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Session 1: Lessons learned from ECDC External
Quality Assessment (EQA) review 2010-15
15th National Microbiology Focal Poi...
1
External Quality Assessment (EQA) or
proficiency testing
• is a system designed to objectively assess the quality of tes...
2
ECDC EQA
• ECDC focuses on appraising proficiency with
microbiological test methods that underpin public health
capabili...
3
ECDC EQA cont’
• ECDC EQAs are an integral part of a quality improvement
cycle and capability strengthening process that...
4
EQA scheme per DP, by network and by
pathogen, by area covered 2010-2015
*D: detection (culture, molecular or serologica...
5
• EU-added value of ECDC EQAs
– The primary effect of EQAs is helping laboratories in obtaining (inter)national
accredit...
6
Lessons learnt 2010- 2015 cont’
• Frequency, composition of test material and types of
EQA scheme
– Since 2014, there ha...
7
Lessons learnt 2010- 2015 cont’
• Member States’ coverage and laboratory
participation
– Participation has been increasi...
8
Lessons learnt 2010- 2015 cont’
• Laboratories/ Member States’ proficiency level
– Individual proficiency reports are sh...
9
Lessons learnt 2010- 2015 cont’
• One of the overarching goals of ECDC EQAs is to verify the
quality and comparability o...
10
Lessons learnt 2010- 2015 cont’
• ECDC would like to open the discussion with the NMFPs on
how could Member States be e...
11
Lessons learnt 2010- 2015 cont’
Benefits for ECDC Disease Networks and the European
laboratory-based surveillance
– Imp...
12
Lessons learnt 2010- 2015 cont’
Benefits for the public health microbiology laboratories
in the EU/EEA Member States
– ...
13
Lessons learnt 2010- 2015 cont’
Benefits for the public health microbiology laboratories
in the EU/EEA Member States
– ...
14
Thank you for listening,
ECDC.Microbiology@ecdc.europa.eu
All ECDC presentations will be available on SlideShare:
http:...
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Lessons learned from ecdc eqa review 2010-2015

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

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Lessons learned from ecdc eqa review 2010-2015

  1. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 15. 14 Thank you for listening, ECDC.Microbiology@ecdc.europa.eu All ECDC presentations will be available on SlideShare: http://www.slideshare.net/tag/15NMFP2016 http://ecdc.europa.eu/en/healthtopics/microbiology/Pages/microbiology.aspx

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