Host Constantine “Aki” Kanakis, MD is joined by Brittany Teeter and Sean to provide lessons learned and real-world takeaways from the world of laboratory management. This episode offers a glimpse into what seasoned lab managers learned across the course of their careers and provides concrete takeaways for lab managers at any stage of their careers on preparing for inspections, creating staff buy in for workflow updates, and relating the success of the lab to a hospital’s financial outcome whe...
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Host Constantine “Aki” Kanakis, MD is joined by Brittany Teeter and Sean to provide lessons learned and real-world takeaways from the world of laboratory management. This episode offers a glimpse into what seasoned lab managers learned across the course of their careers and provides concrete takeaways for lab managers at any stage of their careers on preparing for inspections, creating staff buy in for workflow updates, and relating the success of the lab to a hospital’s financial outcome whe...
S4Ep2: The FDA’s Proposed Rule on Laboratory Developed Tests
Inside the Lab
42 minutes
2 years ago
S4Ep2: The FDA’s Proposed Rule on Laboratory Developed Tests
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 Br...
Inside the Lab
Host Constantine “Aki” Kanakis, MD is joined by Brittany Teeter and Sean to provide lessons learned and real-world takeaways from the world of laboratory management. This episode offers a glimpse into what seasoned lab managers learned across the course of their careers and provides concrete takeaways for lab managers at any stage of their careers on preparing for inspections, creating staff buy in for workflow updates, and relating the success of the lab to a hospital’s financial outcome whe...
