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An Agile Quality Management System For Laboratory Developed Tests, Rita D'Angelo
An Agile Quality Management System For Laboratory Developed Tests, Rita D'Angelo
Wayne State University Dissertations
ABSTRACT
AN AGILE QUALITY MANAGEMENT SYSTEM FOR LABORATORY DEVELOPED TESTS
By
RITA D’ANGELO
MAY 2017
Advisor: Dr. Ratna Babu Chinnan
Major: Industrial & Systems Engineering
Degree: Doctor of Philosophy Statement of the Problem: We explore the 2014 draft guidance by the FDA entitled Framework for Regulatory Oversight of Laboratory Developed Tests (LDT) extended from the medical device industry and discuss how these requirements may be applicable to laboratory medicine. We introduce terms, definitions and provide a call for action for leaders to prepare for the potential adherence to regulatory requirements and explore if compliance was achievable in a laboratory environment …