CMS Review of State Agency (SA) Certification Activities

6030 - CMS Review of State Agency (SA) Certification Activities (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) CLIA has a single set of regulations applicable to all types of laboratories or entities performing laboratory tests based on test complexity. CMS is responsible for reviewing certification activity of the SA. The primary objective of this review is to ensure that the certification decision is supported by appropriate documentation that serves as sufficient evidence of the laboratory’s compliance with the laws and regulations governing program participation. (See section 6230) If CMS determination disagrees with the SA, the decision must be supported by evidence. CMS justifies the determination in writing and attempts to resolve the disagreement.