Active failure is an unsafe act (errors and violations) committed by peo-ple who are in direct contact with the patient or system (Reason J. , Understanding adverse events: human factors, 1995)
Adverse Event stands for a damage caused by the medical treatment
and not by the disease itself.
An adverse event occurred if a patient was injured by healthcare intervention rather than an underlying condi-tion85.
Closed Loop
Management is method which is based on the regulation of meth-ods/models and includes the Plan-Do-Check-Act activities in terms of the PDCA-cycle. With other words, it is a regu-lation model (German: Regelungsmodell). See also the term cybernetic regulation model.
Concept of "clinical": The term "clinical” can have different meanings in different countries. In the standard EN 15224 "clinical" refers to all types of interactions between patients and all kinds of healthcare professionals. Here, “clinical” is not restricted to the hospital context.
Control measure there is a differentiation between:
85 http://www.evidenceintopractice.scot.nhs.uk/patient-safety/what-is-patient-safety.aspx, retrieved 2014-11-24
Reactive control measure: a reactive method to control the implementation of measures set by the achieved feedback reaction (German: reaktive Lenkungsmaßnah-me).
Proactive control measure: proactive method which is used to control measures being implemented proactive to information disclosure (German: proaktive Lenkungsmaßnahme).
Clinical risk: “Clinical risk denotes any risk that could have negative effects on the outcomes for any of the quality require-ments. The risk factors could be non-clinical, but the risk is considered a clinical risk if it could have any negative impact on any of the quality requirements”, (ÖNORM EN 15224, 2012). Aspects of clinical Risk Management are integrated in the standard EN 15224.
Cybernetic
control model according to Schwaiger86 this corresponds to the Open Loop Management: A cybernetic control exists when the management process lacks the control activity, what an open functional chain justifies (Kybernetisches Steuer-ungsmodell).
Cybernetic
regulation model according to Schwaiger86 this corresponds to the Closed Loop Management: Includes the management process a control activity, then there is a closed functional chain and thus a cybernetic regulation exists (German: Kybernet-isches Regelungsmodell)
Error The word error entails different meanings and usages relative to how it is conceptually applied87.
In reference to human error: An 'error' is a deviation from accuracy or correctness. A 'mistake' is an error caused by a fault: the fault being misjudgement, carelessness, or forgetfulness. Explanation: “Now, say that I run a stop sign because I was in a hurry, and wasn't concentrating, and the police stop me, that is a mistake. If, however, I try to park in an area with conflicting signs, and I get a ticket because I was incorrect on my interpretation of what the signs meant, that would be an error. The first time it would
86 Walter S.A. Schwaiger, „Grundlagen der Betriebswirtschaft“, Vienna University of Technology, script, 12/2010, page 160
87 http://en.wikipedia.org/wiki/Error; retrieved 2013-01-11
be an error. The second time it would be a mistake since I should have known better.”88
Failure Failure is the state or condition of not meeting a desirable or intended objective, and may be viewed as the opposite of success89.
Failure Mode Failure Mode is the manner in which a component, sub-system, or system could potentially fail to meet the design intent. The potential failure mode could also be the cause of a potential failure mode in a higher level subsystem, or system, or the effect of a lower level effect. (Stamatis, 1995)
Fault (technology) is defined as an abnormal condition or defect at the com-ponent, equipment, or sub-system level which may lead to a failure90. adverse events: human factors, 1995)
Medical error A medical error is a preventable adverse effect of care, whether or not it is evident or harmful to the patient. This might include an inaccurate or incomplete diagnosis or treatment of a disease, injury, syndrome, behaviour, infec-tion, or other ailment.91
Mistake A 'mistake' is an error caused by a fault: the fault being misjudgement, carelessness, or forgetfulness; see ER-ROR
Near Miss (sometimes referred to as a ‘close call’ or ‘free lesson’) is any incident that could have led to harm but did not, either by chance or through timely intervention85.
Open Loop
Management is a method which is based on the control of meth-ods/models and includes the Plan-Do-Act-activities in
88 Robinson, P. "In the Matter of: The Gatekeeper: The Gate Contracts”
89 http://en.wikipedia.org/wiki/Failure; retrieved 2013-01-11
90 ISO/CD 10303-226
91 http://en.wikipedia.org/wiki/Medical_error, retrieved 2014-05-30
terms of the PDCA-cycle (control model, German: Steuer-ungsmodell). In this model there is no check activity ac-cording to the PDCA-cycle induced and the model is state-dependent. See also the term cybernetic control model.
Risk RISK is defined as the probable rate of occurrence of a hazard causing harm and the degree of severity of the harm (EN 50126, 1999)
Safety is defined as Freedom from unacceptable risk of harm (EN 50126, 1999)
Significant Event is a term mainly used in primary care which is defined as
‘any event thought by anyone in the team to be significant in the care of patients or the conduct of the organisation.’
This broad based definition can also include all other terms such as near miss or patient safety incident. Con-fusingly, it also includes positive events (incidents involv-ing outstandinvolv-ing examples of healthcare delivery) 85. Slip accidentally wrong conduct a really proper behaviour
necessary (German: Ausrutscher)
System failures Failures due to errors in any safety Iifecycle activity, within any phase, which cause it to fail under some particular combination of inputs or under some particular environ-mental condition (EN 50126, 1999).
Treatment failure A treatment failure occurs when a medical treatment was not carried out in compliance with the time of treatment according current knowledge state of medical science, un-less the patient and the treatment provider have agreed and valid a different standard of care. Treatment failure can result from any act or omission. Therapists have to bear the consequences to civil, criminal or administrative must adhere.92 (German: Behandlungsfehler, Kunstfehler)
92 http://patientensicherheit-online.de/service-ps-online/glossar-patientensicherheit#B; retrieved 2014-05-30
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