Types of CLIA Certificates
There are five different CLIA certificate types which all are effective for a period of two years. Except for the Certificate of Compliance and Certificate of Accreditation, renewal of each certificate is accomplished by payment of the certificate fees. Renewal of a Certificate of Compliance and a Certificate of Accreditation is preceded by an inspection as well as the payment of fees. The issuance of the CLIA Fees for renewal is an automated process with no action required on the part of the laboratory.
Certificate of Waiver
The Certificate of Waiver is issued to a laboratory to perform only waived tests. This certificate does not waive you from all CLIA requirements. Complexity of laboratory testing (waived, moderate, high complexity) is determined by the FDA.
Waived tests are laboratory tests that are simple and easy to perform. An example of a waived test is a finger-stick glucose using a glucometer. Test complexity can be reviewed through the FDA Database.
Routine inspections are not conducted for Certificate of Waiver laboratories. However, as of April 2002, two percent (2%) of laboratories with a Certificate of Waiver are visited each year, to ensure quality laboratory testing. Although this is a relatively small percentage of laboratories, all laboratories maintaining a Certificate of Waiver are eligible for an on-site visit.
Certificate for Provider-Performed Microscopy Procedures (PPM)
The Certificate of PPM is issued to a laboratory in which a physician, midlevel practitioner or dentist performs limited tests that require microscopic examination. PPM tests are considered moderate complexity; therefore, the CLIA regulations for moderate complexity testing apply. An example of a PPM test is a wet prep.
The List of PPM Tests will assist you with selecting specific tests and completing the application.
Waived tests can also be performed under this certificate type.
There are no routine inspections conducted for Certificate of PPM laboratories.
Certificate of Registration
The Certificate of Registration is the certificate that is initially issued to a laboratory that has applied for a Certificate of Compliance or a Certificate of Accreditation. This certificate enables the laboratory to conduct moderate and/or high complexity laboratory testing until the survey is performed and the laboratory found to be in compliance with the CLIA regulations.
The Certificate of Registration includes PPM and waived testing as well as all moderate and high complexity testing.
Inspections are required for all Certificate of Registration laboratories. The inspection will be conducted between 90 days and 12 months after the effective date of the certificate in order to permit observation of actual testing during the survey.
Certificate of Compliance
The Certificate of Compliance is the certificate that allows the laboratory to conduct moderate and/or high complexity testing. This certificate is issued to a laboratory after an inspection that finds the laboratory to be in compliance with all applicable CLIA requirements.
The Certificate of Compliance includes PPM and waived testing as well as all moderate and high complexity testing.
Inspections are required for all Certificate of Compliance laboratories. Inspections for Certificate of Compliance laboratories in Louisiana are conducted by Louisiana Department of Health state agency surveyors. Inspections for recertification of laboratories are conducted 6 – 12 months prior to the expiration date of the certificate.
Certificate of Accreditation
The Certificate of Accreditation is the certificate that allows the laboratory to conduct moderate and/or high complexity testing. This certificate is issued to a laboratory after an inspection that finds the laboratory to be in compliance with all applicable CLIA requirements. The laboratory must select a specific accreditation organization and indicate this choice on the CLIA application. Once the facility is enrolled with the organization, proof of enrollment should be forwarded to the Louisiana CLIA Program.
The Certificate of Accreditation includes PPM and waived testing as well as all moderate and high complexity testing.
Inspections are required for all Certificate of Accreditation laboratories. The inspection is conducted by inspectors from the accreditation organization to which you applied. Inspections are conducted according to the protocol of the specific accreditation organization.