How a Lobbying Campaign Pushed the CDC to Relax Protective Gear Guidelines

Rick Lucas’ cellphone chimed, alerting him to an emergency in the acute care unit. He wondered whether it would be another case of COVID-19.

He pulled on his thin surgical mask and dashed into a room where a patient was fighting to breathe.

Lucas, a critical care nurse, and his team at The Ohio State University Wexner Medical Center in Columbus worked quickly, finding a vein for an IV and pulling an oxygen mask over the patient’s mouth and nose as he coughed. Lucas had been instructed to wear the same surgical mask all day for all but the highest-risk procedures, such as intubating patients.

“We’re exposed,” Lucas, who is also a union official, said in a recent interview. “We’re terrified that we’re gonna end up in the bed right next to him with the same thing.”

Routine procedures, such as placing heart monitor leads on a patient’s chest or leaning in to start an IV, make it impossible for him to keep a safe distance. “We’re right there in that danger zone where all of those droplets and those aerosolized particles are hanging out,” he said. He can feel the air flow around the sides of his surgical mask as he breathes.

Just a few days earlier, on March 10, facing a massive national shortage of personal protective equipment, the Centers for Disease Control and Prevention had downgraded its guidance, opening the door for hospitals to provide only surgical masks to health care workers treating confirmed or suspected COVID-19 patients. The announcement marked a dramatic departure from stricter CDC guidelines issued in February, which called for the use of N95 respirators or even more protective gear because it was unknown how the novel pathogen spread.

Lucas’ profound anxiety about getting exposed to the coronavirus underscores the vexing – and potentially lethal – circumstances America’s health care workers have faced since the CDC relaxed its guidelines, spawning a patchwork of policies in hospitals across the country. Some routinely provide N95 masks and full protective gear, while others provide most medical staff with only surgical masks. For example, the Wexner Medical Center’s guidance on April 2, obtained by Reveal from The Center for Investigative Reporting, acknowledged “widespread risk of transmission in the workplace,” yet indicated that most providers would be issued only a surgical mask, which should be reused as long as possible.

“If your mask is not grossly soiled, do not throw it away!” the document reads. (The medical center’s policy has since been revised.)

The CDC’s policy change was not driven by new scientific research. If anything, evidence of airborne transmission has accumulated as the pandemic has unfolded. It was driven instead by political pressure and fear of liability, Reveal has found. And the decision was hotly contested in advance by health and safety experts.

Before the CDC’s rollback, members of Congress urged the agency to relax the guidelines for protective gear for health care workers, citing the shortage. Several large hospital systems were also pushing for reconsideration of the guidelines. In the days leading up to the CDC’s decision, occupational health and aerosol experts urgently objected, desperately arguing that surgical masks would be insufficient.

Earlier coronaviruses, such as the 2003 outbreak of severe acute respiratory syndrome, or SARS, in China, were found to be transmitted by droplets of varying size, including tiny particles in the air. The CDC initially recommended N95 respirators for health care workers treating patients during the H1N1 flu pandemic in 2009.

Peg Seminario, who was the occupational safety and health and safety director of the AFL-CIO from 1990 until her retirement last year, said the CDC’s March policy, by giving license to hospitals to provide inadequate protection to health care providers, has triggered a workplace health crisis.

In her more than 40 years fighting to protect the health and safety of workers, Seminario confronted catastrophes such as the 9/11 attacks, which sickened and killed firefighters and first responders exposed to toxic dust after the World Trade Center collapsed. But she describes the nation’s coronavirus response as “the biggest safety and health failure that has ever occurred in this country. The toll on working people is already enormous.”

Seminario calls the CDC’s decision to loosen its guidelines “criminal.” “Now, because of the policies they’re pursuing, they’re not taking effective measures to get the equipment that’s needed,” she said. “You have health care workers getting sick, overwhelmed.”

When the CDC relaxed its guidelines, there was emerging evidence that the virus could be airborne. Since then, evidence of airborne transmission has mounted. Research published in The New England Journal of Medicine suggested that the virus could remain in the air for hours. University of Nebraska researchers detected the virus in the air, including in air ducts of patients rooms and hallways, though they did not determine whether it was still infectious. In a study published in late April in the journal Nature, scientists found evidence of the virus in the air in two hospitals in Wuhan, China.

Moreover, as Don Milton, an infectious disease aerobiologist at the University of Maryland School of Public Health, explains, there is no “bright line” between respiratory droplets and aerosols, which are droplets so tiny they can remain suspended in the air.

Even with testing so scarce that few medical workers are tested unless they are symptomatic, at least 31,108 health care workers in the U.S. had been infected with COVID-19 and 108 had died as of May 6, according to CDC data. One CDC analysis of about 50,000 U.S. cases with detailed reporting data found that 19% of those cases were among health care workers. More than half of the infected health care workers whose route of exposure was reported said they had come into contact with people with COVID-19 only at work.

In Hong Kong, where standards for personal protective gear are higher, only one health care worker had fallen ill as of late April. In China, after an early wave of health care workers got sick, the government took action to better protect doctors and nurses, and the infection rate among them dropped significantly. By contrast, the number of infections and deaths among U.S. health care workers have risen steadily over the past several weeks.

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In late January and again in February, the CDC issued guidelines that recommended that, at a minimum, all health care providers evaluating or treating potential or confirmed COVID-19 patients wear N95 respirators. The CDC said its earliest guidance was based on the “limited information available” at the time related to the disease’s transmission, among other factors. The idea was to recommend the most protective standards until it was clear how the novel pathogen spread, according to occupational health experts.

Despite calls by dozens of lawmakers, the Trump administration has so far declined to use the Defense Production Act to aggressively direct manufacturers to ramp up production of personal protective equipment, including N95 respirators. This has left hospitals, municipalities, states and even the federal government scrambling to buy such equipment, creating a highly competitive marketplace and driving up the cost. Federal officials have seized shipments bound for states and municipalities.

Against this backdrop of scarcity and chaos, hospitals, public health departments and lawmakers pushed back. They wanted the CDC guidelines rolled back to protect against droplet, not airborne, exposure.

An army of health care organizations and public officials in Washington state – including the Washington State Hospital Association, Washington State Department of Health, Gov. Jay Inslee, the King County director of public health, the University of Washington School of Medicine, the Fred Hutchinson Cancer Research Center and the Seattle Cancer Care Alliance – contacted Democratic Rep. Kim Schrier’s office in early March. They had one imperative: Until they could obtain sufficient protective gear for workers, they wanted the CDC’s guidelines loosened.

Hospitals that failed to comply could be subject to fines and directives from the federal Occupational Safety and Health Administration, they said. They could also face costly lawsuits from workers, their families and labor unions. Looser CDC guidelines allowing surgical masks would remove hospitals’ obligation to adhere to strict OSHA respiratory protection standards, including providing tight-fitting respirators and training workers to use them.

In response, Schrier and five other Democratic lawmakers from Washington wrote to the CDC, urging the agency to effectively give cover to hospitals and state and local health departments.

“Hospitals are already at or near capacity, and continuation of current CDC guidelines in this new phase of the disease presents substantial barriers to managing the increasing patient demand,” the March 4 letter said. “There are limited airborne isolation rooms in both clinics and hospitals, and there are shortages in personal protective equipment (PPE).”

Schrier and her colleagues pressed the CDC to change the recommendations to droplet-level protections and reserve respirators for aerosol-generating procedures, noting that “we have confirmed community spread via respiratory droplets.”

On the same day the members of Congress sent their letter, an email and memo from the New York City Department of Health and Mental Hygiene began circulating, seeking input from other cities regarding a plan to downgrade the city’s policy for protective gear for health care workers. The memo notes that “this recommendation in NYC contradicts current CDC guidance and will likely result in opposition from some healthcare workers and Unions,” and it points out that this risk would be mitigated if the recommendation were made jointly with state officials, infection prevention and control organizations, and other stakeholders. The memo then notes that several large urban hospital systems across the country were requesting a review of the CDC’s recommendations.

“Considering the current and ongoing supply chain issues and increasing surge in hospital demand, the CDC PPE recommendations for healthcare workers (HCWs) are not sustainable,” the memo reads.

A spokesman for the New York City Department of Health and Mental Hygiene did not respond to requests for comment.

In late February, within days of learning that the CDC might revise its guidelines, the nation’s largest health care labor unions, representing hundreds of thousands of workers, scrambled to mobilize against what they viewed as a deadly threat. They were terrified that huge numbers of their members – nurses, doctors and other health workers – would get exposed and that many would die.

Seminario, on behalf of the AFL-CIO, and officials from other health care unions jumped on a call with Arjun Srinivasan, associate director of the Healthcare Associated Infection Prevention Programs, a division within the CDC.

“We told the CDC that employers will immediately move to say surgical masks are OK,” Seminario said. “And it’s not OK. The implications are workers are exposed, infected and not able to work.”

But agency officials wanted to move quickly. “He told us they were concerned about PPE shortages and were looking to change the guidelines to allow for surgical masks” except when health care workers are performing intubations and other aerosol-generating procedures, Seminario told Reveal.

Looser guidelines would create a two-tier system for health care providers, Seminario recalls telling Srinivasan. The shortages should be addressed, she said, rather than make sweeping changes to the guidelines. Seminario said she also pointed to evidence from the 2003 SARS outbreak and 2009 swine flu outbreak that both viruses could be transmitted through the air.

A surgical mask, according to the CDC’s occupational health division, does not reliably protect wearers from inhaling tiny aerosols.

A group of more than a dozen labor unions, including National Nurses United, which represents more than 150,000 nurses, also wrote to Srinivasan to object to the proposed changes, saying they would “not only decrease the level of protection for healthcare workers but would also contribute to the spread of this virus.”

The CDC rolled back its guidelines less than a week later.

“If the CDC had not relaxed their guidelines, it would have forced hospitals to manage and plan,” Seminario said. “It has relaxed the pressure to get PPE for hospitals. They did this based on a disingenuous assessment of the data we know about infectious diseases.”

Srinivasan did not respond to a request for comment.

The CDC and the National Institute for Occupational Safety and Health, the agency’s occupational health division, both declined multiple requests for interviews, but in a written response, NIOSH told Reveal that the CDC’s decision was driven in part by the realities of supply shortages.

“CDC’s goal is to provide infection prevention control recommendations for healthcare personnel that are based on science, but also take into consideration the limited supply of N95 respirators in healthcare settings when it comes to making recommendations for personal protective equipment (PPE),” said Christina Spring, NIOSH’s spokesperson.

Spring declined to respond to a query about whether NIOSH had objected to the CDC’s decision to weaken its guidance on protective gear, but said NIOSH has been “actively involved” in addressing supply chain problems.

“CDC has made every decision and recommendation in this response in keeping with our mission to save lives and protect Americans,” Spring said, adding that CDC recommendations are based on the best science available at the time, and “we revise them as we learn more.”

***

Ron Klain served as the U.S. Ebola czar from October 2014 through February 2015, when the CDC established guidance saying health care workers needed to use respirators, as well as gear that “covers the clothing and skin and completely protects mucous membranes.” The guidance said that health care workers should be comprehensively trained in the proper use of the safety gear and that colleagues should help them remove their respirators to avoid contaminating themselves. That guidance remains in place today.

Klain says the CDC should have based its coronavirus guidance on the best scientific evidence, not shortages.

“We need to fix what’s broken,” he said. “What’s broken is doctors and nurses don’t have the gear they need. They’re entitled to it. They should have it. They should have it right away, and the federal government needs to take the leadership role in producing it.”

He pointed out that the president has authority under the Defense Production Act to incentivize manufacturers to make whatever gear is needed, to whatever standard is required.

“We’re talking about putting in compulsory orders,” he said. “That definitely should be happening right now. And in addition, the federal government should be taking control of the supply chain for these things to make sure that the gear gets to where it needs to get to. One problem is we don’t have enough stuff. The second problem is it’s not in the right place. And the federal government needs to do more now to address both those problems.”

Instead, the CDC’s decision to downgrade its guidelines has offered hospitals a fig leaf, according to Melissa A. McDiarmid, co-chair of a National Academies of Sciences committee on protective gear.

“It definitely gives breathing room,” said McDiarmid, who is director of the occupational and environmental medicine division at the University of Maryland School of Medicine. “Does this breathing room that it gave health organizations mean that they don’t hustle quite as hard to try to find the respirators? That’s an absolutely fair concern.”

Lisa Brosseau, who recently retired as an industrial hygiene professor from the University of Illinois at Chicago, has a harsher assessment. She said that given the growing evidence that the coronavirus spreads through aerosols, which can permeate surgical masks, hospitals are effectively requiring health care workers to put themselves at risk of disease or death on behalf of their patients.

“They have the right to refuse to work in an unsafe environment,” she said. “I don’t think the Hippocratic Oath says you should commit suicide.”

Yet when some hospital employees have objected or refused, they’ve been disciplined or fired.

***

The disparities between hospitals are striking. The nation has more than 6,000 hospitals, including roughly 3,000 nonprofit hospitals, 1,300 for-profit hospitals and a thousand public hospitals, each with starkly different access to resources. The CDC’s revised guidance means each facility, including hospitals and a wide variety of other health care settings, is effectively making its own decisions about what level of personal protective equipment to provide. These policies are also in a rapid state of flux, according to more than a dozen doctors and nurses who spoke with Reveal, sometimes changing by the week. Some health care workers said they felt well protected, while others said they were scrambling to update their wills and end-of-life wishes should they fall ill and die.

Jade Flinn, a critical care nurse in the biocontainment unit at The Johns Hopkins Hospital in Baltimore, often ranked among the top hospitals in the country, goes into patients’ rooms clad in what she says looks like a “moon suit.”

Every shift, she wears a respirator, a face shield, goggles, two pairs of gloves and a disposable gown. Her gear is similar to requirements in Hong Kong and South Korea, where the infection rates among health care professionals appear much lower than in the United States. Her hospital has set aside two special areas – one for putting on gear and another for taking it off – and she says she’s had abundant training in the proper way to don and doff the gear, all of which reduces the risk of infection for herself and others.

“I feel very, very protected whenever I go into a patient room,” she said, “because I know that my training and my team around me will make sure that I am safe.”

But it troubles Flinn that her peers at other hospitals around the country fear for their lives, what she describes as the “haves and have nots” of the health care workforce during the pandemic.

“That is morally distressing to me,” Flinn said. “I feel incredibly, incredibly guilty almost, because I have what I need to take care of myself and to take care of the patient safely.”

Johns Hopkins declined to specify how many among its health care staff have gotten COVID-19.

To Rick Lucas, the critical care nurse at the Wexner Medical Center in Ohio, the loosened CDC guidelines are “a betrayal.” Lucas, who is president of the Ohio State University Nurses Organization, which represents some 4,000 nurses in five hospitals affiliated with the Wexner medical system, recently filed a complaint with OSHA charging that the hospital violated health and safety standards by not providing N95 masks to health care workers caring for confirmed and suspected COVID-19 patients, among other problems.

At least 85 health care workers there had tested positive for COVID-19, according to the April 28 complaint. Medical center officials declined to comment on the number of staff with COVID-19 but said only a small portion has gotten ill.

“We believe the many protective steps we’re taking and our staff’s diligent efforts to follow guidelines are working to keep the impact of the virus to a minimum, below 1% of our workforce,” Marti Leitch, a Wexner spokesperson, wrote in an email response.

Lucas insisted the hospital could do better. “We’re not soldiers headed into battle,” he said. “We need the CDC and the federal government to prioritize our safety, the safety and health of our nation, and to do the right thing and quit watering down standards.”

“We don’t want to go to work and feel like we might die because we’re doing our job,” he added. “We don’t want to spread the infection to other patients and we don’t want to bring it home to our families. We don’t want to spread it to our peers.”

On April 18, the medical center’s policy changed. It now requires N95 masks when treating all suspected and confirmed COVID-19 patients in certain critical care wards, including the acute care unit. The policy still requires that each N95 mask be used at least five times before being decontaminated.

In response to Reveal’s questions, Leitch sent a statement April 30 from Dr. Andrew Thomas, Wexner’s chief clinical officer, who said that while the medical center had not yet received the OSHA complaint, “nothing means more to us than the health and safety of our colleagues, our patients and their families.”

“Like all health systems across the country, we face the challenge of limited supplies of PPE,” Leitch said in a separate email. “By being proactive in leveraging our contacts and buying power as a large academic health center, we’ve been able to maintain adequate supplies. We continue to work tirelessly to purchase these necessary and scarce resources and maximize usage of those we have.”

At the Visiting Nurse Association of Southeastern Connecticut, registered nurse Martha Marx visits six patients per shift, and unless her patients have COVID-19 or are suspected of having it, she’s issued only a surgical mask to use day after day, until it’s visibly soiled.

“My greatest fear is that I’ve been exposed and that I’m going to bring it to one of my patients,” Marx said in early April.

As an official in her union, AFT Connecticut, she’s often in touch with other association staff. She recalls a call she received in early April from one home health aide she knew well, Grisel Escalera. Escalera had a fever, and she was panicking.

“She called me and sobbed,” Marx said. “She was so afraid that she got some of her clients sick.”

Escalera had seen five patients the day before she fell ill. Her COVID-19 test came back positive, and she spent sleepless nights fearing for her life.

“I was afraid to close my eyes,” Escalera said, her voice quaking.

One of the patients she saw the day before she got sick, she recalled, had been short of breath. According to Marx and Escalera, a wave of bad news followed: That patient was soon hospitalized and quickly died. Another patient Escalera visited that day lives with his elderly mother; within a week, they both started coughing and were hospitalized, the mother on life support. A third patient ended up in the hospital with COVID-19.

A few days ago, Marx received news of a second death among Escalera’s patients: the man who had lived with his mother.

Escalera wonders whether she caught the virus from one of them – and passed it to the others.

“It’s a mystery,” she said. “I don’t know. Every day, I feel guilty and I think about that.”

Mary Lenzini, CEO of the visiting nurse association, insists that her staff get N95 masks if they’re assigned to a COVID-19 patient and that they’re kept safe. “I would have a very hard time doing my job every day as I have for almost 39 years if I thought they weren’t safe,” she said. “I do consult the CDC and the Department of Health websites constantly for advice on all of the PPE.”

Marx said that goes to the heart of the problem. “They’re telling us what to do, and it’s based on the CDC,” she said. “So I’m saying the CDC is wrong.”

***

The pressure on the CDC continued even after it relaxed its guidelines March 10. Two days later, the California Hospital Association wrote a letter to members of the state’s congressional delegation, urging them to have the CDC go a step further by making the guidelines allowing surgical masks permanent.

“We need the CDC to clearly, not conditionally, move from airborne to droplet precautions for patients and health care workers,” the letter reads. “Doing so will have multiple positive impacts on patient care, including allocating airborne isolation rooms properly and preserving limited supplies of personal protective equipment for health care workers caring for patients with airborne diseases.”

Jan Emerson-Shea, a vice president of the California Hospital Association, defended her organization’s request, citing the World Health Organization’s guidance, which states that the virus is mostly spread through larger droplets or from objects and surfaces.

“Nothing is more important than the health and safety of our workforce,” she said by email.

Around the time of the CDC change, the House of Representatives drafted provisions directing OSHA to require hospitals to establish infection control programs, including the provision of respirators, as part of the second piece of coronavirus legislation. But the American Hospital Association swung into action. The trade group, Peg Seminario recalls, mounted “a furious campaign” to block that language. “They fought that vociferously, ferociously,” recruiting hospitals to pressure their senators and representatives to remove the worker protection provisions.

As the House negotiated with the Senate and White House on the bill, one member of Congress after another called House staffers because hospitals in their jurisdictions had called quoting an American Hospital Association action alert, according to two House aides who asked not to be named because they were not authorized to discuss the deliberations. Given the urgency to pass the bill, this lobby effort doomed the provisions, according to the aides.

Reveal obtained an email sent by the powerful trade group to the chief executive of the largest nonprofit health system in Texas as part of that mobilization. It asks the Texas hospitals to join in urging members of Congress to yank the provision from the bill because it would be “impossible” to implement due to the shortage of N95 masks.

Congress complied. “The hospitals carried great sway, and they won that round of the fight,” Seminario said.

A spokesperson for the hospital association did not respond to multiple requests for comment.

In an interview, Rep. Kim Schrier, who along with five colleagues wrote to CDC Director Dr. Robert R. Redfield on March 4 urging the agency to relax its guidelines, said she is now rethinking her decision to write the letter and blamed the Trump administration for not increasing the production of N95 masks.

“Look, hindsight is 20/20, and if we knew about the virus what we know now, I would not have necessarily written that letter,” said Schrier, who is a pediatrician.

For the next coronavirus relief bill, Senate Majority Leader Mitch McConnell, R-Ky., has said he will insist on a provision related to the risk of COVID-19 exposure in the workplace. With an exception for cases of “gross negligence,” the language would protect employers from liability if their customers or employees are infected.

This story was edited by Esther Kaplan and Matt Thompson and copy edited by Nikki Frick.