Application for a CLIA certificate requires that a service or complexity level of laboratory be selected for the application process. Specific types of CLIA certifications and the requirements for on-site inspections (surveys) are as follows:
- Certificate of Waiver (COW): A laboratory that performs only waived testing would be eligible for a Certificate of Waiver (COW). CMS does perform random surveys for COW laboratories. However, routine surveys or inspections are not conducted. Some states do perform preliminary (prior to the start of testing) and/or routine surveys for COW laboratories.
- Certificate for Provider-performed Microscopy (PPM) procedures: A limited list of microscopic procedures is allowed under this certificate type in combination with other waived testing. The included microscopy procedures can be performed by a physician, mid-level practitioner, or dentist. Hence, the procedures are called provider-performed microscopy (PPM) procedures. Microscopy is performed during a patient’s clinical visit. PPM is categorized as moderate complexity testing, and compliance requirements are more detailed and stringent. Regular proficiency testing is required for PPM testing. Since the scope of testing permitted is limited, the type of certificate is Provider-performed Microscopy (PPM), and the facility is limited to this list of microscope tests. If the laboratory would like to perform other testing, the required certificate would be determined by the test menu. CMS does perform random surveys for PPM laboratories. However, routine surveys are not conducted.
- Certificate of Registration (CoR): Laboratories applying for a certificate of compliance or a certificate of accreditation will be issued a temporary certificate designated as a certificate of registration (CoR). This certificate is valid for up to 2 years. The purpose of this certificate is simply to demonstrate that the laboratory is registered with CMS. This permits the laboratory to conduct nonwaived (moderate and/or high complexity) testing. This temporary certificate is valid until an inspection/survey is completed and compliance with applicable regulations is determined. All laboratories with a Certificate of Registration will have an inspection. When compliance is confirmed, the Certificate of Registration will be converted to either a Certificate of Compliance or a Certificate of Accreditation.
- Certificate of Compliance (COC): A COC is issued to a laboratory following the determination of compliance with applicable CLIA and state/local regulations, as applicable. This compliance is determined by a survey/inspection by CMS surveyors, a CMS-approved accreditation agency, if a deemed authority, or state/local surveyor, as applicable. This type of certificate is issued to a laboratory that performs nonwaived (moderate and/or high complexity) testing.
- Certificate of Accreditation (COA): A COA is issued to a laboratory that has been deemed compliant with the laboratory’s accreditation agency requirements. Compliance is determined by inspection/survey from an accreditation organization approved by CMS. This type of certificate is issued to a laboratory that performs nonwaived (moderate and/or high complexity) testing.
