CAP Pro Course - Laboratory Management - Monitoring the Quality Control Program

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Author: Sheryl A. Whitlock, MA.Ed, MT(ASCP) BB
Reviewer: Alexandru Casapu, MBA, MLS(ASCP)CM, PBTCM

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 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 laboratory director is reviewing the quality control strategy. Which of the following represents components that the laboratory director should be...
      • A new instrument is installed in the immunology laboratory. The section supervisor is working to establish the QC protocol. He is determining the plac...
      • The shift supervisor performs a weekly review of quality control graphs. The previous review was noted as acceptable. The supervisor notes a change in...
      • Which of the following errors would not be detected even with a comprehensive QC program?
  • 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
      • The laboratory has received a new lot of quality control. In reviewing the package insert, the supervisor cannot find the intended target and ranges. ...
      • The laboratory manager is selecting new quality control material for the chemistry analyzer from a new vendor. Which of the following represents an ap...
      • The chemistry laboratory is collecting data to validate the manufacturer's assay range for a new lot of control material. The testing was run in paral...
  • 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 supervisor has reviewed the monthly QC for all analytes. For calcium, the QC results for the last seven days of the month were below the mean. Var...
      • The hematology department utilizes mean corpuscular volume (MCV) as a delta check. A patient who was in the hospital for four days had the MCV delta c...
      • Which of the following Westgard multi rules will assess random error?
      • Which of the following factors may be attributed to random error?
  • Describe proficiency testing process to include alternate testing processes.
      • Proficiency Testing
      • Proficiency Testing Requirements and Process
      • Assessing Performance When Proficiency Testing (PT) Materials Are Not Available
      • The laboratory performs a single method for analyzing genetic testing for tumor markers for rare cancer in children. No commercial proficiency or assa...
      • A new laboratory is ordering proficiency testing (PT). Which of the following reflects a compliant process?
      • A new laboratory in a small physician's office evaluates chemistry and hematology samples. The laboratory has registered for proficiency testing (PT) ...
  • Evaluate proficiency testing results to ensure appropriate follow-up actions are taken.
      • Reviewing Proficiency Testing (PT) Results
      • Errors That May Cause Proficiency Testing (PT) Failure
      • Suspension or Deemed Limited Use of Certificate and Requirements for Reinstatement
      • The laboratory manager is writing policies and procedures for performing proficiency testing. Which of the following corrective action steps would be ...
      • The laboratory director is reviewing the most recent proficiency testing event. With two exceptions, the results for each analyte are "Acceptable." Th...
  • References
      • References

Additional Information

Level of Instruction: Intermediate
Intended Audience: This program is designed as an educational and training tool for MLS, MT, and MLT personnel, medical laboratory science students and interns, pathology residents, and practicing pathologists.
Author Information: Sheryl A. Whitlock, MA.Ed, MT(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.
Reviewer Information: Alexandru Casapu, MBA, MLS(ASCP)CM, PBTCM, has over 20 years of experience as a medical laboratory scientist, section supervisor, and laboratory manager. He is the former Director of Clinical Laboratory Technology Program at Georgia Piedmont Technical College. He is currently a Program Director at MediaLab, Inc. Alex holds BS degrees in Biology

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