The Centers for Medicare & Medicaid Services (CMS) today announced steps to ensure America’s health care facilities and clinical laboratories are prepared to respond to the threat of Coronavirus Disease (COVID-19).
Specifically, CMS issued two memoranda to advise health care providers and State Survey Agencies (SAs), the entities that inspect healthcare facilities to ensure compliance with current CMS requirements and safety standards, with important information about infection control procedures and the use of certain laboratory tests. CMS is committed to the protection of patients and residents from the spread of infectious disease.
Every Medicare participating facility in the Nation’s healthcare system must adhere to standards for infection prevention and control in order to provide safe, high quality care. The first memo provides information on infection control policies and practices. In addition, CMS urges SAs and health care facilities to review the information provided by the Centers for Disease Control and Prevention (CDC) to aid in self-assessment of infection control and emergency preparedness protocols. The memo also provides links to training and self-assessment tools for facilities to use as they review their processes and, if necessary, improve their practices.
In 2016, CMS established national emergency preparedness requirements to assist providers in planning for natural and man-made disasters and coordinating with federal, state, tribal, regional and local emergency preparedness systems. The guidance for the Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers emphasized the need for all hazards preparation. In February 2019, CMS took additional steps to ensure facilities include planning for infectious diseases within their emergency preparedness program and added “emerging infectious diseases” to the scope of an all-hazards planning approach.
CMS is authorized to ensure quality testing at laboratories under the Clinical Laboratory Improvement Amendments (CLIA) and provides guidance to laboratories to meet CLIA requirements to ensure that laboratories produce accurate, reliable and timely results while being responsive to the pressing needs of our health care providers. The second memo issued today notifies SAs about guidelines related to the use of a laboratory test for COVID-19 authorized on February 4, 2020 by the Food and Drug Administration (FDA), which has been deployed into CDC-qualified laboratories to test for COVID-19.
On February 26, 2019, CMS, FDA, and CDC created a Tri-Agency Task Force for Emergency Diagnostics to standardize the process for implementing use of diagnostic to respond to testing needs during a crisis through the FDA’s Emergency Use Authorization (EUA) process. The FDA issued an EUA for CDC-approved laboratory tests to identify the presence of Coronavirus in patients on February 4, 2020. To support the issuance of the EUA, CMS is providing guidance through this memo to help surveyors confirm that all CLIA-certified laboratories are following protocols to ensure accurate testing and patient safety. The purpose of this Tri-Agency Task Force was to provide timely recommendations to laboratories for rapid implementation of emergency diagnostic tests. This memo is the first issued under that collaborative effort.
For more information about the CMS’s efforts to help facilities prepare for Coronavirus click here.
More information about how CLIA-approved laboratories can test for Coronavirus is available here.
This article was updated on Feb 11 to reflect the naming of the virus from the provisional 2019-nCoV to SARS-CoV-2. The disease caused by SARS-CoV-2 is now called COVID-19.