CLIA Proficiency Testing & External Quality Assessment Flashcards

What score constitutes a 'successful' performance on a single CLIA proficiency testing event?

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.

Which federal agency approves proficiency testing programs for use by CLIA-certified laboratories?

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.

Under CLIA, PT samples must be tested using the same process as patient samples. What does this mean?

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.

What is an 'unsuccessful' PT performance under CLIA for an analyte over a testing period?

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.

If a laboratory does not test an analyte included in a PT program, what must it do?

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.

How long must a laboratory retain PT records under CLIA regulations?

Answer: 2 years

CLIA requires laboratories to retain proficiency testing records for at least 2 years.