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COVID-19 Update
Leadership Message
Important Update Regarding COVID-19 Molecular Diagnostic Testing
On February 29, FDA issued new guidance for its Emergency Use Authorization policy for COVID-19 molecular diagnostic testing. In issuing the new guidance, FDA states that, "[r]apid detection of COVID-19 cases in the United States requires wide availability of diagnostic testing to control the emergence of this rapidly spreading, severe illness. This guidance describes an accelerated policy enabling laboratories to use tests they develop faster in order to achieve more rapid testing capacity in the United States. The announcement can be found here https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#2019-ncov and here https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-new-policy-help-expedite-availability-diagnostics. The revised guidance document can be found here https://www.fda.gov/media/135659/download.
 
SHEA is aware of the growing concern among society members about the limited capacity to test persons under investigation (PUIs) for COVID-19. Some of the concerns expressed include:
  • The length of time it takes to send samples and receive results from CDC and state public health labs
  • The limited number of state public health labs able to run the tests
  • Apparent issues with some of the CDC test kit components
  • Concerns that limited testing capacity has led to PUI testing policies that are too restrictive and variable, even where testing may be clinically indicated
  • FDA's rules for Emergency Use Authorization make it prohibitive for institutions to get approval to run their own COVID-19 PCR testing despite having capacity and expertise
SHEA has conveyed these concerns to CDC officials. They are aware that lab testing capacity is a very serious issue and are committed to keeping SHEA and other stakeholders informed as they continue to explore solutions. Please review the links above containing revised guidance from FDA, as well as the links below outlining CDC guidance. SHEA members who continue to have questions and concerns should email Lynne Batshon at lbatshon@shea-online.org.
 
Message regarding PPE
On February 29, CDC issued new guidance to assist healthcare facilities with N95 respirator shortages. We have heard from several SHEA members about the growing concern over disruptions to the supply chain for personal protective equipment due to surge demand and limited manufacturing capacity. Links to the new guidance can be found below in the Federal Agency News, Guidance, and Guidelines section of this update. SHEA members who continue to encounter issues with access to N95 respirators and other PPE (routine or otherwise) should share their concerns with us. Email questions about the new guidance and observations to Lynne Batshon at lbatshon@shea-online.org.
Federal Agency News, Guidance, and Guidelines
PUIs and Patients with Confirmed COVID-19:
Healthcare:
ICD-10:
Special Populations:
Community:
Travel:
Summaries and Updates:
Tools and Resources
Information for Patients and Visitors
Event Announcements
  • Update on COVID-19 Response
    CDC, March 4, 2020, 3-4 pm ET
    Dr. Jay Butler, CDC Deputy Director for Infectious Diseases, will share guidance for the private sector, including what CDC knows at this point and what CDC is doing in response to this outbreak. Time for Q&A. Email questions in advance to privatesector@cdc.gov.
  • COVID-19 Update: What Clinicians Need to Know to Prepare for COVID-19 in the U.S.
    CDC, March 5, 2020, 2-3 pm ET
    Clinicians will learn what they can do to prepare for COVID-19 including identifying persons under investigation, applying infection prevention and control measures, assessing risks for exposures, optimizing the use of personal protective equipment supplies, and managing and caring for patients (inpatient and at home).
  • SHEA Rapid Response Webinar: Healthcare Facility Outbreak Preparedness
    March 5, 2020 | 3:00 - 4:00 pm EST 
    Planning, simulation, and communication in the inpatient and outpatient setting to decrease the risk of outbreaks, especially novel respiratory viruses, as well as how to train healthcare personnel in PPE use. There will be a recording uploaded onto LearningCE after the live event.
    Speakers: Eileen Korey, Jennifer Hanrahan, DO, Kavita Trivedi, MD, Bruce Ribner, MD, MPH, and Joan Hebden, RN, MS, CI
Trade Press  and Journal Articles
News Highlights
Social Media
  • Hashtags to follow: #coronavirusUS #COVID19US #coronavirus, #2019nCoV, #COVID19 
  • @WHO: Daily media briefing on #COVID19 with @DrTedros #coronavirus 
  • @eliowa: Any update on when the US can start widespread testing for #covid19? We need to be able to test everyone in every hospital and clinic 
  • @ScottGottliebMD: THREAD: On New #COVID19 Diagnosis in California Tonight: We will have community spread of #coronavirus in the U.S. It is likely that we have — right now — more cases that remain undiagnosed but will soon be revealed. We need to keep in mind several key points 
  • @SundermannAJ: @CDCgov just updated #COVID19 PUI testing criteria to include unexplained respiratory illnesses: Fever, ARDS/pneumonia, Hospitalization, No other diagnosis, No source of exposure @APIC @SHEA_Epi 
  • @PergamIC: De-isolating COVID-19 Suspect Cases: A Continuing Challenge | Clinical Infectious Diseases | Oxford Academic Super important paper for IP teams @APIC @SHEA_Epi
Federal Policy Updates
 
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