CLIA CLIA Certificate Types & Test Complexity Classifications 2

Question 1

Under CLIA, what is the minimum education requirement for testing personnel performing HIGH-complexity tests?

Accepted Answer

Bachelor's degree in chemical, physical, biological, or clinical laboratory science

Answer

High school diploma with 2 years of lab experience

Answer

Associate degree in a laboratory science or medical laboratory technology

Answer

Completion of a manufacturer's training course only

Question 2

On the CLIA 7-criterion scoring system, what is the MAXIMUM total score a test can receive, indicating the highest complexity?

Accepted Answer

21

Answer

14

Answer

28

Answer

42

Question 3

A test scoring 12 or less on the CLIA 7-criterion system is categorized as:

Accepted Answer

Moderate complexity

Answer

Waived

Answer

Provider-Performed Microscopy

Answer

High complexity

Question 4

Which organization can grant a laboratory 'deemed status,' allowing it to hold a CLIA Certificate of Accreditation instead of a Certificate of Compliance?

Accepted Answer

An accrediting organization approved by CMS (e.g., CAP, The Joint Commission)

Answer

CMS directly

Answer

The FDA

Answer

The state health department

Question 5

How frequently must all CLIA certificates (except the Certificate of Registration) be renewed?

Accepted Answer

Every two years

Answer

Annually

Answer

Every three years

Answer

Every five years

Question 6

What is the primary purpose of the CLIA Certificate of Registration?

Accepted Answer

To permit a laboratory to begin non-waived testing while awaiting its initial inspection

Answer

To allow waived testing in physician offices

Answer

To certify a laboratory that has achieved accreditation

Answer

To authorize PPM procedures only

Question 7

Which CLIA criterion evaluates how much specialized scientific knowledge is needed to perform a test correctly?

Accepted Answer

Knowledge

Answer

Characteristics of the test system

Answer

Calibration, quality control, and proficiency testing

Answer

Troubleshooting and equipment maintenance