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. 2024 Feb 23;16:16. doi: 10.1186/s13089-024-00364-7
Safety event class Level of harm Harm category Patient description
HI—Harmful incident (reaches the patient)

Harm results from the care or services provided to the patient due to failures in the processes of care or in the performance of procedures, including provider error

Based on expert opinion

DE—Death HI–DE Unexpected death not related to the natural or expected course of the patient’s illness or underlying condition. On balance of probabilities, caused by or brought forward by the incident
SE—Severe HI–SE

Patient harm is symptomatic:

• requiring life-saving intervention or major medical/surgical intervention,

• shortening life expectancy, or

• causing major temporary or permanent impact on physical, mental or social function

• patient experienced enduring psychological difficulty that required specialist treatment (e.g. prolonged counselling and psychotropic medication management)

Includes previous catastrophic disability

MO—Moderate HI–MO

Patient harm is symptomatic:

• requiring intervention (e.g. additional operative procedure, additional therapeutic treatment), and increased length of stay, or

• causing temporary or permanent impact on physical, mental, or social function

• patient experienced psychological difficulty requiring treatment (e.g. counselling with FP, therapist, or psychologist)

MI—Mild HI–MI

Patient harm is symptomatic:

• symptoms are mild

• minimal or no intervention is required (e.g. extra observation, investigation, review, or minor treatment)

• causing minimal (permanent or temporary) impact on physical, mental, or social function

• patient experienced emotional distress that had an impact on lifestyle (e.g. mild sleep disturbances, occasional work absences)

NO—None HI–NO Patient harm is asymptomatic. No symptoms detected and no treatment required
ID—Insufficient detail HI–ID

• Insufficient information is available to evaluate the level of harm

• There may be no description of any clinical outcome

• There may be a patient safety incident but insufficient information to classify level of harm of the outcome

IR—Inherent risk (reaches the patient)

A known risk associated with a particular investigation, medication, or treatment. It is the risk from undergoing a procedure in ideal conditions, performed by qualified staff using current standards, equipment and techniques*

Includes non-preventable missed or delayed diagnosis

Based on expert opinion

DE—Death IR–DE Unexpected death not related to the natural or expected course of the patient’s illness or underlying condition. Caused by or brought forward as a result of the inherent risk of the care
SE—Severe IR–SE

Patient harm is symptomatic:

• requiring life-saving intervention or major medical/surgical intervention,

• shortening life expectancy, or

• causing major temporary or permanent impact on physical, mental or social function

• patient experienced enduring psychological difficulty that required specialist treatment (e.g. prolonged counselling and psychotropic medication management)

Includes previous catastrophic disability

MO—Moderate IR–MO

Patient harm is symptomatic:

• requiring intervention (e.g. additional operative procedure, additional therapeutic treatment), and increased length of stay, or

• causing temporary or permanent impact on physical, mental, or social function

• patient experienced psychological difficulty, requiring treatment (e.g. counselling with FP, therapist, or psychologist)

MI—Mild IR–MI

Patient harm is symptomatic:

• symptoms are mild

• minimal or no intervention is required (e.g. extra observation, investigation, review, or minor treatment)

• causing minimal (permanent or temporary) impact on physical, mental, or social function

• patien t experienced emotional distress that had an impact on lifestyle (e.g. mild sleep disturbances, occasional work absences)

NO—None IR–NO Patient harm is asymptomatic. No symptoms detected and no treatment required. Includes persistence of condition (e.g. myopia, carpal tunnel)
ID—Insufficient detail IR–ID

• Insufficient information is available to evaluate the level of harm

• There may be no description of any clinical outcome

• There may be a patient safety incident but insufficient information to classify level of harm of the outcome

UN—Unknown (reaches the patient)

Harm results from the care or services provided to the patient, but no expert opinion on file to categorize as harm arising from a harmful incident or inherent risk

Usually involves cases with a contributing factor of UNKNOWN

Level of patient harm is not populated due to limited information on the file
NM—Near miss
A patient safety incident that did not reach the patient and therefore no harm results No—None NM–NO Error or capacity to cause harm was caught by an error detection barrier, or by chance, before reaching the patient
No healthcare-associated harm occurred Level of harm Harm category Patient description
NA-not applicable NA Involves all other medical-legal matters that are solely administrative (e.g. documentation) or related conduct (e.g. manner)