ASCP Laboratory Operations 1

Question 1

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

Accepted Answer

High complexity testing

Answer

Waived testing

Answer

Moderate complexity testing

Answer

Provider-performed microscopy

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

Track patient result turnaround times

Answer

Schedule preventive maintenance

Answer

Record reagent lot numbers

Question 3

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

Accepted Answer

Standard deviation divided by mean, multiplied by 100%

Answer

Mean divided by standard deviation

Answer

Mean minus median

Answer

Range divided by mean

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

Test new employees on procedure knowledge

Answer

Validate new reference ranges

Answer

Monitor patient confidentiality compliance

Question 5

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

Accepted Answer

Na+ minus (Cl- plus HCO3-)

Answer

Na+ plus (Cl- plus HCO3-)

Answer

Na+ plus K+ minus Cl-

Answer

HCO3- minus Cl-

Question 6

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

Accepted Answer

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

Answer

The laboratory's historical mean only

Answer

The manufacturer's package insert values exclusively

Answer

Random peer group performance