Gottlieb will speak about the state of AI in healthcare at the event May 11-12
Medical technicians in clinical laboratories and pathology groups may worry that artificial intelligence (AI) will eventually put them out of their jobs.
However, that’s not likely to be the case, according to former Food and Drug Administration (FDA) Commissioner Scott Gottlieb. He was just announced as a top speaker at the Artificial Intelligence in Healthcare and Diagnostics (AIHD) Conference, which takes place May 10-11 in San Jose, Calif.
Instead, expect AI in healthcare to help labs better aggregate and analyze an ever-growing repository of clinical data.
“As we start to digitize more of this information, build out bigger repositories, and correlate more of this information with experimental evidence that’s also captured digitally, it’s going to become an immensely powerful tool,” Gottlieb said during a 2021 webinar hosted by Proscia, which develops pathology software embedded with AI.
Former FDA Commissioner Scott Gottlieb said AI in healthcare will “become an immensely powerful tool.” (Photo courtesy of: Worldwide Speakers Group)
“[AI is] going to be a predictive tool,” he continued. “So, now you start to think about digital data from traditional pathology, digital data from characterizing tumors to sequencing, alongside digital data capture through electronic health records. And you start to have a really powerful, robust set of information.”
Writing for MobiHealthNews last year, Liz Kwo, MD, also noted the potential of AI to deal with unstructured data—in other words, information that is not in a pre-set data model and thus difficult to analyze.
“In many cases, health data and medical records of patients are stored as complicated unstructured data, which makes it difficult to interpret and access,” wrote Kwo, who is Deputy Chief Clinical Officer at insurer Anthem and Faculty Lecturer at Harvard Medical School.
“AI can seek, collect, store, and standardize medical data regardless of the format, assisting repetitive tasks and supporting clinicians with fast, accurate, tailored treatment plans and medicine for their patients instead of being buried under the weight of searching, identifying, collecting and transcribing the solutions they need from piles of paper formatted EHRs,” she added.
AIHD conference to explore the state of artificial intelligence in healthcare
At AIHD, Gottlieb will take part in a fireside chat and also contribute to a panel discussion with other keynote speakers.
“There’s no better individual than Dr. Gottlieb to address AIHD participants about the state of artificial intelligence, where it’s going, how it’s regulatory oversight will unfold, and what’s likely to be the most surprising contribution of AI in patient care,” said Robert Michel, founder of AIHD, Executive Director of the Precision Medicine Institute, and Editor-in-Chief of clinical lab intelligence publication The Dark Report.
The event will bring together senior-level representatives from AI companies, hospitals, physician offices, and diagnostic providers.
Gottlieb promoted greater use of digital tools for clinicians
“I can envision a world where, one day, artificial intelligence can help detect and treat challenging health problems, for example by recognizing the signs of disease well in advance of what we can do today,” Gottlieb stated at the time. “These tools can provide more time for intervention, identifying effective therapies and ultimately saving lives.”
During and after his tenure at the FDA, he has been a prolific commentator about the SARS-CoV-2 pandemic and steps public health agencies have taken to curb COVID-19.
Gottlieb is currently a Senior Fellow at the American Enterprise Institute, a public policy think tank. He is also partner at venture capital firm New Enterprise Associates and serves on the boards of Pfizer and Illumina.
The Department of Justice steps beyond the law’s original focus on opioid-related lab testing fraud
An interesting aspect with enforcement of the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) is the government’s willingness to go after charges tied to fraudulent COVID-19 testing.
The case U.S. vs. Malena Badon Lepetich provides a good example of this approach. A grand jury indicted Lepetich on various healthcare fraud charges last year, including that she allegedly offered to pay kickbacks for referrals of specimens for COVID-19 testing.
“The government had really only used EKRA in the context of addiction treatment space,” attorney Alexander Porter, a Partner at law firm Davis Wright Tremaine in Los Angeles, said in the latest issue of The Dark Report. “The Lepetich case shows that the government’s going to use EKRA beyond that context and go into other areas where they think that it can be useful—in particular, in the area of COVID-19 testing.”
Clinical laboratories and pathology groups should take note of this development.
Attorney Alexander Porter said EKRA enforcement now goes after fraudulent COVID-19 testing. (Photo: Davis Wright Tremaine)
Defendant Allegedly Filed $10 Million in Fraudulent Lab Claims
Lepetich was the owner of MedLogic, a clinical laboratory in Baton Rouge, La.
In addition to the fraudulent COVID-19 testing charges, she allegedly solicited and received kickbacks in exchange for referrals of urine specimens for medically unnecessary tests, according to the U.S. Department of Justice (DOJ).
EKRA Provisions Rose from the Opioid Crisis in the U.S.
EKRA is a criminal law that falls under the Communities and Patients Act, which lifted restrictions on medications for opioid treatment and sought to limit overprescribing of opioid painkillers. Originally, EKRA targeted fraudulent practices at sober homes and substance abuse treatment centers. However, the final draft of the bill added clinical laboratories to the list of providers under potential scrutiny.
At the time Congress passed EKRA, the law was primarily aimed at fraudulent activity in opioid treatment centers, including related lab testing.
Thus, the government’s use of EKRA in the COVID-19 charges against Lepetich case is newsworthy and establishes a precedent, noted Porter. He’ll speak about EKRA at the 2022 Executive War College on Laboratory and Pathology Management. The event takes place April 27-28 in New Orleans.
A contentious part of EKRA for clinical laboratories and pathology groups is that certain conduct protected under the federal Anti-Kickback Statute is treated as a criminal offense under EKRA. Some common lab practices come under that confusing designation, such as paying lab sales reps on a commission-based formula based on testing volumes they generate.
Proof of vaccination, masking, and availability of on-site testing will continue to be measures taken at in-person events for pathologists and medical laboratory professionals
Organizers of in-person clinical laboratory conferences face an interesting dilemma as they plan events in 2022: Where do they draw the line with COVID-19 safety protocols?
On one hand, the surge of cases caused by the SARS-CoV-2 Omicron variant seems to be in its waning stages and large swaths of the population are vaccinated. On the other hand, clinical laboratory and anatomic pathology events want potential registrants to have confidence that it is safe to travel and attend the gatherings.
One lab industry conference producer who happens to be knee-deep in preparing for an in-person meeting this spring is Robert Michel, Editor-in-Chief of The Dark Report and Founder of the 27th Annual Executive War College on Laboratory and Pathology Management. This informative event takes place on April 27-28 in New Orleans and includes COVID-19 protocols to protect attendees.
The CDC chart above shows the daily number of new COVID-19 cases in the US for the six-month period ending Feb. 28, 2022. Clinical laboratory managers should note that the number of new cases is at its lowest level since the Omicron variant showed up early this year.
“It’s important for all those planning to attend this year’s Executive War College to know that screening COVID-19 protocols will be in place to ensure the health and safety of all participants,” Michel noted. “We did a large lab conference in the fall of 2021 that included protocols for COVID-19 and the attendees told us they appreciated the protection provided by those protocols.”
After a significant rise in COVID-19 cases in January 2022 due to the Omicron variant, current daily case levels now are lower than they were six months ago before the new variant hit, according to numbers from the federal Centers for Disease Control and Prevention (CDC).
The in-person 2021 Executive War College, which took place in San Antonio on Nov. 2-3, 2021, followed the CDC’s recommendations:
COVID-19 protocols included a daily set of questions and a temperature check for all speakers and attendees before they were allowed to enter the conference area.
CLIA-complex rapid PCR COVID-19 tests were available for individuals whose temperature and answers to the screening questions indicated the need for such testing.
Attendees used an app to answer the daily screening questions and upload proof of vaccination.
“At last fall’s Executive War College, approximately 400 attendees were screened on each of the three days before entering the conference area and not one rapid COVID-19 test was needed,” Michel said. “Not only is that an outstanding outcome, but a number of attendees also told us they appreciated our efforts to keep them safe and protect their health.”
The 2022 Executive War College will follow the CDC’s updated COVID-19 guidelines, along with any state and local directives in effect as of April 27.
Although 300 attendees were expected at the 2021 Executive War College, 400 registered and participated.
Proof of Vaccination Has Been Required at Other Clinical Lab Industry Events
Organizers of other clinical lab conferences also have dealt with COVID-19 safety protocols. For example, the American Clinical Laboratory Association (ACLA) will hold its annual meeting in Washington, D.C., on March 9. COVID-19-related requirements for attendees will include proof of vaccination uploaded to a vaccine verification vendor and proof of a negative PCR test taken within 72 hours prior to the event.
The annual meeting of the American Society of Clinical Pathology (ASCP) occurs later this year in September in Chicago—too early yet to publish protocols. Last year’s ASCP conference in Boston was a hybrid event, offering both in-person and virtual options. Those who attended in person needed to upload proof of vaccination to a third-party vendor and were required to wear masks. On-site COVID-19 testing was available.
Revived Corporate Travel Could Boost Clinical Laboratory Conferences
The path back to live events across all industries has not been easy given various COVID-19 surges, political divisiveness over masking, frozen corporate travel budgets, and corporate policies banning or limiting employee travel.
Conference organizers throughout the United States universally hope those barriers will lower as 2022 progresses.
“With the fast-spreading Omicron triggering another round of setbacks to start 2022, event planners now are betting on spring to finally mark a turning point for the hard-hit industry,” MarketWatch reported on Feb. 4. “Their hopes hinge on American corporations taking a note from the recovery already under way for domestic air travel for leisure purposes, with the linchpin being a robust revival of trade show attendance and other in-person business gatherings.”
For Michel, offering actionable advice through well-thought-out sessions has been a cornerstone of the content offered each year at the Executive War College. He believes that approach will continue to be the strongest drawing point for clinical laboratory and pathology executives now considering attending the event.
“Our reading of the tea leaves is that across the profession of laboratory medicine, a great many managers, administrators, executives, and pathologists want to return to in-person conferences,” Michel noted. “Registrations for our April event are running ahead of 2019, and people tell us that they recognize the changes in healthcare and the lab marketplace because of the pandemic. They want to understand what’s driving current trends, like greater consumer involvement in lab testing and how to get private payers to reimburse claims for COVID-19 and genetic tests, as well as how a growing number of clinical laboratories are incorporating artificial intelligence solutions in both clinical care settings and lab operations.”
Labs need to rethink recruitment tactics to successfully hire younger workers
We’ve heard a lot anecdotally about the “Great Resignation”—a labor phenomenon rooted in the pandemic that has led to an abnormally large amount of workers, including lab professionals, quitting their jobs.
The trend has hit healthcare hard, as evidenced by the latest numbers from the U.S. Bureau of Labor Statistics. From August 2021 through December 2021, the healthcare and social assistance workforce saw nearly 2.8 million workers quit—an average of 551,000 people each of those months. By comparison, in December 2020, 419,000 healthcare workers left their jobs.
Nearly 2.8 million healthcare and social workers quit their jobs from August through December 2021. Source: Bureau of Labor Statistics.
Anxiety from the pandemic is likely a contributing factor to some job departures. However, in clinical labs, other causes also are behind the abundance of open positions, such as early retirements, graduating individuals experiencing more specialized training programs, and a shift in the way the current working generation views employment, said Tara Luellen, Vice President of Laboratory Director Services at consulting and recruiting firm Lighthouse Lab Services.
“The lab industry has been hurt at the greatest extreme from this Great Resignation just in terms of the dire need for lab roles and the small pool of correctly qualified individuals in many instances,” particularly with COVID-19 testing demand, she noted.
Specialized Laboratory Roles Cramp Further Development for New Hires
Luellen explained that the labor shortage problem is exacerbated because fewer new lab technologists and pathologists are entering the field at the same time that many lab professionals are quitting.
Additionally, younger workers that do go into the clinical lab and pathology industry tend to be trained in specialty areas more so now than the broader training programs of the past.
“We don’t have as many individuals who are more broadly trained; instead, they’re very specialized,” she added. “So, it takes them years working at labs that do a variety of things to gain real-life, hands-on experience with other kinds of testing than that included in their specialty program, in many cases.”
“We don’t have as many individuals who are more broadly trained,” said Tara Luelllen.
‘They Want to Experience a Community at Work’
For clinical labs and pathology groups looking to fill open roles, it may be time to take action beyond just beefing up salaries.
Instead, look at what motivates lab professionals to come to an organization, Luellen suggested. She’ll explore the topic of how to successfully recruit new clinical lab leaders in further detail at her session during the 2022 Executive War College on April 27-28 in New Orleans.
One piece of advice she offered is for lab recruiters to carefully articulate to job candidates how an open lab director position or similar role may contribute to either the local or medical community. It’s also important to explain what type of culture an organization offers new employees.
“What we’re seeing is a big shift in what people are looking for,” Luellen said. “The compensation still has to be there, but it’s also a whole community that these people are looking for.
“They’re looking for more than just a 9 to 5, punch the clock, and go home gig,” she continued. “They want the job to enrich their lives. They want to experience a community at work. It’s a different paradigm in how they look at what work means for them.”
By automating clinical chemistry and immunoassay testing, clinical laboratory leaders can improve throughput while reducing the stress on staff, laboratory expert says
The American Society for Clinical Pathology regularly conducts a vacancy survey of medical laboratories throughout the US. While the problem of lab department vacancy rates has been ongoing, the last survey reported showed increased rates for laboratory positions across all departments surveyed. Last year, burnout among healthcare workers reached a crisis level, reported Clinical Laboratory News.
As a result, staffing the clinical laboratory with qualified lab professionals resounds as a top concern—and at a time when expectations are perhaps the highest they have ever been for performance in healthcare operations, from general hospitals to the most complex integrated delivery networks.
Even in the midst of the clinical laboratory workforce shortage and chronic strain, laboratory leaders must still improve their labs’ processes and workflows; increase productivity; and expand routine and specialty testing to better serve patient populations.
Faced with unrelenting pressures to do more with less, lab directors are turning to automating certain departments of the laboratory as a way to:
Relieve the problems caused by an ongoing workforce shortage;
Improve workflows and processes through standardization;
Keep lab staff working on the most important tasks; and
Enhance the laboratory’s reach and grow the lab business in necessary ways.
How UMC Southern Nevada Prioritized STAT Runs, Consolidated Operations
One case in point highlights the University Medical Center (UMC) of Southern Nevada’s clinical laboratory. Located in Las Vegas, UMC is among the largest public hospitals in the United States. It is part of a recent master-planned Las Vegas Medical District (LVMD), and it is the only Level I trauma center in Nevada.
The laboratory needed to improve turnaround time and expand the test menu, among other goals, explained Scott Keigley, one of two General Laboratory Services Managers at UMC. While limited laboratory automation had already been applied broadly, the lab took its automation initiative one step further by connecting three high-volume automated clinical chemistry and immunoassay analyzers (CC/IA), an automated hematology line, and a coagulation analyzer.
The University Medical Center of Southern Nevada improved efficiency andstreamlined workflow by integrating a consolidated automated clinical chemistry and immunoassay analyzer (above) into the laboratory’s workflow. (Photo copyright: Siemens Healthineers)
An immediate benefit that UMC realized was consolidation of clinical lab operations. “Up until implementing our automated platform, we had a dedicated laboratory in our emergency room specifically to triage our emergency room tests,” Keigley explained. “You’re talking about not only a duplication of consumables, resources, and supplies, but also personnel.
“A big part of automating was showing our administration we were going to be able to eliminate that emergency room lab and still turn our results around as quickly and as efficiently without it,” Keigley added.
One of the ways that using an automated platform enabled consolidation of lab operations was by decreasing the turnaround times of STAT samples. “Our STAT turnaround times are way below many of the national thresholds or standards,” Keigley explained. “I’ll use troponin as an example. National threshold is 60 minutes from received to result, but we average about 30 minutes.
“Throughput definitely increased,” Keigley added, emphasizing that this increased throughput was actually accompanied by a reduced workload. “We’ve seen a reduction in the amount of hands-on time required to do the daily maintenance and quality controls. Once the daily maintenance and controls are completed, the chemistry department can usually be run by one person.”
Choosing a Consolidated Automated Chemistry and Immunoassay Platform
Described as flexible for adding components, modular, and scalable, a consolidated clinical chemistry and immunoassay analyzer (CC/IA) can run from 1 million to 3 million tests per year. Designed with innovative technological internal controls and sample handling—and other capabilities that include automated instrument calibration, maintenance, and quality control (QC) functions—the CC/IA platform also works as a standalone and is a first step toward implementing laboratory automation.
At UMC, multiple factors influenced the decision to add the platform, explained Keigley. “One reason was the increased productivity that it (the Atellica Solution) from Siemens Healthineers offers. This technology frees up our techs to do what we went to school to do. I can show anyone how to load samples on these analyzers in five minutes, but that’s not what it’s about.
“We were able to expand our test menu and our services. The platform allowed us to grow.” Keigley estimates that UMC’s test menu grew up to 20% after the change, both expanding the types of testing that could be offered and decreasing the number of send-outs. He estimates that the chemistry lab now processes about 2.6 million reportable results per year.
There were several (QC) features that Keigley believes UMC’s laboratory benefits from. The key QC features Keigley identified include onboard temperature-controlled storage, programmable run times, and barcode-labelled tube options from the control manufacturer that eliminate manual programming.
Operational Evaluation—Nexus Global Solutions, Inc. (Nexus), Plano, TX
While the primary driving factor in UMC’s decision to use the Atellica Solution platform was based on its individual laboratory’s needs, a recent study commissioned by Siemens Healthineers illustrated the benefits of this system.
An operational comparison report by Nexus found that there are multiple advantages associated with this integrated automation platform—as a standalone component—when compared to a similar offering.
Specifically, the Nexus report found:
Start-up and maintenance time was almost an hour and a half less;
Manual start-up time requirements were 28 minutes, compared to 46 minutes;
From 65% to 69% of samples had a faster turnaround time; and
A system footprint that used 20square feet less space and four fewer analyzers.
Clinical laboratory leaders can review the methodology and results of the Nexus Global report by clicking on this link: www.siemens-healthineers.com/operational.
This article was produced in partnership with Siemens Healthineers.
Start of ex-Theranos president and COO Sunny Balwani’s federal trial will be pushed to mid-March due to COVID-19 spike in California
Just when most clinical laboratory managers and pathologists thought the guilty verdict in the Elizabeth Holmes fraud case would bring an end to the saga, we learn her chapter in the Theranos story will instead extend another eight months to September when the former Silicon Valley CEO will be sentenced. However, a brand-new chapter will begin in March when the fraud trial of ex-Theranos president and COO Ramesh “Sunny” Balwani begins.
Holmes’ fraud trial concluded on January 3 with the jury convicting her on one count of conspiracy to defraud investors and three counts of wire fraud after seven days of deliberation and nearly four months of trial proceedings.
Holmes remains free on a $500,000 bond while awaiting sentencing.
Elizabeth Holmes is seen above arriving at the US District courthouse in San Jose, Calif. On January 3, the former Theranos CEO was convicted on three counts of wire fraud and one count of conspiracy to defraud investors. US District Judge Edward Davila set Holmes’ sentencing date for September 26. Clinical laboratory directors and pathologists who have closely followed the trial will have to wait eight months for the conclusion of this chapter in the Theranos saga. (Photo copyright: The Guardian.)
“I would be utterly shocked if she wasn’t sentenced to some term of imprisonment,” Amanda Kramer, JD, a former federal prosecutor who is now a partner with New York-based Covington & Burling LLP, told NPR.
“What is the sentence that will deter others who have a failing business from making the choice to commit fraud, rather than owning up to the failings and losing their dream?” she added.
Holmes, 37, faces a possible prison sentence of 20 years in prison as well as a $250,000 fine and possible restitution. But some legal experts expect a much shorter prison sentence for the disgraced CEO, who has no prior criminal history and is a first-time mother of a son born last July.
While sentencing typically takes place within a few months of a verdict being reached in a federal criminal trial, US District Judge Edward Davila set 1:30 p.m. September 26, 2022, as the date for Holmes’ sentencing hearing, according to his order dated January 12.
The Mercury News reported the lengthy delay in sentencing may be due to the start of Balwani’s upcoming trial on identical fraud charges. The delay in Holmes’ sentencing will allow for Balwani’s trial to begin in mid-March after being pushed back one month due to a spike in COVID-19 cases in California, The Mercury News reported.
Judge Davila will preside over Balwani’s trial as well.
Jury Acquits Holmes on Patient-related Charges
Holmes was acquitted of conspiracy to defraud patients of the now-defunct blood-testing laboratory and the jury failed to reach a unanimous decision on three other wire fraud charges.
University of Michigan Law Professor Barbara McQuade, a former US Attorney and an NBC News Legal Analyst, told CNBC she expects prosecutors to rethink their strategy in the Balwani trial based on the jury’s acquittal of Holmes on conspiracy and fraud charges involving Theranos patients.
“Knowing that this jury acquitted on all of the patient counts, I think that strategically, they should look to find a more direct way to explain why that is part of the fraud, that they necessarily knew that ultimately patients would be defrauded. And that although they didn’t know these individual patients by name, they knew that they existed in concept,” McQuade said.
One of the jurors in the Holmes’ trial, Wayne Kaatz, told ABC News he and other jurors were dismayed by their inability to come to a unanimous consensus on the three of the charges. A mistrial was declared on those three counts.
“We were very saddened,” Kaatz said. “We thought we had failed.”
Did Holmes Charm the Jury?
When Holmes dropped out of Stanford at age 19 to form Theranos, her goal, she claimed during testimony, was to transform healthcare by creating a blood-testing device capable of performing hundreds of clinical laboratory tests using a finger-stick of blood. She became a Silicon Valley sensation because of her charisma and charm, which she used to sell her dream to big money investors such as Oracle co-founder Larry Ellison and former US Secretary of State George Shultz.
Kaatz acknowledged Holmes’ personality also impacted the jury.
“It’s tough to convict somebody, especially somebody so likable, with such a positive dream,” Kaatz explained to ABC News, noting, however, that he voted guilty on the three counts on which the jury could not agree. “[We] respected Elizabeth’s belief in her technology, in her dream. [We thought], ‘She still believes in it, and we still believe she believes in it.’”
In the light of Holmes’ conviction, McQuade suggested it would not be shocking to see Balwani consider a plea deal in exchange for a lighter sentence.
“Could we perhaps, enter a guilty plea and get a reduction for acceptance of responsibility?” she said. “It’s certainly something that you have to look at.”
And so, the saga continues. Clinical laboratory directors and pathologists who followed Holmes’ trial with rapt interest should prepare for a new set of twists and turns as Ramesh Balwani prepares to face his own day in court.
