CAP Pro Course - Laboratory Management - New Test Method Validation/Verification

Continuing Education Credits

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

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 vs 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
• Physicians want the laboratory to start performing amylase body fluid testing. The manufacturer makes no claim regarding any fluid testing other than ...
• What are some ways a laboratory could test and document the absence of matrix-related bias in body fluids?
• Which of the following processes should a laboratory include when validating a new test system versus verifying a new test system?
• A laboratory is in the process of changing to a different method for analyzing urine amphetamines. Which tool can the laboratory use to compare qualit...
• Choose an appropriate performance standard for the analyte being evaluated.
• Recognizing Acceptable Analytical Performance
• Total Error and Allowable Total Error
• Which is included in the formula for calculating the total error of a test method?
• What is a crucial step in the medical director's decision as to whether to accept a new method for glucose testing?
• A laboratory reported an acetaminophen of 49.05 µg/mL on a proficiency testing (PT) survey. The total allowable error for acetaminophen is ±...
• The laboratory medical director is trying to determine if the total error for amylase testing is acceptable. The allowable error is 6.0. The systemati...
• What is the correct formula to use when determining the total error of a test method?
• 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 (SD) and Coefficient of Variation (CV)
• Statistical Analysis of the Data Determine 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
• What does the bullseye image represent?
• A laboratory performed a precision study for a total protein assay. An SD of 1.0 mg/dL was produced. What other information does the laboratory need t...
• The chemistry supervisor reviewed the method performance data for albumin. The supervisor questioned the %CV for albumin. What %CV would represent goo...
• The laboratory medical director is reviewing the evaluation of a new test method for potassium. What tool can the director use to help make an objecti...
• A laboratory is bringing in new haptoglobin testing and needs to evaluate the assay for precision. How many different concentration levels should the ...
• The State Laboratory is in the process of verifying the accuracy of a creatinine test. How many samples should be used spanning the reportable range o...
• Determine the reportable range and reference intervals.
• Reportable Range/ Analytical Measurement Range (AMR) Verification
• Reference Interval Verification
• What is the set of limits used to interpret patient test results?
• When bringing in a new test method that will only be performed on males, what is the best way to perform a reference interval (reference range) study?
• When evaluating 20 healthy individuals for a reference interval (reference range) verification study, two values fall outside acceptable limits. What ...
• A laboratory is internalizing myoglobin testing and needs to evaluate the reference interval (reference range) for the new assay. How many samples sho...
• What term best describes the range of analyte values that a method can be directly measured without dilution, concentration, or other pretreatment?
• A laboratory is internalizing carbamazepine testing and needs to evaluate the new assay's analytical measurement range (AMR). What is the minimum numb...
• References
• References

Additional Information