Types of Certificates

The Certificate of Waiver is $248.00 for a two year certificate cycle.  The renewal for a Certificate of Waiver is sent to the facility six months prior to the expiration date of the certificate.

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.

There are no personnel requirements for a Certificate of Waiver.  The laboratory can designate any individual from their facility to be the Laboratory Director who is responsible for the oversight of waived testing.  Therefore, there is no additional documentation required to be submitted for this individual.

The Certificate of PPM is $297.00 for a two-year certificate cycle.  The renewal for a Certificate of PPM is sent to the facility six months prior to the expiration date of the certificate.

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.

Fees for a Certificate of Compliance are divided into two separate fees:  the Compliance Fee and the Certificate Fee.  The Compliance Fee is sent to the laboratory 1 year prior to the expiration date of the CLIA certificate.  This fee is assessed for the biennial survey that is conducted.  Once the survey is completed and the laboratory is recommended for recertification, the Certificate Fee is generated to pay for the certificate for the next cycle.  The amount of each fee is dependent on the annual volume of testing performed by the laboratory.  The amounts of both the compliance and certificate fees are depicted in the Table of Compliance Fees according to testing volumes performed.

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.

A Certificate of Accreditation is assessed two different fees; however, both fees are billed at the same time. The fees are generated 6 months prior to the expiration date of the certificate.  The Certificate Fee is based on the volume of testing performed and equates to the same as those applied for a Certificate of Compliance.  There is no Compliance Fee as these laboratories are not routinely surveyed by the state agency; however, for accreditation laboratories a 5% validation fee is charged.  The amounts of both the validation and certificate fees are depicted in the Table of Accreditation Fees according to testing volumes performed.

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.

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.

 An additional certificate can be requested at any time throughout the certificate cycle. A certificate reflecting any changes to the CLIA certificate in the current cycle is a Revised Certificate. A duplicate certificate with no changes is a Replacement Certificate. The associated fees are depicted in the Table of Certificate Fees according to each certificate type.