CLIA

There are four main steps you need to perform to comply with CLIA:

1. Develop a laboratory procedure manual for each of your tests and equipment used.

2. Establish and implement a quality assessment program for your tests. This includes policies and procedures for maintaining quality control of not only your patient specimens but also competency assessments of your testing personnel and safety procedures. You must assess the quality of your testing through two specimens twice a year. This can be done by splitting samples with another provider in your area and comparing results, or you can enroll in a proficiency testing program.

3. Enroll in a proficiency testing program if applicable. Dermatology practices that offer Mohs surgery or that have arrangements such that they have chosen to seek accreditation from an outside body may need a proficiency testing program. However, for most, the quality control steps described above will suffice.

   Important note

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   Specifically, if your lab performs regulated analytes testing and is either a moderate- or high-complexity lab, it must abide by proficiency testing guidelines. A list of regulated analytes is available on the COLA (formerly the Commission on Office Laboratory Accreditation) website.

   If you perform one of these tests and you are a non-waived laboratory, you must enroll in a proficiency testing program through a CMS accredited agency. Download a list of approved agencies (PDF download).

4. Prepare for your inspection, when applicable. Depending on the type of certificate you have, your state CLIA agency or accrediting body will inspect your lab on a routine basis.

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