CAP Pro Course - Laboratory Management - New Test Method Validation/Verification (2026 & 2027)

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

• Determine when a complete method validation is necessary and when performance verification is sufficient prior to implementing a new test method.
• Choose an appropriate performance standard for the analyte being evaluated.
• Determine the precision, accuracy, and total error of the test method and explain how to use this information to decide whether to accept the method.
• Determine the reportable range and reference intervals.

Course Outline

• Determine when a complete method validation is necessary and when performance verification is sufficient prior to implementing a new test method.
• Validation versus Verification
• Evaluation for a Qualitative Method
• Method Validation for Specimens Other Than Those Approved by the Test Method Manufacturer
• Other Situations When Method Verification is Required
• Primary Responsibilities Related to Method Validation/Verification
• A test system has been modified by the laboratory. What validation steps are required before the test is implemented for patient testing?
• A particular laboratory wants to start performing body fluid testing on its chemistry analyzers. The manufacturer makes no claim that the method proce...
• Several physicians have requested peritoneal fluid testing for amylase. The method manufacturer has only evaluated serum or plasma for amylase testing...
• In the United States, regulatory agencies or organizations work together to ensure that clinical laboratories validate their nonwaived methods. Which ...
• Choose an appropriate performance standard for the analyte being evaluated.
• Recognizing Acceptable Analytical Performance
• Total Error and Allowable Total Error
• The proficiency testing (PT) requirement for creatinine has an allowable error of ± 0.3 mg/dL or 15%. What is the allowable error for the upper a...
• What is the best description of a medical decision point when deciding whether to accept a new method or instrument validation?
• What is the ultimate decision tool a laboratory should use in its acceptance and implementation of a new quantitative test method?
• What does a "critical concentration" refer to in the context of method evaluation?
• The laboratory is going to implement a new test method. Choose the correct order of steps in which they should occur in the process.
• Determine the precision, accuracy, and total error of the test method and explain how to use this information to decide whether to accept the method.
• Determining the Precision of a Test System
• Determining the Accuracy of a Test System
• Standard Deviation and Coefficient of Variation
• Statistical Analysis of the Data Determines Acceptable Accuracy of the Method
• Deciding Whether to Accept a New Method
• How Can a Laboratory be Confident About the Decision to Accept or Reject the Method Being Evaluated?
• Using the Method Decision Chart
• Using the Method Decision Chart, continued
• Documentation of Acceptance of the Validation/Verification Study
• Which of the following is the best value to help the medical director determine the acceptability of a new method?
• The slope from your glucose method comparison is 0.99 and the y-intercept is 2.54 mg/dL. What is the systematic error between the two glucose methods ...
• Which test method validation requirement does the bullseye image represent?
• While performing method verification for a new creatinine procedure, the precision data produces a standard deviation (SD) of 0.5 mg/dL. What does the...
• A laboratory is performing method verification studies for a new potassium procedure by following CLIA guidelines. Which of the following represents t...
• You are performing method verification studies for a new glucose procedure. Which of the following represents the best strategy for verifying the meth...
• Determine the reportable range and reference intervals.
• Reportable Range/Analytical Measurement Range (AMR) Verification
• Reference Interval Verification
• A laboratory uses CLIA guidelines for reference interval verification. Which of the following is not required for each reference range study?
• During the validation process, a laboratory must verify the analytical measurement range (AMR) for each analyte. What samples are appropriate to verif...
• What term best describes a set of limit values used to interpret patient test results?
• The validation process for the drug digoxin is complete except for setting the reference interval (reference range). How would the laboratory evaluate...
• Which of these best defines reportable range (analytical measurement range)?
• The chemistry supervisor is evaluating a new creatine kinase (CK) method. According to the manufacturer, the lower limit of the reportable range is 2....
• References
• References

Additional Information