Bio-Rad Laboratories is excited to invite you to our online Quality Control Masterclass! Over the course of three days, you will get the opportunity to learn about quality control in the lab, the importance of quality control with real life examples from the experts and tips to manage your data to help your clinical decision-making needs.
When quality control is more important than ever before, find out about what it means for the future of your lab, your resource and the impact on molecular testing.
These webinars also give you the perfect opportunity to ask the experts their QC recommendations and the best way to manage quality in your lab.
Register for the Quality Control Masterclass
All Masterclasses will include English subtitles.
October 17: QC strategy : Tools to build an efficient QC strategy (Part 1)
Camille Chenevier-Gobeau/ Dr Guillaume Lefevre - Hs troponin assay QC challenges: impact of laboratory results on helping clinical decisions
Cardiac troponins (cTn) are the reference biomarker for cardiac injury. High-sensitive assays are able to detect low values of circulating cTn isoform (either I of T) in patients suspected of acute cardiac syndrome. Little is known about analytical variability and accuracy for these assays in low range values and 99th percentiles. We aim to present in this session the HS troponin assays quality control (QC) challenges for an optimized control of variability and accuracy in a laboratory routine practice. We also propose an analysis of the impact of analytical quality on laboratory results and clinical decision.
David Ricketts - How can you use QC to help with the Risk management requirements of ISO 15189(2022)
ISO15189:2022 is patient and risk focused. This means labs need to find ways of evidencing how they are complying. Internal Quality Control (IQC) is an area that needs to be leveraged to help with both requirements. IQC is more than just confirming a patient result is within confidence limits to release, it can be used to predict trends, calculate measurement uncertainty as well as ensure that the labs can evidence clinical utilisation. The IQC should challenge the clinically relevant levels of assays and be as close as possible to a human matrix. This talk will look at how IQC can help with risk and patient care.
October 18: QC strategy : Tools to build an efficient QC strategy (Part 2)
John Yundt Pacheco/ Dr Lucas Peltier - 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.
Dr Jeremie M. Gras - 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 !
October 19: Quality control challenges in Molecular laboratories
Prof. Vincent Thibault - CMV viral load monitoring : do results expressed in international units guarantee inter-laboratory comparability? Lessons from a multicentre study
Cytomegalovirus viral load quantification is a key marker in the setting of transplantation. In many instances, patients are not necessarily followed in a unique center after their graft and standardization of viral load measurement between laboratories becomes an important clinical issue as it determines treatment initiation. We conducted a multicenter blinded study involving 7 laboratories using different techniques for CMV viral load measurement. We investigated how we could address commutability between laboratories to obtain comparable results between them. Running identical standardized material calibrated against IU/mL might be a solution but is it enough? Based on our data, we will provide some thoughts about the best strategies to limit interlaboratory discrepancies.
Dr. Richard Molenkamp - The Impact of IVDR on Molecular testing for Infectious diseases
“The European regulation on in vitro diagnostics (IVDR) has been in force since May 2022 and will be progressively rolled out further in the next few years. This regulation has impact on manufacturers but also on (hospital) laboratories, in particular in Molecular laboratories, that develop in vitro diagnostics assays “in-house”. This presentation will focus on the implementation of the IVDR and the challenges hospitals may face in this implementation concerning in house developed assays. Although not providing clear-cut answers and solutions to these challenges, this presentation provokes thoughts and discussion that hopefully can lead to best-practices.