CLIA Proficiency Testing & External Quality Assessment Flashcards

What must a laboratory do when it receives its PT results from the provider?

Answer: Review results, investigate any failures, and document corrective actions

CLIA requires that laboratories review PT results, investigate any unsatisfactory scores, and document corrective actions taken in response.

Under CLIA, what happens to a laboratory's testing privilege if it has unsuccessful PT performance for a specialty?

Answer: The laboratory may lose its approval to perform testing in that specialty or subspecialty

Unsuccessful PT performance can result in suspension of the laboratory's ability to perform testing in the affected specialty or subspecialty until corrective action is verified.

Which of the following analytes is NOT subject to mandatory CLIA proficiency testing requirements?

Answer: Routine urinalysis microscopy

Routine urinalysis microscopy is not among the regulated analytes for which CLIA mandates PT enrollment; only specific listed analytes require mandatory PT.

For analytes NOT covered by CLIA's mandatory PT list, what must a laboratory do to ensure quality?

Answer: Establish an alternative performance assessment process twice a year

For non-regulated analytes, CLIA requires laboratories to establish and follow alternative performance assessment procedures at least twice per year to ensure accuracy.

Who within the laboratory is responsible for ensuring PT samples are tested within the specified time frame?

Answer: The general supervisor or laboratory director

The general supervisor or laboratory director is responsible for ensuring that PT samples are tested, results are reported, and documentation is completed within the PT provider's deadline.

What is the purpose of including 'graded' versus 'educational' challenges in a PT shipment?

Answer: Graded challenges determine compliance; educational challenges provide learning feedback without affecting scores

Graded challenges count toward official PT performance scores and regulatory compliance, while educational challenges are provided for learning purposes without affecting the laboratory's compliance record.