February 12, 2024
5 min read
The pandemic early exposed weaknesses in CDC’s laboratories. Organizational and culture changes there are good first steps, but more must be done
Almost unnoted, the fourth anniversary of the beginning of the COVID pandemic in the U.S. passed in January. Missteps made in the early weeks of that tragedy, however, still offer vital lessons about what public health agencies need to do better to keep us safe.
That’s particularly true at the U.S. Centers for Disease Control and Prevention, because the agency’s labs play a fundamental role in developing and deploying tests for new diseases. In early 2020 it became clear that SARS CoV-2 had entered the U.S. and presented a deadly threat. The CDC almost immediately faced challenges, after its first diagnostic test for the virus was released with flaws that prevented its use in state and local public health laboratories. The test was redesigned and released again almost three weeks later. But the delays in diagnosis, quarantine and isolation gave the virus a head start in spreading.
Changes underway since then at CDC to address this tragic failure need to be sped up and funded. The most important change of all will be a culture change at this vital federal public health agency, a change that looks outward to actively involve the nation’s national laboratory system.
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Several published reports have documented in significant detail the events and decision points at CDC that led to its test’s failure. Ultimately, it originated in the fact that testing laboratories at CDC have historically not had adequate levels of staff and resources consistent with the agency’s responsibility as the nation’s premier public health laboratory. Its laboratories have also not had appropriate organizational standing or fiscal authority to drive policy and process for test development and deployment in biological emergencies. Few CDC scientists have the federal qualifications required of a diagnostic laboratory director, and most of CDC’s laboratory leaders report to senior health professionals who lack the specific education and training needed to oversee essential laboratory quality and performance standards. We think that CDC should rely more on special federal pay authorities for health care professionals and scientists to address the urgent need for clinically qualified staff for these laboratory oversight roles, similar to how the NIH and the Veterans Administration handle positions needing specialized expertise.
To support the critical nature of diagnostic testing in public health responses, CDC should elevate the agency’s laboratories within its organizational structure. CDC has already taken a major step in this direction: as part of its Moving Forward initiative the agency established an entirely new Center for Laboratory Systems and Response. The new center reports directly to the office of the CDC director. Its internal focus will be to ensure that CDC’s diagnostic laboratories, of which there are upwards of 40 at its main campus alone, provide timely and accurate diagnostic testing in response to infectious disease outbreaks. Outside the agency, the center is charged with enhancing collaboration with the nation’s public, academic and private laboratories, as well as with diagnostic manufacturers.
That all sounds great, but we should note reasons for caution. At this time, four years after the pandemic’s start, the new center is not yet officially documented on the CDC’s organizational chart, nor is the acting center director publicly acknowledged, in that capacity, as part of its senior leadership. CDC needs to move faster to demonstrate the importance of this organizational change.
With this major organizational change, CDC will move away from its long-standing “only we can do it” approach, and closer to taking advantage of the expertise and testing capacity that exists within the national laboratory system. It has already started to do this. As the pandemic progressed, CDC embraced genomic sequencing to provide national tracking of genomic variants and worked closely with public health, academic and commercial sequencing laboratories, monitoring the real-time evolution of a virus ravaging humanity. Similar collaborations exist for wastewater testing.
In 2023 the CDC also took a major external step forward by issuing two requests for private sector involvement in public health. In the first, the agency queried clinical laboratories about their interest in providing expanded testing capacity, beyond what CDC and other public health laboratories can provide in major outbreaks. The second request asked diagnostic manufacturers for information regarding their interest, as well as the costs and resources needed, to support new test development and production, reducing the risk of the single point of failure that occurred in COVID test development.
Leveraging academic and commercial resources this way can improve future outbreak responses and public health as whole if they are closely coordinated and aligned with existing intra-CDC programs and priorities. The private sector demonstrated its value during the 2022 mpox (formerly known as monkeypox) disease outbreak, when CDC quickly worked with five commercial laboratories to improve access to diagnostic testing for the virus. In pursing these partnerships CDC should more frequently utilize its “other transaction agreement” authority, which allows federal funds for collaborations with private sector partners. The OTA authority is used in the Department of Defense and the Biomedical and Advanced Research and Development Authority (BARDA).
Finally, there needs to be a change in the organization’s culture. CDC has, in the past, perceived itself at the apex of a pyramid in which laboratories in the lower layers have decreasing levels of complexity and capability. In reality all types of laboratories have different but overlapping missions and all are equally essential, especially during a biological emergency. CDC now sees its place at the center of a connected system, as the hub of a wheel rather than at the top of a pyramid.
The last four years have been challenging for CDC, as an organization, and for its many dedicated public health professionals. They are true public servants working to improve the health of the American public 24/7. The changes at CDC will take several years to fully take effect and will bring a new outlook. Essential to success is ensuring that the agency receives levels of federal funding appropriate to its breadth of responsibilities.
All that said, CDC has made great progress since the pandemic’s beginning. However, the rate of infectious disease outbreaks has also increased in the last few years because of climate change, global travel patterns and the incursion of human habitation into areas closer to animal species. We urge the Biden administration to request, and for Congress to provide, CDC with the required funding and necessary authorities to advance its laboratories. The agency must move quickly to restore its position as the nation’s preeminent public health laboratory in time to address rapidly evolving public health needs. The next threat is likely around the corner and as a nation, we must do better.
This is an opinion and analysis article, and the views expressed by the author or authors are not necessarily those of Scientific American.