Update on Reporting Point of Care Antigen Test Results
On January 13, 2021 by Jonathan Lips
The U.S. Department of Health & Human Services (HHS) has granted certified nursing facilities more flexibility in terms of where facilities submit the results of point-of-care antigen tests. We expect the Minnesota Department of Health (MDH) to update its “Reporting Results of COVID-19 Tests” guidance today, to reflect this change.
At this stage in the pandemic, nearly all nursing homes and many assisted living providers have access to antigen testing systems, such as the BD Veritor and Sofia Quidel antigen test machine, and the Abbot BinaxNOW card tests. These systems allow providers with a CLIA Certificate of Waiver to run rapid, point-of-care COVID-19 test in their settings.
When a provider runs these point of care tests, it must report all test results, both positive and negative and for all individuals tested, within 24 hours. Initially both nursing homes and assisted living providers submitted those test results to the Minnesota Department of Health (MDH). In October 2020, however, HHS mandated that nursing homes must submit point of care antigen test results to the CDC’s National Healthcare Safety Network. In response, nursing homes scrambled to obtain Level 3 NHSN security access and began reporting to CDC instead of MDH.
We learned last week that HHS is now allowing more flexibility in terms of where nursing facilities may submit the testing data. HHS issued a Lab Data Reporting Guidance update on Jan. 8, which lists reporting to NHSN as one of four options for submitting data (see p. 2 of the guidance). Previously, this guidance document indicated that nursing facilities must report to NHSN. The CDC website reflects this information, too.
It is important to note this change does not eliminate the requirement to report the test results, but offers flexibility in where reports are sent, allowing facilities to report test results either to NHSN or to a point-of-care testing platform and process established by the State.
What This Means for Providers
If your nursing facility has been reporting your point of care antigen test results to NHSN, you can continue to do that. In fact, MDH prefers for facilities to report to NHSN if you are able to do so. If reporting to NHSN, facilities should not also report directly to MDH, because CDC will send test results to MDH. However, facilities can also choose to report POC antigen test results to MDH instead of to NHSN, if you prefer.
If your nursing facility has applied to NHSN for Level 3 clearance, but you are still in a bottleneck waiting for CDC to complete the process, we recommend that you stick with it. Since you’ve already put time and energy into the process, you might as well complete it so your team will have the Level 3 access, and then then evaluate where you prefer to submit your testing data.
Assisted living providers running point of care antigen tests must also have a CLIA Certificate of Waiver and submit test results data. HHS has never required these providers to report to NHSN, and we suspect most have not voluntarily opted for the NHSN option over reporting to MDH. If you are an assisted living provider, simply continue reporting your test results to MDH as you have been doing.