Introduction to Quality Control

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Authors: Jean Houger Hengesbaugh, MS, CLS(NCA) and Brad Westover, BS
Reviewer: Patrick Tracy, MA, MLS(ASCP)

This course presents the basics of quality control in the clinical laboratory. Topics include assayed and unassayed controls, Levey-Jennings plots, Westgard rules, and standard deviation.

Continuing Education Credits

Objectives

  • Explain the purpose of a quality control program.
  • Define assayed and unassayed controls and the advantages/disadvantages of each type.
  • Discuss various quality control tools.
  • Prepare a Levey-Jennings control chart.
  • Explain the Westgard QC multi-rule approach.
  • Define random and systematic errors and causes for each.
  • Define accuracy and precision and discuss the statistical tools that are used to monitor each.

Course Outline

  • Introduction to Quality Control
      • Quality Control and a Quality Control Plan
      • Which of the following may be included in a quality control plan?
  • Quality Control Tools
      • Quality Control Tools
      • Intralaboratory (Internal) Quality Control
      • Assayed and Unassayed Controls
      • Internal Quality Control Program
      • Determining the Frequency for QC Testing
      • Additional Variables
      • Instrument Maintenance
      • Record Keeping
      • External Quality Assessment
      • Commercially available control materials for some laboratory instruments or method systems may be assayed or unassayed. Both will monitor the accuracy...
      • If a laboratory is part of a system, it can compare its proficiency testing (PT) results with other laboratories in the system prior to submitting the...
      • Delta Checks
  • Statistical Analysis of Control Data
      • Accuracy and Precision
      • Mean and Standard Deviation
      • Calculating Acceptable Ranges
      • Calculating Acceptable Ranges, continued
      • Coefficient of Variation
      • Choose, for each statement, to what it refers to: the mean, standard deviation, or coefficient of variation.
      • For a certain method, a control has a mean result of 12 with a standard deviation (SD) of 2. What is the acceptable 95% range for this control?
  • Quality Control Charts
      • Levey-Jennings Quality Control Charts
      • Random and Systematic Error
      • Random and Systematic Errors, continued
      • Westgard Multi-Rule Approach
      • Westgard Multi-Rule Approach, continued
      • Responding to Out-of-Control Results
      • Which type of error does each rule usually detect?
      • A laboratory uses these Westgard QC rules as criteria for rejecting an analytical run: 13s, 22s, and R4sThe top chart is for control #1 and the bottom...
  • References
      • References

Additional Information

Level of instruction: Basic

Intended Audience: Medical Laboratory Scientists, Medical Laboratory Technicians, and students in MLS and MLT programs.  
 
Course Information: This course provides important basic concepts in quality control that are useful to laboratory personnel who report patient results. Topics include precision, accuracy, random and systematic errors, standard deviation, mean, and coefficient of variation, quality control tools, and an overview of the Westgard multi-rule approach for evaluating QC results. 
 
Author information: Brad Westover received his BS in Physics in 2006 from the California Institute of Technology. He is currently pursuing a Ph. D. at the University of California, San Diego.
 
Reviewer Information: Patrick Tracy, MA, MT (ASCP), has been an MLT program director since 2012. His teaching experience has been in student labs, both face to face and online. His contribution to medical-laboratory education is most pronounced by his microbiology, blood bank and chemistry YouTube channel.

This course is part of:
Compliance & CE
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