Common Formats

The current version is 1.1, issued March 31, 2010. Documentation is available at the PSO Privacy Protection Center.

The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act, Statute) establishes a framework by which doctors, hospitals, and other healthcare providers may voluntarily report information on a privileged and confidential basis regarding patient safety events and quality of care. The Patient Safety Act provides for voluntary formation of Patient Safety Organizations (PSOs), which can be public or private organizations, to collect, aggregate, and analyze information regarding the quality and safety of care delivered in any healthcare setting.

The Statute authorizes the collection of this information in a standardized manner, as explained in the Patient Safety Rule published in the Federal Register on November 21, 2008: 73 FR 70732-70814 (Regulations). As requested by the Secretary of the Department of Health and Human Services (DHHS), the Agency for Healthcare Research and Quality (AHRQ) has coordinated the development of a set of common definitions and reporting formats (Common Formats) that facilitate the voluntary collection of patient safety event information and the reporting of this information to PSOs.

Definitions

Accident

See: Patient safety incident.

Adverse event

See: Harm incident.

Adverse event outcome

See: Unexpected adverse outcome.

Adverse outcome

Undesired patient outcome of healthcare; clinical complication of healthcare (which may or may not be a patient safety incident).

Adverse reaction¹

Unexpected adverse outcome resulting from a justified action where the correct process was followed for the context in which the event occurred.

Bodily injury¹

Physical harm or damage to a person’s body.

Chain of events

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 healthcare, the context within which processes are performed to deliver healthcare 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.

Close call

See: Near miss.

Complete event report

See: Complete patient safety concern report.

Complete patient safety concern report

A complete initial report of a patient safety concern, including, as applicable, data elements comprising the following Common Format forms: healthcare event report form, patient information form, one or more event specific forms, and, finally, summary of initial report.

Complication

See: Adverse outcome.

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.

Detection

Identification of a patient safety concern; a broader concept than discovery as it also encompasses identification by automated and other systems.

Device

See: Medical device.

Discovery

Identification of a patient safety concern during the course of performing duties in a healthcare 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.

Event

See: Patient safety event.

Event episode

Single event or chain of events from point of origin of a process failure or error within a healthcare organization to its termination in a near miss or incident.

Event reporter

See: Reporter.

Facility

See: Healthcare facility.

Factor

See: Contributing factor.

Fail-safe

Process designed to prevent the failure of a healthcare process or error made in the delivery of a healthcare 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 from healthcare

See: Harm.

Harm incident

An incident that resulted in harm to a patient.

Harm scale

See: Patient outcome harm scale.

Harm to health

Impairment of structure or function of the body and/or any deleterious effect arising therefrom.

Health Information Technology (HIT)

The application of information processing involving both computer hardware and software that deals with the storage, retrieval, sharing, and use of health care information, data, and knowledge for communication and decision making. (Brailer, D., & Thompson, T. (2004). Health IT strategic framework. Washington, DC: Department of Health and Human Services.)

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.

Healthcare Event Report Form (HERF)

Common Formats form comprising data elements designed to capture the essence of a patient safety concern.

Healthcare facility

Physical structure, such as a hospital, in which healthcare services are performed.

Healthcare location

Physical place within a healthcare facility; includes a location in which healthcare services are delivered (healthcare 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).

Healthcare setting

See: Healthcare facility & Healthcare location.

HERF

See: Healthcare Event Report Form.

Incident

See: Patient safety incident.

Incident report

See: Healthcare event report form.

Injury

See: Bodily injury & Psychological injury.

Inpatient facility

Healthcare facility with beds for patients to stay overnight.

Location

See: Healthcare location.

Medical device

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.

Medical supply

See: Medical device.

Multiple patient incident

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 healthcare, 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 healthcare 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.

Patient safety concern

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 healthcare practitioner or worker or healthcare 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 Event¹

Something that happens to or involves a patient; encompasses patient safety incident and near miss.

Patient Safety Incident¹

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 healthcare practitioner or worker or healthcare 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.

PIF

See: Patient Information Form.

Potential harm event

See: No harm incident & Near miss.

Preventable

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 (healthcare) 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 healthcare 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.

SIR

See: Summary of Initial Report.

Substance administration

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.

Surgical supply

See: Medical device.

Time of discovery

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

Healthcare-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).

Footnote 1: Definitions with the superscript 1 are similar to the WHO International Classification for Patient Safety (ICPS) definitions.