Regulatory Requirements & Documentation Flashcards

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

Answer: High complexity

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

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

Answer: Annually

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

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

Answer: Expected turnaround time

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

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

Answer: Within 30 days of the change

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

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

Answer: Revocation of CLIA certificate

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

What is the minimum number of quality control samples that must be run each day of patient testing for a quantitative test under CLIA?

Answer: Two controls at different levels

CLIA requires at least two levels of controls (e.g., normal and abnormal) to be run each day patient testing is performed for quantitative tests.

Which CLIA standard requires laboratories to have a written policy addressing the handling of test results that fall outside established reference ranges?

Answer: Quality system essentials

CLIA's quality system essentials require written policies for managing critical or out-of-range results, including notification procedures.