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Maintaining quality diagnosis with digital pathology: a practical guide to ISO 15189 accreditation
  1. Bethany Jill Williams1,2,
  2. Chloe Knowles1,
  3. Darren Treanor1,2
  1. 1Leeds Teaching Hospitals NHS Trust, Leeds, UK
  2. 2Department of Pathology, University of Leeds, Leeds, UK
  1. Correspondence to Dr Bethany Jill Williams, Leeds Teaching Hospitals NHS Trust, Leeds LS1 3EX, UK; bethany.williams2{at}nhs.net

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.

  • digital pathology
  • histopathology
  • laboratory management
  • quality assurance
  • quality control
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Footnotes

  • Handling editor Runjan Chetty.

  • Contributors BJW drafted and revised the manuscript. BJW provided all material pertaining to clinical validation. CK provided themes and reviewed manuscript for laboratory medicine section. DT reviewed and refined manuscript.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests Leeds Teaching Hospitals NHS Trust has a collaborative partnership with Leica Biosystems for a research digital pathology deployment.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement There are no data in this work. Data are available upon reasonable request.

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