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Towards the Lean lab: The Industry Challenge

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Pre-Analytics of Pathological Specimens in Oncology

Part of the book series: Recent Results in Cancer Research ((RECENTCANCER,volume 199))

Abstract

In anatomic pathology, the current state encompassing the pre-analytic processes of tissue collection, handling, examination, preparation, processing, and storage are largely uncontrolled, inconsistently performed, and/or not standardized according to the sound scientific data. Pre-analytic defects result in nearly three-quarters of the problems in laboratory diagnostics. This is evident in quality surveys from well-respected institutions that document high miss rates in the required basics of information related to patient and tissue identity, let alone parameters documenting quality aspects related to the surgical specimen and its preservation. This talk will describe the historical approach to tissue processing and identify gaps from worldwide observations in current laboratory practices. It will also offer potential methodological and technological solutions and process improvements that laboratories may consider in serving the ultimate users of pathology information: the clinician and the patient. It illustrates the need for scientifically validated specimen guidelines and a performance based, standardized and documented “chain of custody” of the pre-analytical steps from the patient’s body through fixation. For thought leaders and professional standard setters, opportunities for optimizing molecular studies exist in specimen collection, transfer, grossing, fixation, and decalcification protocols. In this evolving era of molecular profiling and personalized therapeutic decision-making, a well-reasoned and coordinated focus on pre-analytic processes that optimizes specimens for subsequent testing will result in:

  • Improved specimen quality for molecular testing

  • Improved accuracy of diagnostic and molecular test results

  • Reduced Turnaroundtimes for same-day diagnosis

  • Enhanced satisfaction of clinicians and patients.

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Acknowledgments

I express my gratitude to Prof. Gianni Bussolati, from the University of Turin, Italy, for helpful suggestions and discussion.

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Authors and Affiliations

  1. Milestone Srl, Via Fatebenefratelli 1/5, 24010, Sorisole Bergamo, Italy

    Franco Visinoni

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  1. Franco Visinoni
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Correspondence to Franco Visinoni .

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Editors and Affiliations

  1. Institute of Pathology, Charité University Medicine, Berlin, Germany

    Manfred Dietel

  2. Institute of Pathology, University Hospital Leipzig, Leipzig, Sachsen, Germany

    Christian Wittekind

  3. University of Turin Institute of Pathology, Turin, Italy

    Gianni Bussolati

  4. Institute of Pathology, Charité University Medicine, Berlin, Germany

    Moritz von Winterfeld

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Visinoni, F. (2015). Towards the Lean lab: The Industry Challenge. In: Dietel, M., Wittekind, C., Bussolati, G., von Winterfeld, M. (eds) Pre-Analytics of Pathological Specimens in Oncology. Recent Results in Cancer Research, vol 199. Springer, Cham. https://doi.org/10.1007/978-3-319-13957-9_12

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  • DOI: https://doi.org/10.1007/978-3-319-13957-9_12

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-13956-2

  • Online ISBN: 978-3-319-13957-9

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