External assessment and peer review of healthcare in Europe
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External assessment and peer review of healthcare in Europe
Dr Charles Shaw
April 2012 EPSO Paris 1
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Established external assessments
NationalEFQM awardsLicensing, inspectionAccreditation- Service- TeachingPeer review, visitatie
InternationalWHO: HPH, BFHJCI hospital accreditationISO certification- 9000 series: q systems- 15189: medical
laboratories
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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
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Debatable comparisonsInspection Certification Accreditation
Requirements + ++ +++
Aim Compliance Recognition Development
Facilitation - - +++
Self-assessment
- - +++
Assessors Staff Staff Peers
Engagement - +/- +
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Standards compliance
Regulation AccreditationUnsafe Competent Excellent
4
Num
ber o
f ins
tituti
ons
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The Production Model of Quality
Structure - Process - Outcome
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New accreditation1989-2006 Europe
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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 8April 2012
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Full hospital surveys1999-2008
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Accreditation: hospital uptake
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Public sector licensing, Europe 2008
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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
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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
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15 European supervisory organisations - focus on patient safety
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Area of patient safety Number
Infection control 14Work force (staff levels and/or qualifications) 13Medicine Management 12Safety and suitability of premises 10Reporting 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”
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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
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SANITAS chapter headings1 Mission, Governance, Management 2 Patient Orientation3 Workforce4 Clinical practice and patient care5 Hygiene and Infection6 Human tissue and transfusion7 Hospital facilities management8 Medication9 Surgery, Interventions, Anaesthesia10 Records and Communication
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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”.
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Hospital accreditation assessment procedures, Europe 2009 (percent)
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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”…
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Surveyor days, hospital 2008
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Are accreditation results of named HCOs freely accessible to public?
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Accreditation information on a free public website? N=40
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Comparing hospital assessment
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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
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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)
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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)
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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
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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
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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 SafetyApril 2012 EPSO Paris 29
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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 methodsApril 2012 EPSO Paris 30