New CSA Group Standard on the Validation of Laboratory-Developed Tests (CSA Z316.8)
Carol Cheung, MD, PhD, JD, FRCPC | October 18, 2018 |
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.