__________________ is a complex laboratory test that does not meet the CLIA criteria.

__________________ is a complex laboratory test that does not meet the CLIA criteria.

• A. Profile
• B. Qualitative test
• C. Waived test
• D. Nonwaived test

Answer: (D)

Understanding CLIA categories helps you know which tests require what level of oversight. Waived tests are simple, low-risk, and qualify for CLIA waiver. Nonwaived tests include moderate and high complexity tests that do not meet waiver criteria because they involve more complex procedures, interpretation, and higher potential for error. A complex laboratory test that does not meet CLIA criteria falls into the nonwaived category, meaning it requires stricter certification, trained personnel, quality control, and proficiency testing. The other terms here don’t describe CLIA status: a profile is just a panel of tests, a qualitative test refers to the result type rather than complexity, and a waived test is explicitly eligible for CLIA waiver, not the opposite.

Understanding CLIA categories helps you know which tests require what level of oversight. Waived tests are simple, low-risk, and qualify for CLIA waiver. Nonwaived tests include moderate and high complexity tests that do not meet waiver criteria because they involve more complex procedures, interpretation, and higher potential for error. A complex laboratory test that does not meet CLIA criteria falls into the nonwaived category, meaning it requires stricter certification, trained personnel, quality control, and proficiency testing.

The other terms here don’t describe CLIA status: a profile is just a panel of tests, a qualitative test refers to the result type rather than complexity, and a waived test is explicitly eligible for CLIA waiver, not the opposite.