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Clinical Laboratories and Pathology Groups

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Three Prominent Clinical Laboratory Leaders Make the Same Prediction: COVID-19 Testing Will Be Significant Through 2020 and Throughout 2021

CEOs of NorDx Laboratories, Sonora Quest Laboratories, and HealthPartners/Park Nicollet Laboratories expect demand for SARS-CoV-2 tests to only increase in coming months

AUSTIN, TEXAS—For clinical laboratories and anatomic pathology groups in the United States, the single most urgent question is this: how long will the need for substantial volumes of COVID-19 testing continue? Last Wednesday, that question was answered in a most definitive way by CEOs of three nationally-prominent clinical laboratory organizations during a general session of the virtual Executive War College on Clinical Laboratory and Pathology Management.

The short answer is that large volumes of COVID-19 testing will be needed for the remaining weeks of 2020 and substantial COVID-19 testing will occur throughout 2021 and even into 2022. This has major implications for all clinical laboratories in the United States as they plan budgets for 2021 and attempt to manage their supply chain in coming weeks. The additional challenge in coming months is the surge in respiratory virus testing that is typical of an average influenza season.

The title of this information-filled general session was “Coming Next to Clinical Laboratory and Pathology: A Robust Panel Discussion of How Labs Can Prosper Clinically and Financially Going Forward.” Chair and Moderator for the panel was Robert L. Michel, Publisher and Editor-in-Chief of The Dark Report and Dark Daily.

Panel is David Dexter and Stan Schofield and Rick L. Panning

The panelists were:

Each panelist was asked how his parent health system and clinical laboratory was preparing to respond to the COVID-19 pandemic through the end of 2020 and into 2021.

First to answer was Panning, whose laboratory serves the Minneapolis-Saint Paul market.

A distinguishing feature of healthcare in the Twin Cities is that it is at the forefront of operational and clinical integration. Competition among health networks is intense and consumer-focused services are essential if a hospital or physician office is to retain its patients and expand market share.

Panning first explained how the pandemic is intensifying in Minnesota. “Our state has been on a two-week path of rising COVID-19 case numbers,” he said. “That rise is mirrored by increased hospitalizations for COVID-19 and ICU bed utilization is going up dramatically. The number of hospitalized COVID-19 patients has doubled during this time and Minnesota is surrounded by states that are even in worse shape than us.”

These trends are matched by the outpatient/outreach experience. “We are also seeing more patients use virtual visits to our clinics, compared to recent months,” noted Panning. “About 35% of clinical visits are virtual because people do not want to physically go into a clinic or doctor’s office.

“Given these recent developments, we’ve had to expand our network of specimen collection sites because of social distancing requirements,” explained Panning. “Each patient collection requires more space, along with more time to clean and sterilize that space before it can be used for the next patient. Our lab and our parent health system are focused on what we call crisis standards of care.

“For all these reasons, our planning points to an ongoing demand for COVID-19 testing,” he added. “Influenza season is arriving, and the pandemic is accelerating. Given that evidence, and the guidance from state and federal officials, we expect our clinical laboratory will be providing significant numbers of COVID-19 tests for the balance of this year and probably far into 2021.”

 COVID-19 Vaccine Could Increase Antibody and Rapid Molecular Testing

Arizona is seeing comparable increases in new daily COVID-19 cases. “There’s been a strong uptick that coincides with the governor’s decision to loosen restrictions that allowed bars and exercise clubs to open,” stated Dexter. “We’ve gone from a 3.8% positivity rate up to 7% as of last night. By the end of this week, we could be a 10% positivity rate.”

Looking at the balance of 2020 and into 2021, Dexter said, “Our lab is in the midst of budget planning. We are budgeting to support an increase in COVID-19 PCR testing in both November and December. Arizona state officials believe that COVID-19 cases will peak at the end of January and we’ll start seeing the downside in February of 2021.”

The possible availability of a SARS-CoV-2 vaccine is another factor in planning at Dexter’s clinical laboratory. “If such a vaccine becomes available, we think there will be a significant increase in antibody testing, probably starting in second quarter and continuing for the balance of 2021. There will also be a need for rapid COVID-19 molecular tests. Today, such tests are simply unavailable. Because of supply chain difficulties, we predict that they won’t be available in sufficient quantities until probably late 2021.”

COVID-19 Testing Supply Shortages Predicted as Demand Increases

At NorDx Laboratories in Portland, Maine, the expectation is that the COVID-19 pandemic will continue even into 2022. “Our team believes that people will be wearing masks for 18 more months and that COVID-19 testing with influenza is going to be the big demand this winter,” observed Schofield. “The demand for both COVID-19 and influenza testing will press all of us up against the wall because there are not enough reagents, plastics, and plates to handle the demand that we see building even now. 

“Our hospitals are already preparing for a second surge of COVID-19 cases,” he said.

COVID-19 patients will be concentrated in only three or four hospitals. The other hospitals will handle routine work. Administration does not want to have COVID-19 patients spread out over 12 or 14 hospitals, as happened last March and April.

“Administration of the health system and our clinical laboratory think that the COVID-19 test volume and demand for these tests will be tough on our lab for another 12 months. This will be particularly true for COVID-19 molecular tests.”

As described above, the CEOs of these three major clinical laboratories believe that the demand for COVID-19 testing will continue well into 2021, and possibly also into 2022. A recording of the full session was captured by the virtual Executive War College and, as a public service to the medical laboratory and pathology profession, access to this recording will be provided to any lab professional who contacts info@darkreport.com and provides their email address, name, title, and organization.

Executive War College Closing Session

This week’s closing general session of the virtual Executive War College also will deal with the current state of the clinical laboratory industry and bring together three notable lab industry leaders and thinkers. The session, titled “What Comes Next in Healthcare and Laboratory Medicine: Essential Insights to Position Your Clinical Lab and Pathology Group for Clinical and Financial Success, Whether COVID or No COVID,” takes place Thursday, Oct. 29, 2020, from 2:00 PM to 3:00 PM Eastern.

Your presenters will be:

Given the importance of sound strategic planning for all clinical laboratories and pathology groups during their fall budget process, the virtual Executive War College is opening this session to all professionals in laboratory medicine, in vitro diagnostics, and lab informatics.

To register for access, visit: https://dark.regfox.com/executive-war-college-2020. Enter the code: COURTESYCAPTDR. Next, select “apply code” and complete the registration.

—Michael McBride

Related Information:

Coming Next to Clinical Laboratory and Pathology: A Robust Discussion of How Labs Can Prosper Clinically and Financially Going Forward

Expert Panel—What Comes Next in Healthcare and Laboratory Medicine: Essential Insights to Position your Clinical Lab and Pathology Group for Clinical and Financial Success, COVID or No COVID

UCSF and Stanford Researchers Investigate Why Some Infected with COVID-19 Are Asymptomatic, While Others Become Severely Ill or Die

Might clinical laboratories soon be called on to conduct mass testing to find people who show little or no symptoms even though they are infected with the coronavirus?    

Clinical laboratory managers understand that as demand for COVID-19 testing exceeds supplies, what testing is done is generally performed on symptomatic patients. And yet, it is the asymptomatic individuals—those who are shown to be infected with the SARS-CoV-2 coronavirus, but who experience no symptoms of the illness—who may hold the key to creating effective treatments and vaccinations.

So, as the COVID-19 pandemic persists, scientists are asking why some people who are infected remain asymptomatic, while others die. Why do some patients get severely ill and others do not? Researchers at the University of California San Francisco (UCSF) and Stanford University School of Medicine (Stanford Medicine) are attempting to answer these questions as they investigate viral transmission, masking, immunity, and more.

And pressure is increasing on researchers to find the answer. According to Monica Gandhi, MD, MPH, an infectious disease specialist and Professor of Medicine at UCSF, millions of people may be asymptomatic and unknowingly spreading the virus. Gandhi is also Associate Division Chief (Clinical Operations/Education) of the Division of HIV, Infectious Diseases, and Global Medicine at UCSF’s Zuckerberg San Francisco General Hospital and Trauma Center.

“If we did a mass testing campaign on 300 million Americans right now, I think the rate of asymptomatic infection would be somewhere between 50% and 80% of cases,” she told UCSF Magazine.

On a smaller scale, her statement was borne out. In a study conducted in San Francisco’s Mission District during the first six weeks of the city’s shelter-in-place order, UCSF researchers conducted SARS-CoV-2 reverse transcription-PCR and antibody (Abbott ARCHITECT IgG) testing on 3,000 people. Approximately 53% tested positive for COVID-19 but had no symptoms such as fever, cough, and muscle aches, according to data reported by Carina Marquez, MD, UCSF Assistant Professor of Medicine and co-author of the study, in The Mercury News.

While their study undergoes peer-review, the researchers published their findings on the preprint server medRxiv, titled, “SARS-CoV-2 Community Transmission During Shelter-in-Place in San Francisco.”

Pandemic Control’s Biggest Challenge: Asymptomatic People

In an editorial in the New England Journal of Medicine (NEJM), Gandhi wrote that transmission of the virus by asymptomatic people is the “Achilles heel of COVID-19 pandemic control.”

In her article, Gandhi compared SARS-CoV-2, the coronavirus that causes COVID-19, to SARS-CoV-1, the coronavirus that caused the 2003 SARS epidemic. One difference lies in how the virus sheds. In the case of SARS-CoV-2, that takes place in the upper respiratory tract, but with SARS-CoV-1, it takes place in the lower tract. In the latter, symptoms are more likely to be detected, Gandhi explained. Thus, asymptomatic carriers of the coronavirus may go undetected.

Viral loads with SARS-CoV-1, which are associated with symptom onset, peak a median of five days later than viral loads with SARS-CoV-2, which makes symptom-based detection of infection more effective in the case of SARS-CoV-1,” Gandhi wrote. “With influenza, persons with asymptomatic disease generally have lower quantitative viral loads in secretions from the upper respiratory tract than from the lower respiratory tract and a shorter duration of viral shedding than persons with symptoms, which decreases the risk of transmission from paucisymptomatic persons.”

Rick Wright of Redwood City, CA
Rick Wright (above), an insurance broker in Redwood City, Calif., was infected with the COVID-19 coronavirus while aboard a Diamond Princess Cruise. He underwent 40 days of isolation, and though he consistently tested positive for the coronavirus, he experienced no symptoms of the illness. “I never felt sick. Not a cough, wheezing, headache. Absolutely nothing,” he told Mercury News. (Photo copyright: The Mercury News.)

Stanford Studies Immune Responses in COVID-19 Patients

Meanwhile, scientists at the Stanford University School of Medicine were on their own quest to find out why COVID-19 causes severe disease in some people and mild symptoms in others.

“One of the great mysteries of COVID-19 infections has been that some people develop severe disease, while others seem to recover quickly. Now, we have some insight into why that happens,” Bali Pulendran, PhD, Stanford Professor of Pathology, Microbiology, and Immunology and Senior Author of the study in a Stanford Medicine news release.

The study, published in Science, titled, “Systems Biological Assessment of Immunity to Mild Versus Severe COVID-19 Infection in Humans,” was based on analysis of 76 patients with COVID-19 and 69 healthy people from Hong Kong and Atlanta. The researchers pointed to flailing immune systems and “three molecular suspects” in the blood of COVID-19 patients they studied.

The Stanford research suggested that three molecules—EN-RAGE, TNFSF14, and oncostatin-M—“correlated with disease and increased bacterial products in human plasma” of COVID-19 patients. 

“Our multiplex analysis of plasma cytokines revealed enhanced levels of several proinflammatory cytokines and a strong association of the inflammatory mediators EN-RAGE, TNFSF14, and OSM with clinical severity of the disease,” the scientists wrote in Science.

Pulendran hypothesized that the molecules originated in patients’ lungs, which was the infection site. 

“These findings reveal how the immune system goes awry during coronavirus infections, leading to severe disease and point to potential therapeutic targets,” Pulendran said in the news release, adding, “These three molecules and their receptors could represent attractive therapeutic targets in combating COVID-19.”

Clinical Laboratories May Do More Testing of Asymptomatic People

The research continues. In a televised news conference, President Trump said COVID-19 testing plays an important role in “preventing transmission of the virus.” Clearly this is true and learning why some people who are infected experience little or no symptoms may be key to defeating COVID-19.

Thus, as the nation reopens, clinical laboratories may want to find ways to offer COVID-19 testing beyond hospitalized symptomatic patients and people who show up at independent labs with doctors’ orders. As supplies permit, laboratory managers may want to partner with providers in their communities to identify people who are asymptomatic and appear to be well, but who may be transmitting the coronavirus. 

—Donna Marie Pocius

Related Information:

We Thought It Was Just a Respiratory Virus—We Were Wrong

Coronavirus: Why Don’t People Get Sick Despite Being Infected?

Asymptomatic Transmission, the Achilles’ Heel of Current Strategies to Control COVID-19

Study Reveals Immune System-Deviations in Severe COVID-19 Cases, a Stanford Study Shows

Why Do Some Get Sick and Others Don’t? Study May Unravel Mystery

Systems Biological Assessment of Immunity to Mild Versus Severe COVID-19 Infection in Humans

How Clinical Laboratories Can Avoid COVID-19 Superspreaders, Protect Their Customers and Their Hospital Networks

Understanding how superspreading occurs can help clinical lab leaders slow and even prevent the spread of SARS-CoV-2 within their communities and health systems

Clinical laboratories understand the critical importance of preventing the spread of infection. However, according to the Boston Globe, researchers worldwide are learning that roughly 80% of new COVID-19 cases are caused by just 10% of infected people. Those people are called superspreaders.

It’s critical that medical laboratory managers are aware of the role superspreaders play in transmitting SARS-CoV-2, the coronavirus that causes the COVID-19 illness.

Clinical lab leaders who understand how superspreading occurs can take steps to protect staff, patients, and anyone who visits the facility. Because lab personnel such as couriers and phlebotomists, among others, come into contact with large numbers of people daily, understanding how to identify superspreaders could limit transmissions of the coronavirus within the laboratory, as well as within hospital networks.

Superspreading versus Plodding

Influenza and other viruses tend to spread in a way that epidemiologists call “plodding.” One person infects another, and the virus slowly spreads throughout the population. However, scientists around the globe are finding that SARS-CoV-2 transmission does not fit that pattern. Instead, a few infected people appear to be transmitting the virus to dozens of other people in superspreading events, Boston Globe reported.

“You can think about throwing a match at kindling. You throw one match, it might not light the kindling. You throw another match, it may not light the kindling. But then one match hits the right spot and all of a sudden the fire goes up,” Ben Althouse, PhD, principal scientist and co-chair of epidemiology at the Institute for Disease Modeling in Bellevue, Wash., told the Boston Globe.

But because roughly 90% of infected people aren’t spreading the virus, identifying who the superspreaders are can be a challenge. Nevertheless, limiting situations in which superspreading is likely to occur could greatly reduce the spread of infection.

Samuel Scarpino, PhD Assistant Professor in the Network Science Institute at Northeastern University writing at the class board
Samuel Scarpino, PhD (above), Assistant Professor in the Network Science Institute at Northeastern University, says that “preventing superspreader events could go a long way toward stopping COVID-19,” Scientific American reported. “All of the data I’m seeing so far suggest that if you tamp down the superspreader events, the growth rate of the infections stops very, very quickly,” Scarpino said. (Photo copyright: University of Vermont.)

Examples of Superspreading Events

One of the first big outbreaks in the United States was an example of a superspreading event. The Biogen (NASDAQ:BIIB) leadership conference in late February in Boston resulted in at least 99 cases of COVID-19 just in Massachusetts, reported the Boston Globe.

Several superspreading events have occurred in houses of worship. One well-documented example prompted a CDC Morbidity and Mortality Weekly Report, titled, “High SARS-CoV-2 Attack Rate Following Exposure at a Choir Practice—Skagit County, Washington.” The 122-member choir met for practice twice in March. On March 3 no one had symptoms, but one person had cold-like symptoms at the March 10 practice. Eventually, 53 members tested positive for SARS-CoV-2.

On May 30, a Texas family held a birthday party, Medical Xpress reported. Twenty-five people attended the party, which only lasted a few hours. The family followed the state’s guidelines for gatherings, however one of the hosts was infected with the SARS-CoV-2 coronavirus and wasn’t aware of it. Seven attendees contracted it, and those seven spread the virus to an additional 10 family members. A total of 18 members of a single family were infected.

There are commonalities among the documented superspreading events. Most occur indoors, often in poorly ventilated areas. Some activities cause more respiratory droplets to be expelled than others, such as singing. Some respiratory droplets are released simply by breathing, and many more are expelled when a person talks. Talking louder expels even more droplets into the air.

Are Some People More Likely to Spread the Coronavirus than Others?

The fact that so few people are responsible for the majority of transmissions of the virus raises questions. Do some people simply have more virus particles to shed? Is biology a factor?

“I think the circumstances are a lot more important,” Kristin Nelson, MPH, PhD, Assistant Professor of Epidemiology at Emory University told the Boston Globe.

One factor may be how long the SARS-CoV-2 coronavirus is in the body before symptoms of the COVID-19 illness manifest.

“If people got sick right away after they were infected, they might stay at home in bed, giving them few opportunities to transmit the virus,” noted Scientific American in “How ‘Superspreading’ Events Drive Most COVID-19 Spread.” However, CDC states on its website that “The incubation period for COVID-19 is thought to extend to 14 days, with a median time of 4-5 days from exposure to symptoms onset. One study reported that 97.5% of persons with COVID-19 who develop symptoms will do so within 11.5 days of SARS-CoV-2 infection.”

During that time, infected individuals may transmit the virus to dozens of other people. The CDC estimates that about 40% of transmission occurs in pre-symptomatic people, Scientific American reported.

But it’s not all bad news. The fact that circumstances may be more important than biology might be good news for clinical laboratories. “Knowing that COVID-19 is a superspreading pandemic could be a good thing. It bodes well for control,” Nelson told the Boston Globe.

Clinical laboratory managers are encouraged to follow CDC recommended safety protocols, titled, “Guidance for General Laboratory Safety Practices during the COVID-19 Pandemic.” They include social distancing, setting up one-way paths through lab areas, sanitizing shared surfaces such as counters and benchtops, and implementing flexible leave policies so that sick employees can stay home.

Following these guidelines, and being aware of superspreaders, can help medical laboratories and anatomic pathology groups keep staff and customers free of infection.

—Dava Stewart

Related Information:

Most People with Coronavirus Won’t Spread It. Why Do a Few Infect So Many?  

Birthday Party Leaves 18 in Texas Family with Coronavirus

How the Biogen Leadership Conference in Boston Spread the Coronavirus

Interim Clinical Guidance for Management of Patients with Confirmed Coronavirus Disease (COVID-19)

COVID-19 Pandemic Planning Scenarios Guidance for General Laboratory Safety Practices during the COVID-19 Pandemic

Federal Prosecutors Charge a California Executive with Misleading Investors and Payers about Company’s Clinical Laboratory COVID-19 Test

Charges against this life science company executive include healthcare fraud as well as the first COVID-19 related securities fraud

In the first securities fraud prosecution involving clinical laboratory COVID-19 testing, the US federal Department of Justice (DOJ) charged the president of a Sunnyvale, Calif., life sciences biotechnology company with participating in a scheme to mislead investors and also to commit healthcare fraud, stated a DOJ press release.

The DOJ charged Mark Schena, PhD, president of Arrayit Corporation, with one count of securities fraud and one count of conspiracy to commit healthcare fraud related to submissions of more than $69 million in claims for allegedly unnecessary medical laboratory allergy and COVID-19 tests, the Associated Press (AP) reported.

“The defendant allegedly defrauded Medicare through illegal kickbacks and bribes, and then turned to exploiting the pandemic by fraudulently promoting an unproven COVID-19 test to the market,” said Brian Benczkowski, DOJ Assistant Attorney General, Criminal Division, in the DOJ press release.

According to the Washington Post, Arrayit allegedly bundled its finger-stick allergy test with the COVID-19 test kit.

Authorities Question Bundling of Tests, Claims

An affidavit in support of the criminal complaint stated that Arrayit was promoting “‘microarray technology’ for allergy and COVID-19 testing that allows for laboratory testing on a finger prick drop of blood that is placed on a paper card and sent by mail to Arrayit’s laboratory.”

The government’s investigation actually goes back two years to a time when Arrayit allegedly submitted or caused submission of $5.9 million in Medicare lab test claims and $63 million in lab test claims to private insurers through bribes and kickbacks, MedTech Dive reported.

The company’s clinical laboratory test for COVID-19 failed to receive US Food and Drug Administration Emergency Use Authorization (EUA), because it did not have the level of specificity and sensitivity required, MedTech Dive noted.

“Schena offered an Arrayit COVID-19 test in order to obtain Medicare beneficiary information that then was used to submit false and fraudulent claims for an unrelated and far more expensive allergy test for 120 allergens,” the DOJ complaint stated, adding, “Schena and others transmitted false and fraudulent e-mail communications and marketing materials about the Arrayit COVID-19 test and purported need to bundle the COVID-19 test with Arrayit’s allergy test, while never disclosing there were substantial questions about the accuracy of Arrayit’s COVID-19 test.”

Highlights of DOJ Charges

According to the DOJ press release:

  • Schena and others from 2018 through February allegedly “paid kickbacks and bribes” to recruiters and doctors to run a medical laboratory test for allergy screening (with 120 allergens) on patients “regardless of medical necessity and then make numerous misrepresentations to potential investors.”
  • News releases and social media promoted partnerships with companies and government agencies that either “did not exist” or were minor.
  • As the pandemic heated up, Arrayit representatives “made false claims concerning Arrayit’s ability to provide accurate, fast, reliable and cheap COVID-19 tests in compliance with state and federal regulations,” prosecutors said.

According to the DOJ’s complaint, Schena told investigators developing a test for COVID-19 was “like a pastry chef” who switches from selling “strawberry pies” to selling “rhubarb and strawberry pies.”

David Anderson, US Attorney for the Northern District of California
“The allure of cheap reliable alternatives to today’s standard blood tests panels has captured the imagination of the healthcare industry, making such alternatives a prime subject for fraudsters,” said David Anderson (above), US Attorney for the Northern District of California, in the DOJ press release, adding, “The scheme described in the complaint, in which the defendant allegedly leveraged this allure by appending the fear of the COVID-19 pandemic, amounts to a cynical multi-million-dollar hoax.” (Photo copyright: San Francisco Examiner.)

DOJ Prioritizing Coronavirus Fraud

US Attorney General William Barr earlier this year called for prioritization of investigation and prosecution of coronavirus fraud schemes, noted a DOJ statement, which pointed out that these types of fraud schemes leverage COVID-19 testing information generated by healthcare providers to fraudulently bill Medicare for other tests and procedures.

In April, Dark Daily’s sister publication, The Dark Report (TDR), covered one such kickback scheme in Georgia the DOJ was investigating. In that case, a Georgia man allegedly participated in a fraudulent kickback scheme in which clinical laboratory companies paid him on a per-test basis for referring cancer genetic, coronavirus, and respiratory pathogen panel tests to labs, TDR noted.

Clearly, the DOJ is stepping up its investigation into COVID-19 test fraud. Thus, medical laboratory leaders and pathologists should remain vigilant, as they are likely to observe more enforcement activity as the pandemic persists.

—Donna Marie Pocius

Related Information:

Medical Technology Company President Charged in Scheme to Defraud Investors and Healthcare Benefit Programs in Connection with COVID-19 Testing

California Tech Executive Charged in Coronavirus Testing Fraud

California Biotech Executive Charged with Fraud Over Coronavirus Test Plans

Criminal Complaint: Affidavit in Support of Criminal Complaint

DOJ Charges Arrayit Executive with $69M in COVID-19 Test Fraud

Attorney General William Barr Urges American Public to Report COVID-19 Fraud

DOJ Says Georgia Man Got Kickbacks for COVID-19 Tests

Sean Penn’s Foundation Partners with Healthcare Providers in Four States to Offer Drive-Thru COVID-19 Molecular and Serological Clinical Laboratory Specimen Collections

Goal of his foundation is to provide access to COVID-19 medical laboratory tests for first responders, as well as low-cost tests to the general public

Early in April, when many of the nation’s clinical laboratories were facing numerous challenges in their attempts to obtain adequate supplies for collecting, transporting, and testing for COVID-19, a Hollywood actor was funding his foundation and obtaining enough supplies for his foundation to offer access to COVID-19 testing to residents in his community of Malibu—as well as in other areas.

In many ways, local medical laboratories that offer COVID-19 tests are competing with actor/philanthropist Sean Penn’s Community Organized Relief Effort (CORE) foundation for the supplies they need to provide COVID-19 testing to the patients in their own communities. The non-profit organization says it is working with various healthcare providers to provide free coronavirus testing to first responders, and low-cost testing to the general public, in eleven cities and counties in California, Georgia, North Carolina, and Illinois.

In fact, the volume of COVID-19 testing CORE currently provides is large enough that The Hollywood Report published a story on June 3, titled, “How Sean Penn Made the Biggest COVID-19 Testing Site in U.S.” The article stated that, “In late May, Mayor Eric Garcetti announced the opening of a new COVID-19 testing site at Dodger Stadium in partnership with CORE, the Los Angeles Dodgers, Live Nation Entertainment, Red Rock Entertainment, and the Los Angeles Fire Department. Operated by CORE and LAFD, this site has capacity to test 6,000 residents a day free of charge––making it three times the size of any other location in L.A. County and said to be the largest testing site in the U.S.”

The Reporter did not make the distinction that the Dodger Stadium site is only collecting specimens. And, no news accounts of the CORE COVID-19 testing program names the clinical laboratories that CORE currently uses to perform the coronavirus tests for the specimens it collects.

CORE Partnered with Private Healthcare Provider Elevated Health

CORE first got underway in 2010 providing disaster relief following the catastrophic magnitude 7.0 earthquake in Haiti. It was known then as the Jenkins-Penn Haitian Relief Organization (J/P HRO). The foundation initiated its support of COVID-19 testing efforts in California in April, reported the Orange County Register (OCR). At that time, testing was much more limited than it is today and drive-thru testing in most areas in America was not available.

In Huntington Beach, Orange County, Calif., CORE partnered with Elevated Health to provide molecular polymerase chain reaction (PCR) tests and serological antibody tests for a fee at a drive-thru location in the city of Westminster, reported the OCR.

Elevated Health’s COVID Clinic website enables consumers to complete pre-test enrollment and payment before arriving at the drive-up testing site at the Westminster Mall. 

“Right now, hospitals have very strict guidelines on who can be tested. Public health departments are overwhelmed and possibly underfunded. That’s where I’m trying to bridge the gap,” Matthew Abinante, DO, a doctor of osteopathy and Elevated Health’s founder and CEO, told the OCR.

The coronavirus test kits Elevated Health uses are made in China and were purchased from Georgia-based HealthTrackRx. According to Abinante, they are “FDA authorized, but not FDA approved,” reported the OCR.

Clinical laboratory leaders may be intrigued to see consumers waiting their turn at drive-through testing lines as they take COVID-19 diagnosis into their own hands. Sites like the one above run by Elevated Health at the Westminster Mall demonstrate that people are willing to patronize providers that serve their needs directly. (Photo copyright: Orange County Register.)

CORE Aims to Be a Model for Partnering in Testing

Though CORE’s COVID-19 testing relief efforts are no longer limited to Los Angeles County, that is where it all began. Specimen collection at drive-through sites for COVID-19 tests initially prioritized first responders and essential workers. CORE funds provided for a staff of 70 people at four of the 35 drive-thru specimen collection sites in LA, reported CBS Los Angeles(CBSLA).

CORE-funded services also made it possible for Los Angeles city employees—who were running the drive-thru specimen collection sites—to return to their primary jobs as emergency first responders, reported the Associated Press (AP). 

“It’s something that we can adapt to very quickly with the training of the Los Angeles Fire Department initially. And we’re able to take all those firemen and put them back in to serve the people in the way that we need them to,” said Penn in the AP article.

At that time, city officials planned to perform 10,000 tests a day, Deputy Mayor Jeff Gorell, JD, told the LA Times. The City of Los Angeles purchased the tests and CORE covered the cost of staff, volunteers, and personal protective equipment (PPE), reported the LA Times.

“We have servers and people from the Peace Corps, actresses—a lot of people from the communities where the test site is. We’re trying to hire as much locally as possible,” Ann Lee, CORE’s Chief Executive Officer, told Business Insider.

CORE also partnered with the City of Malibu in western Los Angeles County to provide mobile COVID-19 testing services for the city’s 3,000 residents, first responders, and essential workers from April 6 to 17 at a testing site at Malibu City Hall.

“This is what I hope will be a model in terms of the government and community foundation partnerships that can be replicated not only in the city of Los Angeles and throughout California, but throughout the country,” Sean Penn (above at the COVID-19 drive-thru testing site in Malibu, Calif.), founder of CORE, told CBSLA. Since making that statement, CORE has gone on to partner with healthcare providers in three other states to provide coronavirus drive-thru specimen collection. (Photo copyright: Associated Press/ABC News.)

Should Drive-Through Testing Continue Post-Pandemic?

An April Dark Daily e-briefing reported on drive-thru COVID-19 specimen collection operations across 30 states. The e-briefing also noted that drive-thru collections protects medical laboratory professionals and emergency department staff from possible exposure to infectious agents.

It’s likely many industries—from education and retail to travel and restaurants—will be revamped as a result of the pandemic. Clinical laboratory leaders and pathologists will want to study the different approaches used to develop drive-through COVID-19 specimen collection; how some providers that ran them partnered with charitable organizations such as CORE; why drive-thru specimen collection appeals to consumers; and how it may improve phlebotomists’ safety and increase clinical laboratory business.

—Donna Marie Pocius

Related Information:

How Sean Penn Made the Biggest COVID-19 Testing Site in U.S.

Private Coronavirus Testing Sites Draw Crowds in Malibu and Westminster

Coronavirus: Mayor Garcetti and Sean Penn of CORE in Partnership

Sean Penn’s Non-Profit Helps Los Angeles, Malibu Expand Testing

Sean Penn Wants to “Save Lives” With Free COVID-19 Testing

Sean Penn’s Nonprofit Boosts COVID-19 Testing Efforts in Los Angeles  

Sean Penn Nonprofit, CORE, Provides Coronavirus Testing in Los Angeles

Drive-Through Coronavirus Testing Spreads Across 30 States Lowering Risk of Exposure to Phlebotomists and Clinical Laboratory Professionals

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