CMLA Quality Control & Assurance in Laboratory Practices 5

Question 1

Which concept describes the maximum allowable difference between a test result and the true value, combining both systematic and random error?

Accepted Answer

Total allowable error (TEa)

Answer

Total allowable error (TEa) defines the maximum acceptable combination of bias and imprecision, used as the quality goal for a laboratory method.

Question 2

A laboratory receives a proficiency testing challenge with five specimens. Under CLIA, how many must be reported to avoid a potential PT failure?

Accepted Answer

At least three of five (60%)

Answer

CLIA requires at least 80% satisfactory results on a PT challenge, but since graded on a score basis, typically 4/5 or 3/5 passing meets requirements depending on analyte-specific criteria.

Question 3

What is the correct interpretation when a Levey-Jennings chart shows control values scattered randomly above and below the mean with large variability?

Accepted Answer

The method has a random error problem

Answer

Wide, random scatter of control values above and below the mean indicates random error, often caused by pipetting inconsistencies, temperature fluctuations, or unstable reagents.

Question 4

Which corrective action is most appropriate when a single control value fails the 1-3s rejection rule?

Accepted Answer

Stop patient testing, investigate the cause, and repeat QC before reporting results

Answer

A 1-3s violation is a rejection rule requiring the laboratory to stop reporting, identify the root cause, resolve the issue, and confirm QC is acceptable before continuing.

Question 5

Which of the following is NOT a component of a laboratory quality assurance (QA) program?

Accepted Answer

Patient result billing accuracy

Answer

Billing accuracy is a compliance and revenue cycle function, not a component of the laboratory quality assurance program focused on analytical and clinical quality.

(CMLA) Certified Medical Laboratory Assistant Practice Test

(CMLA) Certified Medical Laboratory Assistant Practice Test

CMLA Quality Control & Assurance in Laboratory Practices 5