LabMind – Details, episodes & analysis

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”