AMR monitoring project

7 April 2017Copenhagen

Javier TellecheaDirectorate F: Health and food audit and analysis

Directorate General Health & Food Safety European Commission

Background• Directive 2003/99/EC: Member States to obtain comparable

data on AMR, assess the trends and report.

• 2011:Commission Action Plan.Action No 10: strengthen surveillance on AMR

Decision 2013/652/EU Decision 2013/653/EU

Objectives of the project• Evaluate the implementation of harmonised AMR monitoring, as required by the Decision

• provide information to stakeholders • make recommendations to Member States• disseminate information on good practices • highlight difficulties • contribute to further development

Countries visited

• 2015 two pilots: DK and DE

• 2016 six : SK, AT, ES, HU, NL, RO

• 2017 proposed: BG, CH, IT, LT, MT, UK,

Audit itinerary: 7-10 days• Opening meeting (discussion of AMR monitoring organisation) • On the spot:

• Three slaughterhouses poultry/porcine/bovine• Two offices organising sampling at local level• Laboratories: AST and ESBL

• Closing meeting

Audit Scope

Sampling Design Retrospective samplingProspective sampling

Laboratory

Reporting

Good practices

Selection of Salmonella isolates - Obtained from randomised sampling design (SNCP and Reg.(EC) No 2073/2005 - Official and Own Checks)

• Selection of isolates from SNCP • Use of Salmonella isolates from own checks under Reg.

(EC) No 2073/2005 to achieve the required number R

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Retrospective sampling-Preliminary findings

Prospective sampling-slaughter-Preliminary findings

• Stratified, 60% of “domestic” animal population• Even distribution of samples over the year• Random selection dates, batches /EPiU• Nr samples - prevalence C. jejuni• Achieving the required samples – supervision

coordination with the lab

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• Sample allocation to NUTS 3 • Sampling allocation at local level to retail • Sampling collection /transport /48 h /Temp.• Packaged fresh meat - not based on origin• Convenience during official controls

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Prospective sampling–retail-Preliminary findings

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Laboratory-Preliminary findings

• MIC determination procedures- In line with ISO and CLSI standards- Time temperatures variations- Treatment of unusual/implausible combinations- Viable colony counts- Cut-off/breakdown points

Use of the reference strain!!!

• Every day that the test is performed• Use and documentation• Reduced use. Documented. CLSI M07-A10• Use of two reference strains? ISO, CLSI

Laboratory-Preliminary findings

• ESBL Protocol –- McConkey validation of shelf life- Controls- Steps to be followed

• Storage of isolates (-80◦C). Recovery

National experts

• In every audit• Technical support• We carry the weight• Evaluate documented procedures and its implementation• To highlight areas for improvement

Lab visit structure I

• NRL coordination role• Accreditation follow-up • Quality control issues identified and corrected• PTs• Procedures alignment with the standards. MIC, ESBL

Structure II

• We select some isolates reported. Traceability (including media and equipment calibration) and procedures followed.• Handling of unusual/implausible results

• NRL-AMR coordination role • PTs, results, actions taken if failures• Quality control system

- Incubation times- Sample traceability- Media, equipment including calibration- Sample acceptance criteria

Laboratory-Preliminary findings

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Reporting-Preliminary findings

• Traceability – records at slaughterhouse and Laboratory (Origin, repeated EPiU, laboratory results)

• Information included for each isolate• Overall description of the AMR monitoring

(sampling design, stratification, randomisation)

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Good practices-Preliminary findings

• Coordination/info sharing between authorities including labs

• One Health – coordination with other authorities• Do the MS use the info obtained - Trend analysis

(e.g. for approval of antimicrobials, setting targets)

• Voluntary testing, imports, vegetables, companion animals, etc.

• Genotyping

Challenges

• Coordination between laboratories – samplers• Transport conditions: 48 hrs sampling-testing • Collection of Salmonella isolates Reg. (EC) No

2073/2005• Adaptation to MIC determination

Questions?