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

Continuing Education Credits

• P.A.C.E.® Contact Hours: 1 hour(s)
• Florida Board of Clinical Laboratory Science CE Credit Hours -
  Supervision/Administration, Quality Control/Quality Assurance, and Safety: 1 hour(s)

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