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The Clinical Immunohistochemistry Laboratory: Regulations and Troubleshooting Guidelines

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Part of the book series: Methods in Molecular Biology ((MIMB,volume 588))

Abstract

The Clinical Laboratory Improvement Amendments (CLIA) set standards designed to improve the quality of all laboratory testing. In the first portion of this chapter, we discuss the CLIA requirements that apply to most Immunohistochemistry laboratories, and explain topics such as certification, test complexity, patient test management, proficiency testing, personnel, quality control, quality assurance, and compliance.

The second portion of this chapter addresses the most common problems encountered in immunohistochemical procedures and the appropriate solutions to correct them.

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References

  1. Department of Health and Human Services, Health Care Financing Administration (2003) Clinical Laboratory Improvement Amendments of 1988: final rule. Fed Regist 68:3640–3714

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  3. Clinical and Laboratory Standards Institute (2007) The CLSI Procedure Manual Toolkit: improving procedure writing in the clinical laboratory, CLSI document GP02–A5-C. CLSI, Wayne, PA

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Correspondence to Patricia A. Fetsch .

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© 2010 Humana Press, a part of Springer Science+Business Media, LLC

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Fetsch, P.A., Abati, A. (2010). The Clinical Immunohistochemistry Laboratory: Regulations and Troubleshooting Guidelines. In: Oliver, C., Jamur, M. (eds) Immunocytochemical Methods and Protocols. Methods in Molecular Biology, vol 588. Humana Press. https://doi.org/10.1007/978-1-59745-324-0_43

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  • DOI: https://doi.org/10.1007/978-1-59745-324-0_43

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  • Publisher Name: Humana Press

  • Print ISBN: 978-1-58829-463-0

  • Online ISBN: 978-1-59745-324-0

  • eBook Packages: Springer Protocols

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