External assessment and peer review of healthcare in Europe

1. External assessment and peer review of healthcare in Europe Dr Charles Shaw EPSO Paris

2. Established external assessments National EFQM awards Licensing, inspection Accreditation • Service • Teaching Peer review, visitatie International WHO: HPH, BFH JCI hospital accreditation ISO certification • 9000 series: q systems • 15189: medical laboratories EPSO Paris

3. Convergent systems Several programmes blend key features eg • Some mandatory accreditation as a tool for regulation • Some regulators described as agencies for medical audit • Some accreditation standards are assessed by certification bodies EPSO Paris

4. Debatable comparisons EPSO Paris

5. Regulation Accreditation Unsafe Competent Excellent Number of institutions Standards compliance EPSO Paris

6. The Production Model of Quality Structure - Process - Outcome EPSO Paris

7. New accreditation1989-2006 Europe EPSO Paris

8. Healthcare accreditation, Europe summary • No national programme • Austria*, Belgium*, Greece, Norway, Slovenia, Sweden • New programme since 2004 • Albania, Croatia, Serbia • Programmes inactive • Hungary, Ireland, Lithuania, Portugal, Latvia, Slovakia EPSO Paris

9. Full hospital surveys1999-2008 EPSO Paris

10. Accreditation: hospital uptake EPSO Paris

11. Public sector licensing, Europe 2008 EPSO Paris

12. Characteristics of External Assessment Agencies • Governance: relation to health ministries, stakeholder representation, funding • Incentives: carrots, sticks • Operations: standards, measurement, skills • Impact: costs, benefits, information • Evaluation: audit, research, peer review, supervision EPSO Paris

13. Standards, criteria for assessment • Accreditation: developed and maintained by the accreditation organisation; ISQua “principles” widely used in the design and international recognition of standards • Certification: developed by national standards institutes, CEN and ISO; interpretations of ISO 9001 for healthcare developed by Swedish SIS and some certification bodies eg DNV, CHKS • Regulation: based on legislation at local, regional or national level according to the responsibilities of government EPSO Paris

14. 15 European supervisory organisations - focus on patient safety EPSO Paris

15. SANITAS project - principal sources on hospital safety • Council of Europe • WHO: EURO, Observatory, HQ • EU guidance: • Legislation, Directives • Parliament, council, directorates • EC research: • proposals, reports, publications • Secondary: NGOs, national agencies EPSO Paris

16. SANITAS chapter headings EPSO Paris

17. External assessment methods • Accreditation: self-assessment, scheduled on-site “surveys”, patient survey, statistical monitoring • Certification: audit of compliance by accredited auditors per ISO 10011 guidelines for auditing quality systems • Supervisory bodies: periodic inspection, unannounced visits, ad hoc investigation. Many now use statistical reports, other assessment programmes to identify priority concerns – “proportionate regulation”. EPSO Paris

18. Hospital accreditation assessment procedures, Europe 2009 (percent) EPSO Paris

19. External assessor competences • Accreditation: Standards for “surveyor” training defined by ISQua; some programmes (eg NIAZ, HAS) thus accredited in Europe • Certification: “Auditors” of compliance with ISO standards are trained and registered according to ISO standards • Regulation: “Inspectors”… EPSO Paris

20. Surveyor days, hospital 2008 EPSO Paris

21. Are accreditation results of named HCOs freely accessible to public? EPSO Paris

22. Accreditation information on a free public website? N=40 EPSO Paris

23. Comparing hospital assessment EPSO Paris

24. Shared challenges • Validity, continuity of criteria and standards • Reliability, consistency of assessment methods • Common data, definitions, indicators • Duplication, gaps, conflicts between approaches • Changing the healthcare system • Micro • Meso • Macro EPSO Paris

25. Assessing the assessors 1 • Accreditation organisations in Europe may choose to be independently assessed and accredited by the International Society for Quality in Healthcare (ISQua) EPSO Paris

26. Assessing the assessors 2 • Certification bodies are assessed by the national ISO accreditation body (NAB) according to ISO /IEC 17020 • NABs themselves are peer reviewed to the standard ISO/IEC 17011 to maintain their status within the European and international mutual recognition arrangements of the European Partnership for Accreditation (EA) EPSO Paris

27. Assessing the assessors 3 • Regulators are subject to government financial audit • Members of EPSO developing a system of voluntary peer review • HAS is accredited by ISQua; Lithuanian State Medical Audit Inspectorate is certificated under ISO 9001 EPSO Paris

28. Current European activities in quality and safety • EC Patient Safety and Quality WG • Joint Action patient safety and quality • EC DUQuE research project • EPSO peer review pilot • ISQua conference, Geneva, October 21-24 • European Accreditation Network, Sheffield Sept 24, 25 EPSO Paris

29. Relevant Euro guidance • Council of EU. Recommendation on patient safety 2009/C 151/01 • EC Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare • EC Regulation 765/2008 “requirements for accreditation and market surveillance” • EC “strategic vision for European standards” COM(2011) 311 • Council of Europe. Recommendation Rec(2006)7 on Patient Safety EPSO Paris

30. Proposals for Europe • CEN and EA should engage with healthcare accreditation organisations and regulators • Standards bodies should, with professions and NGOs, ensure standards are based on evidence • External assessment organisations should themselves be subject to external assessment • EC regulation of health services should recognise the role of professional bodies and peer review • EC support research into the comparative effectiveness of external assessment methods EPSO Paris