We know you have many continued questions regarding the new testing requirement for skilled nursing staff issued by CMS last week.  We are trying to get answers for you as soon as possible, since the rule will be published today, Wednesday September 2^nd.  What we do know is that since this is a CMS requirement, and even though there are a couple of LHJs that have told providers they do not need to follow the CMS guidance, you must follow the CMS guidance for testing and reporting, or you risk a CMP fine under F886, which would be issued during an infection control survey. In the meantime, we’ve obtained the following guidance from RCS, Bett Schlemmer.  

• Providers that have not received an antigen testing machine (or an adequate supply of test kits) by the time the CMS interim final rule is published and takes effect should be documenting and informing local and state health officials.  You will still need to do the testing; it will however be PCR testing instead of the antigen testing. If the facility has documentation that demonstrates their attempts to perform and/or obtain testing in accordance with these guidelines (e.g., timely contacting state officials, multiple attempts to obtain testing or shipping supplies or identify a laboratory that can provide testing results within 48 hours), surveyors should not cite the facility for noncompliance. Surveyors should also inform the state or local health authority of the facility’s lack of resources.  The surveyors will be asking for documentation that the facility contacted state and local health departments to assist with these issues.
• QSO 20-38 states facilities should monitor their county positivity rate every other week (e.g., first and third Monday of every month) and adjust the frequency of performing staff testing according to the table on page 5 of QSO 20-38. In September, the first Monday is the 7^th and 3^rd September 21^st. The facilities would start with these dates for monitoring.  Facilities should use their county positivity rate in the prior week as the trigger for staff testing frequency. We have asked if LHJ data could be used and have been told you need to use the data.cms.gov numbers-this is what you will be surveyed on. County prevalence rates can be found here: https://data.cms.gov/stories/s/COVID-19-Nursing-Home-Data/bkwz-xpvg. 

 “Facility staff” includes employees, consultants, contractors, volunteers, and caregivers who provide care and services to residents on behalf of the facility, and students in the facility’s nurse aide training programs or from affiliated academic institutions. For the purpose of testing “individuals providing services under arrangement and volunteers,” facilities should prioritize those individuals who are regularly in the facility (e.g., weekly) and have contact with residents or staff.

• If the county positivity rate moved decreases to a lower level of activity, the facility should continue testing staff at the higher frequency level until the county positivity rate has remained at the lower activity level for at least two weeks before reducing testing frequency.  However, if the county positivity rate increases and requires more frequent testing, that must begin immediately.

• Testing of Staff and Residents in Response to an Outbreak
  An outbreak is defined as a single new COVID-19 infection in any healthcare personnel (HCP) or any nursing home-onset COVID-19 infection in a resident. In an outbreak investigation, rapid identification and isolation of new cases is critical in stopping further viral transmission. A resident who is admitted to the facility with COVID-19 does not constitute a facility outbreak.

  Upon identification of a single new case of COVID-19 infection in any staff or residents, all staff and residents should be tested, and all staff and residents that tested negative should be retested every 3 days to 7 days until testing identifies no new cases of COVID-19 infection among staff or residents for a period of at least 14 days since the most recent positive result. See CDC guidance “Testing Guidelines for Nursing Homes” section Non-diagnostic testing of asymptomatic residents without known or suspected exposure to an individual infected with SARS-CoV-2.

  For individuals who test positive for COVID-19, repeat testing is not recommended. A symptom-based strategy is intended to replace the need for repeated testing. Facilities should follow the CDC guidance Test-Based Strategy for Discontinuing Transmission-Based Precautions for residents and Criteria for Return to Work for Healthcare Personnel with SARS-CoV2 Infection..

• QSO 20-37 states Facilities conducting tests under a Washington Department of Health Medical Test Site (CLIA certificate of waiver) are subject to regulations that require laboratories to report data for all testing completed, for each individual tested. However, at this time, the reporting system is not in place at DOH. RCS will be working with DOH this week to work out the reporting process to LHJs and the DOH; how data elements and information required should be collected and reported given its critical importance to public health efforts.  In the interim, maintain a facility log that contains all the reporting information within the HHS Lab Reporting Guidelines: https://www.hhs.gov/sites/default/files/covid-19-laboratory-data-reporting-guidance.pdf.  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 location of the individual’s residence. Providers need to document test results within these timeframes, at least in facility records, until the reporting process is established.  Continue to report to the Department CRU hotline, ALTSA reporting portal, and CDC NHSN.  Continue to notify the LHJ of any outbreak.   Please read QSO Memo 20-38 NH for more information on testing and QSO Memo 20-37 CLIA NH for reporting requirements.

This week on the LeadingAge National COVID Update call, Jill Schumann reported that they had attended a meeting with Rachel Kellogg, Deputy Chief of Staff to Assistant Secretary for Health Brett Giroir to discuss questions on antigen testing and the BD and Quidel machines.  Some key information they learned on the call: 

• Test kits are specific to the BD and Quidel machines.  BD test kits cannot be used on the Quidel machine and vice versa.
• Though BD machines are less accurate than Quidel’s, BD is a larger company with more production capacity, so more of these are being distributed.
• Both companies have set up dedicated websites to respond to nursing home requests for test kits.  The links are at https://www.bdveritor.com/ and https://togetheragain.quidel.com/. Training for use of the machines is available on both sites.  Extra test kits can be ordered from Medline or McKesson.
• If machines arrive broken or damaged or with a clearly erroneous number of test kits, providers can contact the companies directly.  If a provider doesn’t receive a machine at all or there are other unusual issues, please let Jodi or Janine Finke-Boyle know and they can consolidate questions and share them with Assistant Secretary Giroir’s office.
• HHS will soon issue its allocation plan for the 150 million rapid result Abbott tests.  If nursing homes have these tests, they may use them in lieu of or in combination with the antigen machines and PCR tests. Recall, the interim final rule requires testing, but it doesn’t explicitly require use of the antigen machine.

Please remember, Jodi Eyigor, Director, Nursing Home Quality & Policy at LeadingAge will be with us to discuss testing and reporting this Friday on our Clinical Update call at 1:30 pm.  The Outlook invitation was sent yesterday, you still have plenty of time to accept!  As always, if you have any questions, please do not hesitate to reach out to your LeadingAge Washington team!

Questions?

Contact:

Laura Hofmann, MSN, RN – Director of Clinical and Nursing Facility Regulatory Services

c: 425-231-4804