CLIA-Exempt Laboratories

6106.3 - CLIA-Exempt Laboratories (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) Laboratories exempt through an approved State licensure program are subject to validation surveys conducted by CMS or its designee. A validation survey of a CLIA-exempt laboratory is conducted to ensure that the exempt laboratory meets CLIA compliance. CMS laboratory surveyor applies the CLIA regulations during a validation survey. When condition-level deficiencies are determined, CMS directs the State to take appropriate enforcement action. (See section 6208)