CMT Laboratory Quality Control and Management

Question 1

What is the primary purpose of running quality control (QC) samples in a clinical laboratory?

Accepted Answer

To monitor the precision and accuracy of test results

Answer

To calibrate analytical instruments

Answer

To train new laboratory staff on procedures

Answer

To document and archive patient results

Question 2

Which Westgard rule is triggered when a single control value exceeds the mean ± 3 standard deviations, indicating a random error?

Accepted Answer

1₃s rule

Answer

2₂s rule

Answer

R₄s rule

Answer

4₁s rule

Question 3

In laboratory quality management, what does 'accuracy' specifically refer to?

Accepted Answer

How close a measurement is to the true or accepted reference value

Answer

The reproducibility of repeated measurements under the same conditions

Answer

The range of values that includes 95% of a reference population

Answer

The lowest analyte concentration an instrument can reliably detect

Question 4

What does the coefficient of variation (CV) primarily assess in laboratory quality control?

Accepted Answer

Imprecision (random error) of an analytical method

Answer

Accuracy of a method compared to a reference method

Answer

Bias between two analytical methods

Answer

The linearity of an assay across its reportable range

Question 5

Which federal agency administers and enforces CLIA regulations for clinical laboratory quality standards in the United States?

Accepted Answer

Centers for Medicare & Medicaid Services (CMS)

Answer

The Joint Commission (TJC)

Answer

College of American Pathologists (CAP)

Answer

American Society for Clinical Pathology (ASCP)

Question 6

When a Westgard 2₂s rule is triggered (two consecutive controls exceed ±2 SD in the same direction), what type of error is most likely present?

Accepted Answer

Systematic error

Answer

Random error

Answer

Gross error

Answer

Pre-analytical error

Question 7

What is the primary purpose of proficiency testing (PT) in clinical laboratories?

Accepted Answer

To compare a laboratory's performance with peer laboratories using unknown samples

Answer

To evaluate individual laboratory employee competency

Answer

To validate new equipment before it is placed into service

Answer

To establish reference ranges for newly implemented assays