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-complexity testing personnel must have at minimum a bachelor's degree in a chemical, physical, biological, or clinical laboratory science, or equivalent training and experience as defined by CLIA.

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

With seven criteria each scored 1 to 3, the maximum possible total score is 21, placing a test in the high-complexity category.

Question 3

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

Accepted Answer

Moderate complexity

Answer

Tests with a total score of 12 or below across the seven criteria are classified as moderate complexity under CLIA regulations.

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-approved accrediting organizations such as the College of American Pathologists (CAP) and The Joint Commission can survey laboratories and confer deemed status, replacing routine CMS inspections.

Question 5

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

Accepted Answer

Every two years

Answer

CLIA certificates are valid for two years and must be renewed biennially to allow the laboratory to continue testing.

(CLIA) Clinical Laboratory Improvement Amendments Certification Practice Test

(CLIA) Clinical Laboratory Improvement Amendments Certification Practice Test

CLIA CLIA Certificate Types & Test Complexity Classifications 2