Lab professionals will learn more at the upcoming 30th annual edition of the event
Big changes and challenges are coming for the clinical laboratory anatomic pathology industry, and with them a slew of opportunities for lab and pathology practice leaders. At the upcoming 30th Annual Executive War College on Diagnostics, Pathology, and Clinical Laboratory Management, expert speakers and panelists will focus on the three most disruptive forces.
There will be more than 169 presenters at this year’s Executive War College. Those speakers include:
David Dexter, MD, clinical and laboratory pathology at M Health Fairview, and Sam Terese, president and CEO at Alverno Laboratories, who will present a strategic case study about the support labs can provide to parent hospitals when navigating new waters.
Paul Wilder, executive director of CommonWell Health Alliance, who will speak on the effort to improve the transferability and portability of patient and healthcare data in ways that improve the quality of care.
“Since the inception of The Dark Report in 1995 there has been continual change both within the US healthcare system and within the profession of laboratory medicine,” noted Robert L. Michel, Dark Daily’s editor-in-chief and creator of the Executive War College. “Now, three decades later, the following three items are imperatives for all labs: controlling costs; having adequate lab staff across all positions; and having enough capital to acquire and deploy new diagnostic technologies, along with the latest information technologies.”
“Most clinical laboratory managers would agree that many of the same operational pain points faced by labs in the 1990s exist today,” said Robert L. Michel (above), founder of the Executive War College. In an interview with Dark Daily, Michel broke down the nuances of this triad of forces and what participants in the Executive War College can expect. (Photo copyright: LabX.)
Forces at Work in Clinical Labs and Pathology Groups
Here’s a more detailed look at each of the forces that Michel noted.
Force 1: An acute shortage of experienced lab scientists
“When you look at the supply-demand for laboratory personnel in the United States today, it is recognized that demand exceeds supply, and that gap continues to widen,” Michel noted. “For example, in the case of anatomic pathologists, the increased number of case referrals grows faster than medical schools can train new pathologists. Currently, the ability of pathology laboratories large and small to hire and retain an adequate number of pathologists is a challenge.”
Executive War College attendees can expect panelists and speakers to highlight creative problem solving techniques to circumvent the challenges labor shortages cause.
Force 2: New applications of artificial intelligence
“Today every instrument vendor, every automation supplier, every software supplier, every service supplier is telling labs that they have artificial intelligence (AI) baked inside,” Michel observed. “It is important for lab managers to understand that a variety of technologies are used by different AI solutions.”
Clinical laboratory managers and pathologists interested in acquiring a deeper understanding of where to start with AI in their lab will find numerous sessions on artificial intelligence at this year’s Executive War College. “There will be a number of sessions this year where clinical labs discuss their success deploying various AI solutions,” Michel said.
Force 3: Financial stress across the entire US healthcare system
“It’s recognized that a significant number of US hospitals and integrated delivery networks (IDNs) are struggling to maintain adequate operating margins,” Michel noted. “This obviously impacts the clinical laboratories serving these hospitals. If the hospitals’ cash flows and operating profit margins are being squeezed, typically the administration comes to the lab team and says, ‘Your budget for next year will be x% less than this year.’
“There are many IDNs and hospital labs where budget cuts have happened for multiple years,” Michel continued. “As a consequence, labs in these hospitals must be nimble to maintain a high-quality menu of diagnostic tests. Several years of such budget cuts by the parent hospital can undermine the ability of the clinical lab team to offer competitive salary packages to attract and retain the clinical lab scientists, pathologists, and clinical chemists they need.”
Recognizing Opportunities in Today’s Lab Market
The good news is that—despite the negative forces acting upon the US healthcare system today—clinical laboratories, genetic testing companies, and anatomic pathology groups have a path forward.
“This path forward is informed by two longstanding precepts recognized by innovative managers. One precept is ‘Change creates new winners and losers.’ The other precept is ‘Change creates opportunity,’” Michel said. “Savvy lab leaders recognize the powerful truths in each precept.
“As healthcare has changed over the past four decades, nearly all the regional and national laboratories that were dominant in 1990, for example, don’t exist today!” he noted. “And yet, even as these lab organizations disappeared, new clinical lab organizations emerged that recognized healthcare’s changes and organized themselves to serve the changing needs of hospitals, office-based physicians, payers, and patients.”
All of these critical topics and more will be covered during the 30th Annual Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management on April 29-30, 2025, at the Hyatt Regency in New Orleans. Signup today to bring your lab’s management team by registering at https://www.executivewarcollege.com.
Robert Michel, founder of TDIG and editor-in-chief of The Dark Report, explained that the acquisition serves as step one to winding down his long career.
“First and most important, this starts my path toward retirement,” Michel said in the March 10 issue of The Dark Report. “I’ve served in the clinical laboratory industry for 34 years now. That’s one-third of a century!”
More Options Ahead for Dark Daily Readers
In purchasing the assets of TDIG, LabX Media Group adds to its powerhouse of resources for clinical laboratory leaders, including Today’s Clinical Lab, G2 Intelligence, and Lab Manager.
The deal will give readers of Dark Daily further options from which to get their laboratory science and operations information, as Today’s Clinical Lab provides free content in areas such as pathology and clinical laboratory technology.
Additionally, “The lab science coverage in Today’s Clinical Lab complements the business intelligence of The Dark Report, allowing LabX Media to offer a more comprehensive range of information for clinical lab professionals,” Today’s Clinical Lab wrote last week.
“The good news for all the clients and long-time readers of The Dark Report is that LabX has both the capital and the specialized expertise required to keep The Dark Report, Dark Daily, and the Executive War College at the top of their games going forward,” said Robert Michel (above), founder of The Dark Intelligence Group, which sold its assets to LabX Media Group. (Photo copyright: LabX.)
Statement on LabX Purchase of The Dark Intelligence Group
In a statement about this transaction, LabX Media Group CEO Bob Kafato said: “We are excited to formally recognize these new additions to the LMG family. TDIG’s flagship publication, The Dark Report, has a 30-year track record of delivering timely business intelligence to the leaders of North America’s most successful clinical laboratories, genetic testing companies, and anatomic pathology groups. During these same 30 years, the Executive War College has become the biggest and the highest-profile laboratory management conference in North America.”
Michel will serve as an advisor to LabX Media Group to ensure a smooth transition while continuing to provide strategic consulting services to the lab industry.
Who is LabX Media Group?
LabX Media Group is a leading business-to-business science media company delivering award-winning editorial coverage, essential industry news, analysis, and insights for members of the scientific research and life science communities. LabX Media Group connects laboratory professionals with resources to help them make smarter buying decisions through powerful, market-leading brands.
One interesting final fact: TDIG and LabX Media Group both were founded in 1995 and are celebrating their respective 30-year anniversaries, Michel noted.
Development of the Critical Values system redefined what STAT means in clinical laboratory testing turnaround times
Where did the concept of critical values and having clinical laboratories report them to referring physicians originate? How did the concept blossom into a standard practice in laboratory medicine? Given the importance of critical values, a lookback into how this aspect of laboratory medicine was developed is helpful to understand how and why this has become an essential element in the practice of medicine and an opportunity for labs to add value in patient care.
According to Stanford Medicine, critical/panic values are defined as “values that are outside the normal range to a degree that may constitute an immediate health risk to the individual or require immediate action on the part of the ordering physician.”
What you’ll read below is an insider’s account of the “birth of critical values reporting.”
According to Lundberg, an unaccompanied man was brought to the hospital in a coma and an examination revealed a laceration to his scalp. The patient was admitted to the neurosurgical unit where clinical laboratory tests were performed, including a complete blood count (CBC) analysis, urinalysis, and serum electrolytes. All the test results came back normal except the patient’s serum glucose (blood sugar level) which was 6 mg% in concentration.
“The hard-copy laboratory results were returned to the ward of origin within two hours of receipt of the specimens in the laboratory. However, the results were not noticed by the house officers who were busy with several other seriously ill patients. Ward personnel also failed to communicate the lab results to the responsible physicians,” Lundberg wrote.
When hospital staff did finally notice the test result the next morning glucose was immediately administered to the patient, but it was too late to prevent irreversible brain damage. The man soon passed away.
Following this incident, the hospital developed a “Critical Value Recognition and Reporting System.” The system generated new numbers that were termed “Panic Values.”
However, “critics complained that good doctors should never panic, so the name was changed to Critical Values,” Lundberg explained.
When any of these critical test values were out of the norm, “we required the responsible laboratory person to quickly verify the result and use the telephone (long before laboratory computers) to personally notify a responsible individual (no messages left) who agreed to find a physician who could quickly act on the result. All was documented with times and names,” he wrote.
“We understand that when a physician wants something, he/she wants it, no matter what. Well, in this patient-focused approach, the physician cannot have it, except as offered by the patient-focused approach, based on TAT [turnaround times of clinical laboratory tests],” wrote George Lundberg, MD (above), President and Chair of the Board of Directors of the Lundberg Institute, and Clinical Professor of Pathology at Northwestern University in an article he penned for the National Medical Journal of India (Photo copyright: Dark Intelligence Group. Shows Dr. Lundberg in 2011 addressing the Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management.)
New Clinical Laboratory Standards
Recognition of the urgency to adopt new hospital standards related to certain clinical laboratory test results came swiftly. In 1972, Lundberg was invited to publish an article explaining the new Critical Value Recognition and Reporting System in Medical Laboratory Observer.
According to Lundberg, “most laboratory tests that are done do not need to be done; the results are either negative, normal, or show no change from a prior result. But some are crucial.”
The original set of Critical Values included the following testing results:
The list of values were later expanded to include “vital values.” These values describe lab results for which “action” is important, but where timing is less urgent. Examples of vital values include:
Lundberg and his colleagues went on to redefine what constitutes a laboratory test and what renders a test successful. They discussed laboratory procedures with committees of clinicians, lab personnel and patients, and reorganized hematology, chemistry, and toxicology based on the turnaround time (TAT) of tests.
“We ‘started the clock’—any and all days/times 24×7—when a specimen arrived at some place within the laboratory, and stopped the clock when a final result was available somewhere in the laboratory,” Lundberg wrote in NMJI. “We categorized all tests as: less than one hour, less than four hours, less than 24 hours, and more than 24 hours, guaranteed, 24×7. As a trade-off, we abolished the concept of ‘STAT’ orders … NO EXCEPTIONS. The rationale of each TAT was the speed with which a result was needed to render proper medical care that mattered to the welfare of the patient, and, of course, that was technically possible.”
Since then, very little has changed for the Critical Values System over the past 50 years. The majority of values added have fallen under the “Vital” category and not the “Critical” category. Today, most health systems and clinical laboratories create their own internal processes and procedures regarding which values need to be reported immediately (critical), which values are not urgent (vital), and how those results should be handled.
Groups representing academic publishers are taking steps to combat paper mills that write the papers and then sell authorship spots
Clinical laboratory professionals rely on peer-reviewed research to keep up with the latest findings in pathology, laboratory medicine, and other medical fields. They should thus be interested in new efforts to combat the presence of “research paper mills,” defined as “profit oriented, unofficial, and potentially illegal organizations that produce and sell fraudulent manuscripts that seem to resemble genuine research,” according to the Committee on Publication Ethics (COPE), a non-profit organization representing stakeholders in academic publishing.
“They may also handle the administration of submitting the article to journals for review and sell authorship to researchers once the article is accepted for publication,” the COPE website states.
In a recent example of how paper mills impact scholarly research, multinational publishing company John Wiley and Sons (Wiley) announced in The Scholarly Kitchen last year that it had retracted more than 1,700 papers published in journals from the company’s Hindawi subsidiary, which specializes in open-access academic publishing.
“In Hindawi’s case, this is a direct result of sophisticated paper mill activity,” wrote Jay Flynn, Wiley’s Executive Vice President and General Manager, Research, in a Scholarly Kitchen guest post. “The extent to which our processes and systems were breached required an end-to-end review of every step in the peer review and publishing process.”
In addition, journal indexer Clarivate removed 19 Hindawi journals from its Web of Science list in March 2023, due to problems with their editorial quality, Retraction Watch reported.
Hindawi later shut down four of the journals, which had been “heavily compromised by paper mills,” according to a blog post from the publisher.
Wiley also announced at that time that it would temporarily pause Hindawi’s special issues publishing program due to compromised articles, according to a press release.
“We urgently need a collaborative, forward-looking and thoughtful approach to journal security to stop bad actors from further abusing the industry’s systems, journals, and the communities we serve,” wrote Jay Flynn (above), Wiley EVP and General Manager, Research and Learning, in an article he penned for The Scholarly Kitchen. “We’re committed to addressing the challenge presented by paper mills and academic fraud head on, and we invite our publishing peers, and the many organizations that work alongside us, to join us in this endeavor.” Clinical laboratory leaders understand the critical need for accurate medical research papers. (Photo copyright: The Scholarly Kitchen.)
Using AI to Detect Paper Mill Submissions
Wiley acquired Hindawi in 2021 in a deal valued at $298 million, according to a press release, but the subsidiary has since become a financial drain for the company.
The journals earn their revenue by charging fees to authors. But in fiscal year 2024, which began last fall, “Wiley expects $35-40 million in lost revenue from Hindawi as it works to turn around journals with issues and retract articles,” Retraction Watch reported, citing an earnings call.
Wiley also revealed that it would stop using the Hindawi brand name and bring the subsidiary’s remaining journals under its own umbrella by the middle of 2024.
The service will incorporate tools to detect signs that submissions originated from paper mills, including similarities with “known papermill hallmarks” and use of “tortured phrases” indicating that passages were translated by AI-based language models, according to a press release.
These tools include:
Papermill Similarity Detection: Checks for known papermill hallmarks and compares content against existing papermills papers.
Problematic Phrase Recognition: Flags unusual alternatives to established terms.
Unusual Publication Behavior Detection: Identifies irregular publishing patterns by paper authors.
Researcher Identity Verification: Helps detect potential bad actors.
Gen-AI Generated Content Detection: Identifies potential misuse of generative AI.
Journal Scope Checker: Analyzes the article’s relevance to the journal.
The company said that the new service will be available through Research Exchange, Wiley’s manuscript submission platform, as early as next year.
Other Efforts to Spot Paper Mill Submissions
Previously, STM announced the launch of the STM Integrity Hub, with a mission “to equip the scholarly communication community with data, intelligence, and technology to protect research integrity,” Program Director Joris van Rossum, PhD, told The Scholarly Kitchen.
In 2023, the group announced that the hub would integrate Papermill Alarm from Clear Skies, a paper mill detection tool launched in 2022 with a focus on cancer research. It uses a “traffic-light rating system for research papers,” according to a press release.
In an announcement about the launch of Wiley’s Papermill Detection service, Retraction Watch suggested that one key to addressing the problem would be to reduce incentives for authors to use paper mills. Those incentives boil down to the pressure placed on many scientists, clinicians, and students to publish manuscripts, according to the research report from STM and COPE.
In one common scenario, the report noted, a paper mill will submit a staff-written paper to multiple journals. If the paper is accepted, the company will list it on a website and offer authorship spaces for sale.
“If a published paper is challenged, the ‘author’ may sometimes back down and ask for the paper to be retracted because of data problems, or they may try to provide additional supporting information including a supporting letter from their institution which is also a fake,” the report noted.
All of this serves as a warning to pathologists and clinical laboratory professionals to carefully evaluate the sources of medical journals publishing studies that feature results on areas of healthcare and lab medicine research that are of interest.
“The timing of EWC with the release of this policy couldn’t be better,” CEO and founder of Momentum ConsultingValerie Palmieri told Dark Daily in an interview at Monday night’s opening reception. “It’s a great conference to not only catch up with colleagues but really hear and have those difficult discussions about where we are today, where we’re going, and where we need to be.”
Final LDT rule ‘radically’ different than draft
Tim Stenzel, MD, PhD, former director of the FDA’s Office of In Vitro Diagnostics called the finalized rule “radically different” from the proposed rule. In some ways it is less complex: “The bar is lower,” he said, noting that he was voicing his personal views and not those of the federal agency. “I was convinced that there would be lawsuits, but I’m now not sure if that’s advisable.”
Still, laboratory teams will have to parse the more than 500-page document to determine how the final rule relates to their specific circumstances. After that, it won’t be as challenging, Stenzel said.
His advice: First, read the rule. Second, reach out to FDA for help—he’s sure, he said, that the office is geared up to respond to a “ton of questions” about the implications for individual labs and are standing by to answer emails from labs. And, he added in a discussion session, emailing the agency is free.
The final rule will be in force 60 days after it’s published. Stenzel provided a timeline for some of the milestones:
1 Year: Comply with MD(AE) reporting and reporting of corrections and removals.
2 Years: Comply with labeling, registration and listing, and investigational use requirements.
3 Years: QS records and, in some cases, design controls and purchasing controls.
3.5 Years: Comply with high risk (class III) premarket review requirements.
4 Years: Comply with moderate and low-risk premarket review requirements.
Executive Chair and CEO of XiFin, Inc.Lâle White welcomed the audience with a morning keynote entitled “Big Changes in Healthcare” on new regulations and diagnostics players poised to reshape lab testing.
The diagnostics business is in constant flux, she noted, from payer requirements to greater regulatory and compliance burdens on labs. Other factors include the growing senior population and increasingly complex health conditions, rising costs throughout the healthcare ecosystem, falling funding and reimbursement, and staffing shortages.
As for the economic challenges, consumers are increasingly making decisions based on cost, convenience and quality. The population is shifting to Medicare advantage, which is more cost effective. But changes to the star ratings system will mean lower pay for payer organizations. Those companies will, in turn, mitigate their losses by making changes to pre-authorizations and tightening denials, even for clean claims.
Still, White said, more money isn’t the answer.
White urged the audience to use technology, including artificial intelligence and advances in genetic testing, to manage these and other industry changes.
“We need to optimize the tests we order,” she said. “And if we did that, lab diagnostics really has the potential to change the economics of health and improve outcomes.”
The FDA, Stenzel added, is “very interested” in stimulating innovation, building on the laboratory industry’s success in responding swiftly to the COVID pandemic and outbreaks of Monkey Pox, for example.
He shared lessons learned from recent public health emergencies, talked about CDC’s efforts to engage with clinical labs to improve future public health readiness and response and provided an overview of the CDC’s first laboratory-specific center.
“Laboratories are fundamental to public health,” he said. The industry is on the “front lines” when it comes to identifying threats, responding to them, and preparing for future responses.
Robert Michel, Editor-in-Chief of The Dark Report wrapped up the day’s regulatory discussions with a general session on the “regulatory trifecta” that includes the LDT final rule, CLIA regulations, and private payers’ policies for genetic claims.
Tim Stenzel, MD, PhD, will discuss what clinical laboratories need to know about the draft LDT rule, FDA memo on assay reclassification, and ISO-13485 harmonization
Many clinical laboratories anxiously await a final rule from the US Food and Drug Administration (FDA) that is expected to establish federal policies under which the agency will regulate laboratory developed tests (LDTs). The agency released a proposed rule on Oct. 3, 2023, setting a Dec. 4 deadline for submission of comments. The White House’s Office of Management and Budget received a draft of the final rule less than three months later on March 1, 2024.
“Given how fast it moved through HHS, the final [rule] is likely pretty close” to the draft version, wrote former FDA commissioner Scott Gottlieb, MD, in a post on LinkedIn. Gottlieb and other regulatory experts expect the White House to submit the final rule to Congress no later than May 22, and perhaps as soon as this month.
Stenzel, who retired from the FDA last year, emphasized that he was not speaking on behalf of the federal agency and that he adheres to all FDA confidentiality requirements. He formed a new company—Grey Haven LLC—through which he is accepting speaking engagements in what he describes as a public service.
“I’m taking a wait and see approach,” said Tim Stenzel, MD, PhD (above), former director of the FDA’s Office of In Vitro Diagnostics, in an interview with Dark Daily. “The rule is not finalized. The FDA received thousands of comments. It’s my impression that the FDA takes those comments seriously. Until the rule is published, we don’t know what it will say, so I don’t think it does any good to make assumptions.” Clinical laboratory leaders will have an opportunity to learn how to prepare for FDA regulation of LDTs directly from Stenzel at the upcoming Executive War College in May. (Photo copyright: LinkedIn.)
FDA’s History of LDT Regulation
Prior to his five-year stint at the agency, Stenzel held high-level positions at diagnostics manufacturers Invivoscribe, Quidel Corporation, Asuragen, and Abbott Laboratories. He also directed the clinical molecular diagnostics laboratory at Duke University Medical Center in North Carolina. In the latter role, during the late 1990s, he oversaw development of numerous LDTs, he said.
The FDA, he observed, has long taken the position that it has authority to regulate LDTs. However, since the 1970s, after Congress passed the Medical Device Amendments to the federal Food, Drug, and Cosmetic Act, the agency has generally exercised “enforcement discretion,” he said, in which it declined to regulate most of these tests.
At the time, “many LDTs were lower risk, small volume, and used for specialized needs of a local patient population,” the agency stated in a press release announcing the proposed rule. “Since then, due to changes in business practices and increasing ability to ship patient specimens across the country quickly, many LDTs are now used more widely, for a larger and more diverse population, with large laboratories accepting specimens from across the country.”
Clinical Labs Need a Plan for Submission of LDTs to FDA
The FDA proposed the new rule after Congress failed to vote on the VALID Act (Verifying Accurate Leading-edge IVCT Development Act of 2021), which would have established a statutory framework for FDA oversight of LDTs. Citing public comments from FDA officials, Stenzel believes the agency would have preferred the legislative approach. But when that failed, “they thought they needed to act, which left them with the rulemaking path,” he said.
The new rule, as proposed, would phase out enforcement discretion in five stages over four years, he noted. Labs would have to begin submitting high-risk tests for premarket review about three-and-a-half years from publication of the final rule, but not before Oct. 1, 2027. Premarket review requirements for moderate- or low-risk tests would follow about six months later.
While he suggested a “wait and see” approach to the final rule, he advises labs that might be affected to develop a plan for dealing with it.
Potential Lawsuits
Stenzel also noted the likelihood of litigation in which labs or other stakeholders will seek to block implementation of the rule. “It’s a fairly widespread belief that there will be a lawsuit or lawsuits that will take this issue through the courts,” he said. “That could take several years. There is no guarantee that the courts will ultimately side with the FDA.”
He acknowledged that it is a controversial issue among clinical laboratories. Many labs have voiced opposition to the rule as well as the Valid Act.
Currently in retirement, Stenzel says he is making himself available as a resource through public speaking for laboratory professionals and other test developers who are seeking insights about the agency.
“The potential value that I bring is recent experience with the FDA and with stakeholders both inside and outside the FDA,” he said, adding that during his presentations he likes “to leave plenty of time for open-ended questions.”
In the case of his talks at the Executive War College, Stenzel said he anticipates “a robust conversation.”
He also expects to address other FDA-related issues, including:
A recent memo in which the agency said it would begin reclassifying most high-risk In Vitro Diagnostic (IVD) tests—those in class III (high risk)—into class II (moderate to high risk).
The emergence of multi-cancer detection (MCD) tests, which he described as a “hot topic in the LDT world.” The FDA has not yet approved any MCD tests, but some are available as LDTs.
A new voluntary pilot program in which the FDA will evaluate LDTs in situations where the agency has approved a treatment but has not authorized a corresponding companion diagnostic.
An FDA effort to harmonize ISO 13485—a set of international standards governing development of medical devices and diagnostics—with the agency’s own quality system regulations. Compliance with the ISO standards is necessary to market products in many countries outside the US, particularly in Europe, Stenzel noted. Harmonization will simplify product development, he said, because manufacturers won’t have to follow two or more sets of rules.
To learn how to prepare for the FDA’s future regulation of LDTs, clinical laboratory and pathology group managers would be wise to attend Stenzel’s presentations at this year’s Executive War College. Visit here to learn more and to secure your seat in New Orleans.
