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Allowing nontraditional laboratories to perform diagnostic testing in a potential pandemic situation was one of the nearly 100 actions proposed by a panel of experts, according to results of a new report published by the Government Accountability Office (GAO).

The new report ultimately yielded four recommendations from the GAO to the Department of Health and Human Services (HHS), with two action items. One of these called for the creation of a national diagnostic testing strategy for infectious diseases with pandemic potential. Another called for the creation of a national diagnostic testing forum that would include a range of expert testing stakeholders from HHS and component agencies, but also the public and private sectors, nonprofit organizations, and academia.

The other two main recommendations were that the national diagnostic testing strategy, once created, be updated regularly with lessons learned from infectious disease threats, other public health threats, or relevant preparedness exercises; and that the national diagnostic testing forum, once created, meet regularly, including both before and during infectious disease threats with pandemic potential, before and during other public health threats deemed relevant, or any related preparedness exercises.

“Pandemics pose an ever-present threat to American lives, national security, and economic interests, and diagnostic testing is critical to tracking infectious disease and helping reduce potential death rates,” said Mary Denigan-Macauley, director of Public Health for the GAO, in an interview.

“Testing helps us know where the disease is, how it is spreading and if it is gone,” Denigan-Macauley said. During the COVID-19 pandemic and the recent mpox outbreaks, the US Department of HHS struggled to lead the nation’s testing efforts, and taking action to improve testing protocols now can boost preparedness for the next infectious disease emergency, Denigan-Macauley said.

Diseases know no borders, she added. “A strain of highly pathogenic avian influenza is widespread in wild birds around the globe and is already on our doorstep, causing outbreaks in poultry and US dairy cows, with several recent human cases in US dairy and poultry workers,” Denigan-Macauley said. “Tracking these and other diseases is critical so we can be prepared and implement measures to control their spread,” she emphasized.

Cooperative Planning Will Promote Current Information

Infectious disease testing is not for the federal government to do alone; everyone from the doctor who tests the patient to local, state, and federal health officials should understand the national diagnostic testing strategy so they can work together, said Denigan-Macauley. “We don’t want key stakeholders working in silos that are fragmented and disjointed; this prevents us from understanding what is happening nationally to control a disease,” she said.

“A national diagnostic testing strategy and coordinating group could help the nation avoid some of the challenges faced during previous public health emergencies,” Denigan-Macauley told Medscape Medical News. “For example, we found that the federal government did not always coordinate its updates to COVID-19 testing guidance with external stakeholders, such as healthcare professional organizations, which led to confusion and disagreement in the practice community,” she said. However, a national testing strategy could establish specific processes for coordination and collaboration related to testing guidance updates, she noted. “A national coordinating group could then facilitate real-time communication of the updates, which would help ensure that frontline providers are prepared to implement new guidance upon its release,” she added.

The current fragmented state of diagnostic testing efforts across numerous government agencies is a barrier to a national strategy, Denigan-Macauley told Medscape Medical News. “Fragmentation refers to circumstances in which more than one agency is involved in the same broad area,” she said. “Our states — simply by the way we are set up as a nation — also have differing capabilities, goals and their own health systems causing further fragmentation,” she explained. Establishing a testing coordinating group and implementing practices for interagency collaboration can help manage fragmentation and overcome this barrier, she said.

Research Gaps

The experts consulted on the report suggested several areas in need of additional research, including determining the types of diagnostic testing required for different types of pathogens, developing diagnostic tests with longer shelf lives, evaluating the new generations of diagnostic testing equipment, and understanding the human behaviors that drive compliance with diagnostic testing guidance, said Denigan-Macauley.

A Specialist’s Take

Having a national diagnostic testing strategy would allow the US to cope more efficiently with the next pandemic, said Romney M. Humphries, PhD, D(ABMM), M(ASCP), professor of pathology, microbiology, and immunology at Vanderbilt University Medical Center, Nashville, Tennessee, in an interview.

The COVID-19 pandemic was challenging in many ways, including the inability of many public health labs to handle the surge in testing needs, said Humphries.

“A national diagnostic testing strategy would promote building an infrastructure and developing partnerships among labs,” said Humphries. In addition, developing a universal approach to testing and standardized testing protocols, as are common in European countries, would streamline the process and facilitate such partnerships, she said.

However, funding is a significant barrier to implementing any national diagnostic testing strategy, Humphries noted. Funding for various public health initiatives is being reduced or eliminated, but a national diagnostic testing strategy should be prioritized given the benefit to public health in general and the value in the event of a pandemic or other public health crisis, she said.

Looking ahead, improvements in management and operations at the federal, state, and local level are needed to make a national diagnostic testing strategy successful, Humphries told Medscape Medical News.

Although no action has yet been taken to create a national diagnostic testing strategy, “HHS officials said they are taking some steps to improve diagnostic testing related to the actions suggested by experts,” according to the GAO website outlining the report.

The GAO researchers and Denigan-Macauley had no financial conflicts of interest. Humphries had no financial conflicts of interest.