Attention: Clinical Laboratories

Please share this announcement with:

  • Medical Director, Laboratory Services
  • Administrative Director and Manager(s), Laboratory Services

The Coronavirus Aid, Relief, and Economic Security (CARES) Act and the HHS Lab Data Reporting Guidance released on June 4, 2020 require every COVID-19 testing site to report specific data elements for every test (e.g., molecular, antigen, antibody) performed to detect SARS-CoV-2. The data are to be reported to the appropriate state or local public health department, based on the individual’s residence.

As outlined in the HHS guidance, beginning Saturday, August 1, 2020, laboratories and other testing sites should make every reasonable effort to report the following required data elements:

• Test ordered – use harmonized LOINC codes provided by CDC
• Device Identifier
• Test result – use appropriate LOINC and SNOMED codes, as defined by the Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests provided by CDC
• Test result date
• Accession number/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 code
• Performing facility name and/or CLIA number, if known
• Performing facility zip code
• Specimen source — use appropriate LOINC, SNOMED-CT, or SPM4 codes, or equivalently detailed alternative codes
• Date test ordered
• Date specimen collected

Once the required data elements are collected and transmitted to public health authorities as specified in the guidance, testing sites should make every reasonable effort to collect and report additional requested data elements. Laboratories and testing sites should collaborate with healthcare providers to collect the required and additional data elements. Note that in the HHS FAQs on Laboratory Data Reporting, the technical specifications table clearly defines each data element. In addition to the “ask on entry” (AOE) questions described in the guidance, HHS has developed optional AOE questions to collect further information – these are defined in the table along with the required (yes/no) and requested data elements.

For more information on the data elements included in the HHS guidance, as well as technical specifications that support implementation, see the COVID-19 Lab Data Reporting Implementation Specifications. For technical assistance, laboratories and testing sites should contact DLSinquiries@cdc.gov. See below for additional resources and information about laboratory reporting.

Online resources:

If you have any questions, please contact info@hfap.org.