Creating a safe culture

‘Culture will trump rules, standards and control strategies every single time’ Don Berwick

Safety culture is the foundation from which safe activities and outcomes occur in a organisation. How safe the culture is depends on how an organisation prioritises, resources and implement patient safety endeavours. The culture results from the interaction between individual and group beliefs, values, and attitudes. A strong safety culture is informed, just, flexible and focused on learning and reporting without retribution.

There are 6 leadership practices necessary to develop and sustain a culture of safety.

1. Establish a compelling vision for safety.
2. Build trust, respect, and inclusion.
3. Engage and develop a board.
4. Prioritize safety in the selection and development of leaders.
5. Lead and reward a just culture.
6. Establish organisational behaviour expectations.

Practices that support a good safety culture include:

• Patient participation: Involve patients and families in the co-creation and accountability of safety governance structures.
• Transparency: Open, timely and accessibly sharing of all data related to safety with patients, staff members and the public
• Psychological safety: Confidence that the team can speak up without rejection, embarrassment, or punishment.
• Appreciative inquiry: Appreciate what is working well, review why it works and highlights the strengths of the organisation.
• Humble Inquiry: Be curious about how a system is working and build respectful relationships.
• Intelligent kindness: Uses ideas of kinship to build supportive and nurturing teams.

A safe culture takes time to build. Shared activities such as handover, huddles and debrief can model good behaviour and highlight their benefits on performance. Repeating behaviours that represent a safe culture can create a virtuous cycle which can change deeply held attitudes and beliefs, then ultimately the safe culture overall.

The NHS National Patient Safety Team have also launched a new NHS Patient Safety Workspace on FutureNHS, to share information, tools and resources with the NHS’s growing patient safety community.

The workspace currently has dedicated areas for work programmes such as the Patient Safety Incident Response Framework (PSIRF) and the Learn from Patient Safety Events Service (LFPSE), as well as frameworks for involving patients in patient safety, safety culture, inequalities in patient safety, and the national patient safety improvement programmes.

They are looking to rapidly expand the content to cover further areas of our work and add additional material to the existing areas. As content grows, the workspace will aim to include tools, templates, reports, podcasts, videos, webinar recordings, and case studies, as well as dedicated discussion forums.

For major programmes, such as PSIRF, FutureNHS will be used more and more to share tools and resources to support providers with local implementation. The NHS Patient Safety workspace is accessible to anyone with a FutureNHS account. If you don’t already have an account, anyone with a @nhs.net / @.nhs.uk / @nhs.scot / @phe.gov.uk email address can self-register, and others can request access via an online form.

Although it is open access on FutureNHS to view the patient safety workspace content, you are encouraged to join as a member so you can download materials and receive notifications. To do this, scroll to the bottom of the patient safety workspace homepage and click ‘join this workspace’. For Patient Safety Specialists the workspace can also be accessed directly through a link that has been created on the existing Patient Safety Specialist FutureNHS workspace.

There are many examples of organised efforts to improve paediatric patient safety around the UK. Here we highlight some examples of excellence

PIER Patient Safety First Projects

Scottish Patient Safety Programme

RCPCH QI Patient Safety Posters

Oxford Academic Health Science Network: Specialised Paediatric Program.

Making It Safer Together (MiST)

MedsIQ

Pan-London Paediatric Sepsis Network

SCRIPT elearning for safe prescribing in paediatrics

Situation awareness requires a shared understanding of what is happening, and takes the perspective of everyone involved in a child’s care so that the best decisions can be made. These tools and techniques developed as part of the RCPCH S.A.F.E Programme show how this can be achieved by sharing non-hierarchical information and regular communication in an acute healthcare setting.

Find the toolkit here: S.A.F.E

This video explains more:

‘Nothing about me without me’ Vallerie Bingham, patient

Patients and their kin are a critical part of creating safe healthcare. They are in a position to both identify harm that has occurred as well as to reduce risk of future harm. They often notice safety problems that are missed by health care professionals (see this study for example).

Healthcare is safer if it is ‘person-centred’. This means caring for the individual and taking into account their preferences, needs and values. We should aim to create care plans together in a respectful and responsive manner. The hierarchy of the healthcare systems creates a barrier to person-centred care. If we can break the hierarchy and make both the clinician and the patient feel psychologically safe, the patients and their family can get involved in their own care and ask questions.  Informed patients have better situational awareness and better therapeutic relationships with clinicians. Creating a relationship where everyone can take an active role in the planning and delivery of care can increase safety.

Examples ‘person-centred’ care approaches include

Hello, my name is…

Me first

Methods for facilitating person centred-safety

There is a spectrum of how patients might be involved in healthcare safety ranging from their individual care to the development of safe care pathways in the system. Patients can get involved in any or all levels including:

Informing -> educating -> consulting -> engaging -> co- designing -> co-producing

Some strategies for ensuring safety through a person-centred approach include:

• Patient-held medical records:  If patients hold their own information it can address the hierarchy, enable transparency and empower people to have more of an active role in their healthcare. NHS digital share information about adoption of personal health records in the NHS here
• Co-design & co-production: Creating health services in partnership with children and their families can be done individually, at group level and across the wider health system. The RCPCH child and young persons engagement team offers resources for this here.
• Shared decision making is where health decisions are made in partnership with the patient, their kin and the health-care team with everyone expressing their preferences based on their unique circumstances, expectations, beliefs and values. In spite of high quality evidence that supports this practice is, it is not widely used in paediatrics. This article ‘Is Sharing really Caring? Viewpoints on shared decision making in paediatrics’ by Jordan et al discusses this further and offers pragmatic solutions.
• Structured tools for enhancing interactions: These can help to address the power imbalances in clinician-patient dynamic. Examples include:
  • Ask me 3 from the IHI
  • 5 moments for medication safety from the WHO
  • Know Check Ask from HSE Ireland
• Teach-back: This is an evidenced-based health literacy intervention where patients explain to their provider, in their own words, what they must know and do about their condition. Find a report of a paediatric teach-back project here
• Peer to peer or group support can be used to give people opportunity to raise, share and solve individual or group concerns with others who have similar experiences and fears.
• Shared medical review groups patients together with a common condition or treatment need so that concerns are shared among the group and patients may learn from each others questions and experiences.

A systems approach to person-centred safety can be created with tools such as patient focused registries, co-designed health information, Community coordination support networks and experience based co-design.

With the best will in the world, errors will occur in healthcare settings with potential resultant harm. We need to measure patient safety and harm, both actual and potential, in order to understand risks within our healthcare system. A range of sources of data can help us capture information about patient safety risks and harms. This is then used to make improvements in the local healthcare setting and also is fed into national reporting structures like the NRLS to address system-wide issues.

Adverse event reporting and monitoring patient outcomes

Measuring episodes of harm that occur as a consequence of patient care enables analysis and learning from incidents. Examples of how we collect data on harm or take proxy-measures of safety in healthcare settings include:

• Datix or similar risk management information systems are used to collect and manage data on adverse events with the goal of identifying learning and implementing improvement. It imperative that there is no blame culture associated with datix (e.g. I’m going to datix you!’) to preserve the psychological safety of the team.
• Never Events are patient safety incidents that are totally preventable as there is national guidance that should have been implemented to prevent them. They are reportable via the National Reporting and learning Service (NRLS) and Strategic Executive Information system (StEIS) and require a Patient Safety Incident Investigation under PSIRF. More information can be found here
• Hospital Standardised Mortality Ratio (HSMR): This aims to measure deaths in hospital (includes up to 30-day post-discharge). It is the ratio of observed to expected deaths x 100 (expected deaths are derived from statistical models that adjust for variables like age). Standard is 100. If HSMR is 80 then there are 20% less deaths than expected and if it is 120 then 20% more. This does NOT mean to say that there are 20% avoidable or preventable deaths. It is a screening tool. A high ratio may suggest that preventable deaths might be occurring & further investigation is needed. For example, Mid Staffordshire NHS Trust had a high HSMR and was found to have substandard care when investigated. See here for more details.
• Summary Hospital-Level Mortality Indicator (SHMI). This is an NHS-produced metric designed after a review of HSMR which was felt by many to be inconsistent and a poor indicator of performance. SHMI considers more variables. It is a ratio between the actual number of patients who die following hospitalisation at the trust and the number that would be expected to die on the basis of average England figures, given the characteristics of the patients treated there. Data is published by the Health and Social Care Information Centre (HSCIC) and an individual trust SHMI will be described as “as expected”, “below expected” or “above expected”. It is divided down to individual specialities & is expressly designed as a ‘smoke alarm’ potential problems. The SHMI does not ‘diagnose’ excess preventable death. More information about mortality indicators can be found here:
• Healthcare-associated infections (HCAI) Surveillance: UK Health Security Agency’s Data Capture System provides an integrated data reporting and analysis system for the mandatory surveillance of Staphylococcus aureus, Escherichia coli, Klebsiella spp., Pseudomonas aeruginosa bacteraemia and Clostridioides difficile infections. It provides the trusts with an assessment of their situation in comparison with others allowing for targeted intervention. Find more infomation about HCAI here
• Emergency Department Wait Target data: A&E Attendances and Emergency Admissions data is collected and shared weekly & monthly (e.g. NHSE) The data includes number of attendances and those who wait >4 hours or >12hours from decision to admit to admission, transfer or discharge. This data can be used to compared hospital sites and identify areas for improvement against the NHS A&E access standards. A&E wait times are associated with excess death. In 2022, when looking at 12-hour wait times there were 23003 excess deaths in England according to Jones et al. The data is published for NHS England here
• Morbidity & mortality meetings: M&M meetings bring the team together to review in-hospital deaths to further professional education. The meetings can also provide accountability and discover patient safety improvement opportunities. Typically junior doctors present cases to other doctors for reflection on diagnostic or treatment decision-making. Frameworks such as OM³ aim to maximise the learning from these meetings & ensure that there is a mechanism to act on any suggested safety improvement outcomes. The key principles of OM3 are:
  • Focus should be only on cases where the adverse outcome is preventable
  • Presenters have a structured approached to case analysis and a framework to guide discussions around QI and patient safety
  • Meetings should be multidisciplinary and inter-professional
  • There must be a formal mechanism in place to effect change

Find out more about OM³ here

Responding to reported harm

• Root cause analysis: This is a process of identifying a source of a problem and then solving the problem at that source. It supports organizations and professionals can look beyond the symptoms of the problem and work on where the real cause exists. This is a process by which all the different perspectives of the incident are analysed e.g., clinical decision making, treatment options and the broader healthcare system. Here is a webinar conducted by the London School of Paediatrics in 2020 on root cause analysis in serious incidents to tell you more:

• Patient Safety Incident Response Framework (PSIRF): This is the latest NHS approach for developing effective systems for responding to patient safety incidents. It has replaced the Serious Incident Framework. The PSIRF supports the development and maintenance of an effective patient safety incident response system with 4 key aims:
  • Engagement and involvement of those affected by patient safety incidents.
  • A system-based approached to learning from patient safety incidents.
  • Considered and proportionate responses to patient safety incidents.
  • Supportive oversight focused on strengthening response system functioning and improvement.

See NHS England PSIRF webpage for more information & here is a video from NHS England explaining more

• System-based Safety Investigation Tools:
  • Safety Engineering Initiative for Patient Safety (SEIPS):

SEIPS is a framework for understanding the relationship between the structures, processes and outcomes. It is specifically designed for healthcare and it is used in many HSIB investigations. It is supported by PSIRF & so will become the most commonly used method encountered by staff working under NHS England. It was developed by Prof Carayon at the University of Wisconsin and is based on Donabedian’s Structure-Process-Outcome model of healthcare quality.

SEIPS looks at how different aspects of a work system result in many different outcomes, including unintended ones. System factors involved include:

person(s): the people working in the system and the patient

tasks: undertaken by the persons which may vary in complexity or variety

tools and technology: used to undertake the tasks which may vary in usability and functionality

internal environment: the space around the persons, e.g. layout, noise, temperature

organisation: conditions, resources, and activity within the organisation

external environment: factors outside healthcare institutions that might include policy, societal or economic factors.

The interactions between these work system components lead to different outcomes, positive and negative. The framework includes feedback loops representing adjustments made by systems over time. Here is the feedback model  (insert saved pic)

See the RCP for a good summary of SEIPS

• • PAcE (People, Activity, Environment) analysis 

This model has been created by NHS Education for Scotland as part of enhanced significant event analysis. It aims to help healthcare professionals apply human factors thinking especially when there is an emotional impact on staff involved. It prompts teams to consider the interactions between the people involved in incidents, the activities they were undertaking and the influence of environment within which they were working to try to implement more meaningful improvement.

See here for a worksheet on applying PAcE  & Visit NHS England for Scotland for further information

• • Yorkshire Contributory Factors Framework

In 2012, a systematic review of 83 research studies focusing on the causes of hospital patient safety incidents was conducted. The result of this piece of work is the first evidence-based framework of accident causation in hospitals: the Yorkshire Contributory Factors Framework

This tool aims to optimize learning and address causes of patient safety incidents by helping clinicians, risk managers and patient safety officers identify contributory factors of patient safety incidents.

See this worksheet from the Improvement Academy for further details.

What is the Difference between Patient Safety and Quality Improvement?

• Patient safety is the prevention of harm to patients by maximising things that go right and minimising things that go wrong.
• Quality is about effective, efficient purposeful care that gets the job done at the right time for the right cost.

Quality care is

• Safe
• Effective
• Patient-centred
• Timely
• Efficient
• Equitable

Patient safety is essential to quality care, but it is just one aspect. Therefore, patient safety initiatives are just one type of QI project.

Both types of projects use similar improvement methods and tools and focus on identifying and addressing system issues that may contribute to sub-optimal care.

However

• Safety projects just address the 1^st domain: aiming to eliminate, prevent, reduce, or mitigate injury and harm.
• Other QI projects address the other 5 issues to increase adherence to evidence-based practice, improve efficiency, equity, timeliness, or patient centeredness of care.

Safety improvement outcomes include things like infection reduction, reduced medication error, increased reporting of near misses. Other QI outcomes include guideline adherence (effectiveness), waste reduction (efficiency), improving care experience or access and reducing wait times.

Patient safety projects differ from other types of QI work in the aims and types of outcomes but all QI work focusses on the system issues that contribute to the problem under investigation. Similar methods and tools may be used across all QI initiatives. Please visit QI Central to access learning about Quality Improvement

Health inequalities are widening in paediatrics. Those that are more disadvantaged experience more safety issues whilst in health care. Patient safety and health inequalities are inextricably linked. Tackling healthcare inequalities can improve safety and vice versa. If we can make our healthcare systems more equitable for the children and young people we can for, they will be safer in our care.

Child health and wellbeing results from overlapping influences (known as the wider determinants of health), such as poverty, family and carer health, and the physical environment including air quality, food and housing. Health inequalities are unfair and avoidable differences in health across the population and between different groups of society. There is growing evidence from the adult population that patient safety incidents are experienced unequally. For example

• there is a greater incidence of perioperative pulmonary embolism and sepsis in black patients compared to white;
• There continue to be racial disparities in maternity care, with Black, Asian, and mixed ethnicity women significantly more likely to die than their white counterparts as seen in the MBRRACE study
•  Delays in diagnosis of sepsis in patients with learning difficulties lead to higher levels of harm (PDF)

The data around the impact of health inequalities on patient safety is not as robust in children in the UK. However, there are clear indicators that health inequalities impact on the health of children and young people. For example we know that between 2014 and 2017 the rise in infant mortality in England disproportionately affected the poorest areas of the country, and those living in the most deprived areas twice as likely to be obese than in affluent areas. Families from marginalised groups have increased risk of healthcare harm due to interpersonal and structural factors such as poor communication, implicit biases of healthcare professionals, medical education and treatment approaches developed with the white population in mind. All these factors increase the risk of harm when receiving healthcare.

What is happening to try to address this problem?

• A BMJ article call ‘Action on patient safety can reduce health inequalities’ by Cian Wade, Mimi Malhotra, Priscilla McGuire, Charles Vincent and Aiden Fowler offers a potential approach to address both patient safety and health inequalities issues. Identifying health inequalities as failures in patient safety may help assign accountability for addressing the problem and provide a number of models and guidelines to help to mitigate them. Read their article here for more information
• Core20PLUS5 is an NHS England targeted approach for reducing health inequalities among children and young people. Core 20 refers to the most deprived 20% of the nation & the ‘Plus’ includes ethnic minority groups, inclusion health groups, people with learning disability and those with protected characteristics among others. The 5 areas identified for extra focus for children and young people aim to to accelerate improvement are asthma, diabetes, epilepsy, oral health and mental health.
• Please visit the RCPCH Health inequalities resources for further information about what the college is doing to address health inequalities.

Restorative culture focuses on healing and repair of relationships. It keeps the needs of those caught up in the incident as paramount. The importance of learning from patient safety events should lie in parallel with a restorative approach that focusses on repairing trust and relationships

Harm from a patient safety incident can be compounded by additional harm due to an organisations lack of response and exclusion of those impacted. Investigation such as those describe in the Kirkup report found that after incidents families and staff can feel invisible, powerless and alienated. Examples of further harm include

• • Not being told what happened
  • Ambiguity around the response process
  • Failure to acknowledge distress from the event
  • No communication about the process of investigation

Historically the culture within the NHS  was a ‘retributive just culture’ as described by Prof Sidney Dekker. In such a culture the questions that are asked in response to an incident are:

• Which rule is broken?
• Who did it?
• How bad was the breach, and what should the consequences be?
• Who gets to decide this?

Conversely the questions asked within a restorative just culture include:

• Who is hurt?
• What do they need?
• Whose obligation is it to meet that need?
• How do you involve the community in this conversation?

Watch this video to see Sidney Dekker explain this further.  Or read this summary PDF on restorative Vs retributive cultures.

How are the restorative just culture principles being incorporated into healthcare?

There has been lots of progress within the NHS and partner organisation to consider how the patient safety incident response framework and the processes and structures associated with it are received by those affected by harm including patients, family members and healthcare staff.

1) NHS England’s PSIRF (Patient incident response framework)  aims to put relationships and systems thinking at the centre with:

•  Compassionate engagement and involvement of those affected by incidents
• Application of a range of systems-based approaches to learning from incidents
• Considered and proportionate responses to incidents
•  Supportive oversight focussing on improvement.

PSIRF guidance on ‘Engaging and involving patients, families and staff following a patient safety incident'(PDF) focusses on preventing compounded harm and outlines principles such as sincere apologies, individualised approaches, respect towards all impacted and clarity in the process and what to expect.

2) There are organisations such as the Harmed Patients Alliance , Making Families Count  and the AvMA (Action against medical accidents)  who are campaigning, educating and training on improving how we respond to patients, families and staff in response to patient safety incidents. Please see their websites to find out more and to seek out training opportunities.