CLIA CLIA Proficiency Testing & External Quality Assessment 2 — Questions and Answers
Question 1: What score constitutes a 'successful' performance on a single CLIA proficiency testing event?
- At least 50% of challenges within acceptable limits
- At least 60% of challenges within acceptable limits
- At least 80% of challenges within acceptable limits (Correct answer)
- 100% of challenges must be within acceptable limits
Correct answer: At least 80% of challenges within acceptable limits
CLIA defines successful PT event performance as achieving at least 80% of the graded challenges within the acceptable performance limits for that analyte.
Question 2: Which federal agency approves proficiency testing programs for use by CLIA-certified laboratories?
- FDA
- CDC
- CMS (Correct answer)
- OSHA
Correct answer: CMS
The Centers for Medicare & Medicaid Services (CMS) approves PT programs under CLIA, ensuring they meet regulatory standards for sample composition, grading, and reporting.
Question 3: Under CLIA, PT samples must be tested using the same process as patient samples. What does this mean?
- PT samples must be sent to a reference lab for confirmation
- PT samples must be rotated through all testing personnel
- PT samples must be tested with the same procedures, reagents, and calibrators used for routine patient testing (Correct answer)
- PT samples must be diluted before testing
Correct answer: PT samples must be tested with the same procedures, reagents, and calibrators used for routine patient testing
CLIA requires that PT samples be handled identically to patient samples, using the same routine procedures, reagents, and calibrators, to ensure PT reflects real laboratory performance.
Question 4: What is an 'unsuccessful' PT performance under CLIA for an analyte over a testing period?
- Failing one of three events in a year
- Failing two of three consecutive testing events for the same analyte (Correct answer)
- Failing any single challenge in any event
- Scoring below 90% on two consecutive events
Correct answer: Failing two of three consecutive testing events for the same analyte
Unsuccessful performance is defined as failing two of three consecutive PT events for the same analyte, which triggers mandatory corrective action and potential sanctions.
Question 5: If a laboratory does not test an analyte included in a PT program, what must it do?
- Still report results for that analyte using reference data
- Grade those challenges as unsatisfactory automatically
- Notify the PT provider that it does not test that analyte (Correct answer)
- Withdraw from the PT program entirely
Correct answer: Notify the PT provider that it does not test that analyte
Laboratories must notify their PT provider of analytes they do not test so those challenges can be excluded from grading rather than counted as failures.
Question 6: How long must a laboratory retain PT records under CLIA regulations?
- 1 year
- 2 years (Correct answer)
- 5 years
- 10 years
Correct answer: 2 years
CLIA requires laboratories to retain proficiency testing records for at least 2 years.
CLIA CLIA Proficiency Testing & External Quality Assessment 2
What score constitutes a 'successful' performance on a single CLIA proficiency testing event?