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Crossing the accreditation bridge: POC testing transition from ISO 15189:2012 to 2022
Navigating the world of Point-of-Care Testing (POCT) accreditation presents unique challenges, especially with recent changes to international standards. The new, unified ISO 15189:2022 standard now fully integrates POCT, eliminating the previous dual-track system and placing a greater emphasis on governance, risk management, and traceability. This shift requires a structured, systemic approach to ensure compliance and, most importantly, patient safety.
In this webcast, we explore a practical roadmap for this new landscape. Jonathan Harris shares the successful accreditation journey of the Cleveland Clinic Abu Dhabi. He demonstrates how a strategy built on four key pillars — non-negotiable governance, unified standards, systemic compliance, and scalable digital tools — can effectively manage a large and complex POCT network. Centralizing oversight and integrating systems for training, quality control, and data management are critical.
This session provides a detailed, clause-by-clause walkthrough of implementing the ISO 15189:2022 standard in a real-world setting. From establishing clear service level agreements to using data-driven analysis for continuous improvement, you will gain valuable insights to apply within your facilities. A proactive, risk-based framework not only meets accreditation demands but also builds a resilient, patient-focused POCT program.
Watch the full video for more insights into strategic planning and creating seamless collaboration between POCT teams, clinical departments, and laboratory leadership, which is critical to implementing change effectively and ensuring organizational success.
The views and opinions expressed in this webinar are those of the speakers and do not necessarily reflect the views or positions of Roche or any other sponsors.
Biography
Jonathan Harris, Director of Point of Care Testing (POCT), National Reference Laboratory, M42 Healthcare Group
Jonathan Harris has over 20 years of experience in the healthcare and laboratory sectors, specializing in Point of Care Testing (POCT), Biomedical Science, Quality Management, and Healthcare Leadership. He holds a Master of Science (MSc) in Healthcare Leadership and Innovation from the Royal College of Surgeons Ireland, Dubai, and an MSc in Biomedical Science from the University of Ulster, UK. His academic background includes two Bachelor of Science degrees in Biochemistry (Honours) from the University of Wolverhampton, U.K., and from the National University of Ireland, Galway. Jonathan is also certified in POCT, Quality Control, Six Sigma, Lean Methodology, and ISO 15189 Accreditation. His career has focused on standardizing POCT, ensuring accreditation compliance, and implementing innovative diagnostic solutions.
As Director of POCT for the National Reference Laboratory (NRL), Jonathan has centralised POCT operations across the M42 Healthcare Group, which includes the Cleveland Clinic and Imperial College London Diabetes Centres in Abu Dhabi. Under his leadership, the group achieved the broadest internationally accredited scope under ISO 15189 (2022).
Jonathan also established the only dedicated annual POCT conference in the Gulf Cooperation Council, a political and economic alliance of six Middle Eastern countries that has now become a key platform for collaboration and innovation. His work continues to shape POCT governance, technology, and quality improvement in the region.
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