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Hill Notification: CLIA Laboratory Guidance During COVID-19 Public Health Emergency

By: Dr. Monica de Baca


"We applaud the decisions highlighted in the CLIA memorandum for March 26, 2020. Pathologists make the diagnoses and thus are the first step in the decision pathways required for patient therapy.


Allowing pathologists to sign out remotely safeguards pathologists and, therefore, the health of the general population."


The U.S. House and Senate sent out the following notification today: Thursday, March 26, 2020 To: Congressional Health Staff From: Office of Legislation Centers for Medicare & Medicaid Services Re: CLIA Laboratory Guidance During COVID-19 Public Health Emergency The Centers for Medicare & Medicaid Services (CMS) today issued a memorandum to laboratory surveyors to provide important guidance to surveyors and laboratories during the COVID-19 public health emergency. CMS is also releasing frequently asked questions (FAQs) on the Clinical Laboratory Improvement Amendments (CLIA) guidance during the public health emergency. Matthew Schulze, Director, Center for Public Policy, American Society for Clinical Pathology summarizes (an excerpt by Dr. Sirintrapun, Association for Pathology Informatics) “as we have done in previous public health emergencies, we are exercising our enforcement discretion and we will not enforce the requirement to have a separate certificate for laboratories that are located at a temporary testing site, provided that the designated primary site or home base has such a certificate (using the address of the primary site) and the work being performed in the temporary testing site falls Page 3 of 6 within the parameters of the primary site’s certificate."

The announcement page is location here:

https://www.cms.gov/medicareprovider-enrollment-and-certificationsurveycertificationgeninfopolicy-and-memos-states-and/clinical-laboratory-improvement-amendments-clia-laboratory-guidance-during-covid-19-public-health


The link to the file is located here:

https://www.cms.gov/files/document/qso-20-21-clia.pdf-0

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