If you are well versed in the Federal and CA State laws, I’m sure you can easily skip through this information. From my experience, however, too many Laboratory Directors leave the applications up to office or administative staff… So here is my layman’s summation not to be misinterpreted as speaking on behalf of anyone but myself.
42 CFR, CLIA, FDA, CDC and CMS are some of the acronyms of importance to a Diagnostic Laboratory. If you are not familiar with the acronyms, I could provide another blog which explains them and others for clarity…maybe.
To make it simple, the U.S. FDA categorizes types of testing, also known as test complexity, and provides a listing for each type. The most complex type of testing a diagnostic laboratory performs determines the type of CLIA certificate and CA State license or registration they will need. Notice, for CA, you need both the CLIA certificate and either a State license or a State Registration.
Test complexity can be one of the following: Non-waived (including high and moderate), PPMP (provider performed microscopy procedures), waived, or uncategorized (such as new technology). Uncategorized are automatically classified as high complexity. LOOK YOUR TESTS UP. Some rather simple tests are not categorized and therefore become high complexity (i.e. even some glucose tests – really!). FYI, the PPMP is a subset of moderate and uses a microscope, but only includes a short list and does not include histology or Mohs etc. LOOK YOUR TESTS UP.
CLIA certificates are as follows: CLIA Certificate of Compliance, CLIA Certificate of Accreditation, CLIA Certificate of PPMP and CLIA Certificate of Waiver.
CA State licenses/registrations are as follows: License, Registration PPMP, Registration Waiver (and notorious Deemed status and Out-of-State License which I won’t go into).
Here you can see which goes with what. there are always exceptions but we will not get into those.
- CLIA Certificate of Compliance + CA State License = Non-waived Testing
- CLIA Certificate of Accreditation + CA State License = Non-waived Testing
- CLIA Certificate of PPMP + CA State Registration-PPMP = PPMP Testing
- CLIA Certificate of Waiver + CA State Registration-Waiver = Waived Testing
A laboratory may test anything less complex but not more. To be clear, for example, a CLIA certificate of PPMP and State Registration-PPMP can test PPMP and waived testing only.
If you test even ONE test per year in Moderate or High, you must apply for the CLIA certificate of compliance or accreditation and State License ⇒ or face sanctions, non-compliance, barring from owning and operating etc.
The Laboratory Director is ultimately responsible for compliance with Federal and State clinical laboratory law.