As COVID-19 continues to spread, an increasing number of rural communities find themselves without their hospital or on the brink of losing already cash-strapped facilities.
This article was published on Wednesday, August 26, 2020 in Kaiser Health News.
After becoming ill with COVID-19, Antone was hospitalized only 65 miles away from his small Alabama town. He is the mayor of Georgiana — population 1,700.
"It hit our rural community so rabid," Antone said. The town's hospital closed last year. If hospitals in nearby communities don't have beds available, "you may have to go four or five hours away."
As COVID-19 continues to spread, an increasing number of rural communities find themselves without their hospital or on the brink of losing already cash-strapped facilities.
Eighteen rural hospitals closed last year and the first three months of 2020 were "really big months," said Mark Holmes, director of the Cecil G. Sheps Center for Health Services Research at the University of North Carolina-Chapel Hill. Many of the losses are in Southern states like Florida and Texas. More than 170 rural hospitals have closed nationwide since 2005, according to data collected by the Sheps Center.
It's a dangerous scenario. "We know that a closure leads to higher mortality pretty quickly" among the populations served, said Holmes, who is also a professor at UNC Gillings School of Global Public Health. "That's pretty clear."
One 2019 study found that death rates in the surrounding communities increase nearly6% after a rural hospital closes — and that's when there's not a pandemic.
Add to that what is known about the coronavirus: People who are obese or live with diabetes, hypertension, asthma and other underlying health issues are more susceptible to COVID-19. Rural areas tend to have higher rates of these conditions. And rural residents are more likely to be older, sicker and poorer than those in urban areas. All this leaves rural communities particularly vulnerable to the coronavirus.
Congress approved billions in federal relief funds for healthcare providers. Initially, federal officials based what a hospital would get on its Medicare payments, butby late April they heeded criticismand carved out funds for rural hospitals and COVID-19 hot spots. Rural hospitals leapt at the chance to shore up already-negative budgets and prepare for the pandemic.
The funds "helped rural hospitals with the immediate storm," said Dr. Don Williamson, president of the Alabama Hospital Association. Nearly 80% of Alabama's rural hospitals began the year with negative balance sheets and about eight days' worth of cash on hand.
Before the pandemic hit this year, hundreds of rural hospitals "were just trying to keep their doors open," said Maggie Elehwany, vice president of government affairs with the National Rural Health Association. Then, an estimated 70% of their income stopped as patients avoided the emergency room, doctor's appointments and elective surgeries.
"It was devastating," Elehwany said.
Paul Taylor, chief executive of a 25-bed critical access hospital and outpatient clinics in northwestern Arkansas, accepted millions in grants and loan money Congress approved this spring, largely through the CARES (Coronavirus Aid, Relief and Economic Security) Act.
"For us, this was survival money and we spent it already," Taylor said. With those funds, Ozarks Community Hospital increased surge capacity, expanding from 25 beds to 50 beds, adding negative pressure rooms and buying six ventilators. Taylor also ramped up COVID-19 testing at his hospital and clinics, located near some meat-processing plants.
Throughout June and July, Ozarks tested 1,000 patients a day and reported a 20% positive rate. The rate dropped to 16.9% in late July. But patients continue to avoid routine care.
Taylor said revenue is still constrained and he does not know how he will pay back $8 million that he borrowed from Medicare. The program allowed hospitals to borrow against future payments from the federal government, but stipulated that repayment would begin within 120 days.
For Taylor, this seems impossible. Medicare makes up 40% of Ozarks' income. And he has to pay the loan back before he gets any more payments from Medicare. He's hoping to refinance the hospital's mortgage.
"If I get no relief and they take the money … we won't still be open," Taylor said. Ozarks provides 625 jobs and serves an area with a population of about 75,000.
There are 1,300 small critical access hospitals like Ozarks in rural America and, of those, 859 took advantage of the Medicare loans, sending about $3.1 billion into the local communities. But many rural communities have not yet experienced a surge in coronavirus cases — national leaders fear it will come as part of a new phase.
"There are pockets of rural America who say, 'We haven't seen a single COVID patient yet and we do not believe it's real,'" Taylor said. "They will get hit sooner or later."
Across the country, the loss of patients and increased spending required to fight and prepare for the coronavirus was "like a knife cutting into a hospital's blood supply," said Ge Bai, associate professor of health policy and management at the Johns Hopkins Bloomberg School of Public Health in Baltimore.
Bai said the way the federal government reimbursed small rural hospitals through federal programs like Medicare before the pandemic was faulty and inefficient. "They are too weak to survive," she said.
In rural Texas about two hours from Dallas, Titus Regional Medical Center chief executive Terry Scoggin cut staff and furloughed workers even as his rural hospital faced down the pandemic. Titus Regional lost about $4 million last fiscal year and broke even each of the three years before that.
Scoggin said he did not cut from his clinical staff, though. Titus is now facing its second surge of the virus in the community. "The last seven days, we've been testing 30% positive," he said, including the case of his father, who contracted it at a nursing home and survived.
"It's personal and this is real," Scoggin said. "You know the people who are infected. You know the people who are passing away."
Of his roughly 700 employees, 48 have tested positive for the virus and one has died. They are short on testing kits, medication and supplies.
"Right now the staff is strained," Scoggin said. "I've been blown away by their selflessness and unbelievable spirit. We're resilient, we're nimble, and we will make it. We don't have a choice."
As some parts of America gingerly begin to open up after months of near-total lockdown, people have questions. Will it be safe to take a train? A plane? Visit the hair salon? An indoor restaurant?
There are many knowable parameters in the equation: your health; the prevalence of cases where you live; the safety precautions being taken anyplace you want to visit. But the final answer may depend on your individual risk tolerance for exposure to infectious disease.
Most Americans alive today have never before had to make that self-assessment.
In the past, deadly outbreaks of plague, flu and polio were regular occurrences. Up until the mid- to late 20th century there were mumps, measles and chickenpox to contend with.
In a world of effective antibiotics and antivirals and other treatments, deaths or even serious illnesses from infectious disease seem nearly incomprehensible. So our fear is enormous, and our risk tolerance for exposure is just about zero.
I hear too many people saying "I'm not going back to life until there's a vaccine" — as if that will immediately eliminate the risk. It won't. Even if one of the current vaccine candidates works, it could be quite a while before it's widely distributed. And to be approved by the Food and Drug Administration, it must protect only half of the people taking it from infection.
For the foreseeable future, we will be living in a world with some level of the coronavirus out there. So if we want to get out of our bunkers, we all need to take stock of our risk tolerance.
As a doctor, I worked in a New York City emergency room and in a remote coastal clinic in Kenya, and then I became a journalist covering disease. I've had to measure my risk tolerance for infection in different situations.
Once, collecting blood from an AIDs patient, I couldn't feel the artery through my glove. The glove came off.
Treating a patient with multi-drug-resistant tuberculosis, I pulled my surgical mask a little tighter, made sure the windows were open and — irrationally — tried to breathe in less.
Reporting from the animal market where the SARS outbreak is thought to have started, I told myself that I should be OK, since it was outdoors. But I stayed away from animals being slaughtered, didn't touch any surfaces and took off my shoes before entering my hotel room.
Note that these decisions do not mean ignoring the data and infectious disease specialists' recommendations, as some conservatives are doing as they push ahead to reopen schools, businesses, restaurants and sports events.
Actually it's kind of the opposite: Accepting risk doesn't mean throwing caution to the wind. It means taking all precautions and deciding you can live with the very reduced risk that remains.
With the coronavirus, the only way to possibly eliminate risk is essentially to move to a house in the countryside and live in your family bubble. And many Americans, particularly wealthy ones, have done just that. This personal response was extreme, but it felt rational to many people because our national response to the coronavirus was so scattershot, flat-footed and incompetent.
But isolation is wearing thin.
So as states and cities engineer sensible reopening policies, everyone is going to have to assess their risk tolerance and cautiously push their personal boundaries bit by bit.
Some, of course, never got to make this decision. Risk tolerance is about duty and conscience but very often it's also about how much you need a paycheck.
Doctors, nurses and others who work in healthcare had no choice but to dive in. These folks did not, as so many have claimed, go into the profession "knowing the risks." They came to work knowing that the risk of infectious diseases could be controlled with careful precautions. That's why they felt angry and betrayed when they were asked to fight the novel coronavirus without an adequate supply of protective gear or (in some places) training about the new pathogen. And, tragically, some died as a result.
Now many physicians I know in COVID-19 hot spots say they actually feel safest in the hospital, where procedures like masking and sanitizing are assiduously followed. (Hell hath no fury like a surgeon who witnesses a medical student touch a sterile surface with an unsterile hand.) In contrast, on the sidewalk, the coronavirus could be roaming free if people aren't wearing masks.
Which is why masking should be mandated and enforced. It's not just about your individual risk tolerance but about keeping everyone safe.
In addition to wearing masks and social distancing when not at home, we should avoid prolonged periods in indoor spaces with crowds or strangers; wash or sanitize our hands — a lot — and try not to touch "high-touch" surfaces that hundreds of people have grabbed before. (Note to my local post office: You should have some kind of automatic door rather than require everyone to pull the handle!)
And we have to demand that anywhere we go — bookstores, medical offices, trains or hair salons — requires that patrons follow these guidelines. I, for one, won't enter if they don't.
I do not blame teachers for being unwilling to return to school in places where administrators and officials have been in denial about COVID-19 or have been unwilling or unable to do this preparatory work. But once schools have put in place appropriate science-based steps, most teachers (those not in high-risk groups) should return to their jobs.
COVID-19 is a very serious disease. But it is not the Black Death, which killed up to half of Europe in the 14th century. A vaccine, when and if it arrives, will be a big help. But in the meantime, we have science. We know what causes COVID-19. We are learning more about how to detect, prevent and treat it every day.
So instead of taking your temperature and checking your pulse oximeter reading twice a day, it may be time to take stock of your risk tolerance. In those places where governments, businesses and administrators have set the stage properly, we can — with sensible precautions — begin to live again.
In a business driven by profit, vaccines have a problem. They're not very profitable — at least not without government subsidies. Pharma companies favor expensive medicines that must be taken repeatedly and generate revenue for years or decades. Vaccines are often given only once or twice. In many parts of the world, established vaccines cost a few dollars per dose or less.
Last year only four companies were making vaccines for the U.S. market, down from more than 20 in the 1970s. As recently as Feb. 11, Dr. Anthony Fauci, the government's top infectious disease expert, complained that no major drug company had committed to "step up" to make a coronavirus vaccine, calling the situation "very difficult and frustrating."
Oxford University surprised and pleased advocates of overhauling the vaccine business in April by promising to donate the rights to its promising coronavirus vaccine to any drugmaker.
The idea was to provide medicines preventing or treating COVID-19 at a low cost or free of charge, the British university said. That made sense to people seeking change. The coronavirus was raging. Many agreed that traditional vaccine development, characterized by long lead times, manufacturing monopolies and weak investment, was broken.
"We actually thought they were going to do that," James Love, director of Knowledge Ecology International, a nonprofit that works to expand access to medical technology, said of Oxford's pledge. "Why wouldn't people agree to let everyone have access to the best vaccines possible?"
A few weeks later, Oxford—urged on by the Bill & Melinda Gates Foundation—reversed course. It signed an exclusive vaccine deal with AstraZeneca that gave the pharmaceutical giant sole rights and no guarantee of low prices—with the less-publicized potential for Oxford to eventually make millions from the deal and win plenty of prestige.
Other companies working on coronavirus vaccines have followed the same line, collecting billions in government grants, hoarding patents, revealing as little as possible about their deals—and planning to charge up to $37 a dose for potentially hundreds of millions of shots.
Even as governments shower money on an industry that has not made vaccines a priority in the past, critics say, failure to alter the basic model means drug industry executives and their shareholders will get rich with no assurance that future vaccines will be inexpensively available to all.
"If there were ever an opportunity" to change the economics of vaccine development, "this would have been it," said Ameet Sarpatwari, an epidemiologist and lawyer at Harvard Medical School who studies drug-pricing regulation. Instead, "it is business as usual, where the manufacturers are getting exclusive rights and we are hoping on the basis of public sentiment that they will price their products responsibly."
In the United States and other developed nations, the solution to drug-company reluctance was to shower them with billions of dollars in public funds to persuade them to help. The Trump administration has announced deals worth more than $10 billion with seven companies to try to turn basic research—often funded by the government—into effective, widely distributed vaccines—but with no guarantee they would be widely affordable or available.
That approach has driven up stock prices in the past four months and enriched drug executives betting with somebody else's money.
AstraZeneca stock and options owned by CEO Pascal Soriot have increased by nearly $15 million in value since early April, according to calculations by KHN based on company disclosures. The stock hit an all-time high in July. The stock market value of Novavax, a biotech that never recorded a profit in more than two decades, soared tenfold to $10 billion after a nonprofit and the Trump administration agreed to give it $1.6 billion to make a vaccine.
Companies "say we have to charge high prices because we are taking a risk," said Mohga Kamal-Yanni, an independent consultant on global health based in the United Kingdom. "Actually, the public is taking the risk. The public is paying for the cost of research and development and probably the cost of manufacturing as well."
Moderna, another company working on a vaccine candidate, received nearly $1 billion from the U.S. government to pay essentially all costs to research the product and get it approved by regulators. It's using a vaccine designed in large part by the National Institutes of Health and academic scientists using federal grants.
If the vaccine works, the company gets an additional $1.5 billion to cover 100 million doses, a deal that U.S. Rep. Lloyd Doggett, a Texas Democrat, likened to giving taxpayers "the privilege of purchasing that same vaccine that we already paid for."
That deal comes to $15 a dose. Moderna told Wall Street analysts it might charge as much as $37 a dose for smaller-volume contracts.
"This is greedy, and the taxpayers who have funded all of this should have expected better negotiation on the part of the U.S. government," said Margaret Liu, a globally respected vaccine scientist who once worked for Merck and is now chairperson of the International Society for Vaccines.
The U.S. Health and Human Services Department "conducted extensive market research and price analysis" to ensure prices are fair, said a senior HHS official who asked for anonymity. "We are prohibited from disclosing price discussions and details."
Even if Moderna distributed a successful vaccine at a loss to make it widely available, it would reap enormous benefits because government support would have helped validate its technology for future products, Liu said. Moderna did not respond to requests for comment.
Nonprofits such as Oxfam and Doctors Without Borders have been pressuring drug companies to change for years. Exclusive patents and high prices that sometimes make lifesaving medicines unaffordable in rich countries often render them completely unavailable in the poor world, they argue.
One workaround has been enormous private and government subsidies, including from the U.K., the United States and the Gates Foundation, to promote developing-nation vaccines through the Geneva nonprofit Gavi, formerly known as the Global Alliance for Vaccines and Immunization.
The Gates Foundation helped launch another non-governmental organization, the Coalition for Epidemic Preparedness Innovations, in 2017. CEPI was created to fight something exactly like the coronavirus: potential infectious threats ignored or slighted by pharmaceutical companies.
CEPI's early principles of "equitable access" drew praise from reformers. The group asked for public data disclosure from drug-company grantees, "transparent" accounting to show true vaccine cost and the right to step in and take over a vaccine project if the developer failed to deliver.
The pharma industry immediately objected. Even though they were bankrolled by public money, drug companies were "concerned about the precedent that could be set if they allowed an outside entity, in this case CEPI, to set [the] price of a product unilaterally," CEPI reported in February. The nonprofit backed down, removing most references to prices in a new policy that Doctors Without Borders called "an alarming step backwards."
The original policy was intended to be "interim," and CEPI's "commitment to equitable access as a principle is the same," said spokesperson Rachel Grant.
Some thought the worst infectious disease crisis in a century, along with the enormous public investments, would change industry behavior.
Governments could have demanded transparency and low prices. They could have offered developers cash prizes for vaccines that would have incentivized science but let the public retain the marketing rights, said Love, of Knowledge Ecology International.
Agreement by researchers to publish the virus genome in January set the stage for global scientific cooperation, many believed.
"The full sequence was shared with the world without any strings attached," said Manuel Martin, a U.K.-based adviser to Doctors Without Borders on access to medical innovations.
"I personally don't believe that in a time of pandemic there should be exclusive licenses," Adrian Hill, director of Oxford's Jenner Institute, which is developing the vaccine, told The New York Times in April.
Instead, little has changed. No vaccine maker has offered open licenses, although NIH is sharing key technology it developed with multiple vaccine companies. Governments are signing lucrative deals with manufacturers to ensure vaccines for their own populations. WHO has made no announcements about contributions to its COVID-19 shared technology pool since it launched in May, patent experts said. WHO officials did not respond to a reporter's queries.
After Oxford announced the exclusive AstraZeneca deal, the company said it would sell vaccines at no profit—but only during the pandemic. Johnson & Johnson's pledge to earn no vaccine profit is similarly limited.
With financial information kept confidential, no one will be able to confirm whether the vaccines are truly being sold at cost. And if vaccine immunity is only temporary and endemic coronavirus strains require regular shots for years, the companies will make plenty of money down the road, critics say.
Under its deal with AstraZeneca, Oxford will receive no royalties during the pandemic but could make millions after it ends through a web of patents including those held by Vaccitech, a for-profit spinoff. Vaccitech's ownership includes a 50% stake held directly or indirectly by Oxford and 5.25% each owned by Hill and Jenner's other top vaccine scientist, Sarah Gilbert, U.K. regulatory filings show.
Pharma company officials say that only decades of industry research could have made it even possible to produce a coronavirus vaccine at the present speed.
"The federal government cannot research, develop and manufacture vaccines and other new treatments on its own," said Andrew Powaleny, a spokesperson for the Pharmaceutical Research and Manufacturers of America, a lobbying group. Large and early government investment "is a well-accepted approach to addressing public health crises," he said.
Many argue that a health crisis is not the time to worry about overpaying for vaccines or backing some candidates that won't deliver. Getting a good vaccine as quickly as possible requires spreading bets, they say.
"Spending some extra billions on vaccines is the right choice when human life is at stake and trillions in economic loss is at risk," said Edward Scolnick, a top scientist at the Broad Institute and former head of research for Merck. He owns no stock in Merck or other pharma companies, he said.
Oxford backed off from its open-license pledge after the Gates Foundation urged it to find a big-company partner to get its vaccine to market.
"We went to Oxford and said, Hey, you're doing brilliant work," Bill Gates told reporters on June 3, a transcript shows. "But … you really need to team up." The comments were first reported by Bloomberg.
AstraZeneca, one of the U.K.'s two major pharma companies, may have demanded an exclusive license in return for doing a deal, said Ken Shadlen, a professor at the London School of Economics and an authority on pharma patents—a theory supported by comments from CEO Soriot.
"I think IP [intellectual property, or exclusive patents] is a fundamental part of our industry and if you don't protect IP, then essentially there is no incentive for anybody to innovate," Soriot told the newspaper The Telegraph in May.
Some see the Gates Foundation, a heavy funder of Gavi, CEPI and many other vaccine projects, as supporting traditional patent rights for pharma companies.
"[Bill] Gates has staked out this outsized role in the vaccine world," Love said. "He has an ideological belief that the intellectual property system is a wonderful mechanism that is necessary for innovation and prosperity."
The Gates Foundation requires all its grantees to commit to making products "widely available at an affordable price," a spokesperson said.
Oxford officials, including Hill and Gilbert, did not respond to requests for comment. AstraZeneca, for its part, would set a "reasonable" post-pandemic price and is "committed to ensure equitable access, globally" in the meantime, a spokesperson said. The company has signed deals with CEPI, Gavi and the Serum Institute of India to bring more than a billion doses to low- and middle-income countries, he said.
If nothing else, governments and vaccine makers should be open about their relationships, including making contracts public, said Duncan Matthews, a patent law professor at the Queen Mary University of London.
"We simply don't know what's in these deals," he said. "The biopharma industry is applying old rules of commercial confidentiality in a situation that is unprecedented."
Two manufacturers that have received FDA authorization say their antigen tests are intended for patients with symptoms, calling into question how valuable the tests would be for broad screenings.
This article was published on Monday, August 24, 2020 in Kaiser Health News.
The Trump administration's latest effort to use COVID-19 rapid tests — touted by one senior official as a "turning point" in arresting the coronavirus's spread within nursing homes — is running into roadblocks likely to limit how widely they'll be used.
Federal officials are distributing point-of-care antigen tests — which are cheaper and faster than tests that must be run by a lab — to 14,000 nursing homes to increase routine screening of residents and staff. The initial distribution targets nursing homes in hot spots and those with at least three COVID-19 cases, senior Trump administration officials said in July, hailing it as a tool that could root out asymptomatic carriers who might still infect others.
But there's a hitch: Two manufacturers that have received Food and Drug Administration authorization and whose instruments are being delivered — Becton, Dickinson and Co., known as BD, and Quidel — say their antigen tests are intended for patients with symptoms, calling into question how valuable the tests would be for broad screening purposes. The Centers for Disease Control and Prevention estimates40% of infected people may be asymptomatic.
"It's important always to use a diagnostic in the way that it has been designed to be used," said Elizabeth Talbot, New Hampshire's deputy state epidemiologist. "We simply don't know how [the tests] will perform in persons who are asymptomatic."
Perhaps the highest-profile example of the problem occurred in Ohio this month, when Gov. Mike DeWine had no symptoms and tested positive for COVID-19 with Quidel's antigen test. Within hours, the Republican governor's diagnosis was reversed after he got a PCR test.
"People should not take away from my experience that testing is not reliable or doesn't work," DeWine said on CNN after his false-positive diagnosis. "The antigen tests are fairly new," he said. "We're going to be very careful in how we use it."
The bigger problem is false-negative results, which show someone isn't infected when they actually are. BD's false-negative rate — how often a test incorrectly says someone isn't infected — is about 15%; Quidel's is 3%.
Quidel and BD say their tests are intended to be used for people within the first five days of showing symptoms. A spokesperson for BD said its test should not be used on asymptomatic individuals. Quidel through a spokesperson deferred to FDA guidelines, which allow asymptomatic testing in certain scenarios.
"For routine surveillance, this is a great tool and these are our best tools that we have available," said Adm. Brett Giroir, assistant secretary for health at the Department of Health and Human Services, on a July call with nursing home officials, according to a recording obtained by KHN. Seema Verma, the administrator of the federal Centers for Medicare & Medicaid Services, on the call referred to the effort as a "turning point" in the fight against the virus.
A month after the initial announcement, the Trump administration invoked the Defense Production Act to bump its contracts with the two companies to the front of the line and expedite shipments. BD will send roughly 11,000 devices and 3.75 million tests to nursing homes; Quidel and HHS declined to answer questions about its volume.
As states and the federal government move to mandate COVID testing inside nursing homes, whose patients are deemed highly vulnerable to infection and severe complications, several industry officials have said they hoped to use the tests on asymptomatic people. But many states restrict the use of antigen tests or still require lab-based testing because of accuracy concerns.
If a person with a negative test result has to default to getting a more accurate PCR test, "then we simply have just added time and cost," Talbot said. "That's a problem."
Officials said the antigen test announcement caught them by surprise, underscoring the administration's chaotic testing strategy. Separate from the federal effort, 10 states have banded together through the Rockefeller Foundation to secure 5 million tests from the two companies in hopes of curbing the virus's spread this fall.
After nursing homes receive an initial batch of tests — each facility gets between 150 and 900 — they would have to buy future supplies. Medicare will cover the costs of diagnostic tests but not expenses for routine surveillance.
"I just have a lot of skepticism," said Brendan Williams, president of the New Hampshire Healthcare Association, which represents nursing homes and assisted living facilities in the state. "Basically you're giving some lousy tests for nursing homes and you're making them pay for them. I don't see that as a win; I see that as a risk."
Public health experts have become increasingly vocal that frequent rapid testing is the best tool for stopping the virus — which has killed more than 174,000 Americans including tens of thousands in nursing care — rather than relying on more accurate lab-based tests that have been plagued by delays and shortages. In a call this month with the industry, Verma estimated that half of the country's nursing homes have experienced cases.
"I don't see an avenue where these will not help to stop transmission chains, and I don't see another option on the table for us," said Dr. Michael Mina, an assistant professor of epidemiology at the Harvard T.H. Chan School of Public Health and a proponent of rapid tests. "It is what we need to be doing right now."
"This is better for the folks in our buildings, without a doubt," added Jason Belden, director of emergency preparedness and physical plant services for the California Association of Health Facilities.
In theory, antigen tests can serve dual purposes — diagnosing a person with a suspected infection or screening a group of people to more quickly identify sick individuals. The tests by Quidel and BD, under their FDA authorizations, can be used on certain asymptomatic individuals, including those suspected of having COVID-19 after exposure to an infected person. The companies would need additional FDA authorization to screen any asymptomatic person regardless of whether they're suspected of being sick, according to agency guidelines.
The CDC has suggested antigen tests could be useful in high-risk settings if performed repeatedly. It said there was limited data to guide using them to screen asymptomatic people.
Nonetheless, HHS recommends universal screening of nursing home residents at least once and regular screening of staff regardless of symptoms, said agency spokesperson Mia Heck, citing the fact that COVID-19 viral loads are similar between patients with and without symptoms. "Only one test in the U.S. is authorized for asymptomatic individuals," she said, referring to a PCR test from LabCorp, "yet the overwhelming majority of testing is being done on asymptomatic individuals."
"If the world were ideal we'd say, 'Oh, we want the more accurate test.' But the more accurate test takes forever to get the results back," said Peter Van Runkle, executive director of the Ohio Healthcare Association, which represents the state's nursing homes.
All targeted nursing homes will receive tests by the end of September, according to federal officials, who recently announced that facilities in states with a positivity rate of at least 5% must test staff each week.
"I don't see this as a federal strategy so much as a stopgap method to bring a little relief to nursing homes," said Katie Smith Sloan, president of LeadingAge, which represents nonprofit nursing homes. "It's really tragic that we are where we are right now."
Boosted by $71 million in federal funds for Quidel and $24.3 million for BD, Quidel plans to produce 1.8 million tests weekly by September; BD will produce similar volumes by October.
"The situation is much too urgent to wait a few months so we can put bows and lipstick on the program. So we're going to build this plane a little bit while we're flying it," Giroir told nursing homes in July. "Just work with us. We want to get you what you need. And then in September, October you can get what you want."
States take different approaches in deploying antigen tests in nursing homes; in at least seven — including California, Illinois and Maryland — officials say PCR tests should still be used to confirm results or to screen patients without symptoms. In Massachusetts, nursing homes must use PCR tests to meet surveillance requirements.
In Maryland, "our goal is to screen out staff who are positive as quickly as possible, particularly asymptomatic folks," said Dennis Schrader, chief operating officer of the health department.
Maryland nursing homes can use antigen tests for weekly staff testing if there isn't an outbreak. But if at least one person tests positive for the coronavirus, all staff and residents must be tested with PCR tests.
JACKSONVILLE, Fla. — On a sweltering July morning, Rose Wilson struggled to breathe as she sat in her bed, the light from her computer illuminating her face and the oxygen tubes in her nose.
Wilson, a retiree who worked as a public health department nurse supervisor in Duval County for 35 years, had just been diagnosed with COVID-19-induced pneumonia. She had a telemedicine appointment with her doctor.
Staring back from her screen was Dr. Rogers Cain, who runs a tidy little family medical clinic a couple of blocks from the Trout River in north Jacksonville, a predominantly Black area where the coronavirus is running roughshod. Wilson, 81, was one of Cain's patients who'd tested positive — he had seven other COVID patients that morning before noon. Three of her grown children had contracted the virus, too.
"It started as a drip, drip, drip in May," said Cain, his voice muffled by his mask. "Now it's more like a faucet running."
Cain and Wilson are nervous. Over the past two decades, both watched as the county health department was gutted of money and people, hampering Duval's ability to respond to outbreaks, including a small cluster of tuberculosis cases in 2012. And now they face the menace of COVID-19 in a city once slated to host this week's Republican National Convention, in one of the states leading the latest U.S. surge.
Florida is both a microcosm and a cautionary tale for America. As the nation starved the public health system intended to protect communities against disease, staffing and funding fell faster and further in the Sunshine State, leaving it especially unprepared for the worst health crisis in a century.
Although Florida's population grew by 2.4 million since 2010 to make it the nation's third-most-populous state, a joint investigation by KHN and The Associated Press has found, the state slashed its local health departments' staffing — from 12,422 full-time equivalent workers to 9,125 in 2019, the latest data available.
According to an analysis of state data, the state-run local health departments spent 41% less per resident in 2019 than in 2010, dropping from $57 to $34 after adjusting for inflation. Departments nationwide have also cut spending, but by less than half as much ― an average of 18%, according to data from the National Association of County and City Health Officials.
Even before the pandemic hit, that meant fewer investigators to track, trace and contain diseases such as hepatitis. It meant fewer public health nurses to teach people how to protect themselves from HIV/AIDS or the flu. When the wave of COVID-19 inundated Florida, the state was caught flat-footed when it mattered most, its main lines of defense eviscerated.
Now, confirmed cases have soared past 588,000 and deaths have risen to more than 10,000. Concerns over the virus prompted Republicans to cancel plans for an in-person convention in Jacksonville, opting for a pared-down version in North Carolina.
Health experts blame the funding cuts on the Great Recession and choices by a series of governors who wanted to move publicly funded state services to for-profit companies.
And when the pandemic took hold, they say, residents got mixed messages about prevention strategies like wearing masks from Republican Gov. Ron DeSantis and other political leaders. Voices within the health departments were muzzled.
"The reality, unfortunately, is people are going to die because of the irresponsibility of the decisions being made by the people crafting the budgets," said Ron Bialek, president of the Public Health Foundation, a nonprofit in Washington, D.C., offering tools and training. "Public health can't help us get out of this situation without our elected officials giving us the resources."
State officials neither answered specific, repeated questions from KHN and The Associated Press about changes in public health funding, nor made staffers available for deeper explanations.
Dr. Leslie Beitsch, a former deputy secretary of Florida's state health department, said failing to prepare for a foreseeable disaster "is governmental malpractice." The nation's pandemic response is only as good as the weakest link, he said. Since the virus respects no borders, other states feel the ripples of Florida's failings.
Those failings are clear in Duval County, which had employed the equivalent of 852 full-time workers and spent $91 per person in 2008 but in 2019 had only 422 workers and spent just $34 per resident, according to the KHN-AP analysis of state data. That's less than the typical list price of a single COVID test. Former county health director Dr. Jeff Goldhagen said the county's team has been "dismantled to the extent that it could not really manage an outbreak."
Yet it must.
Cain's private north Jacksonville medical clinic alone has had about 60 confirmed COVID cases and eight deaths. "We are all on fire right now," he said. "You have to have a fire department that is adequately equipped to put out the fire. "
Dwindling Budgets
Florida faced similar shortcomings around the time of the last great pandemic, the 1918 flu. Back then, according to a 1924 state report, public health workers faced too many demands and their efforts were "to some extent scattered and transitory." The state could have used at least three more district health officers, the report said: "It is a source of regret and a matter of grave concern to public health workers that the funds available are not sufficient."
County-based health departments began in 1930, providing more robust services closer to home. About 50 years later, legislation created state-administered primary care programs in which county health departments provided low-income Floridians with the type of basic healthcare and treatment most people now get at private doctors' offices.
The 1990s saw a move toward privatization, particularly as Medicaid managed care took hold, said a 2004 paper in the Florida Public Health Review. Still, per-person spending on local public health rose until the late 1990s, when adjusted for inflation to 2019 dollars, peaking at $59.
Wilson, the retired public health nurse stricken with COVID-19, recalled how Duval County's department started feeling the financial pain during former Republican Gov. Jeb Bush's administration in the early 2000s and kept losing nurses and other staff until they were "very, very short."
Beitsch, who worked for the state health department in the 1990s, said the downward trend continued under former Republican governors Charlie Crist and Rick Scott, fueled by a growing belief in shrinking government that flourished in many states. Florida's leaders exerted more control over public health, Beitsch said, and "the amount of local autonomy has been diminishing with successive administrations."
The recession that began in late 2007 sparked public health reductions across the nation that were especially harsh in Florida. By 2011, budget cuts and lack of money were the most frequently cited challenges in a Florida public health workforce survey, which pointed to growing needs. In the following years, the state had some of the nation's highest rates of heart disease and diabetes.
Squeezed departments struggled and sometimes stumbled. A reportfrom the state health department's inspector general for the 2018-19 fiscal year, for example, found a series of lost and inconsistent shipments of lab specimens from county health departments to the state lab — not long before the pandemic would make labs more important than ever.
As governor, Scott presided over the state from 2011 to 2019, when funding and staffing dropped most. Now a U.S. senator, he said through a spokesperson that he was unapologetic for health department cuts, which he characterized as a move toward "making government more efficient" without endangering public health.
"I'm sure that he had no problem with the cuts that were being made," said Patrick Bernet, an associate professor in health administration at Florida Atlantic University. "To put it all on him is not fair because a bunch of little henchmen from the counties had to vote that way. … We keep voting in people who undervalue public health."
Democratic state Sen. Janet Cruz, a legislator who has represented the Tampa region for a dozen years and sat on healthcare committees, said she watched lawmakers systematically cut money for health departments. When she questioned it, she said, some colleagues claimed the need wasn't as great because the state was moving toward private family healthcare centers. "Public health in Florida has been wholly underfunded," she said.
Some places have suffered more than others. Departments serving at least half a million residents spent $29 per person in 2019 on average, compared with $90 per person in departments serving 50,000 or fewer — a difference starker than the typical gap between larger and smaller departments nationally, according to an KHN-AP analysis. Experts can't say exactly why the gap is wider in Florida, which has a state-run system, but point to politics and historical decisions about budgets.
Duval County's health department spending was the equivalent of $34 per person, down 63% since 2008. Typically, about 22 workers, or 5% of the total staff, have been dedicated to preparing for and tracking disease outbreaks.
But when the pandemic hit, many there and elsewhere were diverted to fight the coronavirus, leaving little time for their typical duties such as mosquito abatement and tracking sexually transmitted infections such as syphilis.
"Current events demonstrate how bad a decision" the deep cuts to public health were, said Dr. Marissa Levine, a professor of public health and family medicine at the University of South Florida. "It's really come back to haunt us."
Mixed and Muzzled Messages
The pandemic caught fire in Florida this summer as the state's rapid reopening allowed people to flock to beaches, Disney World, movie theaters and bars.
The state has had more than half a million confirmed cases ― among them, players and workers for baseball's Miami Marlins ― and 35,000 hospitalizations, yet DeSantis still hasn't issued a mask mandate. Some local governments have. Jacksonville adopted one in late June, and about a week later Republican Mayor Lenny Curry announced he and his family were self-quarantining because he'd been exposed to someone who tested positive for the virus.
Chad Neilsen, director of infection prevention at the University of Florida-Jacksonville, lauded the mayor for the mask requirement, saying, "We know that masking works." But he pointed out that other counties have different rules and that the inconsistent messaging breeds confusion.
St. Johns County began requiring masks in late July but only in county facilities. And DeSantis has appeared in public without a mask numerous times, including at an Aug. 13 coronavirus update briefing during which some other speakers wore them.
"One voice is so critical during a pandemic," said Dr. Jonathan Kantor, a Jacksonville epidemiologist and dermatologist. "We have to have one voice, and consistent leadership that is modeling behavior if we want to get people to change their behaviors."
Instead, experts in Florida said, public health workers have been silenced or told by top state officials what to say. For example, The Palm Beach Post reported that state leaders told school boards they needed health department approval to keep schools closed, then instructed health directors not to give it.
"All the communication is directed by the state, and localities are very limited in what they can do," said Levine, the University of South Florida professor. "Anything to do with a mandate, there's resistance to do at a state level. This includes the hot debate on masks. The locals have to extend the state messaging." Local health officials "are being told bluntly: 'Shut up,'" Bernet said. "They literally cannot speak."
Beitsch, who now chairs the department of behavioral sciences and social medicine at Florida State University, said such limitations ― and similar mixed messages and silencing of medical experts at the national level ― fuels the politicization of public health and undermining of science.
"People think they should be listening to politicians and state legislative leaders about their healthcare. They're not listening to health experts and the epidemiologists who say if you just wear a mask and if you just wash your hands, we can really, really reduce the spread of the virus," said Cruz, the state senator. "People are confused, and they think this is a hoax and it's nothing more than the flu."
Meanwhile, the COVID caseload continues to rise, surpassing 25,000 in Duval County, with minorities stricken disproportionately, as elsewhere in the nation. In a county that's 29% Black and 60% white, Black residents with COVID have been hospitalized at more than double the rate of white residents. Rates are also high for Floridians grouped together as "other," including Native American, Asian and multiracial residents.
Duval County's overall caseload is rising so fast that Goldhagen, the former health department director, said the agency has given up on contact tracing, which means trying to curb the virus by identifying and warning people who have been exposed.
"It's impossible," Goldhagen said. "Dismantling the system was a complete disregard for the health and well-being of the citizens of Florida."
With an unequipped public health system, Wilson, the retired public health nurse, said it falls to everyone to lead Jacksonville, and Florida, out of the coronavirus crisis.
"My hope is that everybody begins to take this virus seriously, and wear their mask and stay social distancing. It can work if we do that," said Wilson, whose condition has improved. "So, that's my hope. Eventually there will be a vaccine that will curtail this virus. But until then, it's up to us to help do that. And if we're not serious about it, then we're doomed."
This story is a collaboration between KHN and The Associated Press.
Methodology
Spending and staffing data for Florida's local health departments is from the Florida Department of Health. Florida Atlantic University professor Patrick Bernet provided additional state data on staffing by program area. KHN-AP adjusted spending data for inflation using the Bureau of Economic Analysis' state and local government deflator.
COVID-19 data by race is from the Florida Department of Health. KHN-AP calculated rates per 10,000 people using data on race, regardless of ethnicity, from the U.S. Census Bureau's 2018 American Community Survey. Statewide COVID-19 cases per day are from Johns Hopkins University.
Inspired to help during the COVID pandemic, a volunteer SWAT team of engineering and medical talent combines old-fashioned problem-solving and advanced 3D printing — but will it actually help?
This article was first published on Monday, August 24, 2020 in Kaiser Health News.
As the coronavirus crisis lit up this spring, headlines about how the U.S. could innovate its way out of a pending ventilator shortage landed almost as hard and fast as the pandemic itself.
The New Yorker featured "The MacGyvers Taking on the Ventilator Shortage," an effort initiated not by a doctor or engineer but a blockchain activist. The University of Minnesota created a cheap ventilator called the Coventor; MIT had the MIT Emergency Ventilator; Rice University, the ApolloBVM. NASA created the VITAL, and a fitness monitor company got in the game with Fitbit Flow. The price tags varied from $150 for the Coventor to $10,000 for the Fitbit Flow — all significantly less than premium commercially available hospital ventilators, which can run $50,000 apiece.
Around the same time, C. Nataraj, a Villanova College of Engineering professor, was hearing from front-line doctors at Philadelphia hospitals fearful of running out of ventilators for COVID-19 patients. Compelled to help, Nataraj put together a volunteer SWAT team of engineering and medical talent to invent the ideal emergency ventilator. The goal: build something that could operate with at least 80% of the function of a typical hospital ventilator, but at 20% or less of the cost.
For decades, Nataraj has worked on medical projects — like finding a better way to diagnose a potentially deadly brain injury in premature infants — primarily with doctors at Children's Hospital of Philadelphia and the Geisinger Health system in rural Pennsylvania, so key clinical players came together swiftly. By March 23, he had approached engineering faculty about collaborating on a monthslong effort to build the NovaVent, a basic, low-cost ventilator with parts that cost about $500. The schematics would be open-sourced, so others could use them free of charge to mass-manufacture the device.
The New Yorker wasn't alone in referencing the '80s TV series "MacGyver," whose protagonist was a Swiss Army knife-carrying secret agent who got the job done with wits and whatever was at hand. The suggestion was that these ventilators were simple enough to throw together with parts from a medical supply closet or your neighborhood hardware store. "Everybody can make it," one headline read, enticingly. These miracle machines, the thinking went, could be helpful in U.S. hospitals facing critical shortages, perhaps in cities surging with sick patients.
To understand the potential utility and true costs of these emergency ventilators, KHN followed Villanova's team for three months as it developed, tested and prepared to submit the NovaVent for Food and Drug Administration approval.
The team tapped a maker of car parts, along with roboticists. It gathered input from anesthesiologists as well as electrical, mechanical, fluid systems and computer engineers. It tapped nurses to help ensure that users would immediately know how to operate the ventilator. Local manufacturers 3D-printed pieces of the machine.
Nataraj and his team realized that some of the other ultra-bare-bones machines wouldn't meet the standards of the modern U.S. healthcare system. But they also believed there was a lot of room for Villanova's team to innovate between those and the high-end, expensive devices from corporations like Philips or Medtronic.
One thing is clear: The $500 ventilator is something of a unicorn.
While the parts for the NovaVent cost about that much, the brainpower and people hours added uncounted value. In the early phases, the core group — all volunteers — worked 20 to 25 hours a week, Nataraj said, mainly via Zoom calls from home on top of their day jobs.
Teams of two or three were allowed into the lab to work — virtually the only people on campus. The effort, after all, was in line with the university's Augustinian mission, which values the pursuit of knowledge, stewardship and community over the individual.
By the time they realized what they could achieve with the $500 model, the first wave of crisis had passed. Yet in those weeks, an alarm resounded across the land about the dismal state of America's public health system.
So the NovaVent mission pivoted: build better low-cost vents for hospitals in poor and rural U.S. communities that have few, if any, ventilators.
One immediate legacy of the innovation happening at Villanova and elsewhere is the public-spirited nature of the effort, said Dr. Julian Goldman, an anesthesiologist at Massachusetts General Hospital who helps set standards for medical devices: "People from different walks of life in terms of their skills — engineers, clinicians, pure scientists — all thinking and working to try to figure out how to move very quickly to solve a national emergency with many dimensions: How do we make the patient safer? How do we make the caregiver safer? How do we deal with supply chain limitations?"
From other ventures, new designs have already been used as a jumping-off point to build emergency ventilators overseas. They've also bolstered New York City's stockpile and could add to state and national reserves as well.
The early, urgent concerns about a looming ventilator shortage were well founded: On March 13, the U.S. had about 200,000 ventilators, according to the Society of Critical Care Medicine. But because of the surge of COVID patients, it was predicted the country could soon need as many as 960,000.
In early April, New York Gov. Andrew Cuomo said the state would run out of ventilators in six days, leaving doctors with the sort of grim calculation they'd heard about fromhard-hit northern Italy: "If a person comes in and needs a ventilator and you don't have a ventilator, the person dies."
In Philadelphia, 12 miles east of Villanova, hospital administratorsbraced for shortages and reported short supplies of the drugs required to sedate patients on ventilators.
President Donald Trump invoked the Defense Production Act to get major manufacturers to make ventilators, though GM was already working on it. When GM signed a $500 million contract to deliver 30,000 ventilators to the U.S. government by August, the NovaVent team wondered whether its own efforts would be futile.
"We said, 'Well, GM is making it. Why are we making it?'" Nataraj said. "But there was a lot of uncertainty with the epidemiological models. We didn't know how bad it was going to get. Or [the curve] could completely collapse and there'd be no need at all."
And for a few weeks, it did seem the worst was over. The rate of new cases began to slow in the nation's early epicenters. Hot spots flared in nearly every pocket of the country, but those too were mostly contained.
People spilled back into normal life, gathering in backyards, beaches and bars. In June, news coverage moved on to the calls for racial justice and mass protests after the videotaped killing of George Floyd in the custody of Minneapolis police.
In the background, the highly contagious coronavirus tore across the South, through Florida, Georgia, Texas and Arizona, and surged in California. Some states reported ICU beds were quickly at or above capacity. This mercurial virus had proved uncontrollable, and the prospect of ventilator shortages had bubbled up once again.
Past pandemics have been mothers of innovation. Progress in mechanical ventilation began in earnest after a 1952 polio outbreak in Copenhagen, Denmark. According to the American Journal of Respiratory and Critical Care Medicine, 50 patients a day arrived at the Blegdams Infectious Disease Hospital. Many had paralyzed respiratory muscles; nearly 90% died.
An anesthesiologist at the hospital realized patients were dying from respiratory failure rather than renal failure, as was previously believed, and recommended forcing oxygen into the lungs of patients. This worked — mortality dropped to 40%. But one big problem remained: Patients had to be "hand-bagged," with more than 1,500 medical students squeezing resuscitator bags for 165,000 total hours.
"They'd recruit nurses and medical students to stand there and squeeze a bag," says Dr. S. Mark Poler, a Geisinger Health system anesthesiologist on the NovaVent team. "Sometimes they were just so exhausted that they would fall asleep and stop ventilating. It was obviously a catastrophe, so that was the motivation for creating mechanical ventilators."
The first ones were simple machines, much like the basic emergency-use ventilators created during the COVID crisis. But those came with hazards such as damaging the lungs by forcing in too much air. More sophisticated machines would deliver better control. These engineering marvels — the monitors, the different modes of ventilation, the slick touch-screen controls designed to minimize the risk of injury or error — improved patient treatment but also drove costs sky-high.
The emergency ventilators of 2020 focused on models that, typically, used an Ambu bag and some sort of mechanical "arm" to squeeze it. Most people are familiar with Ambu bags from scenes in TV programs like "ER" where paramedics compress the manual resuscitator bags to help patients breathe as they're rushed inside from an ambulance. The bags are already widely available in hospitals, cost $30 to $40 and are FDA-approved.
But making machines that are that simple could render them effectively useless (or, worse, dangerous). Medical experts watching university and hospital teams coalesce across the country this spring to develop low-cost emergency ventilators took notice — and worried.
Goldman, the Massachusetts General anesthesiologist, was among the medical experts nervous about all the slapped-together ventilators.
"We had the maker community being stood up very quickly, but they don't know what they don't know," said Goldman, chair of the COVID-19 working group for the Association for the Advancement of Medical Instrumentation, the primary source of standards for the medical device industry. "There were videos of harebrained ideas for building ventilators online by people who don't know any better, and we were very concerned about that."
The general public doesn't really understand the nuances required to build a safe medical device, Goldman said.
"They look at something and think, well, this can't be that hard to build. It just blows air," he said. "'I'll take a vacuum cleaner and turn it on reverse. … It's a ventilator!'"
AAMI wanted to encourage innovation, but also safety. So Goldman assembled a meeting of 38 engineers, regulators and clinicians to quickly write boiled-down guidelines for emergency-use ventilators.
The simplest ventilators were based on the idea of a piston in a car engine, Poler said: Put a piston on a crankshaft, hook it up to a motor and use a paddle or "arm" to compress the Ambu bag.
"It's better than no ventilator at all, but it goes at one speed. It doesn't really have any controls," Poler said — not ideal when patients need to be monitored for changes in how their lungs are responding, or not, to treatment.
Villanova's team of engineers, doctors and nurses realized that the simplest ventilators, the ones that AAMI was concerned about, seemed to ignore some basic, practical considerations: What sort of hospitals would these be used in, and under what conditions? What sorts of patients would be put on these ventilators? For how long? Would they be used as backups for higher-end ventilators? What about error alarms?
All good questions, Poler said, but the answer to all of them essentially is "we hope to never use these."
Their best use? "A surge situation where you simply don't have enough of the sophisticated ventilators."
Rather than go totally bare-bones, the Villanova team designed the devices as though they would one day be deployed in modern healthcare.
Flow sensors, which monitor patient ventilation, cost several hundred dollars, so the team designed its own in the lab and 3D-printed it at a cost of 50 cents, Nataraj said, enabled by strides in 3D-printing technology that have vastly cut the price of so many devices. Southco, a Pennsylvania-based global manufacturer that makes parts like the latch on your car's glove box, was tapped to use its 3D printers to make airflow tubes and couplings for the ventilator.
Garrett Clayton, director of Villanova's Center for Nonlinear Dynamics and Control, was the day-to-day keeper of the prototype. He was particularly excited about the addition of a handle, which made it easier for him, and eventually others, to lug the 20-pound device from the lab to home and back.
Clayton's computerized control system measures the flow rate of air going into the patient and converts it into volume, much as commercial ventilators do. That controls how hard and fast the Ambu bag is squeezed; it's made of a hobby-grade Arduino microcontroller board. A direct-current motor attached to a linear actuator with a fist-shaped piece of PVC on the end pushes the bag in and out. The operator of the ventilator can control the respiratory rate (the number of breaths per minute), as well as the ratio between inspiration and expiration and the volume of air going in.
While traditional ventilators have many control methods, Clayton's team focused on just one: how much volume is forced into the airway. "We have a set point so we don't damage the lung," he said.
Polly Tremoulet, a research psychologist and human factors consultant for ECRIand Children's Hospital of Philadelphia, was pulled in to focus on error messages and make sure the ventilators' buttons and displays "spoke the user's language," whether that user was an anesthesiologist in New Jersey or a nurse in India pulled into an ICU COVID ward.
Graduate student Emily Hylton and other nursing students were brought in to provide feedback about using the NovaVent and ask questions such as: Would all the controls and monitors look familiar to nurses at the bedside?
The very prospect of these low-cost devices is relatively new, Nataraj said, because of the price of microcontrollers with any real capacity: "Twenty years ago, they cost, oh gosh, $20,000 — and now they're $20."
By May 30, the first NovaVent prototype was complete. It was successfully tested on an artificial lung at Children's Hospital of Philadelphia on June 12. Villanova has applied for a patent for the NovaVent, to help ensure it won't be commercialized by others.
"If you make it free without having a patent, other people can take it and charge for it," Clayton said. "A patent protects the open-source nature of it."
Once a provisional patent is received, the team will submit the ventilator for Emergency Use Authorization from the FDA — hewing to the guidelines set up by AAMI.
Within weeks of kicking off the NovaVent project, the curve in the East Coast had indeed flattened, and states had enough standard ventilators to treat every patient. The life-threatening ventilator shortage had not materialized. Some of the emergency-use ventilators based on designs by other teams, like the one at MIT, did go into production — but even those didn't end up in hospitals, and instead went into city stockpiles meant to reduce potential future reliance on the federal government. So the Villanova team seized on a new, global mission.
"We thought if it wasn't useful in the U.S. market," Nataraj said, "we know the developing world, especially sub-Saharan Africa, Latin America and Central America, they don't have the same kind of facilities that we do here."
Where the ventilators might end up remains to be seen. Early on, Pennsylvania showed interest in helping Villanova find manufacturing partners. The team has spoken with engineers in India, Cambodia and Sudan (which reportedly has only 80 ventilators in the entire country) who are interested in possibly finding a way to manufacture the NovaVent.
Six thousand emergency ventilators based on the design by the University of Minnesota have been manufactured in the U.S., according to Dr. Stephen Richardson, a cardiac anesthesiologist who worked on that project. Three thousand were made by North Dakota aviation and agricultural manufacturer Appareo for state emergency stockpiles in North Dakota and South Dakota. UnitedHealth Group provided $3 million in funding to manufacture another 3,000 units made by Boston Scientific, which were donated to countries like Peru and Honduras through U.S. organizations; others were sent to the U.S. government.
Like the Villanova team, Richardson said he thinks the most promising potential for these ventilators is in developing countries.
"When we were arranging to get these donated to Honduras, we were speaking with a physician who was telling me that [at] his hospital right now, the med students are just hand-ventilating patients. For everything, and for COVID specifically," Richardson said. "Right now, in Pakistan or in any low-resource country, a family member is hand-ventilating a toddler. Before COVID and after COVID, this is a problem."
For Poler, the project was a reminder that the country needs to tend to its stockpiles. "People were thinking about [ventilator reserves] in the '90s, and then they basically quit thinking about it," he said. "COVID is a shocking reminder that we shouldn't have stopped thinking about it."
Goldman said the national efforts may not result in a flood of cheap ventilators in U.S. hospitals. International use could also be tricky. In countries with few resources, even very low-cost ventilators may not be feasible because of lack of electricity or compressed oxygen, though there is "potentially a sweet spot of need and capability where these things could be deployed."
On the upside, he said, the pandemic kicked off a nearly unprecedented global engineering effort to share information and solve the problem.
"If there's going to be a magic bullet to come out of this, it's going to be the capability of our communities and our infrastructure," he said. "People stood up, put in the appropriate processes and spirit, worked hard, made it happen. We've added resilience to the healthcare sector. That's the outcome here."
As for the NovaVent, team members were relieved they didn't have to rush it into manufacturing as COVID-19 was ripping through the Northeast this spring, thanks to aggressive efforts to flatten the curve. "We ended up without a ventilator shortage, which is excellent," Clayton said. "But with the increase in cases now, it's very possible some of them may get used."
To build on the project, Villanova is raising money for a laboratory for affordable medical technologies called NovaMed. The lab formalizes the process of making inexpensive medical equipment that follows the 80-20 function-to-cost rule. The university says the lab is "motivated by the belief that income should not determine who has access to lifesaving care."
The effort to prevent a ventilator shortage, Nataraj said, made him think more critically about the American healthcare system overall.
"How come we haven't built the technology, the economic and social systems that are able to handle a situation like this — especially when something like this was predicted?" he said. "It's absolute nonsense. Why should a single person die because we weren't prepared?"
Even as his state is a hotbed for COVID-19, Florida Gov. Ron DeSantis has been pushing schools to reopen so parents have the choice of sending children back to the classroom or keeping them home to learn virtually.
The Republican governor has said children without any underlying health conditions would benefit from in-person learning and the stimulation and companionship of being among other young people. He has also made clear that he thinks these benefits far outweigh what he considers to be minimal risks.
"The fact is, in terms of the risk to schoolkids, this is lower risk than seasonal influenza," DeSantis said, during an Aug. 10 televised roundtable discussion on education.
DeSantis' assertion got us wondering, so we asked the governor's office what evidence it had to back up the claim.
Looking at the Numbers
A spokesperson responded with data from the Florida Department of Health showing the state's COVID-19 mortality rate is 0.02% for people 24 and younger. That's the same as the influenza mortality rate for this age group.
But for children 14 and younger, the spokesperson said, Florida's COVID-19 mortality rate is 0.009%, far below the 0.01% for flu for that age group.
And the risk of death is not the only concern children face if infected by the COVID-19 virus. They can develop complications that require hospitalization.
"The risk of complications for healthy children is higher for flu compared to COVID-19," according to theCenters for Disease Control and Prevention. "However, infants and children with underlying medical conditions are at increased risk for both flu and COVID-19."
The CDC estimates there were 480 deaths among U.S. children due to flu in the 2018-19 season, including 136 cases in which the virus was confirmed by laboratory testing.
As of mid-August, 90 children died of COVID-19 in the United States, according to the American Academy of Pediatrics.
More than 46,000 children were hospitalized for flu in that 2018-19 period. The hospitalization rate among children 5 to 17 was 39.2 children per 100,000 children.
Thehospitalization rate for COVID-19 is six per 100,000 children for those ages 5 to 17, according to the CDC.
The number and rate of COVID cases in children in the United States steadily increased from March to July. "The true incidence of SARS-CoV-2 infection in children is not known due to lack of widespread testing and the prioritization of testing for adults and those with severe illness," the CDCwrote recently.
While children have lower rates of using a ventilator than adults, 1 in 3 children hospitalized with COVID-19 in the United States were admitted to the intensive care unit, the same rate as for adults, the CDC said.
Dr. Chad Vercio, chair of pediatrics at Riverside University Health System in California, said DeSantis' statement is partly true, with many caveats. Children's risk from COVID-19 "entirely depends on how widespread COVID is in any area," he said.
Data Reflects a Snapshot in Time
U.S. hospitalization rates for children with COVID are lower than for those with flu, Vercio said. But that could be due to parents keeping children home and schools being closed since March, he added. "It is unknown if these COVID hospitalization rates would rise when we open schools," he said.
About two-thirds of Florida school districts have opened in the past two weeks with the rest planning to resume by Aug. 31. Most districts are offering in-person classes while giving parents the option to keep students home for virtual learning. In South Florida, where the pandemic has hit hardest, districts are planning, at least initially, to offer only virtual teaching.
Hillsborough County, which includes Tampa, had initially planned to reopen classrooms but reversed itself after doctors warned that school closures were likely to ensue. The county revised its plan to limit classes to online-only instruction, but the state's education commissioner rejected that approach, saying it denies parents the option of sending their children back to school. Fearing the loss of millions of dollars in state funding, the district now plans to begin virtual learning for all students on Aug. 24, and, on Aug. 31, begin offering students the option to return to the classroom.
"The direct impact of COVID-19 on children is currently small in comparison with other risks and … the main reason we are keeping children at home is to protect adults," concluded a report in theBritish Medical Journal published in June. Still, health authorities say parents should make sure children practice good hygiene and limit playtime with other children.
Based on data from February through mid-May, the report found 44 deaths from COVID-19 for people 19 and younger in France, Germany, Italy, Korea, Spain, England and the United States. In a typical three-month period, there would be 308 deaths from lower respiratory tract infections, including flu, in those countries.
Sources
Email interview with Frederick Piccolo Jr., communications director for Gov. Ron DeSantis, Aug. 14, 2020
Email interview with Sunil Bhopal, academic clinical lecturer of Newcastle University in England, Aug. 14, 2020
Phone interview with Dr. Sean O'Leary, professor of pediatrics at the University of Colorado Anschutz Medical Campus, Aug. 11, 2020
Phone interview with Dr. Gabriela Andujar Vazquez, an infectious disease specialist at Tufts Medical Center, Aug. 12, 2020
Phone interview with Dr. Andrew Pavia, pediatric infectious disease specialist at the University of Utah Health and Intermountain Primary Children's Hospital, Aug. 13, 2020
Phone interview with Dr. Vidya Mony, an infectious disease expert with Santa Clara Valley Medical Center in San Jose, California, Aug. 14, 2020
"At this stage of the pandemic, COVID appears to be less dangerous for children than influenza," said Sunil Bhopal, a co-author of the report and an academic clinical lecturer at Newcastle University in England.
"We don't need to wait for a whole season because, even at its peak in most countries, COVID killed a smaller number of children than estimated influenza deaths averaged from across a year," Bhopal said.
"While flu is likely to have caused more deaths than COVID, this may change as the pandemic progresses and major caution is necessary to ensure this doesn't change," said Bhopal, an honorary assistant professor at the London School of Hygiene and Tropical Medicine.
Dr. Sean O'Leary, professor of pediatrics at the University of Colorado Anschutz Medical Campus, said the growing number of U.S. deaths could be another reason to think about COVID-19 and children.
"We do know for sure that schoolchildren are major drivers of influenza epidemics in the community and, though that is not as much the case with COVID, it doesn't mean they can't spread it," he said.
DeSantis also maintained that kids are less likely to spread COVID-19 than they are the influenza virus. However, experts cautioned that there's still a lot that is unknown about children's ability to transmit the virus to the people they interact with — parents, grandparents and even teachers. The perceived risk for teachers, for instance, is at the root of a lawsuit between the state's largest teachers union and the DeSantis administration. The Florida Education Association wants a Leon County judge to stop the state's order forcing school districts to open classrooms for in-person learning by the end of August.
Dr. Gabriela Andujar Vazquez, an infectious disease specialist at Tufts Medical Center in Boston, said children are more likely to have zero or mild symptoms from COVID-19 compared with adults.
"The bottom line is kids can get infected and they tend to have less severe disease," she said. But the concern over reopening school is that children could spread the disease to others, including adults who are more likely to develop complications.
"Because schools are tied to the community — they are not in a bubble — and if community spread is not controlled in the community, it's likely the school will reflect that," she said. One factor that can determine if the disease is out of control is if positivity rates for people getting tested for COVID are over 5%. Many Florida counties have been well above that mark since June, although the rates have been dropping this month.
Back-to-school risks will be handicapped based on the ability of the school to adopt physical distancing measures and enforce wearing of face masks, said Dr. Andrew Pavia, a pediatric infectious disease specialist at the University of Utah Health and Intermountain Primary Children's Hospital.
"This fall, we may see a lot of kids get infected as schools reopen, and those could be just the tip of the iceberg," he said. "Even though most kids have mild or asymptomatic cases, what I worry about is just how big is the tip of the iceberg," Pavia said.
He also noted there is a vaccine for flu — which about 50% to 70% of children receive. "The vaccine is not perfect but does reduce the impact of the disease, and with COVID everyone is at risk and susceptible," Pavia said.
Dr. Vidya Mony, an infectious disease expert with Santa Clara Valley Medical Center in San Jose, California, said data suggests COVID-19 is not as bad for children as flu and that children are not the main driver of the pandemic. But, she said, there isn't enough data yet to say indisputably that the COVID-19 risk is lower. "We are learning something every day with this."
Our Ruling
DeSantis said that COVID-19 is a lower risk for schoolchildren than is seasonal influenza.
Studies show the numbers of COVID-related deaths and hospitalizations among children are lower than the average rates for flu. Still, it's uncertain if these lower rates among children were partly because schools were closed since March and whether those rates will rise as classrooms reopen this fall. It's also unclear whether opening schools — particularly in communities with a high number of people testing positive — will lead to more spread of the disease.
The failure of California's infectious disease monitoring system for a stretch of at least 20 days in July and August triggered potentially deadly fallout that continues to reverberate across the state.
The fallout has been most severe in heavily populated counties, which rely primarily on a statewide electronic information system to guide their pandemic response. Local health departments couldn't clearly see where the coronavirus was spreading, dramatically slowing their efforts to trace and track new infections — leading to more death and disease, public health officials said.
Data system failures left California with a backlog of about 300,000 lab reports. Of those, nearly 15,000 turned out to be positive for COVID-19, according to state Health and Human Services Secretary Dr. Mark Ghaly.
"By the time you get those cases, even if you do your best to trace the contacts, you might be too late," said David Campos, deputy Santa Clara County executive. "Individuals who were positive didn't know they were positive and therefore may not have isolated and quarantined, so they ended up spreading the virus to other people unknowingly."
"It's frustrating and it's very scary," Campos added.
Gov. Gavin Newsom's administration is still struggling to fix the problems and prevent future breakdowns, even as school districts are weighing difficult decisions about sending kids back into classrooms, businesses are contending with repeated openings and closures, and the state is working to tamp down rising infections — all life-or-death scenarios that rely on accurate COVID-19 data.
"The whole key to lab testing is the speed with which it's done," said Bruce Pomer, a public health expert and chief lobbyist for the California Association of Public Health Laboratory Directors. "The system is slower than it should be, and it means more people are going to get sick and die. The lifeblood of public health is data."
Ghaly said he and Newsom first became aware of the magnitude of the state's data failures on Aug. 3, though the California Department of Public Health had alerted counties about problems as early as July 15.
By the time Ghaly said he was informed, the state infectious disease database — the California Reportable Disease Information Exchange, known as CalREDIE — had experienced a series of breakdowns, including an outage that prevented electronic lab reports from flowing to counties, and a lapsed security certificate needed by the commercial lab giant Quest Diagnostics to transmit records. The problems did not affect death and hospitalization data.
The state says it has since cleared the backlog.
"It is clear that CalREDIE simply does not have the capacity to scale as we had hoped," Newsom said following the resignation of the state's top public health officer, Dr. Sonia Angell, after the data system collapse. "We will reform that."
California isn't alone in its COVID-related data problems. Iowa recently discovered a major flaw that backdated thousands of test results; North Carolina learned that another commercial testing company, LabCorp, had been including out-of-state tests in its data since April; and Alabama found that some labs were not properly sending test results to the state.
But the breakdown in California stands out for its size and consequence.
In Santa Clara County, public health officials felt they finally had resources to aggressively track people who might have been exposed to the virus.
But a contact tracer for the county who declined to be named confirmed that the number of cases trickling in from the state data system was so slow by late July that tracking operations had nearly ground to a halt.
Santa Clara County did not receive data on many residents who tested positive during that time. Dr. Sara Cody, the county's health officer, said earlier this month that she had discovered missing cases of infected people as far back as July 8.
"If we can't get the data from the state system, we're all kind of flying blind," said Contra Costa County health officer Dr. Chris Farnitano. "Then our case investigation and contact tracing efforts aren't very effective."
Contra Costa and other counties are still digging themselves out of the data failures — and working to dramatically expand testing. But public health officials worry that an influx of tests will overwhelm the system, once again undercutting counties' ability to adequately respond to the pandemic.
"This really puts our whole strategy at risk," Farnitano said. "We're looking to start doing in-person school at some point in the fall, if conditions allow, but that would add a whole bunch more tests that need to perform in the system."
Mendocino County provides a glimpse of how vital real-time data is for an aggressive response. Since the beginning of the coronavirus pandemic, the sprawling rural Northern California county has kept up its old-school strategy of tracking infectious diseases by telephone and fax machine, providing a reliable flow of COVID-19 data even as the state system crashed.
That meant local officials could see that cases were spiking in the county even as state data suggested it was faring relatively well, keeping the county off the state watchlist. Mendocino County health officer Dr. Noemi Doohan nonetheless decided to proactively shut down high-risk businesses like bars without being ordered to by the state.
"I wanted to retain local control for our county, and I also wanted to do the right thing," Doohan said.
The county has since been added to the state's watchlist, which means that nine schools that had planned to hold in-classroom instruction now either have to move teaching online or seek permission to open from the county and state.
In Riverside County, where contact tracing efforts were also hampered by the data failure, public health director Kim Saruwatari said she is at the mercy of the state data system. She said fax-and-phone data collection efforts like those used in Mendocino County are not possible for larger counties like hers.
"The volume of data that we have coming in, it would take an army to receive all the reports and enter them into a system separately," she said.
Saruwatari and other county officials had been asking for state assistance to identify potential data discrepancies in the weeks before the state took action. During that time, state health officials knew there were issues but appeared to be unaware of the magnitude of the data failures and were slow to respond, some county officials said.
"We can't get a hold of anyone" at the California Department of Public Health to help, wrote Wendy Hetherington, chief epidemiologist for Riverside County, in an email to a state epidemiologist while trying to figure out why she couldn't access critical data.
"I am not aware of any specific issues, however we are starting to notice problems … because the files are becoming too large for our computers to obtain in this manner," the state epidemiologist responded.
Kate Folmar, a spokesperson for the California Health and Human Services Agency, said in a statement that the administration has "accelerated a replacement project" to ensure accurate, timely COVID-19 data. A state bid for the project went out last week, Folmar said, and Ghaly said this week that the new system is weeks away from being ready.
For years, the state has patched holes in its communicable disease information system, which was designed 20 years ago and also tracks other infectious diseases, including the flu.
Local health officials, who blame the long-standing lack of investment in public health infrastructure, describe it as clunky, slow and at times ineffectual. But COVID-19 has presented an even bigger challenge than routine cases of measles, syphilis and meningitis.
"Our systems were not designed for this kind of pandemic threat," said Daniel Zingale, a former top Newsom adviser who led healthcare initiatives for previous Democratic and Republican administrations.
Data failures are likely to continue given the limitations of the system, and not only will they harm public health officials' ability to trace COVID-19 and prevent its spread, but they will also erode the community's confidence in public health efforts, Saruwatari and others said.
Already, comments on social media and at public meetings suggest that state failures have undercut trust in public health, especially in conservative-leaning regions like the Inland Empire and California's rural north.
"There's been a lot of the questioning of the data all along, like if somebody dies, did they really die of COVID-19," said Lake County health officer Dr. Gary Pace. "Now people that were prone to not trust us or not follow guidance before are even less likely to follow it."
Grifters are taking advantage of a genuine public health intervention that's crucial to stopping the spread of the novel coronavirus.
This article was published on Thursday, August 20, 2020 in Kaiser Health News.
By Julie Appleby State officials and federal agencies warn there's a new phone scam circulating: Some callers posing as COVID-19 contact tracers try to pry credit card or bank account information from unsuspecting victims.
The grifters apparently are taking advantage of a genuine public health intervention that's crucial to stopping the spread of the novel coronavirus: contact tracing.
In one such scheme, detailed in a warning from the Montana attorney general, scammers tell their victims, "I'm calling from your local health department to let you know that you have been in contact with someone who has COVID-19." Then they move in for the kill, asking for payment information "before we continue."
Don't fall for that, say public health advocates and officials. Legitimate contact tracers don't ask for payment or seek other financial information.
"That is absolutely not part of the process," said Crystal Watson, a senior scholar at the Johns Hopkins Center for Health Security. "No one should give bank information or credit card information."
Real contact tracers generally work for health departments. They contact COVID-positive patients to track symptoms; they help the people they call figure out how to isolate themselves from others until they clear the virus, and determine which friends, neighbors, colleagues or acquaintances they might have been near in the days just before or after they tested positive for the coronavirus. Those contacts, in turn, are sought out by the tracers, who are in a race against the clock, hoping to get those folks to quarantine as well.
This tried-and-true public health tool (along with hand-washing, wearing a mask in public and maintaining 6 feet of physical distance from people outside your household) is one of the few strategies available to slow the spread of the virus while scientists work on treatments and vaccines.
Legitimate contact tracing is being employed widely in some areas, such as the District of Columbia and Hawaii, and has been credited with helping countriessuch as New Zealand and Taiwan contain the virus.
But with this success also comes bad actors. The Federal Trade Commission, Department of Justice, and Department of Health and Human Services, as well as the Better Business Bureau and state law enforcement and health officials from across the nation, have issued consumer alerts about unscrupulous people not affiliated with health departments using phone calls, texts or emails to get personal information from those they scam.
What differentiates a real call from a fake one? For one thing, legitimate tracing calls might be preceded by a text message, notifying patients of an upcoming call from the health department. Then, in that initial call, the legitimate tracer seeks to confirm an address and birthdate, especially if you are the COVID-positive patient, Watson said.
"They ask about your identity to make sure you are the person they are trying to reach so they don't disclose potentially private information to the wrong person," Watson said.
The tracers can also help people who must isolate or quarantine by connecting them with resources, such as food or medicine delivery.
"Some can even provide you with a separate place to quarantine safely" if, for example, you live in a multigenerational house with no separate bathroom or bedroom in which to isolate, said Watson.
At the end of the call, the tracer may ask if they can call or text you in the coming days to check on how any symptoms may be progressing.
What should you watch for?
Be concerned if you get an initial text asking you to click on a link, which might be spam and could download software onto your phone, the FTC warned in May.
"Unlike a legitimate text message from a health department, which only wants to let you know they'll be calling, this message includes a link to click," the agency said.
Another clear red alert: being asked for your Social Security number. Contact tracers in most regions do not ask your immigration or financial status, either.
Also, watch out if any names of COVID patients are provided.
"An authorized contact tracer will not disclose the identity of the person who tested positive and is the starting place for that tracing effort," the Wisconsin attorney general's office said in a release warning consumers about scams. Another piece of advice: Do a little research before you respond.
"Anytime someone calls you for information, you should be concerned about who is calling," said Dr. Georges Benjamin, executive director of the American Public Health Association. "If they are legitimate, you can say 'Give me your name and phone number' and you can always call them back" after doing some checking.
Did the caller ID indicate the call was from a health department? Some states are including that information. For example, Virginia's calls are from the "VDH COVID Team." Call the health department if you have any questions.
"Scammers prefer to prey on individuals who may be more trusting, are alone, or may respond out of confusion or fear," Pennsylvania Secretary of Aging Robert Torres said in an Aug. 12 press release. "It's important that they stay alert about any contact from anyone identifying themselves as a contact tracer and do not provide personal information until they are sure the individual and information are legitimate."
And, finally, if you think you've been contacted — by phone, email or text — by a scammer, report it to agencies, such as your state attorney general's office.
"If you see something, say something," California Attorney General Xavier Becerra said in a recentconsumer alerthis office issued. "We are working to track these impostors."
As the coronavirus crisis deepened in April, Georgia officials circulated documents showing that to get through the next month, the state would need millions more masks, gowns and other supplies than it had on hand.
The projections, obtained by KHN and other organizations in response to public records requests, provide one of the clearest pictures of the severe PPE deficits states confronted while thousands fell ill from rising COVID-19 cases, putting health workers at risk.
Georgia on April 19 had 932,620 N95 respirator masks — one of the best protections for health workers against infection — and expected to burn through nearly 7 million within a month. It urgently needed to buy 1.4 million more, according to documentsobtained by the Brown Institute for Media Innovation and shared with KHN. For gowns, officials expected to go through 16.1 million in 30 days, a staggering amount compared with the 21,810 the state had at the time.
"Making progress with PPE needs. Biggest challenge now is gowns and we are working it," Georgia Emergency Management and Homeland Security Agency Director Homer Bryson wrote on April 19 to two of Gov. Brian Kemp's senior-most aides.
Even so, one day later, the first-term Republican governor announced he would begin to reopen the state's economy, including gyms, restaurants, hair salons, theaters and a host of other businesses.
"We have relied on data, science and the advice of healthcare professionals to guide our approach and decision-making," he said at a news conference, "putting the health and well-being of our citizens first and doing our best to protect lives and livelihoods."
"Our state agencies and the governor felt confident in the state's ability to meet daily PPE requests from our local emergency preparedness partners and medical facilities when Georgia began implementing its measured reopening plan," Cody Hall, the governor's spokesperson, said in response to questions. "We have continued to meet those needs since April." He noted the state is now building a PPE stockpile.
A Matter of Life or Death
After Georgia eased its lockdown, COVID cases spiked. Requests for PPE from health workers in the Atlanta area escalated through April and May, according to numbers provided by the nonprofit Atlanta Beats COVID-19, which makes face shields for health workers and other residents.
According to public data on the Georgia Department of Public Health's website, at least 80 Georgia healthcare workers have died from COVID-19, including after the state reopened its economy.
One was John "Derrick" Couch, a nurse practitioner who worked in Fort Oglethorpe, Georgia. Shortly after graduating with his master's degree in nursing on May 10, the worker at Med First Immediate Care Medical Center grew sick with COVID-19. His wife, Karol, cared for him at home for a time before he was hospitalized. He died after 36 days on a ventilator, according to a GoFundMe page set up to help his family cover his healthcare expenses.
"Karol wants everyone to know that Covid-19 doesn't care or discriminate. She says John would want all of his colleagues and friends in healthcare and community to demand proper equipment and protection," it said. Med First Immediate Care did not respond to a request for comment.
Between March 16 and Aug. 9, 48 COVID-19-related complaints regarding inadequate PPE in Georgia healthcare facilities were closed by the Occupational Safety and Health Administration, the federal agency responsible for workplace safety. The PPE complaints accounted for the majority — roughly 6 in 10 — of Georgia's COVID-19 complaints submitted to OSHA during the four-month period.
In April and May, "we received thousands of requests for N95 masks, but we couldn't get our hands on the right materials to even make an N95 mask," said Caroline Dunn, Atlanta Beats COVID-19's communications coordinator.
Nationally, health workers continue to express alarm about protective equipment supplies as COVID-19 hot spots reemerge across the country. A National Nurses Unitedsurvey in July found 87% of nurses working in hospitals reported reusing at least one piece of single-use PPE. Only a quarter of nurses surveyed felt their employers were providing a safe workplace.
"There's really been this normalization and this acceptance that some people are going to be expendable. And that's completely unacceptable," said Dabney Evans, director of the Center for Humanitarian Emergencies at Emory University in Atlanta.
Another document projecting PPE supplies, dated April 10 and developed by Georgia health and emergency management officials, relied on a calculator from the U.S. Centers for Disease Control and Prevention to estimate how quickly Georgia would burn through supplies across hospitals, nursing homes, dialysis clinics, jails and prisons. The state had 527,424 N95 respirators but needed a total of nearly 1.1 million to get through the ensuing seven days. The projected need grew to 4.8 million masks when estimating supplies for the following 31 days.
It had 196,500 gloves on hand but would need more than 12.1 million to get through a week, and 54 million for 31 days. The state had about 122,000 face shields but required more than 458,000 for the coming seven days. For a month, the projected need ballooned to over 2 million.
The April 10 estimates — a day when Georgia's new COVID-19 case count rose by about 1,000 people — were sent to the U.S. Department of Health and Human Services and Federal Emergency Management Agency as part of a broad effort to assess what states needed across healthcare settings to operate for at least seven days and up to a month. Federal officials asked state public health and emergency management officials to submit PPE projections daily, according to emailsamong state personnel, HHS and FEMA.
PPE estimates would be used "to determine projections for our region and the next hot spots within each state," Jeanne Eckes, an HHS official working with FEMA on the federal government's COVID-19 response, wrote in an April 3 email to officials in multiple states throughout the South, according to correspondence obtained by KHN.
Calculations Matter
Georgia officials contend the state's estimated PPE deficits were larger early in the pandemic because projections accounted for all COVID-positive cases. Once the state had more information on how many of these positives were asymptomatic cases and how many led to hospitalizations, it could better gauge what was needed, they argued. Multiple changes were made to its burn-rate calculations, including a May 8 adjustment that replaced the total case count with hospital-based COVID cases, which reduced the projected demand for PPE.
However, multiple experts disputed the idea that knowing the number of asymptomatic patients would be relevant for PPE projections. In facilities like nursing homes and jails — both of which were accounted for in the Georgia estimates — asymptomatic individuals could spread the virus if not quarantined immediately.
"Because there's not on-the-spot, point-of-care testing available for the most part, you have to use PPE throughout the hospital all the time," said Dr. Eric Toner, a senior scholar with the Johns Hopkins Center for Health Security. "In this day and age, you just have to presume that everyone has COVID."
When the state's case count began surging in March, many COVID-19 patients treated at Tift Regional Medical Center in Tifton, Georgia, needed ICU-level care and were from nearby Dougherty County, a Georgia hot spot where hospitals were quickly overwhelmed.
"There were times to which we were down to only having a few days of PPE left," said Dr. Kaine Brown, a physician and medical director at Tift, adding that the hospital was partly saved by donations of N95 and cloth masks. Gowns were the biggest problem. PPE supplies have since improved — as of early July, the hospital had stockpiled more than eight months' worth of surgical masks and enough N95s and gowns to last six months and about three months, respectively.
Georgia's stay-at-home order for most residents expired April 30; it remains in place for individuals at higher risk of severe illness.
"We were very apprehensive about [easing restrictions]," Brown said. "Those of us who had been working on the front lines knew how infectious this was."
Since May, Georgia has reopened a broad swath of businesses. In early July, more than 1,000 healthcare workers signed a letter to Kemp urging him to institute a statewide mandate requiring face coverings, to close bars and nightclubs, and prohibit indoor gatherings of more than 25 people. Georgia currently bans gatherings of more than 50 people if social distancing cannot be observed.
State officials say PPE supplies have "greatly improved" since the start of the public health emergency. As of Aug. 14, the state had distributed 3.9 million N95s, 13.1 million surgical masks, 36.6 million gloves, 4.6 million gowns and 1.6 million face shields, among other items, according to the Georgia Department of Public Health. Early on, Georgia also relied on donations to bolster PPE supplies when many items were unattainable through normal supply channels, which have since become more reliable.
However, even with the increased stocks, workers still reuse protective equipment and many fret over the uncertainty about how long they can do so safely. Another community-based organization, the Atlanta chapter of Sewing Masks for Area Hospitals, said that from April to June the organization gave out over 59,000 cloth masks to 152 healthcare facilities in the Atlanta area, including large hospitals, such as Children's Healthcare of Atlanta and Emory St. Joseph's Hospital. Kayla Hittig, a co-founder of the sewing group, said that healthcare workers were using the cloth masks to cover their N95 or surgical masks to make them last longer.
"That's the thing we hear the most — how often do we have to use these and how protective are they, for how long?" said Richard Lamphier, president of the Georgia Nurses Association.
Lamphier wasn't critical of the state officials' efforts to ensure health workers are protected.
"I think they've done the best they could with the situation they had," he said.
It wasn't enough to protect John Couch, whose family is reeling from his death.
"He was my whole life," Karol Couch said. "My life is shattered."