Appendix 2: Background SIMPATIE Project

Overview

The overall objective of the SIMPATIE project is improving the safety of patients throughout all European countries. More specifically it uses a European wide network of organizations, experts, patients, professionals, and other stakeholders aiming to establish within its two years of duration a common European set of vocabulary, indicators, internal and external instruments for the improvement of safety in healthcare.

To reach the above stated goal the work of the Simpatie project has been divided into several work packages:

- one on mapping activities on patient safety in Europe
- one on vocabulary and indicators
- one on external evaluation of patient safety
- one on instruments for healthcare organisations to improve patient safety

The progress made so far in these work packages is portrayed in the annexes below. In short project results encompass the following:

To reach the overall Simpatie goal the mapping exercise provides a systematic overview of activities related to patient safety in the different European countries, which are categorised into regulations, policies and priorities and activities.

Another work package puts the first steps towards assessing the impact of patient safety efforts by formulating a common European vocabulary and by developing an evaluative framework for patient safety indicators.

Furthermore the work package on external evaluation of healthcare organisations discusses mandatory versus voluntary programs, European and national regulations, minimum versus desirable standards, transparency of results and success factors and barriers to external evaluation.

The last work package gives an overview of instruments to improve patient safety for healthcare organisations in the areas of registration of relevant data, risk-analysis, and incidents & interventions aimed at the system or process level.

The Consensus Conference ‘Building a strategy for patient safety in Europe’ (pdf) gathers and discusses these preliminary project results and draws 1st conclusions for the strategy framework, which will be developed based on the conference results.

Content and Strategy Framework

The strategy framework is being based on findings of the SIMPATIE project delineated along four streams:

present a mapping exercise that provides a systematic overview of activities related to patient safety in the different European countries, structured as legislation/ regulations, policies and priorities / activities,

sets the first steps towards assessing the impact of patient safety efforts by formulating a common European vocabulary and by developing an evaluative framework for patient safety indicators,

discuss issues related to external evaluation of healthcare organisations: mandatory versus voluntary programs, European and national regulations, minimum versus desirable standards, transparency of results and success factors and barriers to external evaluation, and

give an overview of instruments to improve patient safety for healthcare organisations in the areas of registration of relevant data, risk-analysis, incidents & interventions aimed at the system/process level.

In addition, the framework is being based on policy/position papers of key stakeholders at the European level, incl.:

> Recommendation of the Council of Europe,
> Work of the High Level Group on Health Services and Medical Care / working party on patient safety,
> The European Hospital and Healthcare Federation resolution on patient safety, and
> The Luxembourg Declaration on Patient Safety (2005) (pdf-English) and pdf-file French.

Please find more information on the respective work packages in the annexes below.


NOTE: on top of each of the next 5 workpackages, access is provided to their final results

Work Package 2: The Mapping Exercise

Link up for direct access to the results of WP2 on the SIMPATIE-site.


In the last decade most European countries introduced a range of patient safety initiatives on local and national level. Therefore the SIMPATIE consortium introduced a mapping exercise to identify the existing patient safety endeavours, and better practices on European level, and make the findings available for all interested parties.

1. Regulatory background:

According to the data collected in the mapping exercise most member states introduced regulations and in some cases even legislation on patient safety. However, these initiatives are not consistent throughout the European Union.

The conference should further discuss the meaning of a ‘no-blame’ system, and to which extent national legislation could clarify this. “There is a need for discussion and debate to reach better understanding of the real meaning of terms such as ‘no-blame culture’,’no-blame systems’, and ‘open and fair’ culture and systems. Ideally we should seek to reach common understanding around balancing the need to ensure accountability when things go wrong and open, honest reporting to patients, with the desire to develop a culture which is less focussed on blaming individuals and encourages reporting of and learning from incidents.” (Peter Walsh, AvMA). Issues highlighted by the mapping survey, are:


- no fault compensation,
- legal disclosure and availability of data,
- liability arrangements, and
- 'whistle blowing'.

2. Policy content:

The conference should discuss the relevance and possibilities of a 'mix and match' approach to creating a national strategy, e.g.:


- sentinel event monitoring ( e.g. via national reporting systems),
- alerts (e.g. via national campaigns),
- subsidized national training schemes e.g. on RCA (root cause analysis),
- standardized software systems for incident collection and analysis,
- clinical risk management systems (i.e. local incident reporting and training in risk management), and
- patient partnership initiatives (cf. WHO Alliance ‘speak up’ campaign).

Currently existing national patient safety strategies to some extent seem not to reflect a clear consensus on priority within the elements of the strategy or overall level of resource allocation (partly examined in section WP3, below), but examples of good practice in e.g. guidelines and standards and national reporting systems provide an opportunity for benchmarking.

3. Policy priorities and actions

A comprehensive national patient safety strategy can be enabled to make informed choices regarding priori-
ties when resources are a significant constraint. Granted the attempt to build a framework by consensus and using the results of previous European collaborations, how can the experience of some countries be made available to exchange information between member states in discussing and further developing their national strategy, taking into account the difference in history, culture and health systems between EU countries

The consensus conference provides an opportunity for discussion on the importance of building in evaluation of the impact of patient safety initiatives, something that current strategies show little evidence of, but which it is argued, is an important quality aspect, i.e. providing measures to demonstrate the efficacy and cost-effectiveness of components of a national strategy. Examples will be sought from the conference delegates of approaches that have been taken that go beyond academic research analyses.

Work Package 3: Council of Europe’s recommendations on safety and quality

Link up for direct access to the results of WP3 on the SIMPATIE-site.

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



• develop a coherent and comprehensive patient safety policy framework, that:
  
  
  o promotes a culture of safety
  o takes a proactive/preventive approach
  o puts patient safety as a leadership priority
  o emphasises learning from experience
  · develop a Patient Safety Incident Reporting System for learning
  o non-punitive and fair in purpose
  o independent of other regulatory processes
  o encouraging reporting (voluntary, anonymous and confidential)
  o analysis of reports locally
  o national level when needed
  o involvement of patients/carers
  
  
• review existing data sources such as patient complaints and compensation systems, clinical databases and monitoring systems



• develop educational programs (clinical decision making, safety, risk management)



• develop reliable and valid indicators of patient safety for various health-care settings



• promote research on patient safety



• report regularly of actions taken



• cooperate internationally, e.g. on: proactive design of safe health-care systems; nomenclature and taxonomy, methods of risk identifiation and management, standardised patient-safety indicators methods of involving patients and caregivers , content of training programmes standardisation methods

Work Package 4: Toolbox, Developing indicators / outcome measures and vocabulary

Link up for direct access to the results of WP4 on the SIMPATIE-site.

1. Choices in creating vocabulary of Patient Safety: A common understanding and definition of basic elements is a prerequisite for comparative assessment of interventions , priority setting and surveillance in patient safety. Development of such a set of definitions (‘Vocabulary’) requires balancing of several factors:


- Definitions in already existing vocabularies
- Correspondence with acknowledged taxonomies/terminologies of patient safety (WHO)
- Selection of topics according to importance (Which perspective – expert / professional / patient ?)
- Selection of topics (according to cross-cultural differences in basic assumptions about patient safety)
- Selection of topics which supports the proper selection of patient safety tools - indicators

2. Aims of patient safety indicators:


- Surveillance and monitoring the impact of improvement activities in patient safety:
- Diagnosis of ‘unsafe’ practices in healthcare
- Monitor (unintended) patient safety consequences of organizational changes
- Continuous support of external accountability/ patient choice

With the general limitations inherent in interpretation of indicator data.

3. Criteria for selection of patient safety indicators:


A three step procedure has been developed:

I Identification : Patient Safety Indicators are measures that directly/indirectly monitor preventable adverse events

II Characterization in terms of :


- Documented use in a relevant clinical setting
- Risk reduction/ Harm prevention (Structure + Process/ Outcome)
- Application domain ( Institutional property / Theme related / Patient group specific)
- Technical specifications

III. Final selection based on evaluation of:


- Relevance related to aims and clinical setting
- Validity
- Feasibility (Technical - clinical)

Work Package 5: Toolbox, External evaluation of healthcare organisations


Link up for direct access to the results of WP5 on the SIMPATIE-site.


External evaluation mechanisms are an integral part of strategies regarding patient safety in health care organisations. They have taken various forms. More recently, in response to greater expressed needs for accountability and to the recognised value of external recognition to promote improvement, hospital-wide mechanisms, such as accreditation, have gained greater acceptance.

Our draft document categorises and references the trends and evolutions in external evaluation regarding patient safety over the last 20 years. Focuses have shifted from compliance to minimum general safety standards to compliance to safe clinical practices, to measurement of performance and very lately to evaluation of patient safety culture and leadership. To various extents, these trends are common to most programs. We have also discussed success factors and limits of external evaluation mechanisms.
Many issues remain open to discussion.

We are proposing a number of issues that should be addressed at this conference:



1. Character

The pros and cons of mandatory national versus voluntary programs and of the role of government in the development and generalisation of external auditing programs.

2. Transparency

Recognising that external auditing mechanisms rely in part on external incentives based on the publication of the results, the modalities of publication remain an important issue. Related to this issue is that of the possible links between the evaluation result and the attribution of resources.

3. Cooperation

How to cooperate in Europe to promote external evaluation mechanisms that effectively contribute to improved patient safety? What could constitute an European consensus today or in the near future? From sharing common goals and a portfolio of common methods obeying common principles, to common standards, to common process of evaluation and common logics of decision.

4. Diversity

How to take into consideration the realities of the different member countries with their different backgrounds, traditions and economic situations? How to prioritise between these strategies?

Work Package 6: Toolbox, Improving patient safety in healthcare organisations


Link up for direct access to the results of WP6 on the SIMPATIE-site.


The progress in science and technology, combined with advanced specialisation in health care are leading to increasingly complex care situations for increasingly frail patients. We should realise that health care is becoming less safe partly because of this enormous progress in hospital care. Making errors is a normal, but with regard to outcome often undesired deviation in human behaviour. 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. These will be discussed further.

Increasing attention to and action on safety problems is urgently needed. Unfortunately, up to now there is limited scientific evidence on the effectiveness of specific interventions. We are forced to use whatever evidence or experience is available, combined with the analysis and understanding of the problem and the local situation, when selecting actions that should be undertaken in a given organization. The project has developed an overview of these actions / instruments, that is being presented for discussion. However, even as we are discussing them new knowledge is being generated about the ones listed here and new innovative approaches are being initiated.

Therefore the key issue being presented here for discussion, is:



What would be the 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 organizations?


For discussion we have classified instruments evaluated within the project's scope, into three groups (some of the instruments include aspects from more than one group):


1. Instruments for registration of information (data) relevant for safety

These include both specific registration of safety incidents as well as possible data sources for safety information derived from other, more general, registration systems. Important feature here is the possi-
bility to develop or define indicators and benchmarks that can be used for comparison on different level (within organization, between organizations on regional, national and European level)

2. Tools for analysis of safety incidents and risks

The group includes two types of instruments:


- for retroactive analysis: Root Cause Analysis (Systematic Incident Reconstruction and Evaluation, Prisma) and Trigger tool status study.

- for proactive analysis: Health Failure Mode Effect Analysis and Bow tie model

3. Intervention approaches

Two levels of intervention can be roughly distinguished here, although experience indicates that best results of these interventions can be achieved when action is taken simultaneously on both levels.


- Interventions directed towards the system, namely organizational leadership, culture, commu-
nication, management and relations. This includes attention to safety culture, involvement of patients, a safety management system, crew resource management and multidisciplinary team training.

- Interventions directed to specific processes of professional health care delivery. Many of them are specifically developed to improve communication within one or more care processes and teams, including walk rounds, briefings, time out or SBAR. Others have been designed with a specific group of patients at safety risk in mind, like bundles or rapid response teams. Some combine both aspects and include system components, like a package of interventions developed to decrease hospital mortality (move your dot or campaign approach).

- Prerequisites of the Recommendation: - Patient safety recognised as the foundation of good quality and the basic right of everybody - A system-based approach - Creating a culture of safety – no blame, open and fair; a culture where everyone has a constant and active awareness of the potential for things to go wrong, that is open and fair, where people are able to learn about what is going wrong and then put things right - Reporting to learn from errors and act upon it - Education is a key - Patient empowerment - patient safety as a cornerstone for solidarity with patients - Safety first! Savings second! - Legal protection of whistle blowers - Patient safety is not a luxury for the rich, but a must for all!