Carol Cheung

carolcheungEvolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine (also see Emina Torlakovic)

Part 1: Fit for purpose Approach to Classification of Clinical Immunohistochemistry Biomarkers
Presentation (PDF)

This presentation will emphasize the essential role of “purpose” in the immunohistochemistry (IHC) test: 1) that “purpose” is the intended use of an IHC test at the time that the test was developed, 2) that  “purpose” is intrinsic to the identity of any particular IHC test, and 3) that classification based on the “purpose” of the IHC test is helpful in developing proper quality assurance (QA) tools and clarifies the utility of that test in patient management in the era of precision medicine. The type of IHC test is also linked to “purpose”. Recognition that IHC is a qualitative test enables proper design of QA methods around its technical validation and training of pathologists for readout of the test. Also discussed will be the importance of distinguishing between the “readout” and the “interpretation” of the IHC test. Furthermore, IHC tests may also be classified from the perspective of the end user into different categories including diagnostic, screening, prognostic, and predictive assays.

Part 4: Tissue Tools for Quality Assurance in Immunohistochemistry
 Presentation (PDF)

Validation of immunohistochemistry (IHC) testing requires demonstration of appropriate test performance characteristics. Execution of protocol validation and daily quality control lie within the domain of the IHC laboratory. This presentation will clarify, through the lens of laboratory tissue tools, how validation, verification, and revalidation of IHC tests can be performed to develop and maintain high quality “fit-for-purpose” IHC testing in the era of precision medicine. Various tissue tools that enable verification, validation, and daily quality control are described. Specifically, design of tissue tools for initial test development, initial validation, daily on-slide controls, primary, secondary, and tertiary re-validation are presented.

CV

Dr. Carol Cheung, MD, PhD, JD, FRCPC, received her MD and completed her residency in Anatomical Pathology at the Faculty of Medicine, University of Toronto. She obtained her Ph.D. training in cellular and molecular biology at the Ontario Cancer Institute. She received her law degree from the Faculty of Law, University of Toronto. She is currently a consultant pathologist in urologic pathology at the University Health Network (UHN) and is an assistant professor in the Department of Laboratory Medicine and Pathobiology, UofT. She is the Medical Director of the Clinical Immunopathology Laboratory at UHN, founder of the webinar series “Epitopically Speaking…”, co-chair of the UHN Anatomical Pathology Professional Quality Assurance committee, scientific member of the Ontario Cancer Research Ethics Board, and a member of the Canadian Association of Pathologists’ National Standards Committee for Immunohistochemistry/High Complexity Testing. Her main academic activities focus on quality improvement especially in biomarker testing, as well as the legal and ethical issues that affect the development of laboratory medicine and pathology as an evolving discipline.

Selected References

  1. Cheung CC, D’Arrigo C, Dietel M, Francis GD, Fulton R, Gilks CB, Hall JA, Hornick JL, Ibrahim M, Marchetti A, Miller K, van Krieken JH, Nielsen S, Swanson PE, Taylor CR, Vyberg M, Zhou X, Torlakovic EE.  Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine – Part 4: Tissue Tools for the Clinical Laboratory. From the International Society for Immunohistochemistry and Molecular Morphology (ISIMM) and International Quality Network for Pathology (IQN Path).  Appl Immunohistochem Mol Morphol.  2017 Jan;25(1):4-11. PubMed PMID: 27922482.
  2. Torlakovic EE, Cheung CC, D’Arrigo C, Dietel M, Francis GD, Gilks CB, Hall JA, Hornick JL, Ibrahim M, Marchetti A, Miller K, van Krieken JH, Nielsen S, Swanson PE, Vyberg M, Zhou X, Taylor CR.  Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine – Part 3: Technical Validation of Immunohistochemistry (IHC) Assays in Clinical IHC Laboratories. From the International Society for Immunohistochemistry and Molecular Morphology (ISIMM) and International Quality Network for Pathology (IQN Path).  Appl Immunohistochem Mol Morphology.  In Press.
  3. Torlakovic EE, Cheung CC, D’Arrigo C, Dietel M, Francis GD, Gilks CB, Hall JA, Hornick JL, Ibrahim M, Marchetti A, Miller K, van Krieken JH, Nielsen S, Swanson PE, Vyberg M, Zhou X, Taylor CR.  Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine – Part 2: Immunohistochemistry Test Performance Characteristics. From the International Society for Immunohistochemistry and Molecular Morphology (ISIMM) and International Quality Network for Pathology (IQN Path).  Appl Immunohistochem Mol Morphol.  In Press.
  4. Cheung CC, D’Arrigo C, Dietel M, Francis GD, Gilks CB, Hall JA, Hornick JL, Ibrahim M, Marchetti A, Miller K, van Krieken JH, Nielsen S, Swanson PE, Taylor CR, Vyberg M, Zhou X, Torlakovic EE.  Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine – Part 1: Fit-for-purpose Approach to Classification of Clinical Immunohistochemistry Biomarkers. From the International Society for Immunohistochemistry and Molecular Morphology (ISIMM) and International Quality Network for Pathology (IQN Path).  Appl Immunohistochem Mol Morphol.  2016 Dec 9. [Epub ahead of print.]  PubMed PMID: 27941560.
  5. Cheung CC, Taylor CR, Torlakovic EE. An Audit of Failed Immunohistochemical Stains in a Clinical Laboratory: the Role of On-Slide Controls. Appl Immunohistochem Mol Morphol. 2015 Dec 9. [Epub ahead of print].
  6. Cheung CC, Garratt J, Won J, Cutz JC, Gilks CB, Tsao MS, Torlakovic EE. Developing ALK Immunohistochemistry and In situ hybridization Proficiency Testing for Non-Small Cell Lung Cancer in Canada: Canadian Immunohistochemistry Quality Control Challenges and Successes.  Appl Immunohistochem Mol Morphol. 2015 Nov-Dec;23(10)677-82.  doi: 10.1097/PAI.0000000000000267.
  7. Cheung CC, Banerjee D, Barnes PJ, Berendt RC, Butany J, Canil S, Clarke BA, El-Zimaity H, Garratt J, Geldenhuys L, Gilks CB, Manning L, Mengel M, Perez-Ordonez B, Pilavdzic D, Riddell R, Swanson PE, Torlakovic EE. Canadian Association of Pathologists–Association canadienne des pathologistes National Standards Committee for High Complexity Testing/Immunohistochemistry: Guidelines for the Preparation, Release, and Storage of Unstained Archived Diagnostic Tissue Sections For Immunohistochemistry. American Journal of Clinical Pathology. 2014 Nov;142(5):629-633.
  8. Cheung CC, Neufeld H, Lining LA, Pilavdzic D, Quenneville L, Garratt J, Gilks B, Torlakovic EE. The Laboratory  Score/Reference Method Score Ratio (LSRSR) is a novel tool for monitoring laboratory performance in immunohistochemistry proficiency testing of hormone receptors in breast cancer – the CIQC Experience. American Journal of Clinical Pathology. 2011 Jul;136(1):67-73. Principal Author.