The Department of Health and Human Services (HHS) released new guidance, as directed by the CARES Act, (press release; guidance; FAQs) that specifies the additional data laboratories must report to HHS with COVID-19 test results. The guidance outlines: the entities required to report; methods for submission; required data elements; data reporting and transmission requirements; and laboratory data reporting and electronic health records.
The intent of the guidance is to standardize laboratory reporting requirements and ensure public health officials have access to the most comprehensive and up-to-date data to inform decision making related to the COVID-19 response and phased re-opening. Importantly, the guidance requires the inclusion of demographic data like race, ethnicity, age, and sex, so the disease burden among groups can be assessed.
HHS explains in the guidance that testing data should continue to be reported through existing public health data reporting methods within 24 hour of receiving a result, and notes that it prefers information be collected using health information technology certified to the Office of the National Coordinator 2015 Edition certification criteria, be structured in accordance with the US Core Data for Interoperability, and be transmitted electronically using HL7 electronic laboratory reporting implementation guides.