New reporting requirements will affect the information clinical laboratories must collect and report.
On June 4, 2020, the US Department of Health and Human Services (HHS) released new guidance that specifies what data should be reported to HHS by clinical laboratories, in addition to previously existing COVID-19 requirements. “The guidance 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,” according to HHS.
The data that must be collected and reported for SARS-CoV-2 laboratory tests includes:
- Test ordered—using harmonized LOINC codes provided by CDC
- Device identifier
- Test result—using appropriate LOINC and SNOMED codes, as defined by the laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 tests provided by the CDC
- Test result date
- Accession #/Specimen ID
- Patient age
- Patient race
- Patient ethnicity
- Patient sex
- Patient residence ZIP code
- Patient residence county
- Ordering provider name and NPI (as applicable)
- Ordering provider ZIP
- Performing facility name and/or CLIA number, if known
- Performing facility ZIP code
- Specimen source—using appropriate LOINC, SNOMED-CT, or SPM4 codes, or equivalently detailed alternative codes
- Date test ordered (date format)
- Date specimen collected (date format)
HHS Provided Three Options for Reporting SARS-CoV-2 Testing Data
- Submission of laboratory testing data directly to state or local public health departments, as required by state and/or local law or policy. These entities will then submit de-identified data to the CDC on a daily basis using either Health Level 7 (HL7) messaging or the CDC-provided CSV format.
- Submission of laboratory testing data to state and local public health departments through a centralized platform (such as the Association of Public Health Laboratories’ AIMS platform) where such data will then be routed to the appropriate state and local authorities and routed to CDC after removal of elements to achieve de-identification according to applicable rules and regulations.
- Submission of laboratory testing data through a state or regional health information exchange (HIE) to the appropriate state or local public health department and to the CDC as directed by the state.
This guidance includes deadlines, and links to relevant applicable resources and standards. To explore the document in depth, read the full guidance released by HHS and the FAQ page released in conjunction with this guidance.