CLIA Laboratory Quality Systems & Compliance 5

Question 1

Under CLIA, which action constitutes 'PT referral' and is grounds for sanctions?

Accepted Answer

Sending PT samples to a reference lab for testing

Answer

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?

Accepted Answer

Pre-analytic phase

Answer

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?

Accepted Answer

Documents and records

Answer

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?

Accepted Answer

Coefficient of variation (CV)

Answer

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?

Accepted Answer

30 days

Answer

CLIA requires laboratories to notify their state agency within 30 days when a laboratory director vacancy occurs.

(CLIA) Clinical Laboratory Improvement Amendments Certification Practice Test

(CLIA) Clinical Laboratory Improvement Amendments Certification Practice Test

CLIA Laboratory Quality Systems & Compliance 5