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For source citations in parentheses, see the Patient Safety Definitions Source List.


Fault tree analysis: A systematic way of prospectively examining a design for possible ways in which failure can occur. The analysis considers the possible direct proximate causes that could lead to the event and seeks their origins. Once this is accomplished, ways to avoid their origins must be identified. (JCAHO 2001)

Failure mode, effect, and criticality analysis (FMEA, FMECA, HFMEA): (1) A systematic way of examining a design prospectively for possible ways in which failure can occur. It assumes that no matter how knowledgeable or careful people are, errors will occur in some situations and may even be likely to occur. (JCAHO 2001); (2) The systematic assessment of a process or product that enables one to determine the location and mechanism of potential failures. (Zipperer et al.)

Five rights of medication administration: Right patient, right drug, right dose, right time, and right route. (Zipperer et al.)

Fixation error: The “persistent” failure to revise a diagnosis or plan in the face of readily available evidence that suggests a revision is necessary. (Zipperer et al.)

Forcing functions: Something that prevents the behavior from continuing until the problem has been corrected. (Reason 1990)

Genotype of an incident: Patterns about how people, teams, and organizations coordinate activities, information, and problem solving to cope with the complexities of problems that arise. The surface characteristics [phenotype] of a near miss or adverse event are unique to a particular setting and people. Genotypical patterns re-appear in many specific situations. (Woods) [See also phenotype.]

Genotype of an incident: Underlying mechanisms for patient safety problems, deeply rooted characteristics of healthcare systems. Includes: Latent failure in organizational structure or processes; safety culture and the blame process; organizational learning processes and barriers; production pressure; fundamental human limitations; performance-shaping factors; fatigue and sleep deprivation; stress; human factors design in devices and systems. (NPSF); (2) The characteristic collection of factors that lead to the surface, phenotypical appearance of the event. Genotypes refer to patterns of contributing factors. They identify deeper characteristics that many superficially different phenotypes have in common. (Zipperer et al.)

Harm: Death, or temporary or permanent impairment of body function/structure requiring intervention. (NCCMERP)

Hazard: Anything that can cause harm. (NHS)

High reliability organization (HRO): Highly complex, technology-intensive organization that must operate, as far as humanly possible, to a failure-free standard. (Zipperer et al.)

Hindsight bias: Finding out that an outcome has occurred increases its perceived likelihood. Judges are, however, unaware of the effect that outcome knowledge has on their perceptions. Thus judges tend to believe that this relative inevitability was largely apparent in foresight, without the benefit of knowing what happened. (Zipperer et al.)

Hospitalization (Serious Adverse Reaction): If a patient is admitted or has a prolonged hospital stay because of a serious adverse reaction Example: a serious allergic reaction to a product such as latex. (Henkel FDA)

Human factors: Study of the interrelationships between humans, the tools they use, and the environment in which they live and work. (Kohn et al.)

Iatrogenic: (1) Resulting from the professional activities of physicians, or, more broadly, from the activities of health professionals. Originally applied to disorders induced in the patient by autosuggestion based on a physician’s examination, manner, or discussion, the term is currently applied to any undesirable condition in a patient occurring as a result of treatment by a physician (or other health professional), especially to infections acquired by the patient during the ocurse of treatment; (2) Pertaining to an illness or injury resulting from a procedure, therapy, or other element of care. (JCAHO 2001); (3) Any illness that resulted from a diagnostic procedure or from any form of therapy. In addition, we included harmful occurrences (i.e., injuries from a fall or decubitus ulcers) that were not natural occurrences of the patient’s diseases. However, the term iatrogenic should not be construed to mean that there was any culpability on the part of the physician or hospital, or that the illness was necessarily preventable. (Zipperer et al.)

Improper dose: Resulting in overdosage, under dosage or extra. (NCCMERP)

Incident: Involved damage that is limited to parts of a unit, whether the failure disrupts the system or not. (Zipperer et al.)

Incident reporting: A process used to document occurrences that are not consistent with routine hospital operation or patient care. (Zipperer et al.)

Individual accidents: Ones in which a specific person or group is often both the agent and the victim of the accident. The consequences to the people concerned may be great, but their spread is limited. (Zipperer et al.)

Individual errors: Those deriving primarily form deficiencies in the physician’s own knowledge, skill, or attentiveness. (Zipperer et al.)

Interpersonal relations, conflict behaviors that increase risk to patients in operating theatres: Overt hostility and frustration (e.g., patient deteriorates while surgeon and anesthetist are in conflict over whether to terminate surgery after pneumothorax). (Helmreich)

Intervention: May include monitoring the patient’s condition, change in therapy, or active medical or surgical treatment. (NCCMERP)

Isolation: A means [in industry] to separate a process with high probability of failure from other processes to minimize the impact on the products being produced. (Zipperer et al.)

Lack of training (Safety Concern): Lack of training or inadequate training can leave our employees unprepared to perform. Staff not oriented or not understanding the process. (ESRD)

Lack of/limited access to information (Safety Concern): No information or limited information available at the time. Our information systems, medical records, decision support systems should give our employee the information they need when they need it. Examples: missing allergy information could contribute to a medication error. (ESRD)

Lapses: Internal events [that] generally involve failures of memory. (Reason 1997)

Latent condition: Preferred to latent error since it does not necessarily involve either error or failure. (Reason 1997)

Latent error: Errors in the design, organization, training, or maintenance that lead to operator errors and whose effects typically lie dormant in the system for lengthy periods of time. (Kohn et al.)

Latent failure: An error which is precipitated by a consequence of management and organizational processes and poses the greatest danger to complex systems. Latent failures cannot be foreseen but, if detected, they can be corrected before they contribute to mishaps. (JCAHO 2001); (2) Delayed-action consequences of decisions taken in the upper echelons of the organization of system. They relate to the design and construction of plant and equipment, the structure of the organization, planning and scheduling, training and selection, forecasting, budgeting, allocating resources, and the like. The adverse safety effects of these decisions may lie dormant for a very long time. (Zipperer et al.)

Latent systems failures: Small, individually innocuous systems faults that, if occurring in specific combination, can lead to catastrophic events. (ESRD)

Leadership behaviors that increase risk to patients in operating theatres: Failure to establish leadership for operating room team. (Helmreich)

Life-threatening hazard (Serious Adverse Reaction): If the patient was at risk of dying at the time of the adverse reaction or if it is suspected that continued use of a product would cause death. Example: pacemaker breakdown or failure of an intravenous (IV) pump that could cause excessive drug dosing. (Henkel FDA)

Look alike or sound alike situation (Safety Concern): Ambiguous labeling and non-distinct storage containers can lead to inappropriate use of medications or products. Examples: drug names may look or sound similar, intravenous fluids may be packaged alike, reagent bottles may be the same size and color. (ESRD)

Malpractice: Improper or unethical conduct or unreasonable lack of skill by a holder of a professional or official position; often applied to physicians, dentists, lawyers, and public officials to denote negligent or unskillful performance of duties when professional skills are obligator. Malpractice is a cause of action for which damages are allowed. (JCAHO 2001); (2) Negligent errors. (Zipperer et al.)

Medical error: An adverse event or near miss that is preventable with the current state of medical knowledge. (QuIC)

Medical mistake: A commission or an omission with potentially negative consequences for the patient that would have been judged wrong by skilled and knowledgeable peers at the time it occurred, independent of whether there were any negative consequences. This definition excludes the natural history of disease that does not respond to treatment and the foreseeable complications of a correctly performed procedure, as well as cases in which there is a reasonable disagreement over whether a mistake occurred. (Zipperer et al.)

Medical technology: Techniques, drugs, equipment, and procedures used by health care professionals in delivering medical care to individual and the systems within which such care is delivered. (Kohn et al.)

Medication error: Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labeling, packing and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use. (Zipperer et al.)

Medication error index (NCCMERP):

No error:

Category A: Circumstances or events that have the capacity to cause error
Error, no harm*:

Category B: An error occurred but the medication did not reach the patient

Category C: An error occurred that reached the patient but did not cause patient harm Category D: An error occurred that resulted in the need for increased patient monitoring but no patient harm.

Error, harm:

Category E: An error occurred that resulted in the need for treatment or intervention and caused temporary patient harm

Category F: An error occurred that resulted in initial or prolonged hospitalization and caused temporary patient harm
Category G: An error occurred that resulted in permanent patient harm

Category H: An error occurred that resulted in a near-death even (e.g., cardiac arrest)

Error, death:

Category I: An error occurred that resulted in patient death

*harm: death, or temporary or permanent impairment of body function/structure requiring intervention.

Mispractice: Honest misjudgment. (Zipperer et al.)

Mistake: The actions may conform exactly to the plan, but the plan is inadequate to achieve its indented outcome. (Zipperer et al.)

Misuse: When an appropriate service has been selected but a preventable complication occurs and the patient does not receive the full potential benefit of the service. (Zipperer et al.)

Micro-system: Organizational unit built around the definition of repeatable core service competencies. Elements of a micro-system include: (1) a core team of health care professionals, (2) a defined population, (3)carefully designed work processes, and (4) an environment capable of linking information on all aspects of work and patient or population outcomes to support ongoing evaluation of performance. (Kohn et al.)

Monitoring error: Includes contraindicated drugs resulting in a drug-drug interaction, drug-food/nutrient interaction, documented allergy, drug-disease interaction, or clinical reaction (blood glucose, prothromgin, blood pressure, etc.). (NCCMERP)

Monitoring failure, vigilance failure: Those in which the essence is a failure to recognize or act upon visible data requiring a response. (Zipperer et al.)

Multiple entry (Safety Concern): Multiple entry points for identical information can lead to conflicting or ambiguous data, or omissions. Examples: allergy, height and weight information may be entered into the patient record at multiple points in our system. (ESRD)


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