LabMind

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.