All Masterclasses will include English subtitles.
Managing risk of providing erroneous lab results: need to define patient severity of harm category
Patient risk management is an essential subject for clinical diagnostic laboratory which is now central in several quality lab standards (ISO 15989:2022; CLSI document EP23). However, define and graduate a patient harm induced by an erroneous lab result is very subjective task which is not currently the subject of any recommendation. To remedy this, we conducted a survey with laboratory professionals, asking them to rate the patient Severity of Harm for 20 routine analytes. The purpose is to use medical lab knowledge to establish an international consensual classification which can be used to improve patient risk management.
John Yundt Pacheco, MSCS
Principal Scientist/Scientific Fellow
Bio-Rad Laboratories
Mr. Yundt-Pacheco performs research in quality control and patient risk issues in the Informatics Discovery Group at Bio-Rad Laboratoires Plano Texas. John has had the opportunity to work with laboratories around the world, developing practical real time, inter-laboratory quality control and proficiency testing systems. As an innovator, has developed numerous ideas leading to 37 laboratory related invention patents around the globe.
John holds a Master's degree in Computer Science from University of Texas at Dallas with a focus on Intelligent Systems and has a Post Master's Certificate in Sequence Analysis and Genomics, and is a degree candidate for a Master's degree in Biotechnology at Johns Hopkins University. In addition to authoring articles and papers on QC design, he is a popular speaker on laboratory QC and QA topics at international conferences.
Dr Lucas Peltier PharmD, PhD
Medical biologist for the Somatic Cancer Genetics Department at Rennes University Hospital , France
Lucas PELTIER; PharmD, PhD is a medical biologist working at Rennes University Hospital since 2012. After working in the emergency clinical chemistry laboratory for 8 years, Dr Peltier is now working for the Somatic Cancer Genetics Department. During his professional career, Dr Peltier has been involved and developed in-depth expertise in internal quality control management, analytical performance specification setting and QC rule implementation. Dr Peltier has also in-depth expertise in analytical evaluation of laboratory methods. Dr Lucas Peltier has a special interest and follows closely innovations and research in the broad field of medical biology.
An extensive database for the application of Milan Model 3: the "state-of-the-art" concept is alive and kicking!
State-of-the-Art (SoA) is a quite ancient concept that defines a certain level of quality achievable with technologies available today. Currently, SoA can be used to set Analytical Performance Specifications (APS) when APS based on outcomes and biological variation are not available or not achievable. This is often the case for many laboratory tests, even in 2023. Problems associated with SoA is that data is limited, sometimes outdated, and terminology is misleading. To overcome these hurdles, a group of experts composed of Drs. Anne Vassault, Delphine Collin-Chavagnac, Florian Scherrer and led by Dr. Jeremie Gras has performed data mining on Bio-Rad’s Unity Real Time Database. This presentation will address the outcomes of this work, which include the largest database of SoA-based Analytical Goals in many areas of laboratory medicine. These have many applications for laboratory directors, clinical pathologists, quality managers and technologists. This will prove that the State-of-the-Art concept, a.k.a. Milan Model 3, is alive and kicking !
Dr Jeremie M. Gras M.D.
Medical Director at the Institute of Pathology and Genetics (IPG) in Gosselies, Belgium
Jeremie M. Gras, M.D. is a certified specialist in clinical laboratory medicine. After working as a clinical pathologist and laboratory Director in a hospital in his hometown of Namur, Belgium, he is currently Medical Director at the Institute of Pathology and Genetics (IPG) in Gosselies, Belgium.
His main areas of interest are molecular diagnostics, Quality Control, medical strategy and management. Dr. Gras was part of the CLSI C24, 4th edition committee on Statistical Quality Control and published a book entitled "Laboratory Quality Control and Patient Safety". Dr. Gras is currently involved in the practical application of the first strategic plan of IPG; in this context, he acts as a sponsor or as a project manager in many different projects at the interface of medicine and information technology.
Dr. Gras is a member of the American Association for Clinical Chemistry and a Board of Molecular Diagnostics.be, the Belgian association for molecular diagnostics. He is author or co-author of 19 scientific articles and is a regular speaker at molecular diagnostics or quality conferences.