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



Near miss: (1) A situation in which an event or omission, or a sequence of events or omissions, arising during clinical care fails to develop further, whether or not as the result of compensating action, thus preventing injury to a patient. (NHS); (2) An event or situation that could have resulted in an accident, injury or illness, but did not, either by chance or through timely intervention. (QuIC) Also known as close call or near hit. (ESRD)

Needs intervention to avoid permanent damage (Serious Adverse Reaction): If use of a medical product required medical or surgical treatment to prevent impairment. Examples: burns from radiation equipment or breakage of a screw supporting a bone fracture. (Henkel FDA)

Negligence: (1) Care that fell below the standard expected of physicians in their community. (Brennan et al.); (2) Failure to use such care as a reasonably prudent and careful person would use under similar circumstances. (JCAHO 2001)

Negligent injuries: By definition, in negligent injuries the standard of care and the procedures to prevent injury were well know, as well as the likelihood of serious injury if they are not followed. (Zipperer et al.)

Non-standard process (Safety Concern): No procedure or process exists. When processes are improvised there can be subtle differences between standard and non-standard process that are missed in time pressured situations. Examples: micro-waving gel-packs when not the manufacturer’s recommended warming method can result in burns; taking shortcuts on procedures; relying on folklore nursing techniques rather than following protocols. (ESRD)

Normal accident: If interactive complexity and tight coupling — system characteristics — inevitably will produce an accident, I believe we are justified in calling it a “normal accident,” or a “system accident.” The odd term “normal accident” is meant to signal that, given the system characteristics, multiple and unexpected interactions of failures are inevitable. System accidents are uncommon, even rare; yet this is not all that reassuring, if they can produce catastrophes. (Perrow)

Omission: Failure to carry out some of the actions necessary to achieve a desired goal. (Reason 1997)

Order transcription: Manually transcribed order leads to misinterpretation.

Organizational accident: Comparatively rare, but often catastrophic, events that occur within complex modern technologies such as nuclear power plants, commercial aviation, the petrochemical industry, chemical process plants, marine and rail transport, banks and stadiums. Organizational accidents have multiple causes involving many people operating at different levels of their respective companies. (Zipperer et al.)

Overuse: When a health care service is provided under circumstance in which its potential for harm exceeds the benefit. (Zipperer et al.)

Patient: An individual who receives care or services, or one who may be represented by an appropriately authorized person. For hospice providers, the patient and family are considered a single unit of care. Synonyms used by various health care fields included client, resident, customer, individual served, patient and family unit, consumer or health care consumer. (JCAHO 2000)

Patient safety: (1) The avoidance, prevention and amelioration of adverse outcomes or injuries stemming from the processes of health care. These events include “errors,” “deviations,” and “accidents.” Safety emerges from the interaction of the components of the system; it does not reside in a person, device, or department. Improving safety depends on learning how safety emerges from the interactions of the components. Patient safety is a subset of healthcare quality. (NPSF); (2) Freedom from accidental injury; ensuring patient safety involves the establishment of operational systems and processes that minimize the likelihood of errors and maximize the likelihood of intercepting them when they occur. (Kohn et al.): (3) Actions undertaken by individuals and organizations to protect health care recipients from being harmed by the effects of health care services. (Spath)

Phenotype: (1) Safety problems, failures in specific health areas, i.e. the superficial characteristics of the system as opposed to underlying mechanisms: prevalence and cause of medication errors by health care personnel in all settings; Surgery or procedure on wrong part of body; errors in performance of hazardous activities (surgery, anesthesia, radiation therapy, etc.); misdiagnosis, selection of inappropriate treatment; and nosocomial infection. (NPSF); (2) What happens, what people actually do or what they do wrong, what you can observe. Phenotypes are specific to the local situation and context — the surface appearance of an incident. (Zipperer et al.) [See also genotype.]

Potential adverse drug event: An incident in which an error was made but no harm occurred. (Zipperer et al.) [See also Near miss.]

Preparation, planning, vigilance behaviors that increase risk to patients in operating theatres: Failure to plan for contingencies in treatment plan and failure to monitor situation and other team’s activities (e.g., distracted anesthetist fails to note drop in blood pressure after monitor’s power fails). (Helmreich)

Preventability: Implies that methods for averting a given injury are known and that an adverse event results from failures to apply that knowledge. (Zipperer et al.)

Procedural error: (from aviation) followed procedures with wrong execution (e.g., wrong entry into flight management computer). (Helmreich)

Proficiency error: (from aviation) error due to lack of knowledge or skill (e.g., inability to program automation). (Helmreich)

Protocol/checklist inadequate (Safety Concern): No checklist or incomplete checklist or checklist not used. (Reference materials and checklists reduce reliance on memory.) Examples: protocol might be not user friendly, incomplete, non-current, non-standard terminology (metric vs. non-metric, etc.), hard to follow, complex. (ESRD)

Proximate cause: (1) Not “true” cause but domains where the cause most likely exists (BJC); (2) An act or omission that naturally and directly produces a consequence. It is the superficial or obvious cause for an occurrence. Treating only the “symptoms,” or the proximate special cause, may lead to some short-term improvements, but will not prevent the variation from recurring. (JCAHO 2001)

Quality of Care: Degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge. (Kohn et al.)

Recognition and cues not effective (Safety Concern):
Our systems should be designed so that our people can easily recognize when systems begin to fail or have failed. Examples: it should be easy to recognize that a person with a pacemaker is about to receive an MRI, it should be easy for staff to recognize and question abnormalities in a process or procedure. (ESRD)

Reliance on human checks (or rechecks) (Safety Concern): Processes that rely on double-checking or triple-checking are prone to error. (ESRD)

Reliance on memory (Safety Concern): No tools or “memory aids” to assist in guiding individual through the process of tools not used. (Human memory degrades as time goes by. Reliance on memory during multi-tasking is highly error prone.) Examples: Not checking MAR; verbal hand-offs vs. written; didn’t refer to an available protocol. (ESRD)

Reliance on vigilance (Safety Concern): Process relies on frequent or constant observation to ensure accuracy. Examples: humans make poor monitors because they can be easily distracted; an IV pump is more reliable than a nurse in the on-going monitoring of the rate of infusion; patients may fall when not supervised. (ESRD)

Reportable occurrence:
An event, situation, or process that contributes to, or has the potential to contribute to, a patient or visitor injury, or degrade our ability to provide optimal patient care. Reportable occurences can generally be divided into the following types based on severity: Sentinel events, patient and visitor injuries, [adverse events], near misses, and safety concerns. (ESRD)

Risk: The likelihood, high or low, that somebody or something will be harmed by a hazard, multiplied by the severity of the potential harm. (NHS)

Risk containment: Immediate actions taken to safeguard patients from a repetition of an unwanted occurrence. Actions may involve removing and sequestering drug stocks from pharmacy shelves and checking or replacing oxygen supplies or specific medical devices. (JCAHO 2001)

Risk management: (1) Clinical and administrative activities undertaken to identify, evaluate, and reduce the risk of injury to patients, staff, and visitors and the risk of loss to the organization itself. (JCAHO 2001); (2) In the context of hospital operations, the term “risk management” usually refers to self-protective activities meant to prevent real or potential threats of financial loss due to accident, injury, or medical malpractice. (Zipperer et al.)

Root cause: The most fundamental reason an event has occurred. (ESRD)

Root cause analysis: A process for identifying the basic or causal factor or factors that underlie variation in performance, including the occurrence or possible occurrence of a sentinel event. (JCAHO 1996)

Rule-based behavior: Familiar procedures applied to frequent decision-making. (Zipperer et al.)

Safety: The degree to which the risk of an intervention (for example, use of a drug or a procedure) and the risk in the care environment are reduced for patient and other persons, including health care practitioners. (JCAHO 2000)

Safety Concern: Protocols, procedures, products, or equipment that are problem prone, or risk-generating processes that may degrade our ability to provide optimal patient care. (ESRD)

Safety Culture: Five attributes of a safety culture — these are the five high-level attributes of a “safety culture,” that we strive to operationalize through the implementation of strong safety management systems. (ESRD)

  1. A culture where all workers (including front line staff, physicians, and administrators) accept responsibility or the safety of themselves, their co-workers, patients, and visitors
  2. Prioritizes safety above financial and operational goals
  3. Encourages and rewards the identification, communication, and resolution of safety issues.
  4. Provides for organizational learning from accidents.
  5. Provides appropriate resources, structure and accountability to maintain effective safety systems.

Sentinel event: An unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or function. The phrase “or the risk thereof” includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. Such events are called “sentinel” because they signal the need for immediate investigation and response. (JCAHO 2001)

Serious adverse reaction: A reaction that involves death; a life-threatening hazard; hospitalization; disability; birth defects, miscarriage, stillbirth or birth with disease; or needs intervention to avoid permanent damage. (Henkel FDA)

Serious event: One that leads to or prolongs hospitalization, contributes to or causes death, or is associated with cancer or a congenital anomaly. (Zipperer et al.)

Serious outcome: Death, a life-threatening condition, initial or prolonged hospitalization, disability, or congenital anomaly, or when intervention was required to prevent permanent impairment or damage. (Zipperer et al.)

Sharp end: Where practitioners interact directly with the hazardous process in their roles as pilots, mechanics, air traffic controllers, and in medicine, as nurses, physicians, technicians, pharmacists and others (Zipperer et al.)

Sharp end of healthcare system: Practitioners at the sharp end actually interact with the hazardous process in their roles. In medicine, these practitioners are anesthesiologists, surgeons, nurses, and some technicians who are physically and temporally close to the patient (Reason, taken from Cook and Woods, 1994)

Skill-based behavior: Routine tasks requiring little or no conscious attention during execution. (Zipperer et al.)

Slip: (1) Observable actions…commonly associated with attentional or perceptional failures. (Reason 1997); (2) An unintended error or execution of a correctly intended action. (Zipperer et al.)

Standard: A minimum level of acceptable performance or results or excellent levels of performance or the range of acceptable performance or results. The American Society for Testing and Materials lists six types of standards: methods, specification, practice, terminology, guide, and classification. (Kohn et al.)

Standard classification: A systematic arrangement or division of materials, products, systems, or services into groups based on similar characteristics such as origin, composition, properties, or use. (Kohn et al.)

Standard guide: A series of options or instructions that do not recommend a specific course of action. (Kohn et al.)

Standard practice: A definitive procedure for performing one or more specific operations or functions that does not produce a test result. (Kohn et al.)

Standard specification: A precise statement of a set of requirements to be satisfied by a material, product, system, or service that also indicates the procedures for determining whether each of the requirements is satisfied. (Kohn)

Standard terminology: A document comprised of terms, definitions of terms, descriptions of terms, explanations of symbols, abbreviations, or acronyms. (Kohn et al.)

Standard test method: A definitive procedure for the identification, measurement, and evaluation of one or more qualities, characteristics, or properties of a material, product, system, or service that produces a test result. (Kohn et al.)

System: (1) Set of interdependent elements interacting to achieve a common aim. These elements may be both human and non-human (equipment, technologies, etc.). (Kohn et al.); (2) A regularly interacting or interdependent group of items forming a unified whole. (QuIC)

System complexity (Safety Concern): Process with multiple steps and/or decision points. (Complex systems require excessive attention and can be tightly coupled). Examples: a surgical tray arrives missing a critical component; or a delayed or erroneous lab result. If there are no contingencies for these types of events there could be significant consequences. (ESRD)

System errors: The delayed consequences of technical design or organizational issues and decisions. Also refereed to as latent errors. (Zipperer et al.)

Systems approach: Using prompt, intensive investigation followed by multidisciplinary systems analysis…to [uncover] both proximal and systemic causes of errors. It is based on the concept that although individuals make errors, characteristics of the systems within which they work can make errors more likely and also more difficult to detect and correct. Further, it takes the position that while individuals must be responsible for the quality of their work, more errors will be eliminated by focusing on systems than on individuals. It substitutes inquiry for blame and focuses on circumstances rather than on character. (Zipperer et al.)

Systems error: An error that is not the result of an individual’s actions, but the predictable outcome of a series of actions and factors that comprise a diagnostic or treatment process. (QuIC)

Underlying cause: The systems or process cause that allowed for the proximate cause of an event to occur. Underlying causes may involve special-cause variation, common-cause variation, or both. (JCAHO 2001)

Underuse: The failure to provide a health care service when it would have produced a favorable outcome for a patient. (Zipperer et al.)

Unpreventable adverse event: An adverse event resulting from a complication that cannot be prevented given the current state of knowledge. (QuIC)

Violation error: (from aviation) conscious failure to adhere to procedures or regulation (e.g., performing a checklist from memory). (Helmreich)

Wrong time: Administration outside a predefined time interval from its scheduled administration time, as defined by each health care facility. (NCCMERP)



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