Access Type

Open Access Dissertation

Date of Award

January 2018

Degree Type

Dissertation

Degree Name

Ph.D.

Department

Industrial and Manufacturing Engineering

First Advisor

Ratna B. Chinnam

Abstract

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Degree: Doctor of Philosophy Statement of the Problem: We explore the 2014 draft guidance by the FDA entitled Framework for Regulatory Oversight of Laboratory Developed Tests (LDT) extended from the medical device industry and discuss how these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 to design, develop and validate Laboratory Developed Tests. If not, why not, and what would be the limiting steps.

Method: We perform interviews with laboratory professionals to explore their concerns and challenges regarding the FDA draft guidance then translate the results into strategic factors. Based on the feedback, we surveyed laboratory experts in the field of LDT to develop and test strategic factors that would comprise an effective quality management system framework (QMS) to comply with the FDA proposal. We describe the methodology to translate the strategic factors into a design that would transform the existing laboratory structure into a regulatory quality management system.

Conclusion: Nine interviewees and 35 survey respondents shared the importance of risk classification, process validation, patient safety and general ambiguity for the development of LDT. We utilize the top supporting statements and associated factors chosen by experts as extremely important for LDT development as the building blocks for implementation of a regulatory QMS framework. The framework includes six phases of implementation: 1) establishment of a leadership support structure, 2) training, 3) pre-assessment of current laboratory processes, 4) adoption of design control, 5) process controls, 6) process validation and the application of an agile Stage Gate technique for test development.

Respondents agree that a regulatory agile quality management system is needed in laboratories that develop LDT. Utilizing the strategic factors, we develop a novel approach to LDT design, development and testing that extends the existing laboratory structure with a proven product development methodology technique called agile stage gate hybrid with the assignment of dedicated, accountable cross-functional teams for go/no-go approvals at every step and institute a coordinator position to review, document and expedite LDT development throughout the testing process.

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