A Root Cause Analysis Into the High Error Rate in Clinical Immunohistochemistry

Applied Immunohistochemistry & Molecular Morphology : AIMM
Steven A Bogen

Abstract

The field of Clinical Immunohistochemistry (IHC) is beset with a high error rate, an order of magnitude higher than in other types of clinical laboratory testing. Despite the many improvements in the field, these errors have persisted over the last 2 decades. The improvements over the years include an extensive literature describing the potential causes of errors and how to avoid them. More stringent regulatory guidelines have also been implemented. These measures reflect the standard view is that fixing the broad confluence of causes of error will address the problem. This review takes a different tack. To understand the high error rates, this review compares Clinical IHC laboratory practice to practices of other clinical laboratory disciplines. What aspects of laboratory testing that minimize errors in other clinical laboratory disciplines are not found in Clinical IHC? In this review, we seek to identify causal factors and underlying root causes that are unique to the field of Clinical IHC in comparison to other laboratory testing disciplines. The most important underlying root cause is the absence of traceable units of measure, international standards, calibrators that are traceable to standards, and quantitative monitoring...Continue Reading

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Citations

Apr 19, 2019·Applied Immunohistochemistry & Molecular Morphology : AIMM·Mogens Vyberg
Feb 12, 2020·Applied Immunohistochemistry & Molecular Morphology : AIMM·Clive R Taylor
Jan 14, 2020·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Kimberly H AllisonAntonio C Wolff
Apr 10, 2019·Applied Immunohistochemistry & Molecular Morphology : AIMM·Clive R Taylor
Feb 16, 2021·Clinical Chemistry·Emina E TorlakovicSteven A Bogen
Aug 15, 2021·Modern Pathology : an Official Journal of the United States and Canadian Academy of Pathology, Inc·Seshi R SompuramSteven A Bogen

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Methods Mentioned

BETA
nucleic acid extraction
Assay
flow cytometry

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