March 26, 2020 – 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-19 testing 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

Read the memo.