A CLIA certificate is required for any site that performs laboratory testing. There are five categories of CLIA certificates that may apply to POCT.
Certificate of Waiver: This certificate is required for a site that performs only waived tests.
Certificate for Provider-Performed Microscopy Procedures (PPMP): This certificate is required for a site where a physician, midlevel practitioner, or dentist performs only microscopy procedures. With a PPMP certificate, the laboratory can also perform waived tests.
Certificate of Registration: This certificate is required for a site that has applied for a certificate of compliance or accreditation and is awaiting survey by the oversight agency. The site can perform moderate and/or high complexity laboratory testing until CLIA compliance is determined by survey.
Certificate of Compliance: This certificate is issued for a site after a survey that finds the laboratory to be in compliance with all applicable CLIA requirements.
Certificate of Accreditation: This certificate is issued for a site after a survey conducted by the site's accreditation agency survey is administered by an approved accreditation organization.
The site must have the certificate for the highest complexity level of testing performed.
