clia-laboratory-records

CLIA certificate types

Every site that tests human specimens for health purposes in the United States needs a CLIA certificate. There are five.

CertificateWhat it allowsActive laboratories
Certificate of WaiverIssued to a laboratory that performs only waived tests — simple tests with a low risk of an incorrect result, such as many rapid point-of-care tests.245,489
Certificate for Provider-Performed Microscopy (PPM)Issued to a laboratory in which a physician, midlevel practitioner or dentist performs specific microscopy procedures during a patient's visit. It also covers waived tests.22,900
Certificate of RegistrationIssued first to a laboratory that applies to perform moderate or high complexity testing: it lets the laboratory test until an inspection determines whether it meets the CLIA requirements.2,185
Certificate of ComplianceIssued after an inspection by the state agency finds the laboratory in compliance with the CLIA requirements for moderate or high complexity testing.15,087
Certificate of AccreditationIssued to a laboratory that performs moderate or high complexity testing on the basis of its accreditation by an accreditation organization approved by CMS.14,689