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Clinical Laboratories and Pathology Groups

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Clinical Laboratory Scientist in British Columbia Gets Recognition for Identifying the Province’s First Case of COVID-19

Medical technologists and clinical laboratory professionals are the unsung heroes of the COVID-19 pandemic and the public is beginning to notice

Medical technologists (MTs) and clinical laboratory scientists (CLSs) are the foundation of every successful clinical laboratory. But they seldom make the news. Therefore, it is worth noting, during this COVID-19 pandemic, when clinical laboratory professionals receive public recognition for the important role they play in fighting the disease.

A news story published by the Canadian Broadcasting Corporation (CBC), titled, “Lab Tech Who Found B.C.’s 1st Case of COVID-19 Recalls ‘Sheer Terror’ of Discovery,” describes a laboratory technologist’s experience in British Columbia when she discovered the Canadian province’s first positive case of COVID-19 in January of 2020.

Finding COVID-19 for the First Time

On January 27, 2020, Rebecca Hickman, Public Health Laboratory Technologist, Molecular Biology and Genomics at BC Centre for Disease Control (BCCDC) was carefully monitoring samples for COVID-19 and fearing a positive result for the SARS-CoV-2 coronavirus when her worst fear appeared before her eyes.

“I actually started to see it get positive within a few seconds,” Hickman recalled. “My first feeling was sheer terror, from a personal point of view.”

When Hickman realized a sample was going to test positive, she called Tracy Lee, Technical Coordinator at BC Centre for Disease Control and co-designer of the BCCDC’s COVID-19 test. Hickman had to interrupt Lee in a meeting, who then hurried to the lab to watch the test complete. It was a definite positive, the first confirmed case in British Columbia.

“To design, validate, and implement a molecular laboratory test usually takes months if not years, and so to do that in the span of days is a huge achievement,” Hickman told the CBC.

The following day, it was announced to the residents of BC that the COVID-19 coronavirus was in their province and that they needed to start taking necessary precautions. “This is the first time in my life I’ve ever found things out before I read it in the news,” Hickman said.

Supply Shortages Challenge British Columbia Clinical Laboratories

Hickman noted there have been several challenges in dealing with COVID-19 over the past year. “The instability and craziness of it all has been the hardest part,” she said. Last spring, the BC lab, like most labs, had to deal with a shortage of supplies and personal protective equipment.

According to BC Centre for Disease Control (BCCDC) data, as of March 2, 2021, there have been 81,367 confirmed cases of COVID-19 in the province of British Columbia. A total of 75,255 of those individuals have recovered from the coronavirus, more than 300 patients remain hospitalized, and 1,365 British Columbians have perished due to COVID-19. The population of the western Canadian province is approximately 5.1 million.

Today, Hickman, spends a majority of her time in the laboratory doing whole genome sequencing of confirmed COVID-19 cases. The data she collects is used for outbreak response and for tracking new variants of the SARS-CoV-2 coronavirus that are appearing in different parts of the world. “It has been easily the most difficult year of my life, but also the most fulfilling,” she told the CBC. “What we have achieved here over the last year is huge.”

B.C. Centre for Disease Control in British Columbia, Canada, researchers Tracy Lee and Rebecca Hickman
In their laboratory at the B.C. Centre for Disease Control in British Columbia, Canada, researchers Tracy Lee (above left) and Rebecca Hickman (above right) “are designing new tests to quickly identify variants of the COVID-19 virus,” North Shore News (NSN) reported. Now, wrote NSN, “the pair are working on a new type of ‘rapid test’ that will be able to detect ‘variants of concern’—particularly the U.K., South African, and Brazilian variants—at the same time as determining if a test is positive for COVID-19. When it’s finalized, that test is expected to dramatically speed up the process of hunting the variants.” (Photo copyright: North Shore News.)

Clinical Laboratories on the Front Lines

Last year, the American Society for Clinical Pathology (ASCP) produced a docuseries titled, “Laboratories on the Front Lines: Battling COVID-19” which highlighted the critical work clinical laboratories are doing to care for patients during the SARS-CoV-2 pandemic. The five-part series interviewed medical laboratory professionals across the US about their experiences during the pandemic.

In one episode, Stephanie Horiuchi, Clinical Microbiology Specialist at UCLA Health Systems, discussed how challenging and rewarding it has been working on the pandemic.

“Very long days. I’m not going to lie. Very, very long days, but it’s rewarding. I know the importance of what I am doing, and I know the importance of what needs to be done,” she said. “So, the time that I am here, it does go by very fast. You look up at the clock and you’re like oh, its 9pm. And then when I go home, it’s just eat and go to sleep and then rinse and repeat.

“I feel that this is a really important area of work that we all do as microbiologists,” Horiuchi continued. “And to just serve patients every day and to know that I am helping someone, it really warms my soul.”

In another episode of the docuseries, Professor of Pathology and Laboratory Medicine Alyssa Ziman, MD, Division Chief, Clinical Laboratory Medicine at UCLA Health, was interviewed regarding how they are coping with the increased demand for medical laboratory services.

“It’s been a really difficult and challenging time for our health system, for our laboratories, for our staff that are working through to provide the best possible patient care,” she said. Ziman is also Medical Director, Transfusion Medicine, at UCLA Health and Medical Director, Clinical Laboratories, at Ronald Reagan UCLA Medical Center. “Every day is a new challenge and a new way to adapt to changing rules from the CDC and from the LA County Public Health Department and to really evolve, so that we can continue to provide the testing that we have and continue to support our staff and our patients.” 

Unsung Heroes of COVID-19

The COVID-19 pandemic has placed a strain on medical resources throughout the world. Clinical laboratory professionals are emerging as the unsung heroes of the crisis and the entire medical laboratory profession is receiving much deserved positive recognition for the crucial role laboratories are playing in fighting the pandemic.  

—JP Schlingman

Related Information:

Lab Tech Who Found B.C.’s 1st Case of COVID-19 Recalls ‘Sheer Terror’ of Discovery

Who is Doing All Those COVID-19 Tests? Why you Should Care about Medical Laboratory Professionals

Laboratories on the Front Lines: Battling COVID-19

BC COVID-19 Data

Variant-Hunting Researchers on the Cutting Edge of B.C.’s Race Against COVID

Consumer Genetic Testing Company 23andMe to Merge with Sir Richard Branson’s VG Acquisition Corp. and Go Public

The merger is expected to boost investment in 23andMe’s consumer health and therapeutics businesses

After years of spectacular growth, the popularity of direct-to-consumer (DTC) genetic testing is beginning to wane. Nevertheless, opportunities still exist in the DTC genetic testing market for visionaries with funds to invest.

One such visionary is billionaire Richard Branson, founder of the multinational venture capital conglomerate Virgin Group (VG). Branson’s VG Acquisition Corp. (NYSE:VGAC), a special purpose acquisition company (SPAC), announced it is merging with 23andMe of Sunnyvale, Calif., to create a publicly-traded company with the New York Stock Exchange ticker symbol ME.  

In a VG press release, Branson states his reason for the merger. “Of the hundreds of companies we reviewed for our SPAC, 23andMe stands head and shoulders above the rest,” he said. “As an early investor, I have seen 23andMe develop into a company with enormous growth potential. Driven by [CEO Anne Wojcicki’s] vision to empower consumers, and with our support, I’m excited to see 23andMe make a positive difference to many more people’s lives.”

According to a 23andMe press release, the deal values the company at approximately $3.5 billion and will net the consumer genetics and research company as much as $759 million in additional cash. Wojcicki and Branson each invested $25 million themselves as part of the $250 million fund to take the company public.

CEO Anne Wojcicki headshot
“As a fellow industry disruptor as well as an early investor in 23andMe, we are thrilled to partner with Sir Richard Branson and VG Acquisition Corp. as we approach the next phase of our business, which will create new opportunities to revolutionize personalized healthcare and medicine,” 23andMe co-founder and CEO Anne Wojcicki (above) said in the press release. “We have always believed that healthcare needs to be driven by the consumer, and we have a huge opportunity to help personalize the entire experience at scale, allowing individuals to be more proactive about their health and wellness. Through a genetics-based approach, we fundamentally believe we can transform the continuum of healthcare.” (Photo copyright: Inc. magazine.)

Participation in Research Key to Future of DTC Genetics Testing

Though DTC genetic testing kit sales have slowed in recent years for both 23andMe and rival Ancestry, Wojcicki believes the company’s database of 10 million customers—with 80% of customers agreeing to participate in research—is the key to its future.

“We have always seen health as a much bigger opportunity” than genealogy, Wojcicki told The Wall Street Journal (WSJ).

According to the WSJ, 23andMe customers fill out more than 30,000 surveys each day on health and related issues. With that information, the company has determined its database includes 1.7 million people with high cholesterol, nearly 1.6 million with depression and 539,000 with Type 2 diabetes, information that is highly valued by medical researchers and those running clinical trials.

Personalizing Healthcare through DTC Genetic Testing

Wojcicki expects the merger will propel the consumer DNA-testing company into personalized medicine and therapeutics. “We have always believed that healthcare needs to be driven by the consumer, and we have a huge opportunity to help personalize the entire experience at scale, allowing individuals to be more proactive about their health and wellness,” Wojcicki said in a statement. “Through a genetics-based approach, we fundamentally believe we can transform the continuum of healthcare.”

In August 2020, the US Food and Drug Administration “granted 23andMe a 510(k) clearance for a pharmacogenetics report on two medications—Clopidogrel, prescribed for certain heart conditions, and Citalopram, which is prescribed for depression,” 23andMe announced in a blog post.

“This impactful pharmacogenetics information can now be delivered without the need for confirmatory testing, a testament to the clinical validity of 23andMe results,” said Kathy Hibbs, 23andMe Chief Legal and Regulatory Officer, in the blog post. “23andMe remains the only company with direct-to-consumer pharmacogenetic reports cleared by the FDA.”

23andMe’s trove of genetic data already has netted it a partnership with GlaxoSmithKline (GSK). According to a GSK press release, in 2018, the two companies signed a four-year research and development agreement. The collaboration targets novel medicines and potential cures using human genetics as the basis for discovery.

COVID-19 Boosts 23andMe’s Sales

During a joint interview with Branson in Bloomberg News about the merger, Wojcicki said, “COVID-19 has really opened up doors.” Now more than ever, she said, people are interested in preventative healthcare. “I’ve had this dream since 2003 that genetics would revolutionize healthcare and that’s really the era I see we can now usher in,” she added.

As 23andMe pushes further into personalized therapeutics, clinical laboratories and pathology groups would be wise to watch and see if this new entrant accelerates healthcare’s shift to the precision medicine model of personalized care.

—Andrea Downing Peck

Related Information:

23andMe to Merge with Virgin Group’s VG Acquisition Corp. to Become Publicly Traded Company Set to Revolutionize Personalized Healthcare and Therapeutic Development through Human Genetics

23andMe Go Public with Richard Branson Backed SPAC

GSK and 23andMe Sign Agreement to Leverage Genetic Insights for the Development of Novel Medicines

23andMe Lays Off 100 People, CEO Anne Wojcicki Explains Why

FDA Grants 23andMe Clearance to Offer Interpretive Drug Information for Two Medications

Fears over DNA Privacy as 23andMe Plans to Go Public in Deal with Richard Branson

23andMe to Go Public as $2.5 Billion Company via Branson Merger

Apple’s $10 Million Grant Helps COPAN Diagnostics Increase Production of COVID-19 Sample Collection and Transport Products by 4,000%

This is one more example of how Silicon Valley companies are lining up collaborations with in vitro diagnostics companies to gain a foothold in the clinical laboratory marketplace

For years, Apple, Google, and other Silicon Valley companies have taken progressive steps to become more engaged in healthcare. One recent example of a Silicon Valley company willing to invest in clinical laboratory testing came last year in the form of a $10 million grant Apple (NASDAQ:AAPL) made to COPAN Diagnostics of Murrieta, Calif., to increase the speed and production of the company’s COVID-19 sample collection and transport products.

The interesting aspect of this collaboration was that Apple’s primary role was to help COPAN:

  • streamline workflow and speed of throughput,
  • help with the incoming supply chain, and
  • help develop outgoing supply chain solutions—along with some capital investment.

From the start of the pandemic in the winter of 2020, SARS-CoV-2 sample collection kits were one of many items that were in short supply here in the United States. To help address those shortfalls, teams at Apple, COPAN, and multiple other companies across the US worked to improve the work processes, automation, and machinery COPAN uses in its manufacturing and production sites. This collaboration increased production by nearly 4,000%  between April 2020 and February 2021, an Apple news release reported.

Jeff Williams  Apple’s Chief Operating Officer in a blue shirt on a stage
In the news release, Jeff Williams (above), Apple’s Chief Operating Officer, said, “We are proud our Advanced Manufacturing Fund is supporting companies like COPAN who are playing a critical role in the fight against COVID-19 and assisting healthcare professionals and communities across the country. This collaboration helped produce, ship, and deliver millions of sample collection kits to hospitals from coast to coast—and we believe it is this unique combination of American manufacturing and innovation that will help us emerge from this crisis and build a safer world for us all.” (Photo copyright: Apple Insider.)

Healthcare Has Long Been a Target for Big Tech

Investment in different sectors of the US healthcare system by one of the Big Tech companies is not unusual. Apple, Google, Amazon, and Microsoft have looked for ways to expand their respective footholds in the healthcare marketplace for years.

In “How the ‘Big 4’ Tech Companies Are Leading Healthcare Innovation”—published a full year before the COVID-19 pandemic began—Healthcare Weekly noted that, “At a high level, each of the ‘Big 4’ tech companies are leveraging their own core business strengths to reinvent healthcare by developing and collaborating on new tools for patients, care providers, and insurers that will position them for healthcare domination.”

In 2017, Apple announced the launch of the Advanced Manufacturing Fund, saying that the $1 billion fund was a way to give back to communities through job creation. “By doing that, we can be the ripple in the pond. Because if we can create many manufacturing jobs around, those manufacturing jobs create more jobs around them because you have a service industry that builds up around them,” Apple’s CEO Tim Cook told CNBC at that time.

In 2018, Apple boosted the fund from $1 billion to $5 billion, the Mac Observer reported.

Apple’s $10 million investment enabled COPAN Diagnostics to expand into a new facility as well as hire 250 new employees. “We are proud our Advanced Manufacturing Fund is supporting companies like COPAN who are playing a critical role in the fight against COVID-19 and assisting healthcare professionals and communities across the country,” Williams said in the news release.

COPAN and the On-Going Need for COVID-19 Test Kits

COPAN Diagnostics was founded in 1979 in Mantua, Italy, and is now a global force in the manufacture of many sample collection and transport products such as instruments, automation, swabs, pipettes, and, of course, SARS-CoV-2 sample collection and transport kits. At the time of Apple’s investment, COPAN was producing sample collection and transport products at its Murrieta, Calif., facility. But demand for these products far outweighed the supply.

In an interview, Norman Sharples, CEO of COPAN Diagnostics and head of operations for North and South America, said he was hoping to increase production in the earliest days of the pandemic when Jeff Williams, COO at Apple, contacted him regarding the Advanced Manufacturing Fund. Along with the $10 million grant, Williams offered experts in engineering and sourcing to help COPAN increase production, the San Diego Union-Tribune reported.

The result was a new manufacturing facility in Carlsbad, Calif., which increased COPAN’S production of its sample collection and transport products used in SARS-CoV-2 testing by nearly 4,000%.

“From taking the keys to the building to actually getting the California department for public inspection, which allows us to go live and sell the product, that was just over 30 days, which is an incredible campaign that Apple helped us with,” Sharples told the San Diego Union-Tribune, adding, “It wasn’t just the funding. It was [the experts from Apple] applying their know-how and expertise to tilt this up very fast.”

Even as COVID-19 vaccines roll out, demand for SARS-CoV-2 tests—along with the necessary specimen collection and transport supplies—will likely continue. As the economy reopens, workers return to offices, and students return to in-person schools, precautionary screening for COVID-19 will remain necessary. “I think demand is going to flatten a little bit, but in any case, the baseline is going to be high because of surveillance,” Sharples said. “The back-to-work programs will drive more surveillance.”

Pandemic Increases Big Tech’s Dominance in Healthcare

Where many businesses and entire industries struggled with the pandemic, Big Tech apparently did not. In late October 2020, CBS News reported, “America’s largest technology companies are thriving despite the economy’s woes, according to earnings posted by Google-parent Alphabet, Amazon, Apple, Facebook, and Twitter on Thursday.”

Along with growing profits, Big Tech companies also consolidated their dominance. “As the pandemic made us even more dependent on digital technology, it has made the systemic importance and enormous power of the tech giants even more apparent,” according to an article in SciencesPo, titled, “Is the COVID-19 Pandemic a Victory for Big Tech?

Might Big Tech Investments Target Clinical Laboratory Testing?

There’s no reason to believe that the big technology companies will slow their investment in healthcare anytime soon, and that investment may benefit clinical laboratories. In fact, in “11 Recent Big Tech Partnerships in Healthcare,” Becker’s Hospital Review listed several technology companies that will likely affect pathology laboratories.

Big Tech investment in genetic testing, artificial intelligence, telehealth, and other technologies may alter how clinical laboratories operate and revolutionize the healthcare industry. 

—Dava Stewart

Related Information:

Apple’s Advanced Manufacturing Fund Helps COPAN Diagnostics Ship Millions of COVID-19 Test Kits

Apple Awards $10 Million from Advanced Manufacturing Fund to COPAN Diagnostics

Apple Helps Develop COVID-19 Test Kits; Boosted Output by 4,000%

How the “Big 4” Tech Companies Are Leading Healthcare Innovation

Apple Just Promised to Give US Manufacturing a $1 Billion Boost

With Apple’s Help, COPAN Diagnostics Ships Millions of COVID Sample Collection

Kits from New Carlsbad Factory

Big Tech Companies, Fully Recovered from Pandemic, Report Record Earnings

Is the COVID-19 Pandemic a Victory for Big Tech?

11 Recent Big Tech Partnerships in Healthcare

During Pandemic, Clinical Laboratories Should Be Alert for Drug Resistant Infections That Pose High Risk to COVID-19 Patients

On top of everything else during this pandemic, drug-resistant infections are threatening the most vulnerable patients in COVID-19 ICUs

New study by researchers at the University of Minnesota highlights the continuing need for microbiologists and clinical laboratories to stay alert for COVID-19 patients with drug-resistant infections. In their study, researchers highlighted CDC statistics about the number of Candida auris (C. auris) infections reported in the United States during 2020, for example.

In a paper, titled, “Three Cases of Worrisome Pan-Resistant C Auris Found in New York,” the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota reported that “As of Dec 11, the CDC said 941 confirmed and probable C. auris cases have been reported in 13 states, and an additional 1,830 patients have been found to be colonized with the multidrug-resistant fungus. Most of the cases have been detected in the New York City area, New Jersey, and the Chicago area.”

Candida auris is a particularly nasty fungus. It spreads easily, is difficult to remove from surfaces, and can kill. Worst of all, modern drugs designed to combat this potentially deadly fungus are becoming less effective at eradicating it, and COVID-19 ICU patients appear especially vulnerable to C. auris infections.

In “Potentially Fatal Fungus Invades Hospitals and Public Is Not Informed,” Dark Daily reported how Candida auris’ ability to elude detection makes decontamination of hospital rooms far more complicated. And in “CDC Ranks Two More Drug-Resistant Microbes as ‘Urgent Threat’ to Americans; Clinical Laboratories Are Advised to Increase Awareness of Antimicrobial Resistance,” we covered how the federal Centers for Disease Control and Prevention (CDC) added C. auris to its “Biggest Threats and Data: Antibiotic Resistance Threats in the United States” report for 2019.

COVID-19 and C. auris a Potentially Devastating Combination

Hospitals in many areas are at a critical capacity. Thus, hospital-acquired infections such as sepsis can be particularly dangerous for COVID-19 patients. Adding to the problem, C. auris requires special equipment to identify, and standard medical laboratory methods are not always enough. Misidentification is possible, even probable.

A paper in the Journal of Global Antimicrobial Resistance (JGAR), titled, “The Lurking Scourge of Multidrug Resistant Candida Auris in Times of COVID-19 Pandemic,” notes that “A particularly disturbing feature of COVID-19 patients is their tendency to develop acute respiratory distress syndrome that requires ICU admission, mechanical ventilation, and/or extracorporeal membrane oxygenation. … This haunting facet of COVID-19 pandemic has severely challenged even the most advanced hospital settings. Yet one potential confounder, not in the immediate attention of most healthcare professionals, is the secondary transmission of multidrug resistant organisms like the fungus Candida auris in COVID-19 ICUs. … C. auris outbreaks occur in critically ill hospitalized patients and can result in mortalities rates ranging from 30% to 72%. … Both C. auris and SARS-CoV-2 have been found on hospital surfaces including on bedrails, IV poles, beds, air conditioner ducts, windows and hospital floors. Therefore, the standard COVID-19 critical care of mechanical ventilation and protracted ventilator-assisted management makes these patients potentially susceptible to colonization and infections by C. auris.”

One study mentioned in the JGAR paper conducted in New Delhi, India, looked at 596 cases where patients were admitted to the ICU with COVID-19. Fifteen of them had infections caused by C. auris. Eight of those patients died. “Of note, four patients who died experienced persistent fungemia and despite five days of micafungin therapy, C. auris again grew in blood culture,” according to reporting on the study in Infection Control Today (ICT).

Some C. auris mortality rates are as high as 72%. And patients with weakened immune systems are at particular risk, “making it an even more serious concern when 8% to 9% of roughly 530,000 ICU patients in the United States have COVID-19,” ICT reported.

Apparently, the COVID-19 pandemic has created circumstances that are particularly suited for C. auris to spread. “Given the nosocomial transmission of SARS-CoV-2 by those infected, many hospital environments may serve as venues for C. auris transmission as it is a known environmental colonizer of ICUs,” wrote the JGAR paper authors.

CDC Reports and Recommendations

Along with being especially dangerous for people with weakened immune systems, C. auris infections also produce symptoms similar to those of COVID-19, “including fever, cough, and shortness of breath,” according to the CDC’s website. People admitted to ICUs with COVID-19 are especially vulnerable to bacterial and fungal co-infections. “These fungal co-infections are reported with increasing frequency and can be associated with severe illness and death,” says the CDC.

C. auris outbreaks in the United States have mostly been in long-term care facilities, but the pandemic seems to be changing that and more outbreaks have been detected in acute care facilities, the CDC reported. The lack of appropriate personal protective equipment (PPE), changes in infection control routines, and other factors could be to blame for the increase.

Just as community spread is an issue with COVID-19 variants, so too is it a concern with C. auris infections. “New C. auris cases without links to known cases or healthcare abroad have been identified recently in multiple states, suggesting an increase in undetected transmission,” the CDC noted.

As of January 19, 2021, according to the CDC the case count of C. auris infections in the US was 1,625, with California, Florida, Illinois, New Jersey, and New York having more than 100 cases each.

According to a CDC report, “Candida auris (C. auris) is an emerging multidrug-resistant yeast (a type of fungus). It can cause severe infections and spreads easily between hospitalized patients and nursing home residents.” The graphic above, taken from the report, illustrates how “C. auris began spreading in the United States in 2015. Reported cases increased 318% in 2018 when compared to the average number of cases reported in 2015 to 2017.” (Graphic copyright: Centers for Disease Control and Prevention.)

Using Clinical Laboratory Tests to Identify C. Auris

One of the big concerns about C. auris is that it is so difficult to detect, and that medical laboratories in some countries simply do not have the technology and resources to identify and tackle the infection.

“As C. auris diagnostics in resource-limited countries is yet another challenge, we feel that alerting the global medical community about the potential of C. auris as a confounding factor in COVID-19 is a necessity,” wrote the authors of the paper published in the Journal of Global Antimicrobial Resistance.

As if the COVID-19 pandemic has not been enough, drug resistant bacteria, viruses, and deadly fungi are threatening to wreak havoc among SARS-CoV-2 infected patients. Microbiologists and medical laboratory scientists know that testing for all types of infections is vitally important, but especially when it comes to infections caused by antibiotic-resistant bacteria (ARB) and other dangerous organisms that demonstrate antimicrobial resistance (AMR).

Microbiologists and clinical laboratory professionals will want to stay informed about the number of C. auris cases identified in the US and the locations and settings where the fungus was detected. They will want to be on the alert within their hospitals and health networks, as well as with the doctor’s offices served by their labs.

—Dava Stewart

Related Information:

Potentially Fatal Fungus Invades Hospitals and Public Is Not Informed

CDC Ranks Two More Drug-Resistant Microbes as ‘Urgent Threat to Americans; Clinical Laboratories Are Advised to Increase Awareness of Antimicrobial Resistance:

Biggest Threats and Data: Antibiotic Resistance Threats in the United States report for 2019

Three Cases of Worrisome Pan-Resistant C auris Found in New York

COVID Unleashes the ‘Lurking Scourge’ Candida Auris

The Lurking Scourge of Multidrug Resistant Candida auris in Times of COVID-19 Pandemic

CDC: Fungal Diseases and COVID-19

CDC: Candida auris

Families Are Choosing Home Healthcare Over Nursing Home Placements for Elderly Relatives Because of COVID-19

Occupancy rates at skilled nursing facilities remain well below pre-pandemic levels, a trend that weakens the financial health of nursing homes and means fewer test referrals to clinical laboratories that service them

COVID-19 is taking a financial bite out of the nursing home industry as seniors opt for home care rather than entering nursing facilities. If this trend becomes permanent, clinical laboratories may have to ramp up their ability to collect specimens from a growing population of patients who choose non-traditional healthcare settings. And as the SARS-CoV-2 pandemic stretches on, the exodus of seniors from nursing home facilities provides another example of how COVID-19 is altering consumers’ access to healthcare.

According to the most recent “AARP Nursing Home COVID-19 Dashboard Fact Sheets,” the COVID-19 pandemic “has swept the nation, killing more than 160,000 residents and staff of nursing homes and other long-term care facilities.”

Because COVID-19 has hit nursing home residents the hardest, many families have decided elderly parents may be safer living with relatives than in nursing homes that have proven vulnerable to widespread outbreaks. In addition, COVID-19-related lockdowns in skilled nursing facilities (SNFs) have provided families with additional motivation to choose home care for elderly relatives. 

For example, in “Should You Bring Mom Home from Assisted Living During the Pandemic?” retired Seattle physician Alison Webb, MD, told Kaiser Health News (KHN) she moved her 81-year-old father, who has moderate dementia, out of assisted living so he could be with grandchildren and enjoy gardening rather than remain in his senior facility, where COVID-19 protocols kept him sequestered from friends and family.

This is not an isolated example and may have a long-term impact on clinical laboratories that service skilled nursing facilities.

Patient Volume Falls Dramatically at Skilled Nursing Facilities

While hospital discharge rates are rebounding to near pre-pandemic levels, an Avalere Health analysis of Medicare fee-for-service claims found a “more drastic and lasting decline in patient volume” at skilled nursing facilities. In contrast, Avalere found home health has experienced a rebound in patient numbers beginning last May.

“In the early months of the COVID-19 outbreak in the US, we saw a substantial decrease in hospital discharges to both skilled nursing facilities and home health agencies,” said Heather Flynn, Consultant at Avalere, in an Avalere press release. “Hospital discharges are steadily moving back to pre-pandemic levels, but our analysis points to an uneven ‘return to normal’ across care settings.”

The graph above, taken from the Avalere press release, reveals “a stark decline in inpatient hospital discharges and discharges to both SNF and home health beginning in February 2020. The analysis further indicated that the skilled nursing industry has experienced a more drastic and lasting decline in patient volume relative to total hospital volume and discharges to home health (where rebounds were observed beginning in May). Of note, discharges to home health experienced a year-over-year increase in June 2020, at 4.6% greater discharge volume when compared to June 2019, while discharges to SNF remained notably below pre-pandemic levels at a 25.4% decrease in year-over-year discharges.” (Graphic copyright: Avalere Health.)

Bill Kauffman, CFA, Senior Principal at National Investment Center for Seniors Housing and Care (NIC), believes the skilled nursing industry may be experiencing a permanent prolonged reduction in occupancy levels.

“Skilled nursing facility occupancy typically slows in April after an uptick during the flu season, but we haven’t seen anything like this in recent memory,” Kauffman said in an NIC press release which announced nursing home occupancy had dropped to 78.9% last April, 2020, down 5.5% from 2019. “The long-term effect of COVID-19 on skilled nursing occupancy remains to be seen as the industry adjusts to a new normal.”

Since then, the occupancy rate in skilled nursing properties has fallen even further. The latest Skilled Nursing Monthly Report announced a new low of 74.2%.

Will Clinical Laboratories That Service Skilled Nursing Homes Be Affected?

Low occupancy rates may be pushing the nursery home industry toward a financial crisis. According to an August 2020 survey conducted by the American Health Care Association (AHCA) and National Center for Assisted Living (NCAL), 55% of the nation’s nursing homes are operating at a loss and 89% operate with a profit margin of 3% or less.

Mark Parkinson (above), President and CEO of the AHCA and former Governor of Kansas, maintains a successful COVID-19 vaccination rollout and lifting of nursing home visitation bans are keys to the industry’s recovery. “I think the census needs to recover about 1% a month. If we can recover 1% a month on a steady basis, that gets us to the end of 2021,” Parkinson told Skilled Nursing News. “And we’re still down, but we’re down 5% or 6%; we’re not down 13% or 14%. If we recover a half a percent, some businesses will be okay, but not all. If we only recover half a percent, we don’t get any more money, folks are going to have problems. If we don’t have any recovery on census … things are very, very bad.” (Photo copyright: Kansas Health Institute.)

There are signs the nursing home industry may have to contend with home healthcare becoming a permanent competitor for patients. In a news release last spring, the Mayo Clinic announced it was partnering with Medically Home of Boston to launch a virtual hospital-at-home model aimed at delivering “advanced care” from a network of paramedics, nurses, and support team in a home care setting.

The initiative means patients can receive a range of healthcare services in their homes that traditionally required a hospital setting. The services include:

  • Infusions,
  • Skilled nursing,
  • Clinical laboratory and imaging services,
  • Behavioral health and rehabilitation services.

While the initial program rollout will allow Mayo Clinic to free up ventilators and hospital space for COVID-19 patients, John Halamka, MD, an emergency medicine physician and President of Mayo Clinic Platform, told Modern Healthcare, “Next, we’ll look to forward-thinking organizations who believe like we do in that care should be more convenient and accessible.”

Discharge Doctors Now Choose Home Healthcare Over Skilled Nursing Facilities

Physicians also are embracing home care in greater numbers. As reported in Forbes, a 2020 William Blair survey showed 81% of physicians responsible for discharge planning would send patients to a home health agency rather than a skilled nursing facility. Pre-pandemic, only 54% of discharging physicians expressed a preference for home care, according to the survey.

Greg Chittim, Partner at Health Advances, an international strategy consulting firm headquartered in Boston, points to improvements in virtual technologies as the catalyst for home care’s growth.

“One of the silver linings of COVID-19 is the level of investment we are seeing in virtual care technologies,” Chittim told Forbes. “And beyond the technologies, providers and patients are building that comfort with traditional real-time communication. I think we have moved 10 years ahead in 10 months.”

As the COVID-19 pandemic rolls on and home health initiatives become more commonplace and grow in popularity, clinical laboratory managers may want to develop solutions that assist home healthcare providers with collecting and shipping patient specimens for testing.

—Andrea Downing Peck

Related Information:

Decline in Skilled Nursing Occupancy Continues Due to COVID-19 Pandemic

Hospital Discharges to Home Health Rebound While SNF Volumes Lag

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Amazon, Berkshire Hathaway, and JPMorgan Chase Close Haven Healthcare After Only Three Years in Operation

Despite high-hopes and much fanfare, the collaboration failed to transform healthcare and lower healthcare costs for everyday Americans as many anticipated it would

Another anticipated “disruptor” to today’s healthcare market is closing its doors. Three years ago, in 2018, Amazon (NASDAQ:AMZN), Berkshire Hathaway (NYSE:BRK.A), and JPMorgan Chase (NYSE:JPM) announced a joint venture to enter into the healthcare market and use their combined market leverage to secure lower-cost healthcare for their 1.2 million employees. At that time, healthcare business experts suggested Haven Healthcare (Haven), as the non-profit joint venture was named, might become a transformative healthcare model other companies could follow.

But that was not to be. In January, the companies announced Haven would close its doors in February. Why did it fail to accomplish its goals? And how will its demise affect the healthcare benefits provided to the thousands of people employed at these companies? The answers to these questions should be of interest to pathologists and medical laboratory managers who want to position their clinical labs as high-quality, added-value contributors to patient care.

One Expert’s Opinion on Demise of Haven Healthcare

In an article he penned for Harvard Business Review, titled, “Why Haven Healthcare Failed,” John S. Toussaint MD, an internist, former healthcare CEO, and founder and Executive Chairman of Catalysis, a non-profit healthcare educational institute, outlined three major reasons for Haven’s closing:

  • Insufficient Market Power: According to Toussaint, the three companies simply did not have the market power to dominate a large enough share of any local market. In addition, with a combined 1.2 million employees, the companies did not have enough employees to incentivize providers into lowering prices.
  • Perverse Incentives: In the current healthcare environment, US insurers and providers make huge profits from treating disease. This means there is little incentive to keep people out of hospitals or accept the risks associated with fixed-price capitation. 
  • Poor Timing: The COVID-19 pandemic forced providers to focus on and manage the crisis, which, in turn, caused them to postpone or even cancel elective and non-emergency medical procedures, resulting in financial hits and the unwillingness to take on the uncertainty associated with new, possibly dubious arrangements.

Why Is It Hard to Disrupt Healthcare?

Jeff Becker, Principal Analyst, Healthcare, CB Insights, told Quartz, “Haven is yet another cautionary tale to outsiders [who] hope to disrupt the industry that their ambition is likely unrealistic and that solving key industry problems proves to be far more difficult than most anticipate.”

Other experts point to a vague plan, an overly ambitious strategy, difficulty retaining top talent, a lack of visible progress, and the divergence of interests between the three companies as potential reasons for Haven’s demise, Quartz reported.

“Haven’s decision to cease operations proves just how hard it is to disrupt the healthcare system in America,” Robert Andrews, JD (above), a former US Congressman for the state of New Jersey, and CEO of Health Transformation Alliance, told Forbes. “Even three of the largest and most influential employers in the country found the challenge a very steep one. We share with Haven’s founders the conviction that employer sponsorship is key.” (Photo copyright: United States House of Representatives.)

Did Haven Healthcare Demonstrate Any Innovation?

It is unclear what the collaboration accomplished or what exactly led to its demise, but it does seem that some positive developments were created through the venture. 

According to Forbes, Haven Healthcare stated on its now-defunct website, “In the past three years, Haven explored a wide range of healthcare solutions, as well as piloted new ways to make primary care easier to access, insurance benefits simpler to understand and easier to use, and prescription drugs more affordable. Moving forward, Amazon, Berkshire Hathaway, and JPMorgan Chase and Co. will leverage these insights and continue to collaborate informally to design programs tailored to address the specific needs of their own employee populations.”

At least one of the three partners may have anticipated Haven’s closure and taken proactive steps. In January of 2020, Dark Daily reported that Amazon Care launched a pilot program which offers virtual primary care to its Seattle employees, and features both telehealth and in-home care services, including clinical laboratory testing.

At that time, we noted the similarities with Haven Healthcare.

And in “Amazon Building Labs to Do COVID-19 Testing,” Dark Daily’s sister publication The Dark Report covered how, as a result of the COVID-19 pandemic, Amazon built and now operates multiple clinical laboratories for testing its employees.

Amazon has a history of entering an industry and successfully disrupting it. Its willingness to build lab testing facilities to do its own COVID-19 testing may be the first step in a multi-year strategy to enter the clinical laboratory industry and disrupt it by offering better quality lab testing services at a cheaper price.  

Thus, it is likely these medical laboratories will continue to deliver clinical testing even after the pandemic has officially ended and will compete with local independent clinical laboratories.

—JP Schlingman

Related Information:

Why Jeff Bezos, Warren Buffett, and Jamie Dimon Gave up on Their Venture to Disrupt US Healthcare

Amazon’s Haven Healthcare Venture to Shut Down

Why Haven Healthcare Failed

Haven Is Shutting Down, 3 Years After It Terrified Health-Care Investors

Amazon Care Pilot Program Offers Virtual Primary Care to Seattle Employees; Features Both Telehealth and In-home Care Services That Include Clinical Laboratory Testing

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