CLIA Proficiency Testing & External Quality Assessment Flashcards

What is the primary purpose of Proficiency Testing (PT) under CLIA regulations?

Answer: To evaluate laboratory performance by testing unknown samples and comparing results to peers

Proficiency testing evaluates a laboratory's accuracy by sending unknown samples that must be tested and reported, with results compared to reference values or peer group performance.

Under CLIA, how many proficiency testing events are required per year for regulated analytes?

Answer: Three events per year

CLIA requires laboratories to participate in at least three proficiency testing events per year for each regulated analyte.

How many samples must a CLIA-approved PT program send per testing event for each analyte?

Answer: 5 samples

Each PT event must include at least 5 samples (challenges) per analyte to provide statistically meaningful performance data.

What must a laboratory do if it fails a proficiency testing event for a regulated analyte?

Answer: Conduct an investigation, identify root cause, and implement corrective action

CLIA requires that a laboratory investigate the cause of a PT failure, document findings, and implement corrective action to prevent recurrence.

Under CLIA, laboratories must enroll in a CMS-approved PT program for which category of testing?

Answer: Both moderate- and high-complexity testing for regulated analytes

CLIA requires enrollment in a CMS-approved PT program for regulated analytes tested under both moderate- and high-complexity certificates.

What is the consequence of intentional referral of proficiency testing samples to another laboratory under CLIA?

Answer: Suspension or revocation of the CLIA certificate and civil monetary penalties

Referring PT samples to another laboratory for analysis is strictly prohibited under CLIA and can result in suspension or revocation of the certificate and significant civil monetary penalties.