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Assuring a rapid and thorough public health response to the COVID-19 pandemic necessitates complete and comprehensive laboratory testing data, including standardized test results, relevant demographic details, and additional information that can improve both the public health response to SARS-CoV-2 and COVID-19. These data contribute to understanding disease incidence and trends: initiating epidemiologic case investigations, assisting with contact tracing, assessing availability and use of testing resources, and identifying supply chain issues for reagents and other material. Laboratory testing data, in conjunction with case reports and other data, also provide vital guidance for mitigation and control activities. As the country begins to reopen its doors, access to clear and accurate data is essential to communities and leadership as they use data to make decisions for a phased reopening. For individuals, access to personal test results improves feelings of safety, security, and awareness, and empowers them to take action, if necessary, to protect themselves, their families, and their communities.
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 SARS-CoV-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.