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

Waived

Answer

Moderate complexity

Answer

Provider-performed microscopy

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

Every 6 months

Answer

Every 2 years

Answer

Only when procedures change

Question 3

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

Accepted Answer

Expected turnaround time

Answer

Principle of the procedure

Answer

Reference interval (normal values)

Answer

Limitations of the method

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

Before the change occurs

Answer

Within 90 days of the change

Answer

At the next scheduled inspection

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

Warning letter only

Answer

Fine up to $1,000

Answer

Mandatory retraining

Question 6

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

Accepted Answer

Two controls at different levels

Answer

One control at any level

Answer

Three controls at different levels

Answer

Four controls spanning the reportable range

Question 7

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

Accepted Answer

Quality system essentials

Answer

Personnel standards

Answer

Proficiency testing standards

Answer

Test system validation