CDC Launches Effort to Create National Laboratory Response System

In the year since the coronavirus pandemic officially ended, healthcare experts have been urging policy makers to improve clinical laboratories’ preparedness for any future pandemics. The Centers for Disease Control and Prevention (CDC) recently convened a group of laboratory and public health organizations, including ASCP, to conceptualize what a national laboratory response system would look like.  

“We all looked at what happened during the most recent public health emergencies, what worked and what didn’t work, to ensure that the nation’s laboratories are prepared for novel emerging pathogens,” says Ken Landgraf, MSc, Executive Director of ASCP’s Center for Global Health, who attended the March 2024 meeting in Washington, DC. 

The meeting included key laboratory professional organizations, clinical laboratories, commercial laboratories, accrediting bodies, public health organizations, and federal agencies such as the Food and Drug Administration, the Department of Defense, and the Department of Homeland Security. Representatives from high-complexity academic medical center laboratories were not included at the meeting, but Mr. Landgraf believes they should have a seat at the table going forward.  

The goal of the CDC meeting was to define what a national laboratory response system should look like and which laboratory partners and other public health partners need to be included to ensure the country is prepared for future pandemics and is able to respond effectively.  

A framework for success 

The CDC has developed a framework that is divided into multiple phases for a public health response: preparedness; detection; response; and recovery. The preparedness phase addresses the need for enough funds allocated to develop a sufficient workforce, as well as investing in systems that will ensure adequate preparation. The detection phase is where experts have identified an emerging pathogen, followed by the response phase where testing is scaled up, organizations are communicating with each other about testing, and surveillance is conducted to monitor for mutations and epidemiologic trends. At the conclusion of a public health crisis, health experts move into the recovery phase to look back and review actions that were taken, as well as looking ahead to better prepare for the next outbreak.  

“During the CDC meeting, we started by reviewing the overall functional landscape of the National Laboratory Response System, from national level systems like data reporting and supply-chain management down to the nitty-gritty like testing methodologies, training delivery, and other aspects essential during a public health response,” Mr. Landgraf explains. He notes that, during the COVID-19 pandemic, one of the major challenges was the constant shortage of laboratory supplies. Laboratories lacked much of the equipment and supplies necessary for COVID-19 and other testing.  

Representatives of each organization that participated in the meeting described what their roles would be in a public health response. 

“During the meeting, there was talk about what the public health laboratories and the large commercial laboratories can do,” Mr. Landgraf says. “ASCP, in addition to communicating broad messaging out to our constituents during a public health response, can also coordinate with large academic medical centers to support a response. ASCP is also engaged in several workforce development initiatives which will also support laboratory preparedness for future public health crises.    

“Given the regulatory environment and the proper authorization required, these academic medical center high-complexity laboratories were able to get high quality COVID-19 testing up and running and available to their patients very quickly,” Mr. Landgraf adds. “That was essential during the earliest days of the U.S. COVID-19 response. However, with the FDA’s new rule on laboratory developed tests, the skill and expertise of these high-complexity laboratories may go untapped during future public health emergencies.”  

The second day of the gathering, participants broke into small groups for “tabletop exercises.” Each small group was assigned a scenario involving an emerging pathogen, and walked through the scenario and identified what steps would need to be taken to safely conduct testing and scale up diagnostic services.  

“Each scenario was different. If a scenario involved, say, a select agent like Ebola, testing in the early days of an outbreak would be restricted to a limited set of Biosafety Level 3 laboratories with secure facilities and robust protocols,” Mr. Landgraf explains.  

The exercise enabled participants to consider all possible scenarios they might need to pursue. The CDC is in the process of putting together a report based on the meeting. ASCP will continue to provide review and input as the CDC develops the National Laboratory Response System.  

“To be prepared for the next pandemic, we need continued investment in our medical and public health laboratory systems. This includes investment in a strong medical and public health laboratory workforce,” Mr. Landgraf explains.  

While the discussion on how best to prepare for any future pandemic is in its early stages and much work still needs to be done, ASCP looks forward to working with the CDC and other government partners, as well as the laboratory community, to ensure the nation’s laboratories are poised for rapid response, should another pandemic emerge.