Purpose

This policy supports the requirements of the Patient Safety Incident Response Framework (PSIRF) and sets out Regenerage’s approach to developing and maintaining effective systems and processes for responding to patient and service user safety incidents. These responses are conducted for the purpose of learning and improving service user safety.

PSIRF advocates a coordinated and data-driven response to service user safety incidents. It embeds service user safety incident response within a wider system of improvement and prompts a significant cultural shift towards systematic service user safety management.

This policy supports the development and maintenance of an effective service user safety incident response system that incorporates the four key aims of PSIRF:

1. Compassionate engagement and involvement of those affected by service user safety incidents.
2. Application of a range of system-based approaches to learning from service user safety incidents.
3. Considered and proportionate responses to service user safety incidents and safety issues.
4. Supportive oversight focused on strengthening response-system functioning and improvement.

Scope

This policy applies specifically to service user safety incident responses conducted solely for the purpose of learning and improvement across Regenerage’s NHS health contracts.

Responses under this policy follow a systems-based approach. The safety of service users depends on the entire healthcare system working well together, rather than on any single part alone. Safety is provided by interactions between components and not by a single component.

Responses do not take a person-focused approach in which the actions or inactions of individuals, or human error, are stated as the cause of an incident.

There is no remit to apportion blame or determine liability, preventability or cause of death in a response conducted for the purpose of learning and improvement.

Other processes, such as claims handling, human resources investigations into employment concerns, professional standards investigations, coronial inquests and criminal investigations, exist for those purposes. The principal aims of those responses differ from those of a service user safety response and are outside the scope of this policy.

Information from a service user safety response may be shared with those leading other types of responses, but those other processes should not influence the remit of a service user safety incident response.

Roles and Responsibilities Within the Charity

• Chief Executive Officer and Trustee Board: Have ultimate responsibility for all aspects of service user safety.
• Integrated Care Board: Has responsibility for approving this policy.
• Chief Operating Officer and Trustee Assurance Sub-Committee: Have responsibility for policy setting and implementation.
• Director of Care Services and Registered Manager: Have responsibility for embedding this policy and its reporting mechanisms.
• Investigation team: Will include appropriate representatives from the roles listed above.

Our Service User Safety Culture

Regenerage aims to promote a just culture for the safety of all service users receiving support within a community setting. All staff are equipped with the mandatory level of training required for their positions and any duties delegated to them through each contract.

Our systems have been developed to record every engagement, from initial contact to post-engagement or discharge from support. We have robust methods of support in place to help assure a safe service for all service users.

Service user safety is embedded at the core of our employee induction processes. All staff follow a training matrix that provides the minimum levels of competency and structure required for work carried out for and on behalf of the charity.

Our structured staff supervision, appraisal and team-meeting processes include discussions about individual cases, the development of support and best practice. These processes help identify emerging needs or gaps in employee training.

We regularly highlight the importance of safeguarding service users throughout their support and transition from services. This helps foster a robust service user safety culture among everyone employed by the charity.

Feedback, including concerns, complaints and compliments, is welcomed from service users, carers, partners, stakeholders and commissioners. We have processes to ensure feedback is invited, recorded and acknowledged, and that it contributes to the ongoing design and development of our services.

If an investigation raises concerns, we will use the NHS England Just Culture Guide to support the organisation through the process.

Service User Safety Partners

Our work depends on strong collaboration and partnerships. Regenerage has a Trustee Assurance Sub-Committee that provides oversight and support.

Incidents and safeguarding are considered quarterly. The Assurance Sub-Committee discusses incidents, reviews, improvement plans and completed post-action reviews.

Our internal policy-review team meets quarterly to review our policies, the systems contained within them and whether our risk register continues to meet contractual requirements across all services and commitments.

Addressing Health Inequalities

Regenerage recognises that the health inequalities experienced by population groups, communities and individuals are unfair. We also recognise that differences in health across the population and between groups within society are avoidable.

Most of our services are delivered to older people, including people living with dementia and memory concerns, people living in areas of high deprivation, people living with disabilities and people experiencing inequity, including people from Black, Asian and minority ethnic communities.

We recognise that we have a role to play, both nationally and locally, in reducing and removing health inequalities that affect people’s outcomes and experiences.

In accordance with the Equality Act 2010, we seek to ensure that nobody is disproportionately affected on the grounds of a protected characteristic.

Our focus is to provide the best care to our service users regardless of skin colour, culture, ethnicity, faith, gender, sexuality, age or disability. We do not tolerate racial abuse or discrimination in any form.

Engaging and Involving Service Users, Families and Staff Following a Safety Incident

PSIRF recognises that learning and improvement following a service user safety incident can only be achieved when supportive systems and processes are in place.

It supports the development of an effective service user safety incident response system that prioritises compassionate engagement with those affected by an incident, including service users, families and staff.

This involves working with those affected to understand and answer the questions they have about an incident and signposting them to appropriate support when required.

Service User Safety Incident Response Planning

PSIRF supports the charity in responding to incidents and safety issues in a way that maximises learning and improvement, rather than basing responses on arbitrary or subjective definitions of harm.

Beyond nationally set requirements, the charity may explore service user safety incidents that are relevant to its circumstances and the populations it serves, rather than responding only to incidents that meet a defined threshold.

The charity will take a proportionate approach to service user safety events so that the focus remains on maximising improvement.

Our approach will align with the principles in the following documents:

• Guide to Responding Proportionately to Patient Safety Incidents
• Patient Safety Incident Response Standards
• Regenerage Duty of Candour Policy

Resources and Training

• 
  PSIRF NHS Resolution presentation
  
• 
  PSIRF courses
  
• 
  PSIRF early-adopter interview: acute healthcare provider perspective
  
• 
  PSIRF early-adopter interview: patient safety incident investigator perspective
  
• 
  Introducing the PSIRF learning response toolkit
  
• 
  Engaging and involving patients, families and staff following a patient safety incident
  
• 
  General PSIRF resources
  

Safety Culture Resources

• Improving Patient Safety Culture: A Practical Guide
• NHS England: Safety Culture – Learning from Best Practice
• NHS Employers: Safety Culture

Our Service User Safety Incident Response Plan

Our plan sets out how Regenerage intends to respond to service user safety incidents. The plan is not a permanent set of rules that cannot be changed.

We will remain flexible and consider the circumstances in which each incident occurred, the needs of the people affected and the provisions of this plan.

The aims of this plan are to:

• Ensure staff and contracted partners are aware of their obligation to report significant events.
• Create an open and transparent environment in which staff feel supported when reporting events.
• Facilitate learning and improvement from reported events.
• Ensure service users, friends and families feel listened to and supported, and that incidents are handled robustly.

Incident Response Steps

1. Initial report: Staff should submit a Safety Alert within 24 hours of identifying an event. The alert will be received by the Chief Operating Officer.
2. Escalation: The Chief Operating Officer is responsible for escalating the report to the Chief Executive Officer and Chair of the Assurance Sub-Committee within 48 hours of receiving it.
3. Initial review: The Chief Operating Officer will review the report to determine the severity and impact of the incident.
4. Investigation team: For major events, an investigation team will be assembled to conduct a more detailed analysis.
5. Employee interviews: Staff involved may be asked to participate in interviews or provide additional information.
6. Learning and improvement review: Following the investigation, the Chief Operating Officer and Assurance Sub-Committee will review the findings and identify opportunities for learning and improvement.
7. Learning and improvement: Feedback will be provided to staff involved in the incident and, where appropriate, to the wider organisation.
8. Training and development: Additional training will be arranged when skills or knowledge gaps are identified.
9. Supporting staff and contracted partners: All reports will be treated with the utmost confidentiality.
10. Supporting resources: Staff involved in a significant event will be offered support to access external counselling and other appropriate resources.
11. No-blame culture: The focus of reporting and investigating significant events is learning and improvement, not assigning blame.
12. Monitoring and review: The Chief Operating Officer and Assurance Sub-Committee will review this policy and plan annually. Changes will be communicated to staff.

The effectiveness of this policy relies on the willingness of staff and contracted partners to report significant events and engage in subsequent learning and improvement processes. Their cooperation is essential to improving our charitable operations and commitments.

Defining Our Service User Safety Incident Profile

Regenerage has seen an increase in the vulnerabilities of its service user groups. We recognise that service user safety incidents may become increasingly likely and that we need a consistent model for assessing needs and incidents.

Through active stakeholder engagement, we will continue to collaborate with current and former service users, family members and professionals to identify the service user safety issues most relevant to our planning.

We continue to engage with:

• Local forums
• Housing associations
• Healthwatch
• Our carers group
• Community groups
• Frailty teams
• Falls teams
• Memory Assessment Services

We use all relevant data available to assess the likelihood and consequences of low-risk through to high-risk incidents involving service users.

This policy and plan will enable us to embed consistent processes for capturing, responding to and learning from incidents.

Consultation

Quarterly consultation with our commissioners will help us remain informed about local and national needs and priorities.

We are committed to ensuring maximum safety and risk-assessment assurance for service users, together with robust follow-up and incident-review processes.

National Response Requirements

Regenerage will support acute and mental health trusts through cross-organisational working when responding to the following national requirements.

Our Local Focus

Regenerage will be flexible in its investigative approach. It will be informed by the national and local priorities detailed in this plan and will agree the most appropriate response according to the potential for learning, improvement and systemic risk.

Reviewing This Policy and Plan

Our service user safety incident response plan is a living document that will be amended and updated as we use it to respond to incidents.

We will review the plan every 12 months to ensure our focus remains current. As improvement work continues, our service user safety incident profile is likely to change.

The review will provide an opportunity to re-engage with stakeholders and discuss changes made during the previous 12 to 18 months. Updated plans will be published on our website and will replace previous versions.

A detailed planning exercise will be undertaken every four years, or more frequently when agreed with the Integrated Care Board. This will include:

• Reviewing our incident-response capacity
• Mapping our services
• Conducting a wide review of organisational data
• Ensuring resources remain appropriately balanced between learning and improvement

Responding to Service User Safety Incidents

After-Action Review

An after-action review should use the following process:

1. Define the purpose: Clarify the incident or activity being reviewed and the purpose of the review.
2. Gather participants: Include the people involved in the event and ensure that a range of perspectives is represented.
3. Facilitate an open discussion:
   • What happened?
   • What went well?
   • What could be improved?
   • What will we do differently?
4. Document and share: Summarise findings, actions and responsible individuals, and share the report with relevant stakeholders.
5. Follow up: Review agreed actions to ensure improvements are implemented.

This approach promotes accountability, continuous improvement and a focus on learning.

Swarm Work System

Further information is available in the

NHS England Swarm Huddle guidance
.

System Considerations

When reviewing an incident, consider the following interconnected parts of the system.

People

• What were the people involved doing at the time?
• Were fatigue, stress, morale or cognitive load relevant?
• Were roles and responsibilities clearly defined?
• Were people appropriately trained and competent?
• Were communication barriers present?
• Did personal circumstances or health inequalities affect the situation?

Tasks

• How complex was the task?
• Were the demands repetitive?
• Was the task conducted in a particular order or sequence?
• What was the workload?
• Were there workarounds or time pressures?

Tools and Technology

• Were the tools or systems usable and accessible?
• Was the correct equipment available?
• Was alarm or warning information clear?
• Was equipment appropriately maintained?
• Was an adequate supply of equipment available?

Internal Physical Environment

• Were there distractions or interruptions?
• Were lighting, noise, vibration, temperature or air quality relevant?
• Was the layout suitable for the task?
• Was there sufficient space?
• Were service users, staff and equipment clearly visible?

Organisation and Work

• How was information communicated?
• Were workload, staff numbers or work schedules relevant?
• Was information correctly flagged?
• Where was information held?
• Were leadership and supervision appropriate?
• Were roles and responsibilities adequately defined?
• Were there staffing, resourcing or safety-culture concerns?

External Environment

• National targets
• Policy and regulatory demands
• Accreditation standards
• Political decision-making
• Global events
• Other societal and economic factors outside the charity

Interview Process

1. Determine who should be interviewed.
2. Invite participants to an interview.
3. Create an interview plan and prepare the interview space.
4. Conduct the interview.
5. Complete and document the interview.

Service User Safety Incident Reporting Arrangements

Regenerage will report all service user safety incidents quarterly to the Assurance Sub-Committee.

Service User Safety Incident Response Decision-Making

Planning enables the proactive allocation of resources for responding to service user safety incidents. However, a reactive approach will always be necessary as part of the response.

Every service user safety incident, particularly one that indicates an unexpected risk or potential learning opportunity, should be evaluated for an appropriate response. This applies even when the incident falls outside the specific issues described in the organisation’s plan.

Responding to Cross-System Incidents and Issues

Regenerage will work with partners and the Integrated Care Board to establish and maintain robust procedures that facilitate the free flow of information and minimise delays to joint work on cross-system incidents.

Timeframes for Learning Responses

A learning response will begin as soon as possible after a service user safety incident is identified. It should normally be completed within one to three months of its start date.

No learning response should take longer than six months to complete.

Safety Action Development and Monitoring

Following a service user safety event, we will agree and generate safety actions for defined areas of improvement.

Regenerage will establish measures for monitoring each safety action and set out the required review steps. These actions will be overseen by the Chief Operating Officer and Safeguarding Lead.

Safety Improvement Plans

Safety improvement plans bring together findings from responses to service user safety incidents and issues. They may include:

• A charity-wide safety improvement plan summarising improvement work.
• Individual improvement plans focused on a particular service, pathway or location.
• A collective review of learning from individual incidents when there is sufficient understanding of underlying and interconnected system issues.
• A safety improvement plan addressing broader or organisation-wide areas for improvement.

Regenerage will use an appropriate mixture of these approaches based on available data, stakeholder views, improvement priorities, its service user safety incident profile and insight from incident responses.

There is no numerical threshold that determines when a safety improvement plan must be developed. The decision will be based on knowledge gained through the learning-response process and other relevant data.

Oversight Roles and Responsibilities

Our Patient Safety Incident Response oversight team aims to:

• Ensure Regenerage meets national service user safety incident response standards.
• Ensure PSIRF is central to the charity’s overarching safety-governance arrangements.
• Quality-assure learning-response outputs.

Our lead officer will ensure that:

• Incident data, response data, learning findings, safety actions, improvement plans and progress are discussed at senior leadership meetings and, where relevant, by the Assurance Sub-Committee.
• Appropriate roles, training, processes, accountabilities and responsibilities are in place to support an effective organisational response to incidents.

Co-design sessions with stakeholders will address:

• Engagement and involvement of people affected by service user safety incidents.
• Policy, planning and governance.
• Competence and capacity.
• Proportionate responses.
• Safety actions and improvement.

External peer review of a sample of learning is an important part of improving how Regenerage learns from service user safety incidents.

External review can improve the quality of learning, reduce the risk of isolated or biased perspectives and identify potential future issues. Reviewing findings and safety actions developed by other organisations also enables providers to assess whether similar issues could arise in their own services.

Principles for Oversight

• Improvement as the primary goal: Oversight should enable and track improvements in safety, rather than simply assessing the quality of investigations.
• Blame hinders insight: Oversight should identify systemic factors that contribute to incidents rather than assigning blame to individuals.
• Learning drives improvement: Responding to an incident for the purpose of learning is a proactive step towards continuous improvement and is not evidence of organisational failure.
• Collaboration is essential: Effective oversight cannot be achieved by individuals or organisations working in isolation.
• Psychological safety promotes learning: Oversight should foster openness, encourage diverse perspectives and support discussion of vulnerabilities and possible solutions.
• Curiosity is a tool for leaders: Leaders can inspire improvement by seeking to understand rather than judge.

Feedback and Complaints

Positive feedback is valued as a compliment and is shared with the relevant individuals and managers to reinforce good practice.

Negative feedback is treated as a complaint. Concern or dissatisfaction about any aspect of the charity is welcomed as an opportunity to address issues, learn and improve.

Feedback Policy Principles

We aim to ensure that:

• Providing feedback is as easy as possible.
• Feedback is treated seriously and we respond when appropriate or requested.
• Our communication is prompt and polite.
• We learn from feedback and use it to improve.
• We respond appropriately, including apologising when something has gone wrong, thanking people for compliments and providing explanations or information when appropriate.
• We respond positively and effectively to complaints and address shortcomings within our control so that complaints are resolved satisfactorily and promptly.

How to Submit Feedback

It is usually best to contact the person providing the service or the person concerned, as they will normally be best placed to respond.

If there is a complaint or problem, please try initially to resolve it with the relevant service or individual. They may be able to put matters right quickly and simply.

If you do not know who to contact, or do not feel comfortable raising the issue directly, contact the Regenerage Feedback Officer:

Our Response to Feedback

The way in which we respond will depend on the nature of the feedback. For example, a compliment may not require a written response.

When a formal complaint is made, we will send an acknowledgement within five working days. We may need to contact the complainant for additional information.

After acknowledging a complaint, our aim is to investigate it, gather any additional information required and respond within 10 working days of the acknowledgement. If this is not possible, we will explain when a full response can be expected.

All complaints will be treated with an appropriate level of confidentiality. Information will only be shared with staff and volunteers when necessary to understand what happened and provide a response.

We record formal and informal feedback. Reports are submitted to the Board of Trustees summarising positive and negative feedback and identifying relevant trends.