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Clinical Laboratories and Pathology Groups

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Millions of COVID-19 At-Home Tests Set to Flood Market as HHS Asks 12 Test Manufacturers to Produce 200 Million Tests

Free at home clinical-laboratory testing for COVID-19 has been provided in the past, but this time the federal government wants to manufacture as many tests as possible in the US

Pathologists and clinical laboratory managers may be interested to learn that the US market is about to be flooded with millions of at-home COVID-19 rapid tests. The federal government has contracted with 12 US-based test manufacturers to produce 200 million at-home self-tests aimed at detecting “currently circulating COVID-19 variants” through the end of this year, according to a US Department of Health and Human Services (HHS) news release.

Through the Administration for Strategic Preparedness and Response (ASPR), HHS is investing $600 million to fund the self-tests, which are available for delivery through a reopening of the COVID.Gov/Test website.

Federal officials want to head off “supply chain issues” that developed in the past with reliance on tests made overseas, and to address a possible COVID-19 surge during the fall and winter, the Associated Press (AP) reported.

In fact, 500 million tests have already been distributed through US government channels to long-term care facilities, schools, and low-income senior housing.

Dawn O’Connell, JD

“Manufacturing COVID-19 tests in the United States strengthens our preparedness for the upcoming fall and winter seasons, reduces our reliance on other countries, and provides good jobs to hardworking Americans,” said Assistant Secretary for Preparedness and Response Dawn O’Connell, JD (above), in an HHS news release. “ASPR’s investments in these domestic manufacturers will increase availability of tests in the future.” With the federal government preparing for what it expects to be a surge in demand for COVID-19 testing, clinical laboratories may want to track the CDC’s weekly reports on the number of positive COVID-19 cases as this year’s influenza season progresses. (Photo copyright: Administration for Strategic Preparedness and Response.)

In Vitro Diagnostics Test Makers Get Government Gigs

This is not the first time federal officials sent out free COVID-19 tests to consumers. According to the AP, more than 755 million tests went out to US households in previous efforts to fight the spread of infections. But unlike those tests, these tests will be manufactured entirely within the US.

The government’s latest wave of free tests is meant to “complement ASPR’s ongoing distribution of free COVID-19 tests to long-term care facilities, low-income senior housing, uninsured individuals, and underserved communities, with 500 million tests provided to date through these channels,” the HHS news release noted.  

Both large and lesser-known in vitro diagnostics (IVD) manufacturers were selected by the federal government to receive funding. They include:

HHS advises people to take the test at the first sign of symptoms (fever, sore throat, runny nose, others), after coming into contact someone who has COVID-19, or prior to gathering with a group, as a preventative to spread of the coronavirus.

Tracking New BA.2.86 COVID Variant

Currently, the federal Centers for Disease Control and Prevention (CDC) is tracking BA.2.86 (aka, Pirola), a new SARS-CoV-2 variant.

According to CDC’s latest Respiratory Viruses Update:

  • Reporting laboratories say existing antibodies work against the BA.2.86 variant.
  • The variant does not appear to be linked in the US with increasing infections or hospitalizations.
  • It is “unclear how easily BA.2.86 spreads” relative to other variants.
  • BA.2.86 has been detected in nine states: Colorado, Delaware, Michigan, Ohio, Pennsylvania, Virginia, Washington, and in wastewater in New York and Ohio, as well as in other countries. 

For week ending Sept. 23, the CDC reported the following statistics compared to the prior week:

  • 19,079 COVID-19 hospitalizations, down 3.1%.
  • Total hospitalizations: 6.3 million.
  • 2.7% of total deaths were due to COVID-19, up 8%.
  • COVID-19 test positivity rate was 11.6%, down 1.1%.
  • 1.8% of emergency department visits were diagnosed with COVID-19, down 11.7%.

According to Verywell Health, BA.2.86 carries more than 30 mutations.  

“Even with a lot of mutations, there are a lot of spots in the virus that can be recognized by our immune system, and there are many shared mutations as well. There will be some protection from new vaccine booster as well as prior infections,” Rajendram Rajnarayanan, PhD, Assistant Dean of Research and Associate Professor, Basic Sciences, Arkansas State University, told Verywell Health.

During an online media briefing conducted by the World Health Organization (WHO), Maria Van Kerkhove, PhD, COVID-19 Technical Lead at WHO, said that the variant could be classified by WHO as a “variant of concern” in the event of widespread circulation. 

COVID-19, an Endemic Disease?

It’s worth noting that the common cold, influenza, SARS, and SARS-CoV-2 are all in the coronavirus family, and thus closely related with similar symptoms. It would not be a surprise that SARS-CoV-2 joins those other viruses as an endemic virus with a similar yearly cycle of infection rates.

If that happens, and no surge in infections appears that would motivate orders for the new COVID-19 at-home tests, the government may find itself with a lot of unused tests at the end of the year. The US Food and Drug Administration (FDA) is aware of this possibility and provides a website where people can check to see if their test has an extended expiration date.

Plus, folks who are tired of the pandemic may not respond at all to the government’s insistence to prepare for possible surges in infection rates.

“Whether or not people are done with it, we know the virus is there, we know that it’s circulating. We know, if past is prologue, it’ll circulate to a higher degree and spread, and cases will go up in the fall and winter seasons,” said Assistant Secretary for Preparedness and Response Dawn O’Connell, JD, in the HHS new release. “Anticipating that that would be true again, or something similar, we want to make sure the American people have these tools.”

Clinical laboratories may want to prepare as well. Many people are not comfortable with at-home self-testing and prefer to have their local medical labs perform the tests.

—Donna Marie Pocius

Related Information:

Biden-Harris Administration Awards $600 Million to Bolster US Manufacturing of COVID-19 Tests and Announces the Re-Opening of COVIDTests.gov

Biden Administration Announces $600 Million to Produce COVID-19 Tests and Will Reopen Website to Order Them

Free COVID Testing Will Fade with US Health Emergency in May

CDC’s COVID-19 Variant Update

CDC’s COVID-19 Data Tracker

Why B.2.86 Stands Out from Other COVID-19 Variants

CDC Issues New Guidelines to Optimize Hospital Sepsis Programs and Save Lives

Clinical laboratory leaders may be aware that many hospitals still do not have capabilities to make a timely diagnosis of sepsis

Despite the fact that “one in three people who dies in a hospital had sepsis during that hospitalization,” recent data from the Centers for Disease Control and Prevention (CDC) show that many hospitals in the US lack the resources to identify sepsis and begin treatment as soon as possible, CNN reported.

According to the CDC, 1.7 million Americans develop sepsis annually. And of that group, at least 350,000 adults die in hospitals or hospice care centers. Clinical laboratories tasked with performing the plethora of tests needed to diagnose sepsis will agree that it is one of the gravest healthcare dangers patients face.

To address this potentially deadly threat, the CDC developed the “Hospital Sepsis Program Core Elements: 2023” to support the implementation of sepsis protocols at all hospitals, to optimize any existing sepsis programs, and to organize staff and identify resources to lower sepsis rates and raise survivability.

“Modeled after CDC’s Core Elements of Antibiotic Stewardship, which has proven to be an impactful resource to protect patients from the harms caused by unnecessary antibiotic use and to combat antimicrobial resistance, the Sepsis Core Elements were created with the expectation that all hospitals, regardless of size and location, would benefit from this resource,” a CDC press release noted.

Raymund Dantes, MD

“CDC’s Hospital Sepsis Program Core Elements are a guide for structuring sepsis programs that put your healthcare providers in the best position to rapidly identify and provide effective care for all types of patients with sepsis,” said Raymund Dantes, MD (above), Medical Advisor, National Healthcare Safety Network, CDC, and Associate Professor, Emory University School of Medicine, in a CDC press release. Hospital medical laboratories will play a key role in the success of the CDC’s sepsis program. (Photo copyright: Emory School of Medicine.)

Seven Elements to Improve Sepsis Diagnosis

Sepsis can occur when chemicals released into the bloodstream to fight off an infection produce massive inflammation throughout the body. This potentially fatal reaction can cause a deluge of changes within the body that damage multiple organs, leading them to fail.

The CDC designed its hospital sepsis program to improve and monitor the management and outcomes of patients with sepsis. The core elements of the program include seven main points:

  • Hospital Leadership Commitment: Management must dedicate the necessary staff, financial, and information technology resources.
  • Accountability: Appoint a team responsible for program goals and outcomes.
  • Multi-professional Expertise: Make sure key personnel throughout the healthcare system are engaged in the program.
  • Action: Implement structures and processes to improve the identification of the illness and patient outcomes.
  • Tracking: Develop initiatives to measure sepsis epidemiology, management, overall outcomes, and progress towards established goals.
  • Reporting: Provide information on sepsis management and outcomes to relevant partners.
  • Education: Provide healthcare professionals, patients, and family/caregivers with information on sepsis.

“Sepsis is taking too many lives. One in three people who dies in a hospital has sepsis during that hospitalization. Rapid diagnosis and immediate appropriate treatment, including antibiotics, are essential to saving lives, yet the challenges of awareness about and recognition of sepsis are enormous,” said CDC Director Mandy Cohen, MD, in the CDC press release. “That’s why CDC is calling on all US hospitals to have a sepsis program and raise the bar on sepsis care by incorporating these seven core elements.”

Early Diagnosis Presents Challenges

Sepsis care is complex. The condition requires urgent medical intervention to prevent organ damage and death. But the symptoms, which include fever or low temperature, shivering, confusion, breathing difficulties, extreme body pain or discomfort, high heart rate, weak pulse or low blood pressure, and low urine output, can be general and indicative of other illnesses.

The diagnosis of sepsis usually requires the collection of a blood culture specimen that is then incubated until there is enough bacterial growth to identify the specific strains of bacteria in a particular patient. This process can take several days, which can delay the administering of the most effective treatment for the condition. Treatment usually includes antibiotics and intravenous fluids.

A recent CDC survey of 5,221 US hospitals showed that in 2022, only 73% of hospitals reported having a sepsis program, ranging from 53% among hospitals with less than 25 beds to 95% among hospitals with over 500 beds.

That survey, released in the CDC’s August Morbidity and Mortality Weekly Report (MMWR), also discovered that only 55% of all hospitals had personnel with dedicated time to manage and conduct necessary daily activities for a sepsis program. 

Raymund Dantes, MD, Medical Advisor, National Healthcare Safety Network, CDC, and Associate Professor, Emory University School of Medicine, told CNN that as many as 1,400 hospitals have no sepsis program in place at all. Therefore, he added, the CDC’s Hospital Sepsis Program Core Elements documents also include a “getting started guide” to help those hospitals create the needed committees.

“For those hospitals that already have sepsis programs underway and have available resources, we have a lot more details and best practices that we’ve collected from hospitals about how to better improve your sepsis programs,” he said. “The seven elements complement clinical guidelines by describing the leadership, expertise, tracking, education, and other elements that can be implemented in a wide variety of hospitals to improve the quality of sepsis care.” 

Hospital Laboratories Play a Key Role in Reducing Sepsis

According to the CDC, anyone can get an infection and almost any infection can lead to sepsis. However, some populations are more vulnerable to sepsis than others. They include:

  • Older persons
  • Pregnant or recently pregnant women
  • Neonates
  • Hospitalized Patients
  • Patients in Intensive Care Units
  • People with weakened immune systems
  • People with chronic medical conditions

According to the World Health Organization (WHO), there were 48.9 million sepsis cases and 11 million sepsis-related deaths worldwide in 2017. This number accounted for almost 20% of all global deaths. Almost half of all the global sepsis cases occurred in children, resulting in 2.9 million deaths in children under the age of five. 

“Sepsis is complex, often difficult to identify, and takes a tremendous societal toll in the United States,” said Steven Simpson, MD, Professor of Medicine at the University of Kansas and Chair, Board of Directors, Sepsis Alliance, a non-profit organization dedicated to raising awareness and reducing suffering from sepsis, in a press release. “To tackle the number one killer in American hospitals, we need a comprehensive National Action Plan to find cures, get them in the hands of professionals, and educate the public and professionals alike.”

Hospital medical laboratories can help reduce sepsis by finding ways to support their physicians’ diagnoses of this infection that has taken so many lives.

—JP Schlingman

Related Information:

CDC Launches Effort to Bolster Hospital Sepsis Programs

Hospital Sepsis Program Core Elements: 2023

CDC: What is Sepsis?

Sepsis Program Activities in Acute Care Hospitals—National Healthcare Safety Network, United States, 2022

Sepsis Nearly Killed Me. This is What it was Like.

Hospital Sepsis Program Core Elements

CDC Launches New Effort Aimed at Strengthening Survival and Recovery Rates for All Sepsis Patients

Sepsis: The Deadly Disease You Might Not Be Familiar With

Sepsis Alliance Reinforces Call for National Sepsis Action Plan as Awareness of the Term Sepsis Dips to 63%

Sepsis Alliance Calls on Biden-Harris Administration for a National Sepsis Action Plan

Hospitals Worldwide Are Deploying Artificial Intelligence and Predictive Analytics Systems for Early Detection of Sepsis in a Trend That Could Help Clinical Laboratories, Microbiologists

Achieving Faster Sepsis Diagnosis in the Emergency Department: Early Experience with the Monocyte Distribution Width (MDW) Marker and Acceptance by ED and ID Physicians

Australian Researchers Develop Static Droplet Microfluidic Device That Can Detect Cancer Cells via a Simple Blood Test

This is another approach to the liquid biopsy that clinical laboratories and pathologists may use to detect cancer less invasively

Screening for cancer usually involves invasive, often painful, costly biopsies to provide samples for diagnostic clinical laboratory testing. But now, scientists at the University of Technology (UTS) in Sydney, Australia, have developed a novel approach to identifying tumorous cells in the bloodstream that uses imaging to cause cells with elevated lactase to fluoresce, according to a UTS news release.

The UTS researchers created a Static Droplet Microfluidic (SDM) device that detects circulating tumor cells (CTC) that have separated from the cancer source and entered the bloodstream. The isolation of CTCs is an intrinsic principle behind liquid biopsies, and microfluidic gadgets can improve the efficiency in which problematic cells are captured.

The University of Technology’s new SDM device could lead the way for very early detection of cancers and help medical professionals monitor and treat cancers.

The UTS researchers published their findings in the journal Biosensors and Bioelectronics titled, “Rapid Metabolomic Screening of Cancer Cells via High-Throughput Static Droplet Microfluidics.”

“Managing cancer through the assessment of tumor cells in blood samples is far less invasive than taking tissue biopsies. It allows doctors to do repeat tests and monitor a patient’s response to treatment,” explained Majid E. Warkiani, PhD, Professor, School of Biomedical Engineering, UTS, and one of the authors of the study, in a news release. Clinical laboratories and pathologists may soon have a new liquid biopsy approach to detecting cancers. (Photo copyright: University of New South Wales.)

Precision Medicine a Goal of UTS Research

The University of Technology’s new SDM device differentiates tumor cells from normal cells using a unique metabolic signature of cancer that involves the waste product lactate

“A single tumor cell can exist among billions of blood cells in just one milliliter of blood, making it very difficult to find,” explained Majid E. Warkiani, PhD, a professor in the School of Biomedical Engineering at UTS and one of the authors of the study, in the news release.

“The new [SDM] detection technology has 38,400 chambers capable of isolating and classifying the number of metabolically active tumor cells,” he added.

“In the 1920s, Otto Warburg discovered that cancer cells consume a lot of glucose and so produce more lactate. Our device monitors single cells for increased lactate using pH sensitive fluorescent dyes that detect acidification around cells,” Warkiani noted.

After the SDM device has detected the presence of questionable cells, those cells undergo further genetic testing and molecular analysis to determine the source of the cancer. Because circulating tumor cells are a precursor of metastasis, the device’s ability to identify CTCs in very small quantities can aid in the diagnosis and classification of the cancer and the establishment of personalized treatment plans, a key goal of precision medicine.

The new technology was also designed to be operated easily by medical personnel without the need for high-end equipment and tedious, lengthy training sessions. This feature should allow for easier integration into medical research, clinical laboratory diagnostics, and enable physicians to monitor cancer patients in a functional and inexpensive manner, according to the published study. 

“Managing cancer through the assessment of tumor cells in blood samples is far less invasive than taking tissue biopsies. It allows doctors to do repeat tests and monitor a patient’s response to treatment,” stated Warkiani in the press release.

The team have filed for a provisional patent for the device and plan on releasing it commercially in the future.

Other Breakthroughs in MCED Testing

Scientists around the world have been working to develop a simple blood test for diagnosing cancer and creating optimal treatment protocols for a long time. There have been some notable breakthroughs in the advancement of multi-cancer early detection (MCED) tests, which Dark Daily has covered in prior ebriefings.

In “NHS Trial Analysis Finds That Grail’s Galleri Clinical Laboratory Blood Test Can Detect 50 Cancers and Identify the Location of the Cancer,” we reported how the UK’s National Health Service (NHS) had conducted a trial study of an MCED test developed by a California-based healthcare technology company that could provide a less painful/invasive cancer test experience to UK residents.

And in “University Researchers Develop Microfluidic Device That Partitions Cancer Cells According to Size in Effort to Create a Useful Liquid Biopsy Method,” we covered how researchers at the University of Illinois at Chicago (UIC) and Queensland University of Technology (QUT) in Australia had unveiled a diagnostic device that uses microfluidic technology to identify cell types in blood by their size and isolate individual cancer cells from patient blood samples.

According to the Centers for Disease Control and Prevention (CDC), cancer ranks second in the leading causes of death in the US, just behind heart disease. There were 1,603,844 new cancer cases reported in 2020, and 602,347 people died of various cancers that year in the US. 

According to the National Cancer Institute, the most common cancers diagnosed in the US annually include:

Cancer is a force in Australia as well. It’s estimated that 151,000 Australians were diagnosed with cancer in 2021, and that nearly one in two Australians will receive a diagnosis of the illness by the age of 85, according to Cancer Council South Australia.

The population of Australia in 2021 was 25.69 million, compared to the US in the same year at 331.9 million.

The development of the University of Technology’s static droplet microfluidic device is another approach in the use of liquid biopsies as a means to detect cancer less invasively.

More research and clinical studies are needed before the device can be ready for clinical use by anatomic pathology groups and medical laboratories, but its creation may lead to faster diagnosis of cancers, especially in the early stages, which could lead to improved patient outcomes. 

—JP Schlingman

Related Information:

New Technology to Improve Cancer Detection and Treatment

This Device Can Easily, Cheaply Detect Cancer Cells in a Blood Sample

Rapid Metabolomic Screening of Cancer Cells via High-throughput Static Droplet Microfluidics

Multi-cancer Early Detection (MCED) Tests

Static Droplet Microfluidic, the Cancer Cell Analysis Device

NHS Trial Analysis Finds That Grail’s Galleri Clinical Laboratory Blood Test Can Detect 50 Cancers and Identify the Location of the Cancer

University Researchers Develop Microfluidic Device That Partitions Cancer Cells According to Size in Effort to Create a Useful Liquid Biopsy Method

Survey Indicates Zoomers and Millennials Are Ready for Pharmacies to Play a Bigger Role in Their Primary Care

Demand for low cost, convenient access to doctors and drugs is driving transformation to decentralized medical care, and retail pharmacy chains see opportunity in offering primary care services

Retail pharmacies and pharmacists continue to play a growing role in healthcare as consumer demand for lower cost and convenience pushes the nation’s medical landscape away from centralized healthcare systems. Clinical laboratories have seen this in the increasing trend of consumers seeking vaccinations and home-health tests at their local drug stores.

Results of a pair of surveys dubbed “Pharmacy Next” conducted by Wolters Kluwer Health revealed that 58% of people are now willing to be treated for non-emergency healthcare conditions in non-traditional medical environments, such as retail pharmacies and clinics.

This is a finding that clinical laboratory managers and pathologists should incorporate into their labs’ strategic planning. It portends a shift in care away from the traditional primary care clinic—typically located in the campus around the community hospital—and toward retail pharmacies. Labs will want to capture the test referrals originating from the primary care clinics located in retail pharmacies.

This willingness to access medical care in non-traditional environments is especially true among people in Generation Y (Millennials) and Generation Z (Zoomers)—people born between 1981-1996 (Gen Y) and 1997-2012 (Gen Z), according to Journey Matters.

“As we saw in last year’s survey, primary care decentralization is continuing—the traditional one doctor-one patient, single point of coordination is vanishing, and this is especially evident in younger generations,” said Peter Bonis, MD, Wolters Kluwer’s Chief Medical Officer, in a press release

The online surveys of more than 2,000 US adults was weighted by age, gender, household income, and education to be representative of the entire population of the United States. 

“By preparing for this shift today, providers can work in concert across care sites to deliver the best care to patients,” said Peter Bonis, MD, Wolters Kluwer Health Chief Medical Officer, in a press release. “Likewise, newer care delivery models, like retail pharmacies and clinics, can ensure they’re ready to meet the expectations of healthcare consumers, who will increasingly be turning to them for a growing range of care needs.” Clinical laboratories may find new revenue opportunities working with the primary care clinics operating within local retail pharmacists and clinicians. (Photo copyright: Wolters Kluwer.)

Key Findings of the Wolters Kluwer Pharmacy Next Studies

Some key insights of the surveys include:

  • Care is rapidly decentralizing with 58% stating they are likely to visit a local pharmacy for non-emergency medical care.
  • Younger generations are signaling lasting change within the industry as they are more open to non-traditional styles of care.
  • 61% of respondents envision most primary care services being provided at pharmacies, retail clinics, or pharmacy clinics within the next five years. Of the respondents, 70% of Millennials, 66% of Gen Z, 65% of Gen X, and 43% of Baby Boomers believe this transition will occur.
  • Consumers are worried about prescription costs and availability.
  • 92% of respondents said physicians and pharmacists should inform patients of generic options.
  • 59% of surveyed consumers have concerns about drug tampering and theft when it involves mail order or subscription prescription services.
  • One in three respondents believe convenience is more important than credentials in non-emergency situations.

The survey indicates that healthcare consumers across multiple generations are open to a shift in some medical services from doctors to pharmacists. However, there were some notable differences between generations.

Respondents of the Baby Boomer (55%) and Gen X (57%) generations stated they would trust a physician assistant with medication prescriptions, while only 42% of Gen Z and 47% of Millennial respondents felt the same way. 

Additionally, Boomers (57%) and Gen X (67%) said they would feel comfortable with a nurse practitioner issuing their prescriptions, while only 44% of Gen Z and 53% of Millennials said they would. 

Increased Comfort with Genetic Testing at Pharmacies

The surveys also showed that younger generations are more open to the field of pharmacogenomics, which combines pharmacology and genomics to analyze how an individual’s genetic makeup (aka, heredity) affects the efficacy and reactions to certain drugs. This is a key component of precision medicine.

Overall, 68% of individuals polled believe their individual genomic data could guide prescription decisions, with Millennials (77%) and Gen Z (74%) being the primary believers. Additionally, 88% of respondents stated they see an incentive for health insurers to cover genomic testing, and 72% said they would be open to genetic testing for personalized medical care

But pharmacists and clinicians should be aware that advancing pharmacogenomics will require addressing privacy concerns. According to the Wolters Kluwer study, 57% of Gen Z and 53% of Millennials have apprehension surrounding genetic testing due to privacy risks, with 35% of Gen X and Boomers holding that same opinion.

Healthcare Staff Shortages, Drug Cost a Concern

Survey respondents are also concerned about pharmacy staff shortages and expenditures when seeking care at a pharmacy. Half of the participants are worried they will receive the wrong medication, half worry about getting the incorrect dosage, and almost half (47%) fear receiving the wrong directions due to overburdened pharmacy employees.

More people in Gen Z (59%) and Millennials (60%) had these concerns compared to Gen X (44%) and Boomers (38%).

Sadly, a distressing 44% of those surveyed admitted to not filling a prescription due to the costs. That number jumps to a staggering 56% among individuals with no health insurance, compared to 42% for insured patients.

“From hospitals to doctors’ offices, from pharmacies to pharma and beyond, healthcare must move to more affordable and accessible primary care models, adopt innovations that help deliver more personalized care, and address persistent safety and cost concerns that consumers have about their medications,” said Bonis in the press release.

Can Pharmacies Deliver Primary Care as Well as Doctor’s Offices?

Pharmacies may be logical setting for at least some non-emergency health services. According to the Centers for Disease Control and Prevention (CDC), approximately 90% of the US population live within five miles of a pharmacy and about 72% of visits to physician’s offices involve the prescribing and monitoring of medication therapies.

“Pharmacies did step up during the COVID-19 pandemic. The proof is there that pharmacies can do it,” noted Kevin Nicholson, JD, Vice President of Policy, Regulatory, and Legal Affairs for the National Association of Chain Drug Stores (NACDS), during this year’s Healthcare Information and Management Systems Society (HIMSS) in April,  HealthLeaders reported.

“We’re not talking about complicated services. We’re talking low-acuity, very basic care,” said Anita Patel, PharmD, Vice President of Pharmacy Services Development for Walgreens, at the HIMSS conference.

Pharmacies across the country continue to add more healthcare services to their available public offerings. This trend will likely persist into the future as healthcare becomes more expensive, wait times for physician appointments increases, and medical staff shortages rise. Thus, there may be opportunities for clinical laboratories to support pharmacists and doctors working in retail settings.

—JP Schlingman

Related Information:

What the Next Generation’s Expectations for Primary Care Mean for Pharmacists

US Survey Signals Big Shifts in Primary Care to Pharmacy and Clinic Settings as Consumers Seek Lower Medication and Healthcare Costs

Pharmacy Next: Safer, Affordable and Personalized

Pharmacy Next: Health Consumer Medication Trends

Pharmacy Next: Safety, Service, and Spending

Pharmacy Next: Consumer Trends and Industry Transformation

Wolters Kluwer’s Pharmacy Next Survey Shows 58% of Americans Likely to First Seek Non-emergency Healthcare at Pharmacies

The 7 Generations: What do we know about them?

Should a Pharmacist Be Allowed to Deliver Primary Care Services?

Community Pharmacists’ Contributions to Disease Management during the COVID-19 Pandemic

BioReference Laboratories’ Unique Journey during the COVID-19 Pandemic Described in ‘Swab,’ a New Book by former BRLI CEO Jon Cohen, MD

Certainly every clinical laboratory in the United States has a unique story about dealing with the challenges of the SARS-CoV-2 outbreak, but only BioReference did testing for multiple professional sports leagues and the cruise ship industry

Few would challenge the assertion that the nation’s clinical laboratories (along with public health officials) were caught flat-footed when the SARS-CoV-2 coronavirus reached the United States in the winter of 2021. Even as the federal Centers for Disease Control and Prevention (CDC) and some labs rushed to develop reliable medical laboratory tests for COVID-19 in the early weeks of the outbreak, the demand for tests far outstripped supply in this country for many months.

This was the moment when the pandemic’s need meant lab testing opportunity for medical laboratories across the nation. This was particularly true for Elmwood Park, New Jersey-based BioReference Laboratories, Inc. (BRLI), a division of OPKO, Inc. BioReference found itself in the nation’s first pandemic hot zone—New York City and surrounding counties.

Not only was this lab company geographically in the center of the first overwhelming surge of COVID-19 cases, but its management team had important relationships across government and business. For that reason, its management team was pulled into the earliest planning sessions by government officials at the city, state, and federal level.

Consequently, in the earliest days of the outbreak, BioReference was one of the nation’s first labs to help organize and support drive-through COVID-19 specimen collection centers. Its management team went on to accomplish many notable firsts in the lab’s response to the pandemic. All of this is described in the recently-published book “Swab–Leadership in the Race to Provide COVID Testing to America.”

As CEO of BioReference Laboratories during the time of the COVID-19 pandemic in 2020 and 2021, physician Jon R. Cohen, MD (above), energized his clinical lab’s management team and staff to rise to a series of unique challenges, ranging from helping set up the nation’s first drive-through COVID-19 sampling sites in New York City to performing testing for professional sports leagues, such as the NBA, the NFL, and the NHL. (Photo copyright: New York Foundling, Inc.)

Harnessing the Creativity and Energy of a Clinical Lab Staff

The book’s author is Jon R. Cohen, MD, who was CEO of BioReference Laboratories throughout the course of the pandemic. Cohen is now CEO of Talkspace, a virtual behavioral health company.

“Swab” documents BioReference lab’s response to the SARS-CoV-2 pandemic and tells the tale of how the lab company harnessed the creativity of its managers and lab scientists to speedily build up daily test volumes at a time when automation, analyzers, test kits, collection supplies, and reagents were in short supply.

Clinical laboratory professionals interested in lab management will gain valuable insights from Cohen’s approach to writing “Swab.”

While describing BioReference lab’s many innovative COVID-19 testing services, Cohen also provides readers with the management lessons and insights he used to impart needed skills to the company managers, while also inspiring BioReference Lab’s staff to devote the extra effort necessary to deliver COVID-19 testing in novel ways and in unusual settings.

When New York City hospitals were overwhelmed by cases in the earliest days of the pandemic, Cohen’s personal contacts with political leaders came into play. Just a few years earlier, Cohen had run for statewide office as a Democrat. He had friendships with the New York City Mayor Bill de Blasio, with the New York State Governor Mario Cuomo, and with Senators Charles Schumer and Kirsten Gillibrand.

Cohen’s Lab Had a Seat at Government Planning Tables

As these government officials convened various task forces to address the pandemic, Cohen describes how BioReference had a seat at the table and a voice in viable ways to organize specimen collection and COVID-19 testing literally overnight and on an unprecedented scale.

The pandemic’s early days in late February, March, and April of 2020 were only the first challenges to be overcome by the management at BioReference. “Swab” describes a remarkable progression of innovative SARS-CoV-2 testing programs initiated by Cohen and his team. Each of these testing programs was tailored to the specific needs of different industries. No other clinical laboratory organization in the United States was as successful at serving this range of clients. For example:

  • For the last eight games of the National Basketball Association’s 2020 season and playoffs, BioReference created and managed the NBA’s “biosecure bubble” program at Disney World in Orlando. Over the course of 172 games, 150,000 SARS-CoV-2 tests were performed with zero-positivity.
  • The National Football League watched the NBA play in its bubble that summer. BioReference got the call and worked with NFL management to provide COVID-19 tests. For the 2020 season, in support of 268 games played across the United States, BioReference performed 1.23 million tests for 5,000 players, coaches, and staff, with an infection rate of less than 1%.
  • Along with the NBA and NFL, BioReference provided SARS-CoV-2 testing for professional soccer and hockey, the Winter X Games, and the US men’s and women’s Olympic soccer teams.
  • One of the lab company’s more complex SARS-CoV-2 testing programs involved the cruise ship industry. In 2021, BioReference established sites in 13 ports around the US and the Caribbean. The lab placed staff on as many as 24 cruise ships at one time.
  • Of course, testing for schools, colleges, universities, and employers was part of BRLI’s testing services over the course of the COVID-19 pandemic as well.

Creativity of Clinical Lab Managers and Staff

As the examples above illustrate, “Swab” will give readers a ringside seat in how BioReference Laboratories harnessed the creativity and skills of its management team and staff to address the unprecedented demands for timely, accurate COVID-19 testing from the very beginning of the pandemic through its waning months.

Cohen writes with an accessible style and provides readers with an easy-to-read narrative of his lab company’s journey through the pandemic. Each of the book’s 10 chapters ends with a “Leadership Reflection” that Cohen uses to describe the management methods he utilized to keep BRLI’s thousands of employees on task and on time, so that the end result month after month was “mission accomplished.”

In today’s digital age, the statement “this book is available at a bookstore near you” may not be applicable. What is true is that author Jon R. Cohen’s “Swab–Leadership in the Race to Provide COVID Testing to America” can be ordered at Amazon.com, Alibris.com, and other web-based booksellers. 

—Robert L. Michel

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