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online laboratory continuing education for clinical laboratories and med techs

# Quality Control (Online CE Course)

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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.

### 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.

### Customer Ratings

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### 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?
• Precision and Accuracy
• Aiming for the Target
• Closer, but not Quite
• Bull's-eye!
• An assayed glucose control produces the following results in 10 runs: 99, 99, 99, 98, 98, 98, 98, 97, 97, 97. The established range for this control i...
• 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
• Specificity versus Sensitivity
• Using the data and formula to the right, we can calculate sensitivity of the West Nile Virus test to be:
• Random and Systematic Error
• Types of Error
• Random Error
• Systematic Error
• Indicate which of the problems 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
• Match the type of quality control to the benefits it provides.
• Reference Ranges
• Reference Ranges
• 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 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
• 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
• 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 and storage conditions and everything is acceptable. The operator...
• Establishment of Verification of Method Performance Specifications
• Verification of Performance Specifications for Nonwaived Testing
• Verification for Nonwaived Testing
• References
• References

### Additional Information

Level of instruction: Intermediate

Intended Audience: Medical Laboratory Scientists, Medical Technologists, and Medical Laboratory Technicians, Clinical Laboratory Science students.

Author: Garland E. Pendergraph, PhD, JD, MLS(ASCP)SMCM, HCLD(ABB) 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.
Reviewer: Barbara Cebulski, MS, MLS(ASCP)CM is a program director for MediaLab, Inc., responsible for the development of continuing education and competency assessment courses for laboratory professionals. Prior to 2007, Ms. Cebulski was an Inspection Specialist in the Laboratory Accreditation Program for the College of American Pathologists (CAP). During this time, she also presented on behalf of CAP at Inspector Training seminars and Point-of-Care Group conferences. In her career as a medical technologist, she has held management and supervisory positions. Barbara holds a Masters degree in Instructional Design and Technology from Georgia State University.

Course Information: This course provides important concepts in quality control that are useful to laboratory personnel who report patient results. Topics include: precision, accuracy, sensitivity, specificity, random and systematic errors, standard deviation, and interpretation of quality control results using Levey-Jennings charts, Westgard rules, cumulative summation limits, and Youdon plots.
This course was reviewed October 2012.

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