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Appendix B. Cultures of safety/environment

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,

Cultures of safety/environment

See Appendix B (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. Credibility at the highest level of a health-care system is the key factor for developing a safety culture. Government and other decision makers’ policy and action should support measures to allow health-care organisations to be open and fair in all they do:

a. the first stage in developing a safety culture is to define the existing culture of a system and organisation. A safety culture is essentially a culture where everyone has a constant and active awareness of her/his role and contribution to the organisation, and of the potential for things to go wrong. It is an open and fair culture, where people are able to learn about what is going wrong and then put things right;

b. developing a safety culture in an organisation needs strong leadership and careful planning and monitoring. It also requires changes and commitment to safety at all levels of the system, from government to clinical teams and supporting staff;

c. a clear and strong focus on patient safety should be established through the health-care system and organisations: safety should be valued as the primary priority of healthcare, even at the expense of productivity or “efficiency”;

d. the commitment to quality and safety should be articulated at the highest level of the health-care system and translated into policies and political support of public-health and patient-safety issues;

e. necessary financial and logistical resources, incentives and rewards should be provided by the health-care system to make this commitment possible:

risk management in health-care organisations should be obligatory and controlled;

individual incentives and rewards should be completed by team incentives and rewards;

individuals should be rewarded for taking safety-oriented initiatives, even if they turn out to be wrong;

f. quality and risk-management concepts and activities should be included in the under- and postgraduate educational programmes of all health-care professions;

g. recognised national focal points for patient safety, with relevant health-care professionals, should be created and supported;

h. the government should ensure that no legal action is taken in case of self-reported incidents.

2. A system-based approach is the proven way to improve patient safety. Risk management is based on, and integrated in, quality management and also takes into account human-factor engineering in structures and human-factor principles in processes.

a. Effective risk management requires understanding of human behaviour, the varieties of human error, and the conditions likely to cause such error.

b. It must be accepted that people will make mistakes and that processes and equipment will sometimes fail. It must be accepted that under specific circumstances and for various reasons individuals can make errors.

c. The systems-based approach takes into account many components recognised as contributing to an incident or to the events leading up to it. This moves the investigator away from focusing blame on individuals and looks at what was wrong with the system in which the individuals were working.

d. Systems should therefore be designed and maintained to reduce as far as possible the likelihood of patient harm caused by mistakes. By accepting this approach, organisations can focus on change and develop defences and contingency plans to cope with these failures, and can learn lessons and potentially stop the same incident reoccurring or harming patients and providers of care.

3. At the level of health-care organisations, the chief executive, the board and administrative and clinical directors need to establish an environment in which the whole organisation learns from safety incidents and where staff are encouraged to both proactively assess and immediately report risks.

These should be consistent with already established quality-management systems, of which it should be an integral part (Committee of Ministers’ Recommendation No. R (97) 17 on the development and implementation of quality improvement systems (QIS) in health care).

a. Quality and risk management should be led by the highest level of the organisation and translated into shared values, norms and behaviour at all levels.

b. Health-care organisations should introduce systems allowing them to regularly conduct safety-culture assessments and learn from them. Safety should be expressed by quality indicators and followed up.

c. At all levels, from top management to frontline, staff should be educated in human-behaviour (human-factor) and risk-management principles. Potential accidents should be proactively identified and assessed (e.g. by Failure Modes Effects and Criticality Analysis (FMECA)). Systems and processes should be developed to manage the risks.

d. Health-care professionals should interact and communicate openly with and listen to patients. Communication with the public should be transparent.

e. Communication between individuals and teams and across organisational levels should be frequent, cordial, constructive and problem-oriented. Organisational management is kept informed about and involved in the improvement of patient safety.

f. At all levels, actual patient-safety incidents, problems and errors should be properly reported when they occur. Local policies describe clearly how organisations will manage staff involved in incidents, complaints and claims. Staff should be comprehensively trained in clinical and administrative procedures for responding to a serious error. Reporting of incidents should be promoted, locally and nationally.

g. At all levels, problems and errors should be treated openly and fairly in a non-punitive atmosphere. The response to a problem must not exclude individual responsibility, but should focus on improving organisational performance rather than on individual blame.

h. Incidents should be reviewed and investigated thoroughly, transparently and fairly, free from hindsight bias. Problem analysis should focus on organisational performance. All staff should be trained in teamwork-based problem solving and encouraged to use root-cause analysis to learn how and why incidents happen.

i. Solutions to prevent incidents should be implemented through changes in structure and processes. Safety lessons should be communicated to frontline staff and other relevant professional health-care groups and integrated into training curricula. Ongoing interdisciplinary educational programmes allow for discussions about causes and prevention of errors and adverse events. Incidents should be shared with other organisations to broaden learning as much as possible.

j. Best-practice examples and “success stories” should be collected and disseminated.

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