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Description:
This session will provide an overview of a new Canadian standard, CSA Z316.8 - requirements for the design, development, and validation of laboratory developed tests (LDTs) used for the screening, diagnosis, and management of clinical conditions. This project was born from the recognition that Canadian laboratories lacked a national standard for the essential requirements in the design/development/validation of LDTs, as well as recommended resources that provide greater detail for more specific applications (Anatomical Pathology, Biochemistry, Genetics, Hematology, Microbiology). The CSA Group’s accredited, consensus-based standards process in developing this standard will be reviewed. Key stages include: notice of intent, creation of a technical subcommittee, content development, public review, editorial review, and final ballot/approval.
At the end of this webinar you will be able to:
Author: Carol Cheung, MD, PhD, JD, FRCPC
Dr. Carol Cheung received her MD and completed her residency in Anatomical Pathology at the University of Toronto (UofT). She obtained her PhD training in cellular and molecular biology at the Ontario Cancer Institute. She received her law degree from the Faculty of Law, UofT. 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 Immunopathology Laboratory at UHN, founder of the webinar series “Epitopically Speaking…”; she a member of the Ontario Cancer Research Ethics Board, the Canadian Association of Pathologists’ National Standards Committee for Immunohistochemistry/High Complexity Testing, the Canadian Standards Association (CSA) Group’s Technical Committee on Medical Laboratory Quality Systems, and the CSA Group’s Technical Subcommittee on Laboratory Developed Tests. 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 as an evolving discipline.
Recorded: May 26, 2018
PEP hours: 1.25
CPS credits: 0
*Note: PEP hours and/or CPS credits will only be awarded upon successful completion of the quiz.
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