AHA Special Bulletin
March 22, 2021
Includes New Therapeutic Data Fields and Clarifications to Vaccination and PPE Fields
The Department of Health and Human Services (HHS) March 19 updated its guidance to hospitals on the reporting of COVID-19-related data. The updates reflect the new COVID-19 therapeutic and vaccine that received emergency use authorization (EUA) from the Food and Drug Administration (FDA) since HHS last updated its reporting guidance. HHS also converted one of the personal protective equipment (PPE) data fields from mandatory to optional reporting.
New COVID-19 Therapeutic Data Fields
The FDA Feb. 9 authorized a combination therapy of two monoclonal antibodies: bamlanivimab and etesevimab. As a result, HHS adds two new therapeutic data fields that ask hospitals to report once per week on the treatment courses of bamlanivimab/ etesevimab on hand and treatment courses used in the past week. The data fields are available now but will be required beginning on Wednesday, April 7. Consistent with the other COVID-19 data fields that are reported on a weekly basis, HHS asks that hospitals submit the data on Wednesdays.
COVID-19 Vaccination Data Fields
The FDA Feb. 26 authorized Johnson & Johnson’s COVID-19 vaccine for emergency use. In contrast to the previously authorized two-dose COVID-19 vaccines, the Johnson & Johnson vaccine follows a single-dose regimen. As a result, HHS makes several clarifications to the instructions in the COVID-19 vaccination data fields. For example:
- For the field reflecting the previous week’s COVID-19 vaccination doses administered to health care personnel (question 41 in the guidance document), HHS specifies that the count should include personnel who received single-dose vaccines.
- For the field reflecting the count of health care personnel who have received a completed series of COVID-19 vaccination doses (question 44), HHS specifies that the count should include those who received a single-dose vaccine.
The guidance document also includes many new frequently asked questions (FAQs) –specifically, FAQs 11 through 26 – that address several aspects of the vaccination reporting process, including how HHS is using the reported data, and how facilities should count personnel who work across multiple sites. Note that the reporting of the vaccination data fields remains optional – but encouraged – at this time. As is the case with any of the hospital COVID-19 data, HHS may report aggregate and/or facility-level data on vaccinations publicly in the future.
PPE Field Update
Beginning this week, HHS is making it optional for hospitals to report whether they have implemented reuse and/or extended use of certain PPE (i.e., question 31 in the guidance document).
For information on how the Centers for Medicare & Medicaid Services is enforcing the condition of participation for hospitals to report the COVID-19 data requested by HHS, see the AHA’s Oct. 6 Special Bulletin. If you have further questions, please contact AHA at 800-424-4301.