external assessment and peer review of healthcare in europe dr charles shaw april 2012epso paris1

External assessment and peer review of healthcare in Europe

Dr Charles Shaw

April 2012 EPSO Paris 1

Established external assessments

NationalEFQM awardsLicensing, inspectionAccreditation- Service- TeachingPeer review, visitatie

InternationalWHO: HPH, BFHJCI hospital accreditationISO certification- 9000 series: q systems- 15189: medical

laboratories


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


Debatable comparisonsInspection Certification Accreditation

Requirements + ++ +++

Aim Compliance Recognition Development

Facilitation - - +++

Self-assessment

- - +++

Assessors Staff Staff Peers

Engagement - +/- +


Standards compliance

Regulation AccreditationUnsafe Competent Excellent

4

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April 2012 EPSO Paris

The Production Model of Quality

Structure - Process - Outcome

6April 2012 EPSO Paris

New accreditation1989-2006 Europe


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

Full hospital surveys1999-2008


Accreditation: hospital uptake


Public sector licensing, Europe 2008


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


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


15 European supervisory organisations - focus on patient safety


Area of patient safety Number

Infection control 14

Work force (staff levels and/or qualifications) 13

Medicine Management 12

Safety and suitability of premises 10

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”

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


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


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”.


Hospital accreditation assessment procedures, Europe 2009 (percent)


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”…


Surveyor days, hospital 2008


Are accreditation results of named HCOs freely accessible to public?


Accreditation information on a free public website? N=40


Comparing hospital assessment


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


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)



• 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)



• 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


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


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

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

external assessment and peer review of healthcare in europe dr charles shaw april 2012epso paris1

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