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An Agile Quality Management System For Laboratory Developed Tests, Rita D'Angelo Jan 2018

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Degree: Doctor of Philosophy Statement of the Problem: We explore the 2014 draft guidance by the FDA entitled Framework for Regulatory Oversight of Laboratory Developed Tests (LDT) extended from the medical device industry and discuss how these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 ...