Clinical laboratories are required to meet a number of regulatory requirements to ensure accurate patient results. One large requirement that laboratories must fulfill is method verification. This entails the process of ensuring a method is generating accurate results prior to the start of patient testing. The exact requirements of method verification can vary between regulatory agencies. However, most regulatory bodies will require documenting evaluation of precision, linearity/reportable range, accuracy, and interferences. This webinar will discuss approaches that laboratories can take to ensure adequate assessment of new methods. In particular, emphasis will be given on examples of problems that laboratories might encounter during method validation and how to address them.
At the conclusion of this webinar, attendees will be able to
Joshua Hayden, PhD DABCC FAACC is the Chief of Chemistry for Norton Healthcare. Prior to joining Norton, he served as an associate professor and director of toxicology for NewYork Presbyterian-Weill Cornell. He completed a clinical chemistry fellowship at the University of Washington and a research fellowship at MIT. His work is aimed at ensuring patients and providers of Norton Healthcare receive the highest quality laboratory testing available. He has particular experience in the implementation of mass spectrometry.