Facilities that perform laboratory testing on human specimens to diagnose, prevent, or treat disease in the United States are regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

Waived tests are cleared by the FDA or approved for waiver under the CLIA criteria. CLIA requires that waived tests be simple and have a low risk for erroneous results, but waived tests are not completely error-proof. Errors may occur during the testing process, especially if the manufacturer’s instructions are not followed or when testing personnel are not familiar with all aspects of the test procedure.

If performed incorrectly, some waived tests have the potential for serious negative health impact. Examples include results from waived tests like prothrombin times (for patients receiving anticoagulant therapy) and glucose (for diabetic patients) that are used to adjust medication doses. Erroneous results from human immunodeficiency virus (HIV) antibody tests and other similar diagnostics can also have unintended consequences.

To decrease the risk of erroneous results, waived test must be performed correctly by trained personnel and in an environment where good laboratory practices are established.

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