Patient Safety and Incident Management Toolkit
When a patient's safety is compromised, or even if someone just comes close to having a patient safety incident, you need to know you are taking the right measures to address this, now and in the future. In our toolkit we share practical strategies and resources for you to use to manage incidents effectively and keep your patients safe. We consider patients’ and their families’ needs and concerns, and how to effectively engage them throughout the process.
- Topics
- Patient safety
- Health workforce
- Audience
Quality or safety improvement lead
Point of care provider
Person with lived/living experience
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Developed from the best available evidence and expert advice, this toolkit is for people responsible for managing patient safety, quality improvement, risk management and staff training in any healthcare setting.
A patient safety incident is defined as an event or circumstance which could have resulted, or did result, in unnecessary harm to a patient.
For more information, contact us at info@hec-esc.ca.
We developed this toolkit from the best available evidence and designed it to apply to any program, setting or organization. People using this toolkit must consider local legislation, policies and local context when adapting or implementing the toolkit.
What This Toolkit Covers
While patient safety and incident management are the main focus, in the toolkit you will also find some ideas and resources for exploring the broader aspects of quality improvement and risk management.
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Patient Safety Management
The actions that help to proactively anticipate patient safety incidents and prevent them from occurring. In this section, the resources guide you in planning, anticipating and monitoring your response to expected and unexpected safety issues, for safer care today and in the future. We promote a patient safety culture and reporting and learning system.
Patient safety and incident management plans and processes proactively developed and in place, together with active monitoring, analyzing, prioritizing and implementing actions to mitigate risks and improve quality and safety, contribute to effective response to both expected and unexpected safety issues.
Recommended strategies
Incident management: establish plans and processes
Proactively develop local incident management policies, procedures, plans, and processes.
Include tools and resources to support immediate and ongoing response, reporting, disclosure, analysis, tracking implementation of changes (e.g. checklists, flowcharts).
Clearly articulate roles, responsibilities and expectations.
Partner with both patients/families and frontline staff in their development.
Update them on a regular basis.
Ensure they are easily accessible to all staff as well as patients/families as appropriate.
Ensure leadership support for incident management is consistently visible, and not only during times of crisis, (e.g. have leaders participate in communication related to plans and processes, education, celebrating successes).
Allocate and ensure timely access to resources to support:
patients/families (e.g. practical, emotional, financial support)
staff involved in patient safety incidents (e.g. counselling, coaching, coverage of duties)
implementation of recommended actions resulting from incident analysis
communication and information systems (e.g. reporting, tracking, measurement)
incident management training for all staff
Align incident management processes with organizational processes for employee human resource reviews and/or physician performance reviews (including reporting to regulatory/licencing bodies) and just culture principles.
Patient safety management: monitor, analyze, and prioritize safety risks
Continuously identify and monitor risks, safety gaps as well as strengths using multiple organizational sources (e.g. reporting and learning systems, complaints, compliments, coroner reports.)
Seek ways to capture what is not reported (e.g. frustrations, workarounds, inefficiencies, innovations, new ideas, strengths, customized defences) via dialogue, observations, leadership site visits, safety huddles, etc.
Conduct prospective or multi-incident analyses to determine system strengths and vulnerabilities.
Adopt a systematic and consistent approach for tracking, analyzing, quantifying and prioritizing patient safety risks/gaps/hazards and mitigation strategies.
Involve leadership, staff and patient/family partners in the prioritization process so that a broad range of perspectives is included.
Establish structures to ensure patient safety risks and their corresponding actions are tracked, updated, reviewed, and prioritized on a regular basis.
Develop and integrate mechanisms to monitor and respond to unexpected hazards in real time to improve reliability and resilience (e.g. constant vigilance, safety check-ins, early warning systems safety alerts/reports from both staff and patients/families).
Patient safety management: implement action plans to mitigate risks and improve quality and safety
Develop and implement action plans to mitigate safety risks (e.g. evidence based interventions).
outline aims, actions, accountabilities and resources (usually in a project charter format)
Identify actions that are most likely to have the greatest impact in improving patient.
consult with internal stakeholders
review external sources of evidence (e.g. alerts/ advisories/ recommendations/ best practices)
seek expert opinion
Design processes that focus on system-based error reduction strategies as they are the most effective (e.g. using forcing functions, automation, simplification and standardization).
Assess if safety action plans are resulting in improvements.
develop care plans
share concerns and compliments
co-design systems and processes
implement safety and improvement initiatives
Patient safety management: promote teamwork and build capacity
Strengthen team functioning and relationships through team training using simulation whenever possible.
Adopt standardized communication and handoff processes (e.g. I-PASS, SBAR, Ask Me 3).
Promote team collaboration through interdisciplinary care models, interprofessional learning and team goals that focus on the patient/family needs.
Encourage and support continuous patient safety conversation between patients/families, frontline staff and leaders.
Develop multiple strategies that empower staff at all levels to share their concerns (e.g. anonymous reporting system and/or “hot line”) and skills to address hierarchy and power gradient (by using simulation).
Promote an understanding that systems are complex, dynamic and can fail.
Engage all team members, including patients/families, in all phases of quality improvement and patient safety initiatives to leverage their expertise.
Culture refers to shared values (what is important) and beliefs (what is held to be true) that interact with a system’s structures and control mechanisms to produce behavioural norms. It influences patient safety directly by determining accepted practices and indirectly by acting as a barrier or enabler to the adoption of behaviours that promote patient safety. Understanding the components and influencers of culture and assessing the safety culture is essential to developing strategies that creates a culture committed to providing the safest possible care for patients.
“Culture is tribal; it lives and breathes at provider level and in middle management level. The reality is that there are significant cultural differences between shifts and even team members. Furthermore, a unit’s culture can be influenced – both negatively and positively – by a single individual.” -- Hugh MacLeod, past CEO Canadian Patient Safety Institute (now Healthcare Excellence Canada)
Recommended strategies
Understand patient safety culture and its components
Recognize that patient safety culture is multi-dimensional consisting of a number of features:
informed culture – relevant safety information is collected, analyzed and actively disseminated
reporting culture – an atmosphere where people have the confidence and feel safe to report safety concerns without fear of blame, and they trust that concerns will be acted upon
learning culture – preventable patient safety incidents are seen as opportunities for learning and changes are made as a result
just culture – the importance of fairly balancing an understanding system failure with professional accountability
flexible culture – people are capable of adapting effectively to changing demands
Understand how culture influences patient safety outcomes directly by determining accepted norms and practices and indirectly by acting as a barrier or enabler to the adoption of interventions designed to promote patient safety.
Appreciate the interconnection between people, system and culture and how focusing on system improvement and learning, rather than individual performance, drives actions that support patient safety and incident management.
Understand key contributors to a patient safety culture
Appreciate and understand patient safety culture’s multiple influencers, including:
leadership and board commitment and ongoing visibility (at the organization and team levels)
patient/family engagement
effectiveness and openness of teamwork and communication
openness of all team members, including patients/families, in reporting problems and incidents measurement/monitoring and learning from safety and incidents
organizational learning
organizational resources for patient safety
priority of safety versus production
Provide education, training and resources so that everyone is aware of the critical role of culture in patient safety and what they can do to support it.
Assess patient safety culture
Determine the best methods and tools to assess patient safety culture in the organization, engaging safety and measurement experts whenever possible.
Consider assessing both perceptual indicators (front line staff provide majority of data) and organizational indicators of culture (senior leaders provide majority of data).
Obtain informed leadership support for the use of patient safety culture measurement tools to ensure an understanding of the resources required, the barriers that may be encountered, and the potential outcomes.
Engage frontline caregivers in the planning and implementation of the culture measurement initiative.
Analyze the results and identify opportunities for improvement, mapping to the various patient safety dimensions and influencers.
Communicate the results to key stakeholders in a meaningful way including a timeline for next steps and how improvement actions will be identified.
Understand that patient safety culture measurement is a snapshot in time and that ongoing measurement will be needed to monitor progress.
Develop and implement a patient safety culture strategy
Based on the assessment results and environmental factors and with leadership support develop a shared vision and plan for improving patient safety culture.
Identify potential opportunities to implement the plan as well as barriers along with corresponding mitigating strategies.
Address patient safety culture gaps and weaknesses at the organizational and unit/program/service (micro-system) level recognizing that in the same organization culture can be different across units and even between shifts.
Partner with patients and families in patient safety:
empower them to be active participants in their care by encouraging them to speak up, participate in shared decision-making and the development of personalized care plans
engage them in the design of care models, care processes and quality improvement/patient safety initiatives
Partner with providers in patient safety:
develop multiple strategies that empower staff at all levels to share their concerns and speak up (e.g. anonymous incident reporting system, team training that addresses the authority gradient, safety huddles, anonymous email or telephone “hot line” where staff can share concerns)
engage staff in all phases of quality improvement and patient safety initiatives to leverage their expertise
a successful patient safety strategy leads to frontline ownership of local issues and challenges and enables clinicians and providers to action their own solutions
design communication systems that allow for a continuous patient safety conversation between frontline staff and leaders
Reporting systems (frequently referred to as reporting and learning systems) capture patient safety concerns, hazards and/or incidents and are meant to trigger action, facilitate communication, response, learning and improvement. Establishing a reporting system and processes to support it, including identifying and spreading learning, is foundational to patient safety and incident management and essential to advancing a patient safety culture.
“To close the safety gaps in my hospital, first I need to know where they are. Reporting systems serve as a map to show us where the gaps are and guide us in how to close them.” -- Toolkit Faculty
Recommended strategies
Establish a reporting system
Capture information about hazards, patient safety concerns, incidents and near misses, typically by completing a standardized electronic or paper form
Consider establishing alternate reporting mechanisms such as telephone or verbal, particularly for incidents with a high potential for harm to ensure timely response (e.g. stop the line)
Compared to those that are mandatory, voluntary (non-legislated) reporting systems have been shown to facilitate greater reporting and learning
Empower and support reporting by all care participants, including the patient/family, by ensuring they can access the system
Engage the users, including patients/families, in developing and maintaining the system
Incorporate best practices into the design of the reporting system whenever possible:
make the system user-friendly aligning with human factors design principles
limit the information required to what is essential and include a narrative portion to allow reporters to tell the story
provide an option for anonymous or confidential reporting to address concerns about potential negative consequences
embed automatic notification of the appropriate department head or manager, eliminating the need for the reporter to determine where to direct the information
acknowledge reports upon receipt conveying appreciation to the individual submitting the report
develop process(es) for the reporter to clarify the information submitted, if required
enable managers to receive and view reports in real-time to facilitate timely feedback and response
facilitate the review of the reports completed by the patient/family in conjunction with those completed by care providers
prompt users to consider external reporting or notification requirements when appropriate (e.g. National System for Incident Reporting, Canadian Medication Incident Reporting and Prevention System)
create easy-to-use data extraction capability to support timely improvement at the local, organizational and system-wide levels
ensure appropriate data confidentiality and security (including de-identification), in accordance with applicable legislation and organizational policies
Establish processes that support reporting systems
Develop and/or review existing reporting policies, procedures, education and training (example of policy and guideline from AHS) to ensure users know what, how and when to report:
emphasize that reporting is a positive action that contributes to patient safety, and neither the person who reports nor those involved in or caused the event will be reprimanded
develop tools and resources specifically for patients/families
ensure roles and accountabilities around incident reporting are clearly delineated and that staff is familiar with reporting procedures and tools
clearly communicate what happens to the information once it is entered into the reporting system
Integrate reporting processes and the responsibility for reporting within existing work processes, structures and accountabilities including role descriptions, staff orientation and leadership development programs
Allocate adequate resources (including technical and administrative) to maintain the reporting system and its related processes including data analysis, follow-up, and system oversight
Address potential organizational barriers to reporting:
cultivate a patient safety culture, specifically addressing the potential fears associated with reporting, authority gradient, and the risk of reprisal
develop and train leaders to promote openness, facilitate learning, empower teams, and welcome differing perspectives
Optimize and share learning from reporting systems
Analyze data from the reporting system to identify patient safety gaps
Integrate reporting system information with other data sources to anticipate and mitigate clinical risk and system vulnerabilities as well as to identify system strengths
Provide updates on lessons learned and improvements made as a result of reporting as part of routine processes, e.g. regular agenda item at staff and board meetings, “good catch” stories in newsletters, summaries at town hall meetings
Consider sharing lessons learned with patients, families, communities, public and tailor communication to the needs of the specific audience, e.g. quantitative analyses, patient stories, trend summaries, poster campaigns, social media, blogs
Evaluate the effectiveness of the reporting system and its related feedback mechanisms on a regular basis and make improvements
Update the data elements collected to ensure relevance and incorporate identification of emerging issues
Incident Management
This section of the Patient Safety and Incident Management Toolkit provides an integrated set of resources that focus on what actions to take – both immediate and ongoing – following patient safety incidents (including near misses). The resources support people responsible for incident management to respond to incidents and reduce the harm to patients/families and providers when they occur.
The immediate response includes the care, support, and communication actions that take place immediately following an incident to mitigate further patient harm and ensure the safety of patients/families and providers. As appropriate, the immediate response continues throughout the incident management process to promote healing, recovery and learning.
“We could forgive them that our daughter died but we could not forgive them for how they treated us after she died.” -- Mother, Focus Group Participant
Recommended strategies
Depending on the incident and circumstances, the steps taken immediately after an incident can vary in their order or occur simultaneously. Knowledge of local policies, procedures and available resources, developed before the incident, ensure effective management of these crucial early steps in the incident management process.
Immediate care and support for patient(s), family, providers and others.
First and foremost, address the immediate clinical needs of the patient(s) involved in the incident
Attend to the immediate emotional needs of patient(s) and/or family involved in the incident including acknowledgement of the event, empathy, and support
Ensure that other patients, families and visitors impacted by the incident are cared for, including support for their ongoing clinical needs
Attend to the safety and well-being of care providers(s) involved in the incident as needed, including arranging for coverage of duties, facilitating access to counselling, and providing peer support
Document facts in the patient’s health record as soon as possible in accordance with professional standards and organizational policies
Make the environment and surroundings safe.
Institute measures to reduce the risk of imminent recurrence or other potential threats, such as removing potentially harmful medications, equipment or other hazards
Alert others, such other areas within the organization or other institutions, to risks that extend beyond the local environment
Secure items related to the event that may need to be assessed as part of the incident analysis.
Items to be secured can include biomedical equipment, intravenous solutions, medications, packaging, garments, linens, technology, video recordings, etc.
Label and secure items in a protected environment with restricted access
As directed by organizational policies, secure the health record and provide a copy to care providers if the patient is receiving ongoing care
Photograph the items and the area where the incident occurred when appropriate as this may prove to be helpful in the review process
Report the incident and ensure appropriate notifications.
Report the incident in accordance with organizational processes to trigger appropriate notifications and determine next steps in the incident management process
Notify the attending physician and unit manager and consider others including the leadership team, risk management and public relations in accordance with organizational policy
Initiate external notifications as required and depending on the nature of the event, organizational policy and governing legislation; this may include the coroner/medical examiner, Ministry of Health, insurers, and the media
Begin disclosure.
Begin the disclosure process with the patient and family as soon as reasonably possible
Consider adapting the process to fit patient/family needs
Document the disclosure discussion in accordance with organizational policies
Ongoing support
Begin to create a plan to provide support and information to patients/families, providers, and others as appropriate.
Download a transcript of "The Impact of Disclosure: Second Victim of Harm" video.
Disclosure is a formal process involving open discussion between a patient/family and members of a healthcare organization about a patient safety incident (including near misses). Disclosure provides the means for dialogue throughout the incident management process, supports patient safety improvement and promotes healing for the patients/families and providers involved.
It generally occurs in two broad stages (initial and post-analysis) and is an ongoing process in which multiple disclosure conversations occur over time.
“…It made me feel that I could trust my provider because, I mean she took responsibility… had remorse about what happened. She wasn’t defensive.” -- A family member
“I wasn’t allowed to be a part of the disclosure process, I needed to see the family of the boy who died; I needed to say: ‘I’m sorry.’ I’ll always wonder if they know how sorry I am and how it changed my practice.” -- A healthcare provider
Recommended Strategies
Before an incident
Confirm that organizational processes support disclosure
Establish guiding principles for disclosure (e.g. patient-centred healthcare, patient autonomy, honesty and transparency, patient safety, just culture, learning and improvement).
Develop disclosure policies, procedures and tools aligned with the organization’s guiding principles, disciplinary/accountability systems, legislation, regulatory/licensing requirements, and best practices that:
involve patients/ families and frontline staff in their development
articulate when and where disclosure should take place and how it should be conducted
include supports and resources available to the patient/family and healthcare providers
provide guidance on how to deal with the media in the event of a public disclosure
incorporate processes that address special circumstances such as multi-patient disclosures, paediatric patients or those with mental health issues, or incidents related to research
are easily accessible to all, including frontline staff and patients/families (e.g. public site)
are updated regularly to ensure relevance and alignment with other policies and current context
Provide disclosure training programs and educational resources for staff and patients/families.
Allocate resources to assist patients/families involved in patient safety incidents, ensuring they are available without delay (e.g. practical, emotional, financial).
Allocate resources to assist staff at the frontline involved in patient safety incidents as needed, including disclosure support and coaching.
After an incident
Develop a specific disclosure plan
After caring for the immediate needs of the patient/family and providers, develop a customized disclosure plan specific to the incident and the ongoing needs of those involved.
If possible, conduct a pre-disclosure team huddle to determine the best approach, including:
when the initial disclosure will occur taking into consideration patient/family readiness and preferences
where the disclosure will take place, preferably a private area that is free of interruptions or off-site if indicated
what information will be shared with the patient/family, including confirmation of the known undisputed facts
who is the best person to initiate disclosure and coordinate the ongoing disclosure
how the care providers involved in the incident will be supported
how the patient/family will be supported and their questions/concerns addressed
how disclosure will be documented
Inquire with the patient/family who will attend the meeting, encourage the patient/family not to attend alone (e.g. other family members, friends, translator, spiritual support), and ask if the patient/family have preferences on who should attend or not attend from the care team.
Initiate initial disclosure
Use language and terminology that the patient/family can easily understand. Avoid speculation or blame.
Introduce the participants to the patient/family, including their functions and reasons for attendance.
Acknowledge the incident or that something unexpected has happened and express apology using the words ‘I’m sorry’.
Provide an overview of how the meeting will run and ask how the patient/family would like to participate.
Ask about concerns and questions the patient/family would like to discuss and offer support or resources if needed.
Share the following information:
the currently known facts of the incident
the steps for ensuring the ongoing care and well-being of the patient (e.g. clinical care, treatment)
a brief overview of the incident analysis process including expected timelines and what the patient/family can expect during the process
Offer the patient/family an opportunity to speak about their experience and ask questions.
Ask about preferences for future involvement and information (how, when, where).
Ask the patient/family to identify a contact person.
Designate a key contact person from the organization who will provide regular updates.
Provide practical and emotional support (e.g. spiritual care services, counselling, social work, family arrangements, reimbursement of expenses associated with the disclosure process).
Document the disclosure discussion in accordance with organizational policies. Include:
the time, place, date, the names and relationships of all attendees
the facts presented
offers of assistance made and the response, questions raised and the answers given
patient/family preferences about future disclosure discussions
plans for follow-up and key contact information for the organization and the patient/family
Continue disclosure throughout the incident management process as needed
Continue to be engaged with the patient/family according to their preferences:
continue to offer practical and emotional support
transparently correct any incorrect or incomplete information that was provided in previous disclosure meetings
provide new factual information as it becomes available
offer a further apology which might include an acknowledgement of responsibility for what happened as appropriate and in accordance with organizational policies and applicable legislation
describe any actions that are taken as result of the internal analysis such as system improvements in accordance with organizational policies and applicable legislation
Continue to offer updates, and practical and emotional support for providers.
Ensure providers maintain involvement in the disclosure process as appropriate, particularly if leadership takes on a larger role in the post analysis stage.
Continue to document disclosure discussions per organizational policies.
Preparing for analysis consists of a preliminary review to determine the appropriate follow-up and whether a system-based incident analysis is needed. If indicated, an incident analysis method, team, and approach are selected and initial interviews are conducted. The findings, actions and decisions made at this point in the incident management process influence the direction and effectiveness of the analysis process.
Recommended strategies
Refer to your organization’s policies, procedures and jurisdictional requirements when implementing these steps.
Conduct a preliminary investigation.
Determine the most appropriate person to conduct the initial review and data gathering. Someone with formal incident analysis and patient safety training and/or accountability for patient safety is recommended
Create a high level timeline and document the known facts related to the incident from currently available sources such as the incident report, the patient’s health record, and other documentation
If appropriate, find out whether similar incidents or analyses have previously taken place within the organization and beyond to learn from their experience and approach
Offer ongoing support to patients/families and care providers
Select an analysis type and method.
Based on the preliminary understanding of what happened, and using appropriate guidance tools, determine whether a system-based analysis (focused on system improvement) or an accountability review (focused on individual performance) or both is required
A system-based analysis is not recommended for incidents that are thought to be the result of a criminal act or purposely unsafe act related to substance abuse by the provider, or involving suspected patient abuse
In situations where both a system-based analysis and accountability review are conducted, maintain a secure information firewall, i.e. no communication or influence between the two reviews
In the case of a system-based analysis, select the most appropriate analysis method (concise, comprehensive, multi-incident) taking into consideration the complexity of the incident, the extent of its impact, and contextual factors such as the likelihood of recurrence, regulatory mandates, and internal or external pressures
Identify the analysis team.
Guided by organizational policies and applicable legislative protection, establish an analysis team with clear roles and responsibilities captured in a team charter and clarify how confidentiality will be maintained
While team composition will vary depending on the incident, the involvement of frontline providers and leaders is paramount to the success of the analysis as they can advocate for and support change implementation,
The inclusion of a patient/family representative should be considered and is encouraged (e.g. a current or former patient of the service that was not directly involved in the incident being addressed)
The analysis team may include members from outside the organization depending on the context of the incident and instances when the required content expertise does not reside within the organization, providers involved in the incident hold leadership positions, or when there is intense public scrutiny
Due to a variety of reasons including intense emotional response, some individuals involved in the incident may not be ready to participate; it is essential that the analysis team be understanding and keep the lines of communication open
It is recommended that primary responsibility for conducting, coordinating and reporting on the analysis is shared by a facilitator (with expertise in analysis) and a leader (with operational responsibility)
Coordinate meetings.
Before convening the team, gather all of the necessary information to conduct the analysis such as the patient’s health record, the timeline, pertinent equipment, relevant policies and procedures, and other documentation
Secure a comfortable and private setting
Emphasize and maintain confidentiality at all times to ensure information is only communicated in accordance with applicable policies and legislation
Manage documents in accordance with organizational policies
Plan and conduct interviews.
If feasible, meet with the team to confirm the approach and ground rules before conducting interviews
Invite the patient/family and staff to participate in interviews as appropriate, coordinating communication through the key contact assigned earlier
Conduct interviews as soon as is reasonably possible to help ensure that important information and details are recalled
Conduct interviews individually to provide an opportunity for those involved in the incident to share their detailed perspective and unique viewpoint
Consider the ability/readiness of the individuals being interviewed and provide care and support throughout:
clearly convey the purpose of the interview and what will be done with the information
favour the use of open-ended questions to allow the individual to tell their story
ask the individual whether they identified contributing factors related to the incident as well as factors they feel mitigated the outcome
pay particular attention to the needs of patients and family members during interviews, such as assisting with arrangements and logistics of the meeting, careful selection of the location to prevent further trauma, offering support, and providing a list of who will be there in advance
Incident analysis is a structured process, focused on system improvement, that aims to identify what happened, how and why it happened, what can be done to reduce the risk of recurrence and make care safer, and what was learned. Analysis is a core component of incident management therefore it is important to ensure it is thorough, fair, unbiased and the recommended actions provide effective safety solutions.
“Each time we do an incident analysis we are revealing new information, developing a greater understanding about patient safety, and through learning are moving the culture forward.” -- Toolkit Faculty
Recommended strategies
The guidelines below may be adapted in accordance with local policies and procedures, the nature of the incident and the method of analysis selected. As new information about the incident is acquired, previous steps may need to be revisited (e.g. conducting additional interviews to explore new contributing factors) or a change may be needed to the analysis method (e.g. moving from a concise analysis to a comprehensive or multi-incident analysis.)
Understand what happened.
Expand on the preliminary review by synthesizing additional information gathered from incident report(s), the health record, physical evidence, contextual factors, site visit(s), and interviews with those directly or indirectly involved in the incident
Create a detailed timeline, collating facts from various sources
Review additional supporting information such as any related policies and procedures, training materials, or evidence-based guidelines
Consider that a literature review, environmental scan, expert consultation, or analysis of similar incidents may also be indicated depending on the scope and method of analysis
Determine how and why it happened.
Identify contributing factors related to the incident, both those that increased the risk of harm and those that reduced the risk of harm or limited its impact
Consider aspects of the incident that extend beyond the patient-provider level by probing all influencing factors and circumstances
Use systems thinking, human factors methods and guiding questions that prompt an exploration of all system components to avoid cognitive biases and keep the analysis focussed on system-based factors
Use diagramming or other analytical tools to identify and understand the relationships between and among contributing factors
Document discrepancy(ies) in information from conflicting sources and the consensus reached by the analysis team as to the most appropriate direction based on the available information
Articulate concisely what was found in a summary of findings that provides the backbone for the development of recommended actions
Identify what can be done to reduce the risk of recurrence and make care safer.
Develop recommended actions addressing the analysis findings and that are specific, measurable, attainable, realistic and timely
Ground recommended actions in evidence whenever possible, utilize the most effective solutions given the circumstances and target them to the appropriate system level(s) to achieve sustained improvement
Propose an order of priority for recommended actions based on the degree of change required, ease of implementation, organizational factors, and influences from the external environment
Review and validate the recommended actions with the patient/family, providers and experts (whenever possible)
Prepare and hand-off the incident analysis report to those responsible for approving recommended actions, allocating the necessary resources, delegating implementation of the recommended actions and monitoring progress
Include a tracking tool with assigned responsibilities and timeframes in the report to facilitate ongoing monitoring of the recommended actions and their outcomes
Once the recommended actions and their order of priority is approved by the leadership team, and in accordance with organizational policies and applicable legislation, communicate them in a timely manner to the patient/family (post-analysis disclosure), providers, management, public and others as needed
Identify and share what was learned.
Share the learning gained from the analysis (outcome of recommended actions implemented and other changes made to improve safety) within the organization (staff, patient/family, individual who reported the incident) and beyond to prevent additional harm and to make care safer.
Following through after completing an incident analysis consists of implementing the final recommended actions, monitoring their impact on safety, and when the goals and sustainability are achieved, transitioning to ongoing operations. This step involves change and improvement, it spans over a longer period of time, and it is vital in demonstrating that the incident management process improved safety and quality of care.
“Local leaders should ensure that they, or someone they designate, periodically observe care practices to ascertain if recommended actions have been implemented and sustained. By following through important insights and potential hazards and/or opportunities to patient safety can be discovered.” -- Toolkit Faculty
Recommended strategies
Implement recommended actions.
Engage frontline staff and patients/families in the planning and implementation of recommended actions, exploring potential barriers and opportunities as well as mitigation strategies
Ensure ongoing leadership support and adequate human and financial resources for implementation
Use change management and improvement tools to base change on strong methodology
Incorporate a variety of communication strategies to maintain interest and engagement in the changes (e.g. small group and/or organization wide announcements in verbal and/or written format)
Test changes on a small scale to allow for feedback and refinement before broader implementation
Integrate the implementation of the recommended actions within the quality improvement and risk management actions (e.g. using a common platform) to monitor, report progress and align efforts
Monitor and assess the effectiveness of the recommended actions.
Rather than simply tracking the completion of recommended actions, establish relevant outcome, process and balancing measures to monitor whether the desired effect was achieved
Clearly define measures and design data collection to be as practical as possible
Monitor performance over time to demonstrate sustained improvement or lack thereof
Use all of the information available to evaluate the overall effectiveness of the recommended actions, including observations, stakeholder feedback, and unintended consequences
Revisit recommended actions that did not achieve the anticipated improvement and consider adjustments or alternate solutions
Close off the incident analysis and transition to ongoing operations.
Designate the incident analysis as complete once all of the recommended actions have been evaluated for a pre-determined period of monitoring
Determine if ongoing performance monitoring (such as unit or organizational quality indicators) is required to ensure sustainability
Guided by organizational policies and relevant legislation, communicate the status and impact of the recommended actions to the patient/family, staff, the person(s) who reported the incident, and senior leadership in a timely manner
If communicating results of recommended actions, respect patient/family preferences in terms what they want to know and when
Celebrate successes and improvements highlighting the positive contributions to safety resulting from the incident management process
Closing the loop involves sharing what was learned from a systems analysis, both within an organization and beyond, in order to make care safer, prevent the recurrence of similar events, and promote trust and healing. This concluding step, which applies to both patient safety and incident management, offers a valuable opportunity for reflection and the identification of opportunities to further improve quality and safety outcomes as well as the systems and processes supporting them.
“Every time we take a patient safety incident, hazard through this reporting and learning cycle, we reduce risk, improve quality, and – more importantly – strengthen the patient safety culture which means that care becomes safer for patients.” -- Toolkit Faculty
Recommended strategies
This step can take as much, if not more, time than the analysis however, it is very important for learning, improvement and moving the patient safety culture forward. It is most successful when it is a regular process embedded within existing structures, includes established accountabilities and is aligned with local policies and legislation.
Share what was learned internally.
Share what was learned from the analysis with the patient/family, those involved in the incident, the person who reported it, senior management, the board, and others
Communicate results of recommended actions, taking care to respect patient/family preferences in terms of what they want to know and when
Communicate what has been implemented and the results, ensuring messages and channels are appropriate for each audience:
review the purpose of analysis, methodology and the findings as appropriate
share the factors that contributed to the incident, the defences that worked well, and what was learned about how to avoid similar incidents
review the recommended actions, their current status and their impact
maintain transparency and trust by being honest if plans have changed and share the reasons why
In accordance with organizational policies, use multiple mechanisms that transfer learning from the analysis between care units including memos, storytelling, huddles, team based peer review rounds, journal clubs, patient safety workshops using case based learning methods and newsletters
Maintain a record of communication to ensure all appropriate stakeholders have received the information
Recognize that sharing is a dialogue (not a one-way flow of information) and is ongoing (more than one time)
Encourage respectful, open communication around the results of the incident analysis at all levels of the organization
Share what was learned externally.
To prevent harm on a broader scale, disseminate what was learned externally through provincial, national and international reporting and learning systems in accordance with applicable legislation
Alerts, advisories and repositories can serve as vehicles for informing others about what happened, how and why, what actions were taken, and their impact
If appropriate, develop an external communication plan for informing the public about the actions taken, their impact, related relevant background and context, and include or exclude the patient/family perspective in accordance with their wishes
For public announcements, prepare the staff and the patient/family in advance discussing what information will be shared, when and how
Reflect and Improve.
Consider conducting a multi-incident analysis to better identify recurring system issues
Determine if what was learned can be applied to other processes in the organization
Communicate any noteworthy vulnerabilities and/or best practices through senior leadership or other appropriate body (e.g. quality committee, risk management, etc.)
Combine findings with those from different systems (e.g. accreditation, insurers, performance systems at a health system level) to help identify themes/patterns and accelerate learning
Assess the incident management process to identify strengths and opportunities for improvement, taking into consideration:
the timeliness of the analysis
the quality and effectiveness of the recommended actions
organizational guidance and supporting structures
communication and processes for sharing what was learned
the experience of those involved in the incident and the analysis
Support research and innovation focussed on learning from incidents
Peer-to-Peer Support (Second Victim Phenomenon) - An ever-growing body of evidence demonstrates that health professionals feel emotionally distressed after a patient safety incident (PSI), and there is an emerging recognition of the potential negative impact on both the health professionals’ health and on patient safety. As a result of this recognition, healthcare organizations are seeking ways to support health professionals who are emotionally traumatized after a PSI.
The Second Victim Phenomenon is a real and serious consequence related to health care roles. Different studies estimate that the prevalence of the Second Victim Phenomenon ranges from 10.4% up to 43.3 %. Although there seems to be great interest in the topic, there are very few comprehensive programs specifically designed to address second victim phenomenon with even fewer and less developed Canadian programs.
The distress caused by patient safety incidents, particularly harmful incidents can have negative effects on the care providers health and well-being and the safety of patient care. If not addressed, the provider may suffer in silence, change their role, leave the profession and some very unfortunately, will become victims of suicide. As a result, Healthcare Excellence Canada (HEC) has been working to increase awareness of the second victim phenomenon and available resources.
Recommended strategies
While provider support programs are mainly targeted at emotionally supporting health care providers that have experienced a patient safety incident, HEC’s commitment to patient safety remains the same. As part of a comprehensive program, there is a critical need to support patients and families on their journey from harm to healing. Providers, patients, families and leaders are part of the same system and to do better we need to support and collaborate in a manner that allows us to maximize learning and improvement. A provider support program will enable healthcare professionals to re-establish or improve their previous levels of work performance and improve patient safety. Provider programs should not be designed simply to help the provider but must be designed to improve the system and help make patient care safe. The walking wounded, the silent mistake, the loss of providers all contribute to lost opportunities for, and potential liabilities to patient safety.
Immediate care and support for patient(s), family, providers and others.
Peer-to-peer support programs, where health professionals can discuss their experience with a PSI in a non-judgmental environment with colleagues who can relate to what they are going through, are now seen as a potentially useful approach to helping health professionals cope with the PSI.
System Factors
In order to keep patients safe, it is essential that we understand the factors that shape both patient safety and incident management, then identify actions to respond to, align with and leverage these factors. They originate from different system levels (inside and outside the organization) and include legislation, policies, culture, people, processes and resources.
The healthcare system comprises many sub-systems operating at different levels (e.g. outside of the organization, organization and/or program level, point of care), each with specific goals, resources (human, financial, equipment) and processes (formal and informal). Maintaining a system perspective and regularly assessing the sub-systems and their connectivity is critical in identifying how they influence each other, which in turn can inform what actions are needed to strengthen patient safety and incident management.
Assess key system factors and understand how they relate to patient safety and incident management
Outside the boundaries of the organization:
public and community awareness of and engagement in patient safety
healthcare legislation, standards, policies, regulations and accreditation requirements
healthcare infrastructure and resourcing (fiscal, human, facilities and sites, equipment)
education of healthcare providers, labour agreements and workforce trends
social determinants of health, societal trends (income, social status, education, employment, housing, culture, etc.)
health trends, issues and challenges (e.g. disease outbreaks, population health)
political environment (local, provincial/ territorial, national), economic, technological and trends influencing the healthcare industry (e.g. through a PESTLE analysis)
infrastructure, trends, and funding for patient safety research, evaluation and improvement
trends in other sectors that might intersect with healthcare (e.g. technology, social media)
geographic location and regional characteristics (remote vs rural vs urban).
At the organizational and program/service levels:
strategic plans, organizational priorities, values and principles
leadership team and board level commitment and governance, including their knowledge of patient safety science and best practices
leadership visibility and engagement in patient safety
how leadership prioritize patient safety – whether it is at the top of meeting agendas and allocated at least 25% of the meeting time
organizational leadership’s accountability for patient safety performance, alignment with incentives (formal and informal)
patient/family perspective included at board and leadership meetings, in decision-making and in the design of care processes and patient safety initiatives
leadership team stability, experience, and style
organizational patient safety culture
organizational experience, current performance/progress with patient safety
the organization’s funding and financial status, including infrastructure and technology investment needs
proactive design or redesign of policies and practices related to safety
workforce expertise and skill related to patient safety
alignment between patient safety, quality improvement and risk management.
At the point of care:
patient/family partnership in care and safety
team communication, feedback, culture, composition, hierarchy
staff and patients/families being comfortable and able to report incidents, concerns, successes
staff competencies, skill, experience, professional requirements regarding patient safety and incident management
access to resources to manage safety and incidents
staff turnover, staffing levels, protected time for projects.
Identify actions to strengthen patient safety and incident management
Respond – Monitor and anticipate system factors that influence and impact patient safety (e.g. changes in regulations, workforce shortages, changes to health funding), ensure patient safety remains at the forefront of decision-making (e.g. regular updates at key meetings, assigning responsibility to stay informed to key leaders) and take action to respond as appropriate.
Align – Use internal and external system factors in assessing priority of patient safety and incident management initiatives. Initiatives that align at different system levels create multiple wins, which will accelerate uptake and spread, and promote best practices known to reduce harm.
Leverage – Take advantage of system factors to improve patient safety and incident management (e.g. use Accreditation Canada’s Required Organizational Practices as a lever to implement best practices known to improve patient safety).
Partner/collaborate – Work with others to make changes that can positively impact healthcare in your setting; support or endorse the work and successes of others.
Advocate – Promote learning from patient safety incident management to shape system factors for the benefit of your healthcare organization and providers, as well as others (e.g. work with advocacy groups to change public policy, engage funders in addressing known safety issues).
Team
Toolkit Faculty
Below are the faculty members and positions they held when the Patient Safety Incident Management Toolkit was first developed.
Dr. Amir Ginzburg, Medical Director Quality and Performance, Trillium Health Partners; Assistant Professor, Institute of Health Management, Policy and Evaluation, University of Toronto
Dr. Amy Nakajima, MD, FRCSC, Consultant, Bruyère Continuing Care
Dr. John Maxted, Assistant Professor, Department of Family and Community Medicine, University of Toronto
Julie Greenall, Director of Projects and Education, Institute for Safe Medication Practices Canada
Margot Harvie RN, BN, Med, Quality & Safety Education Lead, Health Quality Council of Alberta
Annemarie Taylor, Provincial Director, British Columbia Patient Safety & Learning System
Brent Windwick, Partner, Field Law (Health Industry Services & Privacy)
Carolyn Hoffman, Senior Vice President Quality & Healthcare Improvement, Alberta Health Services
Deborah Prowse, Member, Patients for Patient Safety Canada
Heather Howley, Health Services Research Specialist, Accreditation Canada
Heon-Jae Jeong, Postdoctoral Fellow, Department of Health Policy and Management, Johns Hopkins
Jennifer White, Provincial Quality Care Coordinator, Saskatchewan Ministry of Health
Sharon Nettleton, Past Co-Chair, Patients for Patient Safety Canada
Sherry Espin, Associate Professor, Ryerson University
Toolkit Project Team
Below are the staff members and the positions they held when the Patient Safety Incident Management Toolkit was first developed.
Abigail Hain, Senior Director, Capacity Building and Knowledge Translation, Canadian Patient Safety Institute
Ioana Popescu, Patient Safety Improvement Lead, Canadian Patient Safety Institute
Jennifer Rodgers, Patient Safety Improvement Lead, Canadian Patient Safety Institute
Monique Thibodeau, Project Coordinator, Canadian Patient Safety Institute
Marie Pinard, Manager, Quality Management, The Hospital For Sick Children
Jocelyne Pepin, Assistant Chief, Pharmacy Department, Jewish General Hospital
Toolkit Development and Maintenance
A variety of qualified experts and organizations worked with the Canadian Patient Safety Institute (now Healthcare Excellence Canada) to compile this practical and evidence-based toolkit. The process included:
assigning an inhouse team with support from a writer with experience in the field
seeking advice from an expert faculty that included patient and family representatives
basing the content on the Canadian Incident Analysis Framework
engaging key stakeholders via focus groups and collecting evidence from peer-reviewed journals and publicly available literature
Glossary
Note to Quebec Readers: The toolkit was developed by and for English and French speaking Canadians and the terms used throughout were chosen by consensus. However, given the provisions contained in the Act Respecting Health Services and Social Services (R.S.Q., chapter S-4.2) effective in Quebec, various terms have been adapted. During the toolkit development we also consulted with Accreditation Canada to maintain consistency with the revised Disclosure and Incident Management Required Organizational Practices (2014) and the patient safety terminology used therein. Please make the necessary conversions when reading this toolkit text.
Terms used in the toolkit: Terms used in Quebec
Patient: User
Incident disclosure: Accident disclosure
Harm: Consequence
Patient safety incident: Patient safety incident resulting from the provision of healthcare or social services
Harmful incident: Accident with consequences for the user
No harm incident: Accident without consequences but the user was affected
Near miss: Incident or near miss
Harmful incident, no harm incident, and near miss: Events
This glossary is not intended to be an exhaustive list of terms, but rather a concise list of key terms used throughout the toolkit.
Actions (taken to reduce risk of harm): Actions taken to reduce, manage, or control any future harm, or probability of harm.
Alerts or advisories: An alert or advisory is a piece of information that has been produced and publicly posted that outlines a specific type of patient safety incident or series of incidents that did occur or could occur.
Apology: A genuine expression of sympathy or regret, a statement that one is sorry for what has happened. An apology includes an acknowledgement of responsibility if such responsibility has been determined after the analysis of the adverse event.
Authority gradient: Balance of decision-making power or the steepness of command and hierarchy in a given situation.
Contributing factors: 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.
Culture, Patient Safety: Culture refers to shared values (what is important) and beliefs (what is held to be true) that interact with a system’s structures and control mechanisms to produce behavioural norms.
Disclosure: The process by which a patient safety incident is communicated to the patient by health care providers.
Early warning system: A systemic process for evaluating and measuring risks early in order to take pre-emptive steps to minimize their impact.
Governance: The body having accountability and legal responsibility for the overall performance of an organization and oversight of decisions.
Harm: Impairment of structure or function of the body and/or any deleterious effect arising therefrom. Harm includes disease, injury, suffering, disability and death.
Hazard: Situations with the potential to cause harm.
Healthcare organization: An organization that provides health services in any healthcare sector.
High Reliability Organizations (HROs): Organisations that have few accidents despite operating in highly dynamic, technologically rich and hazardous industries.
Human Factors: A discipline addressing human behaviour, abilities, limitations, and relationship to the work environment (physical, organizational, cultural), with the goal to promote efficiency, safety and effectiveness by improving the design of technologies, processes and work systems.
Incident Analysis: A structured process that aims to identify what happened, how and why it happened, what can be done to reduce the risk of recurrence and make care safer, and what was learned. It is also referred to as system-based analysis.
Incident Management: The various actions and process required to conduct the immediate and ongoing activities following an incident. Incident analysis is a component of incident management.
Patient safety incident: An event or circumstance which could have resulted, or did result, in unnecessary harm to a patient. There are three types of patient safety incidents:
Harmful incident: A patient safety incident that resulted in harm to the patient. Replaces "preventable adverse event”
Near miss: A patient safety incident that did not reach the patient and therefore no harm resulted.
No-harm incident: A patient safety incident that reached the patient but no discernible harm resulted.
Patient safety: The pursuit of the reduction and mitigation of unsafe acts within the health care system, as well as the use of best practices shown to lead to optimal patient outcomes.
Patient: A person who is receiving, has received, or has requested health care.
Family: A person(s) whom the patient wishes to be involved with them in care, and acting on behalf of and in the interest of the patient.
Prospective analysis: An analytical tool to assess and mitigate harm or loss by analyzing a situation or process that carries with it some inherent risk. Its purpose is to identify the way in which a process might potentially fail, with the goal to eliminate or reduce the likelihood or outcome severity of such a failure.
Providers: Refers to physicians, professional, unregulated staff, and others engaged in the delivery of health services.
Quality Improvement (QI): A formal approach to the analysis of performance and systematic efforts to improve it. There are numerous models used.
Reporting: The communication of information about a patient safety incident through appropriate channels inside or outside of healthcare organizations, for the purpose of reducing the risk of occurrence of patient safety incidents in the future.
Resilience: The degree to which a system continuously prevents, detects, mitigates or ameliorates hazards or incidents so that an organization can “bounce back” to its original ability to provide core functions.
Risk management: An organized effort to identify, assess and reduce, where appropriate, risks to patients, visitors, staff and organizational assets. Activities are undertaken to identify, analyze and educate, and to structure processes to reduce the likelihood of adverse events.
Risk mitigation: The process of identifying and implementing precautions or controls that will most effectively reduce the consequence or likelihood of occurrence of a risk.
Risk: The probability that a specific adverse event will occur in a specific time period or as a result of a specific situation.
System Levels: Systems are generally viewed from various levels because they are differences in goals, structures and ways of working in different parts of the system.
System: A health system, or healthcare system, is the sum of all the organizations, institutions, and resources whose primary purpose is to deliver health care services to meet the health needs of a target population.
Systems Thinking: An approach that centers on the dynamic interaction, synchronization and integration of system components and sub-components (e.g. people, processes, technology, incentives, decisions, culture).
Team: Two or more people who interact dynamically, interdependently, and adaptively toward a common and valued goal/objective/ mission. Patients/families are part of the team.
Teamwork: Team members working together to achieve a shared goal.
Resources and Recommended Readings
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Canadian Patient Safety Institute (CPSI). Canadian Disclosure Guidelines: Being open with patients and families. 2011. (Guide, 52 pages)
Diagram B : Circumstances when Disclosure should take place
Diagram C : Stages of Disclosure
Appendix D : Checklist for Disclosure Process
HealthcareCAN. Canadian Patient Safety Officer Course. (Learning program, $)
Canadian Patient Safety Institute (CPSI). Disclosure Training Program offered by The Canadian Medical Protective Association. (Learning program, $)
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Appendix A: Team management checklist.
Appendix C: Analysis team membership, roles and responsibilities.
Appendix D: Sample analysis team charter.
Appendix E: Sample confidentiality agreement.
Appendix F: Checklist for effective meetings with patient(s)/ families.
Appendix G: Incident analysis guiding questions.
Appendix H: Creating a constellation diagram.
Appendix I: Incident Analysis Report Template
Appendix J: Case study - comprehensive analysis: elopement from a long-term care home.
Appendix K: Case study - concise analysis: medication incident.
Appendix M: Legislative Protection for Quality of Care.
Appendix N: Three human factors methods that can be used in incident analysis.
Figure 2.3 : System Levels.
Figure 3.12: Example of tool to track the implementation status of recommended action.
Figure 3.14: Useful questions in designing data collection.
Section 3.6.6 Developing and Managing Recommended Actions.
Section 3.6: Criteria and considerations for selecting an incident analysis.
Section 1.4 Incident Analysis and Management from a Patient Perspective.
Section 2 Essentials of Analysis.
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