A series of events in which one event leads to another with the possibility that the final event reaches the patient; collectively, an event episode.
Circumstance
Condition surrounding and affecting a person, process, etc; as related to health care, the context within which processes are performed to deliver health care services, including culture of safety, management structure and incentives, staffing levels, qualification and training of staff, acquisition and maintenance of devices, condition of care environment, etc.
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.
Detection
Identification of a patient safety concern; a broader concept than discovery as it also encompasses identification by automated and other systems.
Identification of a patient safety concern during the course of performing duties in a health care facility; a narrower concept than detection.
Duration of harm
The period over which disease, disability, disfigurement, dysfunction, etc. may be evident; often denoted as none, transient, temporary (short-term) or permanent (life-long).
Error
Failure to carry out a planned action as intended or application of an incorrect plan.
Single event or chain of events from point of origin of a process failure or error within a health care organization to its termination in a near miss or incident.
Process designed to prevent the failure of a health care process or error made in the delivery of a health care service from propagating; usually an integral element of that process; may be a secondary system designed to insure the continued function or operation of a primary system.
Harm
Physical or psychological injury (including increased anxiety), inconvenience (such as prolonged treatment), monetary loss, and/or social impact, etc. suffered by a person.
Harm arising from or associated with plans or actions taken during the provision of health care rather than an underlying disease or injury.
Healthcare Event Report Form (HERF)
Common Formats form comprising data elements designed to capture the essence of a patient safety concern.
Health care facility
Physical structure, such as a hospital, in which healthcare services are performed.
Health care location
Physical place within a health care facility; includes a location in which health care services are delivered (health care service delivery location), as well as such other areas as corridors, elevators, and those where supporting services are performed (e.g., laundry, meal preparation, and power generation).
A medical device is any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body, and which does not achieve its primary intended purposes through chemical action within or on the body and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
An incident that involves two or more patients (e.g., patient given a medication intended for another – 2 patients affected by the same incident); includes incidents involving a population of patients (e.g., fire in a patient section of a hospital).
Near miss
An event that did not reach a patient. For example: discovery of a dispensing error by a nurse as part of the process of administering the medication to a patient (which if not discovered would have become an incident); discovery of a mislabeled specimen in a laboratory (which if not discovered might subsequently have resulted in an incident).
No-harm incident
An incident which reached a patient but no discernable harm resulted.
Origin of event
The initial process failure or error that eventually gave rise to a near miss or an incident; see also chain of events. An unsafe condition may have been a precursor to this initial failure or error.
Outcome
The result of a process acting on inputs in a given environment; as related to health care, often used to mean patient outcome.
Patient Information Form (PIF)
Common Formats form that comprises data elements to capture the characteristics of a patient involved in an incident.
Patient outcome
The result of receiving a health care service, especially as related to a patient’s health status; usually refers to post-process results or measurements (the observed results of an intervention) whether or not one can confidently attribute those results to the preceding process (intervention).
Patient outcome harm scale
A systematic method to assess and to represent the extent of a patient’s health loss (including anxiety, inconvenience, etc.) at a point in time, especially as related to residual harm following a patient safety incident and any rescue actions that might have been attempted consequently.
A patient safety event that reached a patient and either resulted in no harm (no harm incident) or harm (harm incident). The concept “reached a patient” encompasses any action by a health care practitioner or worker or health care circumstance that exposes a patient to harm. For example: if a nurse gives a patient an incorrect medication to take and the patient recognizes it as such and refuses to take it, an incident has occurred.
Patient Safety Work Product
Patient safety work product includes any data, reports, records, memoranda, analyses (such as root cause analyses), or written or oral statements (or copies of any of this material), which could improve patient safety, health care quality, or health care outcomes, that are assembled or developed by a provider for reporting to a PSO and are reported to a PSO. It also includes information that is documented as within a patient safety evaluation system that will be sent to a PSO and information developed by a PSO for the conduct of patient safety activities.
However, patient safety work product does not include a patient’s medical record, billing and discharge information, or any other original patient or provider information; nor does it include information that is collected, maintained, or developed separately, or exists separately, from a patient safety evaluation system.
Patient Safety Work Product must not be disclosed, except in very specific circumstances and subject to very specific restrictions.
Accepted by the relevant community as avoidable in the particular set of circumstances.
Preventive measure
Process designed, or course of action taken, to keep something possible or probable from happening or existing; as related to patient safety, to prevent a patient safety event.
Principal diagnosis
The condition established after study to be chiefly responsible for occasioning the admission of the patient to the hospital. (Uniform Hospital Discharge Date Set)
Principal procedure
The procedure performed for definitive treatment rather than diagnostic or exploratory purposes, or which is necessary to take care of a complication. (Uniform Hospital Discharge Date Set)
Process
A particular method of doing something, generally involving a number of steps or operations, that results in an outcome or produces an output.
Psychological injury
Harm or damage to a person’s psyche, psychological functioning, or mental well-being.
Reaction
A patient’s response to a stimulus or agent, such as to a medication.
Reporter
Person in a heath care organization who reports a patient safety concern; may (or may not) be the person who discovered the concern.
Rescue action
Action taken or started within the first 24 hours after the discovery of a patient safety incident that is intended to prevent, to minimize, or to reverse harm to the affected patient.
Residual harm
Estimated harm to a patient’s health subsequent to any attempted rescue action taken or started within 24 hours after the discovery of an incident.
Resilience
The ability to resist and/or to recover from process failures or errors; to continue to deliver (health care) services safely in the face of various faults and challenges encountered during the course of normal operations; includes the ability to anticipate and to adapt performance to current conditions.
Risk
The product of 2 dimensions: 1) probability of an event’s occurrence in a specified period, such as a year, and 2) the harm that would typically result if the event were to occur; often limited to (1).
Safeguard
Aspect of a health care process that is designed to prevent harm from reaching a patient in the event of a failure or error (including the failure of a fail-safe).
Severity of harm
The extent of harm at a point in time; often categorized as none, mild, moderate, severe, or death.
Side effect
An effect (usually an adverse outcome) caused by something (such as a drug or procedure) that was not the intended or indicated effect. The occurrence of a known side effect, even if an adverse outcome, by itself, is not a patient safety incident. It should be considered a quality of care problem; if, for example, the prescribing physician failed to weigh properly the potential health benefits and risks of prescribing a medication with a potentially lethal, or otherwise adverse, side effect.
The process by which a substance (e.g., medication) is administered to a patient (whether or not the patient actually receives or takes it).
Summary of Initial Report (SIR)
Common Formats form that comprises data elements to assess and to encode a patient safety concern. The completion of this form completes the initial report of an unsafe condition, near miss, or incident. Such report may (or may not) be followed by an event episode analysis.
Date/time when a patient safety concern was discovered.
Time of occurrence of event
Date/time when a patient safety event occurred (point in time) or started (if it occurred over a period of time).
Unexpected adverse outcome
Adverse outcome that was not expected to be a result of the patient’s treatment plan; harm suffered as a result of an incident.
Unintentionally retained item
Foreign object introduced into the body during a surgical operation or another invasive procedure, without removal prior to finishing the surgery or procedure, that the surgeon or other practitioner did not intend to leave in the body.
Unnecessary harm
Health care-associated harm that was not expected to result from a patient’s treatment plan; harm resulting from an incident.
Unplanned intervention
An intervention that was not part of a patient’s treatment plan prior to the event that necessitated the additional intervention.
Unsafe condition
Any circumstance that increases the probability of a patient safety event; includes a defective or deficient input to or environment of a care process that increases the risk of an unsafe act, care process failure or error, or patient safety event. An unsafe condition does not involve an identifiable patient. For example, an out-of-date medicine on a shelf represents an unsafe condition. It might be given to a patient, but the identity of such patient is unknown at the time of discovery. The attempt to administer the out-of-date medicine to a patient would either represent a near miss (if not administered) or an incident (if administered).
Interested counsel may join a discussion group that offers support and an opportunity to learn about the new legal privileges and challenges of the Patient Safety and Quality Improvement Act of 2005. You can request to join the group by following this link: eepurl.com/rKJaf. This group generally holds conference calls quarterly.
