1. External assessment and peer review of healthcare in Europe Dr Charles Shaw April 2012EPSO Paris1

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 April 2012EPSO Paris2

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 April 2012EPSO Paris3

4. Debatable comparisons InspectionCertificationAccreditation Requirements++++++ AimComplianceRecognitionDevelopment Facilitation--+++ Self- assessment --+++ AssessorsStaff Peers Engagement-+/-+ April 2012EPSO Paris4

5. Standards compliance Regulation Accreditation UnsafeCompetentExcellent 4 Number of institutions April 2012EPSO Paris

6. The Production Model of Quality Structure - Process - Outcome 6 April 2012EPSO Paris

7. New accreditation1989-2006 Europe April 2012EPSO Paris7

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 Paris8April 2012

9. Full hospital surveys1999-2008 April 2012EPSO Paris9

10. Accreditation: hospital uptake April 2012EPSO Paris10

11. Public sector licensing, Europe 2008 April 2012EPSO Paris11

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 April 2012EPSO Paris12

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 April 2012EPSO Paris13

14. 15 European supervisory organisations - focus on patient safety April 2012EPSO Paris14 Area of patient safetyNumber Infection control14 Work force (staff levels and/or qualifications)13 Medicine Management12 Safety and suitability of premises10 Reporting of adverse events (to national body)10 Clinical audits (i.e. inter-hospital comparisons of clinical activity and/or outcomes) 9 Sandra Eismann (CQC), 2011 “European Supervisory Bodies and Patient Safety”

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 April 2012EPSO Paris15

16. SANITAS chapter headings 1 Mission, Governance, Management 2 Patient Orientation 3 Workforce 4 Clinical practice and patient care 5 Hygiene and Infection 6 Human tissue and transfusion 7 Hospital facilities management 8 Medication 9 Surgery, Interventions, Anaesthesia 10 Records and Communication April 2012EPSO Paris16

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”. April 2012EPSO Paris17

18. Hospital accreditation assessment procedures, Europe 2009 (percent) April 2012EPSO Paris18

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”… April 2012EPSO Paris19

20. Surveyor days, hospital 2008 April 2012EPSO Paris20

21. Are accreditation results of named HCOs freely accessible to public? April 2012EPSO Paris21

22. Accreditation information on a free public website? N=40 April 2012EPSO Paris22

23. Comparing hospital assessment April 2012EPSO Paris23

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 April 2012EPSO Paris24

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) April 2012EPSO Paris25

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) April 2012EPSO Paris26

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 April 2012EPSO Paris27

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 April 2012EPSO Paris28

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 April 2012EPSO Paris29

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 April 2012EPSO Paris30