Which types of tests require a Certificate of Compliance according to CLIA?

A Certificate of Compliance is a specific requirement under the Clinical Laboratory Improvement Amendments (CLIA) that verifies that laboratories meet federal standards for quality, accuracy, and reliability in testing. This certificate is essential for labs that perform moderate and high complexity tests, as these types of tests often carry a higher risk for patients and require more stringent quality controls and oversight.

Moderate complexity tests, which may involve more detailed procedures than low complexity tests, necessitate that laboratories adhere to certain quality standards to ensure accurate results. Similarly, high complexity tests, which typically involve intricate methods and require highly skilled personnel to perform, are subjected to rigorous compliance standards as set by CLIA. Therefore, obtaining a Certificate of Compliance is critical for labs performing both categories of tests to validate their adherence to these established standards and to ensure patient safety and care quality.

In contrast, low complexity tests are simpler and do not require a Certificate of Compliance under CLIA regulations, thus distinguishing the necessity of compliance certification for moderate and high complexity tests specifically.