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Scott Gottlieb was hospitalized at the White House in the early hours of Friday, March 13, 2020, when an aide to President Donald Trump passed him a FedEx package. Open it,” the assistant said, giving him a mischievous smile. Inside, Gottlieb discovered two plastic vials filled with enzymes. Gottlieb, a qualified physician, knew what the vials were for: collecting mucus from a nasal swab until the pattern could be analyzed in the lab.
“These two check kits, I told him, were meant for the president,” Gottlieb wrote in his book, “Uncontrolled Spread. “
After Gottlieb briefed the president in the Oval Office that day, Trump held a news conference in the Rose Garden, where he declared COVID-19 a national emergency. It announced a partnership with Quest Diagnostics, Labcorp and test device manufacturers, but mentioned any details. Quest Diagnostics CEO Steve Rusckowski said the company will deliver new high-throughput genetic testing devices to its labs this weekend.
Minutes later, Trump appeared to question the need for better testing.
“Again, we don’t need everyone to take this test; It’s completely useless,” he said. “And it will pass. It will pass, and we will be even more powerful for it. “
Looking back on that stressful day, Gottlieb, a former commissioner of the Food and Drug Administration, now thinks it’s too late.
“It’s a violation of politics,” he said in an interview with NorthJersey. com and The Record. “Someone intended to call ad brands in January [2020] to tell them we needed them to set up a broadband platform. “
The Rose Garden press convention laid out 3 plans for a federal reaction to the pandemic: Presidents on both sides would claim to take seriously the urgency of genetic testing in the country. But they would fail to create a national plan for this and abdicate their duty to Labcorp and Quest.
“We don’t have a regional integration system” for COVID-19 testing and data, said David Perlin of Hackensack Meridian Health. “We don’t have a system of national integration. If we had it, I would quickly know what our COVID-19 prestige was. And we don’t know.
At the beginning of the pandemic, Quest and Labcorp’s extensive logistics networks suffered. There were several reasons for this, said Mara Aspinall, an adviser to the Rockefeller Foundation. In many states, the same emergency orders that closed bars and sporting events were also implemented for Quest and Labcorp sampling sites. In spaces without a closure order, sites remained open but may not simply take nasal swabs because they had the apparatus to draw blood, not mucus.
In addition, normal consumers of the giants have just disappeared, said Robert Michel, editor-in-chief of The Dark Report, an industry publication aimed at the diagnostic testing industry. Elective surgeries were canceled, so hospitals stopped asking for tests. people who can’t breathe because of COVID-19 don’t call Labcorp or Quest, Michel said. They call their doctor or go to the emergency room or emergency room for lab tests.
By the current week of April 2020, overall testing volumes in some labs had declined nearly 90% from pre-pandemic levels, according to data compiled through The Dark Report. This created a crisis for Quest and Labcorp: too many COVID samples to be run through their available machines; there aren’t enough regular non-COVID samples to pay the bills.
Both companies have faced financial crises. Test volume in Quest’s labs was reduced by 40% in March 2020. The company laid off 4,000 workers. Managers, board members and CEO Steve Rusckowski suffered temporary pay cuts. Labcorp’s volume was reduced by 50%, so the company froze hiring and laid off temporary workers. % in a single quarter, according to the Federal Reserve Bank of St. Petersburg. Louis.
“If you look at the disadvantages of centralization, you have a lot of volume in the few labs,” Aspinall said. “If a formula fails, you suddenly have a million no-effect consumers who want to be tested elsewhere. No formula is set for one million new consumers in two weeks.
In the country’s smallest labs, excess testing machines and materials sat idle during the early weeks of the pandemic, said Michel and Mark Birenbaum, executive director of the National Association of Independent Laboratories. This was partly because small laboratories had been intentionally excluded from tight networks.
“The big labs couldn’t take over the testing,” Birenbaum said, “but at first our labs weren’t getting the samples, so they couldn’t step in to help. “
Quest, Labcorp and the rest rallied to post record revenue in 2020. But many experts found it daunting to watch the giants stumble.
“This is a scenario where having two giant labs that control much of the industry can create disruption in emergency scenarios,” Birenbaum said.
As national logistics networks stagnated, hospitals and governments were forced to improvise. Minutes after midnight on a bloodless March 2020 morning, Kim Gomez stopped her car on a two-lane highway in Paramus, New Jersey. For 3 days, his fever remained constant at 104 degrees. On the fourth day, he needed a COVID-19 test.
“I feel so bad. Like someone was squeezing my head,” said Gomez, who was ranked third in line for an access control site in the parking lot of a network school. “I went to the emergency room. They told me to come here. There is nowhere to go there.
At five a. m. , the line of cars starts a mile long. It took hours to treat so many patients, even though each check-up only took a few seconds. These delays were repeated across the country as fitness staff struggled to enter the patient’s fitness. Data in the jury-manipulated computer formula of each contextual site.
Normally, queues at Labcorp and Quest are short. Both companies use online scheduling systems to tailor patients to necessary staff and supplies. The testing giants also get all the medical knowledge they want directly from patients’ doctors.
But pop-up sites emerged so temporarily that their information systems were designed for moderate use. Many were powered by a single laptop.
“The big labs, Labcorp and Quest, are incredibly automated. They have strong knowledge systems, but even they were off guard,” Aspinall said. “It doesn’t seem like a big deal. But when you get a million samples and I only have five thousand, it’s a big deal. “
Improvised computer and logistics systems may not deal with the volume or sophistication of fashionable medical records.
“Leading labs have built-in quality assurances, adding barcodes that are shared with their existing distribution channels and messaging networks,” Aspinall said. “Suddenly, there were counties, cities, pharmacies, none of which used to take very complex samples, in massive volumes, and label them. And they sent those samples to labs, which they had never worked with before.
Once a patient undergoes testing through Quest and Labcorp, the result is communicated to all of the patient’s physicians and public fitness agencies. At pop-up sites, that didn’t happen, said Janet Hamilton, executive director of the Council of State and Territorial Epidemiologists. . In 90 percent of cases reported to public fitness agencies, tactile trackers didn’t get the data they needed to begin their investigations, according to a survey by the Hamilton group.
The result is that pop-up sites helped keep Americans fit. But to protect public health, perhaps the most important reason to seek COVID-19 in the first place, they have provided little value.
“Many of the labs that sprang up in this area had never reported public fitness before. They didn’t know how to do it,” Hamilton said. Also, when they found out, they didn’t like that public health was a priority. “
Doctors and hospitals faced the opposite problem. Their computers were too heavy and stressed to change. Although delivery times at Quest and Labcorp were 12 or 15 days, doctors continued to send them new check orders.
“If this result takes a week to come back, what’s the point?”said Jennifer Nuzzo, a public fitness and epidemiologist at Brown University.
It is illogical, until one considers the alternative.
To circumvent Quest and Labcorp, the doctor would have to negotiate a contract with a lab with excess COVID-19 testing capacity, as well as knowledge and logistics systems that comply with federal privacy law.
Since the new lab wouldn’t seem like an option in the doctor’s computer model, the doctor would write each verification command by hand. said Michelle Meigs, director of the PC program at the Association of Public Health Laboratories, which advocates for public control labs. The doctor then locates and hires a HIPAA-compliant courier to send the pattern to the lab and return the results.
Even in times, no doctor has time for that.
“Providers are very busy,” said Jeffrey Klausner, a public fitness expert at the University of Southern California. ‘It’s a manual thing. The total formula freezes. Therefore, the supplier is heavily biased not to send to a new lab, even if the existing lab is likely to have a seven- to 14-day delay.
In some situations, stressed medical record systems load loads on labs that are already flooded.
Thomas Durant, a computer scientist at Yale School of Medicine, describes a non-unusual experiment in which his Yale lab sees a patient whose medical history indicates he gained two recent COVID-19 checkups. Perhaps any of the controls were done through Yale. Or maybe one checkpoint held a booth at Yale, but the other went through an Abbott device at a CVS pharmacy. That’s data Yale doctors would like to know, Durant said, because studies suggest that controls performed through Abbott’s devices might be less sensitive.
However, knowledge silos operated through hospitals, laboratories and doctors do not record the type of test platform used. If they do, Durant said, that knowledge disappears as the record moves from one silo to another.
When doctors don’t know the answer to a question, they order another test, Durant said. This complex challenge is one of the simplest tactics in which dysfunctional silos slow down testing and restrict the overall source of evidence.
“We can drill a hole in the wall and we can look,” Durant said, describing how Yale’s software stack interacts with stacks operated through other health care facilities. “But I don’t know what’s going on in the scenes at CVS. If you don’t have access to the data, we end up duplicating the work. »
This article made the impression on USA TODAY: Donald Trump’s COVID reaction failed, doctors got stuck