In the absence of a “gold standard,” researchers are finding a high frequency of false negatives among SARS-CoV-2 RT-PCR tests
Serology tests designed to detect antibodies to the SARS-CoV-2 coronavirus that causes the COVID-19 illness have been dogged by well-publicized questions about accuracy. However, researchers also are raising concerns about the accuracy of molecular diagnostics which claim to detect the actual presence of the coronavirus itself.
“Diagnostic tests, typically involving a nasopharyngeal swab, can be inaccurate in two ways,” said Steven Woloshin, MD, MS, in a news release announcing a new report that “examines challenges and implications of false-negative COVID-19 tests.” Woloshin is an internist, a professor at Dartmouth Institute, and co-director of the Geisel School of Medicine at Dartmouth.
“A false-positive result mistakenly labels a person infected, with consequences including unnecessary quarantine and contact tracing,” he stated in the news release. “False-negative results are far more consequential, because infected persons who might be asymptomatic may not be isolated and can infect others.”
Woloshin led a team of Dartmouth researchers who analyzed two studies from Wuhan, China, and a literature review by researchers in Europe and South America that indicated diagnostic tests for COVID-19 are frequently generating false negatives. The team published their results in the June 5 New England Journal of Medicine (NEJM).
For example, one research team in Wuhan collected samples from 213 hospitalized COVID-19 patients and found that an approved RT-PCR test produced false negatives in 11% of sputum samples, 27% of nasal samples, and 40% of throat samples. Their research was published on the medRxiv preprint server and has not been peer-reviewed.
The literature review Woloshin’s team studied was also published on medRxiv, titled, “False-Negative Results of Initial Rt-PCR Assays for COVID-19: A Systematic Review.” It indicated that the rate of false negatives could be as high as 29%. The authors of the review looked at five studies that had enrolled a total of 957 patients. “The collected evidence has several limitations, including risk of bias issues, high heterogeneity, and concerns about its applicability,” they wrote. “Nonetheless, our findings reinforce the need for repeated testing in patients with suspicion of SARS-Cov-2 infection.”
Another literature review, published in the Annals of Internal Medicine, titled, “Variation in False-Negative Rate of Reverse Transcriptase Polymerase Chain Reaction–Based SARS-CoV-2 Tests by Time Since Exposure,” estimated the probability of false negatives in RT-PCR tests at varying intervals from the time of exposure and symptom onset. For example, the authors found that the median false-negative rate was 38% if a test was performed on the day of symptom onset, versus 20% three days after onset. Their analysis was based on seven studies, five of which were peer-reviewed, with a total of 1330 test samples.
Doctors also are seeing anecdotal evidence of false negatives. For example, clinicians at UC San Diego Health medical center treated a patient with obvious symptoms of COVID-19, but two tests performed on throat samples were negative. However, a third test, using a sample from a bronchial wash, identified the virus, reported Medscape.
Sensitivity and Specificity of COVID-19 Clinical Laboratory Tests
The key measures of test accuracy are sensitivity, which refers to the ability to detect the presence of the virus, and specificity, the ability to determine that the targeted pathogen is not present. “So, a sensitive test is less likely to provide a false-negative result and a specific test is less likely to provide a false-positive result,” wrote Kirsten Meek, PhD, medical writer and editor, in an article for ARUP Laboratories.
“Analytic” sensitivity and specificity “represent the accuracy of a test under ideal conditions in which specimens have been collected from patients with either high viral loads or a complete absence of exposure,” she wrote. However, “sensitivity and specificity under real-world conditions, in which patients are more variable and specimen collection may not be ideal, can often be lower than reported numbers.”
In a statement defending its ID Now molecular point-of-care test, which came under scrutiny during a study of COVID-19 molecular tests by NYU Langone Health, Northwell Health, and Cleveland Clinic, according to MedTech Dive, Abbott Laboratories blamed improper sample collection and handling for highly-publicized false negatives produced by its rapid test. An FDA issued alert about the test on May 14 noted that Abbott had agreed to conduct post-market studies to identify the cause of the false negatives and suggest remedial actions.
Issues with Emergency Use Authorizations
In their NEJM analysis, Woloshin et al point to issues with the FDA’s process for issuing Emergency Use Authorizations (EUAs). For example, they noted variations in how manufacturers are conducting clinical evaluations to determine test performance. “The FDA prefers the use of ‘natural clinical specimens’ but has permitted the use of ‘contrived specimens’ produced by adding viral RNA or inactivated virus to leftover clinical material,” they wrote.
When evaluating clinical performance, manufacturers ordinarily conduct an index test of patients and compare the results with reference-standard test, according to the Dartmouth researchers. For people showing symptoms, the reference standard should be a clinical diagnosis performed by an independent adjudication panel. However, they wrote, “it is unclear whether the sensitivity of any FDA-authorized commercial test has been assessed in this way.” Additionally, a reference standard for determining sensitivity in asymptomatic people “is an unsolved problem that needs urgent attention to increase confidence in test results for contact-tracing or screening purposes.”
Continued adherence to current measures, such as physical distancing and surface disinfection.
Development of highly sensitive and specific tests or combinations of tests to minimize the risk of false-negative results and ongoing transmission based on a false sense of security.
Improved RT-PCR tests and serological assays.
Development and communication of clear risk-stratified protocols for management of negative COVID-19 test results.
“These protocols must evolve as diagnostic test, transmission, and outcome statistics become more available,” they wrote.
Meanwhile, clinical laboratories remain somewhat on their own at selecting which COVID-19 molecular and serology tests they want to purchase and run in their labs. Complicating such decisions is the fact that many of the nation’s most reputable in vitro diagnostics manufacturers cannot produce enough of their COVID-19 tests to meet demand.
Consequently, when looking to purchase tests for SARS-CoV-2, smaller medical laboratory organizations find themselves evaluating COVID-19 kits developed by little-known or even brand-new companies.
Limited availability of COVID-19 clinical lab tests is major topic at federal briefings and news stories, yet many of nation’s labs are laying off staff and at point of closing
Cash flow at the nation’s clinical laboratories has crashed, with revenues down by more than $5 billion since early March. This is the biggest financial disaster for the nation’s clinical laboratory industry in its 100-year history and it couldn’t come at a worse time for the American public and the US healthcare system.
At the precise moment when the nation needs clinical laboratories to begin performing millions of tests for SARS-CoV-2, the coronavirus that causes the COVID-19 illness, those same labs are watching their cash flow collapse.
Data from multiple sources gathered by The Dark Report, sister publication of Dark Daily, confirm that—beginning in early March and continuing through last week—clinical laboratories in the United States saw incoming flows of routine specimens decline by between 50% and 60%. During this same time, lab revenue fell by similar amounts.
Clinical Lab Industry Currently Losing $800 to $900 Million Weekly
To give this decline context, the healthcare system spends about $80 billion annually on medical laboratory testing. Thus, labs across the US generated about $1.5 billion in revenue each week during 2019 and into 2020. By April 5, the decline in routine lab specimen volumes reached 55% to 60%. Since then, the clinical lab industry now loses between $800 million and $900 million each week. Total revenue loss from previous levels is already estimated to be $5.2 billion, and it is growing by an additional $800 million to $900 million every week that patients stay away from hospitals and physicians’ offices.
The recent dire financial condition of labs small and large has gone unremarked by federal healthcare officials at the daily White House COVID-19 Task Force briefings. National news sources have yet to report on this development and its implications for successfully expanding the availability and numbers of COVID-19 tests in response to the pandemic.
The rapid and deep decline in specimens and revenue is not limited to clinical laboratories. Biopsy cases referred to anatomic pathology groups have declined by 50% to 60%. Some subspecialty pathology labs saw case referrals drop by 80% or more.
The nation’s two biggest clinical laboratory companies confirmed similar declines in their normal daily flow of routine specimens. Both companies recently reported first-quarter earnings (which included the month of March).
Quest Diagnostics, LabCorp Each Disclose Volume Declines of 50% to 60%
During its Q1 2020 earnings conference call, Chairman, President, and CEO of Quest Diagnostics (NYSE:DGX), Steve Rusckowski, stated, “In April, volume declines continue to intensify as we are seeing signs that volume declines are bottoming out at around 50% to 60%.”
The drop-off in routine lab test referrals was the similar at LabCorp (NYSE:LH). “In our diagnostics business, at the end of the quarter, we experienced reductions in demand for testing of 50% to 55% versus the company’s normal daily levels,” explained Glenn Eisenberg, Executive Vice President and CFO during LabCorp’s Q1 2020 earnings call. “This reduction in demand impacted testing volume broadly but was more heavily weighted towards routine procedures.”
Interviews with independent clinical lab owners and the administrative directors of hospital and health system labs further confirm this rapid and dramatic decline in the number of routine specimens arriving in their labs. Fewer specimens mean fewer claims, which means less revenue to laboratories.
Two Different Financial Futures for ‘Have’ Labs and ‘Have Not’ Labs
What happens next to the clinical laboratory industry in the United States—and to its ability to continue ramping up the availability of adequate numbers of COVID-19 tests in major cities, small towns, and rural areas—will be a story of “haves” and “have nots.”
The “haves” are clinical labs that have access to money. These are publicly-traded lab companies, academic medical center labs, and the sophisticated labs of health networks that operate multiple hospitals. In each case, these organizations have capital reserves and access to loans that will probably enable them to sustain COVID-19 lab testing services at the large volumes required to respond to the pandemic.
clinical labs operated by community hospitals and rural hospitals that were not financially robust before the onset of the pandemic; and,
specialty lab companies that perform a specific number of proprietary diagnostic tests (and for which demand has collapsed as patients stopped seeing their doctors).
Medicare Led Payers in the ‘Lab Test Price Race to the Bottom’
Prior to the onset of the SARS-CoV-2 pandemic, the finances of the “have-not” labs were already shaky, with many on the verge of filing bankruptcy, closing, or selling to a bigger lab company. Much blame for the deteriorating finances at a large proportion of community lab companies, community hospital labs, and rural hospital labs can be attributed to the deep, multi-year price cuts to the Medicare Part B clinical laboratory fee schedule as mandated by the Protecting Access to Medicare Act of 2014 (PAMA).
Medicare’s multi-year cuts to lab test prices were immediately copied by most state Medicaid programs. During this period, private payers followed Medicare’s lead and enacted their own deep cuts to the prices they paid labs for both routine tests and molecular/genetic tests.
That is why—when the pandemic intensified in early March—the 50% to 60% drop in specimens and revenue that hit these labs starved them of essential cash flow. When polled, the owners and directors of these labs acknowledge layoffs of the majority of their staff in all departments. They also reported substantial delays—both in submitted lab test claims and in getting payment for those claims—because claims-processing departments at the labs and private health insurers are understaffed due to shelter-in-place directives.
COVID-19 Test Revenue Helps Only Labs Performing Those Tests
Revenue from COVID-19 testing is helping certain labs offset the revenue loss from fewer routine specimens. XIFIN, Inc., a San Diego company that provides revenue cycle management (RCM) services for clinical laboratories and pathology groups, analyzed the lab test claims for COVID-19 rapid molecular tests. It determined that labs performing these tests are generating enough revenue from these test claims to equal about 20% of their pre-pandemic revenue.
Many CLIA-certified community laboratories and hospital labs have the diagnostic instruments and experience to perform rapid molecular tests for COVID-19. But when contacted, they tell us that their suppliers do not ship them even minimal quantities of the COVID-19 kits, the reagents, and the consumables. Thus, they cannot meet the needs of their client physicians. Instead, they watch as these physicians refer COVID-19 tests to the nation’s largest labs. The supply shortage prevents these smaller labs from doing larger numbers of COVID-19 test for the patients in the communities they serve. It also prevents them from earning the revenues from COVID-19 testing that currently helps the nation’s “have” labs offset the decline in revenue from routine testing.
Congress, national healthcare policymakers, and state governors need to immediately address this situation. Each week that passes during the COVID-19 pandemic and the shelter-in-place directives drains another $800 million to $900 million in revenue from routine lab testing that previously flowed into the nation’s clinical laboratories.
‘Have-not’ Clinical Labs in Small Towns Will Quietly Shrink and Disappear
Without timely intervention and financial support, the nation’s network of ‘have not’ labs, which have so capably served towns away from big metropolitan centers and rural areas, will quietly begin shrinking. One at a time, labs in small towns will close or sell. Local lab facilities will be shuttered and specimens from small-town patients will be transported to big labs hundreds or thousands of miles away.
It is also true that the financial disaster besetting the nation’s clinical laboratory industry will have comparable dramatic consequences for the in vitro diagnostics (IVD) manufacturers that sell them automation, analyzers, reagents, and other supplies. Since early March, IVD manufacturers watched as the pandemic caused orders for new instruments to collapse. During these same weeks, their clinical lab customers ceased ordering routine test kits at pre-pandemic levels. Dark Daily will cover the challenges confronting the IVD and other diagnostics industries in future e-briefings.
Announcing Free COVID-19 STAT Intelligence Briefings for Clinical Labs
With the COVID-19 pandemic creating chaos in nearly every aspect of healthcare, business, and society, clinical labs and their suppliers need timely intelligence and analysis about the innovations and successes achieved by their peers. This week, Dark Daily and The Dark Report are launching COVID-19 STAT Intelligence Briefings (Copy and paste this URL into your browser: https://www.covid19briefings.com). This comprehensive service is free and will cover four basic areas of needs for clinical laboratories as they ramp up COVID-19 testing:
Daily and weekly COVID-19 testing dashboards to guide every lab’s short-term planning;
Proven steps for labs to introduce and validate COVID-19 tests (both rapid molecular tests and serology tests);
Getting paid for COVID-19 testing to ensure every lab’s financial stability and clinical quality; and
Legal and regulatory updates for labs doing COVID19 tests to ensure full compliance.
Also, to help clinical laboratory leaders deal with the coming wave of COVID-19 serology tests, we are producing a free webinar led by James O. Westgard, PhD, FACB, and Sten Westgard, Director of Client Services and Technology, of Westgard QC, Inc.
Each week that the SARS-CoV-2 pandemic continues, and strict shelter-in-place directives are in place, the clinical laboratory industry loses another almost $900 million in revenue from lower volumes of routine testing. No industry can survive when its incoming revenue collapses by 50% to 60% for sustained periods of time.
Will Congress Recognize the Need for a Financial Rescue of ‘Have-not’ Labs?
Thus, it is incumbent on Congress, elected officials, and healthcare policymakers to recognize the financial consequences of the pandemic to the nation’s clinical laboratories. That is particularly true of the ‘have-not’ clinical labs. They do not have the same access to decisionmakers in government as billion-dollar lab companies.
And yet, these labs located in small communities and rural areas often are the only local labs that can do STAT testing in a couple of hours, and where clinical pathologists are personally familiar with local physicians and patients.
These “have-not” labs are vital healthcare resources. They should receive the help they need to get through this unprecedented crisis that is the COVID-19 pandemic.
Strategists agree that big tech is disrupting healthcare,
so how will clinical laboratories and anatomic pathology groups serve virtual
healthcare customers?
Visionary XPRIZE founder Peter Diamandis, MD, sees big tech as “the doctor of the future.” In an interview with Fast Company promoting his new book, “The Future Is Faster Than You Think,” Diamandis, who is the Executive Chairman of the XPRIZE Foundation, said that the healthcare industry is “phenomenally broken” and that Apple, Amazon, and Google could do “a thousandfold” better job.
Diamandis, who also founded Singularity University, a global learning and innovation community that uses exponential technologies to tackle worldwide challenges, according to its website, said, “We’re going to see Apple and Amazon and Google and all the data-driven companies that are in our homes right now become our healthcare providers.”
If this prediction becomes reality, it will bring significant changes in the traditional ways that consumers and patients have selected providers and access healthcare services. In turn, this will require all clinical laboratories and pathology groups to develop business strategies in response to these developments.
Amazon Arrives in Healthcare Markets
Several widely-publicized business initiatives by Amazon, Google, and Apple substantiate these predictions. According to an Amazon blog, healthcare insurers, providers, and pharmacy benefit managers are already operating HIPAA-eligible Amazon Alexa for:
Alexa also enables HIPAA-compliant blood glucose updates as part of the Livongo for Diabetes program. “Our members now have the ability to hear their last blood glucose check by simply asking Alexa,” said Jennifer Schneider, MD, President of Livongo, a digital health company, in a news release.
And Cigna’s “Answers By Cigna” Alexa “skill” gives members who install the option responses to 150 commonly asked health insurance questions, explained a Cigna news release.
“Google plans to disrupt healthcare and use data and artificial intelligence,” Toby Cosgrove, Executive Advisor to the Google Cloud team and former Cleveland Clinic President, told B2B information platform PYMNTs.com.
PYMNTs speculated that Google, which recently acquired Fitbit, could be aiming at connecting consumers’ Fitbit fitness watch data with their electronic health records (EHRs).
Apple Works with Insurers, Integrating Health Data
The Apple Watch health app also enables people to access medical laboratory test results and vaccination records, and “sync up” information with some hospitals, Business Insider explained.
Virtual Care, a Payer Priority: Survey
Should healthcare providers feel threatened by the tech giants? Not necessarily. However, employers and payers surveyed by the National Business Group on Health (NBGH), an employer advocacy organization, said they want to see more virtual care solutions, a news release stated.
“One of the challenges employers face in managing their healthcare costs is that healthcare is delivered locally, and change is not scalable. It’s a market-by-market effort,” said Brian Marcotte, President and CEO of the NBGH, in the news release. “Employers are turning to market-specific solutions to drive meaningful changes in the healthcare delivery system.
“Virtual care solutions bring healthcare to the consumer
rather than the consumer to healthcare,” Marcotte continue. “They continue to
gain momentum as employers seek different ways to deliver cost effective,
quality healthcare while improving access and the consumer experience.”
“If you use Google in the United States to check symptoms,
you’ll get five-million to 11-million hits,” Schwab told The Dark Report.
“Clearly, there’s plenty of talk about symptom checkers, and if you go online
now, you’ll find 350 different electronic applications that will give you
medical advice—meaning you’ll get a diagnosis over the internet. These
applications are winding their way somewhere through the regulatory process.
“The FDA just released a report saying it plans to regulate
internet doctors, not telehealth doctors and not virtual doctors,” he
continued. “Instead, they’re going to regulate machines. This news is
significant because, today, within an hour of receiving emergency care, 45% of
Americans have googled their condition, so the cat is out of the bag as it
pertains to us going online for our medical care.”
Be Proactive, Not Reactive, Health Leaders Say
Healthcare leaders need to work on improving access to primary care, instead of becoming defensive or reactive to tech companies, several healthcare CEOs told Becker’s Hospital Review.
Clinical laboratory leaders are advised to keep an eye on
these virtual healthcare trends and be open to assisting doctors engaged in
telehealth services and online diagnostic activities.
According to Damo Consulting’s 2019 Healthcare
IT Demand Survey, when it comes to spending money on information
technology (IT), healthcare executives believe AI and digital healthcare
technologies—though promising—need more development.
Damo’s report notes that 71% of healthcare providers
surveyed expect their IT budgets to grow by 20% in 2019. However, much of that
growth will be allocated to improving EHR functionality, Healthcare Purchasing News reported
in its analysis of Damo survey data.
As healthcare executives plan upgrades to their EHRs,
hospital-based medical laboratories will need to take steps to ensure
interoperability, while avoiding disruption to lab workflow during transition.
The survey also noted that some providers that are considering
investing in AI and digital health technology are struggling to understand the
market, the news release states.
Providers More
Positive Than Vendors on IT Spend
Damo Consulting is a Chicago-area based healthcare and
digital advisory firm. In November 2018, Damo surveyed 64 healthcare executives
(40 technology and service leaders, and 24 healthcare enterprise executives). Interestingly, healthcare providers were more
positive than the technology developers on IT spending plans, reported HITInfrastructure.com, which
detailed the following survey findings:
79% of healthcare executives anticipate high
growth in IT spending in 2019, but only 60% of tech company representatives
believe that is so.
75% of healthcare executives and 80% of vendor
representatives say change in healthcare IT makes buying decisions harder.
71% of healthcare executives and 55% of vendors say
federal government policies help IT spending.
50% of healthcare executives associate
immaturity with digital solution offerings.
42% of healthcare providers say they lack
resources to launch digital.
“While information technology vendors are aggressively
marketing ‘digital’ and ‘AI,’ healthcare executives note that the currently
available solutions in these areas are not very mature. These executives are
confused by the buzz around ‘AI’ and ‘digital,’ the changing landscape of who
is playing what role, and the blurred lines of capabilities and competition,” noted
Padmanabhan in the survey report.
The survey also notes that “Health systems are firmly
committed to their EHR vendors. Despite the many shortcomings, EHR systems
appear to be the primary choice for digital initiatives among health systems at
this stage.”
Some Healthcare
Providers Starting to Use AI
Even as EHRs receive the lion’s share of healthcare IT
spends, some providers are devoting significant resources to AI-related
projects and processes.
For example, clinical
pathologists may be intrigued by work being conducted at Cleveland Clinic’s Center for
Clinical Artificial Intelligence (CCAI), launched in March. The CCAI is using
AI and machine learning in pathology, genetics, and cancer research, with the
ultimate goal of improving patient outcomes, reported Becker’s Hospital Review.
“We’re not in it because AI is cool, but because we believe
it can advance medical research and collaboration between medicine and
industry—with a focus on the patient,” Aziz Nazha, MD, Clinical
Hematology and Oncology Specialist and Director of the CCAI, stated in an
article posted by the American Medical Association (AMA).
AI Predictions Lower
Readmissions and Improve Outcomes
Cleveland Clinic’s CCAI reportedly has gathered data from
1.6 million patients, which it uses to predict length-of-stays and reduce
inappropriate readmissions. “But a prediction itself is insufficient,” Nazha told
the AMA. “If we can intervene, we can change the prognosis and make things
better.”
The CCAI’s ultimate goal is to use predictive models to “develop
a new generation of physician-data scientists and medical researchers.” Toward
that end, Nazha notes how his team used AI to develop genomic biomarkers that identify
whether a certain chemotherapy drug—azacitidine (aka,
azacytidine and marketed as Vidaza)—will work for specific patients. This is a
key goal of precision
medicine.
CCAI also created an AI prediction model that outperforms
existing prognosis scoring systems for patients with Myelodysplastic
syndromes (MDS), a form of cancer in bone marrow.
Meanwhile, at Johns
Hopkins Hospital, AI applications track availability of beds and more. The
Judy Reitz Capacity Command Center, built in collaboration with GE Healthcare Partners, is a
5,200 square feet center outfitted with AI apps and staff to transfer patients
and help smooth coordination of services, according to a news release.
Forbes described the Reitz command
center as a “cognitive hospital” and reports that it has essentially enabled
Johns Hopkins to expand its capacity by 16 beds without undergoing bricks-and-mortar-style
construction.
In short, medical laboratory leaders may want to interact
with IT colleagues to ensure uninterrupted workflows as EHR functionality evolves.
Furthermore, AI developments suggest opportunities for clinical laboratories to
leverage patient data and assist in improving the diagnostic accuracy of providers
in ways that improve patient care.
Defamation, libel, harassment, and causing emotional distress are some of the charges patients who launched online negative review campaigns are defending themselves against in court
Healthcare systems, surgeons, family practitioners, clinical laboratories, anatomic pathologists—none are immune to receiving negative online reviews from patients who believe they’ve been damaged by their caregivers. And these reviews can have such an impact on practice revenues, doctors and hospitals have begun suing patients for damages caused by harmful online reviews. And they are winning.
Several notable cases involve high-profile healthcare systems. One such lawsuit involved the Cleveland Clinic. A patient who claimed a 2008 prostate surgery left him impotent and incontinent due to negligence on the part of the surgeon launched a negative campaign that spanned a decade, USA Today reported.
David Antoon, a retired Air Force Colonel, filed a malpractice lawsuit against urologist, Jihad Kaouk, MD, and the Cleveland Clinic. Antoon alleged Kaouk was not present in the operating room during his surgery, even though he insisted that only Kaouk perform the procedure. Antoon also claimed the Cleveland Clinic’s urology department did not have the proper credentials to operate the robotic device used during his surgery.
In addition to filing the lawsuit, Antoon complained to the federal Centers for Medicare and Medicaid Services (CMS) and the State Medical Board of Ohio.
However, Antoon also vented his frustrations on social media, as well as sending e-mails to Kaouk, which the doctor felt were threatening and made him concerned about the situation escalating. “What would be next—showing up at my door?” Kaouk asked during the criminal trial against Antoon. “That’s what we feared.”
Jihad Kaouk, MD (above), a urologist with the Cleveland Clinic, giving testimony atCuyahoga County Common Pleas Court during a lawsuit involving patient David Antoon, a retired Air Force Colonel. Kaouk and the Cleveland Clinic prevailed in that lawsuit and the State Medical Board of Ohio closed a five-year investigation into Kaouk without reprimanding him. (Photo copyright: USA Today.)
Antoon posted unfavorable online comments about Kaouk for a decade. The urologist eventually petitioned the court, which granted him a civil stalking protective order against Antoon. It banned Antoon from contacting the doctor. Nevertheless, the day after that order was granted, Antoon posted another bad review about Kaouk on Yelp and urged people to avoid Kaouk when seeking medical care.
Antoon was later arrested on felony charges of menacing by stalking, telecommunications harassment, and violating a protection order. He faced up to one year in prison if indicted. In addition to spending two days in jail, he paid $40,000 for a defense attorney and a $50,000 bond after being arrested. He also agreed to pay $100 as part of a plea deal.
Above is David Antoon (left), Col USAF Ret, and Don Malarcik (right), an attorney with Malarcik, Pierce, Munyer, and Will in Akron, Ohio. Malarcik argued that “the Yelp review doesn’t violate the protection order because Antoon did not make direct contact with Kaouk,” Cleveland.com reported. (Photo copyright: USA Today.)
Other Lawsuits Against Patients Involving Social Media
Joon Song, MD, PhD, a New York City area gynecologist sued patient Michelle Levine over critical reviews she left about his practice on several online sites. Though Levine removed her posts from the sites after being sued, Song wants her to pay $1 million in legal fees and damages. The doctor accused Levine of defamation, libel, and causing emotional distress. Sound familiar?
Two Scottsdale, Ariz., doctors—Albert Carlotti, MD, and Michelle Cabret-Carlotti, MD, DDS,—successfully sued patient Sherry Petta for defamation after she posted negative statements about the doctors online. After filing a complaint with the Arizona Medical Board and clashing with Carlotti over access to her medical records, Petta posted unfavorable reviews about the practice on several online sites and created a website to warn others about Carlotti. The doctors claimed the statements Petta made were untrue and portrayed them in a false light. A jury agreed and awarded the doctors $12 million, which was later vacated on appeal.
Cleveland cosmetic surgeon Bahman Guyuron, MD, sued a former patient after she posted adversarial reviews on several online review sites about her dissatisfaction with a nose job. The patient, who remains unidentified, alleges that Guyuron acted in an untrustworthy and unprofessional manner, that she received no follow-up care, and that Guyuron urges people to post erroneous positive reviews online. She also claims that there was no informed consent to the procedure and that her nose is now twice as large as before.
Guyuron is seeking monetary damages, an injunction against the patient to prevent her from posting negative reviews about him online, and an order to remove all existing statements about him from the Internet.
Clinical Laboratories Vulnerable to Negative Reviews
Healthcare is complicated and positive outcomes can never be guaranteed. When patients do not get satisfaction by complaining to the doctors and facilities, they may seek other ways to be heard. And negative comments made on social media and online review websites can harm the reputations and businesses of physicians and medical facilities.
“It would be great if the regulators of hospitals and doctors were more diligent about responding to harm to patients, but they’re not, so people have turned to other people,” Lisa McGiffert, former head of the Consumer Reports Safe Patient Project, told USA Today. “This is what happens when your system of oversight is failing patients.”
However, Ryan Lorenz, Petta’s attorney warns consumers to be aware of the consequences of posting critical online reviews, especially if they post factually inaccurate information. “Make sure what you are saying is true—it has to be truthful,” he told USA Today.
Similar situations can arise in the clinical laboratory industry as well. There were multiple postings on Yelp in 2014 and 2015 by patients criticizing blood-testing company Theranos regarding discordant test results they’d received from Theranos’ lab, which Dark Daily covered in multiple e-briefings.
Trust is the hardest thing to earn, the easiest thing to lose, and once gone, can be impossible to get back. Clinical laboratories are just as susceptible to negative reviews as hospitals and doctors.
Worse yet, labs can be drawn into lawsuits simply because they service the hospital systems and caregivers involved. Preparing in advance for this possibility should be on every clinical laboratory manager’s do list.