APhA coronavirus watch: Guidance specifies data that COVID-19 testers must collect and report to HHS

New guidance requires laboratories performing COVID-19 testing under a CLIA Certificate of Waiver—including pharmacies enrolled as independent clinical laboratories—to report test results and other data to the U.S. Health and Human Services (HHS) or its designee while the federal public health emergency declaration is in effect. The data will be used to help identify disease incidence and trends and inform mitigation and control activities. While these new reporting requirements add to the administrative costs to testers, it will also help to attribute COVID-19 testing done by pharmacists and pharmacies with CLIA Certificate of Waivers. Testers should begin collecting the data as soon as possible but must begin to do so by August 1, 2020, the data must be submitted daily within 24 hours of receipt of test results.

According to the HHS guidance, released June 4, 2020, testers 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 new reporting requirements will be helpful in attributing actions to pharmacists, APhA representatives say.

Per HHS guidance, pharmacies enrolled as independent clinical laboratories must submit the following for COVID-19 tests:

  1. Test ordered
  2. Device identifier
  3. Test result
  4. Test result date
  5. Accession number/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
  17. Date test ordered (date format)
  18. Date specimen collected (date format)

Testers should also collect and report to state or local public health agencies patients’ last name, first name, and middle initial; street address; phone number with area code; and date of birth, as well as the address and phone number of the ordering provider. These data, however, will not be collected by CDC or other HHS agencies, and state and local privacy standards still apply.

The guidance recommends recording patients’ pregnancy status but does not list it among the required data. On June 5, more than 60 Members of the U.S. House of Representatives sent a letter to HHS Secretary Alex Azar asking him to detail his agency’s efforts to use data to assess COVID-19’s impact on pregnancy patients, particularly pregnant patients of color. The letter’s signers note that although the CDC form includes a field for pregnancy status, it is rarely used.

HHS requires the data to be submitted though existing public health reporting systems. Testing data should be reported to state or local public health departments as required by law. The public health departments will then remove any identifying information and submit it to CDC daily. Data must be submitted via messages that conform to Health Level 7 standards or the CDC-provided CSV format.

Lab testing data can also be submitted to state and local public health departments through centralized platforms, like the Association of Public Health Laboratories’ AIMS platform, which can strip the data of identifying information and route it to the proper authorities. Additionally, data can be submitted to state or regional health information exchange, or HIE.

An FAQ document on the June 4 guidance explains what to do if testers are unable to capture required data and additional data that should be reported but are not required, including pregnancy.