Practice Test Geeks(CLIA) Clinical Laboratory Improvement Amendments Certification Practice Test
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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.

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  1. Which statistical measure is used to assess the systematic error (bias) of a new method compared to a reference method during method validation?

    Answer: Inaccuracy

    Inaccuracy measures systematic error (bias) — the difference between the new method's mean result and the true or reference value.

  2. Under CLIA, when must a laboratory re-validate a test method?

    Answer: When there is a significant change in reagents, equipment, or methodology

    CLIA requires re-verification or re-validation whenever a significant change occurs in reagent lots, equipment, or the testing process itself.

  3. The Westgard 1₃s rule is violated when:

    Answer: One control value exceeds ±3 SD

    The 1₃s rule is a warning/rejection rule triggered when a single control result falls outside ±3 standard deviations of the mean.

  4. What is the primary purpose of performing a linearity study during method validation?

    Answer: To confirm the method produces accurate results across its reportable range

    A linearity study verifies that the method produces results proportional to analyte concentration across the claimed analytical measurement range.

  5. A laboratory introduces a new whole blood glucose analyzer. According to CLIA, what is the minimum number of patient samples required for a comparison-of-methods experiment?

    Answer: 40

    CLIA guidance (and CLSI EP09) recommends a minimum of 40 patient samples spanning the analytical range for a method comparison study.

  6. Which interferent category encompasses endogenous substances such as bilirubin, hemoglobin, and lipids that may affect test results?

    Answer: Endogenous interferents

    Endogenous interferents are substances naturally present in the specimen that can falsely elevate or suppress analyte measurements.

  7. When verifying the reference interval for a non-waived quantitative test, CLIA guidelines suggest using a minimum of how many healthy reference subjects?

    Answer: 20

    CLIA and CLSI recommend verifying a manufacturer's reference interval with at least 20 healthy reference individuals.