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

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

Hosted by Robert Michel
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University of Pittsburgh Pathologists Create World Tumor Registry to Assist Medical Professionals in the Identification and Diagnosis of Cancers

As the cancer registry expands it will increasing become more useful to anatomic pathologists, histopathologists, oncologists, and even clinical laboratories

Oncologists, histopathologists, anatomic pathologists, and other cancer physicians now have a powerful new Wikipedia-style tumor registry to help them with their diagnoses and in educating patients on their specific types of cancer. Clinical laboratory managers may find it useful to understand the value this searchable database, and it can help their staff pathologists as well.

Free to use by both physicians and patients the World Tumor Registry (WTR) is designed “to minimize diagnostic errors by giving doctors a searchable online database of cancers that have been collected and categorized with cellular images collected from around the world,” Pittsburg-Post Gazette reported.

Prompt, accurate cancer diagnoses offer cancer patients the best chance for optimal treatment outcomes. However, many medical professionals around the globe do not have the training and resources to offer superior cancer diagnoses. That deficiency can translate to inferior treatment options and lower survival rates among cancer patients. 

To help improve cancer diagnoses, pathologist Yuri E. Nikiforov, MD, PhD, Division Director, Molecular and Genomic Pathology, Vice Chair of the Department of Pathology,  and Professor of Pathology, University of Pittsburgh, developed the WTR to provide educational and practical resources for individuals and organizations involved in cancer research.

Officially announced at the United States and Canadian Academy of Pathology (USCAP) annual convention, the WTR is an open-access catalog of digital microscopic images of human cancer types and subtypes.

The lower cost of technology and improved speed of access via the internet are technologies enabling this effort.

“We are creating sort of a Wikipedia for cancer images,” said Alyaksandr V. Nikitski, MD, PhD (above), Research Assistant Professor of Pathology, Division of Molecular and Genomic Pathology at Pittsburg School of Medicine and Administrative Director of the WTR, in an exclusive interview with Dark Daily. “Anyone in the world, if they can access the internet, they can look at the samples,” said Nikitski. Clinical laboratories may also find this new pathology tool useful. (Photo copyright: UPMC Pathology, University of Pittsburg.)

Minimizing Diagnostic Errors

Based in Pittsburgh, the WTR is freely available to anyone for viewing digital pathology slides of known cancer tumors as well as borderline and questionable cases. On the website, individuals can search for pictures of tumors in the registry by diagnosis, specific cohorts, and by microscopic features. Individuals may search further by tumor type and subtype to receive a picture of related tumors. 

According to the WTR website, the mission of the nonprofit “is to minimize diagnostic errors, eliminate inequality in cancer recognition, diagnosis, and treatment in diverse populations, and improve outcomes by increasing access to the diagnostic pathology expertise and knowledge of microscopic characteristics of cancers that occur in different geographic, environmental, and socio-economic settings.”

This new comprehensive initiative will eventually encompass cancer images from all over the world. 

“Let’s assume that I am a pathologist who has little experience, or I don’t have access to collections of atypical tumors,” Nikitski explained. “I can view tumor collections online [in the WTR database] and know which cancer is likely and also presents an improved metastasis at the peak of the health emergency.”

Once an image of a slide is selected, users will then receive a brief case history of the tumor in addition to such data as the age of the patient, their geographic location, sex, family history of the disease, and the size and stage of the tumor.

Increasing Probability of Correct Diagnosis

Pathologists and clinicians may also predict the probability of a particular diagnosis by searching under the microscopic feature of the database. This feature utilizes an innovative classifier known as PathDxFinder, where users may compare a slide from their lab to slides in the database by certain criteria. This includes:

After completing the questions above, the user presses the “predict diagnosis” button to receive the probability of cancer and most likely diagnosis based on the answers provided in the questionnaire.

WTR Editorial Boards

The WTR represents collections for each type of cancer site, such as lung or breast. A chairperson and editorial board are responsible for reviewing submitted slides before they are placed online. The editorial boards include 20 pathologists who are experts in diagnosing cancer categories, along with four editors, Nikitski explained.

Thousands of identified microscopic whole slide images (WSI) representing various types of cancer are deposited by the editors and other contributors to the project. The editorial board then carefully analyzes and compiles the data before posting the images for public viewing. 

The editorial boards are located in five world regions:

  • Africa and the Middle East
  • Asia and Oceania
  • Central and South America
  • North America and Europe
  • Northern Asia

Any physicians or pathologists can contribute images to the database, by “simply selecting the editor of [their] region on the website, writing [their] name, and asking if [they] can donate,” Nikitski stated.

“Pathologists are in the region, and our editors are actually in the same region, so they are contacting their regional editors,” he added.

Helping Physicians Identify Cancer Types 

In a YouTube video, Nikiforov states that the WTR is an “educational nonprofit organization rooted in [the] beliefs that every cancer patient deserves accurate and timely diagnosis as the first and essential step in better treatment and outcomes.”

“We believe this can be achieved only when modern diagnostic tools and technologies are freely available to every physician and pathologist. Only when we understand how microscopic features of cancer vary in different geographic, environmental and ethnic populations, and only by integrating histopathology with clinical immunohistochemical and molecular genetic information for every cancer type,” he stated.

Since patient privacy is important, the database contains only basic data about patients, and all patient information is protected.

Launched in March, there are currently more than 400 thyroid tumor slides available to view in the online database. At the time of the announcement, the WTR platform was planned to be implemented in three phases:

  • Thyroid cancer (released in March of this year).
  • Lung cancer and breast cancer (anticipated to be completed by the third quarter of 2026).
  • Remaining cancers, including brain, soft tissue and bone, colorectal, head and neck, hematolymphoid, female genital, liver, pancreatic, prostate and male genital, skin, urinary system, pediatric, other endocrine cancers, and rare cancers (anticipated to be completed by the end of 2029).

“We believe that this resource will help physicians and pathologists practicing in small or big or remote medical centers to learn how cancer looks under a microscope in their own communities,” Nikiforov said in the video. “We also see WTR as a platform that connects physicians and scientists from different parts of the world who can work together to better understand and treat cancer.”

Catalogs like the World Tumor Registry might potentially create a pool of information that that could be mined by analytical and artificial intelligence (AI) platforms to ferret out new ways to improve the diagnosis of certain types of cancer and even enable earlier diagnoses. 

“It is an extremely useful resource,” Nikitski said.

Anatomic pathologists will certainly find it so. And clinical laboratory managers may find the information useful as well when interacting with histopathologists and oncologists. 

—JP Schlingman

Related Information:

“Free for the World:” Pittsburgh Pathologist Prepares to Launch a Wikipedia for Cancer

USCAP 113th Annual Meeting

World Tumor Registry

Video: Message from the Founder and President of the World Tumor Registry

Boston Children’s Hospital Hires a Prompt Engineer to Help the Healthcare Organization Deploy and Use Artificial Intelligence Applications

This may be a new ‘sign of the times’ as hospitals, clinical laboratories, and other healthcare providers working with AI find they also need to hire their own prompt engineers

Boston Children’s Hospital last year hired a “prompt engineer” to propel the hospital forward in using Artificial intelligence (AI) as part of its business model. But what is AI prompting? It’s a relatively new term and may not be familiar to clinical laboratory and pathology leaders.

AI “prompting,” according to Florida State University, “refers to the process of interacting with an AI system by providing specific instructions or queries to achieve a desired outcome.”

According to workable.com, prompt engineers specialize “in developing, refining, and optimizing AI-generated text prompts to ensure they are accurate, engaging, and relevant for various applications. They also collaborate with different teams to improve the prompt generation process and overall AI system performance.” 

Healthcare institutions are getting more serious about using AI to improve daily workflows and clinical care, including in the clinical laboratory and pathology departments. But adopting the new technology can be disruptive. To ensure the implementation goes smoothly, hospitals are now seeking prompt engineers to guide the organization’s strategy for using AI. 

When Boston Children’s Hospital leaders set out to find such a person, they looked for an individual who had “a clinical background [and] who knows how to use these tools. Someone who had experience coding for large language models and natural language processing, but who could also understand clinical language,” according to MedPage Today.

“We got many, many applications, some really impressive people, but we were looking for a specific set of skills and background,” John Brownstein, PhD, Chief Innovation Officer at Boston Children’s Hospital and Professor of Biomedical Informatics at Harvard Medical School, told MedPage Today.

“It was not easy to find [someone]—a bit of a unicorn-type candidate,” noted Brownstein, who is also a medical contributor to ABC News.

After a four-month search, the hospital hired Dinesh Rai, MD, emergency room physician and AI engineer, for the position. According to Brownstein, Rai had “actually practiced medicine, lived in a clinical environment,” and had “successfully launched many [AI] applications on top of large language models,” MedPage Today reported.

“Some of the nuances I bring to the table in terms of being a physician and having worked clinically and understanding really deeply the clinical workflows and how we can implement the [AI] technology—where its limits are, where it can excel, and the quickest way to get things [done],” Dinesh Rai, MD (above), told MedPage Today. “I’m happy to be able to help with all of that.” Hospital clinical laboratory and pathology managers may soon by engaging with prompt engineers to ensure the smooth use of AI in their departments. (Photo copyright: LinkedIn.)

Prompt Engineers are like F1 Drivers

“It’s kind of like driving a car, where basically anyone can drive an automatic car, and anyone can go onto ChatGPT, write some text, and get a pretty solid response,” said Rai, describing the act of AI prompting to MedPage today.

Then, there are “people who know how to drive manual, and there are people who will know different prompting techniques, like chain-of-thought or zero-shot prompting,” he added. “Then you have those F1 drivers who are very intimate with the mechanics of their car, and how to use it most optimally.”

The American Hospital Association (AHA) believes that AI “holds great promise in helping healthcare providers gain insights and improve health outcomes.” In an article titled, “How AI Is Improving Diagnostics, Decision-Making and Care,” the AHA noted that, “Although many questions remain regarding its safety, regulation, and impact, the use of AI in clinical care is no longer in its infancy and is expected to experience exponential growth in the coming years.

“AI is improving data processing, identifying patterns, and generating insights that otherwise might elude discovery from a physician’s manual effort. The next five years will be critical for hospitals and health systems to build the infrastructure needed to support AI technology, according to the recently released Futurescan 2023,” the AHA wrote.

The graphic above is taken from the American Hospital Association’s article about Futurescan’s 2023 survey results on AI in healthcare. “Healthcare executives from across the nation were asked how likely it is that by 2028 a federal regulatory body will determine that Al for clinical care delivery augmentation (e.g., assisted diagnosis and prescription, personalized medication and care) is safe for use by our hospital or health systems,” AHA stated. This would include the use of AI in clinical laboratories and pathology group practices. (Graphic copyright: American Hospital Association.)

The AHA listed the top three opportunities for AI in clinical care as:

  • Clinical Decision Tools: “AI algorithms analyze a vast amount of patient data to assist medical professionals in making more informed decisions about care.”
  • Diagnostic and Imaging: The use of AI “allows healthcare professionals to structure, index, and leverage diagnostic and imaging data for more accurate diagnoses.”
  • Patient Safety: The use of AI improves decision making and optimizes health outcomes by evaluating patient data. “Systems that incorporate AI can improve error detection, stratify patients, and manage drug delivery.”

The hiring of a prompt engineer by Boston Children’s Hospital is another example of how AI is gaining traction in clinical healthcare. According to the Futurescan 2023 survey, nearly half of hospital CEOs and strategy leaders believe that health systems will have the infrastructure in place by 2028 to successfully utilize AI in clinical decision making. 

“I’m lucky to [be] in an organization that has recognized the importance of AI as part of the future practice of medicine,” Rai told MedPage Today.

Pathologists and managers of clinical laboratories and genetic testing companies will want to track further advancements in artificial intelligence. At some point, the capabilities of future generations of AI solutions may encourage labs to hire their own prompt engineers.

—JP Schlingman

Related Information:

Why One Hospital Hired an AI Prompt Engineer

This Children’s Hospital is Integrating AI with Healthcare

How Five Healthcare Organizations Are Investing in AI for Patient Care

What is a Large Language Model (LLM)?

How AI is Improving Diagnostics, Decision-making and Care

Prompt Engineer Job Description

Chain-of-Thought Prompting

Zero-Shot Prompting

Futurescan 2023: Health Care Trends and Implications

Artificial Intelligence in the Operating Room: Dutch Scientists Develop AI Application That Informs Surgical Decision Making during Cancer Surgery

UK Study Claims AI Reading of CT Scans Almost Twice as Accurate at Grading Some Cancers as Clinical Laboratory Testing of Sarcoma Biopsies

Stanford Researchers Use Text and Images from Pathologists’ Twitter Accounts to Train New Pathology AI Model

Wiley Launches Paper Mill Detection Tool after Losing Millions Due to Fraudulent Journal Submissions

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.

“Often journals will invite contributions to a special issue on a specific topic and this provides an opening for paper mills to submit often many publications to the same issue,” explained a June 2022 research report from the COPE and the International Association of Scientific Technical and Medical Publishers (STM).

“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.

To combat the problem, Wiley announced it would launch an artificial intelligence (AI)-based service called Papermill Detection in partnership with Sage Publishing and the Institute of Electrical and Electronics Engineers (IEEE).

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.

—Stephen Beale

Related Information:

Potential “Paper Mills” and What to Do about Them: A Publisher’s Perspective

Up to One in Seven Submissions to Hundreds of Wiley Journals Flagged by New Paper Mill Tool

Guest Post: Addressing Paper Mills and a Way Forward for Journal Security

Paper Mills Research Report from COPE and STM

Wiley Paused Hindawi Special Issues amid Quality Problems, Lost $9 Million in Revenue

‘The Situation Has Become Appalling’: Fake Scientific Papers Push Research Credibility to Crisis Point

Publisher Retracts More than a Dozen Papers at Once for Likely Paper Mill Activity

STM Integrity Hub Incorporates Clear Skies’ Papermill Alarm Screening Tool

The New STM Integrity Hub

Upholding Research Integrity in the Age of AI

Laboratory Leaders at 2024 Annual Executive War College Discuss Critical Challenges Facing Clinical Laboratory and Pathology Managers for 2024 and Beyond

Trifecta of forces at work that will affect the clinical laboratory and pathology industries have been described as a ‘perfect storm’ requiring lab and practice managers to be well informed

Digital pathology, artificial intelligence (AI) in healthcare, and the perfect storm of changing federal regulations, took centerstage at the 29th Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management in New Orleans this week, where more than 1,000 clinical laboratory and pathology leaders convened over three days.

This was the largest number of people ever onsite for what has become the world’s largest event focused exclusively on lab management topics and solutions. Perhaps the highlight of the week was the federal Food and Drug Administration’s (FDA’s) announcement of its final rule on Laboratory Developed Tests (LDTs). Overall, the conference featured more than 120 speakers, many of them national thought leaders on the topic of clinical lab and pathology management. More than 65% of the audience onsite were executive level lab managers.

 “The level of interest in the annual Executive War College is testimony to the ongoing need for dynamic, engaging, and highly relevant conference events,” said Robert Michel (above), Editor-in-Chief of Dark Daily and its sister publication The Dark Report, and founder of the Executive War College. “These in-person gatherings present great opportunities for clinical laboratory and pathology managers and leaders to network and speak with people they otherwise might not meet.” (Photo copyright: Dark Intelligence Group.)

Demonstrating Clinical Value

For those who missed the action onsite, the following is a synopsis of the highlights this week.

Lâle White, Executive Chair and CEO of XiFin, spoke about the future of clinical laboratory testing and the factors reshaping the industry. There are multiple dynamics impacting healthcare economics and outcomes—namely rising costs, decreasing reimbursements, and the move to a more consumer-focused healthcare. But it is up to labs, she said, to ensure their services are not simply viewed as a commodity.

“Laboratory diagnostics have the potential to change the economics of healthcare by really gaining efficiencies,” she noted. “And it’s up to labs to demonstrate clinical value by helping physicians manage two key diagnostic decision points—what tests to order, and what to do with the results.”

But even as labs find ways to increase the value offered to clinicians, there are other disruptive factors in play. Consumer-oriented tech companies such as Google, Apple, and Amazon are democratizing access to patient data in unforeseen ways, and Medicare Advantage plans are changing the way claims are processed and paid.

Redefining Human Data

Reynolds Salerno, PhD, Director of the Division of Laboratory Services for the federal Centers for Disease Control and Prevention (CDC) provided an update on the agency’s top priorities for 2024.

Clinical labs are fundamental components of the public health infrastructure. So, the CDC plans on focusing on delivering high-quality laboratory science, supported by reliable diagnostics and informatics for disease outbreaks and exposures, and engaging with public and private sector partners.

Salerno is an active member of the Clinical Laboratory Improvement Act Committee (CLIAC), which has been working on a number of initiatives, including revisions to the Clinical Laboratory Improvement Act (CLIA) that would change the definition of “materials derived from the human body” to include data derived from human specimens such as medical imaging, genetic sequences, etc.

New Molecular Testing Codes

The history of MolDX and Z-Codes were the topics discussed by Gabriel Bien-Willner, MD, PhD, Chief Medical Officer for healthcare claims and transaction processing company Palmetto GBA. Molecular testing is highly complex, and the lack of well-defined billing codes and standardization makes it difficult to know if a given test is reasonable and necessary.

Z-Codes were established to clarify what molecular testing was performed—and why—prompting payers to require both Z-Codes and Current Procedural Terminology (CPT) codes when processing molecular test claims. Medicare’s MolDX program further streamlines the claims process by utilizing expertise in the molecular diagnostics space to help payers develop coverage policies and reimbursement for these tests.

FDA Final Rule on LDT Regulation

Timothy Stenzel, MD, PhD, CEO of Grey Haven Consulting and former director of the FDA’s Office of In Vitro Diagnostics reviewed the latest updates from the FDA’s Final Rule on LDT (laboratory developed test) regulation. Prior to the FDA releasing its final rule, some experts suggested that the new regulations could result in up to 90% of labs discontinuing their LDT programs, impacting innovation, and patient care.

However, the final rule on LDTs is very different from the original proposed rule which created controversy. The final rule actually lowers the regulatory burden to the point that some labs may not have to submit their LDTs at all. The FDA is reviewing dozens of multi-cancer detection assays, some of which have launched clinically as LDTs. The agency is likely to approve those that accurately detect cancers for which there is no formal screening program.

Stenzel explained the FDA’s plan to down-classify most in vitro diagnostic tests, changing them from Class III to Class II, and exempting more than 1,000 assays from FDA review. He also discussed the highlights of the Quality Management System Regulation (QMSR). Launched in January, the QMSR bought FDA requirements in line with ISO 13485, making compliance easier for medical device manufacturers and test developers working internationally.

Looming Perfect Storm of Regulatory Changes

To close out Day 1, Michel took to the stage again with a warning to clinical laboratories about the looming “Perfect Storm” trifecta—the final FDA ruling on LDTs, Z-Code requirements for genetic testing, and updates to CLIA ’92 that could result in patient data being considered a specimen.

Laboratory leaders must think strategically if their labs are to survive the fallout, because the financial stress felt by labs in recent years will only be exacerbated by macroeconomic trends such as:

  • Staff shortages,
  • Rising costs,
  • Decreasing and delayed reimbursements, and
  • Tightening supply chains.

Lab administrators looking for ways to remain profitable and prosperous should look beyond the transactional Clinical Lab 1.0 fee-for-service model and adopt Clinical Lab 2.0, which embraces HEDIS (Healthcare Effectiveness Data and Information Set) scores and STAR ratings to offer more value to Medicare Advantage and other payers.

Wednesday’s General Session agenda was packed with information about the rise of artificial intelligence, big data, and precision medicine in healthcare. Taking centerstage on the program’s final day was Michael Simpson, President and CEO of Clinisys. Simpson gave a global perspective on healthcare data as the new driver of innovation in diagnostics and patient care.

Michel closed the conference on Wednesday by recapping many of these highlights, and then inviting his audience to the 30th annual Executive War College Diagnostics, Clinical Laboratory, and Pathology Management conference to be held on April 29-30, 2025, here at the Hyatt Regency New Orleans. Register now to attend this critical gathering.

—Leslie Williams

Related Information:

Executive War College: The Ultimate Event for Helping Solve Your Diagnostics, Clinical Lab and Pathology Management Challenges

Labs Should Prepare for Arrival of ‘Perfect Storm’

Executive War College 2025 Registration

From Regulations to Innovations: Annual Executive War College Convenes in New Orleans

29th Conference Features Information on What Clinical Lab Leaders Need to Know About a ‘Perfect Storm’ of New Compliance Challenges

There are signs that the US Food and Drug Administration (FDA) is poised to release the final rule on laboratory developed tests (LDTs)—perhaps even during the 29th annual Executive War College on Diagnostic, Clinical Laboratory, and Pathology Management, which kicks off in New Orleans this week.

The Office of Management and Budget (OMB) concluded its review of the final rule on April 22. Former FDA commissioner Scott Gottlieb, MD, and other regulatory experts expect the White House to send the final rule to Congress as early as late April and no later than May 22.

Either way, Tim Stenzel, MD, PhD, former director of the FDA’s Office of In Vitro Diagnostics, and other regulatory experts will be on hand at Executive War College (EWC) to walk attendees through what promises to be a “perfect storm of clinical lab and pathology practice regulatory changes.” Stenzel is scheduled to speak about the LDT rule during three sessions with fellow panelists on Day 1.

On Tuesday morning, Lâle White, executive chair and CEO of San Diego’s XiFin, Inc., will present a keynote on new regulations and diagnostics players that are “poised to reshape lab testing.” Her presentation is followed by a general session on Clinical Laboratory Improvement Amendments (CLIA) regulations featuring Salerno Reynolds, PhD., acting director at the U.S. Centers for Disease Control and Prevention (CDC) Center for Laboratory Systems and Response.

Robert Michel, Editor-in-Chief of The Dark Report will wrap day one with a general session on the regulatory trifecta coming soon to all labs, from LDT to CLIA to private payers’ policies for genetic claims.


Innovation in the spotlight

“It’s a rich mix of expert speakers, lab leaders who are doing innovative things in their own organizations, along with the consultants and the lab vendors who are pushing the front edge of laboratory management, operations, and clinical service delivery,” says Michel, who each year creates the agenda for EWC.

Several sessions, master classes, and speakers will look to the future with discussions about how healthcare data drives innovations in diagnostics and patient care, digital pathology adoption around the world, and hot topics such as artificial intelligence (AI), big data and precision medicine.

Panels offer a variety of viewpoints

“One valuable benefit of participating at the Executive War College is the various panel discussions,” Michel says. “Each panel brings together national experts in a specific area of the laboratory profession. As an example, our lab legal panel this year brings together four prominent and experienced attorneys who share opinions, insights, and commentary about relevant issues in compliance, regulations, and contractual issues with health plans and others.”

This allows attendees to experience a breadth of opinions from multiple respected experts in this area, he adds.

For example, a digital pathology panel will bring together representatives from labs, service providers, and the consultants that are helping labs implement digital pathology. The session will be especially helpful to labs that are deciding when to acquire digital pathology tools and how to deploy them effectively to improve diagnostic accuracy, Michel says.

And a managed care panel will feature executives from some of the nation’s biggest health plans—the ones that sit on the other side of the table from labs—to provide insights and guidance on how labs can work more effectively with them.

Networking opportunities abound

The event is about much more than politics and policy, however. There’s also a distinct social aspect.

“This is a friendly tribe,” Vicki DiFrancesco, a US HealthTek advisory board member who first attended EWC more than two decades ago, wrote in a recent post.

“Everyone is welcome, and everyone appreciates the camaraderie, so don’t be shy about going up and introducing yourself to someone. The quality of the crowd is top-notch, yet I’ve always experienced a willingness for those of us who have been to this rodeo to always be welcoming,” she notes.

Michel agrees. “One of the special benefits of participation at the EWC is the superb networking interactions and collaboration that takes place,” he says.

 “From the first moments that attendees walk into our opening reception on Monday night until the close of the optional workshops on Thursday, one can see a rich exchange happening amongst circles of attendees. Introductions are being made. Connections are developing into business opportunities. The sum of an attendee’s experience at the Executive War College is to gain as much knowledge from the networking and collaboration as they do from the sessions.”

–Gienna Shaw

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