CLIA CLIA Proficiency Testing & External Quality Assessment 1 — Questions and Answers
Question 1: What is the primary purpose of Proficiency Testing (PT) under CLIA regulations?
- To train new laboratory staff
- To evaluate laboratory performance by testing unknown samples and comparing results to peers (Correct answer)
- To audit a laboratory's financial operations
- To certify laboratory equipment manufacturers
Correct 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.
Question 2: Under CLIA, how many proficiency testing events are required per year for regulated analytes?
- One event per year
- Two events per year
- Three events per year (Correct answer)
- Five events per year
Correct answer: Three events per year
CLIA requires laboratories to participate in at least three proficiency testing events per year for each regulated analyte.
Question 3: How many samples must a CLIA-approved PT program send per testing event for each analyte?
- 2 samples
- 5 samples (Correct answer)
- 8 samples
- 10 samples
Correct answer: 5 samples
Each PT event must include at least 5 samples (challenges) per analyte to provide statistically meaningful performance data.
Question 4: What must a laboratory do if it fails a proficiency testing event for a regulated analyte?
- Immediately suspend testing for that analyte and notify CMS
- Conduct an investigation, identify root cause, and implement corrective action (Correct answer)
- Simply retest the PT samples using a different method
- Contact the PT provider and request a score adjustment
Correct 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.
Question 5: Under CLIA, laboratories must enroll in a CMS-approved PT program for which category of testing?
- Waived testing only
- Moderate-complexity testing only
- High-complexity testing only
- Both moderate- and high-complexity testing for regulated analytes (Correct answer)
Correct 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.
Question 6: What is the consequence of intentional referral of proficiency testing samples to another laboratory under CLIA?
- A written warning for the first offense
- Suspension or revocation of the CLIA certificate and civil monetary penalties (Correct answer)
- Mandatory enrollment in additional PT programs
- A temporary increase in laboratory inspection frequency
Correct 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.
CLIA CLIA Proficiency Testing & External Quality Assessment 1
What is the primary purpose of Proficiency Testing (PT) under CLIA regulations?