HHS clarifies data labs must submit for COVID-19 testing

June 12, 2020

Last week, the Department of Health and Human Services (HHS) issued additional guidance for labs and other entities performing COVID-19 testing regarding exactly what demographic data is required to be submitted to local health authorities.

While these requirements fall under the CARES Act, HHS felt additional guidance was necessary to show exactly what data is required to be submitted and what information is only being requested on a voluntary basis. The guidance acknowledges that since this data is beyond what has traditionally been requested, labs have until Aug. 1, 2020 to report it to the appropriate entity.

These are the 18 data points that HHS clarified MUST be reported to the CDC (typically through state and local health departments) for SARS-CoV-2 lab tests. They should be reported 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 patient’s residence.

  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)

These standards also apply to home-based testing.

The problem is that many labs do not receive information such as race or ethnicity with a patient’s EHR file, placing them in a bind for how exactly to collect this data. Further complicating matters, the guidance issued by HHS isn’t exactly clear on how labs can backtrack to obtain this info if it’s not provided in a patient’s record. The document simply states the following:

“…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. When information is not available, ordering health care providers (or their designees), laboratories performing SARS-CoV-2 and associated tests, and State Public Health departments should consider leveraging resources like state or regional HIEs and National Health Information Networks (HIN) to obtain missing, required information.”

It’s currently unclear exactly what penalties labs that fail to collect and submit all required data may face. However, those penalties, if enforced, would most likely be done at the state level, meaning labs could face a patchwork of consequences depending on where they operate.

Additionally, HHS is also encouraging labs to report the following data points. However, they are not required.

  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

The data may reported through the following methods, according to the guidance document issued by HHS:

  1. 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 deidentified data to the CDC on a daily basis using either Health Level 7 (HL7) messaging or the CDC-provided CSV format.
  2. 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.
  3. 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.

If you have questions about how to comply with these reporting requirements, or how to best obtain the necessary data, don’t hesitate to reach out to us directly at 517-486-4262.

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