MSACL 2018 US Abstract

Topic: Practical Training

A Regulatory Review of QA Monitoring for LC-MS/MS: the Real Work Begins After Validation : Part 1

Kara Lynch (Presenter)
University of California San Francisco

Bio: Dr. Kara Lynch is an Associate Professor of Laboratory Medicine at the University of California San Francisco and the Co-Director of the Core Laboratory (Clinical Chemistry and Toxicology) at Zuckerberg San Francisco General Hospital and Trauma Center. She received her PhD in Biochemistry from the University of Wisconsin and did a post-doctoral fellowship in Clinical Chemistry in the COMACC approved training program at UCSF. Her primary area of research is in Clinical Toxicology. Her laboratory conducts studies aimed at identifying and quantifying toxins, drugs of abuse and adulterants in biological specimens using mass spectrometry and correlating the findings with clinical pathologies.

Authorship: Kara L. Lynch
University of California San Francisco

Short Abstract

For mass spectrometry testing in the clinical laboratory, post-implementation monitoring for quality is just as important as method development and validation but often receives less attention. Assuring that your laboratory has designed and implemented a quality management system for LC-MS/MS testing is vital to maintaining quality. This talk will review available guidelines (CLSI C62A, CLSI EP23, CLSI QMS01, QMS06, QMS12) and typical parameters that are used to monitor the entire testing process. Example tools for monitoring quality assurance will be presented.

Long Abstract

Introduction

Methods

Results

Conclusions & Discussion


References & Acknowledgements:


Financial Disclosure

DescriptionY/NSource
Grantsno
SalaryyesPain and Rehabilitative Consultants Medical Group
Board Memberno
Stockno
Expensesno

IP Royalty: no

Planning to mention or discuss specific products or technology of the company(ies) listed above:

no