Introduction of quality management in a National Reference Laboratory in Germany

Susanne Homolka,Heidi Albert,Katharina Kranzer,Anne-Kathrin Witt,Julia Zallet

doi:10.1371/journal.pone.0222925

Abstract

BackgroundHigh 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 findingsUsing 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).ConclusionThis 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.

Highlights

Introduction of quality management in aNational Reference Laboratory in GermanySusanne HomolkaID1,2☯*, Julia Zallet1,2☯, Heidi AlbertID3, Anne-Kathrin Witt1, Katharina Kranzer1,4 Abstract
Using a multipronged approach reviews of facilities, equipment, processes, 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
Actions aimed at improving analytical quality, health and safety and information management were prioritised for initial implementation in parallel with each other

Summary

Introduction

Introduction of quality management in aNational Reference Laboratory in GermanySusanne HomolkaID1,2☯*, Julia Zallet1,2☯, Heidi AlbertID3, Anne-Kathrin Witt, Katharina Kranzer Abstract. High-quality laboratory services are an essential component for tuberculosis care and control. [1] New diagnostic methods and increasing awareness about medical errors and their consequences emphasizes the great importance of quality in health.[2] A strong laboratory quality management system (QMS) is critical to ensuring the quality of testing. Laboratory quality management is generally accepted as state of the art practise and is legally prescribed in many countries such as Germany and the USA.[7, 8] Integral parts of a QMS, often implemented in the early stages of an improvement initiative, include quality control (QC), external quality assessment (EQA), standard operating procedures (SOP) and competency assessment (CA). Several studies have shown that QMS implementation results in a measurable improvement in the quality of services and increased patient safety due to a reduction in laboratory errors.[4, 9,10,11]. Editor: Adriano Gianmaria Duse, School of Pathology, National Health Laboratory Service (NHLS) and University of the Witwatersrand, South Africa, SOUTH AFRICA

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