HHS Announces New Laboratory Data Reporting Guidance for COVID-19 Testing

The US Department of Health and Human Services (HHS, Washington, D.C., USA) has announced new guidance that specifies what additional data must be reported to HHS by laboratories along with Coronavirus Disease 2019 (COVID-19) test results.

As the US begins to reopen, access to clear and accurate data is essential to communities and leadership for making decisions critical to a phased reopening. Laboratory data serves not only as important information to support decision-making related to the public health emergency, but also as a critical piece to better understanding the impact on socially vulnerable populations. Laboratory testing data, in conjunction with case reports and other data, also provide vital guidance for mitigation and control activities.


The new guidance from HHS standardizes reporting to ensure that public health officials have access to comprehensive and nearly real-time data to inform decision making in their response to COVID-19. The new reporting requirements will provide information needed to better monitor disease incidence and trends by initiating epidemiologic case investigations, assisting with contact tracing, assessing availability and use of testing resources, and anticipating potential supply chain issues.

“HHS and the entire Trump administration are deeply concerned that COVID-19 is having a disproportionate impact on certain demographics, including racial minorities and older Americans,” said HHS Secretary Alex Azar. “High quality data is at the core of any effective public health response, and standardized, comprehensive reporting of testing information will give our public health experts better data to guide decisions at all levels throughout the crisis.”

“The requirement to include demographic data like race, ethnicity, age, and sex will enable us to ensure that all groups have equitable access to testing, and allow us to accurately determine the burden of infection on vulnerable groups,” said ADM Brett P. Giroir, MD, Assistant Secretary for Health. “With these data we will be able to improve decision-making and better prevent or mitigate further illnesses among Americans.”

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US Department of Health and Human Services