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Laboratory Operations Flashcards

6 cards from real ASCP 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. Under CLIA, which category of testing has the most stringent regulatory requirements?

    Answer: High complexity testing

    High complexity testing has the most stringent CLIA requirements: qualified laboratory director (MD/PhD/board-certified), technical supervisor, clinical consultant, and testing personnel meeting specific educational and training requirements.

  2. A Levey-Jennings chart is used in laboratory quality management to:

    Answer: Monitor quality control results over time to detect systematic and random errors

    Levey-Jennings charts plot QC results over time against mean plus or minus 1s, 2s, and 3s control limits. Visual patterns (shift, trend, random scatter) help identify systematic errors (bias) and random errors (imprecision).

  3. The coefficient of variation (CV) in laboratory medicine is calculated as:

    Answer: Standard deviation divided by mean, multiplied by 100%

    CV% equals (SD/mean) times 100%. It expresses imprecision as a percentage of the mean, allowing comparison of precision across different tests and concentration levels regardless of the unit of measurement.

  4. Proficiency testing (PT) in CLIA-regulated laboratories is required to:

    Answer: Assess laboratory performance by testing unknown samples against peer group results

    CLIA mandates proficiency testing: laboratories receive unknown samples from PT providers such as CAP or COLA, test them under routine conditions, and submit results. Results are compared to a peer group; a score of 80% or more acceptable results is required; failure triggers corrective action.

  5. The anion gap (AG) is calculated from serum chemistry as:

    Answer: Na+ minus (Cl- plus HCO3-)

    Anion gap equals Na+ minus (Cl- plus HCO3-). Normal range is 8–12 mEq/L (or 12–16 if K+ is included). AG represents unmeasured anions (albumin, phosphate, sulfate, organic acids) and helps classify metabolic acidosis.

  6. When a laboratory method validation study is performed, the acceptable performance criterion for bias (accuracy) is typically compared to:

    Answer: CLIA total allowable error (TEa) limits and clinically meaningful differences

    Method validation bias is judged against total allowable error (TEa) criteria established by CLIA proficiency testing criteria, RCPA, or clinical decision-making requirements. A method is acceptable if bias plus imprecision expressed as total error falls within TEa.