Trump’s FDA authorized emergency use of plasma therapy for COVID-19, despite a lack of proof that it saves lives. Staff at CSL Plasma, an industry leader, raised alarms about faulty masks as donors flooded in, but the FDA and OSHA were slow to act.
by J. David McSwane, ProPublica
Heather Steadman, a nurse at a CSL Plasma donation center near Pittsburgh, was about to enter a tiny closed-door room to administer an exam when the doctor handed her a mask in a translucent wrapper labeled KN95. The folded white mask, visible behind Chinese characters, was all her employer was providing to protect her from COVID-19.
Over a nearly 20-year career, she’d worn certified respirators in intensive care units and cared for patients dying from respiratory disease. That night in late June, she was about to lean into the face of a stranger, checking his throat and peering into his eyes, guarded only by a mask of questionable origin.
“There were just red flags all over it,” she said of the mask, which corporate records show was advertised to employees as just as good as the vaunted American-made N95 respirator at stopping the spread of the coronavirus.
She stared at the doctor incredulously, then marched to a nearby storage hutch. She plunged her hand into a blue box of 50 or so masks, then two more boxes, like a kid frantically scrounging through cereal boxes for a magic ring.
From each, she pulled out a sheet of paper, hoping for evidence that the masks had been cleared as effective by the U.S. government — from the federal Food and Drug Administration, maybe, or the National Institute for Occupational Safety and Health, NIOSH, which certifies N95s that can filter out 95% of particles.
Instead, she read aloud the first line of English: “NOT for medical purpose.”
Steadman, 41, had been in a standoff with her employer for months over inadequate personal protective equipment. She’d gone on leave in April, pressing CSL to provide decent masks. She’d complained, without success, to the federal Occupational Safety and Health Administration, which is supposed to ensure safe workplaces. Other CSL employees across the country had made similar complaints. Ten weeks later, though her complaints had been dismissed, she returned because the company said workers now had access to medical-grade masks.
CSL, a leader in the global plasma industry, says it was adhering to federal guidelines to protect front-line workers as it geared up a major national push — endorsed by President Donald Trump — to secure blood plasma donations from recovered COVID-19 patients. The FDA had authorized emergency use of convalescent plasma therapy as a treatment for the severely ill, despite a lack of scientific proof that it saves lives.
Steadman and other blood plasma workers feared a new level of risk as donors came in from the street and attested that they had been symptom-free for 14 days. The workers knew what the studies said: People looking to be paid in exchange for being stuck with a needle are more likely to conceal illness than those without financial incentive.
“These are not people that are going to tell me that they’re sick,” Steadman told me.
This, on top of the routine flow of non-COVID-19 donors coming in for $40 a draw, mostly poor people in high-risk groups, such as those working “essential” jobs where infections can spread wildly. A plasma donation involves repeated and prolonged contact with staff — in the reception area, in waiting rooms, during physical exams in closed spaces and when blood is drawn.
The company said it was following all federal guidelines, although no agency had quantified the dangers posed to workers like Steadman due to stepped-up plasma donations. Steadman had seen the many reports of counterfeit masks making their way to hospitals, endangering nurses and doctors. Rather than face what she saw as “imminent danger,” Steadman told CSL she wouldn’t return until she had assurances the company was providing safe masks. She also filed another OSHA complaint.
After weeks of waiting for regulators to act, she contacted ProPublica. She sent correspondence, CSL training materials, internal social media posts and samples of three masks from CSL’s stockpile. She’d spent hours trying to track the masks’ origins, to see if her colleagues were adequately protected, and none of the Chinese KN95s provided were at the time on the FDA’s authorized list of masks that are roughly comparable to U.S.-approved N95s.
“They literally bought some off Amazon,” she said, referring to records the company gave to OSHA.
Her story offers a glimpse into the confusion, anxiety and fear wrought by lax government oversight of the coronavirus mask market, where intense demand and low supply bred graft and fraud and left some front-line health care workers reliant on face coverings that might or might not work.
I’d spent the last six months delving into the murky world of PPE, tracking foreign vendors and middlemen, and documenting price gouging and questionable contracts. All of it unfolded against a backdrop of confusing and evolving guidance from the federal government.
When Steadman and some other CSL workers agreed to talk, I got in my car and made the windy four-hour drive to the strip mall in McKeesport, Pennsylvania, where they worked.
The parking lot of the Olympia Shopping Center could be artfully rendered in pencil and pastel and slapped on a postcard labeled “Poverty, U.S.A.” There’s a payday loan store, a Dollar Tree, a Rent-A-Center, a shuttered Payless ShoeSource and in the corner, the glowing red sign of CSL Plasma.
With unemployment at near-record highs, CSL had made donating plasma an attractive option and mobilized workers nationwide to recruit new donors. In McKeesport, it offered a $100 cash bonus to donors who could prove they’d once tested positive for COVID-19 and advertised that regular donors could make about $700 monthly.
As FDA Hypes, OSHA Chills
CSL has more than 260 U.S. plasma donation centers with plans to open dozens more next year. Based in Australia, the company is proud of a history that spans from its early use of plasma to beat diphtheria a century ago to helping develop the swine flu vaccine a decade ago. With $2.2 billion in profits last year, CSL gave out a record dividend to U.S. shareholders.
Its business seems poised to get even better.
An alliance of research institutions, plasma banks and drug companies promotes donations through “The Fight Is In Us” campaign, pitched online and on TV by stars such as Dwayne “The Rock” Johnson and Helen Mirren who urge COVID-19 survivors to visit plasma centers including CSL’s. The Trump administration has praised the initiative and refers donors to the alliance.
Since the pandemic’s early days, the administration has been pushing plasma donations and cleared the way for a limited study to see if treatments of concentrated antibodies, derived from the serum surrounding the blood cells of COVID-19 survivors, could help others recover.
In late August, the FDA opened the door for widespread use of convalescent plasma therapy, citing a study that kinda sorta showed the potential upsides of the treatment outweighed the risks. In doing so, FDA Commissioner Stephen Hahn claimed that the treatment could have saved 35 out of 100 patients, a statement he later recanted after scientists called it a gross exaggeration. Still, Alex Azar, secretary of the U.S. Department of Health and Human Services, called the approval of convalescent plasma therapy a “milestone achievement in President Trump’s efforts to save lives from COVID-19.”
This pushed CSL into high gear.
Weeks earlier, CSL Limited CEO Paul Perreault had made the case for the industry-led race to get antibody-laden plasma in a roundtable appearance with Trump and other federal officials at the American Red Cross headquarters in Washington.
“We need plasma. We need plasma donors. We need them wherever they are,” Perreault told Trump.
Aside from the president’s support, the company had also enlisted top pharmaceutical lobbyists to press the value of plasma therapy in Washington.
But many unknowns remained. Trump’s administration skipped the tedious — and, scientists say, important — step of a randomized controlled study, comparing outcomes of patients who got plasma therapy with those who didn’t. And while federal agencies stressed that plasma donation centers should remain open during the pandemic to keep the nation’s blood supply flowing, worker safety went largely unmentioned.
Tom Inglesby, a director at Johns Hopkins’ Center for Health Security, said the risk to workers in plasma donation centers depends on the spread in each community. The bigger risk, he said, might not be the people who have recovered from COVID-19 but all the other donors who are being let in without prior screening to a place where infections can spread easily.
“If I were working in this type of facility, I would like to have an N95 mask,” Inglesby said.
“You’d have to call these people health care professionals, for sure. They’re drawing blood.”
Since March, OSHA has received about a dozen COVID-19-related workplace safety complaints from CSL workers in Pennsylvania, Indiana, Michigan, Minnesota and Texas. Half were about inadequate PPE such as masks, the rest about fear the company wasn’t enforcing public health guidelines.
In late May, for instance, a Houston employee reported that a staff member tested positive and “six people working near the infected person were quarantined,” according to OSHA data.
“Other staff members are being sent out to work at other locations,” that complaint stated, “exacerbating the spread.”
Anthony Farina, CSL’s spokesman, said OSHA has assessed no penalties based on these complaints.
“CSL Plasma has cooperated promptly with all requests for information, and has routinely shared documentation of our safety practices in place to prevent exposure. The company also investigated the allegations and reviewed our applicable requirements to confirm compliance with appropriate OSHA COVID-19 guidance,” his statement said.
All but three of those cases were closed.
Debbie Berkowitz, a former top OSHA official in the Obama administration, said Steadman’s journey is part of a larger trend. “OSHA has decided not to enforce the law and has abandoned its mission,” she said. “Workers are on their own.”
The agency has received more than 33,000 COVID-19-related complaints, according to OSHA data. More than two-thirds of those are closed. Nearly 9,000 complaints were about PPE at work.
She was particularly concerned about a company presentation that told CSL workers that KN95s, approved under Chinese standards, were just as good as N95s, approved by U.S. scientists.
Providing questionable Chinese masks “and sort of implying to workers that this is like an N95 — that is completely deceiving and dangerous because it gives these workers a false sense of security,” Berkowitz said.
Afraid at Work
The angst among CSL workers began in March, when corporate guidance stated that “a mask does not adequately protect healthy people from an infection of coronavirus.” In fairness, this was around the time U.S. Surgeon General Jerome Adams sent out a tweet he’d later recant:
“Seriously people- STOP BUYING MASKS! They are NOT effective in preventing general public from catching #Coronavirus”
CSL employees, including managers, described an internal tracker on the company’s network showing hundreds of employees took leave from March through September because they were either exposed to COVID-19, sick or afraid. None of those workers were able to share raw data. CSL did not directly respond.
Steadman shared emails that hint at concern sweeping through CSL as employee absences shuttered entire centers.
March 17: “Due to staff illness, the Hillsboro [Florida] 126 center will delay opening …”
March 27: “Little Rock [Arkansas] 234 is closed due to staffing issues.”
March 30: “… Peoria [Arizona] closed for the day due to staffing issues.”
The company shared online presentations outlining evolving pandemic guidelines. On April 10, it told workers that N95 respirators effectively filtered out airborne contaminants. But the company wasn’t supplying them and mask use was voluntary.
Later correspondence indicates masks were not required because the company had no OSHA-approved respiratory program, which involves training on how to wear them and fit testing to ensure proper use.
That week, Steadman lodged her first complaint to management, took leave and complained to OSHA.
“I continued to work in good faith, despite genuinely believing that imminent danger exists,” she wrote in a lengthy letter to CSL management. “However, the policy for ‘recovered donors’ is a risk I am not willing to take.”
The drumbeat of staff absences indicated she was not alone in her fear.
April 17: “Taylor 240 [Pennsylvania] temporarily closed due to staffing issues.”
On May 4, soon after the FDA gave emergency use authorization to import masks from 80 little-known Chinese manufacturers, the company announced it wasn’t distributing those gold-standard N95s. It was instead providing Chinese KN95s. And 10 days later, a presentation told employees there was “very little difference in certification requirements between a N95 and KN95.”
But company records show the three brands of KN95s CSL purchased and distributed were not on the FDA’s list of Chinese masks that are roughly comparable to N95s and suitable for health care workers. And all three used earloops, which can be less snug than those that wrap around the head.
The move to distribute Chinese KN95s didn’t halt the ongoing staff issues.
June 21: “… Homestead [Pennsylvania] unable to open due to staffing.”
Meanwhile, CSL continued to aggressively recruit donors who had recovered from COVID-19, with workers posting flyers and hanging signs across the country, according to internal social media posts, some of which show workers improperly wearing KN95s.
Weeks passed, so Steadman called OSHA. She was told to file a new complaint. Too much time had passed. So she did.
In early July, OSHA told the company that regulators wouldn’t investigate Steadman’s updated complaint, deferring to CSL to look into it.
CSL reported to OSHA that its investigation had found no problem. A July 15 follow-up from corporate headquarters in Boca Raton, Florida, gave details about CSL’s masks, including pictures and a snapshot of thousands apparently purchased through Amazon. According to CSL, the masks were sourced by the Utah-based medical equipment company HemaSource. Executives at HemaSource did not respond to messages from ProPublica.
In a letter the next day, an OSHA broke the news to Steadman.
“CSL Plasma has advised me that the hazards you complained about have been investigated. The employer states that the hazards have been corrected,” Area Director Christopher Robinson wrote. “With this information, OSHA feels the case can be closed.”
Steadman believed the mask details provided to OSHA demanded further inquiry.
“Who’s going to make sure people have safe masks if not OSHA?” she said.
She rebutted her employer’s response in a document that reads like a prosecutor’s exhibit.
“Every certificate provided in this document is easily identifiable as plagiarized, and fits each criterion from the [Centers for Disease Control and Prevention] and NIOSH on identifying counterfeit masks and falsified documents,” she wrote on July 19.
Here’s where Steadman descended into the maddening vortex that’s subsumed my reporting these last six months. After the FDA opened the gates for masks from China, later reversing course as junk masks ended up in health care settings, it became pretty dang hard to tell what was what. This is especially true of brands of masks the CDC or a private lab hasn’t tested and published findings about, which is the case here.
Steadman went down a Google hole, cross-referencing images, technical data, model numbers and more. All of CSL’s KN95s were labeled as not for medical use.
One type of mask connected back to a Chinese diaper company.
Another shipment, apparently from Amazon, came in packages of four (sterile masks typically come individually wrapped). Plus, the “CE” markings claiming they’d passed muster with European regulators were skewed and placed in different spots mask to mask, as if applied by hand with an ink stamp rather than precise machinery.
The third type, the KN95 Steadman was handed that stressful June night, links to a company registered with the FDA as ZK-Best, which sells masks approved by Chinese regulators for working around dust or filtering polluted air. The Chinese manufacturer did not respond to email requests for comment.
But CSL included a technical data sheet for these masks in its submission to OSHA that raises questions. The document purports to show that SGS, a global firm that deploys inspectors to factories to test goods for far-flung buyers, had found the ZK-Best respirator highly effective.
The document looked odd. The date format was month, day, year: “July 1st, 2015.” That’s an American convention I hadn’t seen on other SGS documents. The inspection also appeared to be for a completely different mask model, a so-called PM2.5 mask designed for industrial use.
I reached out to experts who had imported and sold legitimate masks. I also reached out to SGS.
Richie Hecker, director of the medical supply company Traction and Scale, sold PPE to New York City and others. With his help, ProPublica asked a researcher in China to investigate. When the results came back, Hecker said he wouldn’t buy these masks because SGS said the report provided to OSHA was fake, a “cut and paste job.”
“This is not an original SGS document,” SGS also wrote to me. “This document is thus of no value whatsoever and we advise you not to rely on it for any purpose.”
Hecker said phony documents are common fare in the PPE market and “the KNs are the dirtiest item on the market.” That’s why reliable chain-of-custody documents connecting the mask in Steadman’s hand to a specific factory are crucial.
When I asked CSL about the fake SGS document, a spokesperson said that the company would investigate and that it takes its responsibility to provide accurate information to federal regulators with “utmost seriousness.”
On Sept. 2, just two days after I first asked CSL about the ZK-Best masks, its ZKG 9501 KN95 mask appeared on the FDA’s list as allowed under the emergency use authorization. This wasn’t the case earlier in my research or during the months Steadman refreshed and refreshed the same website and sent questions to several government agencies.
An FDA official told me that brand of mask was authorized based on testing and approvals from the FDA’s European Union counterpart, though the masks CSL distributed and their packaging lack the CE mark. NIOSH has seen multiple instances of counterfeit masks sold using the branding of manufacturers on the list. U.S. regulators have not tested the ZK-Best masks themselves, but anyone worried about masks at their workplace is encouraged to send them to NIOSH for testing, officials said.
A few days later, on Sept. 13, CSL provided new documents it said proved the masks were legitimate, including a new testing document and a letter apparently from a ZK-Best manager named “Chensu,” who said the masks had been approved by SGS after all. There was a mixup with the mask models, the letter said, but the masks were good.
I tried to authenticate those documents with the factory but didn’t hear back.
I asked a CSL spokesperson for proof the documents came from the factory, perhaps an email thread showing a chain of custody. The company declined but said, “We assure you that we did not alter any of the documentation.”
I shared all of this with Steadman, who remains skeptical.
“That Put Me at Risk”
Workers in McKeesport remain on edge because of the masks but also CSL policies they say are conflicting and dangerous.
CSL says workers are safe because the centers don’t treat patients who are currently sick with COVID-19.
Donors receive a blood pressure, temperature and pulse check, said Farina, the company spokesman, and COVID-19 survivors “must provide a doctor’s note confirming their diagnosis and confirmation that they have recovered from COVID-19.”
Yet late last month, two workers were potentially exposed to a donor who later tested positive, according to internal emails and interviews with CSL employees. That donor wasn’t properly wearing her mask, employees told me.
Samantha Kelly, 30, was told she had contact with this person. She worked the reception desk and spent several minutes pricking the fingers and taking the blood pressure of walk-in donors. She said the company refused to tell her when that contact occurred, making it impossible to retrace her steps and warn those close to her.
Kelly is the primary caregiver for her mother, who has diabetes and a chronic inflammatory lung disease.
“That put me at risk,” she told me. “That put my family at risk, everyone we had come in contact with.”
She’s technically still a CSL employee, on unpaid leave since Aug. 20, but she said she’s not going back.
A CSL spokesperson said the company follows CDC and local guidelines on contact tracing but said patient privacy laws limit what they can tell employees.
Company records show CSL stopped doing temperature readings at the door in June.
CSL employees say the checks detailed by CSL’s spokesman happen long after patients enter the centers, sometimes after they’ve signed in, talked with staff and sat in a waiting room before screening.
Ultimately, CSL staff don’t have much but donors’ word that they’re not sick, employees say and records show.
This month, a woman who said she’d recovered from COVID-19 came into the McKeesport office to sell her plasma, according to CSL staff. Well after she arrived, a staffer found she was running a fever. She was sent home. Employees are still rattled.
CSL employees told me their need for good PPE was heightened by a recent policy change. Employees were told they cannot ask donors who refuse to wear masks to leave, according to corporate instructions sent out in late June.
Responding to Steadman’s persistence, OSHA reopened its investigation. That inquiry is ongoing, and the agency won’t say more until it’s complete, a spokeswoman said in an email.
On Sept. 1, the company launched a COVID-19 antibody testing program in about 30 cities to help identify more potential donors who have recovered from the disease. That same day, the National Institutes of Health said there’s no evidence to support convalescent plasma therapy as a standard treatment for COVID-19.
In the end, I found only some answers for Steadman, who remains on leave from CSL. She said she and her co-workers could have avoided heartache if the company had simply addressed her questions and found FDA-authorized masks back in May.
“Why would the company let me flail over here and let me freak out and contact several different agencies if everything is just fine?” she said. “Nothing that you’ve just told me convinces me that anybody is sure those masks would protect me from COVID — at all.”
On a recent warm afternoon, as we talked in front of her parent’s long log cabin home, Steadman was wearing scrubs even though she hadn’t been to work in weeks. I asked why.
She was going to a job fair.
Yeganeh Torbati and Mollie Simon contributed reporting.
This article published by ProPublica on September 21, 2020, here…
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