International Journal for Quality in Health Care 2009; Volume 21, Number 1: pp. 18 –26 10.

1093/intqhc/mzn057

Towards an International Classification for

Patient Safety: key concepts and terms
WILLIAM RUNCIMAN1*, PETER HIBBERT2, RICHARD THOMSON3, TJERK VAN DER SCHAAF4,
HEATHER SHERMAN5 AND PIERRE LEWALLE6
1
University of South Australia, Joanna Briggs Institute and Royal Adelaide Hospital, Level 5 McEwin Building, Royal Adelaide Hospital,
North Tce Adelaide 5000, SA, Australia, 2National Patient Safety Agency, 4-8 Maple St, London W1T 5HD, UK, 3Institute of Health and
Society, Newcastle University Medical School, Framlington Place, Newcastle upon Tyne NE2 4HH, UK, 4Hasselt University, Campus
Diepenbeek, Agoralaan, Building D, Room A 55, BE-3590 Diepenbeek, Belgium, 5Department of Health Services Research, Division of
Quality Measurement and Research, The Joint Commission, One Renaissance Boulevard, Oakbrook Terrace, IL 60181, USA, and
6
Measurements and Health Information Systems Department, Information, Evidence and Research, World Health Organization, 20,
Avenue Appia, CH-1211 Geneva 27, Switzerland

Abstract
Background. Understanding the patient safety literature has been compromised by the inconsistent use of language.
Objectives. To identify key concepts of relevance to the International Patient Safety Classification (ICPS) proposed by the
World Alliance For Patient Safety of the World Health Organization (WHO), and agree on definitions and preferred terms.
Methods. Six principles were agreed upon—that the concepts and terms should: be applicable across the full spectrum of
healthcare; be consistent with concepts from other WHO Classifications; have meanings as close as possible to those in
colloquial use; convey the appropriate meanings with respect to patient safety; be brief and clear, without unnecessary or
redundant qualifiers; be fit-for-purpose for the ICPS.
Results. Definitions and preferred terms were agreed for 48 concepts of relevance to the ICPS; these were described and the
relationships between them and the ICPS were outlined.
Conclusions. The consistent use of key concepts, definitions and preferred terms should pave the way for better understand-
ing, for comparisons between facilities and jurisdictions, and for trends to be tracked over time. Changes and improvements,
translation into other languages and alignment with other sets of patient safety definitions will be necessary. This work rep-
resents the start of an ongoing process of progressively improving a common international understanding of terms and con-
cepts relevant to patient safety.
Keywords: patient safety, definitions, concepts, terminology, classification

Introduction by concepts with agreed definitions [3, 4], each labelled by

‘preferred terms’.
Understanding patient safety has been compromised by The core to the classification is the clear definition of a
inconsistent use of language. Similar concepts have different concept (e.g. failure to carry out a planned action as intended
terms (e.g. near miss, close call) and terms are used to or application of an incorrect plan), which is then given a
embrace several concepts (‘medical error’ for errors, viola- preferred term (in this case error).
tions and system failures). In a survey, 17 definitions were An opportunity to address this arose with the launch of
found for error and 14 for ‘adverse event’ [1]. Another the World Health Organization (WHO) World Alliance for
review found 24 definitions for error, with a range of Patient Safety [5]. The formation of a drafting group for an
opinions as to what constitutes an error [2]. A need was thus International Classification for Patient Safety (ICPS) is
identified for a comprehensive classification, populated described in a companion paper, with some guiding

*
Address reprint requests to: William Runciman, University of South Australia, Joanna Briggs Institute and Royal Adelaide
Hospital, Level 5 McEwin Building, Royal Adelaide Hospital, North Tce Adelaide 5000, SA, Australia

International Journal for Quality in Health Care

Published by Oxford University Press 2009
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 Towards an ICPS: key concepts and terms

principles for its development [6]. In another paper [7], a How key terms and concepts chosen relate to the ICPS
Delphi survey and an iterative refinement process are conceptual framework is shown in Fig. 1. Definitions,
described, undertaken to develop a conceptual framework labelled by preferred terms, are listed in Table 1 in the
populated by relevant concepts. In a parallel iterative process, sequence in which they are discussed below, with preferred
guided by expert opinion and the Delphi respondents’ sug- terms listed alphabetically in Table 2.
gestions, definitions of relevant key concepts with preferred Concepts are progressively introduced to allow under-
terms were agreed. The present paper describes this process, standing to be ‘built’, starting with the concepts in the title
the key concepts and their resulting definitions and preferred of the ICPS (classification, patient, safety). The terms in
terms, and how they relate to each other and to the ICPS italics have been deemed ICPS-preferred terms. Where terms
conceptual framework. Further development of the classifi- have been highlighted, the agreed definitions for relevant
cation will support the measurement of safety, for example, concepts follow.
through its application in data collection systems such as A classification is an arrangement of concepts (bearers or
incident- reporting systems. embodiments of meaning) into classes (groups or sets of like
things, e.g. ‘contributing factors’, ‘incident types’ and ‘patient
outcomes’) and their subdivisions linked to express the seman-
Methods tic relationships between them (the way in which they are
associated with each other on the basis of their meanings).
Many sources of concepts and terms were drawn upon (dic- For example, ‘contributing factors’ precede and play a role in
the generation of any ‘incident type’. Similarly, detection
tionaries, literature, Internet), including the report of a pre-
vious Delphi process (itself drawing upon 165 sources) [1], precedes ‘mitigating factors’ and is followed by ‘outcomes’;
together with examination of over 700 responses to the the progression of an incident cannot be limited until it has
Delphi process [7, 8]. Many refinements to the definitions been detected and its nature determined, and outcomes
were made through exchanges by email and at five cannot be described until attempts at limitation have exerted
face-to-face meetings of the drafting group [9]. Six principles their influence (Fig. 1).
Each class has hierarchically arranged subdivisions popu-
were agreed, two of which overlap with the principles out-
lated by concepts (e.g. ‘fatigue/exhaustion’ under the class
lined for the development of the ICPS [6]. It was decided:
† that concepts and terms should be applicable across ‘contributing factors/hazards’). Concepts may be represented
the full spectrum of healthcare from primary to highly by a number of terms that allow for regional dialects, differ-
specialized care and should be consistent with the exist- ent languages, different clinical disciplines and/or provider
ing processes and systems. or patient preferences.
† that concepts should, whenever possible, be consistent A patient is a person who is a recipient of healthcare, itself
defined as services received by individuals or communities to
with concepts from other terminologies and classifi-
cations in the WHO Family of International promote, maintain, monitor or restore health. Patients are
Classifications [10]; referred to rather than clients, tenants or consumers,
† that definitions of the concepts and the preferred although it is recognized that many recipients such as a
terms should reflect colloquial use; healthy pregnant woman or a child undergoing immunization
† that definitions of the concepts should convey the may not be regarded, or regard themselves, as patients.
Healthcare includes self-care. Health is ‘a state of complete
appropriate meanings with respect to patient safety;
physical, mental and social well-being and not merely the
† that definitions should be brief and clear, without
unnecessary or redundant qualifiers, starting with basic absence of disease or infirmity’—the WHO definition [11].
definitions and then ‘building’ upon them for each Safety is the reduction of risk of unnecessary harm to an
subsequent definition; and acceptable minimum, and hazard a circumstance, agent or
† that key concepts and preferred terms be fit-for- action with the potential to cause harm. A circumstance is a
purpose for the ICPS. situation or factor that may influence an event, agent or
person(s), an event is something that happens to or involves a
patient, and an agent is a substance, object or system that acts
Results to produce change.
Patient safety is the reduction of risk of unnecessary harm
Forty-six key concepts were identified (including those associated with healthcare to an acceptable minimum.
describing the 10 ICPS classes), and definitions and pre- Healthcare-associated harm is harm arising from or associated
ferred terms were agreed upon at the drafting group with plans or actions taken during the provision of health-
meetings. care, rather than an underlying disease or injury.
Following this, experts were invited to a ‘challenge group’ A patient safety incident is an event or circumstance that
meeting to review the concepts and preferred terms, and could have resulted, or did result, in unnecessary harm to a
suggest refinements and/or clarification. Consequently, two patient. In the context of the ICPS, a patient safety incident
additional key concepts were identified, defined and given will be referred to as an incident. The use of the term
preferred terms—giving a total of 48 key concepts and pre- ‘unnecessary’ in this definition recognizes that errors, viola-
ferred terms. tions, patient abuse and deliberately unsafe acts occur in

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W. Runciman et al.

Figure 1 Conceptual framework for the ICPS. Solid lines enclose the 10 major classes of the ICPS and represent the
semantic relationships between them. The dotted lines link relevant preferred terms to classes. The numbers in parentheses
as given in Table 2 represent the sequence in which they appear in the text and in Table 1.

20
 Towards an ICPS: key concepts and terms

Table 1 List of preferred terms and definitions for key concepts

1 Classification: an arrangement of concepts into classes and their subdivisions, linked so as to express the semantic
relationships between them.
2 Concept: a bearer or embodiment of meaning.
3 Class: a group or set of like things.
4 Semantic relationship: the way in which things (such as classes or concepts) are associated with each other on the basis
of their meaning.
5 Patient: a person who is a recipient of healthcare.
6 Healthcare: services received by individuals or communities to promote, maintain, monitor or restore health.
7 Health: a state of complete physical, mental and social wellbeing and not merely the absence of disease or infirmity.
8 Safety: the reduction of risk of unnecessary harm to an acceptable minimum.
9 Hazard: a circumstance, agent or action with the potential to cause harm.
10 Circumstance: a situation or factor that may influence an event, agent or person(s).
11 Event: something that happens to or involves a patient.
12 Agent: a substance, object or system which acts to produce change.
13 Patient Safety: the reduction of risk of unnecessary harm associated with healthcare to an acceptable minimum.
14 Healthcare-associated harm: harm arising from or associated with plans or actions taken during the provision of
healthcare, rather than an underlying disease or injury.
15 Patient safety incident: an event or circumstance which could have resulted, or did result, in unnecessary harm to a
patient.
16 Error: failure to carry out a planned action as intended or application of an incorrect plan.
17 Violation: deliberate deviation from an operating procedure, standard or rule.
18 Risk: the probability that an incident will occur.
19 Reportable circumstance: a situation in which there was significant potential for harm, but no incident occurred.
20 Near miss: an incident which did not reach the patient.
21 No harm incident: an incident which reached a patient but no discernable harm resulted.
22 Harmful incident (adverse event): an incident that resulted in harm to a patient.
23 Harm: impairment of structure or function of the body and/or any deleterious effect arising there from. Harm
includes disease, injury, suffering, disability and death.
24 Disease: a physiological or psychological dysfunction.
25 Injury: damage to tissues caused by an agent or event.
26 Suffering: the experience of anything subjectively unpleasant.
27 Disability: any type of impairment of body structure or function, activity limitation and/or restriction of
participation in society, associated with past or present harm.
28 Contributing factor: a circumstance, action or influence which is thought to have played a part in the origin or
development of an incident or to increase the risk of an incident.
29 Incident type: a descriptive term for a category made up of incidents of a common nature, grouped because of
shared, agreed features.
30 Patient characteristics: selected attributes of a patient.
31 Attributes: qualities, properties or features of someone or something.
32 Incident characteristics: selected attributes of an incident.
33 Adverse reaction: unexpected harm resulting from a justified action where the correct process was followed for the
context in which the event occurred.
34 Side effect: a known effect, other than that primarily intended, related to the pharmacological properties of a
medication.
35 Preventable: accepted by the community as avoidable in the particular set of circumstances.
36 Detection: an action or circumstance that results in the discovery of an incident.
37 Mitigating factor: an action or circumstance that prevents or moderates the progression of an incident towards harming
a patient.
38 Patient outcome: the impact upon a patient which is wholly or partially attributable to an incident.
39 Degree of harm: the severity and duration of harm, and any treatment implications, that result from an incident.
40 Organizational outcome: the impact upon an organization which is wholly or partially attributable to an incident.
41 Ameliorating action: an action taken or circumstances altered to make better or compensate any harm after an incident.
(continued )

21
W. Runciman et al.

Table 1 Continued

42 Actions taken to reduce risk: actions taken to reduce, manage or control any future harm, or probability of harm,
associated with an incident.
43 Resilience: The degree to which a system continuously prevents, detects, mitigates or ameliorates hazards or incidents.
44 Accountable: being held responsible
45 Quality: the degree to which health services for individuals and populations increase the likelihood of desired
health outcomes and are consistent with current professional knowledge.
46 System failure: a fault, breakdown or dysfunction within an organization’s operational methods, processes or
infrastructure.
47 System improvement: the result or outcome of the culture, processes, and structures that are directed towards the
prevention of system failure and the improvement of safety and quality.
48 Root cause analysis: a systematic iterative process whereby the factors that contribute to an incident are identified by
reconstructing the sequence of events and repeatedly asking why? Until the underlying root causes have been
elucidated.

Table 2 List of preferred terms for key concepts in alphabetical order

Accountable (44) Incident characteristics (32)

Actions taken to Reduce Risk (42) Incident type (29)
Adverse reaction (33) Injury (25)
Agent (12) Mitigating factor (37)
Ameliorating action (41) Near miss (20)
Attributes (31) No harm incident (21)
Circumstance (10) Organizational outcome (40)
Class (3) Patient (5)
Classification (1) Patient characteristic (30)
Concept (2) Patient outcome (38)
Contributing factor (28) Patient safety (13)
Degree of harm (39) Patient safety incident (15)
Detection (36) Preventable (35)
Disability (27) Quality (45)
Disease (24) Resilience (43)
Error (17) Risk (18)
Event (11) Root cause analysis (48)
Harm (23) Safety (8)
Harmful incident (adverse event) (22) Semantic relationship (4)
Hazard (9) Side effect (34)
Reportable circumstance (19) Suffering (26)
Health (7) System failure (46)
Healthcare (6) System improvement (47)
Healthcare-associated harm (14) Violation (16)

The numbers in parentheses refer to the sequence in which these preferred terms appear in Table 1 and in the text.

healthcare and are unnecessary incidents, whereas certain a failure to carry out a planned action as intended or appli-
forms of harm, such as an incision for a laparotomy, are cation of an incorrect plan. Errors may manifest by doing
necessary. The former are incidents, whereas the latter is not. the wrong thing (commission) or by failing to do the right
Incidents arise from either unintended or intended acts. thing (omission), at either the planning or execution phase
Errors are, by definition, unintentional, whereas violations [12, 13]. Thus, if screening for bowel cancer involves regular
are usually intentional, though rarely malicious, and may testing for occult blood, then a screening colonoscopy in the
become routine and automatic in certain contexts. An error is absence of prior occult blood testing comprises an error of

22
 Towards an ICPS: key concepts and terms

commission (the application of an incorrect plan), whereas Table 3 Incident type

failure to arrange testing for occult blood would constitute
an error of omission. Violation is a deliberate deviation from
an operating procedure, standard or rule. Both errors and † Clinical administration
violations increase risk, even if an incident does not actually † Clinical process/procedure
occur [12, 13]. Risk is the probability that an incident will † Documentation
occur. † Healthcare-associated infection
A reportable circumstance is a situation in which there was sig- † Medication/IV fluids
nificant potential for harm, but no incident occurred, for † Blood/blood products
example, a busy intensive care unit remaining grossly under- † Nutrition
staffed for an entire shift, or taking a defibrillator to an † Oxygen/gas/vapour
emergency and discovering it does not work, although it was † Medical device/equipment
not needed. A near miss is an incident which did not reach † Behaviour
the patient, for example, a unit of blood being connected to † Patient accidents
the wrong patient’s IV line, but the error detected before the † Infrastructure/building/fixtures
infusion started. A no harm incident is one in which an event † Resources/organizational management
reached a patient but no discernable harm resulted, for
example, if the unit of blood was infused, but was not
incompatible. A harmful incident (adverse event) is an incident
that results in harm to a patient, for example, if the wrong
unit of blood was infused, and the patient died from a hae- attributes of an incident, e.g. care setting, treatment status,
molytic reaction. specialties involved and date of an incident.
Harm implies impairment of structure or function of With reference to medication, an adverse reaction is unex-
the body and/or any deleterious effect arising there from, pected harm arising from a justified treatment, for example,
including disease, injury, suffering, disability and death, and unexpected neutropenia due to a drug not known to have
may be physical, social or psychological. Disease is a physio- this effect. Recurrence of a previously encountered adverse
logical or psychological dysfunction, injury is damage to reaction may be preventable (e.g. avoiding re-exposure of a
tissues caused by an agent or event and suffering is the experi- patient with drug allergy). Side effect is a known effect, other
ence of anything subjectively unpleasant. Suffering includes than that primarily intended, related to a medicine’s pharma-
pain, malaise, nausea, depression, agitation, alarm, fear and cological properties, such as nausea after morphine has been
grief. Disability implies any type of impairment of body given to alleviate pain.
structure or function, activity limitation and/or restriction of Preventable is being accepted by the community as avoid-
participation in society, associated with past or present harm. able in the particular set of circumstances. Detection is an
A contributing factor is a circumstance, action or influence action or circumstance that results in the discovery of an inci-
(such as poor rostering or task allocation) that is thought to dent, e.g. by noticing an error, by a monitor or alarm, by a
have played a part in the origin or development, or to change in patient condition or by a risk assessment.
increase the risk, of an incident. Contributing factors may be Detection mechanisms may be part of the system (such as
external (not under the control of a facility or organisation), low pressure disconnect alarm in a breathing circuit),
organizational (e.g. unavailability of accepted protocols), may result from a checking process or from vigilance and
related to a staff factor (e.g. an individual cognitive or beha- ‘situation awareness’.
vioural defect, poor team work or inadequate communi- A mitigating factor is an action or circumstance that prevents
cation) or patient-related (e.g. non-adherence). A contributing or moderates the progression of an incident towards
factor may be a necessary precursor of an incident and may harming a patient. The mechanism by which damage may
or may not be sufficient to cause the incident. occur is already in train, but has not yet led to either any or
Incidents are classified into a number of different types. the maximum possible harm.
An incident type is a category made up of incidents of a The term ‘recovery’ has been used to describe the combi-
common nature, grouped because of shared agreed features nation of detection and mitigation; it does not refer to clini-
(Table 3) and is a ‘parent’ natural category under which cal recovery (recuperation) but to the process of recovering
many concepts may be grouped. from an incident that has started. Reconnecting a breathing
An incident can be assigned to several incident types. circuit after a disconnect alarm warning is an example of
Thus, for example, an incident in which an infusion pump recovery. By collecting information about how and why
was set up wrongly and delivered a sedative overdose, ‘saves’ are made, system design, training and education can
causing respiratory arrest, would be allocated both ‘medi- be informed.
cation’ and ‘equipment’ incident types. Patient outcome is the impact upon a patient which is wholly
Patient characteristics are selected attributes of a patient, such or partially attributable to an incident. Where harm has
as patient demographics or the reason for presentation to occurred, the degree of harm is the severity and duration of any
healthcare. Attributes are qualities, properties or features of harm, and any treatment implications, that result from an
someone or something. Incident characteristics are selected incident. It would seem, from first principles, desirable to

23
W. Runciman et al.

record the nature, severity and duration of harm separately. Discussion

However, there are problems in doing this with substantial
overlap existing between these parameters and previous The consistent use of key concepts with agreed definitions
attempts to rank the degree of harm tend to conflate these and preferred terms, in conjunction with a comprehensive
parameters into one scale [14 – 16]. but adaptable classification, will pave the way for researchers
Incidents also affect healthcare organizations. to understand each others’ work, and facilitate the systematic
Organizational outcome is the impact upon an organization that collection, aggregation and analysis of relevant information.
is wholly or partially attributable to an incident, e.g. adverse This will allow comparisons between facilities and jurisdic-
publicity or additional use of resources. tions, and allow trends to be tracked over time.
Ameliorating action is an action taken or circumstance Forty-eight concepts were identified, and definitions and
altered to make better or compensate any harm after an inci- preferred terms agreed. The concepts defined and terms
dent. Patient ameliorating factors are actions taken or circum- chosen so far represent a collection of basic building blocks
stances altered to make good harm to a patient, such as to enhance the study of patient safety. Definitional refine-
fixing a fracture after a fall, whereas healthcare system ameli- ment will be necessary as our understanding widens and
orating factors reduce loss or damage to an organization, e.g. further needs are identified. Translation into other languages
good public relations management after a publicized disaster is ongoing. More concepts will need to be identified and
will ameliorate the effects on a facility’s reputation. defined, and decisions made with respect to which terms
Actions taken to reduce risk are actions taken to reduce, should be preferred and which terms avoided. An on-going
manage or control any future harm, or probability of harm, process is planned by which patient safety experts from
associated with an incident. Such actions can affect incidents, different cultures and parts of the world will test the ICPS
contributing factors, detection, mitigating factors or amelior- for the appropriateness and relevance of the concepts to
ating actions, and can be pro-active or reactive. Pro-active
ensure they are fit-for-purpose in all the contexts in which
actions may be identified by techniques such as failure mode
the classification will be used. This will ensure that the con-
and effects analysis [17] and probabilistic risk analysis [18],
cepts defined and terms chosen will facilitate the understand-
whereas reactive actions are taken in response to insights
ing and transfer of information among the increasing
gained after incidents (e.g. root cause analysis).
number of people with an interest in patient safety.
Resilience refers to the degree to which a system continu-
Some terms for concepts were excluded because their
ously prevents, detects, mitigates or ameliorates hazards or
meanings vary across jurisdictions (e.g. ‘negligence’); they
incidents. Resilience allows an organization to ‘bounce back’
have discipline-specific meanings (e.g. ‘accident’—in aviation
to its original ability to provide core functions as soon as
meaning the loss of an aircraft hull) or are already being
possible after incurring damage.
A number of terms are commonly used regarding organiz- used with special meanings in a WHO classification (e.g.
ational management. Accountable is being held responsible. ‘complication’, ‘misadventure’ or ‘sequela’). The term
Quality is the degree to which health services for individuals ‘healthcare-associated’ was preferred to ‘iatrogenic’ and
and populations increase the likelihood of desired health out- ‘nosocomial’; these terms are associated with physicians and
comes and are consistent with current professional knowl- hospitals, respectively, and the classification is intended to be
edge. System failure refers to a fault, breakdown or of relevance across all healthcare.
dysfunction within an organization’s operational methods, Other sets of definitions and terms of relevance to patient
processes or infrastructure. Factors contributing to system safety have been developed. Our primary consideration was
failure can be latent (hidden or apt to elude notice) or appar- to try to ensure that our definitions would be ‘fit-for-
ent, and can be related to the system, the organization, staff purpose’ in the specific context of the ICPS. Given the
or a patient. A latent factor might be a breathing circuit dis- plethora of terms, concepts and definitions, it was inevitable
connect alarm with no power failure warning or battery that ours would differ from many others. For example, a
backup [19]. System improvement is the result or outcome of Canadian set of patient safety definitions exist, which [20] is
the culture, processes and structures that are directed somewhat discursive but provides insightful, valuable reflec-
towards the prevention of system failure and the improve- tions on 26 concepts, 8 of which terms are defined in our
ment of safety and quality. Processes to counter the latent current paper. Comparing the Canadian definitions with the
failure described would include modification of the equip- ICPS definitions of the same terms underlines the complex-
ment to alarm when the power supply is compromised, or ity of trying to unify language and understanding. For
use of an additional device, such as a capnograph, to alarm example, in the Canadian dictionary, one definition of safety
if carbon dioxide is not detected in expired air. is given that describes a concept similar to that agreed by the
Finally, root cause analysis, a reactive form of risk assessment ICPS, but the ‘recommendation’ is for another definition to
to inform the development of actions taken to reduce risk, is be used which describes the ‘processes’ for ‘enhancing’ safety
a systematic iterative process whereby the factors that con- (‘ . . . the reduction and mitigation of unsafe acts within the
tribute to an incident are identified by reconstructing the healthcare system . . . ’).
sequence of events and repeatedly asking ‘why?’ until the A European set of definitions [21] was also developed at
underlying root causes (contributing factors or hazards) have the same time as the ICPS. Although the World Alliance and
been elucidated. the Australian Council for Safety and Quality are cited as

24
 Towards an ICPS: key concepts and terms

sources for this work, of the 6 definitions in their list of 24, patient safety classification. Qual Saf Health Care 2006;15 (Suppl
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