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Immunohistochemistry Quality Management and Regulation

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Handbook of Practical Immunohistochemistry

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Abstract

Immunohistochemistry testing is highly complex with multiple steps. Assuring the optimum performance of your immunohistochemistry laboratory requires attention to numerous quality monitors. For testing performed on patient specimens, there are also additional regulatory requirements. This chapter answers questions about best practices in quality management in preanalytic, analytic, and postanalytic phases of the total immunohistochemistry test providing examples of possible quality improvement opportunities. It also provides information related to CLIA and FDA regulatory oversight medical devices, in vitro diagnostics (IVD), and analyte-specific reagents (ASR). With regard to immunohistochemistry laboratory accreditation, the final portion of this chapter draws attention to current best practice guidelines of the College of American Pathologists (CAP) relating to immunohistochemistry to prepare for inspection.

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  1. Surgical Pathology, Pathology and Laboratory Medicine, Geisinger Medical Center, 100 N. Academy Ave., Danville, PA, 17822, USA

    Jeffrey Prichard DO

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  1. Jeffrey Prichard DO
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Correspondence to Jeffrey Prichard DO .

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Editors and Affiliations

  1. Laboratory Medicine, Geisinger Health System, Danville, Pennsylvania, USA

    Fan Lin

  2. Laboratory Medicine, Geisinger Medical Center, Danville, Pennsylvania, USA

    Jeffrey Prichard

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Prichard, J. (2015). Immunohistochemistry Quality Management and Regulation. In: Lin, F., Prichard, J. (eds) Handbook of Practical Immunohistochemistry. Springer, New York, NY. https://doi.org/10.1007/978-1-4939-1578-1_1

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