On April 17, 2025, at 20:00 (UTC/GMT+8), the first session of the DiagHub Series on Clinical Chemistry which was granted with IFCC auspices was held successfully, bringing together leading experts in the field.

Opening Address

The event opened with a welcome address from Prof. Tomris Ozben, President of the IFCC. She warmly welcomed attendees and emphasized the IFCC’s mission to advance global healthcare through standardization and innovation in laboratory medicine. She introduced Zybio, a leading IVD manufacturer recognized for its technological advancements across multiple product lines, and praised DiagHub for launching this important new series aimed at fostering academic exchange and collaboration. Prof. Ozben concluded by expressing her confidence in the event’s success and its role in driving continued progress within the diagnostics industry.

The webinar was moderated by Mr. Vincent Mina Abrena, Head of the Clinical Microscopy Section at San Lazaro Hospital, Philippines. The session featured two insightful presentations. Dr. Khanittha Punturee, Head of the AMS CMU EQA Unit at Chiang Mai University, shared practical approaches to risk management in clinical chemistry laboratories. Ms. Junqing Wang, Manager of the Reference Systems Department at Zybio, highlighted the importance of metrological traceability in biochemical detection.

Risk Management in Clinical Chemistry Laboratory: From Theory to Practice

Dr. Khanittha Punturee delivered an insightful lecture titled "Risk Management in Clinical Chemistry Laboratory: From Theory to Practice". She began by explaining the definitions of risk from various international standards, highlighting that risk involves both the probability of harm and its potential severity. Dr. Punturee emphasized that effective risk management in clinical laboratories is a continuous process rather than a one-time project.

The lecture detailed laboratory error phases, noting most errors are pre - analytical. She introduced a risk management framework including risk identification, evaluation, solution - seeking, implementation, and monitoring. Dr. Punturee discussed the importance of both internal and external data sources for identifying risks, and presented tools such as heat maps and risk matrices for prioritizing actions. She concluded that a proactive risk management culture benefits patient safety, compliance, and laboratory performance. Her talk provided practical guidance grounded in ISO standards and encouraged laboratories to embed risk awareness into their daily operations.

The Traceability of Quantitative Values for Biochemical Detection Items

Ms. Junqing Wang from Zybio delivered her insights on “The Traceability of Quantitative Values for Biochemical Detection Items.” She highlighted the importance of metrological traceability in ensuring the accuracy and comparability of biochemical testing results across laboratories and platforms.

Traceability is defined by ISO 17511:2020 as the ability to relate a measurement result to a reference through a documented, unbroken chain of calibrations. The presentation outlined different cases of traceability—from reference measurement procedures (RMPs) with primary reference materials (RMs), to systems based on manufacturer-defined calibrators. Zybio has developed closed and open systems for traceability, and its Reference System Department is accredited under ISO/IEC 17025:2017. Notably, 16 measurands are linked to RMPs, some certified by CNAS and JCTLM. At the end of the presentation, Ms. Junqing Wang emphasized, Zybio, as a stakeholder member of JCTLM, will continue to pursue international standards, contributing to the global harmonization of laboratory medicine.

Together, the speakers delivered valuable academic insights and real-world strategies, sparking engaging discussion during the Q&A. Stay tuned for upcoming DiagHub sessions as we continue exploring the future of diagnostics!