COVID-19 Pandemic Response, Laboratory Data Reporting: CARES Act Section 18115

Public Law 116-136, § 18115(a), the Coronavirus Aid, Relief, and Economic Security (CARES) Act, requires “every laboratory that performs or analyzes a test that is intended to detect SARSCoV-2 or to diagnose a possible case of COVID-19” to report the results from each such test to the Secretary of the Department of Health and Human Services (HHS). In addition, the statute authorizes the Secretary to prescribe the form and manner, and timing and frequency, of such reporting. This document outlines the requirements for data submission to HHS as authorized under this law.

In an effort to receive these data in the most efficient and effective manner, the Secretary is requiring that all data be reported through existing public health data reporting methods, described below. As a guiding principle, data should be sent to state or local public health departments using existing reporting channels (in accordance with state law or policies) to ensure rapid initiation of case investigations by those departments, concurrent to laboratory results being shared with an ordering provider, or patient as applicable.

Source: https://www.hhs.gov/sites/default/files/covid-19-laboratory-data-reporting-guidance.pdf