HHS Laboratory Data Reporting Guidance for COVID-19 Testing

On June 4, 2020, the U.S. Department of Health and Human Services (HHS) issued new Laboratory Data Reporting Guidance for COVID-19 Testing (Guidance) and related Frequently Asked Questions. Under the Guidance, in addition to providing the results of COVID-19 testing, laboratories will be required to report demographic information, including the patient’s age, race, ethnicity, sex, residence zip code, and county. The Guidance further recommends reporting the patient’s name, street address, date of birth, ordering provider address, and ordering provider phone number to state and/or local public health departments, although this data would not be collected by the Centers for Disease Control and Prevention (CDC) or HHS. Data for each test completed must be submitted within 24 hours of the results being known or determined, providing public health officials with “nearly real-time data.

Reporting is required for both diagnostic and serologic testing, and the Guidance specifically includes laboratory testing that relies on home-based sample collection. Laboratories, defined to include “laboratories, non-laboratory testing locations, and other facilities or locations offering point-of-care testing or in-home testing related to SARS-CoV-2,” must comply with the new requirements by Aug. 1, 2020. The Guidance specifies that reporting should be made through existing channels to state or local public health departments that will, in turn, submit de-identified data to the CDC.

According to HHS, “[t]he 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 also indicated that the requirements may help officials understand and address disproportionate impacts of COVID-19 on certain demographic groups and ensure equitable access to testing.

Although this reporting requirement is being imposed by HHS, it is unclear what impact the new data may have at a national level. Under HHS’s COVID-19 Strategic Testing Plan issued on May 24, 2020, states are largely responsible for developing and implementing their own COVID-19 testing strategies.