Coronavirus

How to Report COVID-19 Laboratory Data

The reporting requirements differ for laboratories and clinicians: Laboratories Laboratories are not responsible for reporting these data since they do not have the patient-identifying information required to comply with reporting requirements. However, local, tribal, or state health department rules and regulations apply and may differ from this general guidance. Clinicians In clinical trials or other…

The reporting requirements differ for laboratories and clinicians:

Laboratories

Laboratories are not responsible for reporting these data since they do not have the patient-identifying information required to comply with reporting requirements. However, local, tribal, or state health department rules and regulations apply and may differ from this general guidance.

Clinicians

In clinical trials or other clinical studies, clinicians who are responsible for clinical care of trial or study participants are responsible for linking de-identified specimen test results to participant demographic information and are required to report the positive results daily to the appropriate local, tribal, or state public health department based on the patient’s residence. Demographic information required for reporting is detailed in HHS’s June 4, 2020 guidanceexternal icon.

Clinicians are not required to report negative test results. However, local, tribal, or state health department rules and regulations apply and may differ from this general guidance.

The requirements for reporting laboratory testing data are intended to inform rapid public health responses.  Reporting requirements do not apply to specimens that were collected 2 months prior to the date of testing. However, local, tribal, or state health department rules and regulations apply and may differ from this general guidance.

If a clinician receives test results related to COVID-19 from duplicate specimens that were collected in the same manner and tested with different test methods (e.g., different platforms) or in different CLIA-certified laboratories, the clinician should not report both results. In the case of two positive test results, the clinician should report the result that is provided first. In the case of discrepant test results, the clinician should report the positive result. However, local, tribal, or state health department rules and regulations apply and may differ from this general guidance.

If the clinician requests testing related to COVID-19 for study participants independent of research activities or for clinical management, results should be reported to the appropriate local, tribal, or state public health department.

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