QSO-20-38-NH – Interim Final Rule on Staff and Resident Testing in SNFs (this QSO does not apply to RCF/AL facilities). For compliance purposes, LAIN encourage all SNFs to document all decisions made or not made in detail. If/when surveyors ask questions about actions taken, it will be critical for SNFs to provide evidence of why decisions were made.  
 
Some Limited QSO and Point of Care Testing FAQs:
Q: If a facility has the CLIA waiver in place, must the facility notify CMS of the additional testing now being conducted under waiver once the point of care machine is delivered?
 
If your facility already holds a CLIA Certificate of Waiver, it can begin performing COVID-19 testing that has been authorized by the FDA for use in Point of Care settings (i.e., in patient care settings operating under a CLIA Certificate of Waiver) or Certificate of Waiver settings. Facilities holding a CLIA Certificate of Waiver are generally not required to update their test menus with CMS.
 
Q: Facilities conducting current testing under CLIA waiver do not report results to CLIA; although it has been implied these COVID results (both positive and negative) must be reported. Will further instruction be provided as to how and to whom this reporting of all test results must occur?
 
All laboratories must have a CLIA Certificate and report the results of the COVID-19 tests that they conduct to the appropriate federal, state, or local public health agencies.
 
Please see the memo QSO 20-17 CLIA-NH that discusses the most recent requirements for reporting. More guidance should be coming out in the future. Please also use this link for guidance from the Indiana State Department of Health regarding reporting of antigen tests to the state with results for SARS-COV 2.
 
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. Please visit the CDC website for more information about data reporting requirements.

Q: Should a facility have a standing Doctors’ order to provide resident testing under the new testing protocol?
 
ISDH recommends a standing order from the facility medical director for both staff and resident testing.
 
Q: What should be the source of truth to trigger compliance with the new QSO rule?
 
ISDH has not formally commented as to whether communities may use CMS data points or those found on the ISDH website(s) when determining what category of testing (low, medium, high) to deploy. We are pursuing more clarity on this issue but we urge facilities to document all aspects of every decision made and the basis for those decisions.
 
Q: What if my Antigen test has not arrived? Do I still need to comply with the QSO testing Rule?
 
The QSO memo implies that failure to receive the antigen test does not excuse compliance with its testing (universality and frequency) requirements. ISDH has not yet taken a formal position. We are pursuing more clarity on this issue but we urge facilities to document all aspects of every decision made and the basis for those decisions. 
More Q&As will come as they develop.
From LeadingAge National
QSO-20-38-NH – Interim Final Rule on Staff and Resident Testing in SNFs
Reminder that analysis of the rule can be found here. Note – this rule will be effective – upon publication on the Federal Register on September 2.

Point-of-Care Testing: This tool should be used to act as a quick reference for the most common questions.

NHSN updates: NHSN has updated the COVID-19 module for long-term care. Updates include 4 new data elements to collect information on point-of-care antigen testing. The Table of Instructions and CSV templates for group reporting have also been updated and can be accessed here under “Data Collection Forms & Instructions” and “Group Resources”. CDC will host 2 webinars next week to review these changes: September 1 at 1:00pm ET and September 3 at 1:00pm ET. Register here under “Upcoming Trainings”.

Reminder - Latest $2.5B in SNF Provider Relief Funds Uses Limited: See – this link to what we believe to be the correct terms and conditions for this tranche. SNFs will now need to carefully track their “infection control expenses” that offset the funds they received. Here is an updated the article as well. 

Senior Housing Weekly. Our recap of LeadingAge senior housing updates for the week is available here.

Nursing Home Weekly. Our recap of LeadingAge nursing home updates for the week is available here.
From ISDH
Total positive cases: 93,313
Total deaths: 3,072
Total tested: 1,065,356
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