CLIA Laboratory Quality Systems & Compliance 3 — Questions and Answers
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?
- 1-2s warning rule (Correct answer)
- 1-3s rejection rule
- R-4s rejection rule
- 10x rule
Correct answer: 1-2s warning rule
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?
- Running PT samples with routine patient samples
- Testing PT samples in duplicate
- Referring PT samples to another laboratory for analysis (Correct answer)
- Documenting PT results before the deadline
Correct answer: Referring PT samples to another laboratory for analysis
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?
- Calibration verification
- Delta checking of patient results
- Specimen labeling and collection procedures (Correct answer)
- Reporting reference intervals
Correct answer: Specimen labeling and collection procedures
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?
- Repeat proficiency testing
- Recalibrate using the new lot and verify acceptability (Correct answer)
- File a variance report with CMS
- Obtain physician approval for the lot change
Correct answer: Recalibrate using the new lot and verify acceptability
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?
- Specificity
- Positive predictive value
- Sensitivity (Correct answer)
- Accuracy
Correct answer: Sensitivity
Sensitivity (clinical sensitivity) is the proportion of true disease cases correctly identified as positive by the test.
Question 6: A CLIA inspector finds that a laboratory has not performed annual competency assessments for testing personnel. This deficiency falls under which CLIA quality system component?
- Proficiency testing
- Personnel management (Correct answer)
- Equipment maintenance
- Test method validation
Correct answer: Personnel management
Annual competency assessment of testing personnel is a CLIA personnel management requirement.
Question 7: Which CMS form is used to apply for a CLIA certificate?
- CMS-116 (Correct answer)
- CMS-485
- CMS-1500
- CMS-855B
Correct answer: CMS-116
Form CMS-116, the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification, is used to apply for all CLIA certificate types.
CLIA Laboratory Quality Systems & Compliance 3
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?