A Framework for Establishing a Patient Safety Culture
The Framework is based on a set of evidence-based practices that must all be applied in order to deliver good, safe care.
- Topics
- Health workforce
- Patient safety
- Policy
- Audience
Healthcare leader
Quality or safety improvement lead
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Patient Safety Culture "Bundle" for CEOs/Senior Leaders
What is the Patient Safety Culture "Bundle"?
Strengthening a safety culture necessitates sequential, iterative and simultaneous interventions that enable, enact and learn in a way that is attuned to the existing culture. Through a literature review of more than 60 resources, we created a Patient Safety Culture “Bundle” that has been validated through interviews with Canadian thought leaders. The Bundle is based on a set of evidence-based practices that must all be applied in order to deliver good care. All components are required to improve the patient safety culture.
The Patient Safety Culture "Bundle" for CEOs and Senior Leaders encompasses key concepts of safety science, implementation science, just culture, psychological safety, staff safety/health, patient and family engagement, disruptive behaviour, high reliability/resilience, patient safety measurement, frontline leadership, physician leadership, staff engagement, teamwork/communication and industry-wide standardization/alignment.
Why was this Bundle created?
A patient safety culture is difficult to operationalize. Improving safety requires an organizational culture that enables and prioritizes patient safety. The importance of culture change needs to be brought to the forefront, rather than taking a back seat to other safety activities.
The National Patient Safety Consortium Education Working Group verified the critical role senior leadership plays in ensuring patient safety is an organizational priority. A working group of partners, led by the Canadian Patient Safety Institute (now Healthcare Excellence Canada), Canadian College of Health Leaders (CCHL), HealthCareCAN and the Healthcare Insurance Reciprocal of Canada (HIROC), joined together to establish a framework and advance this work.
Testimonials
"Patient safety and healthcare quality are advanced when boards and senior leaders are committed to it and are able to show evidence of that commitment. Missing until now is a concise "how to" guide. The Patient Safety bundle for Leaders fills that gap."
Catherine Gaulton, CEO, HIROC
"Leadership is critical to developing a patient safety culture and building leadership capacity requires a vision of the knowledge, skills and behaviours necessary to achieve this. The Patient Safety Leadership Bundle provides this and will be a practical tool for health leaders across the healthcare continuum to assess their personal capabilities. It will also provide both organizations and the system, as a whole, a checklist for what's missing from our collective leadership education toolkits so that we can strategically respond to these needs. HealthCareCAN is committed to the spread of this tool across the country as part of a cultural shift to safety and a drive towards high-reliability culture."
Dale Schierbeck, Vice-President, Learning & Development, HealthCareCAN
and Co-Chair, Patient Safety Education for Leaders Working
"The drive to quality and patient safety must start at the top with the board of directors – they are a critical enabler of culture change. It has been well-recognized that taking a passive role in this fundamental responsibility is not an option. Governors need insight into best practice principles and a corresponding framework to help guide them in this important task – this bundle delivers that."
Elizabeth Martin, Board Chair, HIROC;
former Board member, Sunnybrook Health Sciences Centre
"Preventable harm must remain a focus for all Boards as they consider their organization's commitment to the people they care for. The depth of information and insight contained within the Patient Safety Culture Bundle will assist all leaders, boards and organizations to fully appreciate the importance culture plays in achieving these goals. Armed with this knowledge, the dedicated people within healthcare organizations can be supported to deliver consistently safe care."
Ruthe Anne Conyngham, Faculty, Canadian Patient Safety Institute;
Member, Cancer Quality Council of Ontario
"For years, senior leaders have promoted the use of checklists to support evidence-informed clinical practice. Now leaders have their own checklist to support a safety culture. The Patient Safety Leadership Bundle will be an invaluable resource to help leaders walk the talk and lead by example"
Maura Davies, Former President and CEO, Saskatoon Health Region;
President, Maura Davies Healthcare Consulting Inc.
"The patient safety and quality culture bundle is a key resource that provides useful guidance for senior leaders on the critical knowledge and actions needed to support improvements in safety culture and outcomes."
Ross Baker, Ph.D., Professor and Program Lead, Quality Improvement and Patient Safety,
Institute of Health Policy, Management and Evaluation,
Dalla Lana School of Public Health,
University of Toronto
"One of many actions resulting from the work of National Patient Safety Consortium is the Safety Bundle for Leaders/CEOs, which demonstrates the critical role senior leadership plays in ensuring patient safety is an organizational priority. The Safety Bundle will help identify the best practices, skills, tools and resources healthcare leaders can deploy to advance patient safety and facilitate the spread of this knowledge within their organizations."
Chris Power, Chief Executive Officer, Canadian Patient Safety Institute
"The Board is ultimately accountable for the performance of the organization. The "Patient Safety Culture Bundle" is an excellent resource to assist the Board in improving organizational culture and advancing its patient safety agenda."
Joan Dawe, Peer facilitator Effective Governance for Quality and Patient Safety
Education Program; Past Chair, Eastern Health Regional Authority;
Past Chair, Health and Community Services, St. John's Region
"The Board, CEO and Senior Leaders all play critical roles in setting the tone and championing the importance of a safety culture in their organizations. Engaging staff in this effort starts at the top and demands attention and concerted ongoing effort. It requires support for and engagement with front line staff and respect for what they do, and equally important, engaging those being served and the shared knowledge this experience generates for improving care processes. This work is complex and the Bundle will serve as a useful guide for the scope of effort required to improve safety and eliminate harm."
Ray Racette, former CEO Canadian College of Health Leaders.
Testimonials
"Patient safety and healthcare quality are advanced when boards and senior leaders are committed to it and are able to show evidence of that commitment. Missing until now is a concise "how to" guide. The Patient Safety bundle for Leaders fills that gap."
Catherine Gaulton, CEO, HIROC
"Leadership is critical to developing a patient safety culture and building leadership capacity requires a vision of the knowledge, skills and behaviours necessary to achieve this. The Patient Safety Leadership Bundle provides this and will be a practical tool for health leaders across the healthcare continuum to assess their personal capabilities. It will also provide both organizations and the system, as a whole, a checklist for what's missing from our collective leadership education toolkits so that we can strategically respond to these needs. HealthCareCAN is committed to the spread of this tool across the country as part of a cultural shift to safety and a drive towards high-reliability culture."
Dale Schierbeck, Vice-President, Learning & Development, HealthCareCAN
and Co-Chair, Patient Safety Education for Leaders Working
"The drive to quality and patient safety must start at the top with the board of directors – they are a critical enabler of culture change. It has been well-recognized that taking a passive role in this fundamental responsibility is not an option. Governors need insight into best practice principles and a corresponding framework to help guide them in this important task – this bundle delivers that."
Elizabeth Martin, Board Chair, HIROC;
former Board member, Sunnybrook Health Sciences Centre
"Preventable harm must remain a focus for all Boards as they consider their organization's commitment to the people they care for. The depth of information and insight contained within the Patient Safety Culture Bundle will assist all leaders, boards and organizations to fully appreciate the importance culture plays in achieving these goals. Armed with this knowledge, the dedicated people within healthcare organizations can be supported to deliver consistently safe care."
Ruthe Anne Conyngham, Faculty, Canadian Patient Safety Institute;
Member, Cancer Quality Council of Ontario
"For years, senior leaders have promoted the use of checklists to support evidence-informed clinical practice. Now leaders have their own checklist to support a safety culture. The Patient Safety Leadership Bundle will be an invaluable resource to help leaders walk the talk and lead by example"
Maura Davies, Former President and CEO, Saskatoon Health Region;
President, Maura Davies Healthcare Consulting Inc.
"The patient safety and quality culture bundle is a key resource that provides useful guidance for senior leaders on the critical knowledge and actions needed to support improvements in safety culture and outcomes."
Ross Baker, Ph.D., Professor and Program Lead, Quality Improvement and Patient Safety,
Institute of Health Policy, Management and Evaluation,
Dalla Lana School of Public Health,
University of Toronto
"One of many actions resulting from the work of National Patient Safety Consortium is the Safety Bundle for Leaders/CEOs, which demonstrates the critical role senior leadership plays in ensuring patient safety is an organizational priority. The Safety Bundle will help identify the best practices, skills, tools and resources healthcare leaders can deploy to advance patient safety and facilitate the spread of this knowledge within their organizations."
Chris Power, Chief Executive Officer, Canadian Patient Safety Institute
"The Board is ultimately accountable for the performance of the organization. The "Patient Safety Culture Bundle" is an excellent resource to assist the Board in improving organizational culture and advancing its patient safety agenda."
Joan Dawe, Peer facilitator Effective Governance for Quality and Patient Safety
Education Program; Past Chair, Eastern Health Regional Authority;
Past Chair, Health and Community Services, St. John's Region
"The Board, CEO and Senior Leaders all play critical roles in setting the tone and championing the importance of a safety culture in their organizations. Engaging staff in this effort starts at the top and demands attention and concerted ongoing effort. It requires support for and engagement with front line staff and respect for what they do, and equally important, engaging those being served and the shared knowledge this experience generates for improving care processes. This work is complex and the Bundle will serve as a useful guide for the scope of effort required to improve safety and eliminate harm."
Ray Racette, former CEO Canadian College of Health Leaders.
How can you use the Patient Safety Culture “Bundle”?
The key components required for a Patient Safety Culture are identified under three pillars.
Adapted from: Singer & Vogus (2013). Reducing hospital errors: Interventions that build safety culture. ARPH 34:373-96 JANUARY 2018
Organizational priority setting, leadership practices that motivate the pursuit of safety
Organizational priority
Board educated, engaged, accountable, prioritizes patient safety?
Safety/quality vision, strategy, plan, goals (with input from patients, families, staff, physicians)?
Safety/quality resources/infrastructure?
CEO/senior leadership behaviours
Relentless communication about safety/quality vision, stories, results?
Regular/daily interaction with care settings/units, staff, physicians, patients and families?
Model key values (e.g. honesty, fairness, transparency, openness, learning, respect, humanity, inclusiveness, person-centredness)?
Human resources
Leaders/staff/physicians engaged, clear expectations/incentives for safety/quality?
“Just culture” program/protocol?
Disruptive behaviour protocol?
Staff and physician safety (physical/psychological/burnout); safe environment program?
Health information/technology/devices
E-health records support safety (e.g. decision support, alerts, monitoring)?
Technology/devices support safety (e.g. human factors, traceability)?
Healthcare system alignment
Community/industry-wide collaborations?
Align with national/international standards (e.g. accreditation, regulatory, professional, industry)?
Frontline actions that improve patient safety
Care settings and managers
Integrated, unit/setting-based safety practices (e.g. daily briefings, visual management, local problem solving)?
Managers/physician leaders foster psychological safety (speaking up)?
Care processes
Standardized work/care processes where appropriate?
Communication/patient hand-off protocols (e.g. between shifts/units, across care continuum)?
Patient and family engagement/co-production of care
Patients/families partners in all aspects of care (e.g. planning, decision-making, family presence policy, rounds, access to health record/test results)?
Patients/families involved in local safety/quality initiatives?
Disclosure and apology protocols?
Situational awareness/resilience
Processes for real-time/early detection of safety risks and patient deterioration (by staff/patients families/physicians)?
Protocols for escalation of care concerns (by staff/patients/families/physicians)?
Learning practices that reinforce safe behaviours
Education/capability building
Leaders/staff/physicians trained in safety and improvement science, teamwork, communication?
Team-based training, drills?
Incident reporting/management/analysis
Effective risk/incident reporting system for events related to patients/families and staff/physicians (e.g. near misses, never events, mortality/morbidity reviews)?
Structured processes for responding to and learning from safety events/critical incidents (e.g. systems analysis, patient/family/staff/physician involvement and support)?
Safety/quality measurement/reporting
Regular measurement of safety culture; patient/family complaints; and staff/physician engagement (by unit/setting and organization)?
Retrospective/prospective safety and quality process and outcome measures?
Regular, transparent reporting of safety/quality plan results?
Operational improvements
Structured methods, infrastructure to improve reliability, streamline operations (e.g. PDSA, lean, human factors engineering, prospective risk analysis)?
Resources
Singer and Vogus – Interventions That Build Safety Culture (2013)
Piecemeal initiatives to improve a patient safety culture are inadequate; improving a patient safety culture requires sequential, iterative and simultaneous interventions that:
Enable: e.g., "transformational" leadership; critical role of senior leaders; leadership characteristics; human resources; information technology (IT); external regulators
Enact: e.g., teamwork; communication; mindfulness; patient involvement; reporting; coordination between areas /at transitions
Elaborate: e.g., learning (e.g., reports, complaints, morbidity and mortality rounds); education; monitoring (prospective, retrospective, concurrent); operational improvements (industrial techniques, infrastructure).
Baker – Beyond the Quick Fix (2015)
Recommendations: Patient safety /quality improvement strategy; board monitoring of performance; measurement (organizational and microsystem levels); event reporting and analysis (focus on gaps and feasible recommendations); investments in work climate; patients and care givers included in patient safety and quality improvement; investments in patient safety /quality improvement infrastructure; leadership development; collaboration across organizations; pan-Canadian information systems.
Canadian Patient Safety Institute – Patient Safety Culture
Dimensions: informed; reporting; learning; just; flexible.
Contributors: leadership; patient/family engagement; teamwork and communication; openness to reporting; learning; resources; priority of safety versus production; education and training.
British Columbia – Culture Change Toolbox: Components of Patient Safety Culture (2013)
Teamwork and communication; safety climate; psychological safety; organizational fairness; just culture; stress recognition; working conditions; leadership; learning and improvement; patients as partners; transparency.
American College of Healthcare Executives (ACHE) / Institute for Healthcare Improvement (IHI) / National Patient Safety Foundation (NPSF) – Leadership Blueprint for Culture of Safety (2017)
Six leadership domains: vision; trust, respect and inclusion; board engagement; leadership development; just culture; behaviour expectations.
IHI Whitepaper – Patient Safety (2006)
Patient safety strategy/aims; senior leader communication and awareness building (e.g., walk-rounds); engage stakeholders (board, leaders, physicians, staff, patients/families) in patient safety; implement "just" culture; focus on process redesign/improved reliability (e.g., evidence-based standardization, human factors); leader/ manager/staff accountability (e.g., for safety reporting, reliable processes/"daily work") and aligned incentives for patient safety; patient safety infrastructure (staff and committees); assess patient safety culture; measure/track patient safety (e.g. mortality, trigger tool); support patients/families impacted by errors.
IHI Whitepaper – 7 Leadership Leverage Points (2008)
System-level aims; executable strategy; leadership attention; patients /families; Chief Financial Officer (CFO) as quality champion; engage physicians; improvement capability.
IHI Whitepaper – High-Impact Leadership (2013)
Person-centredness (e.g., patient involvement/stories); front-line engagement (e.g., regular presence at frontlines, visible champion, lead projects); relentless focus (e.g., talk about vision every day, align schedule with high-priority initiatives; designate resources); transparency; build will to improve (e.g., communicate and model desired behaviours, openness, swift action against undesired behaviour); boundary-lessness (e.g., systems thinking, harvest ideas from and partner with other organizations).
IHI Whitepaper – Sustaining Improvement (2016)
Quality control, improvement, culture; standardization; accountability (standard work); visual management; problem solving; escalation; integration; prioritization; daily work; policy; transparency; trust.
IHI Whitepaper – Safe, Reliable and Effective Care (2017)
Leadership; psychological safety; accountability (act in safe and respectful manner); teamwork and communication; negotiation; continuous learning; improvement and measurement; reliability; transparency.
Key Concepts
Safety science – focusses on contributing factors and underlying causes of risk and harm, including errors and human factors. It includes many disciplines not typically considered part of healthcare. Recognizes the fundamental importance of system design in driving workforce behaviour. In other industries, such as aviation, safety experts accept that human error must be expected, anticipated, and its effects mitigated. Safety science and human factors engineering is used to design systems to prevent errors, and to mitigate harm when errors occur. (Berwick et al., 2015).
Implementation science – supplements patient safety science; focusses on identifying and implementing valuable practices and lessons learned, and scaling up/translation across the organization and system. (Berwick et al., 2015).
Just culture – a culture that recognizes that individual practitioners should not be held accountable for system failings over which they have no control. A just culture recognizes many individual or "active" errors represent predictable interactions between humans and the systems in which they work. A just culture also does not tolerate conscious disregard of clear risks to patients or gross misconduct. (Berwick et al., 2015).
Psychological safety – an environment where: anyone can ask questions without looking stupid; anyone can ask for feedback without looking incompetent; anyone can be respectfully critical without appearing negative; anyone can suggest innovative ideas without being perceived as disruptive. (Frankel, 2017).
Staff safety/health – A precursor to providing high quality care are staff that are free from physical harm during daily work. (Perlo, 2017)
Patient and family engagement – recognized as a primary area of focus in patient safety and quality; includes engagement at three levels: direct care (diagnosis, treatment decisions, monitoring), organizational design and governance (planning, patient advisory councils, quality improvement projects), policy making (public health, research priorities, resource allocation). (Carman, 2013).
Disruptive behaviour – any behaviour that shows disrespect for others or any interpersonal interactions that impede the delivery of patient care; this behaviour poses a threat to patient safety. (AHRQ PS Net, 2017).
High reliability/resilience – reliable/mindful organizations are: preoccupied with failure (look for small signals of failure vs. preoccupation with success); reluctant to simplify interpretations (acknowledge complexity); sensitive to operations (aware of what is happening at frontlines); committed to resilience (acting quickly when things go wrong, e.g., patient deterioration); and defer to experts (vs. authority). (Weick & Sutcliffe, 2015).
Patient safety measurement – five dimensions: past harm (incidents, mortality); reliability (compliance); sensitivity to operations (walk-rounds, staffing levels, escalation); anticipation and preparedness (risk registers, safety culture scores, absenteeism); integration and learning (automated alerts, board dashboards). (Vincent, 2016).
Frontline leadership/distributed leadership – recognized as a key driver for change in healthcare; local leaders translate senior leader priorities/values into action at the microsystem level; they have great impact on unit cultures and learning processes. (IHI, 2016).
Physician leadership – recognized as a key driver for change in healthcare; six strategies for engaging physicians: discover common purpose; reframe values and beliefs; segment the engagement plan; use engaging improvement methods; show courage; adopt an engaging style. (Reinertsen, 2007).
Staff engagement – A joyful, engaged workforce will have: physical and psychological safety; meaning and purpose; choice and autonomy; recognition and rewards; participative management; camaraderie and teamwork; daily improvement; wellness and resilience; real-time measurement. (Perlo, 2017)
Teamwork/communication – gaps in communication and/or poor teamwork are frequently noted as contributing factors to many patient safety events. Strong teams which train together and have established and reliable communication practices will have superior patient safety performance. (Baker, 2015).
Industry-wide standardization/alignment – A key feature in other high-risk industries is alignment across the sector related to key priorities, national/international standards and regulation of safety-critical practices and technologies. (Dixon-Woods, 2016, Berwick et al., 2015).
Environmental Scan
ACHE, NPSF Lucian Leape Institute. (2017). Leading a culture of safety: a blueprint for success.
AHRQ PS Net. (2017). Disruptive and unprofessional behavior.
Baker R. (2015). Beyond the quick fix – strategies for improving patient safety. Institute of Health Policy, Management and Evaluation at the University of Toronto.
Baker R, Norton P, et al. (2004). The Canadian Adverse Events Study: the incidence of adverse events among hospital patients in Canada. CMAJ. 170(11):1678-86.
BC Patient Safety and Quality Council. (2013). Culture change toolbox.
Berwick D, Shojania K, et al. (2015). Free from harm: accelerating patient safety improvement fifteen years after To Err Is Human. National Patient Safety Foundation.
Berwick D, Feely D. (2017). WIHI: the next wave of patient safety. Institute for Healthcare Improvement (IHI) webinar.
Botwinick L, Bisognano M, Haraden C. (2006). Leadership guide to patient safety. IHI White Paper.
Canadian Institute for Health Information, Canadian Patient Safety Institute (2016). Measuring patient harm in Canadian hospitals.
Canadian Patient Safety Institute (CPSI). (Date unknown). Patient safety culture.
Carman L, Dardess P, Maurer M, et al. (2013). Patient and family engagement: a framework for understanding the elements and developing interventions and policies. Health Affairs. 32(2):223-231.
CPSI, AHQPSC, HQO, PFPSC. (2017). Engaging patients in patient safety: a Canadian guide.
Dixon-Woods M, Pronovost P. (2016). Patient safety and the problem of many hands. BMJ Qual Saf. 25(7):485-488.
Frankel A, et al. (2017). A framework for safe, reliable, and effective care. IHI White Paper.
IHI. (Date unknown). What is a bundle?
IOM. (2001). Crossing the quality chasm: a new health system for the 21st century. Washington, DC: National Academy Press.
The Joint Commission. (2017). The essential role of leadership in developing a safety culture. Sentinel event alert.
Kizer, K. (1999). Large system change and a culture of safety. In: Enhancing patient safety and reducing errors in health care. Chicago, IL: National Patient Safety Foundation.
Kristensen S, Christensen K, Jaquet A, Beck C, Sabroe S, Bartels P, Mainz, J. (2016). Strengthening leadership as a catalyst for enhanced patient safety culture: a repeated cross-sectional experimental study. BMJ Open. 1-10.
National Patient Safety Foundation. (2017). Call to action: preventable health care harm is a public health crisis and patient safety requires a coordinated public health response.
Perlo J, Balik B, Swensen S, et al. (2017). IHI framework for improving joy in work. IHI White Paper.
Reinertsen J, Bisognano M, Pugh M. (2008) Seven leadership leverage points for organization-level improvement in health care (second edition). IHI White Paper.
Reinertsen J, Gosfield A, Rupp W, et al. (2007). Engaging physicians in a shared quality agenda. IHI White Paper.
Sammer C, et al. (2010). What is patient safety culture? A review of the literature. J Nur Schol. 42:2;156-165.
Scoville R, Little K, Rakover J, Luther K, Mate K. (2016). Sustaining improvement. IHI White Paper.
Singer S, Vogus T. (2013). Reducing hospital errors: interventions that build safety culture. Annu Rev Public Health. 34:373-396.
Swensen S, et al. (2013). High-impact leadership: improve care, improve the health of populations, and reduce costs. IHI White Paper.
Vincent C, et al. (2016). A framework for measuring and monitoring safety: a practical guide to using a new framework for measuring and monitoring safety in the NHS. The Health Foundation Quick Guide.
Weick, K, Sutcliffe, K. (2015). Managing the unexpected: sustained performance in a complex world. Hoboken, NJ: John Wiley & Sons.