title: Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine: Part 4: Tissue Tools for Quality Assurance in Immunohistochemistry.
abstract: The numbers of diagnostic, prognostic, and predictive immunohistochemistry (IHC) tests are increasing; the implementation and validation of new IHC tests, revalidation of existing tests, as well as the on-going need for daily quality assurance monitoring present significant challenges to clinical laboratories. There is a need for proper quality tools, specifically tissue tools that will enable laboratories to successfully carry out these processes. This paper clarifies, through the lens of laboratory tissue tools, how validation, verification, and revalidation of IHC tests can be performed in order to develop and maintain high quality "fit-for-purpose" IHC testing in the era of precision medicine. This is the final part of the 4-part series "Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine."
authors.affiliation: *Department of Laboratory Medicine and Pathobiology, University of Toronto Departments of †Pathology §§§§Laboratory Hematology, University Health Network, Toronto, ON §§Vancouver General Hospital, University of British Columbia, Vancouver, BC ###Department of Pathology and Laboratory Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB ∥∥∥∥Canadian Immunohistochemistry Quality Control (CIQC)/Canadian Association of Pathologists National Standards Committee for High Complexity Testing/Immunohistochemistry, Canada ‡Poundbury Cancer Institute §Dorset County Hospital NHS Foundation Trust ∥Cancer Diagnostic Quality Assurance Services (CADQAScic), Dorchester ¶¶Department of Surgery & Cancer, Division of Cancer, Imperial College London ***UK National External Quality Assessment Scheme (UK NEQAS), University College London, London, UK ∥∥International Quality Network for Pathology (IQN Path), Luxembourg City, Luxembourg ¶School of Medicine, Institute of Pathology, Charité-University Hospital Berlin, Berlin, Germany #Griffith University, Gold Coast ††Genomics For Life, Brisbane, Qld **RCPA Quality Assurance Program, Sydney, NSW, Australia ‡‡Phenopath, Seattle, WA ##Brigham and Women's Hospital, Harvard Medical School, Boston, MA ****Keck School of Medicine, University of Southern California, Los Angeles, CA †††Center of Predictive Molecular Medicine ‡‡‡Center for Excellence on Ageing and Translational Medicine, University of Chieti-Pescara, Chieti, Italy §§§Department of Pathology, Radboud University Medical Centre, Nijmegen, The Netherlands ∥∥∥Institute of Pathology, Aalborg University Hospital and Department of Clinical Medicine, Aalborg University ¶¶¶Nordic Immunohistochemistry Quality Control (NordiQC), Aalborg, Denmark ††††Department of Pathology, Beijing Friendship Hospital, Capital Medical University, Beijing ‡‡‡‡Chinese Committee for Pathologists-Immunohistochemistry Quality Control, China.
authors.forename: Carol C
authors.initials: CC
authors.lastname: Cheung
authors.forename: Corrado
authors.initials: C
authors.lastname: D'Arrigo
authors.forename: Manfred
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authors.lastname: Dietel
authors.forename: Glenn D
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authors.lastname: Francis
authors.forename: Regan
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authors.initials: CB
authors.lastname: Gilks
authors.forename: Jacqueline A
authors.initials: JA
authors.lastname: Hall
authors.forename: Jason L
authors.initials: JL
authors.lastname: Hornick
authors.forename: Merdol
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authors.lastname: Ibrahim
authors.forename: Antonio
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authors.lastname: Marchetti
authors.forename: Keith
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authors.lastname: Miller
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authors.initials: JH
authors.lastname: van Krieken
authors.forename: Soren
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authors.lastname: Nielsen
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authors.initials: PE
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authors.forename: Clive R
authors.initials: CR
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authors.lastname: Vyberg
authors.forename: Xiaoge
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authors.lastname: Zhou
authors.forename: Emina E
authors.initials: EE
authors.lastname: Torlakovic
mesh_terms: D019411:Clinical Laboratory Techniques; D006801:Humans; D007150:Immunohistochemistry / Q000295:instrumentation / Q000379:methods*; D007753:Laboratories; D057285:Precision Medicine; D011785:Quality Assurance, Health Care