Answers and effective solutions to the lab profession’s most urgent challenges will be front and center at the innovative ‘Lab Management Essentials Workshop’
Three powerful forces are slamming clinical laboratories today. One is the urgent need to cut costs. Second is the struggle to achieve and maintain full lab staffing. Third is the pressure to increase revenue and expand market share.
All of this is happening even as hospitals and health systems must deal with almost identical issues. Cost-cutting, recruiting more staff, and finding ways to increase revenue dominate the thoughts and actions of senior health administrators.
Most Hospitals and Health Systems Report Substantial Financial Losses
News reports about the financial losses at hospitals and health systems tell the story. For example, one report in Becker’s Healthcare described the financial damage at three major, multi-state health systems:
AdventHealth, a 48-hospital health system, reported a $417.7 million net loss in the first quarter of 2022. It reported that, because of inflation, costs had increased by 15% over prior year.
Kaiser Permanente, with 12.6 million members in seven regions of the United States, reported a net loss of $961 million in the first quarter of 2022. One major factor in these losses was the increase in expenses, which was 9.5%. For second quarter 2022, Kaiser Permanente showed a loss of $1.3 billion, most of that from a decline in the value of its investment portfolio.
Ascension Health, with 143 hospitals in 19 states, reported a net loss of $884.7 million in first quarter of 2022. It said its costs increased by 10.6% over the same period last year.
Most hospital-based clinical laboratory managers and pathologist are aware of these staggering financial losses. They also are watching how the shortage of nurses and other skilled personnel has hospitals scrambling to close that gap by paying more overtime, using temporary nurses who are paid at much higher rates, and increasing nurse salaries to prevent existing staff nurses from taking more lucrative offers from other hospitals in the community.
Clinical Laboratories Under Pressure to Cut Costs and Maintain Adequate Staff Levels
Hospital-based laboratories are on the frontline of these hurricane forces. Facing operating losses, hospitals ask their laboratories and other clinical service lines to cut costs below authorized budgets. Meanwhile, the labs themselves must deal with their own shortage of medical technologists (MTs) and clinical laboratory scientists (CLSs)—along with other skilled positions—that are required to provide the full menu of lab testing services.
This “perfect storm” of pressures to cut costs, keep staffing at authorized levels, and generate more revenue (that can offset rising costs of lab supplies and the higher salaries being paid to MTs and CLSs) is without precedent in the past four decades. To provide lab managers with the knowledge to resolve these challenges swiftly and confidently in their own laboratories, the team behind the Executive War College assembled experts to conduct a one-and-a-half-day interactive workshop.
Using Lab Case Studies to Teach Proven Solutions for Reducing Expenses
Each of the three important topics will be addressed in half-day learning modules. Following case study presentations on best practices, attendees at Lab Management Essentials will break out into smaller roundtable groups facilitated by lab industry experts. The groups will brainstorm how to apply these proven methods to cut costs, retain employees, and create revenue. They will then describe their findings to all participants.
Lab Management Essentials Workshop facilitators (clockwise from top left): Tafney Gunderson, Carlton Burgess, Dorothy Martin, Rick VanNess, Jane Hermansen, and Kim Zunker.
On the morning of day one, leaders of the lab cost-cutting module will be:
Carlton Burgess, Vice President of Laboratory Services at Prime Healthcare in Ontario, Calif.
Tafney Gunderson, Quality Systems Supervisor at Avera McKennan Laboratory in Sioux Falls, S.D.
On the afternoon of day one, leaders of the lab staff recruiting, hiring, and retention module will be:
Dorothy Martin, Regional Laboratory Manager at Dartmouth-Hitchcock Health in Lebanon, N.H.
Kim Zunker, MBA, MLS(ASCP), CAPM, Consulting Manager at Accumen in Scottsdale, Ariz.
On the morning of day two, leaders of the lab staff recruiting, hiring, and retention module will be:
Jane Hermansen, MBA, MT(ASCP), Manager of Outreach and Network Development at Mayo Clinic in Rochester, Minn.
Rick VanNess, Director of Product Management at Rhodes Group and TriCore Reference Laboratories in Albuquerque, N.M.
Delivering Essential Knowledge to Up-and-Coming Laboratory Managers
This Lab Management Essentials workshop is a first for the clinical laboratory profession. It brings together experienced, effective lab leaders to teach, guide, and coach your lab’s smartest up-and-coming lab managers. It accomplishes this in just one-and-a-half days, to minimize the time they are away from your lab.
To gain maximum benefits from this well-designed program, it is recommended that you send three or four of your front-line lab managers. Together, they will hear and learn at the same time, while working during the intimate sessions to identify the techniques and methods that will work best for your lab. This is important because, upon their return, they will have both enthusiasm and the knowledge to light the right fires under your lab staff and energize them into quickly deploying ways to slash expenses, attract top candidates to fill open positions, and even to tap new sources of revenue—all of which they learned during Lab Management Essentials.
Because the number of attendees to each workshop is limited, you are encouraged to click here to register yourself and your designated lab managers today.
Shultz and fellow whistleblower Erika Cheung spoke to clinical laboratory scientists and attendees at the AACC Annual Scientific Meeting in Chicago
Two whistleblowers who raised concerns about the accuracy of Theranos’ blood test results offered thought-provoking comments on how the maligned company operated within current requirements for clinical laboratory-developed tests (LDTs) during last week’s American Association of Clinical Chemistry (AACC) Annual Scientific Meeting.
“The laboratory-developed test loophole that Theranos exploited should be closed,” said Tyler Shultz, who complained about Theranos’ inaccurate testing to regulators and TheWall Street Journal. Both Shultz and fellow Theranos whistleblower Erika Cheung were former employees at the now-defunct company.
“There are a lot of good use cases for LDTs, so they shouldn’t all be shut down,” Shultz continued. “But in general, I do think that if FDA-cleared clinical laboratory tests are available, those tests should be used instead of a homebrew test that hasn’t been held to the same standard that an FDA-cleared product has.”
Both trials examined the dubious claims that Theranos’ technology worked properly during the company’s blazing ascent with both Silicon Valley investors and the media from 2003 to 2014. The company said it could take a few drops of blood from a patient and successfully analyze the specimen using a machine called Edison, although Shultz, Cheung, and others questioned the results.
By 2015, problems with Theranos’ testing began to go public. The company shut down in 2018 after Holmes and Balwani were indicted.
However, proposed legislation is before Congress that would transfer oversight of LDTs to the US Food and Drug Administration (FDA). The bill, known as the Verifying Accurate Leading-edge IVCT Development (VALID) Act, is now embedded in the larger Senate bill FDA Safety and Landmark Advancements Act of 2022 (S.4348).
Theranos’ saga did provide at least some inspiration for legislators filing the VALID Act. However, Cheung noted that trying to regulate all LDTs based the bad behavior of Theranos’ executives is a complex issue.
“Regulation is always tricky,” she said. “When you take an example of a very extraordinary case and a very specific circumstance [such as Theranos] and try to generalize that in terms of what is the behavior of all labs, you have to be careful.”
Proponents state FDA pre-market approval is needed for in vitro diagnostic tests because they are like medical devices. Opponents counter that the VALID Act would stifle innovation because of the costs involved with FDA review, particularly at academic medical laboratories.
Cheung questioned whether FDA review of Theranos’ technology would have averted patient and investor fraud by Holmes and Balwani.
“Would it have been the case that if it was necessary for the FDA to review Theranos’ LDTs, that it could have stopped it? Maybe,” Cheung told AACC attendees. “But you’re also dealing with a company that lied a lot. There were lots of things that Theranos had to submit to CLIA or to CMS in order to say that they were able to test certain types of patients.”
Shultz had similar feelings regarding a hypothetical FDA review of Theranos’ product, which will ring true with pathologists and clinical laboratory professionals who understand medical laboratory compliance and how the FDA regulate diagnostic instruments and kits.
“When you bring something to the FDA, they look at the data. They don’t go in and actually do third-party validation to see if your device works,” he said. “They just look at the data, and the [Theranos] data was largely manipulated. So, if you forced Theranos to go through the FDA process, I’m not sure if it would have prevented [the fraud].”
With Millennials soon to make up the majority of the medical laboratory workforce, it’s only natural that digital networking is gaining momentum at events like the Executive War College
At any hour during the in-person event in New Orleans, attendees scheduled meetups, participants asked questions to conference organizers, and users discussed important clinical laboratory and anatomic pathology topics. All of those interactions occurred within the Whova meeting application, which served as the Executive War College’s virtual guide.
In many ways, widespread use of the meeting app reflects a younger crowd that lives life on mobile phones. It’s not all that different than the changing face of the clinical lab industry as laboratory veterans retire and new faces come in, said Robert Michel, Founder of the Executive War College (EWC) and Editor-in-Chief of Dark Daily’s sister publication The Dark Report.
“It’s clear from the soaring use of our conference’s meeting app at the Executive War College that a younger generation is changing how business is conducted during and after a lab industry conference,” he observed. “Generation X and Millennials are steadily influencing how people network at live events.”
“It is remarkable that, among the 900 attendees at this year’s event, there were more than 750,000 impressions involving the sponsors and companies supporting this year’s conference,” said Robert Michel (above), Editor-in-Chief of Dark Daily and Founder of the Executive War College. “It shows that these attendees are serious about identifying solutions and vendors who can help them solve the various pain points in their laboratories.” (Photo copyright: Dark Intelligence Group.)
88% of Attendees at Executive War College Used the Event App
Usage numbers aggregated during the EWC conference of people who downloaded and used the meeting app speak for themselves:
A large majority of attendees (88%) downloaded the app.
Users sent 11,398 messages in the app.
There were 136 community board discussions posted.
Users created 80 meetups, with 677 people attending those gatherings.
There were 764,745 sponsor impressions in the app (in other words, clicks on a sponsor link or attendees navigating to sponsor material).
What the numbers don’t convey is that the conference’s meeting app was also fun to use!
Butterworth spoke during a special session at the Executive War College. She also took the No. 1 spot on the meeting app’s leaderboard for the event, collecting an impressive 225,900 points. Users gained points for the leaderboard based on activities they completed in the app.
Spirited competition ensued among the leaderboard’s top users, who jockeyed for position as the conference progressed. Plenty of off-topic conversations took place in the app as well, as attendees helped each other navigate New Orleans with tips about restaurants, local cemetery tours, or where to work out.
The leaderboard on the Whova meeting application (above) at the conclusion of this year’s Executive War College on Laboratory and Pathology Management showed the top point gainers. (Photo copyright: Dark Intelligence Group.)
Clinical Laboratory Sponsors Reached Out to Attendees in New Ways
For sponsors and other vendors visiting the conference, the meeting app provided a different avenue to approach attendees beyond the typical networking that takes place during breaks, cocktail receptions, luncheons, and off-site parties.
For example, some sponsors shared white papers or YouTube videos via the app’s community boards or asked questions about topics of interest. Additionally, sponsors could respond directly to queries from attendees.
“At the Executive War College, there was clearly a sustained exchange between vendors looking to engage business development opportunities and participants who have pain points that need to be addressed and are looking for solutions,” Michel said.
The next Executive War College will return to New Orleans on April 25-26, 2023. Click on this link to access early registration discounts.
Labcorp, the commercial laboratory giant headquartered in Burlington, N.C., has billions of diagnostic test results archived. It takes samplings of those results and runs them through a machine learning algorithm that compares the data against a condition of interest, such as chronic kidney disease (CKD). Machine learning is a subdiscipline of AI.
Based on patterns it identifies, the machine learning algorithm can predict future test results for CKD based on patients’ testing histories, explained Stan Letovsky, PhD, Vice President for AI, Data Sciences, and Bioinformatics at Labcorp. Labcorp has found the accuracy of those predictions to be better than 90%, he added.
Labcorp also has created an AI-powered dashboard that—once layered over an electronic health record (EHR) system—allows physicians to configure views of an individual patient’s existing health data and add a predictive view based on the machine learning results.
For anatomic pathologists, this type of setup can quickly bring a trove of data into their hands, allowing them to be more efficient with patient diagnoses. The long-term implications of using this technology are significant for pathology groups’ bottom line.
Stan Letovsky, PhD (above), Vice President for AI, Data Sciences, and Bioinformatics at Labcorp, discussed AI developments in digital pathology during his keynote address at the 2022 Executive War College in New Orleans. “The best thing as a community that we can do for patients and their physicians with AI is to identify care gaps early on,” he said, adding, “If pathologists want to grow and improve their revenue, they have to be more productive.” (Photo copyright: Dark Intelligence Group).
Mayo Clinic Plans to Digitize 25 Million Glass Slides
In other AI developments, Mayo Clinic in Rochester, Minn., has started a project to digitally scan 25 million tissue samples on glass slides—some more than 100 years old. As part of the initiative, Mayo wants to digitize five million of those slides within three years and put them on the cloud, said pathologist and physician scientist Jason Hipp, MD, PhD, Chair of Computational Pathology and AI at Mayo Clinic.
“We want to be a hub within Mayo Clinic for digital pathology,” Hipp told Executive War College attendees during his keynote address.
Hipp views his team as the bridge between pathologists and the data science engineers who develop AI algorithms. Both sides must collaborate to move AI forward, he commented, yet most clinical laboratories and pathology groups have not yet developed those relationships.
“We want to embed both sides,” Hipp added. “We need the data scientists working with the pathologists side by side. That practical part is missing today.”
The future medical laboratory at Mayo Clinic will feature an intersection of pathology, computer technology, and patient data. Cloud storage is a big part of that vision.
“AI requires storage and lots of data to be practical,” Hipp said.
Investigators may look into various angles, including drive-through testing sites for COVID-19 and whether uninsured patients were verified before free tests
Three healthcare compliance attorneys gave a clear and concise message to clinical laboratory managers and pathologists at the 2022 Executive War College Conference on Laboratory and Pathology and Management: Expect the government to scrutinize reimbursements it paid for COVID-19 testing, particularly for testing conducted at drive-through sites that popped up all over the country.
“The important question is: What is the fair market value of those specimens?” noted attorney Emily Johnson, JD, a Member at law firm McDonald Hopkins in Chicago. Johnson spoke during a legal panel on Wednesday at the Executive War College in New Orleans.
The panel spent 75 minutes discussing various legal concerns, many of them related to COVID-19 testing, before a crowd of about 80 attendees.
Attorney Emily Johnson, JD, of Chicago law firm McDonald Hopkins explained possible COVID-19 test fraud enforcement to attendees at the 2022 Executive War College. (Photo copyright: The Dark Intelligence Group.)
Audits May Be Coming of HRSA Reimbursements for COVID-19 Testing
Consumer Reports noted in a January article that COVID-19 testing prices varied wildly both in traditional healthcare settings and popup sites—in some cases, exceeding $1,400.
The average price for such a test within an insurance company’s network was $130.
Some people paid for those tests out of pocket or got them covered by insurance. For uninsured patients, the federal Health Resources and Services Administration (HRSA) established a pool of money to reimburse labs for free COVID-19 tests. That pool recently dried up and Congress has not approved more funding.
The U.S. Department of Justice may investigate the uninsured aspect of claims—specifically, whether there were attempts by laboratory staff members to verify whether a patient truly was not covered by health insurance, explained Karen Lovitch, JD, Chair of the Health Law and Healthcare Enforcement Defense Practice at law firm Mintz in Washington.
These issues bring up False Claims Act risks, especially if a clinical laboratory audits its own COVID-19 test claims. “If labs go back retroactively and determine a claim was paid that shouldn’t have been paid, those labs must absolutely be prepared to return that money,” Lovitch warned.
Clinical Laboratories Need a Business Plan for Post-COVID-19 Testing
Related to HRSA payments ending for COVID-19 testing of uninsured payments, clinical laboratories should be wary about outright ending such testing without a documented business plan demonstrating the rationale for doing so, Johnson noted. That advice is relevant for labs and pathology groups that received financial assistance from HRSA’s Provider Relief Fund during the pandemic.
Some have interpreted information about the fund to mean providers are obligated to treat uninsured patients, Johnson added.
“If I stop accepting uninsured patients for COVID testing, am I in violation of the Provider Relief Fund?” she asked. A clearly documented reason for doing so, such as a need to keep the business afloat through paid testing, would be a first step for concerned medical laboratories to take, she added.
Another point for labs to ponder: In March, the federal government named Kevin Chambers, JD—who is currently Associate Deputy Attorney General at the DOJ—as the first Director of COVID-19 Fraud Enforcement.
That appointment emphasizes the government’s commitment to undercovering SARS-CoV-2 wrongdoing, said attorney David Gee, JD, a Partner at law firm Davis Wright Tremaine in Seattle. Gee rounded out the panel at the Executive War College.
“I guarantee Chambers’ bosses want him to demonstrate the government is serious about COVID-19 fraud,” Gee commented.
EKRA Becomes New Tool against COVID-19 Fraud
Finally, as Dark Daily previously reported, the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) is sometimes being used to prosecute cases of alleged COVID-19 testing fraud.
EKRA has generally been associated with rules against paying clinical laboratory sales reps a commission based on testing volumes they generate. However, Johnson predicted more EKRA cases will be filed related to alleged kickbacks paid in return for referrals for COVID-19 testing.
“Prosecutors seem willing to go after these cases aggressively,” she added.
And in The Dark Report’s upcoming Regulatory Update, “Dept. of Justice: EKRA Governs Lab Sales and Marketing Commissions,” Dark Daily’s sister publication covers how a recent ruling by a federal judge may weaken EKRA and “immunize conduct that drives up medical costs.”
Subscribers to The Dark Report will want to stay informed on critical changes taking place that affect how EKRA operates.
27th annual meeting of medical laboratory and pathology managers delivers insights on the path ahead for diagnostics, ranging from the supply chain shortage and the ‘Great Resignation’ to advances in artificial intelligence and whole genome sequencing in service of precision medicine
What’s coming as healthcare providers move to post-COVID-19 pandemic workflows will be of keen interest to clinical laboratory leaders attending this critical event. Several new and dynamic market changes are reshaping the development of, ordering, and reimbursement for medical laboratory tests. They include:
Millennials as change agents in how care is accessed and delivered.
New buyers of large volumes of clinical lab tests, such as retail pharmacies.
How clinical laboratories can earn new sources of revenue while supporting precision medicine.
Clinical Labs Should Prepare for the ‘Coming Roller Coaster Ride’
Robert L. Michel, Editor-in-Chief of Dark Daily’s sister publication, The Dark Report, and Founder of the Executive War College, described the “coming roller coaster ride” for the pathology and clinical laboratory industries.
Amid the usual operational issues labs deal with (e.g., workforce shortages, supply chain disruptions, regulatory pressures), he noted the emergence of new and powerful forces pulling clinical laboratories and pathology groups in all directions.
“One primary factor is how Millennials will use healthcare differently than Gen Xers and Baby Boomers,” Michel noted. “Similarly, Millennials will make up 75% of the pathologists and the lab workforce by 2025.
“Another major force for change will be new buyers of clinical laboratory tests,” he continued. “For example, expect to see national retail pharmacy chains build thousands of primary care clinics in their retail pharmacies. These clinics will need lab tests and will become major buyers of near-patient analyzers and lab tests.
“A third interesting factor is that a new class of in vitro diagnostics (IVD) manufacturers are developing analyzers and test systems that use minimal amounts of specimens and return answers in minutes. Primary care clinics in retail pharmacies will be interested in buying these lab testing solutions,” Michel concluded.
Robert L. Michel (above), Editor-in-Chief of The Dark Report and Founder of the Executive War College, has studied and worked with leaders of clinical laboratories and pathology groups for more than four decades. During his keynote address, he predicted that powerful economic forces are about to be unleashed on the traditional market for clinical laboratory testing. Those forces include the use of artificial intelligence (AI) in digital pathology, primary care in retail pharmacies, and increased focus on precision medicine. (Photo copyright: The Dark Intelligence Group.)
Peer-to-Peer Learning Opportunities
With approximately 90 presenters scheduled, clinical laboratory leaders from such prestigious institutions as Johns Hopkins Hospital, Mayo Clinic, United Indian Health Services, and more will facilitate peer-to-peer learnings throughout the conference.
In addition, several sessions and panel Q/A discussions will cover critical legal and regulatory issues and payer challenges facing the industry.
New Technologies, Workflows, Analytics
The 2022 Executive War College master classes, breakouts, panel discussions, and benefactor sessions will highlight several significant themes:
Lab data analytics and utilization. Sessions this year are heavily weighted toward data analytics, aggregation, and utilization. Look for case studies demonstrating the value of lab data, and where and how data has become actionable and monetized. As Dark Daily previously reported, useful data structures have been difficult to achieve for clinical laboratories; however, the case studies featured during this week’s conference will demonstrate signs of progress and highlight lessons learned.
Automation. Several case studies are planned that focus on expansion and modernization using laboratory automation. From Butler Health System, an independent hospital system in western Pa., Robert Patterson, MD, Medical Director of Pathology, Laboratory Medicine, and Laboratory Outreach, will detail steps Butler took that enabled its labs to better compete with other area health systems and national reference laboratories. Likewise, Eric Parnell, System Supervisor of Microbiology for Bronson Healthcare in southern Mich., will discuss his lab’s transition to and implementation of total laboratory automation.
Genetic testing and next-generation sequencing (NGS). Quickly becoming the foundational disruptor technology on which many new and powerful clinical laboratory tests and procedures are based, genomic testing has now become accessible and affordable. Many clinical laboratories and pathology groups are using molecular diagnostics testing to deliver clinical value to referring physicians.
Other sessions include:
Launching and scaling clinical NGS testing in a clinical environment (featuring a project at Rady Children’s Hospital in San Diego).
How labs and payers can work together to achieve better outcomes and health equity using genomic testing.
Effective ways to repurpose PCR and other genetic test instruments to build specimen volume and increase lab revenue.
Paths Forward for Clinical Labs and Pathology Groups
Another important topic being discussed at the 2022 Executive War College is how to position clinical laboratories and pathology groups for the next phase of modern healthcare.
Attracting capital for clinical labs and pathology groups.
Emerging concepts in growth strategies.
Business valuation factors.
Unexpected disruptions during sales closings.
These are just a few highlights of the informative sessions and expert speakers scheduled during this week’s 27th annual Executive War College in New Orleans. Look for more coverage in Dark Daily during the days ahead and in upcoming editions of our sister publication The Dark Report.
Full details about the 2022 Executive War College can be found by clicking on this link. (Or copy/paste this URL into your web browser: http://www.executivewarcollege.com.)
Speakers, session topics, and the conference agenda can be viewed by clicking on this link. (Or copy/paste this URL into your web browser: https://executivewarcollege.darkintelligencegroup.com/executive-war-college-agenda-2022.)
