Regulations and Accreditation

Clinical laboratories, including Mohs laboratories, operate under a highly regulated environment intended to protect patients by ensuring accurate and reliable laboratory testing. The Clinical Laboratory Improvement AmendmentsClinical Laboratory Improvement Amendments (CLIA) is the law that impacts clinical laboratory testing including testing performed by Mohs laboratories. The Center for Medicaid and Medicare Services (CMS) is the federal agency tasked with putting forth regulations to implement CLIA and oversee compliance. CLIA allows for third party accrediting organizations to work within the CLIA regulatory structure as an alternative to CMS’ oversight over the CLIA program. While CLIA is central to clinical laboratory regulatory requirements, there are other federal and state regulatory agencies with requirementsRequirements that clinical laboratories must be aware of and abide by.