CDC issues guidance for CLIA laboratories on asymptomatic testing

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CDC issues guidance for CLIA laboratories on asymptomatic testing
tjordan_drupal
Dec 8, 2020

The Centers for Medicare & Medicaid Services yesterday updated its guidance on enforcement discretion during the COVID-19 public health emergency for laboratories performing molecular and antigen tests for the virus on asymptomatic individuals at the point of care or in patient care settings operating under a Clinical Laboratory Improvement Amendments certificate.

The update addresses situations in which POC tests are performed outside of their emergency use authorizations based on recommendations and information provided by the Food and Drug Administration; or non-waived facilities modify POC tests and perform them without establishing performance specifications. 

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CDC issues guidance for CLIA laboratories on asymptomatic testing
tjordan_drupal
Dec 8, 2020

The Centers for Medicare & Medicaid Services yesterday updated its guidance on enforcement discretion during the COVID-19 public health emergency for laboratories performing molecular and antigen tests for the virus on asymptomatic individuals at the point of care or in patient care settings operating under a Clinical Laboratory Improvement Amendments certificate.

The update addresses situations in which POC tests are performed outside of their emergency use authorizations based on recommendations and information provided by the Food and Drug Administration; or non-waived facilities modify POC tests and perform them without establishing performance specifications. 

Novel Coronavirus (SARS-CoV-2/COVID-19)
COVID-19: CDC, FDA and CMS Guidance

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