Concepts of quality in healthcare
Dr Charles Shaw
Ides of March 2016
Quality concepts BCS
1
Defining quality dimensions & measures
OECD Health Care Quality Indicator Project
• Effectiveness: achieving desirable outcomes
– appropriateness, competence, capability and economy
• Safety: avoiding, preventing, and ameliorating adverse
outcomes or injuries due to health care
• Responsiveness: meeting legitimate expectations
– patient-centeredness, acceptability, continuity, timeliness
Edward Kelley, Jeremy Hurst. Health care quality indicators project conceptual framework paper OECD
http://www.oecd.org/els/health-systems/36262363.pdf
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Quality concepts BCS
2
The Production Model of Quality
Avedis Donabedian, Henry Ford
Structure - Process - Outcome
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Quality concepts BCS
3
Cycle of improvement
Standards
“requirements”
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Assessment
“audit”
Change management
improvement
Quality concepts BCS
4
Words and trends
1980s
Q control, Q assurance
Customer service, patient satisfaction
Health economics, efficiency, value for money
1990s
Q improvement, total quality management
Effectiveness, evidence based medicine, clinical audit
Performance management
Patient safety, risk management
Clinical governance
2000s
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Quality concepts BCS
5
Clinical evaluation in Europe
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Clinical registries eg Denmark
Specialist peer review eg Netherlands
Confidential enquiries eg UK
Clinical benchmarking eg Germany
Medical, clinical audit eg France
Reference networks eg EU
Quality concepts BCS
6
External assessment in Europe
EC ExPeRT project 1996-9
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(Healthcare) accreditation
EFQM: “business excellence”
ISO certification
Visitatie
Regulatory inspection
Quality concepts BCS
7
Accreditation organisations, HC global
1951
1953
1955
1957
1959
1961
1963
1965
1967
1969
1971
1973
1975
1977
1979
1981
1983
1985
1987
1989
1991
1993
1995
1997
1999
2001
2003
2005
2008
50
45
40
35
30
25
20
15
10
5
0
1951-2009
Independent
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Mixed
Quality concepts BCS
Government
8
Certification of HCOs to harmonised standards
• National, European or international standards bodies define
requirements; compliance assessed by multiple bodies
recognised by accreditation bodies (NABs, EA etc)
• Many key words have different meanings in context eg
accreditation, standard, requirement, sub-process
• Focus on systems, departments > continuum of care, hospitals,
networks
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Quality concepts BCS
9
Number of institutions
Regulation
Accreditation
Unsafe Competent
Excellent
Standards compliance
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Quality concepts BCS
QA to QI – expectations of clinical services
> process requirements
• Expand domains to include service planning, governance,
health literacy, training, research, improvement, evaluation
• Identify markers of optimal performance and impact
• Review structure, content of clinical service peer review and
accreditation standards beyond cancer, Europe
– principles for healthcare standards development. ISQua v4
– draft “Public Access Specification” PAS 1616 for provision of clinical
services. BSI, HQIP 2016
– IGO guidance eg patient safety (WHO), medications (CoE), European
reference networks (EU)
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Quality concepts BCS
11
QA to QI – assessing breast cancer services
> reference documents
• Criteria reflect evidence of (proxy) outcomes
• Compliance with criteria can be quantified or graded to show
improvement potential and achievement
• Resulting scores can be weighted and aggregated, with
thresholds to determine awards
• Documentary evidence includes personnel files, clinical
records, internal reports, minutes of governing body etc
• Other sources: observation, interviews, data reporting
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Quality concepts BCS
12
QA to QI - Essentials for improvement
Guidance documents available to BCS
Preliminary self-assessment – interactive, online
Team feedback on-site – no surprises
Analytical, timely written report with (re)commendations
Graded awards to discriminate between compliance and
excellence
• Regular sharing of problems and solutions among BCS
• Comparative benchmarking of performance indicators
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Quality concepts BCS
13
Accreditation of assessment bodies
> ISO 17065
• ISQua standards for external assessment organisations
• Government criteria for franchising assessment organisations
– Australian Commission on Patient Safety, federal
– New Zealand Ministry of Health compliance Health and Disability Act
– Care Quality Commission, England “Requirements and Guidance for
the Accreditation of Certification Bodies providing Clinical Service
Certification schemes” v1.13 UKAS February 2016 (ISO 17065)
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Quality concepts BCS
14
QA of the quality system
• BCS evaluate the QA scheme, assessment team – feedback
recorded centrally
• BCS offered appeal against decisions, independent review
• Raw datasets, performance indicators and reports from each
BCS recorded centrally
• Central monitoring of compliance scoring, CAB workload and
consistency, cross-border variation
• Evaluation and revision of requirements, criteria, scoring,
assessment and report writing
• Transparency, public reporting locally, NCPs, centrally
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Quality concepts BCS
15
Estimates of QASDG effort and deliverables
• Requirements of BCS: expanded structure, detail, scoring
– PAS1616 57pp; ISQua principles eg 44pp; Eusoma 31pp
– ?30 pages x 6 modules = 180 page manual
• Performance indicators: definitions, data quality, sharing
– WHO PATH working group and European network group; OECD quality metrics
• Pilot testing, feedback, evaluation, revisions
– ?15 BCS in 5 countries; training, logistics and costs eg EC DUQuE
• Requirements of assessor organisation and training
– ISQua 64+7pp, ISO 17065
• Software development, platform for guidance, evidence, database
– online (self-)assessment, benchmarking, learning, QA of quality system
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Quality concepts BCS
16
Conclusions
• Improvement and learning is more complex than QA
– In development phase
– In operational phase
• Sustainability of both systems depends on
– Credibility and market uptake
– Perceived benefits – commercial, developmental, regulatory
– User costs - compliance and assessment, “surveyor days”
– System costs – central coordination and maintenance
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Quality concepts BCS
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