CLIA Laboratory Quality Systems & Compliance 2

Question 1

Under CLIA, how long must a laboratory retain quality control records?

Accepted Answer

2 years

Answer

CLIA requires laboratories to retain quality control records for at least 2 years.

Question 2

A laboratory's proficiency testing (PT) sample is tested by the same method used for patient samples but the result is graded as unsatisfactory. What is the FIRST required action?

Accepted Answer

Investigate and document the cause of failure

Answer

Laboratories must investigate and document the root cause of PT failure before taking corrective action.

Question 3

Which CLIA category requires the highest level of quality control and personnel qualifications?

Accepted Answer

High complexity tests

Answer

High complexity testing carries the most stringent CLIA requirements for personnel, QC, and proficiency testing.

Question 4

A new analytic method is being validated before clinical use. Which parameter evaluates how closely results agree with a reference method?

Accepted Answer

Accuracy

Answer

Accuracy measures agreement between the new method's results and a reference or true value.

Question 5

Under CLIA, who is responsible for the overall operation and administration of a laboratory?

Accepted Answer

Laboratory director

Answer

The laboratory director bears ultimate responsibility for all aspects of laboratory operation under CLIA.

(CLIA) Clinical Laboratory Improvement Amendments Certification Practice Test

(CLIA) Clinical Laboratory Improvement Amendments Certification Practice Test

CLIA Laboratory Quality Systems & Compliance 2