Presentation of the 15th NMFP meeting, held on 13-14 October 2016 in Stockholm

1. 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

2. 1
External Quality Assessment (EQA) or
proficiency testing
• is a system designed to objectively assess the quality of test
results obtained by a laboratory by means of an external
agency (i.e., EQA provider).
• allows for comparison of the performance of a laboratory’s
testing to an outside source of a peer group of laboratories
or to the performance of a reference laboratory.
Participation to EQA is a fundamental aspect of laboratory
quality management.

3. 2
ECDC EQA
• ECDC focuses on appraising proficiency with
microbiological test methods that underpin public health
capabilities for:
– Disease surveillance reporting to The European
Surveillance System (TESSy) according to EU case
definitions;
– Outbreak detection, investigation and response;
– Communicable disease control.

4. 3
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 public
health microbiology laboratories in the EU/EEA countries to:
– Verify the quality and comparability of surveillance data
reported at European level;
– Ensure threat detection capability for emerging and
epidemic disease or drug resistance.

5. 4
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

6. 5
• 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

7. 6
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

8. 7
Lessons learnt 2010- 2015 cont’
• 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

9. 8
Lessons learnt 2010- 2015 cont’
• 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.

10. 9
Lessons learnt 2010- 2015 cont’
• 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.

11. 10
Lessons learnt 2010- 2015 cont’
• 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?

12. 11
Lessons learnt 2010- 2015 cont’
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)

13. 12
Lessons learnt 2010- 2015 cont’
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;
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)

14. 13
Lessons learnt 2010- 2015 cont’
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.
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)

15. 14
Thank you for listening,
ECDC.Microbiology@ecdc.europa.eu
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