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Appendix A: Prerequisites
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,
Prerequisites
See Appendix A (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. In developing patient-safety strategies, governments should take a proactive, preventive and systematic attitude: to admit that errors happen, to identify and manage risk points in processes, to learn from errors and minimise their effects, to prevent further occurrences of patient-safety incidents and to encourage both patients and health-care personnel to report those patient-safety incidents they are confronted with. This could be achieved by proactive management and systematic design of safe structures and processes.
2. Patient safety should be recognised as the necessary foundation of quality health care, and should be based
on a preventive attitude and systematic analysis and feedback from different reporting systems: patients’ reports, complaints and claims as well as systematic reporting of incidents, including complications, by health-care personnel. The patient-safety strategy should become an integral component of the overall continuing quality-improvement programme (Recommendation No. R (97) 17 (here) on the development and implementation of quality improvement systems (QIS) in health care). Investment in patient safety, as in quality improvement, should be considered as economically sound and good value for money.
3. A system-based approach presupposes the systematic design of safe structures, procedures and processes, together with corrective reactions in response to safety incidents. It is accepted that errors are a consequence of normal human fallibility and/or deficiencies of the system; these could be prevented by improving the conditions in which humans work. The aim is a system designed with built-in defences.
4. Patient-safety programmes should use the same language, consistent terminology and be focused around similar concepts. “Patient-safety incident” is understood as any unintended and/or unexpected incident that could have led, or did lead, to harm for one or more patients receiving healthcare. In this document it is covered by various expressions, including “adverse event”, “medical/clinical error” and “near miss”.
5. Patient safety is dependent on many factors, including: an adequate level of resources; sufficient financing; an appropriate number of well-trained staff; appropriate buildings; use of high-quality material, technical equipment and medicines; the establishment of standard diagnostic and therapeutic procedures (clinical practice guidelines); a clear division of tasks and responsibilities; appropriate and smooth connections between processes; proper infor-
mation systems; accurate documentation and good communication between health-care professionals and teams, patients and informal caregivers. The creation of suitable working conditions and atmosphere through: correct work organisation, the reduction of stress and tension; the provision of good, safe, social and health conditions for health-service workers; and increased motivation reduces the role of the “human-factor” issues in patient-safety incidents. It includes prevention of causes contributing to (near) incidents and errors, such as: time-pressure on health-care providers (leading to insufficient time to communicate properly among professionals and with patients and other informal caregivers); frequent “handing over” of patients from one health-care professional to another (which leads to poor communication and errors related to poor transfer of information); shortage of staff; pressure on health-care professionals to quickly discharge a patient from hospital; intrusion of commercial elements in health care and side-effects of competing commercial insurance companies.
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