What must any lab or clinic performing diagnostic tests have?

For any laboratory or clinic conducting diagnostic tests, having a CLIA number is essential. The Clinical Laboratory Improvement Amendments (CLIA) were established to regulate laboratory testing and ensure public health and safety. A CLIA number signifies that the laboratory meets the standards set by the Centers for Medicare & Medicaid Services (CMS) and is authorized to perform specific types of testing.

This requirement is crucial because it helps maintain quality control in laboratory settings and assures that testing meets established regulations. Laboratories must comply with various standards depending on the complexity of the tests they perform, and the CLIA number is a key part of that compliance.

While a license from the state health department, an accreditation certificate, and certification from the CDC may be relevant to specific types of facilities or testing, the CLIA number is the universal requirement for all labs performing diagnostic tests. It ensures that every laboratory meets the minimum requirements necessary for operation and follows proper procedures and regulations.