Practical Guide to ISO 15189 Accreditation for Digital Pathology in Clinical Laboratories

Original abstract

An ever-increasing number of clinical pathology departments are deploying, or planning to deploy digital pathology systems for all, or part of their diagnostic output. Digital pathology is an evolving technology, and it is important that departments uphold or improve on current standards. Leeds Teaching Hospitals NHS Trust has been scanning 100% of histology slides since September 2018, and has developed validation and validation protocols to train 38 histopathology consultants in primary digital diagnosis. In this practical paper, we will share our approach to ISO inspection of our digital pathology service, which resulted in successful ISO accreditation for primary digital diagnosis. We will offer practical advice on what types of procedure and documentation are necessary, both from the point of view of the laboratory and your reporting pathologists. We will explore topics including risk assessment, standard operating procedures, validation and training, calibration and quality assurance, and provide a checklist of the key digital pathology components you need to consider in your inspection preparations. The continuous quest for quality and safety improvements in our practice should underpin everything we do in pathology, including our digital pathology operations. We hope this publication will make it easier for subsequent departments to successfully achieve ISO 15189 accreditation and feel confident in their digital pathology services.