CLIA Regulatory Requirements & Documentation 3

Question 1

Which CLIA complexity category requires the most stringent regulatory oversight and personnel requirements?

Accepted Answer

High complexity

Answer

High complexity testing requires the most stringent CLIA requirements for personnel qualifications, QC, and quality assurance.

Question 2

Under CLIA, a laboratory's procedure manual must be reviewed and signed by the laboratory director at least how often?

Accepted Answer

Annually

Answer

CLIA requires the laboratory director to review and sign the procedure manual at least annually.

Question 3

Which of the following is NOT a required element of a CLIA-compliant test procedure document?

Accepted Answer

Expected turnaround time

Answer

Turnaround time is not a required element of a CLIA procedure document, though principle, reference intervals, and limitations are required.

Question 4

Under CLIA, when must a laboratory notify CMS of a change in laboratory director?

Accepted Answer

Within 30 days of the change

Answer

CLIA requires laboratories to notify CMS within 30 days of a change in laboratory director.

Question 5

A CLIA-certified laboratory that intentionally refers proficiency testing samples to another laboratory for analysis is subject to which penalty?

Accepted Answer

Revocation of CLIA certificate

Answer

Referring PT samples to another laboratory for analysis is a serious violation that can result in revocation of the laboratory's CLIA certificate.

(CLIA) Clinical Laboratory Improvement Amendments Certification Practice Test