Quality, Safety & Oversight - General Information

CMS maintains oversight for compliance with the Medicare health and safety standards for laboratories, acute and continuing care providers (including hospitals, nursing homes, home health agencies (HHAs), end-stage renal disease (ESRD) facilities, hospices, and other facilities serving Medicare and Medicaid beneficiaries), and makes available to beneficiaries, providers/suppliers, researchers and State surveyors information about these activities. 

The survey (inspection) of these facilities is done on behalf of CMS by the individual State Survey Agencies. The functions the States perform for CMS under the agreements in Section1864 of the Social Security Act (the Act) are referred to collectively as the certification process. This includes, but is not limited to:

Identifying Potential Participants - Payment for health services furnished in or by entities that meet stipulated requirements of the Act. Identification includes those laboratories seeking to participate in the CLIA program.

Conducting Investigations and Fact-Finding Surveys - Verifying how well the health care entities comply with the "conditions of participation" (CoPs) or requirements.  This is referred to as the "survey process."

Certifying and Recertifying - Certifications are periodically sent to the appropriate Federal or State agencies regarding whether entities, including CLIA laboratories, are qualified to participate in the programs.

Explaining Requirements - Advising providers and suppliers, and potential providers and suppliers in regard to applicable Federal regulations to enable them to qualify for participation in the programs and to maintain standards of health care consistent with the CoPs and Conditions for Coverage (CfCs) requirements.