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Three-Agency Task Force to Coordinate Speedy Response, Access to Diagnostics in Emergencies

NEW YORK (GenomeWeb) – Members from three government agencies will form a task force responsible for quickly coordinating the development of diagnostics during public health emergencies. 

The US Food and Drug Administration, the Centers for Disease Control and Prevention, and the Centers for Medicare & Medicaid Services will put forth experts who will be part of the newly formed Tri-Agency Task Force for Emergency Diagnostics (TTFED), which will meet at least twice a year and as needed to during public health emergencies. According to a charter describing the scope of the task force released today, TTFED is being formed to "coordinate the implementation of emergency-use IVD assays in laboratories within the US healthcare system, with the ultimate goal of improving responses to public health emergencies." 

"Public health emergencies, like Ebola outbreaks, remind us that we're a global community when it comes to public health protection. Bacteria and viruses don't respect territorial boundaries," said Jeffrey Shuren, director of FDA's device division. "To that end, 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."

At biannual meetings, TTFED members will review response procedures used in the past to identify gaps and refine and update procedures to close those gaps for future emergencies. During a public health emergency, the task force will also be a forum to discuss the IVDs being used and to come up with a plan for their rapid deployment. The recommendations issued by the task force will require consensus of the members. 

In a public health crisis, TTFED can deploy assays designated for emergency use and developed by commercial labs, by the CDC, or the US Department of Defense. However, in the past, clinical lab community stakeholders have been unclear about how to deploy emergency-use diagnostics and how to meet lab regulations outlined under the Clinical Laboratory Improvement Amendments when performing these tests. The members representing CDC, FDA, and CMS will contribute specific expertise to the task force's efforts to streamline these processes and clarify lab procedures to avoid confusion in future emergencies.

In a public health emergency, CDC will provide epidemiology and lab expertise specific to the agent of interest and guide clinicians and labs on how to respond. When an FDA- cleared or approved IVD is not available to accommodate a particular emergency, and the CDC can provide one, the agency will develop the assay, request emergency-use authorization from the FDA, and deploy the test to federal, state, and local public health labs.

When there aren't already FDA-approved tests to address the needs of an emergency, the FDA can issue emergency-use approvals for tests that have some evidence of effectiveness and the potential benefits of providing the test outweigh the risks to public health. The agency can make designations about the complexity of the test which would impact lab requirements under the Clinical Laboratory Improvement Amendments (CLIA). The FDA can also designate tests to be performed only at CDC-designated labs or allow their use more broadly.

CMS administers the federal lab regulations under the CLIA program and facilitates surveys, certification, and inspections of labs to ensure the quality and safety of tests being conducted. When a public health emergency occurs, CMS will advance guidance on how labs performing emergency-use tests must meet CLIA requirements and instruct lab surveyors.

"Timely implementation of emergency-use authorization diagnostic assays in the US 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, said in a statement. "As part of this taskforce, it is our goal to provide clear and consistent guidance to laboratories on the application of CLIA requirements for these emergency assays."