Appendix 4: Strategy Framework

Introduction

Making errors is a frequent occurrence causing an undesired result and leading to unintended harm to patients. The risk of errors increases in complex situations with hierarchical relationships. To be able to reduce the risk of errors and incidents in hospitals, many different actions could be undertaken.
There is an urgent need for attention and action with regard to safety problems. Unfortunately, up to now there is limited scientific evidence on the effectiveness of specific interventions. However, the limited evidence or experience that is available at the moment is being used, combined with the analysis and understanding of the problem and the local situation.

The SIMPATIE project has developed an overview of actions and instruments, regarding patient safety. Subdivided into several Work Packages (WP’s), expertise had been gained to generate preliminary result and conclusions.

The project’s overview of actions and instruments is being presented here for discussion. However, even as we are discussing them new knowledge is being generated and innovative approaches are being initiated.

One of the key issues being presented here for discussion, is:

What could be ways and means of further cooperation in Europe in order to increase learning, knowledge and exchange related to different approaches to improve patient safety and facilitate their implementation in health care organisations?

The Consensus Conference ‘Building a strategy for patient safety in Europe’ has gathered and discussed preliminary results of the SIMPATIE project and has drawn first conclusions for the strategy framework, which will be developed based on the conference results.

Methods

The Consensus Conference has been organized by the Standing Committee of European Doctors (CPME) in close cooperation with the Dutch Institute for Healthcare Improvement (CBO), the Council of Europe (COE), the European Society for Quality in Healthcare (ESQH), Haute Autorité de Santé (HAS), the European Hospital and Healthcare Federation (HOPE), Long Term Medical Conditions Alliance (LMCA) and Action against Medical Accidents (AvMA).

Delegates of a European wide network attended the conference in September 2006, representing the European Commission, national governments, organizations, experts, medical professionals, patients and other stakeholders involved in the project.

The WP’s preliminary results and contiguous issues where presented and discussed, intended to reach expert consensus on a strategy for patient safety in Europe.

The debate was realised, making use of plenary presentations and discussions. Analysis of the strategy framework was organized in two intensive workshops:

1. on patient safety at the national and European level
2. on patient safety at the provider level

Rapporteurs of the workshops proposed consensus conclusions accordingly. Reportage of the event resulted in a basis for the subsequent strategy framework conclusions and recommendations.

Distribution of the provisional conference conclusions and contribution of all participants assured the consensus and a common consent among the stakeholders.

Towards a strategic approach to patient safety

The input given by the conference participants have resulted in a set of recommendations. These recommendations concern actions on different levels and should not be conceived in a particular order of priority.

Basic assumption here is that whilst patient safety, as issue of health care policy, is primarily the responsibility of Member States, action at EU level should be supportive to help Member States achieve their patient safety objectives. In addition, for a number of issues and specific actions concerted action and coordination on patient safety at EU level is desired, as listed below:

Actions that should be considered by the EU institutions:


• Define an integrated approach to patient safety at European level and establish a coordination mechanism for patient safety like a European network to share and promote knowledge and solutions between Member States and stakeholders. All action should be reinforced by a political commitment of the Member States, as well as the European Parliament. This network should also liaise closely with other relevant international endeavours, including the Council of Europe, the OECD and the WHO (EURO and HQ- with the World Alliance on Patient Safety and Action on Patient Safety).



• Within such a network, facilitate development of knowledge repositories enabling collection and public access to relevant information; this could include regulation/legislation, policies, priorities, actions and best practices.



• Facilitate, support and coordinate programs and projects at national level:



• that promote the involvement of all stakeholders, including patients, patient organizations, acute and long term health care providers, healthcare professionals, patient safety organizations and insurers,



• that define indicators, reporting and supporting mechanisms as well as a body of knowledge and evidence on interventions that could improve safety; including research on safety but also evaluation of interventions,



• that develop national policies and programs, including education and training of health professionals, and



• that facilitate the exchange of information and lead to the development of a new legal framework on several aspects of safety including e.g. complaints procedures, compensation systems and professional responsibility, by using a network.


• Adopt a common vocabulary, as well as a set of patient safety indicators and instruments for internal and external evaluation to ensure the comparability of results on EU level and to produce the necessary public health and economic evidence for patient safety interventions.



• Make use of the already existing agreements, procedures and regulations at European level to enhance safety; explore possibilities to improve the regulations on medical technologies, materials of biological origin and European registration of medicines.



• Raise awareness of the patient safety impact on public health.



• Ensure Patient Safety is an integral part of the health services initiatives.



• Make an inventory of existing reporting systems regarding medical errors and describe them in such a way that this will lead to a common definition and understanding in Europe.

Actions that should be considered at national level


• Ensure that patient safety is the cornerstone of all relevant health policies, per se policies to improve quality.



• Develop national platforms to ensure a coherent and comprehensive patient safety policy framework that:



• promotes a culture of safety



• takes a proactive/preventive approach



• focuses on system errors



• puts patient safety as a leadership priority



• emphasises learning from experience



• leads to harmonization of activities



• collects annual reports on national and regional level


• Introduce ‘no blame’ reporting systems regarding medical errors, leading to respective cultural changes without jeopardizing the rights of patients getting compensation. Therefore these systems should combine liability issues and the development of non fault compensation regulations.



• Introduce policies and procedures to ensure that patients or their families affected by medical errors are fully informed of them and offered appropriate explanations, apologies and support



• Develop state-of-the-art educational and training programs that ensure core patient safety competencies, including clinical governance, safety and risk management, and include them in basic and postgraduate curricula, as well as in continuous professional development programmes for health professionals



• Guarantee the needed quantity and quality of human resources to ensure a high level of safety



• Educate and empower patients on Patient Safety



• Promote research on patient safety



• Introduce regulations ensuring the safe design and safe use of medical devices and pharmaceuticals, thus preventing look-alike and sound-alike drugs, as well as unsafe medical devices. These regulations should be consistent with EU actions on this matter.



• Develop evaluation tools to ensure safe clinical practice, e.g. through regular performance measurement on clinical and administrative level



• Review and improve the quality of existing data sources such as patient complaints and compensation systems, clinical databases and monitoring systems



• Identify the public health and economic impact of adverse events and patient safety interventions



• Introduce monitoring systems ensuring external evaluation of healthcare organisations to:



• identify common goals



• develop a portfolio of common methods, obeying common principles



• aim for common standards, ensuring one process of evaluation and common logics of decision



• ensure transparency in external evaluation


• Develop reliable and valid indicators of patient safety for various health-care settings, in order to improve patient safety and clinical governance, based on outcomes and findings within the EU network



• Develop a Patient Safety Incident Reporting System for learning, with the following principles and goals:



• non-punitive and fair in purpose



• independent of other regulatory processes



• encouraging reporting (voluntary, anonymous and confidential )



• analysis of reports locally



• national level when needed



• involvement of patients/carers


• Report regularly of actions taken, e.g. through annual reports by the Ministries of Health

Actions that should be considered by health care providers (both individual providers and institutions/organisations)


• Facilitate a multidisciplinary and collaborative approach between health professionals and health care providers, aimed at enhancing patient safety



• Initiate and promote co-operation between patients/carers and health care professionals in order that patients/carers are made aware of near misses, adverse events and risks



• Implement work place projects focusing on patient safety and establish an open culture to deal with errors and omissions more effectively, for example “medical quality circles”, peer review groups and training of supervisors/presenters in peer review



• Exchange of information between healthcare organisations on best practices, open to the wider public



• Consider collaborating on national guidelines on complaints procedures, (economic) compensation systems and professional responsibility



• Implement evidence-based educational programs that ensure core patient safety competencies, including clinical governance, safety and risk management, in basic and postgraduate curricula, as well as in continuous professional development programmes for health professionals



• Evaluate new initiatives in dealing with adverse events, e.g. patient arbitration schemes or no-fault liability insurance. If successful, incorporate them into training and continuing professional development



• Assess the economic impact of adverse events and patient safety interventions within healthcare organisations



• Introduce tools to measure and improve clinical governance based on sound scientific evidence



• Introduce instruments for registration of information and data relevant for safety in healthcare organisations, in line with proposals at EU level, to:



• ensure a common understanding and definition of basic elements through a common European vocabulary and a joint set of indicators



• safeguard ongoing surveillance and monitoring of the impact of patient safety activities



• support external accountability and patient choice


• Introduce tools for analysis of safety incidents and risks:



• for retroactive analysis: as e.g. Root Cause Analysis (Systematic Incident Reconstruction and Evaluation, Prisma) and Trigger tools, and



• for proactive analysis: for instance Health Failure Mode Effect Analysis and Bow tie model.


• Implement intervention approaches:



• directed towards the system: namely organizational leadership, culture, communication and management (taking into account issues such as safety culture, involvement of patients, a safety management system, crew resource management and multidisciplinary team training),



• directed to specific processes of professional health care delivery (including walk rounds, briefings, time out, SBAR (Situation-Background-Assessment-Recommendation), bundles or rapid response teams), and



• directed to the system and health care delivery, as e.g. packages of interventions developed to decrease hospital mortality (such as ‘move your dot’ or ‘campaign approach’).


• Implement internal and external evaluation mechanisms that effectively contribute to improve patient safety and transparency to patients and stakeholders. These evaluation mechanisms should be integrated into healthcare organisations’ quality and security improvement strategies.