• Types of Clinical Laboratory Certificates

    Before your laboratory can perform any testing, your practice must obtain the appropriate CMS CLIA certification. 

    CLIA, which is administered by CMS, FDA, and CDC, regulates the quality and safety of U.S. clinical laboratories to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed. CLIA has regulatory requirements for quality that all laboratories must meet. 

    Certificate type is based on the highest level of test complexity performed by a laboratory. Laboratories can apply for one of the following:

    1. Certificate of Waiver (COW): Simple tests or examinations with low risk for erroneous results known as waived tests. Tests must be performed according to manufactures instructions without variation to meet the CLIA certificate of waiver criteria.
    2. Certificate for Provider Performed Microscopy Procedures (PPMP): Is a subset of moderate complexity tests preformed by physician or midlevel practitioner. PPMP test consist of specific microscopy examinations performed during a patients visit.
    3. Certificate of Compliance (COC) or Accreditation (COA): laboratories performing moderate and/or high complexity tests can choose either COC or COA based on the agency who will survey laboratory for compliance to CLIA regulations.

    a. COC is issued to a lab after an inspection by state agency and found to be in compliance.

    b. COA is issued to a lab after an inspection by a CMS approved non-profit accreditation organization, such as COLA, and found to be complying with CLIA regulations.

    For questions about applying for a CLIA certificate or filling out the application: