News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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Multiple Studies Raise Questions About Reliability of Clinical Laboratory COVID-19 Diagnostic Tests

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 Their research was published on the medRxiv preprint server and has not been peer-reviewed.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.

The lesson for clinicians is that they can’t rely solely on test results but must also consider their own observations of the patient, Joshua Metlay, MD, PhD, of Massachusetts General Hospital told 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.”

Stephen Rawlings, MD, PhD
“To truly determine false negatives, you need a gold standard test, which is essentially as close to perfect as we can get,” Stephen Rawlings, MD, PhD, (above), a resident physician of internal medicine and infectious diseases fellow at UC San Diego’s Center for AIDS Research (CFAR), who has been working on SARS-CoV-2 test validation since March. “But there just isn’t one yet for coronavirus,” he told Medscape. (Photo copyright: University of California, San Diego.)

In a perspective for Mayo Clinic Proceedings, Colin P. West, MD, PhD; Victor M. Montori, MD, MSc; and Priya Sampathkumar, MD, offered four recommendations for addressing concerns about testing accuracy:

  • 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.

—Stephen Beale

Related Information:

New Report Examines Challenges and Implications of False-Negative COVID-19 Tests

Questions about COVID-19 Test Accuracy Raised Across the Testing Spectrum

COVID-19 Test Results: Don’t Discount Clinical Intuition

FDA Provides New Tool to Aid Development and Evaluation of Diagnostic Tests That Detect SARS-CoV-2 Infection

EUA Authorized Serology Test Performance

Emergency Use Authorization (EUA) Information and List of All Current EUAs 

Coronavirus (COVID-19) Update: FDA Provides Promised Transparency for Antibody Tests

Understanding Medical Tests: Sensitivity, Specificity, and Positive Predictive Value

Webinar Part 1: Quality Issues Your Clinical Laboratory Should Know Before You Buy or Select COVID-19 Serology Tests

Webinar Part 2: Achieving High Confidence Levels in the Quality and Accuracy of Your Clinical Lab’s Chosen COVID-19 Serology Tests, featuring James Westgard, PhD

COVID-19 Triggers a Cash Flow Crash at Clinical Labs Totaling US $5.2 Billion in Past Seven Weeks; Many Labs Are at Brink of Financial Collapse

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.

In the eight weeks since the COVID-19 pandemic caused patients to cease coming to hospitals and visiting their doctors, incoming routine specimens and revenue fell by 60%, causing cumulative lost routine revenue of $5.2 billion for the clinical laboratory industry in the United States. Each week that the existing shelter-in-place directives are effective, labs lose another $800 million to $900 million. The Dark Report based these estimates on data provided by multiple companies working with lab billing/claims, middleware analytical solutions, and customer relationship management (CRM) and electronic health record (EHR) products. (Chart copyright: The Dark Intelligence Group, Inc.)

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.

Examples of “have” labs would range from public lab companies like LabCorp, Quest Diagnostics, Sonic Healthcare USA, and BioReference Laboratories to the labs of healthcare organizations such as Mayo Clinic, Cleveland Clinic, Geisinger Health, Advocate Aurora Health, and ARUP Laboratories.

The “have nots” will be:

  • clinical laboratories that are privately-owned;
  • 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.

The chart above was prepared by XIFIN, Inc., of San Diego and is based on the changes XIFIN observed in the volume of routine clinical laboratory test claims generated by client labs on a weekly basis. In the first two months of 2020, routine lab test claims ran at expected levels until the first week of March. During the rest of March, routine lab test claims declined by 60%. During April, incoming routine lab test claims remained 55% to 60% below pre-pandemic levels. The shaded area shows the number of COVID-19 test claims coming into clinical labs. XIFIN says COVID-19 test claims make up about 20% of the decline in routine test specimens for those labs performing COVID-19 tests. The Dark Report estimates that the clinical laboratory industry has lost $800 million to $900 million in routine test revenue each week since March 23. Weekly revenue losses will continue at this rate until patients begin visiting their physicians and hospitals again perform elective services.  (Chart copyright: XIFIN, Inc.)

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.

Quality Issues Your Clinical Laboratory Should Know Before You Buy or Select COVID-19 Serology Tests,” will take place on Thursday, May 21, at 1:00 PM EDT. For details and to register, copy and paste this URL into your browser: https://www.darkdaily.com/webinar/quality-issues-your-clinical-laboratory-should-know-before-you-buy-or-select-covid-19-serology-tests.

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.

—Robert L. Michel
Editor-in-Chief

Related Information:

Quality Issues Your Clinical Laboratory Should Know Before You Buy or Select COVID-19 Serology Tests

COVID-19 STAT Intelligence Service: Resources and Help for Labs During the SARS-CoV-2 Pandemic

COVID-19 Disruptions of Supply Chains Are One More Challenge for Clinical Laboratories to Bring Value to Hospitals and Healthcare Networks

FDA Issues First Approval for At-Home COVID-19 Test to LabCorp’s Pixel; Other Clinical Laboratory-Developed At-Home Test Kits May Soon Be Available to General Public

Serological Antibody Tests a ‘Potential Game Changer’ and Next Phase in Efforts to Combat the Spread of COVID-19 That Give Clinical Laboratories an Essential Role

A Tale of Two Countries: As the US Ramps Up Medical Laboratory Tests for COVID-19, the United Kingdom Falls Short

Medical Laboratories Need to Prepare as Public Health Officials Deal with Latest Coronavirus Outbreak

Antibody Tests Were Supposed to Help Guide Reopening Plans. They’ve Brought More Confusion than Clarity

Is the Coronavirus Antibody Test a Magic Bullet—Or False Hope?

XPRIZE Founder Diamandis Predicts Tech Giants Amazon, Apple, and Google Will Be Doctors of The Future

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:

  • Appointments at urgent care facilities,
  • Tracking prescriptions,
  • Employee wellness incentive management, and
  • Care updates following hospital discharge.

For example, the My Children’s Enhanced Recovery After Cardiac Surgery (ERAS Cardiac) program at Boston Children’s Hospital uses Amazon Alexa to share updates on patients’ recovery, the blog noted.

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 Strikes Agreements with Health Systems 

Meanwhile, Google has agreements with Ascension and Mayo Clinic for the use of Google’s cloud computing capability and more, Business Insider reported.

“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).

“Ultimately what’s best is human and AI collaboratively,” Peter Diamandis, MD, founder of XPRIZE Foundation and Singularity University told Fast Company. “But I think for reading x-rays, MRIs, CT scans, genome data, and so forth, that once we put human ego aside, machine learning is a much better way to do that.” (Photo copyright: SALT.)

Apple Works with Insurers, Integrating Health Data

In “UnitedHealthcare Offers Apple Watches to Wellness Program Participants Who Meet Fitness Goals; Clinical Laboratories Can Participate and Increase Revenues,” Dark Daily noted that by “leveraging the popularity of mobile health (mHealth) wearable devices, UnitedHealthcare (UHC) has found a new way to incentivize employees participating in the insurer’s Motion walking program.” UHC offered free Apple Watches to employees willing to meet or exceed certain fitness goals.

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.”

More than 50% of employers said their top initiative for 2020 is implementing more virtual care solutions, according to NBGH’s “2020 Large Employers Health Care Strategy and Plan Design Survey.”

AI Will Affect Clinical Laboratories and Pathology Groups

Diamandis is not the only visionary predicting big tech will continue to disrupt healthcare. During a presentation at last year’s Executive War College Conference on Laboratory and Pathology Management in New Orleans, Ted Schwab, a Los Angeles-area healthcare strategist and entrepreneur, said artificial intelligence (AI) will have a growing role in the healthcare industry.

“In AI, there are three trends to watch,” said health strategist Ted Schwab (above) while speaking at the 2019 Executive War College. “The first major AI trend will affect clinical laboratories and pathologists. It involves how diagnosis will be done on the Internet and via telehealth. The second AI trend is care delivery, such as what we’ve seen with Amazon’s Alexa—you should know that Amazon’s business strategy is to disrupt healthcare. And the third AI trend involves biological engineering,” he concluded. (Photo copyright: Dark Daily.)

Schwab’s perspectives on healthcare’s transformation are featured in an article in The Dark Report, Dark Daily’s sister publication, titled, “Strategist Explains Key Trends in Healthcare’s Transformation.”

“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.

—Donna Marie Pocius

Related Information:

2020 Executive War College on Lab and Pathology Management – April 28-29

Amazon and Apple Will Be Our Doctors in the Future, Says Tech Guru Peter Diamandis

Introducing New Alexa Healthcare Skills

Livongo for Diabetes Program Releases HIPAA-Compliant Amazon Alexa Skill

“Answers by Cigna” Skill for Amazon Alexa Simplifies, Personalizes Healthcare Information

2020 Predictions for Amazon, Haven, Google, Apple

Health Strategies of Google, Amazon, Apple, and Microsoft

How Big Tech Is Disrupting Big Healthcare

Large Employers Double Down on Efforts to Stem Rising U.S. Health Benefit Costs which are Expected to Top $15,000 per Employee in 2020: Employers cite virtual care and strategies to manage high cost claims as top initiatives for 2020

How to Compete Against Amazon, Apple, Google: Three Healthcare CEOS on How to Compete Against the Industry’s Most Disruptive Forces

UnitedHealthcare Offers Apple Watches to Wellness Program Participants Who Meet Fitness Goals; Clinical Laboratories Can Participate and Increase Revenues

Strategist Explains Key Trends in Healthcare’s Transformation

Damo Consulting Survey Predicts Future Health Network Spending Will Primarily be on Improving EHRs; Could be Positive Development for Medical Laboratories

Survey shows healthcare providers plan to wait for AI and digital health technologies to mature before making major investments in them

Clinical laboratories must develop strategies for connecting to their client doctors’ electronic health record (EHR) systems. Thus, a new survey that predicts most healthcare networks will continue to focus health information technology (HIT) spending on improving their EHRs—rather than investing in artificial intelligence (AI) and digital healthcare—provides valuable insights for medical laboratory managers and stakeholders tasked with implementing and maintaining interfaces to these systems.

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.

“Digital and AI are emerging as critical areas for technology spend among healthcare enterprises in 2019. However, healthcare executives are realistic about their technology needs versus their need to improve care delivery. They find the currently available digital health solutions in the market are not very mature,” explained Paddy Padmanabhan (above), Chief Executive Officer of Damo Consulting, in a news release. (Photo copyright: The Authors Guild.)

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.

Partners HealthCare (founded by Brigham and Women’s Hospital and Massachusetts General Hospital) recently announced formation of the Center for Clinical Data Science to make AI and machine learning a standard tool for researchers and clinicians, according to a news release.

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.

—Donna Marie Pocius

Related Information:

2019 Healthcare IT Demand Survey

Digital and AI are Top Priorities in 2019 as EHR Investments Continue to Dominate

Healthcare IT Spending Priorities Include Big Data Analytics, AI

Healthcare IT Demand Survey: Digital and AI are Top Priorities in 2019 as EHR Systems Continue to Dominate IT Spend

Cleveland Clinic Launches Clinical AI Center: 4 Things to Know

Cleveland Clinic Ready to Push AI Concepts to Clinical Practice

Cleveland Clinic Creating Center for AI in Healthcare

Partners HealthCare Embraces Democratization of AI to Accelerate Innovation in Medicine

Johns Hopkins Hospital Launches Capacity Command Center to Enhance Hospital Operations

The Hospital Will See You Now

Patients Who Post Negative Comments about Healthcare Experiences on Social Media Review Sites Are Being Sued by Physicians and Hospitals; Clinical Laboratories Might Be Similarly Vulnerable to Being Drawn into Lawsuits

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 at Cuyahoga 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.

—JP Schlingman

Related Information:

Doctors, Hospitals Sue Patients Who Post Negative Comments, Reviews on Social Media

Doctor Sues Patient for $1 Million for Posting Negative Reviews Online

I Wrote a Negative Yelp Review—and it Made My Life a Nightmare

Hospital Sues Over Facebook Post and Picketing

Previously High-Flying Theranos Provides Clinical Laboratories and Pathology Groups with Valuable Lesson on How Quickly Consumer Trust Can Be Lost

Federal Appeals Court Rules Yelp Not Responsible for Bad Reviews; Labs Advised to Examine Their Online Presence

Online Negative Reviews Can Threaten Clinical Laboratories Not Prepared to Address Feedback or Manage Their Internet Presence

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