CMS is issuing this memorandum to laboratory surveyors to provide important guidance to surveyors and laboratories during the COVID-19 public health emergency, such as:
- CMS’ Exercise of enforcement discretion to ensure pathologists may review pathology slides remotely if certain defined conditions are met
- Ensuring that laboratories located in the United States wishing to perform COVID-19testing that apply for CLIA certification are able to begin testing as quickly as possible during the public health emergency
- Highlighting that laboratories within a hospital/University Hospital Campus may hold a single certificate for the laboratory sites within the same physical location or street address
- Offering enforcement discretion as to Proficiency Testing (PT) During the duration of the Public Health Emergency
- Addressing alternate Specimen Collection Devices
- Addressing Laboratory Developed Tests
CMS is committed to taking critical steps to ensure America’s clinical laboratories are prepared to respond to the threat of 2019 Novel Coronavirus (COVID-19) and other respiratory illnesses to ensure reliable testing as well as ensuring patient health and safety.
All guidance in this memorandum is applicable only during the COVID-19 public health emergency.
Laboratories that are accredited must follow their accrediting organization (AO) requirements and must follow applicable State laws, which may be more stringent than the CLIA requirements.
The CLIA program is unable to approve section 1135 waiver requests with respect to waivers of CLIA program requirements. The section 1135 waiver authority is only applicable to specified programs (or penalties) authorized by the Social Security Act (SSA). The CLIA program does not fall into this category of programs.