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WP3 Text of Recommendation
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,
Text
See Text (pdf-file) of Recommendation Rec(2006)7 of the Council of Europe
NOTE: text markers added to increase readability (not applied in the original).
Recommends that governments of member states, according to their competencies:
i. ensure that patient safety is the cornerstone of all relevant health policies, in particular policies to improve quality;
ii. develop a coherent and comprehensive patient-safety policy framework, which:
a. promotes a culture of safety at all levels of health care;
b. takes a proactive and preventive approach in designing health systems for patient safety;
c. makes patient safety a leadership and management priority;
d. emphasises the importance of learning from patient-safety incidents;
iii. promote the development of a reporting system for patient-safety incidents in order to enhance patient safety by learning from such incidents; this system should:
a. be non-punitive and fair in purpose;
b. be independent of other regulatory processes;
c. be designed in such a way as to encourage health-care providers and health-care personnel to report safety incidents (for instance, wherever possible, reporting should be voluntary, anonymous and confidential);
d. set out a system for collecting and analysing reports of adverse events locally and, when the need arises, aggregated at a regional or national level, with the aim of improving patient safety; for this purpose, resources must be specifically allocated;
e. involve both private and public sectors;
f. facilitate the involvement of patients, their relatives and all other informal caregivers in all aspects of activities relating to patient safety, including reporting of patient-safety incidents;
iv. review the role of other existing data sources, such as patient complaints and compensation systems, clinical databases and monitoring systems as a complementary source of information on patient safety;
v. promote the development of educational programmes for all relevant health-care personnel, including managers, to improve the understanding of clinical decision making, safety, risk management and appropriate approaches in the case of a patient-safety incident;
vi. develop reliable and valid indicators of patient safety for various health-care settings that can be used to identify safety problems, evaluate the effectiveness of interventions aimed at improving safety, and facilitate international comparisons;
vii. co-operate internationally to build a platform for the mutual exchange of experience and knowledge of all aspects of health-care safety, including:
a. the proactive design of safe health-care systems;
b. the reporting of patient-safety incidents, and learning from the incidents and from the reporting;
c. methods to standardise health-care processes;
d. methods of risk identification and management;
e. the development of standardised patient-safety indicators;
f. the development of a standard nomenclature/taxonomy for patient safety and safety of care processes;
g. methods of involving patients and caregivers in order to improve safety;
h. the content of training programmes and methods to implement a safety culture to influence people’s attitudes (both patients and personnel);
viii. promote research on patient safety;
ix. produce regular reports on actions taken nationally to improve patient safety;
x. to this end, whenever feasible, carry out the measures presented in the appendix to this recommendation;
xi. translate this document and develop adequate local implementation strategies; health-care organisations, professional bodies and educational institutions should be made aware of the existence of this recommendation and be encouraged to follow the methods suggested so that the key elements can be put into everyday practice.
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