Join us at this year's QC Masterclass Webinars!
Sign up to learn about the importance of quality control in the lab, with real life examples from the experts and tips for managing your data to help your clinical decision-making needs.
Take the opportunity to ask the experts for QC recommendations and the best way to manage quality in your lab, during the live Q&A session
All masterclasses will include English subtitles.
SESSION 1
Advancing Quality Control Processes in Modern Laboratories
Tuesday, 15 October 2024, 15:00‑17:00 CET
Tired of only using the same statistical quality control rules? Using analytical quality specifications can help ‑ with Nico Vandepoele
Throughout the history of quality control, traditional statistical methods have provided a solid foundation for ensuring product consistency and reliability. However, these conventional rules may sometimes fall short in addressing real analyte‑specific quality challenges. This presentation explores the limitations of standard statistical quality control techniques and introduces the concept of analytical quality specifications as an additional approach. By integrating analytical specifications, which focus on specific metrics tailored to the unique analyte characteristics, laboratories can gain deeper insights and optimize their quality control efforts.
This session will cover the theoretical underpinnings of analytical quality specifications, practical implementation strategies, and real‑world case studies demonstrating their advantages over traditional methods. Attendees will gain actionable knowledge on how to leverage these advanced techniques to achieve more precise and adaptable quality control, ultimately driving operational efficiency.
A wind of change in quality control management in a biochemistry department lab ‑ with Dr. Sandrine François‑Ngo
Numerous studies have shown that biological results impact therapeutic decisions in 60‑70% of medical diagnoses. While automation technology has made great strides in recent years, many biologists continue to rely on multi‑day quality control processes to ensure reliable and reproducible results.
The statistical tools for quality control management have also improved, especially with Unity Real Time (Bio-Rad), leading to a more comprehensive approach for both technicians and biologists.
The aim of this presentation is to share the experience of our university hospital laboratory and describe the stages of change in the implemented strategy, from an approach initially based on Westgard’s rules and analytical objectives, towards an approach based on the total error.
Speakers
Nico Vandepoele, BSc,
Bio-Rad Laboratories Quality Systems Division, Irvine, CA, USA
Nico Vandepoele works as Global Product Manager, Informatics for the Bio-Rad Laboratories Quality Control Division. He works on the Unity and EQAS software development by collecting information about quality control processes from laboratories and regulatory bodies. He also promotes an understanding of laboratory regulations and best practices as they pertain to QC and EQA/PT programs. Nico is a well‑recognized speaker and presents trainings, workshops, and lectures at symposia around the world. He volunteers on several CLSI committees and ISO TC212 Working Group 2.
Dr. Sandrine François‑Ngo, MD, PhD,
Ambroise Paré University Hospital, Boulogne‑Billancourt, France
Dr. Sandrine François-Ngo is medical biologist and head of the biochemistry-hormonology and pharmacotoxicology sector at the Ambroise Paré University Hospital Center, Boulogne-Billancourt, France. After several years researching and teaching biochemistry (UFR Médicale Paris-Ouest, Université Paris Vxx), she has since 2004 devoted herself to hospital activity in various laboratories in Ile de France (Villeneuve-Saint Georges, Saint-Denis, Boulogne-Billancourt). Since 2013, Dr. François-Ngo has been responsible for the biochemistry sector of the laboratory of the Ambroise Paré University Hospital. She manages quality control for the entire biochemistry sector, routine and specialized.
SESSION 2
One Step Further in Daily QC: A Patient Risk Approach
Wednesday, 16 October 2024, 15:00‑17:00 CET
A patient centric approach to Quality Control - with John Yundt-Pacheco
Clinical diagnostics has gone through profound changes in the last 20 years, but these changes have not always extended to the way we manage quality control (QC). The transition from batch testing to discrete testing in the clinical laboratory means that there is no longer a direct relationship between the test conditions of the QC and the patients being tested. Instead of focusing our QC on the instrument - an "instrument-centric" approach - we need to focus on how our QC strategies impact the patient - a "patient-centric" approach.
Instrument-centric QC focuses on metrics like the probability of error detection, where patient centric QC focuses on metrics like what is the probability of producing an incorrect patient result. In contrast, the patient centric approach directly leads to managing the risk of patient harm from erroneous results.
This presentation will cover:
- Risk managed QC design
- The ISO Acceptable Risk Model
- Severity of harm
- Probability of in-control erroneous results
- Probability of out-of-control erroneous results
- Predicted probability of harm
- Computing a risk management index (RMI)
Practical implementation of a QC strategy based on risk with Mission: Control – with Dr. Hervé Dupont-Gaudin
QC strategy is an important issue in the clinical laboratory. The usual strategy is very often not optimal and leads to either an excessive number of QC runs for many analytes or an insufficient number for some other, more fragile analytes. There was no reliable way to optimize this strategy with a tool giving clear recommendations. So, when Bio-Rad showed us Mission: Control, we asked them to use it to evaluate our activity in biochemistry in our core lab. The results are an invaluable help to optimize both the performance and the cost of our QC strategy.
Speakers
John Yundt‑Pacheco, MSCS,
Bio-Rad Laboratories Quality Systems Division Irvine, USA
John is a Senior Principal Scientist at the Quality Systems Division of Bio-Rad Laboratories. He leads the Informatics Discovery Group in Plano, TX, doing research in quality control and patient risk issues. He has been with Bio-Rad for over 35 years and has worked with laboratories around the world — developing real time, inter-laboratory quality control systems, proficiency testing systems, risk management and other quality management systems.
Dr. Hervé Dupont-Gaudin, PharmD, PhD,
Bioxa Laboratory, Reims, France
Hervé Dupont-Gaudin has been a medical biologist in a French private lab since 1990. After working in different parts of the lab, in 2005 he managed the installation of the first biochemistry and immunology automated core lab in France. In 2018, he was responsible for the installation of the biochemistry and immunology systems in the new Bioxa core lab around an Aptio track, including all the routine activities of the lab. He has been consistently involved in the internal quality control follow-up and management, analytical performance specification setting, and QC rule implementation in the lab.
SESSION 3
A New Era in Molecular Lab Quality
Thursday, 17 October 2024, 15:00‑17:00 CET
Internal QC in molecular labs: a matter of quality with Dr. Dominique Challine
A laboratory’s commitment to quality assurance ensures that all its processes are under control, guaranteeing the quality of the results on which the diagnostic and therapeutic management of patients will be based. Therefore, both the selection of the diagnostics systems (instrument/reagent pairs) and their performance verification before and after implementation are critical. To meet quality requirements such as those set out in ISO15189, the performance of the analytical process must be continuously monitored throughout its lifecycle. This involves analyzing the results of internal quality controls (IQCs) ‑ those provided in‑kit by assay manufacturers as well as independent IQCs manufactured by other suppliers ‑ and external quality assessment programs.
This presentation focuses on IQCs used in molecular biology, particularly in virology. The detection and quantification of viral genomes have taken on a major role in the diagnosis and monitoring of viral infections. Many instruments are automated, with each series of runs validated by default by the in‑kit IQC provided by the assay manufacturer. This is not sufficient, and continuous performance monitoring of the system and validation of the various PCR steps ‑ including the notoriously variable genome extraction phase ‑ also require the implementation of quality controls independent from the assay. The selection of independent IQCs is based on the biologist’s expertise as well as the instrument throughput (large series or single specimens), run frequency, and cost. The biologist also defines the interpretation rules and actions to be taken in the event of IQC non‑compliance. Drawing from several years of experience with independent IQCs, the practices of the virology laboratory at Henri Mondor Hospital are presented here as an example.
Impact of IVDR - Insight into the key elements of IVDR for healthcare institutions ‑ with Prof. Elisabeth Dequeker
IVDR Implementation in Molecular Diagnostic Laboratories: Impacts and Benefits for In‑House Devices. The IVDR 2017/745 regulation is an enormous change to the IVD industry and health institutions. For industry it requires a change to technical documentation and quality management system, as well as new requirements for economic operators. But the impact for medical laboratory community is also high. In-house testing within molecular laboratories under the In Vitro Diagnostic Regulation (IVDR) involves a complex set of requirements and standards to ensure the quality, safety, and performance of in vitro diagnostic (IVD) medical devices.
Implementing in-house testing requires setting up a comprehensive quality management system, performing performance evaluations, maintaining detailed documentation, and ensuring continuous post-market surveillance. Adherence to international standards such as ISO 15189, ISO 13485, and ISO 14971 is crucial to demonstrate compliance and ensure the safety and efficacy of IVD tests.
This presentation will focus on the challenges of offering in‑house manufactured devices by healthcare institutes in the EU under the IVDR and more specific to the group of molecular diagnostic laboratories.
Speakers
Dr. Dominique Challine, MD
Henri Mondor University Hospital, Créteil, France
Dr. Dominique Challine is a medical biologist and virologist in the Virology Department of the Henri Mondor Hospital (APHP) in Créteil, France. She earned her medical degree from the University of Paris and is a graduate in virology from the Pasteur Institute in Paris. She has been actively involved in the creation of the emergency and qualification sector for organs, tissues, and cells intended for transplantation for a large territory, for which she has been responsible for 24 years. She has also been involved in quality assurance for the virology laboratory, which has been ISO 15189 accredited for 10 years for its serology and molecular biology activities.
Prof. Elisabeth Dequeker, MS, PhD,
University Hospital Leuven, Belgium
Professor Elisabeth Dequeker earned her MS and PhD in Organic Chemistry from the University of Leuven (Belgium). During her postdoctoral research, she specialized in quality assessment aspects of medical diagnostic laboratories. She is currently Full Professor and Head of the Biomedical Quality Assurance Research Unit (University of Leuven). She is also Head of the Quality Department and Regulatory Affairs Officer for Medical Diagnostics at the University Hospitals Leuven.