CLIA Certificates
Five types of certificates may be issued to providers, who perform waived, moderate, or high complexity tests and procedures:
Certificate of waiver – Issued to a laboratory to perform only waived tests (i.e., simple examinations or procedures that use methodologies that are so simple and accurate that the likelihood of erroneous results is negligible and poses no reasonable risk of harm to the patient if the test is performed incorrectly).
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 procedure (a procedure categorized as moderately complex where the primary instrument for per- forming the test is a microscope). This certificate permits the laboratory to also perform waived tests.
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.
Certificate of compliance – Issued to a laboratory after an inspection that finds the laboratory to be in compliance with all applicable CLIA requirements.
Certificate of accreditation – Issued to a laboratory on the basis of the laboratory ’ s accreditation organization approved by CMS.
