lessons learned from ecdc eqa review 2010-2015

Session 1: Lessons learned from ECDC External Quality Assessment (EQA) review 2010-15

15th National Microbiology Focal Points meeting

Barbara Albiger, Expert Microbiology, Office of the Chief Scientist

European Centre for Disease Prevention and Control

Joint NSFP/NMFP session, Stockholm, 13 October 2016

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External Quality Assessment (EQA) or proficiency testing

• is a system designed to objectively assess the quality of testresults obtained by a laboratory by means of an externalagency (i.e., EQA provider).

• allows for comparison of the performance of a laboratory’stesting to an outside source of a peer group of laboratoriesor to the performance of a reference laboratory.

Participation to EQA is a fundamental aspect of laboratoryquality management.

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ECDC EQA

• ECDC focuses on appraising proficiency withmicrobiological test methods that underpin public healthcapabilities for:

– Disease surveillance reporting to The EuropeanSurveillance System (TESSy) according to EU casedefinitions;

– Outbreak detection, investigation and response;

– Communicable disease control.

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ECDC EQA cont’

• ECDC EQAs are an integral part of a quality improvement cycle and capability strengthening process that is collectively developed within ECDC Disease Networks and include technical training and capacity building activities.

• ECDC commissions and supports EQA exercises across publichealth microbiology laboratories in the EU/EEA countries to:

– Verify the quality and comparability of surveillance datareported at European level;

– Ensure threat detection capability for emerging andepidemic disease or drug resistance.

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EQA scheme per DP, by network and by pathogen, by area covered 2010-2015

*D: detection (culture, molecular or serological) and/or identification; T: typing; V: Virulence/resistance determinants screening; A: Antimicrobial susceptibility testing; I: Interpretation and analysis

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• EU-added value of ECDC EQAs

– The primary effect of EQAs is helping laboratories in obtaining (inter)national accreditation by 75% of the respondents.

– More than half of respondents were able to detect capacity gaps they were not aware before, thanks to EQAs, and have by consequence adopted measures to strengthen their capacities in these areas.

Lessons learnt 2010- 2015

Source: The second independent evaluation of the ECDC in accordance with its Founding Regulation (European Parliament and Council Regulation (EC) no 851/2004. FINAL REPORT October 2014, PAGE 89

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Lessons learnt 2010- 2015 cont’

• Frequency, composition of test material and types of EQA scheme

– Since 2014, there has been a clear decrease in the number of ECDC EQAs schemes/rounds performed each year;

– Some EQA providers have indicated that current funds do not cover all the costs related to the work:

some have reduced the number of services offered as well as the number of biological samples tested in each EQA distribution;

– Priority criteria need to be defined

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• Member States’ coverage and laboratory participation

– Participation has been increasing over time, but not reaching yet full EU/EEA coverage;

– Although voluntary, the Member States/laboratories participation should be incentivised and the reason for non-participation should be understood.

Laboratories reporting to TESSy

Laboratories participating in EQA

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• Laboratories/ Member States’ proficiency level

– Individual proficiency reports are shared with participating laboratories, very seldom with ECDC;

– The anonymity of the results is valued by laboratories who participate on a voluntary basis to ECDC EQAs to protect the legitimate interests and reputation of individual laboratory.

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• One of the overarching goals of ECDC EQAs is to verify the quality and comparability of surveillance data reported at European level.

• Due to the conventional approach to confidential feedback of results at laboratory and country level, incomplete and voluntary EQA participation for laboratories reporting to TESSy:

– The proficiency level could not been used in interpreting the quality of data reported to TESSy at country level;

– The impact of EQA participation on surveillance data quality has not been monitored nor evaluated.

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• ECDC would like to open the discussion with the NMFPs on how could Member States be encouraged to share their individual EQA results with ECDC for better linkage:

– to the assessment of surveillance quality;

– to capacity building, e.g., possibility to provide more objective performance assessment within EULabCap NRL capability indicators not only for EQA participation but also for proficiency

How can we achieve this without compromising the reputation and the interest of individual laboratories?

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Benefits for ECDC Disease Networks and the European laboratory-based surveillance

– Improvement of surveillance data quality and accuracy;

– Harmonisation of microbiological testing methods;

– Increasing adherence to EU case definitions for reporting to TESSy;

– Establishment and maintenance of capacity for emerging and/or rare diseases;

– Increasing the good reputation of and interest in the ECDC Disease Networks outside the EU/EEA;

– Improvement of the EU level laboratory capacities for surveillance, prevention and control of infectious diseases.

Source: ECDC internal review and Study on cost-benefit analysis of reference laboratories for human pathogens (European Commission: Consumers, Health, Agriculture and Food Executive Agency Health Unit)

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Benefits for the public health microbiology laboratories in the EU/EEA Member States

– Identification of technical issues and improvement of the laboratory quality by corrective actions;

– Documentation of proficiency testing for the laboratory national accreditation credentials;

– Accessibility to the service (where no alternative scheme exists or participation in a commercial EQA is not affordable);

– Improvements and harmonisation of the methods in use, allowing comparability intra- and inter-laboratories;


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Benefits for the public health microbiology laboratories in the EU/EEA Member States

– Support to introduction of new technologies and methods;

– Staff skills development and expertise;

– Increasing sharing information and collaboration between laboratories and between Member States;

– Increasing Member States laboratory preparedness and surge capacity for coordinated response to outbreaks and laboratory capacities for surveillance, prevention and control of infectious diseases.


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Thank you for listening,

[email protected]

All ECDC presentations will be available on SlideShare: http://www.slideshare.net/tag/15NMFP2016

http://ecdc.europa.eu/en/healthtopics/microbiology/Pages/microbiology.aspx

lessons learned from ecdc eqa review 2010-2015

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