Description of the work

Objectives of a common European vocabulary on patient safety

The patient safety terms are meant for use of professionals, e.g. risk managers, administrators, project managers, and others working with patient safety. The purposes of the vocabulary are to:

• Define basic terms and concepts related to patient safety


• Ease communication and understanding across Europe


• Be easily understood by non native speaking English people


• Take cross-cultural European aspects into account

Organisation

To develop the vocabulary a sub group of the expert group was formed. Members of the sub group were: Dr. Ian Callanan (Chair man), Dr. Jannes van Everdingen, Dr. Joergen Hansen and Dr. Paul Bartels. The work in the vocabulary sub group was managed by MHS Solvejg Kristensen, ESQH-office for Quality Indicators in Aarhus.

Methodology

To find patient safety terms suitable for the vocabulary, web pages of organisations working with (patient) safety were identify and screened. The most frequently used terms were identified, and in the first place considered suitable for the vocabulary. A literature review was done by the ESQH-office in Aarhus in order to identify all relevant sources for the description of concepts and terminology related to patient safety. Calls for terms to be contained in the vocabulary were made amongst the expert group.

A list of 18 terms were produced and discussed at the initial expert group meeting. In the cause of the meeting different frameworks of understanding of the most vital terms of patient safety e.g. adverse event, complication and near miss were presented, their connections illustrated and discussed. Also more terms were added, and some deleted from the vocabulary. Finally a list of 30 basic terms to be included in the vocabulary was proposed. It was decided that the vocabulary should contain 20-30 terms. Apart from the objectives of the vocabulary listed above, further criteria for including terms in the vocabulary were agreed as:

1) To include frequently used terms in the works with patient safety in Europe
2) To include terms needing a common European definition as a basis for mutual understanding.
3) Not to include terms covering fixed notions or methods e.g. double loop learning, root cause analysis
4) Definitions in the vocabulary should be consistent and their relations illustrated
5) The terms should be categorised

The list of the 30 terms was discussed in further detail in a telephone conference of the expert group. It was decided to categorise the terms according to the stage of patient safety work to support the work of WP5. Following this expert group telephone conference the list of 30 terms, the agreed criteria and three suggested overviews of relations of terms were handed to the elected vocabulary sub group for further development.

For each of the 30 terms in the list definitions were identified from existing glossaries/vocabularies of organisations working with (patient) safety. A new list of the terms was produced, showing all the available alternative definitions of the terms. The list of terms and a suggestion of categorising the terms was send to the full expert group with a call for input and comments. Suggestions of definitions were added e.g. nationally used definition, and the list was sent to the vocabulary sub group. Each of the sub group members commented in writing, comments were added to the list and circulated within the sub group.

The vocabulary sub group agreed on 24 definitions of terms sub divided in four categories and an overview of relations of the core terms of the vocabulary. The vocabulary sub group held a telephone conference and met once for a one day meeting.

The final suggestion for the vocabulary was sent to the full expert group for comments in writing and to two representatives of patient. The sub group held a telephone conference to discuss the comments made, and finalise the vocabulary.

Used background sources and literature

Information of the organisations mentioned below was taken into account in developing the vocabulary. Either the web page was screened for identification of terms for the vocabulary, or definitions of terms considered. It was decides to take all available material/information both European and international into account as a basis for the discussions in developing the vocabulary. We found this relevant to ensure most possible terms and concepts, also such not yet dominant in Europe to be considered suitable for the vocabulary.

Information of the following institutions and organisations was reviewed:

- Australian Commission for Safety and Quality in Health Care (ACSQHC)
- Agency for Healthcare Research and Quality (AHRQ)
- Act on Patient safety in the Danish Health Care System (APSDHCS)
- Council of Europe (CoE)
- Institute of Medicine (IOM)
- Information Security Group (ISG)
- International Organisation for Standardization (ISO)
- Dutch Consensus Group with participants of (semi)government and different professional groups (JPSG)
- Joint Commission on accreditation in Health Care (JCAHO)
- Joint Commission International (JCI)
- National Patient Safety Agency (NPSA)
- The Danish Society for Patient Safety (DSPS)
- The Quality Interagency Coordination Task Force (QuIC)
- Socialstyrelsens Författningssamling, Sweden (SF)
- The National Board of Health, Denmark (SST)
- Veterans Affairs (VA)
- World Health Organisation (WHO)

Selecting terms for the vocabulary

All together 24 patient safety terms are defined in a cross cultural perspective. Please see Table 1 (pdf) for selected terms and definitions. In the process of choosing the terms suitable and necessary for a common European vocabulary, we emphasised terms, which we found were ambiguous and or interpreted differently in different European settings and clinical cultures. Defining the terms and the mutual relations of the five core terms was done testing the question: “Do we comprehend this term alike?”

The core terms are defined according to their relation to either process or outcome. An overview of the core terms and their relations is given in Diagram 1 (pdf). The five core terms of the vocabulary are:

• Adverse event


• Adverse outcome


• Actual event


• Near miss (Sub event)


• Harm

The terms of the vocabulary are ordered according to the four categories:

• Detection of risk


• Analysis of risk


• Resulting actions


• Failure mode

Table 2 (pdf) shows the categorising of the terms.

In the process of deciding terms suitable for the vocabulary, a lot of terms were considered, but not chosen. Terms that were not chosen, were considered to be general well know terms already well defined across Europe, yet another new definition would not clarify nor add anything new. A list of such terms not chosen for the vocabulary is provided beneath:

It is referred to the wide range of international patient safety literature and to the reference list (1-14) for further definitions of these and other terms.

- Accident
- Active error
- Active failure
- Blame
- Clinical decision
- Clinical expectation
- Clinical intended result
- Clinical process
- Clinical result
- Clinical unintended result
- Injury
- Latent failure
- Latent error
- Non-harmful result
- Potential for harm
- Preventable adverse event
- Protection
- Reporting
- Root cause analysis
- Situational awareness
- System error
- Unintended adverse event
- Unpreventable adverse event
- Voluntary Reporting

Table 1. Definitions of the 24 terms of the vocabulary. NO TERM DEFINITION DETECTION OF RISK 1 Patient Safety The continuous identification, analysis and management of patient-related risks and incidents in order to make patient care safer and minimising harm to patients. Safety emerges from interaction of the components of the system. Improving safety depends on learning how safety emerges form such interactions. 2 Adverse Event An unintended and undesired occurrence in the healthcare process because of the performance or lack of it of a healthcare provider and/or the healthcare system. Please note: In this vocabulary adverse events are considered as preventable (Please see Diagram 1) although realising, that the clinical distinction between preventable and non preventable events is rather academic. 3 Actual Event An adverse event, which causes harm. 4 Near Miss (sub-event) An adverse event, with the capacity to cause harm but which does not have adverse consequences, because of for instance timely and appropriate identification and correction of potential consequences for the patient. 5 Complication An unintended and undesired outcome which develops as a consequence of intervention of an already present illness. It may be non preventable under the given circumstances. Please note the related definition of term number 12; “Adverse Outcome”. 6 Sentinel Event Sentinel reflects the seriousness of the injury and the likelihood that investigation of an event will reveal serious problems in current policies or procedures. Such occurrences signal the need for immediate investigation and response. 7 Critical Incident Occurrences, which are significant or pivotal, in either a desirable or an undesirable way. Significant or pivotal means that there was significant potential for harm (or actual harm), but also that the event has the potential to reveal important hazards in the organisation. In other words, these incidents, whether near misses or events in which significant harm occurred, provide valuable opportunities to learn about individual and organisational factors that can be remedied to prevent similar incidents in the future. 8 Complaint Each expression of resentment or discontent with the practice, operation or conduct of a healthcare provider made by a potential user or a user of the health care services or someone acting on their behalf. 9 Reporting System A system which is designed to contain reports on adverse events. On the basis of reports analysis and communication of known causes and risk situations is possible. The system can contain reports on human and technical errors as well as organisational circumstances, which affects the occurrence of adverse events in the health care process. Reporting systems include input from all stakeholders – providers and service users. 10 Professional Standard The standard of performance in particular circumstances taking into account recent insights and evidence-based norms and a standard of practice to be expected of a comparable experienced and qualified prudent practitioner in equal circumstances. Please note the related definition of term number 24; “Negligence”.

Table 1. Definitions of the 24 terms of the vocabulary (cont.) NO TERM DEFINITION ANALYSIS OF RISK 11 Harm Negative consequence experienced by a patient leading to; death, a permanent or temporary impairment of physical, mental or social function or a more intense or prolonged treatment. 12 Adverse Outcome An unintended and undesired occurrence in the healthcare process, which causes harm to the patient. Please note related definition of term number 5; “Complication” 13 Risk The probability or chance that something undesirable will happen. A measure of the probability and severity of potential harm. 14 Calculated Risk A deliberately and consciously taken risk in which the benefits of a treatment are deemed to offset/countervail the possible burden of serious harm. 15 Barrier Protect people and structures from adverse events. 16 Situational Awareness Refers to the degree to which one’s perception of a situation matches reality. RESULTING ACTIONS 17 Risk Management Identifying, assessing, analysing, understanding, and acting on risk issues in order to reach an optimal balance of risk, benefits and costs. 18 Error Management An approach to manage the aftermath of an error with the goal of reducing future errors, avoiding negative consequences and dealing quickly with consequences once they occur. 19 Action Plan An Action Plan can be the result of analysis of adverse events. The Action Plan addresses system and process deficiencies; improvement strategies are developed and implemented. 20 Culture of Safety An integrated pattern of individual and organisational behaviour, based upon shared beliefs and values that continuously seeks to minimise patient harm, which may result from the processes of care delivery. 21 Human Factor Refers to the study of human abilities, behaviours and characteristics as they affect the design and suggested intended operation of equipment, systems, and jobs. The field concerns itself with considerations of the strengths and weaknesses of human behaviour, physical and mental abilities and how these affect the systems design. FAILURE MODE 22 Error Preventable event leading to an adverse outcome being either an act of commission (doing something wrong) or omission (failing to do the right thing) that leads to an undesirable outcome or having significant potential for such an outcome. 23 Situational Factor The factor in a process, which activates an error in the system. 24 Negligence Care provided failed to meet the standard of care reasonably expected of a reasonably prudent and careful practitioner qualified to care for the patient in question. Please note the related definition of term number 10; “Professional standard”