Tests that are designed in-house to fulfill a clinical need (but aren’t FDA approved) qualify as laboratory developed tests. And these LDTs are currently regulated by CLIA. But the FDA is proposing a new rule that would give them oversight of the design and development of laboratory developed tests. So, what does that mean for us? How would this new legislation impact everyday practice inside the lab?
On this episode of the podcast, your hosts, Ms. Kelly Swails, MLS(ASCP), and Dr. Ali Brown, MD, FASCP, are joined by Dr. Gregory Sossaman, MD, Clinical Pathologist and Service Line Lead for Pathology and Lab Medicine at Ochsner Health, Dr. Jonathan Genzen, MD, Clinical Pathology Professor at the University of Utah and Chief Medical Officer and Senior Director of Government Affairs at ARUP Laboratories, and Mr. Matthew Schulze, Senior Director for the Center for Public Policy at ASCP, to discuss the implications of the proposed FDA regulations for LDTs.
Our panelists share their anxiety around the labor and costs involved in complying with the new rule and describe how lab professionals might be forced into situations where we deny care due to regulations. Listen in to understand why public opinion favors the proposed rule and learn how to share your concerns with the FDA during the public comment period from October 3rd to December 4th, 2023.
Topics Covered
· How tests that are not FDA approved but designed in-house to fulfill a clinical need fall into the category of laboratory developed tests
· Examples of common LDTs used in academic medical centers + large community health systems
· The current regulations re: performance standards for LDTs under CLIA
· Dr. Sossaman, Dr. Genzen & Mr. Schulze’s concerns around the labor and costs involved in complying with the proposed FDA rule
· The lack of clarity re: what modifications to FDA approved tests would be allowed under the proposed regulations
· How direct-to-consumer testing, the pandemic and technological advances influenced the proposed FDA rule and why the general public is in favor of it
· How the proposed FDA regulations would affect our ability to respond in future pandemics
Connect with ASCP
ASCP
ASCP on Facebook
ASCP on Instagram
ASCP on Twitter
Connect with Dr. Sossaman
Dr. Sossaman on LinkedIn
Connect with Dr. Genzen
Dr. Genzen on LinkedIn
Connect with Mr. Schulze
Mr. Schulze on LinkedIn
Connect with Ms. Swails & Dr. Brown
Ms. Swails on Twitter
Dr. Brown on Twitter
Resources
ASCP Membership 2024
Proposed FDA Regulation of Laboratory Developed Tests
Public Comment on the FDA’s Proposed Rule
Inside the Lab in the ASCP Store
Ep18: Lab Week Games and the Importance of Celebrating the Lab
Ep17: COVID-19 Patients: The Lab Saved My Life
Ep16: COVID-19 Vaccine Safety
Ep15: Getting People in the Seats: Recruitment for MLS Programs
Ep14: Infectious Disease as a Bridge Between Anatomic Pathology and Clinical Pathology
Ep13: Laboratory Staffing Shortages
Ep12: Transgender Pathology
Ep11: Mentorship in the Laboratory
Ep10: The Importance of Empowered Patients
Ep09: Native American-Specific Challenges with COVID-19
Ep08: The Laboratory's Role in Inclusion
Ep07: Forensic Pathology and Patient Advocacy during COVID-19
Ep06: Research and Publication
Ep05: Laboratory Turnaround Times During COVID-19
Ep04: Burnout in the Lab
Ep03: Online Teaching and Learning in Pathology and Laboratory Medicine
Ep02: The Impact of COVID-19 on Community Hospitals and MLS Programs
Ep01: Disparities in COVID-19 Cases Among Minorities
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