As of September 2024, there remains enormous uncertainty about the FDA’s final rule on laboratory-developed tests (LDTs). Will it hold up in court? Which tests are subject to which requirements? How can laboratories best prepare? In this interview, Dr. Jonathan Genzen, ARUP’s chief medical officer and senior director of governmental affairs, responds to questions sent in by members of the laboratory community. 

Related Information: 

• ARUP Resources on the FDA’s Final Rule on Laboratory-Developed Tests (https://www.aruplab.com/fda-ldt-final-rule)
• ARUP Webinar--The FDA’s Final Rule on LDTs: What You Need To Know (https://youtu.be/nGQ3sRfWkBg)
• ARUP Files Declaration to Support Lawsuit Challenging the FDA's Rule to Regulate Lab-Developed Tests (https://www.aruplab.com/news/05-30-2024/arup-files-declaration-support-lawsuit-challenging-fdas-rule) 
• FDA email address for questions on the final rule: (ldtfinalrule@fda.hhs.gov)

Fixing American healthcare will require more than mere tweaks around the edges. Dr. Vikas Saini, president of the Boston-based Lown Institute, believes that it will require a return to medicine’s humanist roots. In this interview he describes some of the ways in which many healthcare organizations prioritize revenue and profit over patients and communities. He also explains why he remains optimistic that Hippocratic principles will ultimately prevail. 

Related Information: 

• Lown Institute (https://lowninstitute.org/)
• 2024 Top Hospitals: America’s Most Socially Responsible Hospitals (https://lownhospitalsindex.org/the-most-socially-responsible-hospitals-in-the-u-s-2024/)
• 2023 Shkreli Awards: The Lown Institute’s Top Ten List of the Worst Examples of Profiteering and Dysfunction in Healthcare (https://lowninstitute.org/projects/2023-shkreli-awards/)

A public debate is raging around the regulation of artificial intelligence (AI). One side argues that AI is potentially dangerous and needs to be carefully controlled, whereas the other side argues that any regulation would slow innovation. In this interview, Dr. Ryan Metcalf, section chief of Transfusion Medicine and medical director of Transfusion Service/Blood Bank at ARUP Laboratories, makes a strong case for a safety-first approach to healthcare AI. He also explains why embedding AI development and use within a strong quality management framework could actually lead to more innovation over the long term, even as it prevents patient harm in the short term.

RELATED INFORMATION:  Creation and Adoption of Large Language Models in Medicine 

The FDA recently announced a plan to regulate laboratory-developed tests (LDTs) as medical devices. In this interview, Dr. Meghan Delaney from Children’s National Hospital and Dr. Eric Konnick from the University of Washington explain why many tests that are critical to patient care, particularly in the areas of pediatrics, transplantation, and rare diseases, may become unavailable if the rule the FDA has proposed is enacted. Other tests may remain available, but at a significantly increased cost. Dr. Jonathan Genzen, ARUP’s chief medical officer and cohost of this episode, describes how laboratory professionals can provide public feedback to the FDA before the rule takes effect.

Related Information:

• Click Here to access the FDA public comment webpage for the newly proposed LDT rule. 
• ARUP Joins Industry Partners in Opposing Proposed FDA Rules Seeking to Regulate Laboratory-Developed Tests 
• ACLA Opposes Unilateral FDA Action to Regulate Laboratory Developed Tests Under Medical Device Authority 
• Laboratory-Developed Tests Account for a Small Minority of Tests Ordered in an Academic Hospital System 
• Laboratory-Developed Tests: A Legislative and Regulatory Review 

Dr. Ila Singh, chief of laboratory medicine at Texas Children’s Hospital, founded the Test Renaming for Understanding and Utilization in the Laboratory (TRUU-Lab) initiative several years ago to tackle challenges related to the nonstandardized and uninformative naming of laboratory tests. In this interview, Dr. Singh describes the surveys her CDC-funded collaborative has conducted with hundreds of physicians and other providers, and she shares insights about how to improve the ordering of tests through more effective naming.

Related Information:

• Click Here to Listen to this Podcast Episode on the ARUP EDU Official Website.
• Click Here to Listen to Dr. Singh's 2019 Appearance on LabMind Entitled "An Interview with Dr. Ila Singh: The TRUU-Lab Initiative to Improve Laboratory Test Names." 
• Click Here to View Dr. Singh's 2019 Video Lecture Entitled "Ordering the Right Lab Test: It All Begins With the Right Test Name."

Individuals pursue careers in academic medicine for many reasons. A love of organizational politics is rarely one of them, but faculty need to understand potential landmines if they are to avoid them. In this interview, Dr. Michael Cohen, a professor emeritus of pathology at Wake Forest University, draws on his experiences serving on faculty and in senior leadership at multiple institutions to explain how to thrive within the paradoxes of academic medicine.

Click here to listen to this episode on ARUP's website.

Related Information:
VIDEO LECTURE: A Discourse on Working in Academic Health Centers With Some Practical Observations by Michael B. Cohen, MD 

Sustainability is a hot topic for American corporations, and health systems are no exception. In this interview, Glen Garrick, system sustainability director for Intermountain Healthcare, explains how his and other healthcare organizations are addressing their environmental, social, and governance responsibilities. He also describes how clinical laboratories can make the most positive impact.

Related Information:
New Building Embodies ARUP’s Commitment to Environmental Stewardship
ARUP’s Environmental Sustainability Efforts Pay Off
Recycling Coalition of Utah Names ARUP the Thomas A. Martin Business Recycler of the Year
Impressive New Structure Will Enhance ARUP’s Environmental Stewardship Efforts  
Top 10 Ways ARUP Helps Our Environment 

Click Here to Listen to This Episode from the ARUP Website 

Three and a half years after the emergence of COVID-19 is a good time to reflect on the capabilities of U.S. laboratories to respond to future pandemics. In this interview, Dr. Marc Couturier, medical director of Emerging Public Health Crises at ARUP Laboratories, explains how the U.S. laboratory sector has improved in its ability to respond quickly to emerging and reemerging infections, but he emphasizes the need to go further. He specifically explains why testing can’t be rapidly scaled up unless there’s tight coordination between public health labs and clinical labs (particularly reference labs and large academic labs).

Click here to Register for Dr. Marc Couturier's Upcoming Webinar entitled: “How to Avoid Building an Airplane Mid Flight: Lab Medicine in the Face of Emerging Public Health Crises”

Click Here to Listen to this Episode on ARUP's Official Website. 

Nurses and laboratory professionals rely on each other to ensure accurate test results, but their relationships are sometimes challenging. As president of St. Alphonsus Medical Center in Nampa, Idaho, as well as a registered nurse with a doctorate degree in nursing practice, Clint Child often mediates when these two professional cultures collide. In this interview, he explains why nursing practice is less predictable and requires greater flexibility than laboratory practice. He also shares his perspective on why it’s valuable for hospital leaders to have strong ties to their local communities.

Click Here to view this episode of the LabMind podcast on ARUP's website.

Physicians and patients expect laboratory tests to produce the same results, regardless of where they are performed. Unfortunately, that’s not always the case, even for FDA-approved assays. As the current chair of the College of American Pathologists committee for accuracy-based proficiency testing, Dr. Andy Hoofnagle is an authority on this industrywide problem. In this interview, he explains the root causes of inconsistent results across platforms, and how manufacturers, regulators, and professional societies might work together to solve it.

Responses from the FDA and manufacturer can be found at https://arup.utah.edu/education/podcasts/labmindEp68.php.

Additional Resources:  

• “Using mass spectrometry to overcome the longstanding inaccuracy of a commercially-available clinical testosterone immunoassay” 
• “Accuracy-Based Vitamin D Survey: Six Years of Quality Improvement Guided by Proficiency Testing”

The key to successful clinical lab automation doesn’t lie in the instruments or the conveyor belt. It lies in clarifying what the organization most needs to improve (labor efficiency? turnaround time? reliability?) followed by optimizing those factors through modeling and planning. In this interview, Dr. Lauren Pearson, ARUP’s chief medical officer for University of Utah Health, shares lessons she has learned from her recent automation projects.

To view this podcast episode on the ARUP website: https://arup.utah.edu/education/podcasts/labmindEp67.php

To register for Dr. Pearson's upcoming webinar entitled "Verification of Automated Urinalysis Instrumentation: Analytical and Clinical Considerations" on June 20th, 2023: https://arup.utah.edu/education/pearson-autourinalysis-2023.php

For her doctoral dissertation, Dr. Susan Edralin dove into the issue of communicating the value contribution of pathology and laboratory medicine to healthcare administrators. What she found in her conversations surprised her. In this interview, she lists some of the misunderstandings regarding laboratory value and describes how lab directors can raise the status of their laboratory operations and expert staff.

To access this episode on the ARUP website: https://arup.utah.edu/education/podcasts/labmindEp66.php 

Clinical laboratories offer great careers, but lack of awareness and other barriers can prevent excellent candidates from pursuing laboratory science professions. In this interview, Isak Schmidley, MLS(ASCP), explains how he first stumbled across medical laboratory science while attending community college in his early teens and then persevered past age stereotypes to land his first hospital laboratory job at the impressive age of 16. He shares advice for laboratory leaders on what his generation expects from employers and tips on how to recruit the next generation. 

You know what a patent is, but do you know what’s patentable in the field of laboratory diagnostics? Or how patent law has changed over the years? In this interview, Dr. Bert Ley, a registered patent agent with decades of experience in the clinical laboratory industry, unpacks some of the mysteries of the U.S. patent system and how it ultimately benefits society.

Laboratory testing can either lead to the correct diagnosis or take a clinician down a blind alley, depending on how carefully the tests are selected and performed. In this interview, a practicing neurologist (Dr. Tammy Smith) and a clinical laboratory immunologist (Dr. Lisa Peterson) explain some of the complexities of laboratory diagnosis of autoimmune neurologic disease, and how to ensure good diagnostic outcomes.

Many hospitals test newborn babies for exposure to drugs of abuse. Although this sounds fairly straightforward, in practice it has been difficult to standardize testing protocols, let alone keep up with substance use trends. Compared with other areas of laboratory medicine, drug testing is also associated with unique social and legal ramifications, specimen collection processes, and result reporting decisions. In this interview, Dr. Gwen McMillin describes current academic perspectives on these issues, and where she sees the field heading.

Within our current healthcare institutions, patients’ voices are often drowned out by the voices of providers, scientists, and industry. Andrea Downing’s life work is to fix this. As a BRCA1 cancer previvor and a patients’ rights activist, she was a spokesperson for one of the plaintiffs in the U.S. Supreme Court case that ultimately overturned gene patenting. Years later, while moderating an online patient support group, she discovered a major privacy vulnerability in Facebook, which led her into cybersecurity research. In this interview, she chronicles her journey and lays out her vision for patients as cocreators within medicine and medical science.

To most laboratorians, quality control is all about rules, metrics, and thresholds. To Dr. Fred Strathmann, on the other hand, it’s about gaining understanding of the underlying processes. In this interview, he shares examples of ways to think more deeply about measurements in order to drive organizational improvement.

ARUP Laboratories was recently recognized by Forbes Magazine as being among the country’s best workplaces for women. In this interview, ARUP’s president, Dr. Tracy George, explains how companies can create healthier models of work-life balance that support women (and men) in their personal and professional roles.

The curricula of pathology and laboratory medicine training programs are heavily weighted toward technical and medical knowledge. In this interview, Dr. Wayne Chandler makes the case for more emphasis on leadership training, and he shares experiences from his 40-year clinical pathology career that illustrate the impact of people skills.

The VALID Act currently being debated in Congress would increase the regulatory burden on clinical laboratories. In this interview, Dr. David Grenache from TriCore Laboratories and the University of New Mexico, together with Dr. Vince Stine from the American Association for Clinical Chemistry, explain why VALID would slow down innovation while it raises costs, and why VALID appears to be designed to benefit a particular industry sector rather than patients.

In 2022, laboratory professionals have more choices about whom to work for and whether to even continue working in laboratory medicine. In this discussion, Stephanie Whitehead, MBA, MPH, MLS(ASCP), executive director of pathology and laboratory services at University Health, San Antonio, describes what managers should be doing to recruit and retain exceptional staff.

Despite their explicit healthcare mission, clinical laboratories often fall short when it comes to employee mental health. Laboratory managers know how to troubleshoot an assay or write a procedure, but how many know how to support an employee with crippling anxiety or de-escalate an emotional crisis? In this discussion, Brysen Bocchino, CMHC, NCC, ARUP’s newly hired mental health clinician, describes an innovative model for recognizing and addressing mental health needs in the workplace.

Most hereditary cancers, including those associated with BRCA1 mutations and Lynch syndrome, can be prevented through a combination of genetic testing, surveillance, and surgery. Yet only a small minority of eligible individuals currently receive this lifesaving intervention. In this interview, Dr. Brian Shirts, director of the Institute for Public Health Genetics at the University of Washington, discusses a new nonprofit organization that uses family connections to identify individuals at high risk for hereditary cancers and other adult-onset hereditary diseases. 
connectmyvariant.org 
#connectmyvariant 

How will lab testing be different a decade from now? Many answers are likely to be found in the numerous projects championed by the roughly 200 medical directors and scientists of the ARUP Institute for Clinical and Experimental Pathology. In this discussion, Dr. Adam Barker, chief scientific officer for ARUP Laboratories, explains how and why these R&D scientists are prioritizing the practical needs of patients and their providers.

Improving physicians’ use of laboratory tests is not usually a problem of motivation. They’re already motivated to deliver high-quality care to their patients. More often, it’s about choice architecture, i.e., making sure that correct choices are easier to make than incorrect ones. In this discussion, Dr. Valerie Vaughn explains the science behind nudging and choice architecture. She also explains how her own research convinced her that improving the use of diagnostic tests is often the key to improving therapeutic outcomes.

The needs of transgender and nonbinary patients are compelling laboratories to reexamine historic practices in areas such as patient demographics, reference intervals, and terminology. In this discussion, Drs. Joely Straseski and Jenna Rychert express confidence in the laboratory community's ability to meet the needs of both patients and clinicians by embracing fundamental principles of biology and respect for individuals.

Many physicians see board certification as a one-time hurdle along their career pathway. Dr. Gary Procop, incoming CEO of the American Board of Pathology, sees it instead as a longitudinal partnership “to help make great pathologists, and make great pathologists greater.” In this discussion he explains how ABPath and other specialty boards are using adult learning theory to make their programs more adaptive and relevant to real world clinical practice.

It’s surprisingly common for individuals to harbor undiagnosed genetic conditions. For example, newborns with abnormally high bilirubin levels often reach adulthood without any discovery of the biologic cause. In this discussion, Dr. Archana Agarwal delves into the value of using focused genetic panels to end the diagnostic odysseys for about half of these patients while potentially avoiding risky and expensive diagnostic workups down the road.

When most people think of laboratorians, they picture introverts following rigid processes to perform technical tasks. These stereotypes sell laboratory professionals short. True, laboratory testing does involve technical chemistry and biology tasks, and some scientists might be introverts, but our field is far broader than this picture suggests. In this two-part episode, Stephanie Whitehead from the University Health System San Antonio and Kathy Sakas from NW Laboratory (Part I), and Chris Bradley from Wisconsin Diagnostic Laboratories, along with Charles Daniels and Karen Corson from Adventist Health (Part II), shatter these stereotypes with their stories of ingenuity, creativity, and sheer grit.

When most people think of laboratorians, they picture introverts following rigid processes to perform technical tasks. These stereotypes sell laboratory professionals short. True, laboratory testing does involve technical chemistry and biology tasks, and some scientists might be introverts, but our field is far broader than this picture suggests. In this two-part episode, Stephanie Whitehead from the University Health System San Antonio and Kathy Sakas from NW Laboratory (Part I), and Chris Bradley from Wisconsin Diagnostic Laboratories, along with Charles Daniels and Karen Corson from Adventist Health (Part II), shatter these stereotypes with their stories of ingenuity, creativity, and sheer grit.

Dennis Strenk, PA(ASCP)CM, has interviewed more than 70 people in pathology and laboratory medicine for his podcast, “People of Pathology.” We discuss the remarkable range of backgrounds, professional interests, and career paths he’s encountered, and why it’s never too late to pursue a laboratory career.

Global health is ultimately achieved by meeting the health needs of people in diverse real-world settings. Creative innovations developed to meet the needs of lower-resourced countries can often benefit wealthy countries as well. In this discussion, Dr. Karen Heichman, director of diagnostics for the Bill and Melinda Gates Foundation, explains the need for fast, inexpensive testing that is easy to perform in any location. She also discusses the value of bringing large corporations, government agencies, and nonprofits together to accomplish these breakthroughs and, in the Foundation’s words, “help all people live healthy, productive lives.”

Andy Theurer recently became the seventh CEO in ARUP’s almost 40-year history. In this interview, he reflects on lessons learned from all six of his predecessors, shares why he’s been skipping to work almost every day for the more than 30 years he’s been with ARUP, and talks about how he hopes to guide the future of ARUP.

Due to genetic variation, patients metabolize and respond to medications in vastly different ways, so why do most drug therapy regimens continue to be one-size-fits-all? In this interview, Dr. Yuan Ji, ARUP’s section chief of Molecular Genetics and Genomics, discusses how currently available genetic tests can be used to improve both the safety and effectiveness of pharmacotherapy.

Related Content:
Current Clinical Pharmacogenomic Testing: How Do Clinical Laboratories Stay on Top of Changes to Technologies, Professional Guidelines, and Regulations?   https://arup.utah.edu/education/ji-pharmtest-2024.php 

Dr. Sherrie Perkins never planned, nor aspired, to become CEO of a large clinical laboratory business. But after a long and successful career as an academic hematopathologist, she was tapped as the sixth chief executive in ARUP Laboratories’ nearly 40-year history. In this interview, she describes her journey from art student to pathologist, how every CEO leaves a distinctive mark on a company, and why diversity and inclusion are so important to ARUP’s future.

Few guests on LabMind have been as attuned to broad technologic trends in pathology as Dr. Joseph Anderson. He has worked in multiple settings, including private practice, academia, and industry, and is currently engaged in with several early-stage pathology companies. Anderson also hosts a podcast in which he interviews leaders in the domain of digital pathology. In this interview, we discuss his insights into what’s required for successful innovation, and why he’s optimistic about pathology’s future.

Patients’ needs and preferences don’t always match the preconceived notions of laboratory and medical professionals. In this interview, Heidi Wallis, president of the Association for Creatine Deficiencies, shares her family’s diagnostic odyssey. She also provides insights about how the biomedical establishment could better serve families like hers. Ms. Wallis has two children with GAMT deficiency, an inherited disorder that prevents the body from producing creatine. Her children were diagnosed in very different ways, with very different consequences.

See more about Heidi's story:
GAMT Deficiency: The Power of Newborn Screening
Association for Creatine Deficiencies

Transfusion medicine has arguably led other pathology subspecialties in improving patient safety through industrial quality management and standardization methods. However, standardization practices, such as the use of transfusion triggers, are in some respects a one-size-fits-all approach. And as we undoubtedly know, real patients aren't standardized. In this discussion, Ryan Metcalf, section chief for transfusion medicine in the University of Utah Department of Pathology, describes the development of data visualization tools to help surgeons and anesthesiologists optimize their transfusion decisions based on individual patient needs.

Paul Epner’s more than four-decade career started at Abbott Diagnostics and has involved collaboration with the CDC and a tenure as president of the Clinical Laboratory Management Association (CLMA). He now serves as CEO of the Society to Improve Diagnosis in Medicine (SIDM). Throughout his career, Epner has been a powerful advocate for the role of laboratory professionals. In our special Lab Week interview, we discuss why diagnosis is a team sport, how cross-disciplinary collaboration is fundamental to the critical impact of laboratory medicine, and the overall quality of medical care.

When Dr. Nicola Longo, professor of Pediatrics at the University of Utah, encounters a child with an undiagnosed syndrome, he has a unique resource: Dr. Marzia Pasquali, professor of pathology and section chief of Biochemical Genetics at ARUP Laboratories. Their connection extends back to high school in Parma, Italy, and grew through years of medical and scientific training, marriage, and clinical practice. In our discussion, they describe their combined life’s work to solve diagnostic mysteries and develop diagnostic tools to enable long, healthy, and productive lives in children who might otherwise face neurologic decline and early death.

Ron Weiss, MD, MS, MBA, served as president and COO of ARUP Laboratories in the early 2000s. He was one of the principle authors of ARUP's “Five Pillars” statement of ethical principles. He pulls from his experiences growing up with a family business to explain how ARUP's early success required both business acumen and patient-centered values. Weiss also discusses why he's optimistic about the future of U.S. healthcare.
Originally published June 21, 2019

As an infectious disease physician and medical microbiologist, Dr. Kim Hanson has had a busy year. In this interview, she reflects on some of the successes during the COVID-19 era, such as the collaboration among rival regional health systems to provide testing for our communities. She discusses how COVID-19 testing needs are evolving, pointing to the pressing need for a national variant surveillance system in which academic medical center laboratories could play a large role. Finally, she offers some predictions for the coming year. 

Nadine Fydryszewski is program director for the world’s first Doctor of Clinical Laboratory Science (DCLS) program at Rutgers University. Modeled after other health professional degree programs, including those for pharmacy and physical therapy, this doctorate-level role for clinical laboratorians was developed to complement interdisciplinary patient care teams. Brandy Gunsolus, the program’s first graduate, currently practices at Augusta University Medical Center in Georgia. In this conversation, the two explain what it took to get the DCLS program off the ground and why clinicians are so enthusiastic about including DCLSs on their care teams and hospital committees.

Since its founding in 2013 at Seattle Children’s Hospital, PLUGS (Patient-Centered Laboratory Utilization Guidance Services) has brought together laboratory professionals, genetic counselors, clinicians, patients, and insurance companies across the country to improve the application of laboratory tests in clinical practice. In this interview, PLUGS cofounder Dr. Jane Dickerson describes some of the ingredients that have contributed to the program’s remarkable success.