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Data Collection Requirements for COVID-19 Tests

The Coronavirus Aid, Relief, and Economic Security (CARES) Act requires laboratories to report testing-related data to the Department of Health and Human Services (HHS).

HHS released guidance on this requirement on June 4.

Starting August 1, all laboratories must report data for all testing completed, for each individual tested, within 24 hours of results being known or determined, on a daily basis to the appropriate state or local public health department based on the individual's residence.

Overview of Requirement

The following data elements must be collected and reported for SARS-CoV-2 laboratory tests, for the transmission of complete laboratory testing data to HHS (which includes the CDC).

  1. Test ordered – use harmonized LOINC codes provided by CDC
  2. Device Identifier
  3. 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
  4. Test Result date (date format)
  5. Accession #/Specimen ID
  6. Patient age
  7. Patient race
  8. Patient ethnicity
  9. Patient sex
  10. Patient residence zip code
  11. Patient residence county
  12. Ordering provider name and NPI (as applicable)
  13. Ordering provider zip
  14. Performing facility name and/or CLIA number, if known
  15. Performing facility zip code
  16. Specimen Source - use appropriate LOINC, SNOMED-CT, or SPM4 codes, or equivalently detailed alternative codes
  17. Date test ordered (date format)
  18. Date specimen collected (date format)

The following additional demographic data elements should also be collected and reported to state or local public health departments but these data will not be collected by HHS.

  1. Patient name (Last name, First name, Middle Initial)
  2. Patient street address
  3. Patient phone number with area code
  4. Patient date of birth
  5. Ordering provider address
  6. Ordering provider phone number

In order to meet this requirement, any person or entity ordering a diagnostic or serologic test, collecting a specimen, or performing a test should make every reasonable effort to collect complete demographic information and should include such data when ordering a laboratory test to enable the entities performing the test to report these data to state and local public health departments.

The following data fields are specific to SARS-CoV-2 and considered "ask on order entry" (AOE) questions for traditional Electronic Health Records or Laboratory Information Management Systems. These elements should be collected and be conformant with the HL7 Version 2.5.1 Lab Order Interface Implementation Guide and associated standards, and comprehensive of the above data fields.

  1. First test (Y/N/U)
  2. Employed in healthcare? Y/N/U
  3. Symptomatic as defined by CDC? Y/N/U; if yes, then Date of Symptom Onset mm/dd/yy
  4. Hospitalized? Y/N/U
  5. ICU? Y/N/U
  6. Resident in a congregate care setting (including nursing homes, residential care for people with intellectual and developmental disabilities, psychiatric treatment facilities, group homes, board and care homes, homeless shelter, foster care or other setting): (Y/N/U)
  7. Pregnant? Y/N/U

ACEP Position on Requirement

ACEP understands that the burden of collecting this information may ultimately fall on emergency physicians and is working with the Centers for Disease Control and Prevention (CDC) on operational issues emergency physicians may face trying to collect the data. Emergency physicians themselves will not be held accountable if they are unable to collect the information-- laboratories are ultimately responsible for submitting the data to HHS.

We have also had conversations with the American Medical Association (AMA) on this requirement. The AMA recommended that physicians look into electronic case reporting (eCR), which is the automatic generation and transmission of case reports from EHRs to public health agencies. eCR improves the quality and timeliness of the data health departments receive – including contact info needed for contact tracing, race and ethnicity data, but also co-morbid conditions, vaccines, and treatments. The CDC has developed some useful resources on eCR: www.cdc.gov/ecr and https://www.cdc.gov/coronavirus/2019-ncov/hcp/electronic-case-reporting.html.

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