By Jonathan Springston, Editor, Relias Media
Three federal agencies have joined forces to create a task force to improve the development, distribution, and usage of diagnostic tests during public health emergencies.
The CDC, CMS, and FDA this week announced the formation of the Tri-Agency Task Force for Emergency Diagnostics and charged its members with developing a process to collaborate on future emergency diagnostic response needs, such as large-scale episodes that involve infectious diseases like Ebola or Zika.
“This task force will help our agencies better collaborate to prepare for, and respond to, public health threats, including identifying threats and ensuring the appropriate diagnostics are in place to support efforts in the field,” Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement. “The FDA knows that collaborating with our federal partners to employ our collective expertise, experiences from previous incidents, and resources will better assist in a global response. We also believe that this task force could lead to more innovation for diagnostic tests as developers will see a more predictable federal regulatory response through the agencies’ coordination.”
When a crisis arises, the FDA uses the Emergency Use Authorization (EUA) to help distribute appropriate diagnostic tests. In addition to developing the right tests for these emergencies, the CDC offers subject matter experts who provide guidance to clinicians and laboratories responding to these emergencies. CMS regulates lab testing through the Clinical Laboratory Improvement Amendments (CLIA) to ensure accurate, reliable, safe, and timely results. With so much bureaucracy, confusion and stress levels can skyrocket, complicating an already-difficult situation.
“Timely implementation of EUA diagnostic assays in the U.S. healthcare system is dependent upon laboratories understanding the instructions for use and applying them to the patient samples received for testing,” Kate Goodrich, director of the Center for Clinical Standards and Quality and CMS chief medical officer, said in a statement. “As part of this task force, it is our goal to provide clear and consistent guidance to laboratories on the application of CLIA requirements for these emergency assays.”
On a related note, HHS recently released updated guidance and support tools for decontaminating large groups who have been exposed to chemicals. The updated Primary Response Incident Scene Management guidance includes new scientific evidence and in-depth details about thorough decontamination protocols.
“Our goal was to provide emergency managers and first responders with scientific evidence and guidance they needed to make fundamental and fast decisions on how to save the greatest number of lives in chemical emergencies,” Biomedical Advanced Research and Development Authority Director Rick Bright, PhD, said in a statement. “Building on the first groundbreaking studies and guidance, we now have a larger body of scientific evidence that is incorporated into the latest guidance, and we have made it even easier for responders to use in preparing for disasters and on the scene in an emergency.”
A trio of episodes of Relias Media’s “Rounds With Relias” podcast series highlights the dangers of certain infectious diseases and how to manage outbreaks of Legionella, tickborne illnesses, and acute flaccid myelitis.
For even more information about protecting patients and healthcare workers from infectious diseases, as well as more about new federal initiatives mentioned above, be sure to check out the latest issues of Hospital Employee Health, Hospital Infection Control & Prevention, and Infectious Disease Alert.