On June 4, the U.S. Department of Health and Human Services (HHS) released guidance for laboratories performing COVID-19 testing on the requirements for data submission to HHS required under the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The guidance expands the data elements that were previously required to be reported to now include demographic data like race, ethnicity, age and sex, in recognition that COVID-19 is taking a disproportionate toll on some demographics, such as racial minorities and older Americans.

Thus, beginning as soon as possible, but no later than August 1, 2020, the following eighteen (18) data elements must be collected and reported for SARS-COV-2 laboratory tests for the transmission of complete laboratory testing data to CDC or the HHS Secretary's designee:

  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 (LIVID) Test Code Mapping for SARS-CoV-2 Tests provided by CDC
  4. Test Result date
  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
  18. Date specimen collected

Additional information specific to SARS-CoV-2 must also be collected as "ask on order entry" questions for traditional Electronic Health Records or Laboratory Information Management Systems, as follows:

  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

Last, the following six (6) data elements should also be collected and reported to state or local public health departments, although this data will not be collected by CDC or the HHS Secretary's designee (note, too, that additional data elements may be requested by the state, local or federal health departments at any time):

  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

To meet this requirement, HHS indicates that any person or entity ordering a diagnostic or serologic test, collecting a specimen, or performing the test itself should make every reasonable effort to collect complete demographic information, or, when the information is not available, health care providers, laboratories and state Public Health departments should consider leveraging state and regional Health Information Exchange (HIE) and National Health Information Networks to obtain the missing, required information.

HHS's reporting guidance requires all laboratories on a daily basis to report data for all COVID-19 testing completed, for each individual tested, within 24 hours of results being known or determined, to the appropriate state or local public health department based on the tested individual's residence. Laboratories for the purpose of this guidance include traditional laboratories, testing locations operating as temporary overflow or remote locations for a laboratory, and other facilities or locations performing testing at point of care or with at-home specimen collection related to the virus SARS-CoV-2. Note that while facilities only collecting or preparing specimens (or both) or only serving as a mailing service and not performing testing are not considered laboratories, laboratories may direct these specimen collection facilities to provide the information required to be reported by the laboratories themselves. Indeed, HHS indicates that for home-based collection of samples that are sent to a laboratory for testing, the laboratory must be able to collect the required information for reporting, so submission of the data elements to the lab performing the test should be included in the process for sample collection.

The data submission requirements from HHS can be met by laboratories in three different ways:

  1. Submission of testing data directly to a state or local public health department, as required by state/local law or policy, in which case these entities will then submit de-identified data to the Centers for Disease Control and Prevention (CDC);
  2. Submission of 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; or
  3. Submission of testing data through a state or regional HIE to the appropriate state or local public health department and to the CDC as directed by the state.

In addition, HHS recommends, but does not require, that the laboratory results transmitted back to the ordering provider include the following at a minimum, whenever possible:

  1. Test results with appropriate LOINC and SNOMED codes
  2. Test result date
  3. Unique patient identifier
  4. Test ordered, using appropriate LOINC codes
  5. Device identifier
  6. Accession #/specimen ID

Finally, HHS also recommends, but does not require, that test results be sent directly to the patient tested or their parent/guardian, either in writing by mail, electronically by email, and/or via a secure patient portal or similarly secure application programming interface.

If you have any questions regarding the above changes, please do not hesitate to contact any member of the Health Law Practice Group at Shipman & Goodwin LLP.

Originally published 9 June 2020

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