There are several different types of CLIA certificates. The most simple is a “Certificate of Waiver” (or COW). Under this certificate, a laboratory may only performed tests classified as “waived” by the Food and Drug Administration (FDA). Additionally, a COW must follow manufacturer’s instructions for the tests that are performed. This type of certificate is not routinely inspected. However, CLIA conducts inspections of 2% of laboratories holding a Certificate of Waiver each year. Inspections are largely educational and are typically announced about two weeks prior to the inspection date.
A “Certificate for Provider Performed Microscopy Procedures” (PPMP) is slightly more complex. This certificate is issued when a physician, mid-level practitioner (i.e. physician’s assistant, nurse practitioner, etc.), or dentist performs only certain microscopic procedures, as outlined in the CLIA regulations. With a PPMP certificate, the laboratory may also perform waived testing. Technically, a PPMP certificate is considered “non-waived”, but is not routinely inspected. On occasion, the PPMP laboratory is included in the 2% of waived inspections held each year.
A “Certificate of Registration” is a temporary certificate issued to a “non-waived” (moderately complex, highly complex, or both) laboratory. The laboratory will have this certificate until an inspection has determined the laboratory is in compliance with CLIA regulations. Inspections typically occur within three months of the “effective date” on the certificate of registration and are usually announced about two weeks prior to the inspection date.
A “Certificate of Compliance” is issued to non-waived laboratories after a CLIA inspection has determined the lab is in compliance with CLIA regulations. This type of certificate is inspected every two years. Inspections typically take place six to twelve months prior to the certificate expiration date and are usually announced about two weeks prior to the inspection date. A laboratory holding a CLIA Certificate of Compliance is expected to maintain compliance with all applicable CLIA regulations.
A “Certificate of Accreditation” is issued to non-waived laboratories that are accredited by a CLIA approved agency. Inspections of laboratories holding a certificate of accreditation occur through the accrediting agency and may be announced or unannounced, depending on the agency’s policies. CLIA chooses a small number of accredited laboratories each year to perform a “validation” inspection on. A “validation” inspection must occur within three months of the accrediting agency’s inspection, per CLIA policies. Though CLIA accepts the accrediting agency’s standards and inspection processes, the purpose of a validation inspection is to determine compliance with CLIA regulations.
Note: A “non-waived” laboratory is a laboratory that performs moderately complex tests, highly complex tests, or both. Tests are categorized based upon how difficult they are to perform and interpret. The CLIA regulations include a set of qualification requirements for personnel performing moderate and highly complex tests. It’s important for each laboratory to know the complexity of the testing they perform and how the personnel performing the testing meet the CLIA qualification requirements.