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COVID-19 Update
Leadership Message
FDA revised guidance for emergency use authorization (EUA) for COVID-19 diagnostics
On February 29, the Food and Drug Administration (FDA) released a revised guidance document outlining a revised emergency use authorization (EUA) pathway for COVID-19 diagnostic testing development which now allows hospitals to develop their own laboratory tests. SHEA heard from many members expressing concern over the barriers that had previously existed for using laboratory developed tests for suspected COVID-19 cases. This created a severe bottleneck on testing samples since testing at that time had been restricted to CDC test kits which have not been widely distributed yet. We are hopeful that FDA's expanded guidance offers some relief to the barriers encountered previously. We welcome feedback from members of the society and what if any challenges still exist. Additional guidance on evaluating and testing persons for COVID-19 was issued by CDC in a March 8 Health Alert Network Update (see link in the Federal Agency News section). Send your emails to Lynne Batshon at lbatshon@shea-online.org.
 
Share your resource needs and concerns
We are hearing from many members about their concerns about short- and long-term shortages of personal protective equipment (PPE). CDC is aware of strong concerns over shortages of N95 masks. The CDC has made it a top priority for finding solutions to meeting the high demand for N95 masks and is exploring alternative strategies for protecting providers, clinicians, and healthcare personnel where facilities are experiencing shortages. CDC has issued guidance about Strategies for Optimizing the Supply of N95 Respirators (accompanied by a checklist) that providers should be using to optimize current supplies.  The CDC is in the process of revising its infection prevention and control guidance for COVID-19 and will address use of N95 respirators versus facemasks in the next update. CDC maintains that N95 respirators are the superior product when considering what will provide the best respiratory protection for healthcare personnel.
 
It is imperative that members continue to share these concerns and on the ground observations. While the society may not be able to assist with local supply chain issues, we will continue to inform key CDC and ASPR officials of these ongoing challenges. Keeping government officials informed is what drives changes in policy and guidance so that barriers to effectively caring for patients can be minimized. Also, please read further on what the emergency supplemental funding legislation for the COVID-19 covers and tell us what you think. Send your questions and comments to Lynne Batshon at lbatshon@shea-online.org.
SHEA Coronavirus News
Federal Agency News, Guidance, and Guidelines
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Information for Patients and Visitors
Event Announcements
Professional Convention Management Association (PCMA) Webinar: Get the Facts on COVID-19
March 10, 2020 3:30 PM – 4:30 PM CDT
With so much media coverage of COVID-19, and the global developments changing by the minute, it's hard to determine what steps are necessary – and when to act. PCMA and the American Society for Microbiology (ASM) are delivering this joint webinar featuring a panel of medical experts to separate fact from fiction helping you decide if and how this impacts your event audiences and stakeholders.
Register Here
Trade Press  and Journal Articles
News Highlights
Social Media
Coronavirus: Last Week Tonight with John Oliver
(HBO, accessed via YouTube March 1, 2020)
Federal Policy Updates
Emergency Funding Bill Making its Way to the Oval Office
At the time of this writing, a bill to provide for $8.3 billion in emergency supplemental funding to respond to the COVID-19 outbreak was passed by the House and Senate. The bill is now on its way to the president's desk for signature, where it is expected to be signed on Friday, March 6.  Key provisions of the bill include:
  • $2.2 billion for the Centers for Disease Control and Prevention. Within this bolus of funding,
    • $475 million will be distributed to the states to support state, local, territorial, and tribal public health activities. Among the many activities covered, it includes surveillance for COVID-19, laboratory testing, contact tracing, infection control, and preparedness/response.
    • No less than $40 million allocated to tribes.
    • Existing Public Health Emergency Program (PHEP) grantees will receive emergency supplemental allocations in an amount that is at least equal to 90% of their current annual PHEP award.
    • The full $475 million must be disbursed to the states within 30 days.
    • There is a 3-year period of availability for these funds.
  • $1 billion for medical supplies, pharmaceutical procurement, healthcare preparedness for surge capacity, community health centers. Within this $1 billion bolus of funding,
    • $500 million will be allocated for PPE, procurement of pharmaceuticals, and medical supplies that may be in shortage in certain areas due to surge management or supply chain disruptions
    • $100 million to support community health centers
    • Support for the National Ebola and Special Pathogens Treatment Centers (NETEC) and hospital preparedness cooperative agreements
    • Funding for medical surge capacity to increase the supply of biocontainment beds
Other notable provisions include:
  • $3 billion for research of vaccines, therapeutics, and diagnostics for COVID-19
  • $300 million to replenish the Infectious Diseases Rapid Response Reserve Fund
  • $300 million for global disease detection and emergency response
  • $61 million to FDA to facilitate device and product reviews
  • $500 million in mandatory funding for telehealth during emergency periods
  • CDC support for repatriation and quarantine efforts, laboratory testing capacity, epidemiological investigations, public information, and surveillance and data analysis
  • For most programs, funding is available through 2024
Full text of the bill can be found here.
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