Some of the former employees worked for public health labs involved in tracking HIV, hepatitis, and STDs
More than 450 federal employees who were laid off from the Centers for Disease Control and Prevention (CDC) during the April cutbacks are being reinstated by the Department of Health and Human Services (HHS).
Nearly half (214) worked for the National Center for HIV, Viral Hepatitis, STD, and Tuberculosis Prevention (NCHHSTP), which includes specialized public health laboratories. Another 158 worked at the National Center for Environmental Health (NCEH). Others were employed by the Immediate Office of the Director and Global Health Center.
“I think people are very tacitly hopeful that this means they can get their jobs back and continue serving in ways that they love,” NCEH health scientist Kathryn Sisler, MPH, told NPR. “But there has been so much instability and chaos that I think a lot of people would hesitate to say it is good news.”
Sisler, who works in NCEH’s Division of Environmental Health Science and Practice, received an email notification of her reinstatement on June 11, NPR reported.
She described the rehiring as “a step in the right direction,” but noted that she was among some employees in her division who had moved away from Atlanta, where the CDC is based. “Other employees had taken other jobs or had been offered them,” NPR reported.
In an interview with NPR, Scott Becker, CEO of the Association of Public Health Laboratories, admitted to being “happily flabbergasted” to hear about HHS’ offer to rehire the former federal workers. (Photo copyright: Association of Public Health Laboratories.)
Impact at Critical Labs
As part of the cutbacks, the CDC shut down two laboratories at NCHHSTP that were involved in tracking viral hepatitis and sexually transmitted diseases, even as “some of those scientists performed disease surveillance work unlike any other labs in the world,” NPR noted.
NCHHSTP staffers told NPR that some of the division’s labs were damaged due to the “lapse in activity” during April and May, and that “some disease outbreaks had not been properly tracked.” One employee said that, due to the cutbacks, the division’s hepatitis lab was unable to assist health workers tracking a hepatitis C outbreak in Florida. The CDC employees requested anonymity.
“It’s great to see that there is some recognition of the importance of these workers and that being in those positions is critical for the public health of America and that they are being reinstated in order to continue their important work,” Carmen J. Marsit, PhD, of Emory University’s Rollins School of Public Health, told NPR. He added, however, that “there’s still a lot of people that are not being reinstated.”
HIV Not Being Tracked
KFF Health News reported that the reinstatements included “dozens of HIV experts” who were laid off in April. At the time, they were working on a national survey conducted among 30,000 individuals at risk of acquiring the infection. They haven’t been told if the project will resume.
Public health departments use data from the survey as part of their efforts to reduce spread of the disease, KFF Health News stated, noting that “preventing HIV is far cheaper than treating people once they’re infected.”
Since the cutbacks, many HIV researchers at CDC have obtained new jobs or moved. Some employees “called the reinstatements perplexing because the notices don’t say what they’ll be doing when they return and for how long,” KFF Health News reported.
“I am concerned about how many of the people have already moved on or might move on and the trauma that they really must be going through with the uncertainty,” Scott Becker, CEO of the Association of Public Health Laboratories, told NPR about the reinstatements at CDC. “But all in all, it’s good news and I’ll take it.”
Programs Cut by Mistake
The reinstatements amount to approximately 20% of the 2,400 CDC employees laid off following the March 27 announcement of a massive restructuring at HHS.
HHS secretary Robert F. Kennedy, Jr. told ABC News in early April that some programs had been cut by mistake. “Personnel that should not have been cut were cut—we’re reinstating them, and that was always the plan,” he said.
In May, Kennedy said that 328 employees of the CDC’s National Institute for Occupational Safety and Health (NIOSH) would be reinstated, NPR reported, following “considerable pushback from labor organizations and congressional lawmakers.”
NPR and other outlets had earlier reported that HHS planned to cut at least 900 NIOSH employees, amounting to 90% of the institute’s workforce.
HHS Office of Inspector General was the latest to examine the quality control problems that led to distribution of inaccurate test to clinical laboratories nationwide
Failure on the part of the Centers for Disease Control and Prevention (CDC) to produce accurate, dependable SARS-CoV-2 clinical laboratory test kits at the start of the COVID-19 pandemic continues to draw scrutiny and criticism of the actions taken by the federal agency.
In the early weeks of the COVID-19 pandemic, the CDC distributed faulty SARS-CoV-2 test kits to public health laboratories (PHLs), delaying the response to the outbreak at a critical juncture. That failure was widely publicized at the time. But within the past year, two reports have provided a more detailed look at the shortcomings that led to the snafu.
“We identified weaknesses in CDC’s COVID-19 test kit development processes and the agencywide laboratory quality processes that may have contributed to the failure of the initial COVID-19 test kits,” the OIG stated in its report.
Prior to the outbreak, the agency had internal documents that were supposed to provide guidance for how to respond to public health emergencies. However, “these documents do not address the development of a test kit,” the OIG stated.
“If the CDC can’t change, [its] importance in health in the nation will decline,” said microbiologist Jill Taylor, PhD (above), Senior Adviser for the Association of Public Health Laboratories in Washington, DC. “The coordination of public health emergency responses in the nation will be worse off.” Clinical laboratories that were blocked from developing their own SARS-CoV-2 test during the pandemic would certainly agree. (Photo copyright: Columbia University.)
Problems at the CDC’s RVD Lab
Much of the OIG’s report focused on the CDC’s Respiratory Virus Diagnostic (RVD) lab which was part of the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD). The RVD lab had primary responsibility for developing, producing, and distributing the test kits. Because it was focused on research, it “was not set up to develop and manufacture test kits and therefore had no policies and procedures for developing and manufacturing test kits,” the report stated.
The RVD lab also lacked the staff and funding to handle test kit development in a public health emergency, the report stated. As a result, “the lead scientist not only managed but also participated in all test kit development processes,” the report stated. “In addition, when the initial test kit failed at some PHLs, the lead scientist was also responsible for troubleshooting and correcting the problem.”
To verify the test kit, the RVD lab needed samples of viral material from the agency’s Biotechnology Core Facility Branch (BCFB) CORE Lab, which also manufactured reagents for the kit.
“RVD Lab, which was under pressure to quickly create a test kit for the emerging health threat, insisted that CORE Lab deviate from its usual practices of segregating these two activities and fulfill orders for both reagents and viral material,” the report stated.
This increased the risk of contamination, the report said. An analysis by CDC scientists “did not determine whether a process error or contamination was at fault for the test kit failure; however, based on our interviews with CDC personnel, contamination could not be ruled out,” the report stated.
The report also cited the CDC’s lack of standardized systems for quality control and management of laboratory documents. Labs involved in test kit development used two different incompatible systems for tracking and managing documents, “resulting in staff being unable to distinguish between draft, obsolete, and current versions of laboratory procedures and forms.”
Outside Experts Weigh In
The OIG report followed an earlier review by the CDC’s Laboratory Workgroup (LW), which consists of 12 outside experts, including academics, clinical laboratory directors, state public health laboratory directors, and a science advisor from the Association of Public Health Laboratories. Members were appointed by the CDC Advisory Committee to the Director.
This group cited four major issues:
Lack of adequate planning: For the “rapid development, validation, manufacture, and distribution of a test for a novel pathogen.”
Ineffective governance: Three labs—the RVD Lab, CORE Lab, and Reagent and Diagnostic Services Branch—were involved in test kit development and manufacturing. “At no point, however, were these three laboratories brought together under unified leadership to develop the SARS-CoV-2 test,” the report stated.
Poor quality control and oversight: “Essentially, at the start of the pandemic, infectious disease clinical laboratories at CDC were not held to the same quality and regulatory standards that equivalent high-complexity public health, clinical and commercial reference laboratories in the United States are held,” the report stated.
Poor test design processes: The report noted that the test kit had three probes designed to bind to different parts of the SARS-CoV-2 nucleocapsid gene. The first two—N1 (topology) and N2 (intracellular localization)—were designed to match SARS-CoV-2 specifically, whereas the third—N3 (functions of the protein)—was designed to match all Sarbecoviruses, the family that includes SARS-CoV-2 as well as the coronavirus responsible for the 2002-2004 SARS outbreak.
The N1 probe was found to be contaminated, the group’s report stated, while the N3 probe was poorly designed. The report questioned the decision to include the N3 probe, which was not included in European tests.
Also lacking were “clearly defined pass/fail threshold criteria for test validation,” the report stated.
Advice to the CDC
Both reports made recommendations for changes at the CDC, but the LW’s were more far-reaching. For example, it advised the agency to establish a senior leader position “with major responsibility and authority for laboratories at the agency.” This individual would oversee a new Center that would “focus on clinical laboratory quality, laboratory safety, workforce training, readiness and response, and manufacturing.”
In addition, the CDC should consolidate its clinical diagnostic laboratories, the report advised, and “laboratories that follow a clinical quality management system should have separate technical staff and space from those that do not follow such a system, such as certain research laboratories.”
The report also called for collaboration with “high functioning public health laboratories, hospital and academic laboratories, and commercial reference laboratories.” For example, collaborating on test design and development “should eliminate the risk of a single point of failure for test design and validation,” the LW suggested.
CBS News reported in August that the CDC had already begun implementing some of the group’s suggestions, including agencywide quality standards and better coordination with state labs.
However, “recommendations for the agency to physically separate its clinical laboratories from its research laboratories, or to train researchers to uphold new quality standards, will be heavy lifts because they require continuous funding,” CBS News reported, citing an interview with Jim Pirkle, MD, PhD, Director, Division of Laboratory Sciences, National Center for Environmental Health, at the CDC.
