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HHS Releases Data Reporting Guidance for Labs Performing SARS-CoV-2 Testing

NEW YORK – The US Department of Health and Human Services announced Thursday new data reporting guidance for laboratories performing SARS-CoV-2 testing.

Additional data beyond test results is required to "ensure public health officials have access to comprehensive and nearly real-time data to inform decision making in their response to COVID-19," the agency said in a statement. 

Under the guidance, the required data elements that must be submitted and will be collected by the US Centers for Disease Control and Prevention include what test was ordered; the device identifier; the test result and result data; specimen ID or accession number; patient's age, race, ethnicity, sex, residence zip code, and residence county; ordering provider's name, identification number, and residence county; performing facility's name and zip code; specimen source; and the dates the test was ordered and specimen was collected.  

Other data including the patient's name, address, phone number, and date of birth should be collected and sent to public health departments but won't be collected by the CDC or HHS.

Labs must report the data daily through existing public health data reporting methods for all testing completed and for each person tested within 24 hours of results. Those existing reporting methods include submission directly to state or local public health departments through a centralized platform like the Association of Public Health Laboratories' AIMS platform, or through a state or regional health information exchange, HHS said.

The data must be made available no later than August 1. The guidance applies to laboratories, temporary overflow locations, and other facilities performing point-of-care testing or testing of at-home specimens.

The new data will be used to initiate epidemiologic case investigations, assist with contact tracing, anticipate potential supply chain issues, and assess availability of testing resources, the agency said.

The American Clinical Laboratory Association said in a statement that it will help HHS gather the data although ACLA President Julie Khani noted that clinical laboratories don't usually interact directly with patients, making the collection of information missing from a test order difficult. She added that the organization hopes the guidance will "give clarity to providers about what information needs to be collected at the point of care." 

Earlier this year, the Trump administration sent a letter to hospitals with in-house labs requesting daily reporting of COVID-19 testing data to the HHS to help the CDC "support states and localities in addressing and responding to the virus."