action (2)
- Possible Corrective Action (3)
- Possible Corrective Action (4)
- Possible Corrective Action (5)
- Put the troubleshooting steps below in the order in which they should be tried.
- Establishment of Verification of Method Performance Specifications
- Verification of Performance Specifications for Nonwaived Testing
- Verification for Nonwaived Testing
Additional Information
Dr. Pendergraph currently serves as laboratory director for Doctors Laboratory, Inc. at their Savannah, Brunswick, Kingsland, Georgia locations and as the corporate privacy officer. He is also the clinical laboratory director at Moody Air Force Base. He has served as chairman of the medical technology programs at East Carolina University, Greenville, NC and Western Carolina University, Cullowhee, NC. He is the author of various books, monographs, and scientific publications. Dr. Pendergraph received a PhD from the University of North Carolina, Chapel Hill and a JD from the Concord Law School, Kaplan University. He is a member of numerous professional organizations and is certified as a drug screen collection trainer by the Drug and Alcohol Testing Industry Association, MLScm and specialist in microbiology by the American Society of Clinical Pathology, and as a High Complexity Clinical Laboratory Director, by the American Board of Bioanalysts.
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