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This forum will attract laboratory and diagnostic imaging professionals interested in learning about the challenges and solutions in meeting accreditation requirements. 
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Thank you for attending IQMH Spring Forum 2018!

A Summary of the Event




New CSA Group Standard on Requirements for the Design, Development and Validation of Laboratory-Developed Tests by Isolde Seiden-Long, Clinical Biochemist with Calgary Laboratory Services, Foothills Medical Center and Peter Lougheed Center hospitals; Clinical Associate Professor, Department of Pathology and Laboratory Medicine, University of Calgary

Isolde presented the details of a new standard for lab-developed tests, specifically the quality management system, pre-validation, validation and post validation requirements.

Pre-validation:

  • Test requirements
  • Validation master plan
  • Analytical instrument qualification
  • Documentation
  • Risk assessment

Validation:

  • Preliminary experiments
  • Establish performance characteristics
  • Excluded characteristics
  • Measurement uncertainty
  • Software verification

Post Validation:

  • Transfer to routine use
  • Test interpretation
  • Documentation
  • Retention of validation records



Integrated Quality Management System: Lessons Learned from High Risk Industries by Zoran Bojic, Quality Management Leader, Vascular Access/Diagnostic Imaging, Diagnostic Imaging, The Hospital for Sick Children

Zoran opened the diagnostic imaging stream with an inspiring look at lessons learned from other high-risk industries such as aviation, nuclear power, and petrochemical. He walked us through the benefits of an integrated quality system, and the necessary human elements:



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