Last week we
that the Centers for Medicare and Medicaid Services (CMS) had authorized the distribution of rapid point-of-care diagnostic test instruments and test kits to all nursing homes in the country.
In that communication we noted that Washington labs do not operate under CLIA Certificates of Waiver and instead are licensed as state “Medical Test Sites.” Washington is only one of two states that are exempt from CLIA. We inquired with DOH and CMS about Washington’s nursing home located Medical Test Site’s eligibility to receive the distribution of rapid point-of-care diagnostic test instruments and test kits. After some investigation, DOH and CMS report that Washington’s regulatory framework will allow distribution of these test instruments and test kits from CMS to skilled nursing facility located Medical Test Sites. DOH also reports that at the start of the COVID-19 crisis, it sought authority from the FDA, and received, the ability to authorize labs in our state to perform COVID tests.
Based upon information provided by DOH, Washington State requires Medical Test Sites performing tests that are waived by the FDA to report to DOH that they are adding tests to their sites. Here is
they can use to do that. You can send the form to the address on the top left of the form or email to
CMS will be distributing the Quidel Sofia and Sofia 2 Instruments and BD Veritor Plus Systems. Both use antigen tests that can quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity using swabs, providing results in minutes. Antigen tests will play a critical role in the fight against COVID-19 and will be essential to reach the nation’s goal of testing millions of Americans each day. The two antigen detection tests are: (1) the Sofia SARS Antigen FIA manufactured by Quidel Corporation (Quidel) and (2) the Veritor System for Rapid Detection of SARS-CoV-2 manufactured by Becton, Dickenson and Company. It should be noted that these test may be slightly more likely to have a false negative result than molecular PCR COVID tests. For more information click
WHCA encourages SNFs to complete the DOH form so that the SARS COVID 19 test is included in the DOH list of waived test. The SNF could be determined to be out of compliance with state testing guidelines absent making this change. WHCA has been provided a list of 204 SNFs with Medical Test Sites. Based upon information provided to us, there are six SNFs that do not house a Medical Test Site. WHCA will be checking with those six SNFs to confirm their status.
The distribution of the testing instruments will occur over the course of the next six to eight weeks. Based upon our experiences over the last five months, we expect the distribution to be haphazard, with many fits and starts. We will continue to monitor the distribution process and, as always, keep you informed.