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Storm chasers: A Minnesota clinic races from one epidemic to another

Medical assistant Nupur Kamat and registered nurse Hillary Schmalz collect samples in Valley Medical’s Burnsville parking lot.

Medical assistant Nupur Kamat and registered nurse Hillary Schmalz collect samples in Valley Medical’s Burnsville parking lot. Susan Du

I. A roll of the dice

In the Cliff Cove neighborhood of suburban Burnsville, Drs. Ashwin George and Svetlana Zaydman run a small practice called Valley Medical. There, they treat patients living with chronic pain and their addictions to the anesthetizing firepower of opioids, meth, and alcohol.

The doctors are both immigrants. He hails from India and she from Russia. They met during their residency in New Jersey. When they first went into business together six years ago, pairing Zaydman’s pain specialty with George’s chemical dependency experience, it was still something of a novel concept.

The opioid crisis that gripped the nation in the years since kept the doctors busy. They opened clinics in Minneapolis and Woodbury, employing about 40 full-time staff.

Minnesota’s first recorded COVID-19 case appeared on March 1, and its spread soon forced clinics like theirs to make an abrupt pivot into virtual healthcare. At Valley Medical, the doctors rolled out curbside and telehealth appointments, restrictive adaptations that weigh heavier on Valley’s patients than most.

In hopeless times, the path from addiction to sobriety seems to narrow into a tightrope. Chemical dependency experts often say the root of addiction is isolation. Casualties of the coronavirus include in-person support groups like Alcoholics and Narcotics Anonymous and therapy sessions. Telehealth does nothing for people who don’t have internet or cell phones robust enough to host video calls.

The opioid crisis is growing stronger even as it joins all of America’s other problems in the back seat.

If testing were widespread, policymakers might have a better sense of how life could work around the virus. Valley patients who test negative could go back to work. They could gain entry to group homes that are wary of new residents. They could see their sponsors and their friends in recovery.

One day in April, Zaydman suggested Valley Medical start testing for coronavirus.

The fight against COVID had come to resemble a world war effort, with everyone on the same side, and the critical hour for testing had arrived. But the southern metro areas surrounding Valley’s clinic—including Burnsville, Eagan, and Apple Valley—shared just a single testing center, at Park Nicollet in Lakeville.

The logistical landmines were plenty. Valley has a small toxicology lab for urine drug testing, a chemical discipline, whereas COVID-19, a zoonotic disease thousands of years in the evolutionary making, is a matter of molecular biology. They’d need a larger lab, for starters. Complicated new equipment. A specialist to operate it. Nurses to swab patients. Sufficient industry-standard masks and scrubs to protect them.

They’d never attempted anything on that scale. It would be ridiculously expensive. Not to mention, they’d have to track down the tests themselves, along with the chemical reagents needed for processing them—ingredients that large hospital systems and governments alike were competing to buy from limited vendors.

It was impossible, thought George. But then he ruminated, spending two sleepless weeks scouring scientific literature and the news for information about supply bottlenecks and how large research institutions around the country were finding ways around them.

Time was of the essence. The doctors decided they would roll the dice.Valley Medical would become a COVID-19 testing center.

II. Cycles of pain

Behind the doctors’ sudden fixation on COVID-19 testing is an addiction recovery community in a state of suspension.

Valley Medical stayed open so patients living with intractable pain could get vitals checked and prescriptions filled, their physical therapy and emergency joint injections. Those without coronavirus symptoms could make in-person appointments, but the doctors wanted those with the slightest cough or fever to get tested for COVID-19 first.

Patients kept saying it was impossible. Short of life-threatening complications, hospitals weren’t testing anyone.

“We were like, ‘What is going on here? Why is nobody being tested?’” said George. “It’s because there are really no tests available, and symptomatic patients had nowhere to go.”

For patients in recovery, the pandemic also dealt a blow to their group treatment programs.

Kenneth Roberts, 16 years sober, is the chief clinical officer of NuWay, an intensive treatment program that serves more than 1,000 clients across Minnesota daily.

His wife is also in long-term recovery, and while the pandemic rages on, they’ve been trying to stay in touch with extended family virtually. While the boredom and stress of quarantine magnified signs of substance abuse that had existed only in a latent way before, trying to manage it all by Zoom posed a formidable challenge. Roberts understands what NuWay’s clients are going through.

In addition to the opioid crisis, Minnesota’s addiction counselors are dealing with a concurrent wave of meth, Roberts says. By the time policymakers declare one drug an epidemic and levy huge resources to fight and regulate it, another is ready to take its place. Addiction’s just a void that almost any drug can fill.

One of the proverbs used around NuWay is, “The solution to addiction isn’t sobriety. It’s community.”

“So if we’re saying the antidote is community, meaning connecting with other people, then the pandemic has basically said, ‘OK, that’s out the window,’” Roberts says.

“I know we do great clinical work at treatment but I think any of our counselors or staff will also tell you that some of our most useful and valuable time with clients is when they’re on their break and interacting with one another. That’s not happening right now.”

Valley is also deeply entwined with Create, a Twin Cities recovery program that serves inmates of the Hennepin and Dakota County jails. Valley’s Minneapolis clinic is embedded in Create’s headquarters, while Create has an office inside Valley’s Burnsville location.

Executive Director Lynn Allar says that while many of Create’s clients are being released because the crowded living conditions of detention centers pose an outsized risk of viral spread, the challenges of finding housing for people with a criminal record have multiplied.

Many group homes have a moratorium on admissions. Some require anyone coming out of jail to quarantine elsewhere before moving in. Meanwhile, people have to find friends to crash with for two weeks—a lot to ask even in times of abundance.

“I don’t see anything changing until there is a vaccine and that vaccine is available to everyone no matter their health insurance status,” Allar says.

“I’m just hoping there are a lot more Dr. Georges out there that can do this, so we can keep things moving and make testing accessible to as many people as possible.”

III. Homemade reinforcements

Once Valley Medical decided to provide COVID-19 testing for their patients, Zaydman assumed command of the usual practice while George concentrated all his energy on developing their diagnostics lab.

Their upstart operation had to find a way around the obstacles keeping the government and corporations from rolling out widespread coronavirus testing in America.

From the onset, scientists raced to design a test for the disease, trace its path, and isolate the infected. As COVID-19 engulfed Wuhan, the Chinese government published a map of its genetic material—the key to identifying the virus.

Drs. Svetlana Zaydman and Ashwin George treat patients recovering from opioid addiction. To give their patients access to COVID tests, Valley Medical had to make them from scratch.

Drs. Svetlana Zaydman and Ashwin George treat patients recovering from opioid addiction. To give their patients access to COVID tests, Valley Medical had to make them from scratch. Susan Du

In February the CDC created America’s first and only COVID-19 test, and sent copies to states’ public health labs, including Minnesota’s. But there was a problem. When scientists tried to verify these tests, even distilled water—used as a negative control—tested positive for coronavirus.

“It points to a contamination somewhere along the line,” said Sara Vetter of the Minnesota Department of Health. “Our worst fear as a laboratory was that it’s ours, that we did something. But then as our lab started talking, we realized it was a much bigger problem.”

The CDC, the nation’s first line of research on new infectious diseases, was no factory. While it got the basic design of its test kit right, it failed to properly manufacture as many as the states wanted.

So commercial diagnostic companies like LabCorp and Quest stepped up. But their test kits and the equipment used to process them were elusive and expensive, requiring brand-name chemicals and proprietary parts.

Large hospital systems clamored over a finite supply of test kits and the most basic of raw materials, like the nasopharyngeal swabs that slide into patients’ nostrils. Reports came from around the country that the federal government was outbidding states—including Minnesota—for N95 masks that nurses had to wear while they took samples from patients, and seizing vital cargo local governments ordered from Asia. Governors countered by rerouting flights and stockpiling supplies in top-secret warehouses guarded by state police.

“That’s what the problem is, that everybody wants that same equipment and that same reagent,” George realized.

“I read everything about how [the test] is done. I reached out to the University of Minnesota’s genomics lab and picked their brains. And then I read about bottlenecks and figured out OK, there is a way to do this, but we must go around these bottlenecks.”

One of the U of M researchers George called for advice was Dr. Andrew Nelson, a molecular pathologist instrumental in Minnesota’s testing breakthrough.

In March, the medical school came to the conclusion that Minnesota wasn’t going to acquire a sustainable supply of tests anytime soon. The dean challenged Nelson and other geneticists at the U’s molecular diagnostic lab to cook up a homemade test, one that could be fast-tracked for FDA approval if it was only used in-house and not sold for profit.

The scientists delivered, following a recipe based on the CDC’s basic design but using research-grade chemicals that allowed the school to circumvent the supply shortages stymying the production of commercial tests.

The university converted two research buildings in its Biomedical Discovery District into a COVID-19 testing facility and joined forces with the Mayo Clinic, which had been racing to develop its own test.

These efforts by Minnesota’s heaviest hitting research institutions led to the state’s mid-April breakthrough, when Gov. Tim Walz promised tests would soon ramp up to 20,000 daily. (Minnesota’s currently testing about 8,600 people a day at most.)

By then, more than a month after business closures and controversial stay-at-home orders went into effect, some 700 Minnesotans had been hospitalized and nearly 300 had died. Untold more were infected and contagious.

The Minnesota Department of Health webpage listing every COVID testing center in the state was in constant flux. Large areas had none, while some sites ran out of tests before 10 a.m. every day, and had to be delisted from the map while they restocked.

Fresh from contributing to the U’s efforts, Nelson gave George his personal recipe for making a generic COVID-19 test and schooled him on getting it authorized by the FDA.

Even the smallest neighborhood clinic could make a difference, Nelson explained. In other states, even veterinary clinics that test pet excrement for disease were retooling to pitch in.

“Everybody everywhere, big systems, small systems are using out-of-the-box thinking to try and come up with different ways that we can increase test capacity and have it run as smoothly and quickly as possible.”

But there’s a reason why most Minnesota testing centers are affiliated with large health systems that outsource their diagnostics to out-of-state companies, even if they take days to produce results.

The hardware alone—ventilated biosafety cabinets with ultraviolet filtration, a polymerase chain reaction machine, freezers—would cost Valley Medical about $100,000. Building out the lab space to house it all doubled the bill. Valley would need to contract registered nurses to collect samples and hire a specialist with multiple disciplines in laboratory medicine to process them.

All told, it was a rocky investment of more than a quarter of a million dollars, not including the tests themselves.

After COVID-19, Valley could try to pawn equipment for a fraction of its cost, or reuse it for things like STD screening. Currently there’s no way to totally validate a drug test other than to watch patients as they pee. This genomics equipment would allow Valley to identify urine samples using DNA—a far less invasive option.

But from a profitability standpoint, the clinic would be lucky to break even, said Valley’s laboratory medical director, Dr. Gregory Post.

Valley’s lab techs spend half their days running drug tests, and the other half helping analyze COVID-19 tests.

Valley’s lab techs spend half their days running drug tests, and the other half helping analyze COVID-19 tests. Susan Du

“There are a lot of risks associated with it because a lot of people just can’t afford to be philanthropic,” he said. “Dr. George sees the need for his employees. He sees it as a need for the state of Minnesota, and he sees it from the standpoint of repurposing this equipment later on down the road for things he’s looking at.”

COVID-19 testing would also allow Valley to keep seeing patients safely. Many essential workplaces are screening patients’ temperatures as a precaution, but that just isn’t effective when many people who come down with COVID-19 never develop a fever.

“It’s kind of a false sense of security just doing that and saying you’re healthy,” Post said. “You listen to Dr. Fauci, anybody, the only way to get a good handle on this pandemic is through testing, period, because in many instances it’s an invisible disease.”

IV. A new wheel

Clinic coordinator Rachel McNeill remembers the morning Dr. Ashwin George casually asked which staff would be willing to help him run a COVID-19 pop-up testing center in the parking lot of Valley Medical. It caught everybody off-guard.

The doctor explained that testing would entail direct contact with patients. Collecting nasal secretions would require swabbing the deep, brain-tickling juncture of the nose and throat with something that looks like an articulated Q-tip. Most people wouldn’t have felt anything like it before. They’d sneeze or cough, potentially spraying COVID-19 straight into the collector’s face. Those who weren’t comfortable being near the operation could help with the administrative side—phone calls, billing, and checking medical supply vendors multiple times a day for things like latex gloves.

McNeill, who starts medical school in the fall and has ambitions of becoming a large hospital director someday, was excited to enlist.

“I don’t know of any other clinics that are doing this,” she says. “When I get to tell my family what I’m doing, they’re super proud. This is something I’m going to remember. And if I were working somewhere else, I wouldn’t get the opportunity.”

A juggernaut of moving pieces, simultaneous action and contemplation, had to fit together for Valley to start testing in such a short time. The Minnesota Department of Health dispatched positive COVID-19 samples so Valley could validate its homemade test and seek FDA emergency use authorization. Burnsville fast-tracked building permits. Highland Construction Services built a lab to spec in three weeks, finishing the final touches as the first samples of the virus were being broken down next door in a small office used for temporary storage.

Because the clinic couldn’t buy more than its normal allocation of personal protective equipment from its vendors, Valley commissioned 100 homemade masks from local seamstress Victoria Kalinin, who did alterations for Dr. Svetlana Zaydman in normal times. Kalinin, whose husband has brain cancer and recently underwent surgery, now spends all her spare time making masks for sale and donation. Valley’s COVID-19 collections staff wear N95 masks. Everyone else, including the doctors, wear cloth ones.

One month after George asked who wanted to work in the parking lot, signs promoting COVID-19 testing popped up in the Cliff Cove neighborhood, directing traffic to Valley Medical. An orange tent sat on the lawn, adjacent to dedicated spots for patients to park. A knot of extension cords connecting computers snaked out of an open window and laced a nearby picnic table.

As a man drove up in a black SUV, Valley medical assistant Nupur Kamat, decked out in scrubs, gloves, N95 mask, and a face shield, explained what the test would entail.

Hillary Schmalz, a registered nurse laid off by Regions hospital after the governor suspended elective surgeries, advanced with swab in hand. It’s a seconds-long maneuver, but it caused the man to hack.

“That sucks. You guys are evil,” he croaked when she finished, making the women laugh apologetically.

The collection kit consists of a nasopharyngeal swab and a lip gloss-sized tube of sterile transport saline. The sample gets mixed with a chemical solution that breaks down the human cells and isolates the virus’s RNA, which is extracted and fed into a polymerase chain reaction machine, a piece of equipment the size of a Xerox. The machine cycles the temperature of the virus up and down repeatedly, causing it to multiply. Because viruses are invisible even to the microscopic eye, they must be copied millions of times over to detect. Making more copies creates more chromophores—atoms that reflect a signal when the machine flashes them with a laser, announcing the presence of coronavirus.

People tested at Valley get results texted to them within 24 hours. If they’re positive, they’ll also receive a phone call from the clinic with instructions for continuing care.

Valley’s patients get tested for free. But everyone else is welcome as well. Insurance will cover anyone found to have COVID-19 symptoms by a primary doctor. The asymptomatic can also get tested for $75 out-of-pocket.

If the virus resurges in the fall as some experts predict, George says Valley stands ready to continue testing through the year. He hopes to soon offer blood tests to screen for antibodies in those who suspect they’ve already contracted and recovered from the virus.

On Valley’s first day of coronavirus testing, only one patient stopped by. Within a week, there were 100 a day. Yet Valley has the capacity to run 10 times as many samples.

George says his next challenge is convincing health systems to refer their patients to him. Large hospitals that have chosen to use commercial test kits are still beholden to supply shortages, forcing them to restrict testing to healthcare workers and people with symptoms. Not everyone can get that peace of mind.

“We are a small company, but we can help,” George says.

The people trickling through so far are getting tested ahead of visiting older relatives, going in for surgery, and returning to work as Minnesota cautiously resumes business.

“The country wants everybody to go back to work. Companies are reopening. Employees have no way to get tested, so they’re coming to us. We wanted to help the big health systems. Right now we’re helping people get back to work safely. Either way, that’s a nice feeling.”