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Appendix C. Assessment of patient safety – The role of indicators
The Committee of Ministers, under the terms of Article 15.b of the Statute of the Council of Europe,
Considering that the aim of the Council of Europe is to achieve a greater unity between its members and that this aim may be pursued in particular by the adoption of common rules in the health field;
Considering that access to safe health care is the basic right of every citizen in all member states;
Recognising that although error is inherent in all fields of human activity, it is however possible to learn from mistakes and to prevent their reoccurrence and that health-care providers and organisations that have achieved a high level of safety have the capacity to acknowledge errors and learn from them;
Considering that patients should participate in decisions about their health care, and recognising that those working in health-care systems should provide them with adequate and clear information about potential risks and their consequences, in order to obtain their informed consent to treatment;
Recalling that Article 2 of the Council of Europe’s Convention on Human Rights and Biomedicine (ETS No. 164) establishes the primacy of the human being over the sole interest of society or science, and recalling its Article 3 on the equitable access to health care of appropriate quality;
Considering that the methodology for the development and implementation of patient-safety policies crosses national boundaries and that their evaluation requires substantial resources and expertise and should be shared;
Recalling its Recommendations Nos. R (97) 5 on the protection of medical data, R (97) 17 on the development and implementation of quality improvement systems (QIS) in health care, and R (2000) 5 on the development of structures for citizen and patient participation in the decision-making process affecting health care, and its Resolution ResAP(2001)2 concerning the pharmacist’s role in the framework of health security, which explicitly suggests working in partnership with other health professionals;
Noting the relevance of the World Health Organisation (WHO) “Health for All” targets for the European Region (target 2) and of its policy documents on improving health and quality of life and having regard to its Health Assembly Resolution 55.18 (2002) on “Quality of care: patient safety”, which recognises the need to promote patient safety as a fundamental principle of all health systems;
Considering that patient safety is the underpinning philosophy of quality improvement and that all possible measures should therefore be taken to organise and promote patient-safety education and quality of health-care education;
Considering that the same principles of patient safety apply equally to primary, secondary and tertiary care and to all health professions as well as to health promotion, prevention, diagnosis, treatment, rehabilitation, and other aspects of health care;
Recognising the need to promote open co-ordination of national and international regulations concerning research on patient safety,
Assessment of patient safety – The role of indicators
See Appendix C (pdf-file) of Recommendation Rec(2006)7 of the Council of Europe
NOTE: text markers added to increase readability (not applied in the original).
1. There is a major need to assess patient safety on an ongoing basis, implement a learning organisation, demonstrate ongoing safety improvement and determine when lapses in patient safety occur.
2. Systematic collection and analysis of patient-safety indicators should help prevent future “unsafe” methods of care and, in the long term, their adverse effect on treatment.
3. Patient safety is an outcome of many factors, especially safe practices within the framework of a safe system. While patient safety is the ultimate goal, belonging to “good outcomes”, what ultimately determines safety is a safer care environment during the patients’ whole “journey of care”.
4. Prior to embarking on actual patient-safety assessment activities, a systematic strategy should be established at an institutional or regional level to measure, report, and use information about the most common services associated with a high probability of error.
5. The assessment of process safety should be carried out through both qualitative and quantitative methods.
6. The qualitative methods map the various activities that exist in the routine delivery of services, for example using methods used in pathways analysis without, however, recommending one pathway as more appropriate than another. The purpose of the descriptive phase is to “map the genome of safety” in the delivery of care and services.
7. The quantitative approach uses indicators and epidemiological methods of analysis to systematically quantify distinct aspects of processes and their immediate outputs in relation to:
- adverse events;
- adverse events causing harm to patients;
- adverse events causing harm to providers; and
- for the risk of adverse events.
8. The Organisation for Economic Co-operation and Development (OECD) produced a report on patient-safety indicators in 2004 that would best allow the assessment of patient safety in an ongoing way, given current available knowledge. A total of 21 patient-safety indicators were selected (OECD health technical paper (DELSA/ELSA/
WD/HTP(2004)18)), which address hospital patient-safety incidents and include only measures that focus on specific clinical outcomes. Another approach is to use indicators that apply at an organisational level, for example whether a hospital or practice uses electronic prescribing, or has implemented practices that have been shown to reduce the rate of ventilator-associated pneumonia.
9. Quality and safety indicators should be determined and reasonably applied to the entire treatment process (both outpatient and hospital treatment).
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