CLC Laboratory Operations & Quality Management 3

Question 1

A laboratory's turnaround time (TAT) for STAT troponin consistently exceeds its target of 60 minutes. Which quality improvement tool would best identify the root causes of delays?

Accepted Answer

Pareto chart

Answer

A Pareto chart ranks the most frequent causes of delay in descending order, helping prioritize which factors contribute most to TAT failures.

Question 2

Which CLSI guideline specifically addresses laboratory method comparison and bias estimation?

Accepted Answer

EP9-A3 (Measurement Procedure Comparison and Bias Estimation)

Answer

CLSI EP9-A3 provides guidelines for comparing patient sample results between two measurement procedures to estimate bias.

Question 3

Under OSHA's Bloodborne Pathogens Standard (29 CFR 1910.1030), which control measure has the highest priority in the hierarchy of controls?

Accepted Answer

Engineering controls such as needleless systems and sharps containers

Answer

Engineering controls are the highest-priority control measure under the Bloodborne Pathogens Standard because they eliminate or isolate the hazard at the source.

Question 4

A laboratory consultant is asked to evaluate a new point-of-care glucose meter for use in an ICU. Which factor is LEAST relevant to the regulatory assessment?

Accepted Answer

The color of the meter casing and display screen

Answer

Physical appearance has no regulatory relevance; CLIA complexity classification, QC requirements, and training are all regulatory considerations.

Question 5

When calculating the sigma metric for a laboratory test, which four parameters are used?

Accepted Answer

Bias, CV, allowable total error (TEa), and the formula: (TEa − |Bias|) / CV

Answer

Sigma = (TEa − |Bias|) / CV, where TEa is the allowable total error, Bias is the systematic error, and CV is the imprecision expressed as a coefficient of variation.

(CLC) Certified Laboratory Consultant Practice Test

(CLC) Certified Laboratory Consultant Practice Test

CLC Laboratory Operations & Quality Management 3