ASCP Laboratory Operations

Question 1

Under CLIA, which category of testing has the most stringent regulatory requirements?

Accepted Answer

High complexity testing

Answer

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.

Question 2

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

Accepted Answer

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

Answer

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).

Question 3

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

Accepted Answer

Standard deviation divided by mean, multiplied by 100%

Answer

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.

Question 4

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

Accepted Answer

Assess laboratory performance by testing unknown samples against peer group results

Answer

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.

Question 5

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

Accepted Answer

Na+ minus (Cl- plus HCO3-)

Answer

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.

ASCP Practice Test

ASCP Practice Test

ASCP Laboratory Operations