Practice Test Geeks(CLIA) Clinical Laboratory Improvement Amendments Certification Practice Test
← All CLIA Flashcard Decks

Testing Procedures & Method Validation Flashcards

7 cards from real CLIA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

Read the first 7 Testing Procedures & Method Validation flashcards as text

  1. A technologist performing a glucose assay obtains QC results of 98 mg/dL and 102 mg/dL for a control with a mean of 100 mg/dL and SD of 3 mg/dL. Which Westgard rule applies?

    Answer: Within acceptable limits — no rule violated

    Both values fall within ±2 SD of the mean (±6 mg/dL), so no Westgard warning or rejection rule is triggered.

  2. What is 'carryover' in the context of analytical testing, and why is it evaluated during method validation?

    Answer: The transfer of analyte from a high-concentration sample to a subsequent low-concentration sample, potentially causing falsely elevated results

    Carryover occurs when residual analyte from a previous high-concentration sample contaminates the next sample, and it must be evaluated to prevent false results.

  3. Which parameter best describes a method's ability to detect small differences in analyte concentration between two samples?

    Answer: Analytical sensitivity

    Analytical sensitivity refers to the ability of a method to detect small changes in analyte concentration, often expressed as the slope of the calibration curve.

  4. When validating a laboratory-developed test (LDT) for a high-complexity analyte, which performance characteristic is NOT required by CLIA to be established?

    Answer: Cost per test

    CLIA mandates validation of accuracy, precision, reportable range, reference intervals, and interferences, but cost per test is a business consideration, not a regulatory requirement.

  5. A laboratory is validating a new serum creatinine method. Specimens with creatinine >10 mg/dL are routinely diluted 1:5. The laboratory must verify that:

    Answer: The dilution protocol does not alter the matrix significantly and diluted results are accurate

    When dilution extends the reportable range, the laboratory must verify that the dilution protocol maintains accuracy and does not introduce matrix-dependent errors.

  6. Which statistical test is most appropriate for comparing bias between a new method and a comparative (reference) method in a method comparison study?

    Answer: Paired t-test or Deming regression

    Paired t-tests assess average bias between methods, and Deming (or Passing-Bablok) regression accounts for error in both methods during comparison.

  7. According to CLIA, for non-waived tests, how long must a laboratory retain records of quality control results?

    Answer: 2 years

    CLIA requires non-waived laboratories to retain QC records for a minimum of 2 years.