Update on Nursing Homes Point of Care Antigen Testing Initiative

Posted on July 29, 2020 by Jonathan Lips

We have gathered additional details about the U.S. Department of Health & Human Services’ initiative to supply rapid point-of-care antigen testing instruments and tests to nursing homes throughout the country to aid in identification and mitigation of COVID-19. 

We have compiled all of the information we have relating to this initiative into a Frequently-Asked-Questions document, which combines information from MDH, CMS/HHS, CDC and the FDA, and we will update this resource on a regular basis.

Key updates for this week, which are included in our FAQ, concern CLIA certificates of waiver, prioritization for shipments of these testing platforms, and additional information about the reporting that providers will be required to do if conducting these antigen tests:

CLIA Certificate of Waiver

As we have reported earlier, nursing homes must have a CLIA Certificate of Waiver both to receive the instruments and tests HHS will be distributing and to perform the tests.  Here is some additional information about this aspect of the program.

On Monday this week, Minnesota Department of Health (MDH) CLIA program staff reached out proactively to 54 nursing homes identified by CMS as not having CLIA Certificates of Waiver.  Based on a conversation with MDH today, if your facility has a Certificate of Waiver, but you still received that MDH communication, here are two possible reasons why:

• Hospital-Attached:  MDH recently received guidance from CMS indicating each nursing home facility must have its own CLIA Certificate of Waiver if it wishes to be included in the initiative.  Note: Participation in the initiative is not mandatory.  It is acceptable for hospital attached/associated facilities to continue using the hospital laboratory for their COVID-19 testing if that is their preference and the laboratory is able to accommodate the volume.
• Laboratory Type: The CLIA Application for Certification (CMS-116) includes a section to designate the type of laboratory (i.e. facility type).  One issue MDH has identified is that some facilities’ certificates are categorized under a catch-all category called “Other”.  According to MDH, the facility will need to submit a CMS-116 to change the lab type to #27 – Skilled Nursing Facility/Nursing facility if it wishes to be included in the initiative.

If you wish to participate in the HHS initiative, work directly with MDH to identify the specific reason why its records show you do not have a Certificate of Waiver. Contact the Minnesota Department of Health CLIA Program: health.clia@state.mn.us or 651-201-4120.  MDH will identify to CMS facilities that have contacted MDH to make changes to their certificates.

Prioritization for Shipments

CMS has prioritized roughly 3,900 nursing homes to receive instruments and tests in the coming weeks. Once those shipments are complete, HHS will continue a phased distribution of antigen testing supplies to nursing homes with a current CLIA Certificate of Waiver and based on updated epidemiological data.

A list of nursing homes receiving instruments and tests in a first phase of 635 facilities is available on this Nursing Home Data - Point of Care Device Allocation webpage.  There were no Minnesota facilities included in the first wave.

Today we learned that a second distribution is underway (or soon will be), and that a small number of Minnesota facilities – approximately 12 – will be included in this phase.

According to HHS, the prioritization is based on CDC epidemiological hotspot data, as well as nursing homes that CMS considers to have an elevated risk for COVID-19 transmission, based on data submitted to the National Healthcare Safety Network. However, several facilities across the country have reported to LeadingAge national that they received instruments and tests despite, by their reckoning, not falling into either of the prioritized categories – geographical hotspot or elevated risk – and that they instruments and tests, but without training materials. 

If your facility receives an instrument and associated test kits, we would be very eager to hear what you received and what the communication from the manufacturer included.

Reporting Test Results

Information from CMS instructs that facilities must report the results of the COVID-19 tests that they conduct to the appropriate federal, state, or local public health agencies:  “Laboratories must report data for all testing completed, for each individual tested. This data must be reported within 24 hours of test completion, on a daily basis, to the appropriate state or local public health department, based on the individual’s residence. Testing sites must report all diagnostic test data in accordance with the HHS Lab Data Reporting Guidance for COVID-19 issued June 4, 2020 and meet these reporting requirements by August 1, including providing your facility name and CLIA number when reporting results.”

The following links from CDC and HHS provide additional information on this critical operational issue:

• CDC laboratory reporting website
• HHS laboratory reporting guidance 
• HHS FAQs

This is a rapidly-evolving story, and we will continue to share new information with members as we receive it.