CAP Pro Course - Laboratory Management - Monitoring the Quality Control Program (2026 & 2027)

Author: Sheryl A. Whitlock, MAEd, MLS(ASCP)BB
Reviewer: Joshua J. Cannon, MS, MLS(ASCP)CMSHCM

Continuing Education Credits

Objectives

  • Describe how to develop a quality control (QC) strategy.
  • Select appropriate QC materials and describe the process for establishing QC ranges.
  • Analyze QC results and suggest appropriate corrective action.
  • Describe the proficiency testing process to include alternate testing processes.
  • Evaluate proficiency testing results to ensure appropriate follow-up actions are taken.

Course Outline

  • Describe how to develop a quality control (QC) strategy.
      • The Purpose of Quality Control
      • Quality Control Strategy
      • QC Strategy: Position of Control Samples in an Analytic Run
      • Testing Frequency for Controls
      • QC Strategy: Recognizing Systematic and Random Errors
      • CLIA Requirements for QC Testing: Waived and Nonwaived Testing
      • CLIA Requirements for QC Testing: Frequency and Number of QC Materials
      • CLIA Requirements for QC Testing: Alternate QC Procedures
      • Six Sigma
      • The chemistry supervisor is reviewing the monthly quality control graphs. The attached graph for one of the analytes was included. Which of the follow...
      • The manager is working to establish a sigma score for each analyte on the chemistry analyzer. What does a sigma score of 5 imply for the analysis?
      • You observe a change in the mean of your monthly low control. Which type of error is most likely affected?
      • The lead technologist is reviewing the quality control (QC) graph shown on the right, which represents ten days of QC testing for one level of control...
  • Select appropriate QC materials and describe the process for establishing QC ranges.
      • Choosing Appropriate Control Materials
      • Liquid Controls versus Lyophilized Controls
      • Assayed and Unassayed Controls
      • Collecting Data for Calculating Control Ranges
      • Setting the Control Range
      • Setting the Control Range, continued
      • Verifying Ranges of Assayed Controls
      • Establishing QC Ranges for Unassayed Controls
      • Choosing QC Materials for Qualitative Tests That Use a Cutoff Value
      • A new lot of quality control is being implemented for all chemistry analytes. Ranges for each control are being established. The mean of the calcium c...
      • The lead technologist is setting up a new qualitative test method based on quantitative measurement. The technologist is evaluating the control materi...
      • You need to establish control ranges for unassayed liquid controls from a new vendor (Note: these are liquid and not lyophilized controls). You will b...
  • Analyze QC results and suggest appropriate corrective action.
      • Quality Control Rules
      • Reviewing QC
      • Reviewing QC Results and Implementing Corrective Action
      • Adjusting the Mean
      • Delta Checks
      • The quality control review revealed the graph on the right. The supervisor is reviewing this with all testing personnel and requesting assistance with...
      • On the weekly QC review, the graph at the right was noted on one analyte. This graph is referred to the laboratory manager for review as the technolog...
      • The instrument operator for the day has obtained unacceptable control results for a certain analyte, with both levels of control between 2 and 3 stand...
      • You are the supervisor for the automated chemistry bench reviewing the monthly QC. A portion of the data is shown on the chart to the right. Your labo...
  • Describe the proficiency testing process to include alternate testing processes.
      • Proficiency Testing
      • Proficiency Testing Requirements and Process
      • Assessing Performance When Proficiency Testing Materials Are Not Available
      • A set of proficiency testing samples is being tested. Two samples yielded all results within the laboratory's published normal range, and no flags wer...
      • A technologist working alone is unsure of the low analyte value obtained on a single proficiency testing sample. The result was outside of the normal ...
      • A laboratory is performing a test for which no proficiency testing materials are available. It is an esoteric test with few abnormal results, making i...
  • Evaluate proficiency testing results to ensure appropriate follow-up actions are taken.
      • Reviewing Proficiency Testing Results
      • Errors That May Cause Proficiency Testing Failure
      • Suspension or Deemed Limited Use of Certificate and Requirements for Reinstatement
      • Proficiency testing results are returned to the laboratory director. One event is "Unscored" with a comment "Lack of Consensus." Which of the followin...
      • A small laboratory has had three unsuccessful PT events for electrolytes. All remaining analytes and test specialties have had successful PT. They hav...
  • References
      • References

Additional Information

Level of Instruction: Intermediate
Intended Audience: Medical laboratory scientists, medical laboratory technicians, laboratory supervisors, and laboratory managers. This course is also appropriate for MLS and MLT students and pathology residents.
Author Information: Sheryl A. Whitlock, MAEd, MLS(ASCP)BB is the owner of ARK Laboratory Consulting, LLC and a part time technical consultant for McKesson. Sheryl served as the laboratory coordinator for the Student Health Services Laboratory at the University of Delaware for 15 years. Sheryl received her master’s degree in Education from Arcadia University. She has more than 35 years of experience in laboratory science to include management, education, and hands-on bench experience. She has written and published textbooks and laboratory manuals as well as having contributed to numerous online and print articles in the field of laboratory medicine.
The author has no conflict of interest to disclose.  
Reviewer Information: Joshua J. Cannon, MS, MLS(ASCP)CMSHCM received his Bachelor of Science and Master of Science in Medical Laboratory Science from Thomas Jefferson University in Philadelphia, PA. He holds Medical Laboratory Scientist and Specialist in Hematology certifications through the ASCP Board of Certification. He was a professor at Thomas Jefferson University for seven years before transitioning into his current role as Education Developer at MediaLab by Vastian. His areas of expertise and professional passions include clinical hematology and interprofessional education.

This course is part of the CAP Competency Assessment Hub.

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