Using Method Navigator for Establishing and Implementing Laboratory Test Methods

Lucia Berte has many years’ experience as a trainer and consultant in laboratory quality management. She has authored many articles, chapters, and books and provided webconferences, workshops, and learning courses about medical laboratory quality management for several laboratory professional organizations. She served on the drafting team for the last two editions of the ISO 15189 medical laboratory standard and has developed guidelines, educational materials, and online learning programs about laboratory quality management systems for CLSI.

Ms. Kern is a director of Standards Development and Project Administration at CLSI and has been apart of the organization for over three years. She has her Master’s degree in Medical Laboratory science and is an ASCP-certified Medical Laboratory Scientist. Prior to CLSI she spent 12 years working in an Immunology and Flow Cytometry medical laboratory. Her project focus has been on documents in Method Evaluation area. Ms. Kern has helped with the development and implementation of this novel product.