The Clinical Laboratory Improvement Amendments (CLIA) and the CLIA regulations establish mandatory quality standards for laboratory testing. CLIA compliance is an essential component of a broader laboratory compliance program, as failure to comply with CLIA or the CLIA regulations can have severe consequences. On top of loss of CLIA certification, labs that fail to maintain compliance can face civil monetary penalties (CMP). Since these CMP are imposed on a per-violation basis, labs that violate CLIA or the CLIA regulations can easily face hundreds of thousands of dollars—if not millions of dollars—in penalty liability.