State Agency (SA) Role

6032 - State Agency (SA) Role (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) State agencies are responsible for CLIA survey and certification activities (including most data entry) for non-Federal laboratories within their respective States. Lists of laboratories ready to be inspected are available to SAs through the CLIA Data System. The SA makes determinations of compliance with CLIA requirements based on survey findings. The policies and procedures for these actions are in the SOM Chapters 5 and 6. In the area of laboratories, they include but are not limited to: • Identifying and enrolling potential laboratory participants. • Communicating effectively and timely in a verbal and written manner with laboratories, peers, supervisors and CMS according to standard operating procedures (SOPs). • Managing the CLIA database using CLIA system applications according to procedure. • Responding timely to complaints, as per CMS direction. • Attending CMS training courses, as directed. • Developing internal systems and processes to effectively and efficiently perform CLIA related duties and meet the State Agency Performance Review (SAPR) requirements. • Providing technical assistance to laboratories concerning the regulations to enable laboratories to qualify for participation in the program (meet applicable requirements). • Scheduling, preparing for, conducting and appropriately following up surveys in which the SA determines the laboratory's compliance with the CLIA requirements in accordance with the Outcome Oriented Survey Process (OOSP) and within stated timeframes. • Citing deficiencies according to CLIA Principles of Documentation (PoD) as needed using the most appropriate citation. • Soliciting and reviewing a PoC, recommending certification and recertification, and other follow-up actions. • Recommending sanctions to CMS if laboratories do not meet the CLIA requirements. • Conducting validation surveys of accredited laboratories per the SOM protocol. • Performing periodic PT desk review and corresponding follow ups. • Participating in federally directed efforts.