Introduction of quality management in a National Reference Laboratory in Germany

Autoři: Susanne Homolka aff001;  Julia Zallet aff001;  Heidi Albert aff003;  Anne-Kathrin Witt aff001;  Katharina Kranzer aff001
Působiště autorů: National Reference Laboratory for Mycobacteria, Research Center Borstel, Borstel, Germany aff001;  Molecular and Experimental Mycobacteriology, Research Center Borstel, Borstel, Germany aff002;  Foundation for Innovative New Diagnostics (FIND) South Africa, Cape Town, South Africa aff003;  Clinical Research Department, London School of Hygiene and Tropical Medicine, London, England, United Kingdom aff004
Vyšlo v časopise: PLoS ONE 14(10)
Kategorie: Research Article



High quality diagnostic services are crucial for tuberculosis (TB) diagnosis, treatment and control. A strong laboratory quality management system (QMS) is critical to ensuring the quality of testing and results. Recent initiatives to improve TB laboratory quality have focused on low and middle-income countries, but similar issues also apply to high-income countries.

Methods and findings

Using a multipronged approach reviews of facilities, equipment, processes (purchasing, pre-analytic, analytic and post-analytic), staff, health and safety, documentation, information management and organization based on the ISO 15189 and the twelve quality system essentials were conducted between October 2015 and January 2016 at the National TB Reference Laboratory in Germany. Outcome assessment included proportion of smear positive slides, proportion of contaminated liquid cultures and DNA contamination rates before and after implementation of QMS. The odds ratio for these outcomes was calculated using a before/after comparison. Reviews highlighted deficiencies across all twelve quality system essentials and were addressed in order of priority and urgency. Actions aimed at improving analytical quality, health and safety and information management were prioritised for initial implementation in parallel with each other. The odds ratio for a sample to be tested as microscopically positive increased by 2.08 (95%CI 1.41–3.06) comparing the time before with the time after implementation of quality managed fluorescence microscopy. Liquid culture contamination rates decreased from 23.6- 7.6% in April-July 2016 to <10% in November 2017-March 2018. The proportion of negative controls showing evidence of DNA contamination decreased from 38.2% in 2013 to 8.1% in 2017, the corresponding odds ratio was 0.14 (95%CI 0.07–0.29).


This study showed marked improvement on quality indicators after implementation of a QMS in a National TB Reference Laboratory. The challenges and lessons learned in this study are valuable not just for high-income settings, but are equally generalizable to other laboratories.

Klíčová slova:

Biological laboratories – Clinical laboratory sciences – Equipment – Government laboratories – Research laboratories – Company laboratories – Safety equipment – Fire safety


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2019 Číslo 10
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