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Laboratory Operations & Quality Management Flashcards

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

Read the first 7 Laboratory Operations & Quality Management flashcards as text

  1. A laboratory is transitioning from paper-based to electronic laboratory information system (LIS) records. Which federal regulation governs the retention of laboratory records?

    Answer: CLIA 42 CFR 493.1105 (Retention Requirements)

    CLIA regulations at 42 CFR 493.1105 specify minimum retention periods for laboratory records, including test requisitions, results, and QC data.

  2. Which statistical measure best describes the random error component of a laboratory test's analytical performance?

    Answer: Coefficient of variation (CV%)

    The coefficient of variation (CV%) expresses imprecision as a percentage of the mean, quantifying the random error component of analytical performance.

  3. A laboratory's wastewater contains formalin from histology processing. Which agency primarily regulates disposal of this chemical into the municipal sewer system?

    Answer: EPA (Environmental Protection Agency) via local POTW permits

    The EPA regulates chemical discharge into public water systems; local publicly owned treatment works (POTWs) issue permits governing formalin disposal limits.

  4. During a FMEA (Failure Mode and Effects Analysis) exercise, the team calculates a Risk Priority Number (RPN). Which formula is used?

    Answer: RPN = Severity × Occurrence × Detectability

    RPN is calculated by multiplying Severity, Occurrence, and Detectability scores, each rated 1–10, to prioritize failure modes for corrective action.

  5. A hospital laboratory is considering offering a new esoteric test. Which scenario would qualify the test as a laboratory-developed test (LDT) rather than an FDA-cleared assay?

    Answer: The laboratory modifies the specimen type specified in the FDA-cleared package insert

    Any modification to an FDA-cleared assay—including specimen type, reagent, or instrumentation changes—converts it to an LDT subject to different regulatory requirements.

  6. A CLC reviews a laboratory's personnel records and finds that a medical laboratory scientist (MLS) has not completed annual competency assessment in phlebotomy for 14 months. Under CLIA, what is the maximum allowable interval for competency assessment of testing personnel?

    Answer: Annually (every 12 months)

    CLIA requires competency assessment for testing personnel at least annually (every 12 months) for all testing performed.

  7. Which of the following best describes a 'critical value' in laboratory medicine?

    Answer: A result that represents a life-threatening physiological state requiring immediate clinical notification

    Critical values represent results at life-threatening thresholds that must be reported immediately to a responsible healthcare provider for urgent clinical action.