CLIA
How do I apply for a CLIA certificate?
There are two options available to physicians when applying for a CLIA certificate:
Option 1
Go through your state CLIA office and submit appropriate application materials and fees. CMS offers contact information for each state.
Option 2
Go through an accreditation agency that certifies the laboratory in place of the state. Find more information on these agencies.
All laboratories must pay certificate fees to the Centers for Medicare & Medicaid Services (CMS) and may have additional fees depending on their level of complexity.
Determining the level of CLIA certification
CLIA has different certificates for labs based on the complexity levels of the tests they perform.
There are three levels of complexity:
Waived: Simple tests that do not require additional quality assessment. Download a list of these tests.
Moderate Complexity: Most automated tests that do not meet the waiver criteria (e.g., KOH exams, Tzanck smears, fungal cultures with DTM, and staining procedures) or provider-performed microscopy procedures (PPMP).*
High Complexity: Non-automated tests (e.g., histopathology, Mohs surgery, cytodiagnosis of molluscum contagiosum, and microscopic hair shaft evaluation).
In order to be considered high complexity, the following criteria must be met:
Moderate complexity test
Uses microscope
Personally performed by either an MD, DO, PA, or NP
Labile specimen
Quality control is not available
Limited specimen handling or processing required
A list of these tests is also available on the CMS website.
For more information, please review this CMS guide on how to obtain a CLIA certificate (PDF).
* Most dermatologists who perform laboratory procedures not affiliated with Mohs surgery will fall into the moderate complexity/PPMP category. This category contains all tests personally performed by a provider that are not considered high-complexity tests.
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