Journal article
Implementing a Quality Management System in the Medical Microbiology Laboratory
Clinical microbiology reviews, Vol.31(3), 10.1128/CMR.00062-17
07/2018
DOI: 10.1128/CMR.00062-17
PMCID: PMC6056841
PMID: 29720490
Abstract
This document outlines a comprehensive practical approach to a laboratory quality management system (QMS) by describing how to operationalize the management and technical requirements described in the ISO 15189 international standard. It provides a crosswalk of the ISO requirements for quality and competence for medical laboratories to the 12 quality system essentials delineated by the Clinical and Laboratory Standards Institute. The quality principles are organized under three main categories: quality infrastructure, laboratory operations, and quality assurance and continual improvement. The roles and responsibilities to establish and sustain a QMS are outlined for microbiology laboratory staff, laboratory management personnel, and the institution's leadership. Examples and forms are included to assist in the real-world implementation of this system and to allow the adaptation of the system for each laboratory's unique environment. Errors and nonconforming events are acknowledged and embraced as an opportunity to improve the quality of the laboratory, a culture shift from blaming individuals. An effective QMS encourages "systems thinking" by providing a process to think globally of the effects of any type of change. Ultimately, a successful QMS is achieved when its principles are adopted as part of daily practice throughout the total testing process continuum.
Details
- Title: Subtitle
- Implementing a Quality Management System in the Medical Microbiology Laboratory
- Creators
- Roberta B Carey - Centers for Disease Control and Prevention, Atlanta, Georgia, USA rbcmicrobio@gmail.comSanjib Bhattacharyya - City of Milwaukee Health Department Laboratory, Milwaukee, Wisconsin, USASue C Kehl - Children's Hospital of Wisconsin, Milwaukee, Wisconsin, USALarissa M Matukas - Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, CanadaMichael A Pentella - Department of Epidemiology, University of Iowa, Iowa City, Iowa, USAMax Salfinger - National Jewish Health, Denver, Colorado, USAAudrey N Schuetz - Division of Clinical Microbiology, Mayo Clinic, Rochester, Minnesota, USA
- Resource Type
- Journal article
- Publication Details
- Clinical microbiology reviews, Vol.31(3), 10.1128/CMR.00062-17
- DOI
- 10.1128/CMR.00062-17
- PMID
- 29720490
- PMCID
- PMC6056841
- ISSN
- 0893-8512
- eISSN
- 1098-6618
- Language
- English
- Date published
- 07/2018
- Academic Unit
- Central Control Hygienic Laboratory; Epidemiology
- Record Identifier
- 9984214818102771
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