Hospital workers around the country report frustrating failures by management to notify them when they have been exposed to co-workers or patients known to be infected with COVID-19.
This article was first published on Wednesday, May 13, 2020 in Kaiser Health News.
Dinah Jimenez assumed a world-class hospital would be better prepared than a chowder house to inform workers when they had been exposed to a deadly virus.
So, when her boyfriend, an employee of a popular seafood restaurant in Seattle, received a call from his boss on a Sunday in late March telling him a co-worker had tested positive for COVID-19 and that he needed to quarantine for 14 days, she said she assumed she'd get a similar call from the University of Washington Medical Center. After all, the infected restaurant employee worked a second job alongside her at the hospital's Plaza Cafe.
That call never came, she said.
America's health care workers are dying from the coronavirus pandemic. These are some of the first tragic cases.
Jimenez, 42, said she returned to her job as a cashier at the hospital cafeteria two days later, and "it was like nothing had happened. They didn't say anything." She said the infected worker, a fellow cashier, was stationed just 2 feet from her during a typical shift and that neither had been wearing a mask. "He was as close to me as the person sitting behind you in an airplane," Jimenez said.
Word slowly spread among the cafeteria crew that a co-worker had the virus, she said. In the days that followed, two more workers fell ill. But communication about the outbreak was not broadly disseminated through the ranks, according to Jimenez and other employees interviewed. It wasn't until April, Jimenez said, that the hospital started providing workers with one mask per day. A few weeks later, workers said, they learned a fourth staff member had tested positive for the virus.
From cafeteria staff to doctors and nurses, hospital workers around the country report frustrating failures by management to notify them when they have been exposed to co-workers or patients known to be infected with COVID-19. Some medical centers do carefully trace the close contacts of every infected patient and worker, alert them to the exposure and offer guidance on the next steps. Others, by policy, do not personally follow up with health workers who unknowingly treated an infected patient or worked with a colleague who later tested positive for the virus.
"It's an enormous issue," said Debbie White, president of the Health Professionals and Allied Employees, a union representing nurses and other health care professionals in New Jersey. "When a patient is positive, our expectation is that the employer would go back and do their due diligence in terms of investigating who was participating in that patient's care."
Instead, she said, union members often report "there is very, very little follow-up" to inform them after an exposure.
The disconnect between hospital policy and worker expectations often centers around the lack of clear, direct communication with individual workers who have been potentially exposed to the coronavirus. And when workers are informed about an infected colleague or patient, some say that the efforts to conceal that person's identity can make it difficult to gauge the level of risk.
Melissa Johnson-Camacho, a nurse at UC Davis Medical Center in Sacramento, California, said she was informed that another nurse in her unit tested positive, but not which one.
"I don't know who that nurse is. I don't know if I had lunch with that nurse. I don't know if I helped that nurse with a patient," said Johnson-Camacho, who is a chief nurse representative for the California Nurses Association.
UC Davis Health spokesperson Charles Casey said federal and state privacy laws prevent the hospital from identifying individuals who test positive. HIPAA, the federal privacy rule, does permit some disclosures of personal health information to health care workers during an outbreak of infectious disease, but only the "minimum necessary," according to recent guidance from the Office for Civil Rights, which is part of the U.S. Department of Health and Human Services.
Other hospitals contend that because community transmission of COVID-19 is so widespread, workers should assume anyone they encounter, inside or outside the hospital, could be infected and adapt their behavior accordingly.
OHSU Health Hillsboro Medical Center, a major provider outside Portland, Oregon, for example, recently sent an email to all employees saying that because COVID-19 is widespread in that community, "you will no longer receive notification from [the Employee Health program] after caring for a patient with COVID-19. Instead, we ask that you serve as our eyes and ears and report any concerns for exposure to Employee Health as soon as possible."
Based on similar reasoning, the federal Centers for Disease Control and Prevention issued updated guidelines in April to say hospitals should consider forgoing contact tracing for their workers — a fundamental of public health work that involves identifying people who have been exposed and asking them to quarantine — in favor of universal masking and screening for symptoms at the beginning of shifts.
While all hospital employees, from food service to custodial staff, are vulnerable to exposure, nurses and other direct-care providers who interact closely with patients are at greatest risk. Informing them of patient exposures is generally less important in intensive care units and wards designated for COVID-19 assessments, where patients are assumed to have the virus and proper protective gear should be used. But when providers care for a patient hospitalized for an unrelated condition who later tests positive, workers say the information can be crucial.
"A lot of nurses are caregivers, too, and we have people at home who are in the high-risk group," said Johnson-Camacho, the UC Davis nurse. "No one wants to take this home to their family or someone they love."
Knowing about an exposure might make the difference when deciding whether to hug your children or move out of the family home, Johnson-Camacho added.
At Stroger Hospital in Chicago, nurse Elizabeth Lalasz said she contracted the coronavirus after spending several hours with a patient who came in with what initially was believed to be a chronic respiratory condition, but who later was sent home with a presumed case of COVID-19. Lalasz said the hospital never followed up with her about the presumed exposure, even though she had not been wearing proper protective gear. She said she subsequently fell ill and tested positive for the virus — and that her co-workers were never informed about her condition.
"The contact-tracing idea didn't even exist," Lalasz said.
Cook County Health, which operates Stroger, did not directly respond to questions about its policies on informing workers about exposure to the virus. But spokesperson Deborah Song said the system is following CDC guidelines.
At UW Medicine in Seattle, where the cafeteria outbreak played out, spokesperson Tina Mankowski said the hospital is not doing contact tracing when workers or patients test positive for COVID-19. She said that is because the medical center is not asking workers to quarantine at home following a potential exposure.
Under current policy, if an employee contracts the virus, that person's manager is notified in general terms, and is supposed to share that information with other staff members. Employees are asked to self-monitor for fever or upper-respiratory symptoms, and to stay home if they are ill.
Mankowski confirmed that four cafeteria employees had tested positive for the virus. She said employees were notified but did not provide specifics about how or when.
"The safety of University of Washington Medical Center patients and employees is our top priority," Mankowski wrote in an email. "If an employee tests positive for COVID-19, the manager is informed that one of their employees has tested positive and then discusses this with the staff in that area."
Jimenez and three other workers said that was not their experience and that communication about the outbreak was muted.
Luis Rios, a cook at the cafeteria for 17 years, said he was not informed after the first colleague tested positive, though he had chatted with the sick cashier in the staff locker room several times, no more than 2 feet away. A few days after that worker was diagnosed, Rios said, he was taste-testing a dish when he noticed his sense of taste was dulled, a symptom of COVID-19. He also felt cold, even in the warm kitchen. He was tested at an area medical clinic, and became the unit's second confirmed case.
"Honestly, I don't know if UW or my managers care about workers' lives," said Rios, 49, who spoke through an interpreter. "They only care if we can go in and work."
Justin Lee, communications director for the Washington Federation of State Employees (WFSE), which represents the cafeteria workers, said supervisors did post a copy of an email from the employee health department to cafeteria directors notifying them in general terms when the first worker tested positive. A printout was tacked near the employees' time clock. But many workers did not see it or may have been unable to understand it because it was written in English, according to Lee. Information shared days later in a small huddle did not reach the whole staff, he said.
In early April, cafeteria workers delivered a petition to hospital management, with the support of WFSE and Service Employees International Union Local 925, with 450 signatures. They requested the hospital close the Plaza Cafe for a deep cleaning, install a temporary protective barrier around the cashiers and bring in a medical professional to educate all cafeteria staff about COVID-19, with translations in other languages.
The cafeteria was not closed, but Mankowski said the hospital has disinfected it and all workstations, and now requires workers throughout the hospital to wear masks. The hospital has declined to install Plexiglas barriers at the cafeteria, she said, because it believes the universal masking offers the necessary safety precautions.
The Occupational Safety and Health Administration has no rule requiring that employers inform workers of exposures to infectious diseases. But Dr. Alyssa Burgart, a bioethicist at Stanford, said hospitals do have an ethical obligation. She acknowledged the challenges: With dozens of employees going in and out of a patient's room each day, tracking every single one can be difficult, particularly with limited resources. Hospitals are trying to figure out in real time exactly what they need to disclose and how to do it.
"Everything is a disaster now, and no one has time to answer anything. So you're seeing organizations fumble when figuring out how to do this in a way that meets their ethical obligation to protect employees but doesn't violate federal privacy laws," Burgart said.
"The typical way these decisions would be made would be over a very long deliberative process, and that is a luxury we do not have right now. Some organizations are going to miss the mark the first time."
For older adults contemplating what might happen to them during this pandemic, ventilators are a fraught symbol, representing a terrifying lack of personal control as well as the fearsome power of technology.
This article was first published on Tuesday, May 12, 2020 inKaiser Health News.
DENVER ― Last month, Minna Buck revised a document specifying her wishes should she become critically ill.
"No intubation," she wrote in large letters on the form, making sure to include the date and her initials.
Buck, 91, had been following the news about COVID-19. She knew her chances of surviving a serious bout of the illness were slim. And she wanted to make sure she wouldn't be put on a ventilator under any circumstances.
"I don't want to put everybody through the anguish," said Buck, who lives in a continuing care retirement community in Denver.
For older adults contemplating what might happen to them during this pandemic, ventilators are a fraught symbol, representing a terrifying lack of personal control as well as the fearsome power of technology.
Used for people with respiratory failure, a signature consequence of severe COVID-19, these machines pump oxygen into a patient's body while he or she lies in bed, typically sedated, with a breathing tube snaked down the windpipe (known as "intubation").
For some seniors, this is their greatest fear: being hooked to a machine, helpless, with the end of life looming. For others, there is hope that the machine might pull them back from the brink, giving them another shot at life.
"I'm a very vital person: I'm very active and busy," said Cecile Cohan, 85, who has no diagnosed medical conditions and lives independently in a house in Denver. If she became critically ill with COVID-19 but had the chance of recovering and being active again, she said, "yes, I would try a ventilator."
What's known about people's chances?
Although several reports have come out of China, Italy and, most recently, the area around New York City, "the data is really scanty," said Dr. Carolyn Calfee, a professor of anesthesia at the University of California-San Francisco.
Initial reports suggested that the survival rate for patients on respirators ranged from 14% (Wuhan, China) to 34% (early data from the United Kingdom). A report from the New York City area appeared more discouraging, with survival listed at only 11.9%.
But the New York data incorporated only patients who died or were discharged from hospitals — a minority of a larger sample. Most ventilator patients were still in the hospital, receiving treatment, making it impossible for researchers to draw reliable conclusions.
Calfee worries that data from these early studies may not apply to U.S. patients treated in hospitals with considerable resources.
"The information we have is largely from settings with tremendous resource gaps and from hospitals that are overwhelmed, where patients may not be treated with optimal ventilator support," she said. "I would be very worried if people used that data to make decisions about whether they wanted mechanical ventilation."
Still, a sobering reality emerges from studies published to date: Older adults, especially those with underlying medical conditions such as heart, kidney or lung disease, are least likely to survive critical illness caused by the coronavirus or treatment with a ventilator.
"Their prognosis is not great," said Dr. Douglas White, a professor of critical care medicine at the University of Pittsburgh. He cautioned, however, that frail older adults shouldn't be lumped together with healthy, robust older adults, whose prospects may be somewhat better.
Like other clinicians, White has observed that older COVID patients are spending considerably longer on ventilators ― two weeks or more — than is the case with other critical illnesses. If they survive, they're likely to be extremely weak, deconditioned, suffering from delirium and in need of months of ongoing care and physical rehabilitation.
"It's a very long, uphill battle to recovery," and many older patients may never regain full functioning, said Dr. Negin Hajizadeh, an associate professor of critical care medicine at the School of Medicine at Hofstra/Northwell on New York's Long Island. "My concern is, who's going to take care of these patients after a prolonged ventilator course ― and where?"
In St. Paul, Minnesota, Joyce Edwards, 61, who is unmarried and lives on her own, has been wondering the same thing.
In late April, Edwards revised her advance directive to specify that "for COVID-19, I do not want to be placed on a ventilator." Previously, she had indicated that she was willing to try a ventilator for a few days but wanted it withdrawn if the treatment was needed for a longer period.
"I have to think about what the quality of my life is going to be," Edwards said. "Could I live independently and take care of myself — the things I value the most? There's no spouse to take care of me or adult children. Who would step into the breach and look after me while I'm in recovery?"
People who've said "give a ventilator a try, but discontinue it if improvement isn't occurring" need to realize that they almost surely won't have time to interact with loved ones if treatment is withdrawn, said Dr. Christopher Cox, an associate professor of medicine at Duke University.
"You may not be able to live for more than a few minutes," he noted.
But the choice isn't as black-and-white as go on a ventilator or die.
"We can give you high-flow oxygen and antibiotics," Cox said. "You can use BiPAP or CPAP machines [which also deliver oxygen] and see how those work. And if things go poorly, we're excellent at keeping you comfortable and trying to make it possible for you to interact with family and friends instead of being knocked out in a coma."
Heather McCrone of Bellevue, Washington, realized she'd had an "all-or-nothing" view of ventilation when her 70-year-old husband developed sepsis — a systemic infection ― last year after problems related to foot surgery.
Over nine hours, McCrone sat in the intensive care unit as her husband was stabilized on a ventilator by nurses and respiratory therapists. "They were absolutely fantastic," McCrone said. After a four-day stay in the hospital, her husband returned home.
"Before that experience, my feeling about ventilators was 'You're a goner and there's no coming back,'" McCrone said. "Now, I know that's not necessarily the case."
She and her husband both have advance directives stating that they want "lifesaving measures taken unless we're in a vegetative state with no possibility of recovery." McCrone said they still need to discuss their wishes with their daughters, including their preference for getting treatment with a ventilator.
These discussions are more important than ever ― and perhaps easier than in the past, experts said.
"People are thinking about what could happen to them and they want to talk about it," said Dr. Rebecca Sudore, a professor of medicine at the UCSF. "It's opened up a lot of conversations."
Rather than focusing on whether to be treated with a ventilator, she advises older adults to discuss what's most important to them — independence? time with family? walking? living as long as possible? ― and what they consider a good quality of life. This will provide essential context for decisions about ventilation.
"Some people may say my life is always worth living no matter what type of serious illness or disability I have," she said. "On the other end of the spectrum, some people may feel there are health situations or experiences that would be so hard that life would not be worth living."
Sudore helped create Prepare for Your Care, a website and a set of tools to guide people through these kinds of conversations. Recently it was updated to include a section on COVID-19, as have sites sponsored by Compassion & Choices and The Conversation Project. And the Colorado Program for Patient Centered Decisions has published a decision aid for COVID patients considering life support, also available in Spanish.
Some older adults have another worry: What if there aren't enough ventilators for all the COVID patients who need them?
In that situation, "I would like to say 'no' because other people need that intervention more than I do and would benefit, in all probability, more than I would," said Larry Churchill, 74, an emeritus professor of medical ethics at Vanderbilt.
"In a non-scarcity situation, I'm not sure what I'd do. I'm in pretty good health, but people my age don't survive as well from any major problem," Churchill said. "Most of us don't want a long, lingering death in a custodial facility where the chances of recovery are small and the quality of life may be one we're not willing to tolerate."
Health care runs a lot like the restaurant industry. When people stop showing up for Sunday brunch — or for elective hip replacements, colonoscopies and face-lifts — the enterprise runs short of cash fast.
This article was first published on Monday, May 11, 2020 in Kaiser Health News.
You've probably noticed that the U.S. economy is crashing. What you might not expect is that almost half of the economic devastation comes from just one sector — health care.
That's according to a first-quarter 2020 estimate of U.S. gross domestic product from the Bureau of Economic Analysis, which pundits later shared on social media.
Much of the slowdown came after hospitals postponed elective surgeries and as Americans skip routine medical care to avoid potential exposure to the coronavirus.
The episode includes interviews with Kaiser Health News senior correspondent Jenny Gold, who spoke with struggling pediatricians; and ProPublica reporter Isaac Arnsdorf, who found that even emergency room docs fighting COVID-19 aren't immune to the economic downturn.
As a society, we need health care workers like never before to fight COVID-19, but many medical professionals are feeling the financial pinch because of the way we pay for health care in this country.
Health care runs a lot like the restaurant industry. When people stop showing up for Sunday brunch — or for elective hip replacements, colonoscopies and face-lifts — the enterprise runs short of cash fast.
Episode 5 explores the COVID downturn, how health care is fueling the recession and what that could mean for our wallets.
“SEASON-19” of “An Arm and a Leg” is a co-production of Kaiser Health News and Public Road Productions.
For-profit companies that typically pay $50 per donation of plasma used in other lifesaving therapies are advertising aggressively — and significantly bumping up their rates for COVID donors.
This article was first published on Monday, May 11, 2020 in Kaiser Health News.
Diana Berrent learned she had tested positive for COVID-19 on a Wednesday in mid-March. Within a day, she had received 30 emails from people urging her to donate blood.
Friends and acquaintances, aware of her diagnosis, passed along a pressing request from New York's Mount Sinai Health System, one of the first centers to seek plasma, a blood component, to be used in a therapy that might fight the deadly disease. Berrent, 45, said she immediately recognized the need for the precious plasma — and the demand that would follow.
"When I saw that email going around, I saw what was going to happen in the landscape," said Berrent, a photographer and mother of two who lives on Long Island. She went on to found Survivor Corps, a grassroots clearinghouse that connects people who have recovered from COVID-19 with organizations eager to collect their blood.
"What I saw was going to emerge was a free market where survivors were a commodity."
Nearly two months later, Berrent's prediction is coming true. The coronavirus has infected more than 1.2 million people in the U.S., and now government scientists, academic researchers and for-profit pharmaceutical firms all are scrambling for blood plasma from COVID-19 survivors in hopes of developing a range of potential treatments.
In Minnesota, a program coordinated by the Mayo Clinic has collected plasma from more than 12,000 COVID survivors for transfusion into more than 7,000 gravely ill patients, the result of a massive public appeal led by government leaders and nonprofit groups like the Red Cross.
Meanwhile, for-profit companies that typically pay $50 per donation of plasma used in other lifesaving therapies are advertising aggressively — and significantly bumping up their rates for COVID donors.
In Utah, John and Melanie Haering, who contracted COVID-19 aboard the ill-fated Diamond Princess cruise ship, received gift cards worth $800 after making two donations apiece at a Takeda Pharmaceuticals BioLife Plasma Services center. BioLife runs several of the more than 800 paid-plasma collection sites in the U.S., part of an industry that produces plasma protein
"Given the urgency and importance of collecting convalescent plasma from the small population of recovered COVID-19 patients, BioLife is currently offering an added incentive for the first two donations from recovered COVID-19 patients," Takeda spokesperson Julia Ellwanger said in an email.
The money was "a nice surprise" for the Haerings, though they said they were motivated more by the opportunity to prevent others from suffering.
"If we could help anybody, we'd go every day," said John Haering, 63, a retired railroad manager who spent two weeks in a hospital in Japan after testing positive for the virus.
Donors like Berrent and the Haerings are needed to supply the building blocks of potentially lifesaving treatments. Rich with antibodies, convalescent plasma from COVID-19 patients is being tested as apossible therapy to promote recovery in people who are critically ill with the disease.
It's also being collected to create a concentrated antibody serum known as hyperimmune globulin that may prevent or halt infection in the future. Similar products are used to treat rabies and illnesses like infant botulism. If plasma from COVID-19 donors is shown to halt the disease, coming up with an antidote could offer companies the prospect of making millions of dollars.
And there's the possibility of a third treatment, monoclonal antibody therapy, which would use antibody-producing cells from high-antibody donors to create lab-produced molecules to fight the disease.
All three therapies are promising, but all three require human blood plasma, said Dr. Michael Busch, a professor of laboratory medicine at the University of California-San Francisco and director of the Vitalant Research Institute, one of the largest blood center-based transfusion medicine research programs in the U.S.
"At some level, they're all competing with the regular blood banks like mine," Busch said.
Only a fraction of those infected with COVID-19 have recovered sufficiently to donate,though more are eligible every day. But as demand for donors has grown, so has the need to wrangle the supply, ensuring that competition for plasma doesn't undercut the larger mission, said Dr. Michael Joyner, who heads the Mayo Clinic program.
"We're going to get it all worked out," he said. "It's in everybody's enlightened self-interest to do this in an intelligent way."
To avoid what Joyner described as a "range war" for COVID-19 plasma, he's spearheading an effort that calls for unprecedented collaboration to distribute separate streams of plasma among producers of therapies in a global market estimated toreach $35.5 billion by 2023.
"It's like the oil market," he said. "You send oil that needs one type of refining to one market and oil that needs another type of refining to another market."
His plan — floated last month to a group that included representatives from philanthropic organizations along with executives from for-profit and nonprofit blood collectors — relies in part on blood plasma from up to 10,000 Hasidic women in New York City, where the Orthodox Jewish community has been hit hard by the disease.
Tens of thousands of people have fallen ill with the virus in the city's Hasidic neighborhoods, and more than 700 have died. In recent weeks, thousands of men in the community who have recovered from COVID-19 have rushed to donate plasma. Chaim Lebovits, 45, who has helped organize the effort, said the donations are an act of faith.
"We have an obligation to protect and save lives," Lebovits said.
So far, however, many women in the Hasidic community have been unable to participate. Hasidic families are often large, and women who have had several children may have high levels of certain antibodies that are sometimes produced during a pregnancy. Rarely, such antibodies can cause a dangerous reaction — transfusion-related acute lung injury — in some recipients of plasma from women who have been pregnant. In COVID-19 patients, battling a virus that targets the lungs, such reactions could be deadly.
Given the risk, many Hasidic mothers who want to join the men in donating have been deferred from providing plasma for immediate transfusion, Joyner said. But those women could be an ideal and ongoing source of plasma for hyperimmune globulin, which is processed in a way that dilutes or removes the antibodies.
Roughly 10,000 women could donate up to four times each, generating some 30,000 liters of COVID-19 plasma that could be directed to the for-profit collectors to make hyperimmune globulin, Joyner estimated. That's enough for the companies to get started.
"This is the basis of a true win-win," Joyner said.
In the future, other groups deemed ineligible to provide convalescent plasma for transfusion, out of concern about disease transmission, could be diverted for hyperimmune globulin creation, he said.
One key part of the plan will be the ability to identify eligible donors through antibody tests, Joyner said. Mayo Clinic scientists have already conducted more than 5,000 serology tests and identified hundreds of potential plasma donors.
So far, however, neither the nonprofit organizations nor the for-profit firms have agreed to the plan.
"Ways to facilitate these donations and recommendations for how to allocate donors to one donation stream or the other are still in progress," said Natalie de Vane, a spokesperson for CSL Behring, a biopharmaceutical company based in King of Prussia, Pennsylvania.
CSL has joined with Takeda, a Japanese pharmaceutical company, to lead the CoVIg-19 Plasma Alliance, a coalition of six companies developing a single, unbranded hyperimmune globulin product that could treat COVID-19.
Meanwhile, officials with the AABB, an international nonprofit focused on transfusion medicine and cellular therapies, have focused efforts primarily on collecting plasma for immediate use. But they acknowledged that convalescent plasma could end up serving as "bridge therapy" to buy time until the hyperimmune globulin products are available.
"AABB recognizes the importance of ensuring that convalescent plasma is available as a transfusion therapy for patients today, as well as to develop future treatments," the agency said in a statement.
Representatives from all sides agree that the most pressing need is to increase the pool of COVID-19 survivors willing to donate plasma. They downplay talk of jockeying for donors in the nonprofit and for-profit worlds.
"We don't view it as competition," said Chris Healey, president of corporate affairs at Grifols, a Spanish pharmaceutical company that has receivednearly $13 million in funding from the U.S. Department of Defense to develop its own hyperimmune globulin product. "We're all pointed in the same direction."
One solution may be groups like Berrent's nonprofit Survivor Corps, which started in late March with a Facebook group that's grown to 42,000 members and now includes international partnerships and a pro bono advertising campaign,A Call to Arms.
Berrent has given plasma four times now, including to a biotech firm that sent a phlebotomist to her home and gave her a $100 Amazon card for her trouble.
Survivor Corps aims to function as a "one-stop shop" for donors interested in giving COVID-19 plasma, said Berrent. And, she said, it also could serve as a single source for recruitment, freeing scientists in government, academia and industry to focus on finding answers, not scouting survivors.
"Free markets work beautifully in many, many situations," said Berrent. "During a global pandemic, during a time of crisis, we need collaboration and efficiency."
The Trump administration has sent hundreds of millions of dollars in pandemic-related bailouts to health care providers with checkered histories, including a Florida-based cancer center that agreed to pay a $100 million criminal penalty as part of a federal antitrust investigation.
This article was first published on Saturday, May 9, 2020 in Kaiser Health News.
The Trump administration has sent hundreds of millions of dollars in pandemic-related bailouts to health care providers with checkered histories, including a Florida-based cancer center that agreed to pay a $100 million criminal penalty as part of a federal antitrust investigation.
At least half of the top 10 recipients, part of a group that received $20 billion in emergency funding from the Department of Health and Human Services, have paid millions in recent years either in criminal penalties or to settle allegations related to improper billing and other practices, a Kaiser Health News review of government records shows.
They include Florida Cancer Specialists & Research Institute, one of the nation’s largest U.S. oncology practices, which in late April said it would pay a $100 million penalty for engaging in a nearly two-decade-long antitrust scheme to suppress competition. A top Justice Department lawyer described the plot as “limiting treatment options available to cancer patients in order to line their pockets.” The company, which is required to pay the first $40 million in penalties by June 1, received more than $67 million in HHS bailout funds.
HHS distributed emergency funding to hospitals and other providers to help offset revenue losses or expenses related to COVID-19. In April, it distributed the first $50 billion based on providers’ net patient revenue, a calculation that gives more money to bigger systems or institutions charging higher prices.
Companies that have attested to receiving payments as of May 4 collectively received roughly $20 billion. The list is likely to change in the coming days as other companies confirm they’ve received money.
In total, the CARES Act, signed into law by President Donald Trump in March, provides $100 billion in emergency funding. Subsequent coronavirus relief legislation added another $75 billion. Money has also been steered to hot spots with high numbers of COVID-19 patients, rural health care providers and the Indian Health Service.
Of the companies documented to date, other top recipients ― including Dignity Health in Phoenix, the Cleveland Clinic, Houston’s Memorial Hermann Health System and Massachusetts General Hospital in Boston — have paid millions in recent years to resolve allegations related to improper billing in federal health programs, false claims to increase their payments or lax oversight that enabled employees to steal prescription painkillers.
Dignity Health, one of the largest hospital systems in the West, received $180.3 million in HHS bailout funds, making it the top recipient listed. It has settled civil accusations by DOJ that it submitted false claims to Medicare and TriCare, the military health care program.
The Cleveland Clinic, which in 2015 paid $1.74 million to settle federal allegations that it mischarged Medicare for costly spinal procedures to increase their billings and has entered into other similar settlements, received $103.3 million from HHS, the second-largest amount.
Memorial Hermann Health System and Massachusetts General Hospital received more than $93 million and $58 million, respectively. In 2018, Memorial Hermann paid nearly $2 million to the government to settle allegations that it improperly billed government health care programs by charging for higher-cost services when patients only needed lower-cost outpatient services.
Massachusetts General Hospital in 2015 paid the federal government $2.3 million to settle allegations that lax oversight enabled hospital employees to steal thousands of prescription medications, mostly addictive painkillers, for personal use.
Malcolm Sparrow, a professor at the Harvard John F. Kennedy School of Government, said the HHS methodology for its general distribution of relief funds is “a little bit worrying.”
“If you peg the amount based on historical volume and you’ve got good reason to believe that historical volume is inflated due to fraud and abuse, the irony is that they get more money because they’re more dishonest,” Sparrow said. “But you can’t prove that in a short period of time.”
Public tolerance for fraud and abuse naturally rises during times of emergency, Sparrow said, and now is not the time to revisit historical decisions to determine which companies are entitled to federal relief based on legal issues.
“I think that’s a tough case to make,” he said.
HHS has criteria for disqualifying providers from receiving bailout money. But even the strongest condition carries a broad caveat: None of the funds may be used for grants to any corporation convicted of a felony criminal violation within the preceding two years ― unless officials have decided that it is not necessary to prohibit them from doing business with the federal government.
“It’s sort of a high bar” for someone to be disqualified for this money, said Roger Cohen, a health care lawyer at Goodwin who specializes in fraud and anti-kickback law.
The Florida oncology provider has been charged with a felony and admitted to an antitrust crime, however federal prosecutors agreed to defer any prosecution and trial because a criminal conviction would have “significant collateral consequences” for its patients, the DOJ said.
Beyond that, HHS in its terms states that providers have to certify that they are not excluded from participating in federal health care programs like Medicare and Medicaid and have not had their Medicare billing privileges revoked.
The HHS Inspector General has the authority to exclude practitioners and health care companies for a wide variety of reasons — including a conviction of fraud ― but it’s highly unusual for the federal government to do so with large institutions, experts say.
“I imagine there would be hesitancy to exclude the provider,” Cohen said. “I think you’d have concerns about interrupting access to care.”
An HHS spokesperson declined to comment on its existing allocations but said the department has rules in place to recoup funds and address fraudulent activity if necessary.
“Failure to comply with any term or condition is grounds for HHS to recoup some or all of the payment from the provider,” the spokesperson said.
In a statement, Florida Cancer Specialists signaled it intended to use the funding.
“During this health crisis, we have continued to keep the doors of our more than 80 facilities open to ensure that cancer patients have access to care and treatment,” Thomas Clark, the company’s chief legal officer, wrote in an email. “We plan to use these funds, if needed, in accordance with government guidelines to continue providing affordable, safe and high-quality cancer care.”
Dignity Health said, “We have had to bear significant costs to prepare for and manage the pandemic in our communities even as patient volumes have been dramatically reduced across our hospitals.”
In October 2014, Dignity agreed to pay $37 million after the Department of Justice alleged it admitted patients to 13 of its hospitals in California, Nevada and Arizona who could have been treated on a “less costly, outpatient basis.” The civil case involved patients treated for elective heart procedures, such as pacemakers and stents, and other conditions. The company did not acknowledge wrongdoing in settling the case.
“Charging the government for higher-cost inpatient services that patients do not need wastes the country’s vital health care dollars,” acting Assistant Attorney General Joyce Branda for the Justice Department’s Civil Division said at the time. “This department will continue its work to stop abuses of the nation’s health care resources and to ensure patients receive the most appropriate care.”
Dignity said that independent annual audits were conducted after the False Claims Act settlement in 2014 and “no additional concerns were raised related to this issue.”
Massachusetts General Hospital and Memorial Hermann did not respond to requests for comment. The Cleveland Clinic confirmed the amount of money received from HHS but declined to comment further.
The patient described it as the worst headache of her life. She didn't go to the hospital, though. Instead, the Washington state resident waited almost a week.
When Dr. Abhineet Chowdhary finally saw her, he discovered she had a brain bleed that had gone untreated.
The neurosurgeon did his best, but it was too late.
"As a result, she had multiple other strokes and ended up passing away," said Chowdhary, director of the Overlake Neuroscience Institute in Bellevue, Washington. "This is something that most of the time we're able to prevent."
Chowdhary said the patient, a stroke survivor in her mid-50s, had told him she was frightened of the hospital.
She was afraid of the coronavirus.
The fallout from such fear has concerned U.S. doctors for weeks while they have tracked a worrying trend: As the COVID-19 pandemic took hold, the number of patients showing up at hospitals with serious cardiovascular emergencies such as strokes and heart attacks shrank dramatically.
Across the U.S., doctors call the drop-off staggering, unlike anything they've seen. And they worry a new wave of patients is headed their way — people who have delayed care and will be sicker and whose injuries will be exacerbated by the time they finally arrive in emergency rooms.
It has alarmed certain medical groups, such as the American College of Cardiology and the American Heart Association. The latter is running ads to urge people to call 911 when they're having symptoms of a heart attack or stroke.
"I haven't seen anything like it, ever," he said. "We anticipated, actually, higher volumes."
But doctors say once-busy emergency rooms have slowed to an eerie calm.
"It was very scary because it was so quiet," Dr. David Tashman, medical director of the ER at USC Verdugo Hills Hospital in Glendale, California, said about the early days of the outbreak.
"We normally see 100 patients a day, and then, you know, overnight, we were down to 30 or 40."
Some of that decrease in normal patient volume was deliberate.
As hospitals prepared for a surge of COVID patients, officials advised people to avoid emergency rooms if at all possible. Tashman said he wasn't surprised to see fewer trauma patients, because the roads were emptier. But soon he and other ER physicians noticed that even truly urgent cases were not coming in.
"We know the number of heart attacks isn't going to go down in a pandemic. It really shouldn't," Tashman said.
Dr. Larry Stock, an ER doctor at Antelope Valley Hospital in Lancaster, California, thought the same thing.
"I mean, we've all been scratching our heads — where are all these patients?" Stock said. "They're at home, and we're starting to get … the tip of the iceberg of this phenomenon."
One studycollected data from nine hospitals across the country, focusing on a crucial procedure used to reopen a blocked cardiac artery after a heart attack. The hospitals performed 38% fewer of those procedures in March than in previous months.
At Harborview Medical Center in Seattle, Dr. Malveeka Sharma has tracked a 60% decline in stroke admissions in the first half of April compared with the previous year.
Nationally, 911 call volumes for strokes and heart attacks declined in March through early April, according to data collected by ESO, a software company used by emergency medical service agencies.
In Connecticut, Dr. Kevin Sheth noticed a similar trend at Yale New Haven Hospital.
Sheth started calling other stroke doctors, trying to understand what was happening.
"The numbers had dramatically plummeted almost everywhere," said Sheth, chief of the division of neurocritical care and emergency neurology at Yale School of Medicine. "This is a big deal from a public health perspective."
Sheth said clinical stroke centers have seen an "unprecedented" drop in stroke patients being treated, with decreases from 50% to 70%.
In April, the American Heart and American Stroke associations put out emergency guidance to ensure health care providers keep stroke teams active and ready to treat patients during the pandemic.
Sheth said he worries it could be challenging to care for all the patients who eventually show up at hospitals in even worse shape after delaying care.
"When those stroke numbers come back, we could have serious capacity issues," he said. "We were already bursting at the seams."
"People are in this fear mode," said Dr. John Harold, a cardiologist at Cedars-Sinai Medical Center in Los Angeles and board president of the Los Angeles chapter of the American Heart Association.
Harold said the full public health consequences of people avoiding the hospital aren't yet clear.
"The big question is, are these people dying at home?" he asked.
Patients Fear The Hospital
Patients who are already at higher risk of experiencing medical emergencies describe a mix of fear and confusion about how to get safe and adequate care.
In March, Dustin Domzalski ran out of his epilepsy medication.
The 35-year-old from Bellingham, Washington, had trouble reaching his doctor, whom he would normally see in person, to get a refill.
Within a few days of not taking the medication, he had a major seizure while in the shower. His caregiver called an ambulance, which took him to the ER.
"I woke up and asked where I was and what happened," Domzalski said. "The guy in the next room to me was coughing and doing all kinds of stuff."
The experience was so unnerving that Domzalski now plans to avoid the hospital if at all possible.
"I am not going to the hospital unless I have a seizure and injure myself," he said. "I'd rather stay here than potentially have problems from the virus."
Miami resident Stayc Simpson recalled a frightening ordeal when she went to the ER in mid-March.
Simpson, a cancer survivor with heart failure, woke up with a pounding heart rate that she worried could signal a heart attack.
At the hospital, she was screened for COVID-19 and was soon moved to a unit for suspected cases because she had a cough, even though that is also a symptom of heart failure.
"When the reality hit that I was in the COVID unit, I thought, 'If I didn't have it before, then I probably will now,'" Simpson said.
She spent a day there, wracked with anxiety. Six days later, back at home, she learned she had tested negative for the virus.
Simpson knows the hospitals have made many changes since the early days of the pandemic, but the thought of calling 911 still scares her.
"I have seen news reports that tell me it's safer now. … I don't know if I have full confidence in that right now," she said. "The risk of COVID is terrifying."
Dangerous Risks Of Postponing Care
Some physicians are already glimpsing the consequences of patients putting off care.
"I've never seen the number of delays that I have in the last month or so," said Dr. Andrea Austin, an ER physician in downtown Los Angeles.
She's treating more serious cases because patients are waiting. "That's really one of the tragedies of COVID-19," Austin said. "They're staying at home and trying to diagnose themselves or really playing down their symptoms."
Chowdhary, the neurosurgeon from Bellevue, Washington, said some of his stroke patients have already seen life-altering consequences.
One older man noticed weakness on the left side of his body but avoided the hospital for four days.
"Now, at that point, we couldn't do anything to reverse the stroke," Chowdhary said. "That weakness is permanent."
Because of the stroke damage, the patient could no longer take care of his wife, who has cognitive issues. Eventually, the couple had to leave their home and move into a nursing home.
Jennifer Kurtz, stroke program coordinator at Overlake in Bellevue, said some patients who delayed care are now grappling with the physical and emotional toll.
"They feel so much guilt and regret that they didn't come to the hospital earlier," she said.
A caregiver confessed to Kurtz that she didn't bring her husband to the hospital when she first noticed symptoms of a stroke.
"She can't even tell her daughter [that] … because she is so ashamed," Kurtz said.
Doctors Plead: 'Don't Delay'
Patients must navigate the sometimes conflicting messages from public officials as well as disruptions to their routine medical care.
The surge of COVID-19 patients in hot spots such as New York City and New Orleans led to "the sense of an overstretched health care system without capacity," said Dr. Biykem Bozkurt, president of the Heart Failure Society of America and a cardiologist at Baylor College of Medicine in Houston.
"This may have created a false sentiment that routine care is to be deferred or that there is no capacity for non-COVID patients — this is not the case," Bozkurt said. "We would like our patients to seek care, not wait."
Hospitals are also trying to reassure patients they are taking precautions to keep them safe. Many have set up protocols for admitting suspected COVID-19 patients, such as separate screening areas inside the ER and dedicated areas of the hospital for coronavirus inpatients.
Tashman, the emergency physician at USC Verdugo Hills Hospital, is pleading with patients to come in for help immediately for heart attack and stroke symptoms: "Don't delay. You're not bothering us. You're not imposing on us."
This story is part of a partnership that includes KPCC, NPR and Kaiser Health News.
The fight over social distancing highlights the preexisting political divide in the U.S. that now has taken on more edge given the economic and life-or-death implications for all.
This article was first published on Thursday, May 7, 2020 in Kaiser Health News.
Even as Montana begins a gradual easing of stay-at-home restrictions intended to curb the spread of the coronavirus, the political schism it highlighted is creating reverberations in one community in the northwestern corner of the state.
A Flathead County health board member who led a movement to disparage the protective safety orders and downplay the virus is now the subject of two competing petitions — one to expel her from office and another to keep her.
When the commissioners in this county of about 104,000 people appointed Dr. Annie Bukacek to the health board in January, they might have known they were getting into a political hornet's nest. "Dr. Annie," as she's known in the Flathead Valley, is a well-known and outspoken opponent of vaccinations.
Then, as the coronavirus spread into Montana and the crisis deepened here and across the country, she became a leading voice locally and in this politically purple state against government restrictions to curb its spread.
In a widely circulated video posted on social media, Bukacek cast doubt over official COVID-19 death tolls, saying medical professionals were pressured to attribute non-COVID deaths to the virus. In many communities, such as New York City, though, the deaths from the virus are now believed to have been initially undercounted. Many public health experts say historical comparisons show the counts nationwide are still underestimating the COVID-19 death toll.
On her Facebook page, Bukacek often posted criticisms of Democratic Gov. Steve Bullock's stay-at-home orders, stating they weren't based in science. Bukacek did not respond to requests for comment for this story. But on April 25, just days after the governor announced the state would begin easing restrictions that he credited with flattening the COVID-19 curve, Bukacek wrote, "I fervently pray we stay awake, as governors return freedoms they never had the right to take away in the first place."
All this might seem to be just another fringe backlash against public health regulations, but Bukacek's critics say she has power and authority as a member of the county health board, which manages the local response to disease outbreaks, including quarantine and isolation orders, plus related directives to businesses and schools. They say her actions risk lives.
Her critiques also mirror a growing movement that has mounted protests across the United States. While surveys show an overwhelming majority of Americans have supported stay-at-home directives and other measures to slow the spread of the virus, loud protests have materialized from Montana to Michigan to Kentucky. Health workers and others, in turn, are countering the protesters.
This fight over social distancing highlights the preexisting political divide in our country that now has taken on more edge given the economic and life-or-death implications for all.
The Flathead Valley is a microcosm of this fight. It's a gateway to Glacier National Park, making it a haven for affluent tourists and retirees. It's also a predominantly white populace in a spot bordering two large Native American reservations. And it has been a frequent, often reluctant, haven for political controversy, sometimes branded a haven for white supremacists and anti-government activists.
In 2010, right-wing pastor Chuck Baldwin moved from Florida to the county seat of Kalispell and built a following with his Liberty Fellowship, which defied coronavirus public health orders early on and held in-person church services.
Though Montana has been one of the states hit least hard by COVID-19, with a confirmed caseload of fewer than 500 and 16 deaths as of May 5 in a population of 1 million, Flathead County has had more cases than all but three of the state's 56 counties. As of Tuesday, the county had reported 37 cases.
In Kalispell, where nearly 24,000 people live, many health care workers fear Bukacek's anti-social-distancing movement could be risking their lives and the health of their patients.
Joan Driscoll, a nurse practitioner who has worked in health care in Kalispell for 20 years, said protests and false information spread by Bukacek have created widespread anxiety in the community.
"The danger to our community is that she is in a position of authority, as a physician and a voting member of the board that oversees our community health clinic," said Driscoll. "By ignoring the mandates of staying at home and avoiding crowds, she is with her actions telling people those mandates — that are flattening our curve and keeping our hospitals under control — are wrong. That's harmful to me and all other health care workers as we see more and more people infected with this virus."
Human rights groups fear Bukacek and the backlash against COVID-19 restrictions will recruit new adherents to the far right. Residents of Kalispell have already reported that a new Friday night "community cruise" of cars parading down the main drag has included displays of Confederate flags in a county that borders Canada and wasn't a state during the Civil War.
"For a lot of people, it feels like she's come out of nowhere over the last couple of weeks," said Travis McAdam of the Montana Human Rights Network. "The reality is she has a long history of work in these far-right circles and is a fairly known quantity, especially for organizations who work around the legislature."
Cherilyn DeVries of the Love Lives Here anti-discrimination advocacy group in Whitefish, a smaller community in Flathead County that weathered a white supremacist troll storm, said locals need to speak out against the anti-science, anti-public-health messages being broadcast in the region.
"Right now, she is intentionally creating controversy," DeVries said of Bukacek. "She is trying to pit people against each other. She's trying to get people to see the hospital and the health department as the enemy, when these are the very people who you're going to go to to save your life."
Seattle mourned the news: Elizabeth and Robert Mar died of COVID-19 within a day of each other. They would have celebrated 50 years of marriage in August.
But their deaths at the end of March were not the same. Liz, a vivacious matriarch at 72, died after two weeks sedated on a ventilator. Her analytical engineer husband, Robert, 78, chose no aggressive measures. He was able to communicate with their adult children until nearly the end.
Clinician Darrell Owens helped the Mar family navigate this incredibly difficult time.
Owens, like other palliative care specialists in COVID-19 hot spots around the country, has seen his professional duties transformed by the deadly coronavirus. Patients and their families face abrupt decisions about the kind of care they want, and time for sensitive deliberation is scarce. Conversations once held in person are now over the phone, with all the nuances of nonverbal communication lost. The comfort of family at the bedside of the dying is all but gone.
Owens, like other palliative care specialists in COVID-19 hot spots around the country, has seen his professional
This is the new reality for those who practice palliative medicine — a speciality focused on relieving pain and symptoms, improving quality of life, and providing support to patients and families during severe, chronic or fatal illness.
Doctors and nurses trained in this branch of medicine are in high demand as hospitals treat thousands of terribly ill patients who may end up on life support with only a small chance of survival.
"This is a horrible virus that we don't have a cure for," Owens said. "As much as we are obligated to save people's lives, we are as obligated to save their deaths."
Before the coronavirus, Owens rarely worked in the emergency room. Now he's there regularly, called in whenever a suspected or confirmed coronavirus patient at high risk of complications comes through the doors.
"It is a totally different atmosphere in an emergency room," Owens said. "The conversations are more abbreviated than they would be because you are behind a mask, you are in a loud room, completely gowned up."
Essential Conversations Under Strain
It's a tough way to talk through sensitive and crucial questions about a patient's chance of survival and what they want.
"This is completely unprecedented," said Dr. Diane Meier, director of the Center to Advance Palliative Care and a professor at the Icahn School of Medicine at Mount Sinai.
During the surge of coronavirus patients in New York City, Meier said, her hospital system set up a palliative care hotline for family members of patients.
"You can't see their facial expression, all the cues you normally get with face-to-face communication are very hard to pick up over the phone," Meier said.
Nonetheless, she said, these conversations — especially with such a fast-moving and poorly understood virus — are an essential piece of the pandemic response.
"Palliative care specialists are a scarce resource, just like ventilators and ICU beds," she said.
Dr. Hope Wechkin, medical director of EvergreenHealth Hospice and Palliative Care in Kirkland, Washington, said palliative medicine is fundamentally about "being with patients during times of profound uncertainty, and continuing to place comfort and enhanced quality of life front and center."
"We now have this new player [coronavirus] — as we are evaluating a patient's goals of care," she said.
One Family, Two Kinds Of Death
While much of the country was still waking up to the pandemic, siblings Angie Okumoto, Rich Mar and Rob Mar were already navigating these wrenching decisions about their parents' care.
In early March, their mother, Liz, contracted the coronavirus and was admitted to the hospital.
Lively and hardworking, Liz was co-owner of the family's popular Hawaiian restaurant, Kona Kitchen, which she founded with her daughter and son-in-law.
"She was one of those people that quickly made friends and made an impression on everyone," said her son Rich. "Young people would look to her as a grandmother figure."
Known for her warmth, she enjoyed giving customers a hug or word of advice. Angie said that when she and her siblings were growing up, her parents made sure they had family dinners, and her mother brought that same feeling of togetherness to their restaurants.
"She cared for people and wanted to know what was going on in their lives," she said.
Liz had been in good health before contracting the virus. When her oxygen levels fell, her son took her to the ER.
"It was the last time I got to hear a response from her," Rob said. "That was the hardest part — not knowing it would be the last time."
The hospital was still adjusting its operations to account for the wave of COVID-19 patients and wasn't yet specifically screening patients with the coronavirus about their end-of-life wishes.
As she was admitted, the hospital staff asked about what kind of medical interventions she wanted, if necessary. "Do you want CPR? Do you want to be put on life support?"
Their mother was weak but still conscious. She said yes. Her children agreed.
"We just had no idea what this virus was going to do," Angie said. "We were trying to give her the opportunity to fight it."
But their mother's health worsened, and soon she was on a ventilator in the intensive care unit.
"For 14 days on the ventilator, she was alone," Angie said. Her brother Rob adds: "That's the part that hurts the most, and what will haunt me forever."
Near the end, the three children did get to visit their mother one last time.
"We were all gowned up and she was sedated," Rich said. "We were trying to talk to her and let her hear our voices."
Meanwhile, their father, Robert, had also become sick. He had been a civilian operations analyst for the Navy.
"He was on a Ph.D. track and quit his program to support his new son, me," Rob remembered. "My dad was more of the analytical type, he could give you a practical solution for everything."
In the early years of his marriage, Robert was supporting a household of seven, including their grandparents. His children describe him as cerebral, a perfect complement to his more extroverted wife.
"They really meshed well together — it worked for them," Rich said.
Robert was admitted to the same hospital as his wife. He seemed stable the first few days. But then his oxygen levels decreased and he started to decline.
He had been clear about his end-of-life care wishes.
"From Day One, he said he did not want to be on life support," Angie said.
'This Awful, Awful Truth'
Darrell Owens started managing Robert's care. The family talked and texted with Owens. He'd give them regular updates and tell them what to expect.
"He had to deliver this awful, awful truth, but the way he did it was so compassionate," Angie said. "He helped us arrange everything we needed for our dad."
"I appreciated the honesty," Rob said. "I found that the most reassuring and valuable thing."
Because he had decided against aggressive treatment, their father was never moved to the ICU. He was able to have a few in-person visits with his three children. Since he wasn't on a ventilator, they could have a conversation.
Rob said his father's treatment at the end of his life was on his own terms: "That was very important to him."
Owens managed Robert's care to the very end, and ensured that Robert could read the last few text messages from his son.
"They were basically goodbyes," Rich said.
Robert also shared memories with Owens about his wife and children.
"My dad opened up to him about our family," Angie said. "Dr. Owens knew quite a bit about us."
The Mars are deeply grateful to the nurses and doctors who cared for their parents. They understand that hospitals are restricting visitors to minimize the chance of infection and preserve limited supplies of masks and gowns.
Still, it doesn't stop Angie from wondering what might have been different if she had said goodbye to her mother before she was intubated, or had the chance to sit next to her while on the ventilator.
"What if I got to be bedside to my mom earlier, when she wasn't heavily sedated, holding her hand and just being present," Angie said. "That we'll never know."
It's a new way of experiencing death that families are coming to know as the coronavirus keeps them at a distance in these final moments.
This story is part of NPR's reporting partnership with Kaiser Health News.
Months into the spread of the coronavirus in the United States, widespread diagnostic testing still isn't available, and California offers a sobering view of the dysfunction blocking the way.
It's hard to overstate how uneven the access to critical test kits remains in the nation's largest state. Even as some Southern California counties are opening drive-thru sites to make testing available to any resident who wants it, a rural northern county is testing raw sewage to determine whether the coronavirus has infiltrated its communities.
County to county, city to city — even hospital to hospital within a city — testing capacity varies widely, as does the definition of who qualifies for testing.
Testing deserts, stemming from an overwhelmed supply chain and a disjointed public health system, have hit hardest in California's rural north and in lower-income urban neighborhoods with concentrations of residents who already were struggling to get quality medical care. In the absence of a coordinated federal response, local health departments, hospitals and commercial labs across the state have been competing for the same scarce materials. Whether they are "haves" — or have-nots — is determined largely by how deep their pockets are, their connections to suppliers and how the state is allocating emergency supplies.
Compounding these problems is the lack of a state or federal public health infrastructure empowered to acquire and allocate resources on a grand and equitable scale. Hospitals and health systems where many people go for care are, by design, set up to focus resources on their own patients and workers. Their bureaucracies can't readily adapt to do the community outreach and education that could bring testing to the masses; nor are they set up to do the contact tracing that ensures that people who have been exposed to COVID-19 patients are tested and monitored.
Those roles typically fall to county health departments, which in much of California operate on bare-bones budgets that make it a struggle to contain perennial STD outbreaks, let alone a deadly pandemic.
Over the past two months, the state has triaged one testing disaster after another, but it is finally making headway on making tests more widely available, in part by cutting its own deals for supplies and expanding testing sites in underserved areas, said Dr. Bob Kocher, one of three people on a testing task force convened by California Gov. Gavin Newsom.
But conversations with dozens of local health officials, hospital systems, scientists and elected officials reveal just how complicated a task it will be.
Take Lake County, a recreational mecca just over two hours north of San Francisco. With 65,000 residents, it has had so few testing supplies that officials have resorted to buying swabs on Amazon and pilfering chlamydia testing kits for swabs and the liquid used to transport specimens to labs. Through what the county has cobbled together, it has identified six cases of COVID-19, all found via nurses or volunteers who have gone out looking for patients. "We're basically having to do tea leaves to figure out what's going on," said Dr. Gary Pace, the county's health officer.
He knows the county has community transmission, both from the cases they've identified and because they've started running tests on raw sewage to check for the COVID-19 virus; samples from four treatment plants have come back positive. "It is a way to just get more information because we can't do testing," he said. Unlike the diagnostic kits — which make use of supplies every health department in the country is competing for — the sewage sampling is done pro bono by a technology startup.
While announcing an ambitious program to increase testing last week, Newsom highlighted the rural-urban divide. "One of the big struggles we have had in the last few weeks of this pandemic is getting to rural and remote parts of this state and getting up testing sites and making them available," he said.
Newsom is promising to dramatically increase the level of coronavirus testing, with a focus on rural towns and communities of color. California currently tests about 25,000 people a day but has a strategy to raise that to 60,000 to 80,000 per day. The state has opened the first of 86 pop-up testing sites targeted for areas in need. It is launching a program to train 10,000 workers to serve as temporary disease investigators who can do the contact tracing considered fundamental in stemming the spread of the virus.
Pace said he wrote the governor to ask for one of the pop-up sites. "Statewide, there's a situation where there's not enough testing, and if you're trying to demonstrate progress, the way you do that is numbers," he said. "We are interested in equity, though, and in my view, we need some horizontal coverage instead of just lots of numbers."
In Mendocino County, situated along California's rugged North Coast, officials expressed similar frustration. In late April, a health center on the Round Valley Indian Reservation got a rapid test machine made by Abbott Laboratories, distributed via the Indian Health Service. That same day, a tribal member came in feeling sick. That person tested positive for COVID-19, as did five family members. The county previously had identified just five cases, all linked to travel.
Dr. Noemi Doohan, the Mendocino County public health officer, fears a broader outbreak among the six tribes who live on the reservation. The state since has provided 2,000 test kits for people who live or work around the reservation. Doohan's office will have to hire couriers to drive 2½ hours to a public lab in Sonoma County, which also has limited supplies, to get them processed.
It's Every Lab — And County — For Itself
A mix of commercial and public labs are responsible for testing in California, and supply chain limitations have plagued them all. But those with deeper pockets and stronger commercial relationships have been out-competing counties and public labs with limited resources.
Rural Tulare County, spanning the peaks and foothills of the Sierra Nevada, is home to half a million people. It also has one of the highest per capita death counts of COVID-19 in California. Until recently, the local public lab was the only place in the county that could test for the disease. After borrowing staff from another county, buying additional machines, and suspending testing for most other diseases, they are now able to process 85 tests a day. Officials also can send specimens to commercial labs in other parts of the state, but say days-long turnarounds create bottlenecks for tracking patients and finding contacts.
Monterey County, in the heart of the state's "salad bowl" coastal farming region, has relied on donations — and horse-trading — to meet demand. A local hospital found the expensive materials needed to make a missing reagent and mixed a batch for the public lab, said lab director Donna Ferguson. The hospital also gave the county 1,000 swabs, which Ferguson used to barter with Riverside County for extraction kits.
And through the kindness of strangers, she found a stopgap for limits on another important resource: lab workers.
During an interview with a local public radio station in March, Ferguson mused that if one of the three microbiologists working in her lab got sick, it could be disastrous for the county's ability to process tests. The next day, she got a call from a graduate student at Stanford's nearby Hopkins Marine Station. He'd heard the interview. Could he and his colleagues help? The crew of six graduate students from three universities has been volunteering at the lab since, tripling its capacity to 120 tests a day.
Though the supply chain is a concern for labs of all sizes, manufacturers appear to be prioritizing orders from commercial labs and big health systems over public health labs, said Eric Blanks, chief program officer for the Association of Public Health Laboratories, which represents most of the labs run by public health departments in the nation.
Quest Diagnostics, the medical testing giant headquartered in New Jersey, is running 350,000 coronavirus tests a week in its facilities around the nation. But it is being inundated with samples from across the country, and even as it has worked to ease backlogs, counties and private hospitals are waiting days for results.
Kaiser Permanente says it can test 2,000 to 2,500 people throughout the state each week. Sutter Health, a major provider in Northern California, tests around 650 people each day across its hospitals. CommonSpirit Health, which includes Dignity Health hospitals, says it could process 50,000 samples a week if it had to. As of last week, Stanford had run more than 20,000 tests for Bay Area residents. (Kaiser Health News, which produces California Healthline, is not affiliated with Kaiser Permanente.)
But even the giants don't have unlimited supplies. "It really is the manufacturing lines. They're the ones that right now are the limiting factor," said Karen Smith, system vice president of laboratory services at CommonSpirit Health.
Moreover, hospitals are not set up to solve the broader issue of statewide disparities in access. They can generally handle the patients sick enough to seek out their ERs. But it hasn't historically been their role to arrange community-wide supplies and testing.
"You're not going to go to an emergency room if you're asymptomatic. That's the last place in the world you want to be right now," said Dr. Omid Bakhtar, medical director for outreach laboratory services at Sharp HealthCare in San Diego. "It's frustrating for me. I have the ability to do more [specimens], but how do I get them?"
Tests But No Takers
In pockets around the state, some counties have been able to stabilize their flow of supplies, in some cases because they have more financial means, in others because of their relationships with major hospital systems and research institutions.
With more confidence in their supply chains, Los Angeles and Riverside counties say they are ready to offer testing to any resident. Several other counties, including much of the Bay Area, are asking more people, including workers deemed essential without COVID symptoms, to get tested.
But some counties that have managed to ramp up testing are wrestling with yet another problem: not enough people to test. The reasons are twofold. After weeks of being told they shouldn't go for testing because of shortages, the public seems to be adhering to that message even now that more testing is available. And the public health workforce tasked with locating those in need of testing is depleted.
San Francisco can test 4,300 people each day in its publicly supported labs but was receiving just 500 samples a day as of late April. Los Angeles is testing roughly 10,000 people daily but says it needs to double that to lift the shelter-in-place orders. Its focus in coming weeks is to increase testing among the uninsured and those in at-risk living environments such as homeless encampments and skilled nursing facilities.
Health officials say part of the challenge is they aren't getting the word out to poorer residents and communities of color, even as those same groups are being hit harder by the virus in many cities. In San Francisco, for example, Latino residents make up 16% of the population but 25% of COVID-19 cases. In Los Angeles, black people are 9% of the county's population but represent 15% of the deaths from COVID-19 for which race and ethnicity data is available.
Kocher, of the state testing task force, acknowledged the state has more work to do. But, he argued, there's also a sufficient amount of testing capability available today, especially via high-capacity commercial labs where the state says the vast majority of specimens should be processed.
"Right now, we're concerned with not having enough samples collected," he said.
When officials do slowly begin to let people return to work and school, experts agree that cases will go up, creating even more need for labs, testing and contact tracers. Preparing for that future will require even more resources.
"We need money," said Santa Barbara County Health Officer Dr. Henning Ansorg. "Lots of money. Lots and lots of it."
There are 21 sites in Southern California where people can provide a sample by swishing a cotton swab around their mouths, putting it in a tube and dropping it in a receptacle on their way out — all within the comfort of their cars.
This article was first published on Friday, May 1, 2020 in Kaiser Health News.
Coronavirus testing is commonly an unpleasant, even painful experience in which a health care provider pushes a torturously long swab up your nostril. President Donald Trump declared that submitting to the process was “a little bit difficult.”
Since late March, three Southern California jurisdictions ― Los Angeles County, and the cities of L.A. and Long Beach ― have offered a more palatable alternative to this nasopharyngeal sampling, whose very name poses a challenge. At 21 drive-thru sites, anyone can now provide a sample by swishing a cotton swab around their mouths, putting it in a tube and dropping it in a receptacle on their way out — all within the comfort of their cars. Some experts suggest this self-sampling approach may provide an easier way to ramp up massive testing in the U.S.
“I strongly advocate for the oral self-swab,” said Dr. Clayton Kazan, medical director for the L.A. County Fire Department, which is overseeing the county’s drive-thru testing program. “It may or may not be inferior, depending on the study you read, but, logistically, there is no comparison.”
But many public health officials balk at relying on the simpler tests unless scientific data convincingly shows they work as well as the accepted methods.
“I have real concerns about decisions that are made based on studies that have not been peer-reviewed,” said Dr. Richard Besser, CEO of the Robert Wood Johnson Foundation and former acting head of the Centers for Disease Control and Prevention.
“In the middle of this pandemic, we don’t want to compromise, especially if people are going to use that information to decide if they’re going to follow social distancing,” said Dr. Adam Jarrett, chief medical officer at Holy Name Medical Center in Teaneck, New Jersey.
Nasopharyngeal samples have long been standard for diagnosing influenza and other respiratory infections because the pathogens are known to colonize the upper part of the throat behind the nose. In contrast, the simpler method being used in L.A. County — in which patients are asked to cough and then swab their cheeks and the back of their mouths — is based on a limited body of emerging research.
The CDC currently calls nasopharyngeal swabs the “preferred choice” for coronavirus testing. It doesn’t recommend self-collected oral fluids, and the number of jurisdictions pursuing this strategy remains limited.
In early April, Middlesex County, New Jersey, also began to offer symptomatic individuals drive-thru tests using oral samples produced after a cough. On Monday, officials in New York City said they planned to begin offering testing using self-collected oral and nasal samples at public hospitals.
Scientists and public health experts have promoted increased viral testing and surveillance as key to any strategy for safely loosening societal restrictions — and the need to collect nasopharyngeal samples by professionals dressed in protective gear represents a major obstacle. That’s why interest is rising in the use of oral samples as well as nasal swabs that can be self-administered, said Lisa Barcellos, an epidemiologist at the University of California-Berkeley.
“It’s impossible to scale up anything that requires health professionals to do it, and with equipment that’s hard to get,” Barcellos said. The surge in demand for the specialized 6-inch swabs required for the nasopharyngeal procedure has led to critical shortages, she added.
The L.A. County, Los Angeles and Long Beach drive-thru sites — designed for people experiencing symptoms — collectively process about 7,000 oral swab tests a day, with a positive rate of just over 7%, according to Curative, the diagnostics company that provides the tests. Curative is holding discussions with jurisdictions in other areas and last week announced an agreement to test Air Force personnel.
Kazan acknowledged that nasopharyngeal sampling is considered the most trustworthy method but noted recent studies have reported promising results from oral samples. Moreover, he said, relying on self-administered techniques eliminates the danger to health care personnel and minimizes the need for personal protective equipment in short supply, like masks, face shields and protective suits.
Kazan said people who receive the tests are relieved to find that collecting secretions from their mouths is relatively quick and easy.
“I think that a lot of folks envision what they saw on YouTube, people in PPE that look like astronauts putting swabs way up people’s noses,” he said.
But to be useful, diagnostic tests must be accurate. A “false negative,” in which the test fails to detect the coronavirus, could lead someone who is infected to think they are safe and pose no danger to others.
Since the pandemic began, a growing body of research — some of which has not yet undergone peer review — has compared how accurately different sampling techniques detect the virus. “Everybody’s looking for better ways to do this,” said Barcellos, who is involved in a major study of the prevalence of coronavirus infection in the East Bay region.
Both oral and nasal samples can be obtained in more and less invasive ways. Oropharyngeal swabs require the instrument to be inserted down the throat; like nasopharyngeal swabs, they are supposed to be performed by a trained provider because the procedure can be uncomfortable and tends to produce a gag reflex.
And swabs of secretions gathered from just inside the nostril can be self-administered, unlike the nasopharyngeal swabs. A Seattle study of hundreds of coronavirus patients found that self-collected samples were almost as accurate as nasopharyngeal swabs in identifying viral infections. In March, Seattle public health agencies launched a home-testing surveillance project using the nasal self-swab, with local residents registering online.
The emerging research has also investigated oral fluid tests, like those being conducted in L.A. County, with subjects generally required to cough in order to bring up virus-rich saliva before they swab their mouth or spit into a container. A non-peer-reviewed study of 65 patients in China reported that the detection rate of the novel coronavirus was higher in saliva than in other respiratory samples. Other studies have found that oral fluid tests aren’t as accurate when people are not reminded to cough beforehand.
Carey-Ann Burnham, medical director of microbiology at Barnes-Jewish Hospital in St. Louis, said the early research on oral fluids looks “remarkably promising.”
But “a nasopharyngeal swab is a standardized sampling technique that’s been done for decades,” said Burnham, who is also a professor of immunology and pathology at Washington University School of Medicine. “Saliva, oral secretions — that’s not a standard way we’ve looked for respiratory viruses, and right now everyone’s doing it a little bit differently.”
That makes it harder to compare studies and results, she said.
The FDA’s authorization for the Curative test recommends that the self-collection process be “observed by a trained healthcare worker.” Kazan, the fire department medical director, said that trained staffers observe the oral self-swabbing. While acknowledging the limitations of the early data, Kazan insists that the needs of the moment are paramount.
“This is the space between smart people reading medical literature and those of us who are tasked with operationalizing these recommendations,” he said.