PATHOLOGY VISIONS 2014 PRESENTER
  
Kim Dickinson


Kathleen M. Sayles, MS

SUNY Upstate Medical University

Presenting:
Implementation of WSI: Regulatory Considerations


Abstract: The experience of the Pathology Laboratory at SUNY Upstate with respect to decisions regarding the use of LDT's vs FDA approved tests will be discussed. Our lab is CLIA exempt and validates all testing through the NYSDOH (New York State Department of Health). Historically, if an FDA approved kit or test becomes available, we will consider its use but do not always make the decision to do so as long as the LDT in current use has been validated and approved through the NYSDOH. We view Digital Pathology much in the same way as we view traditional LDT's and IVD's. The FDA has classified WSI as a Class III Medical Device but has not yet issued guidance for use. Although the FDA has not approved it for IVD use beyond Her2 reading on a monitor, we intend to validate WSI for internal use following our procedure used for other tests/platforms requiring validation. We will validate using the guidelines set forth by the CAP, consult CLIA regulation CFR 493.1253 for guidance regarding off label use of devices (similar to the situation when the FDA published guidance for off label use of Glucose meters for critically ill patients) and develop policies and procedures that ensure the safety and efficacy of WSI.


Biography: Kathy is the Manager of Anatomic Pathology and Assistant Director of the Pathology Laboratory at SUNY Upstate Medical University in Syracuse, NY. She is a licensed Clinical Laboratory Technologist with 32 years of experience which includes all aspects of histologic technique, optical, fluorescence, confocal and electron microscopy as well as laboratory compliance and regulation. She is currently implementing Whole Slide Imaging (WSI) and Digital Pathology for research and education at Upstate Medical University.  She has a masters degree from Hofstra University in biology and chemistry and  is an active member of the Clinical Laboratory Management Association.

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