CLIA Laboratory Quality Systems & Compliance 3

Question 1

A laboratory implements a Levey-Jennings chart for monitoring QC data. Which Westgard rule flags a systematic error when one control result exceeds the mean by more than 2 standard deviations?

Accepted Answer

1-2s warning rule

Answer

The 1-2s rule is a warning rule triggered when one control exceeds ±2 SD and prompts closer scrutiny but not automatic rejection.

Question 2

Under CLIA, which of the following is considered an unacceptable proficiency testing practice?

Accepted Answer

Referring PT samples to another laboratory for analysis

Answer

Referring PT samples to another lab for testing is explicitly prohibited by CLIA and can result in sanctions.

Question 3

Which element is part of the CLIA quality systems framework for the pre-analytic phase?

Accepted Answer

Specimen labeling and collection procedures

Answer

Specimen labeling and collection are pre-analytic processes governed by the CLIA quality systems framework.

Question 4

A laboratory's reagent lot is changed for a high-complexity assay. What validation step is MOST critical before using the new lot for patient testing?

Accepted Answer

Recalibrate using the new lot and verify acceptability

Answer

Reagent lot changes require recalibration and verification that results remain within acceptable limits before patient use.

Question 5

Which term describes the measure of a test's ability to detect true positives?

Accepted Answer

Sensitivity

Answer

Sensitivity (clinical sensitivity) is the proportion of true disease cases correctly identified as positive by the test.

(CLIA) Clinical Laboratory Improvement Amendments Certification Practice Test

(CLIA) Clinical Laboratory Improvement Amendments Certification Practice Test

CLIA Laboratory Quality Systems & Compliance 3