Patients encounter risk of harm each time they seek health-care services. Some risks are directly related to assessment procedures and interventions, while others relate to environmental factors (e.g., fire, flood, tornado) or are sector-specific (e.g., telerehabilitation services).
Four distinct elements provide the foundation for managing patient safety incidents:
- Proactive identification of risks to patient safety.
- Effective responses to near misses, no-harm, and harmful incidents when they do occur.
- Implementation and refinement of risk-mitigation strategies based on reviews of patient safety incidents and their root causes.
- Evaluation of the effects (including unintended consequences) of implemented recommendations.
All physiotherapists are required to:
- Be familiar with the risks and harms associated with the assessment and treatment interventions they employ, including common and mild side effects and rare, severe harms.
- Communicate risks and potential harms in a meaningful way when obtaining patient informed consent for assessment or treatment.
- Develop plans and processes for managing patient safety incidents, and train individuals involved in the management of patient safety incidents in these plans and processes.
- Track patient safety incidents arising in the practice setting, using incident reports to refine patient safety incident management plans and adapt clinical practices to enhance patient safety.
- Be familiar with sector specific and environmental risks relevant to their practice and practice setting and develop management plans to address these risks.
This Practice Guideline is intended to:
- Help physiotherapists reflect on the patient risks and harms associated with their clinical practice and the assessment and treatment interventions they employ.
- Develop a framework to classify harms, track the harms occurring in their individual practice and engage in continuous quality improvement.
- Develop Patient Safety Incident Plans relevant to their practice.
The incident planning template contained in Appendix 1 can also be modified and used to develop plans for the management of non-patient care related incidents, if such plans do not already exist within the practice setting (e.g., fire, tornado, site evacuation, violent patient).
Classifying patient safety incidents
The term Patient Safety Incident refers to any event or circumstance which could have resulted or did result in unnecessary harm to a patient. Patient Safety Incidents consist of near miss events, no-harm incidents, and harmful incidents.
Near Misses are patient safety incidents that do not reach the patient and, therefore, no harm resulted. Example: the physiotherapist realizes that the acupuncture needles they were about to use have become contaminated. The physiotherapist discards the needles in an appropriate sharps container.
No-harm Incidents are patient safety incidents that reach the patient, but no discernible harm resulted. Example: a patient reports that their hot pack is too warm and requests additional padding. Extra towelling is provided to address the concern. After the incident, the physiotherapist discovers that the temperature on the hydrocollator was set too high and adjusts it to the appropriate temperature.
Harmful Incidents are patient safety incidents that result in harm to the patient. Sometimes referred to as adverse events, sentinel events, or critical incidents.
Example: the physiotherapist attends a patient to perform post-operative mobilization. The patient experiences a sudden decrease in blood pressure and faints, falling to the floor and sustaining a laceration to their head and a fractured hip on their non-operative side.
Harm classification system
Mild: Asymptomatic or mild symptoms, self-care only (e.g., ice/heat, over-the-counter analgesic)
Moderate: Limiting age-appropriate activities of daily living (e.g., work, school) OR sought care from a medical doctor
Severe: Medically significant but not immediately life-threatening; temporarily limits self-care (e.g., bathing, dressing, eating) OR urgent or ER assessment sought
Serious: Results in death OR a life-threatening harm OR a harm resulting in inpatient hospitalization or prolongation of existing hospitalization for more than 24 hours; a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; a congenital anomaly/birth defect
(Adapted from Pohlman, et al. Development and Validation of Providers’ and Patients’ Measurement Instruments to Evaluate Adverse Events After Spinal Manipulation Therapy. European Journal of Integrative Medicine 2014; 6: 451-466.)
Harmful incidents may include adverse reactions (unexpected harms arising from a justified treatment applied correctly and appropriately) and side effects (known effects other than the primary, intended effect, which may be negative in nature).
Understanding the severity of harmful incidents
In addition to considering near misses, no-harm and harmful incidents within physiotherapy practice, it is also necessary to consider the severity of harm experienced by the patient.
Importantly, when assessing the severity of harm, it is essential that the patient’s perspective and their values are the primary considerations, not those of the physiotherapist. For example, use of needles may commonly result in bruising. The physiotherapist may consider this an expected side effect of the intervention. In many cases bruising may be asymptomatic and mild in nature. However, a bride who experiences needling-related bruising on their wedding day, to an area of skin visible when wearing their wedding dress may view this harm differently. Similarly, exercise-based physiotherapy interventions commonly result in muscle soreness and may require self-care such as ice or heat. However, for some patients, exercise interventions may result in significant impairment in the ability to perform self-care activities, resulting in severe harm.
Tracking and categorizing patient safety incidents by nature and severity
While large employers may have internal incident reporting systems, smaller physiotherapy organizations may lack a rigorous method to collect and track this information, impeding their ability to analyze contributing factors and apply measures to mitigate against future incidents.
The physiotherapy profession currently lacks a consistent and universally applied method of describing patient safety incidents and collecting data regarding the severity of incidents. To address this issue, the College of Physiotherapists of Alberta endorses the use of the terminology adopted by the World Health Organization and Healthcare Excellence Canada to increase the consistency of categorization and description of these incidents. We encourage physiotherapists to adopt the severity classification system developed by Pohlman et al. as part of the SafetyNet study to increase consistency in how harm severity is described and to ensure that impacts to the patient’s function are considered when discussing the severity of patient safety incidents.
Employing consistent language to describe the nature and severity of patient safety incidents and tracking information regarding these incidents will facilitate quality improvement initiatives and research, enhancing efforts to increase patient safety and prevent incidents within the physiotherapy practice environment. Quality data regarding the common patient safety incidents encountered within a specific practice setting will also inform the development of plans and processes to address incidents when they occur.
A shared responsibility
The Standards of Practice for Physiotherapists in Alberta include several expectations specific to the creation and maintenance of a safe practice environment including identification of risks, documentation of patient safety incidents, implementation of measures to mitigate against future patient safety incidents, and maintenance of competence in safety protocols. However, one of the key advances in patient safety over the past three decades is the recognition that patient safety efforts must employ a systems approach, and that clinicians and employers alike have important roles to play in developing a safety culture within organizations by preventing and responding to patient safety incidents.
Physiotherapy employers’ actions to prevent and respond to patient safety incidents include:
- Developing and maintaining patient safety incident reporting systems appropriate for the practice setting, to collect site specific data related to risks and harms.
- Monitoring emerging risks and patient safety incident reports.
- Providing individuals working in the practice setting with plans for managing patient safety incidents (including near misses) and other emergencies when they occur.
- Providing training and education to individuals working in the practice setting regarding patient safety, patient safety incident management plans and reporting expectations.
- Developing and implementing a Just Culture approach to investigating patient safety incidents, identifying underlying contributing factors and implementing changes to reduce the risk of recurrence.
- Engaging in other safety improvement processes to facilitate safe patient care and appropriate incident response, including:
- Developing methods to gather harms data directly from patients.
- Providing staff with training in communication skills related to incident response and providing an apology.
- Providing patients with clear processes for raising concerns and having them addressed by the organization.
Considerations when creating patient safety incident management plans
Physiotherapists must consider the people, equipment, processes and data available regarding risks within their practice setting when designing patient safety incident management plans. Patient safety incident management plans should include:
- Strategies for when the incident occurs while the patient is in the clinic, including whether it is safe for the patient to leave the setting unaccompanied and follow up after the patient has left the setting.
- Strategies for when the patient safety incident becomes apparent after the patient has left the practice setting.
- Procedures for timely communication between the treating therapist and the patient when the patient:
- Reports a patient safety incident.
- Requires guidance on how to manage harms identified after leaving the practice setting.
- Regular review of incident management plans with all individuals working within the practice setting.
Patient Safety Incident Identifier
Identify the situation/incident type this plan applies to.
Date the plan was created
Define the purpose of the plan, its application and limitations.
List the steps and strategies to prevent and/or manage the incident/harm should it arise.
Equipment (type and location)
List the equipment required to manage the event, and where the equipment is located.
- List the individuals involved in managing the event.
- Describe their roles and responsibilities.
- List the actions to be undertaken by the patient/family while in the practice setting.
- List the routine instructions to be provided to the patient/family for care after the patient leaves the practice setting, including the need for accompaniment or supervision and ongoing communication with the treating physiotherapist.
- Include any protocols that the patient is directed to follow to assist with management of the event.
Recommended Follow-up Actions
List actions to be undertaken by the treating therapist or others involved in the management of the incident and relevant documents or resources, including:
- Signs and symptoms to be monitored by the patient or on subsequent visits
- Communication to be completed by the treating therapist
- Follow up with other health professionals involved in the patient’s care
- Patient communication to address concerns/provide advice
- Incident Review, including:
- Site specific forms for tracking and reporting.
- Incident analysis to understand contributing factors.
- Identification of measures to mitigate risk and reduce the chance of recurrence.
- Disclosure to the patient/patient’s family of findings of the incident review and measures implemented.
- Issuing an apology when appropriate
- Supports available to personnel involved in the incident.
Date of Next Review
Patient safety incident management plans should be reviewed on a regular basis to ensure currency and continuing appropriateness.
Training Frequency and Date(s) Completed
When did training of involved personnel occur?
Confirmation of Training (optional)
Names and signatures of individuals attending training.