HHS Distribution of Tests Raises CLIA-Waived Testing Questions

The federal government announced last week that it would be distributing rapid point-of-care diagnostic test instruments and tests to nursing homes in COVID-19 hotspots. This one-time procurement of devices and tests is intended to support on-site testing of nursing home residents and staff. Given the low prevalence of COVID-19 in New York currently, and the rising prevalence in many other states, New York nursing homes are not likely to be targeted for distributions of the rapid testing instruments.

However, New York facilities may want to add COVID-19 point-of-care tests to their Limited Service Laboratory Registration or obtain a Limited Service Laboratory Registration in order to administer these tests. New York’s Clinical Laboratory Evaluation Program, which licenses and registers clinical labs, is allowing the following COVID-19 tests to be administered and analyzed under Limited Service Laboratory Registrations:

• COVID-19 Antigen
  • Becton, Dickinson (BD) Veritor System for Rapid Detection of SARS-CoV-2
  • Quidel Sofia 2 SARS Antigen FIA
• COVID-19 Molecular
  • Abbott ID NOW COVID-19
  • Cepheid Xpert Xpress SARS-CoV-2
  • Cue Health COVID-19 Test
  • Mesa Biotech Accula SARS-CoV-2

In order to add these tests to an existing laboratory registration, facilities must submit a "Limited Service Laboratory Registration Notification to Add and/or Delete Test Procedure(s)" form to the Department of Health (DOH). The document may be completed, scanned, and submitted via email. To ensure proper routing, providers should include the following information in the subject line of the email: their PFI # and the test(s) to be added. These applications are generally approved quickly, and an approval form is returned via email.

Facilities that do not have a Limited Service Laboratory Registration may apply for one by submitting a registration application via U.S. Mail, along with a registration fee. More information is available here. In order to determine whether a facility is registered as a Limited Service Laboratory, search here.

Because New York State has a Centers for Medicare and Medicaid Services (CMS)-approved laboratory program, New York State labs are exempt from Clinical Laboratory Improvement Amendment (CLIA) certification, and a New York State Limited Service Laboratory Registration is the equivalent of a CLIA certificate of waiver.

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