February 12, 2024
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The pandemic exposed the weaknesses of CDC laboratories early on. Organizational and cultural changes are good first steps, but more needs to be done
Almost without being noticed, the fourth anniversary of the beginning of the COVID pandemic in the US it happened in January. However, the missteps made in the first weeks of that tragedy still offer vital lessons about what public health is Agencies must do more to keep us safe.
This is particularly true at the U.S. Centers for Disease Control and Prevention, because the agency’s laboratories play a critical role in developing and deploying tests for new diseases. In early 2020 it became clear that SARS CoV-2 had entered the US. and posed a deadly threat. The CDC faced challenges almost immediately 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 launched again almost three weeks later. But delays in diagnosis, quarantine and isolation gave the virus an advantage in diffusion.
The changes that have since been made at the CDC need to be accelerated and funded to address this tragic failure. The most important change of all will be a cultural shift at this vital federal public health agency, a shift that looks outward to actively engage the nation’s national laboratory system.
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Several published reports have documented in great detail the events and decision points at CDC that led to the failure of his test. Ultimately, it stemmed from the fact that CDC testing laboratories have historically not had adequate levels of staffing and resources consistent with the agency’s responsibility as the nation’s primary public health laboratory. Their laboratories also have not had the adequate organizational position or fiscal authority to drive policies and processes for the development and deployment of tests in biological emergencies. Few CDC scientists have the federal qualifications required to diagnostic laboratory director, and most CDC laboratory leaders report to senior healthcare professionals who lack the specific education and training necessary to oversee essential laboratory quality and performance standards. We believe that CDC should rely more on special federal payment authorities to healthcare professionals and scientists to address the urgent need for clinically qualified personnel for these laboratory oversight functions, similar to how the NIH and the Veterans Administration Handle positions that require specialized experience.
To support the critical nature of diagnostic testing in public health responses, CDC should elevate agency laboratories within its organizational structure. The CDC has already taken an important step in this direction: as part of its Initiative Moving Forward the agency established a completely new Laboratory and Response Systems Center.. The new center reports directly to the CDC director’s office. His internal focus will be ensuring that CDC’s diagnostic laboratories, of which there are more than 40 on its main campus alone, provide timely and accurate diagnostic testing in response to infectious disease outbreaks. Outside the agency, the center is responsible for improving collaboration with the country’s public, academic and private laboratories, as well as diagnostic manufacturers.
That all sounds great, but we should consider reasons to be cautious. Right now, four years after the start of the pandemic, the new center is not yet officially documented on the CDC organizational chart, nor the center’s acting director publicly recognized, in that capacity, as part of its senior management. CDC must act faster to demonstrate the importance of this organizational change.
With this major organizational change, CDC will move away from its traditional “only we can do it” approach and move closer to leveraging the expertise and testing capacity that exists within the national laboratory system. He has already started doing this. As the pandemic progressed, the CDC adopted genomic sequencing to provide national tracking of genomic variants and worked closely with academic, commercial, and public health sequencing laboratories, monitoring the real-time evolution of a virus ravaging humanity. Similar collaborations exist for wastewater testing.
In 2023, the CDC also took an important external step by issuing two requests for private sector participation in public health. In the first, the agency consulted clinical laboratories about their interest in providing expanded testing capability, beyond what the CDC and other public health laboratories can provide in major outbreaks. The second request asked diagnostic manufacturers for information about their interest, as well as the costs and resources needed, to support development and production of new testsreducing the risk of the single point of failure that occurred in the development of the COVID test.
Leveraging academic and commercial resources in this way can improve responses to future outbreaks and public health as a whole if they are closely coordinated and aligned with existing programs and priorities within CDC. The private sector demonstrated its value during the 2022 Mpox disease (previously known as monkeypox) outbreakwhen CDC quickly worked with five commercial laboratories to improve access to diagnostic tests for virus. In pursuing these partnerships, CDC should more frequently use its “other transactional arrangements” authority, which allows federal funds for collaborations with private sector partners. OTA authority is used in the Defense Department and the Biomedical and Advanced Research and Development Authority (IN THE BAR).
Finally, there needs to be a change in the culture of the organization. In the past, the CDC has perceived itself in the vertex of a pyramid in which the laboratories of the lower layers have increasingly lower levels of complexity and capacity. In reality, all types of laboratories have different but overlapping missions and are all equally essential, especially during a biological emergency. CDC now sees its place at the center of a connected system, as the center of a wheel rather than at the top of a pyramid.
The past 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 hours a day, 7 days a week. The changes at the CDC will take several years to take effect and will bring a new perspective. Essential to success is ensuring that the agency receives levels of federal funding appropriate to its breadth of responsibilities.
All that said, the CDC has made great strides since the start of the pandemic. However, the rate of infectious disease outbreaks has increased. It has also increased in recent years. due to climate change, global travel patterns, and the incursion of human habitat into areas closer to animal species. We urge the Biden administration to ask the CDC, and Congress to provide it, with the necessary funding and authorities needed to advance its laboratories. The agency must act quickly to restore its position as the nation’s premier public health laboratory in time to address rapidly evolving public health needs. The next threat is likely just around the corner, and as a nation we must do better.
This is an article of opinion and analysis, and the opinions expressed by the author(s) are not necessarily those of American scientist.