CMS Role

6026 - CMS Role (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) CMS is responsible for ensuring that CLIA laboratories provide appropriate quality services and the SAs operate in accordance with the Section 1864 agreement using CLIA policies and procedures. Their major responsibilities are as follows: • Reviewing survey and certification reports submitted by the SA; • Initiating all adverse actions, imposing alternative sanctions in addition to or in lieu of principal sanctions, canceling or suspending all or part of the laboratory’s approval to receive Medicare payments, as applicable, based on SA/CMS recommendations, and issuing of final notices; • Monitoring and surveillance of SA expenditures and approval of SA budgets for the provision of cost efficient and effective survey and certification activities; • Assisting with training, projects, workgroups and policy development, and problem resolution; • Coordinating with the SA the orientation of all new CLIA surveyors and staff; • Performing validation and complaint surveys of laboratories in States whose laboratory licensure programs have been approved by CMS and accredited laboratories. (See SOM Chapter 5 regarding additional information about complaint investigations of laboratories); • Conducting onsite surveys of federally and State-operated CLIA-certified laboratories; • Performing transfusion-related fatality surveys and investigations according to CMS policies and procedures; • Coordinating follow-up of complaints with SAs and AOs and communicating findings; • Performing SA Performance Reviews (SAPR) and Federal Monitoring Surveys (FMS) to ensure SA conformance with CMS policies and procedures; • Providing technical assistance to SAs and laboratories; • Implementing CMS CLIA policies and procedures in their respective States and ensuring consistent application by the SA; and • Identifying administrative/program problems at the State, regional or national level.