Diagnosis involves much more than a number on a lab report. This is particularly true when the patient has disordered bleeding or clotting. In this interview, Dr. Karen Moser from the University of Utah Department of Pathology describes some of the ways she works with her laboratory and clinician colleagues to ensure that patients get the answers and the therapies they need. 

What does it mean to have a quality culture? Technical competence and strict adherence to protocols are certainly part of the story. But so are factors such as workforce engagement and customer service. In this interview, Nancy Ross, assistant director of clinical pathology and quality at Montefiore Medical System and the founder of Improov, a laboratory improvement consulting company, draws on her diverse career experience to argue for a holistic and people-centered approach to quality management.

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.

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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."