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Requirements of Reporting by CLIA Laboratories

Posted Aug 27, 20201 min Read

Regulatory & Clinical

On August 26, 2020, the Centers for Medicare and Medicaid Services issued QSO 20-37, which outlines details on CLIA requirements for the use of COVID-19 Point of Care (POC) testing machines in nursing facilities based on the new Interim Final Rule.  For a IHCA/INCAL’s summary on the Interim Final Rule, please click here.

Under the QSO memorandum, all CLIA-certified laboratories that perform or analyze any test that is intended to detect SARSCoV-2 or to diagnose a possible case of COVID-19 (i.e., molecular, antigen, antibody) are required to report, regardless of the type of laboratory (type of CLIA certificate) performing the testing.  All negative and positive COVID-19 results must be reported irrespective of the method (i.e., molecular, lateral flow) used.  This means that health care facilities using POC testing machines under a CLIA Certificate of Waiver, including nursing facilities, will be required to report test results under this regulation and maintain documentation of all tests conducted.

The U.S. Department of Health and Human Services Reporting Guidance can be found in full here.

Five (5) percent of Certificate of Waiver laboratories will receive onsite surveys throughout the remainder of the public health emergency.  Failure of a CLIA-certified laboratory to report COVID-19 test results as required by the new requirements at §§ 493.41 and 493.1100(a) will result in a mandatory citation.  Civil monetary penalties will be applied in the amount of $1,000 for the first day of noncompliance and $500 for each subsequent day.

About the Author

Laura Brown, Director of Legislative and Legal Affairs