CLIA CLIA Certificate Types & Test Complexity Classifications 3

Question 1

If a Certificate of Waiver laboratory begins performing non-waived tests without obtaining the appropriate certificate, what is the regulatory consequence?

Accepted Answer

The lab may face civil monetary penalties and must cease non-waived testing immediately

Answer

The lab receives an automatic upgrade to Certificate of Compliance

Answer

The lab is placed on a 90-day provisional status with no penalty

Answer

CMS issues a warning letter only for a first offense

Question 2

Which federal agency is primarily responsible for implementing and enforcing CLIA regulations?

Accepted Answer

Centers for Medicare & Medicaid Services (CMS)

Answer

Food and Drug Administration (FDA)

Answer

Centers for Disease Control and Prevention (CDC)

Answer

Occupational Safety and Health Administration (OSHA)

Question 3

For a test to qualify for FDA waiver categorization, manufacturers must demonstrate that the risk of an erroneous result is:

Accepted Answer

Negligible and poses no unreasonable risk of harm if performed incorrectly by a layperson

Answer

Less than 5% error rate under ideal conditions

Answer

No greater than that posed by a moderate-complexity predicate test

Answer

Equivalent to or less than existing high-complexity gold-standard methods

Question 4

To which entity is a CLIA certificate issued?

Accepted Answer

Each specific laboratory location (site)

Answer

The individual laboratory director

Answer

The parent health system or hospital corporation

Answer

The state health department on behalf of the lab

Question 5

Which statement best describes a 'high-complexity' test under CLIA?

Accepted Answer

A test that scores 13 or higher on the 7-criterion scoring system

Answer

Any test not listed on the FDA waived test database

Answer

Any test requiring a licensed physician to perform

Answer

A test that requires specialized equipment costing more than $50,000

Question 6

Under CLIA, which of the following activities does the Certificate of Waiver NOT exempt a laboratory from complying with?

Accepted Answer

Manufacturer's instructions for performing the test

Answer

Proficiency testing enrollment requirements

Answer

Personnel qualification standards for testing personnel

Answer

Biennial inspection by CMS surveyors

Question 7

Provider-Performed Microscopy (PPM) procedures are classified under which complexity level?

Accepted Answer

Moderate complexity

Answer

Waived

Answer

High complexity

Answer

A separate category exempt from complexity classification