Practice Test Geeks(MLS) Medical Laboratory Scientist Practice Test
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Quality Assurance & Standards Flashcards

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  1. Which document type from CLSI provides consensus-based guidelines for laboratory procedures and standardization?

    Answer: EP documents

    CLSI EP (Evaluation Protocol) documents provide standardized methods for evaluating analytical performance characteristics such as precision, accuracy, and interference.

  2. A laboratory notices a gradual upward trend in QC values over 10 days. The MOST likely cause is:

    Answer: Reagent degradation

    A gradual upward trend in QC values over time suggests progressive reagent deterioration, which introduces a systematic drift into the results.

  3. The term 'medical decision level' in QC refers to:

    Answer: A clinically critical concentration used to place QC materials

    Medical decision levels are clinically important concentrations (e.g., a glucose level indicating hypoglycemia) at which QC materials should ideally be targeted.

  4. Which accreditation organization uses the concept of 'deemed status' under CMS to accredit clinical laboratories?

    Answer: CAP

    The College of American Pathologists (CAP) has CMS-deemed status, meaning CAP-accredited laboratories are considered compliant with CLIA requirements.

  5. The analytical measurement range (AMR) of an assay defines:

    Answer: The range over which the assay produces accurate results without dilution

    AMR is the range of analyte concentrations that the instrument can directly measure accurately without sample dilution or concentration.

  6. Which statistic is used to assess the agreement between two measurement methods in a Bland-Altman plot?

    Answer: Limits of agreement

    Bland-Altman plots display the mean difference (bias) and limits of agreement (±1.96 SD of differences) between two methods to assess clinical acceptability.

  7. A laboratory verifies a manufacturer's reference interval using 20 healthy individuals. If no more than how many values fall outside the interval is the range considered acceptable?

    Answer: 2

    CLSI EP28-A3c guidelines allow up to 2 of 20 (10%) reference interval values to fall outside the interval when verifying a manufacturer's claimed range.