The Clinical Laboratory Improvement Amendments (CLIA) of 1988 established authority to regulate clinical laboratories and laboratory testing. Under the CLIA program, clinical laboratories are required to have the appropriate certificate before they can accept human samples for testing. The objective of the CLIA program is to ensure quality laboratory testing. The Centers for Medicare & Medicaid Services (CMS), the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC) are the three federal agencies responsible for administering the CLIA program.

Here are the different types of CLIA certificates:

• Certificate of Waiver (COW): Issued to a laboratory that performs only waived tests.
• Certificate for Provider-Performed Microscopy Procedures (PPMP): Issued to a laboratory in which a physician, midlevel practitioner, or dentist performs no tests other than the microscopy procedures CMS considers to be Provider Preformed Microscopy. This certificate also permits the laboratory to perform waived tests. No other testing may be performed on this certificate.
• Certificate of Registration: Issued to a laboratory that enables the entity to conduct moderate or high complexity laboratory testing or both until the entity is determined, by survey, to be in compliance with the CLIA regulations. This is a temporary/intermediate certificate between the facility’s initial application (compliance and accreditation only) and their first compliance survey.
• Certificate of Compliance: Issued to a laboratory after an inspection that finds the laboratory to be in compliance with all applicable CLIA requirements. This certificate allows the facility to perform moderate or high complexity testing or both. The facility may also perform waived tests.
• Certificate of Accreditation: Issued to a laboratory that has been accredited by an accreditation organization approved by CMS. This certificate allows the facility to perform moderate or high complexity testing or both. The facility may also perform waived tests.

If a facility performs tests for the purpose of diagnosis, prevention, or treatment of disease, or assessment of health, it is considered a laboratory under CLIA and generally must apply and obtain a certificate from the CLIA program that corresponds to the complexity of tests performed. However, a CLIA certificate may not be needed if the laboratory is located in the states of New York or Washington, as those states operate their own laboratory regulatory programs.