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COVID-19 Point-of-Care Test Update

The federal government has expanded the list of nursing homes that will receive rapid point-of-care testing instruments and testing supplies, and nearly all New York State nursing homes have been selected to receive the tests. The updated list of facilities is available here. A Frequently Asked Questions (FAQ) document from the Centers for Medicare and Medicaid Services (CMS) is available here.

As previously reported, in order to administer the point-of-care tests, facilities must have a New York State limited service laboratory registration certificate that includes the point-of-care antigen tests. If a facility does not have a limited service laboratory registration, it may apply by submitting the application materials available here. The application must list the tests that your organization will be performing. In order to administer the rapid tests distributed by the federal government, your application should include the COVID-19 Antigen, Quidel Sofia 2 Instrument or Becton, Dickinson and Company (BD) Veritor™ Plus System.

Similarly, facilities that already have a limited service laboratory registration must add the COVID-19 rapid tests to their list of approved tests. To add a test to a registration certificate, a facility must submit an application to add test procedures that includes the COVID-19 Antigen, Quidel Sofia 2 Instrument or BD Veritor™ Plus System. Facilities are advised to review their registration certificate prior to submitting the application and determine whether it reflects their current laboratory director. If the director has changed, facilities must also submit a notification form reflecting this change. Facilities are reminded that labs are responsible for notifying the Department of Health's (DOH) Clinical Laboratory Evaluation Program (CLEP) when various material changes are made in their laboratory operations. The forms used to add tests and notify CLEP of other changes are available here. More information about adding the rapid point-of-care tests to an existing registration is available here.

Limited service laboratories are subject to stringent reporting requirements related to COVID-19. All test results, whether negative, positive, or inconclusive, must be reported within 24 hours. Reporting can be conducted manually or via automated data exchange. Additional New York State guidance about reporting is available here and here.  Recently released federal guidance on reporting is available here. The staff at the CLEP Electronic Clinical Laboratory Reporting System (ECLRS) will assist limited service laboratories to establish the most appropriate mode of reporting based on their volume of testing. ECLRS may be contacted by telephone at 866-325-7743 or by email here.

Additionally, facilities should be aware that the Department of Health and Human Services (HHS) will be hosting a webinar with BD and Quidel on Thurs., Sept. 3rd from 12 to 1 p.m. ET to walk through each manufacturer’s testing training modules. Each manufacturer will have a 30-minute time slot to present and answer any questions. Registration is available here.

Concerns have been raised about the sensitivity of the rapid point-of-care antigen tests and whether confirmatory PCR tests are required for negative results. The CDC’s “Considerations for Interpreting Antigen Test Results in Nursing Homes” is available here. LeadingAge National’s antigen testing memo is available here.

Contact: Karen Lipson, klipson@leadingageny.org, 518-867-8838