CLIA Laboratory Quality Systems & Compliance 5 — Questions and Answers
Question 1: Under CLIA, which action constitutes 'PT referral' and is grounds for sanctions?
- Sending PT samples to a reference lab for testing (Correct answer)
- Reviewing PT performance reports with staff
- Retesting failed PT specimens using an alternative in-house method
- Submitting PT results by the provider's deadline
Correct answer: Sending PT samples to a reference lab for testing
Sending PT samples to another laboratory for analysis is prohibited PT referral under CLIA regulations.
Question 2: A laboratory's performance improvement plan identifies a recurring specimen rejection rate of 8% for hemolyzed samples. This type of improvement initiative targets which phase of testing?
- Analytic phase
- Post-analytic phase
- Pre-analytic phase (Correct answer)
- Proficiency testing phase
Correct answer: Pre-analytic phase
Hemolysis occurs due to pre-analytic issues such as collection technique, transport, or handling—not the testing process itself.
Question 3: A CLIA inspection finds that a laboratory's standard operating procedures (SOPs) have not been reviewed or signed by the laboratory director for 3 years. This is a deficiency in which quality system element?
- Documents and records (Correct answer)
- Proficiency testing
- Equipment maintenance
- Personnel competency
Correct answer: Documents and records
CLIA requires that SOPs be reviewed and approved by the laboratory director at least every 2 years, making this a documents and records deficiency.
Question 4: Which statistical measure expresses the degree of agreement between repeated measurements of the same sample and reflects precision?
- Coefficient of variation (CV) (Correct answer)
- Bias
- Sensitivity
- Likelihood ratio
Correct answer: Coefficient of variation (CV)
The coefficient of variation (CV) expresses the standard deviation as a percentage of the mean, quantifying imprecision across repeated measurements.
Question 5: Under CLIA, a laboratory must notify CMS within how many days if the laboratory director position becomes vacant?
- 10 days
- 30 days (Correct answer)
- 60 days
- 90 days
Correct answer: 30 days
CLIA requires laboratories to notify their state agency within 30 days when a laboratory director vacancy occurs.
Question 6: Which CLIA requirement mandates that a laboratory establish and verify reference intervals (normal ranges) for each test it performs?
- Proficiency testing enrollment
- Method validation (Correct answer)
- Calibration verification
- Personnel qualification
Correct answer: Method validation
Method validation under CLIA includes establishing or verifying reference intervals appropriate for the laboratory's patient population.
Question 7: A cytology laboratory's workload for a cytotechnologist exceeds the CLIA-mandated slide limit. Which CLIA standard is being violated?
- Proficiency testing frequency requirement
- Cytology workload limitation (Correct answer)
- Quality control frequency standard
- Personnel qualification minimum
Correct answer: Cytology workload limitation
CLIA sets a maximum of 100 gynecologic slides per 24-hour period for cytotechnologists to prevent fatigue-related errors.
CLIA Laboratory Quality Systems & Compliance 5
Under CLIA, which action constitutes 'PT referral' and is grounds for sanctions?