Held Health is committed to providing safe, effective, and compassionate care for all families. This Patient Safety Incident Response Framework (PSIRF) outlines how we identify, investigate, and learn from patient safety incidents to improve care quality and reduce harm.  

Purpose

The purpose of this policy is to set out Held Health’s approach to managing patient safety incidents. It ensures compliance with national guidance and supports a culture of openness, learning, and continuous improvement.

Scope

This policy applies to all staff, contractors, and volunteers within Held Health. It covers the identification, reporting, investigation, and response to patient safety incidents.

Principles

- Patients and families will be treated with compassion, openness, and honesty.
- Staff will be supported throughout incident reporting and investigation processes.
- Investigations will focus on learning and improvement, not individual blame.
- Responses will be proportionate to the scale and impact of the incident.
- Learning will be shared across the organisation to strengthen patient safety

Roles and Responsibilities

Clinical Director - Overall responsibility for patient safety, governance oversight, and ensuring compliance with national frameworks.

Governance Lead: Responsible for coordinating PSIRF implementation, monitoring compliance, and supporting learning responses.

Incidents and Complaints Lead: Manages the logging, triage, and investigation of incidents and complaints, ensuring timely response and communication with families.

Safeguarding Lead: The Safeguarding Lead provides assurance to the Board that safeguarding and patient safety processes are aligned, statutory responsibilities are met, and that learning from incidents involving vulnerable groups is acted upon to strengthen systems of care.

Patient Safety Specialist (PSS) is responsible for leading and embedding the Patient Safety Incident Response Framework (PSIRF) within the organisation. The PSS also acts as a point of contact for national and system-level patient safety programmes and provides assurance to the Board that PSIRF is being implemented effectively across the organisation.

All Staff: Required to report incidents promptly and participate in investigations where relevant.

Incident Reporting and Triage

All staff must report incidents as soon as possible using the Held Health incident reporting system. There is a dedicated email incidents@held.health to be used for reporting incidents. The Incidents and Complaints Lead will triage incidents within 48 hours to determine severity, level of investigation required, and whether external reporting is necessary (e.g., to regulators).

Held Health is registered with the NHS LfPSE. All incidents will be reviewed in the monthly governance meeting and submitted via the LfPSE portal where necessary.

Review Process: Each incident is discussed at the meeting, using the information recorded in the local incident management system.

The group considers:

-          The severity of harm (actual and potential).

-          Whether the incident involved a patient, service user, staff member, visitor, or contractor.

-          Whether the event represents a patient safety incident, a near miss, or other reportable occurrence under NHS England definitions.

-          Whether the event highlights systemic learning that should be shared regionally or nationally.

-          If additional information or investigation is required, the incident is deferred for further review at the next meeting.

Decision on Submission to LFPSE
Following discussion, the meeting will decide one of the following actions:

Submit to LFPSE – where the incident meets NHS reporting criteria, involves patient safety concerns, or presents learning value for wider sharing.

Do not submit to LFPSE – where the event is non-patient-safety related (e.g., purely operational, staff-only, or facilities issues) but will be managed locally.

Escalate for further review – where the severity, complexity, or learning potential indicates that higher-level governance input (e.g., Clinical Governance Group, Risk Committee) is required before submission.

Documentation of Decision

The decision and rationale must be clearly recorded in the meeting minutes and/or incident management system.

Any agreed actions or learning points should be assigned, monitored, and reviewed at subsequent meetings to ensure completion.

Where an incident is submitted to LFPSE, the unique reference number and submission date should be recorded.

Feedback and Learning

Outcomes from LFPSE submissions and feedback received from NHS England should be shared with relevant teams to promote continuous improvement.

Investigation and Learning Responses

The Patient Safety Incident Response Framework (PSIRF) promotes a flexible, proportionate, and learning-focused approach to responding to patient safety incidents. Not all incidents require a full investigation; instead, the organisation will select from a range of investigation and learning responses depending on the severity, complexity, and potential for learning.

Principles

Proportionality: Responses will be matched to the scale of harm and potential system learning, avoiding unnecessary burden or duplication.

Systems-based approach: All investigations will focus on understanding contributory factors within systems and processes rather than individual blame.

Just Culture: Staff, patients, and families will be engaged openly and fairly, with emphasis on learning and improvement.

Timeliness: Responses will be delivered in a timeframe that supports prompt learning and action.

Types of Responses

Patient Safety Investigation (PSI):

-          Used for incidents with significant actual or potential harm where detailed systems analysis is required.

-          Structured, proportionate, and carried out by trained investigators.

-          Includes meaningful involvement of patients, families, and staff.

Rapid Review / Scoping Exercise:

-          Short, structured review to clarify what happened and identify if further investigation is needed.

-          May highlight quick actions or immediate risks to be addressed.

Thematic Review

-          Used where several similar incidents suggest a recurring issue.

-          Focuses on identifying patterns, systemic issues, and opportunities for wider improvement.

After Action Review (AAR):

-          Structured team discussion conducted shortly after an incident.

-          Encourages staff to reflect openly on what went well, what could have been improved, and what should change.

-          Suitable for moderate-harm incidents or where team learning is a priority.

Learning Response without Formal Investigation:

-          Where harm is low or no new learning is anticipated, the incident may be closed with local learning actions, such as updated guidance, staff briefings, or targeted training.

-          Involvement of Patients, Families, and Carers

Across all responses, patients and families will be offered meaningful involvement. They will be informed of the process chosen, invited to share their perspective, and updated on findings and resulting actions in a compassionate and transparent way.

Governance

Selection of response type will be agreed by the Patient Safety Specialist (PSS) in consultation with relevant clinical leaders.

All responses will be logged and monitored through PSIRF governance structures.

Learning from investigations and reviews will be disseminated to staff, reported to the Governance Committee, and, where relevant, shared externally with system partners.

Just culture

Held Health is committed to fostering a Just Culture as a central principle of the Patient Safety Incident Response Framework (PSIRF).

A Just Culture recognises that most patient safety incidents arise not from wilful neglect or individual incompetence, but from weaknesses in systems, processes, and environments. It is a culture that balances learning and accountability: staff are supported to be open about mistakes and near misses, while reckless or deliberately harmful behaviour is not tolerated.

A Just Culture creates the conditions for staff to speak up without fear of unfair blame. It acknowledges that:

Human error is inevitable and should be anticipated.

The majority of unsafe actions are better addressed through system redesign, education, and support rather than disciplinary action.

Individuals will be held accountable only where there is evidence of conscious disregard for safety or wilful misconduct.

Within the PSIRF, this approach is critical to ensuring that patient safety investigations are learning-oriented rather than punitive. Staff are encouraged and expected to contribute openly and honestly to safety investigations, secure in the knowledge that the purpose is to understand and learn, not to assign blame. Leaders and managers play a key role in modelling this culture by responding to incidents with curiosity, compassion, and fairness, and by focusing on improvement actions that strengthen systems.

Embedding a Just Culture supports:

Psychological safety for staff, enabling transparency in incident reporting.

Learning from incidents at an organisational level, identifying contributory factors and opportunities for improvement.

Trust and confidence among staff, patients, and families that the organisation is committed to fairness, openness, and continuous improvement.

This policy commits to upholding the principles of a Just Culture in all aspects of patient safety incident response, recognising that learning and accountability must exist side by side in order to create a safe and resilient healthcare system.

Safeguarding

Held Health recognises its statutory duty to safeguard and promote the welfare of children, young people, and adults at risk. Safeguarding is integral to patient safety and is therefore fully embedded within our Patient Safety Incident Response Framework (PSIRF).

Principles

Safety first: Where a patient safety incident indicates an actual or potential safeguarding concern, the safeguarding response takes precedence over the incident response.

Integration: Safeguarding processes and patient safety processes will run in parallel, with effective communication between safeguarding leads and patient safety specialists.

Just Culture: Staff involved in incidents that raise safeguarding issues will be treated fairly and supported to engage openly in the process.

Family and carer involvement: Where appropriate, and with consent, patients, families, and carers will be involved in safeguarding discussions to ensure transparency and trust.

Processes

Identification: If, during the course of incident reporting or investigation, concerns about abuse, neglect, or exploitation are identified, these must be escalated immediately to the Safeguarding Lead.

Referral: Referrals to local authority safeguarding services will be made in line with statutory guidance (e.g. Working Together to Safeguard Children and Care and Support Statutory Guidance).

Coordination: The Patient Safety Specialist (PSS) will liaise with the Safeguarding Lead to determine whether a safeguarding enquiry, Section 42 enquiry (Care Act 2014), or Section 47 investigation (Children Act 1989) is required.

Joint working: Where safeguarding enquiries and PSIRF investigations overlap, roles and responsibilities will be clearly defined to avoid duplication, ensure proportionality, and maintain focus on both immediate protection and wider system learning.

Information sharing: Information relevant to safeguarding will be shared securely with external agencies (e.g. police, local authority) in accordance with legislation and data protection requirements.

Learning: Any safeguarding themes identified through PSIRF investigations will be shared with the Safeguarding Committee, and learning will feed into organisational safeguarding training and strategy.

Oversight

The Safeguarding Lead will have a standing role within PSIRF governance processes, ensuring safeguarding issues are considered in all patient safety investigations. Regular reports on safeguarding-related incidents will be presented to the Quality and Safety Committee and the Board.

Training

Training for Level 1 and Level 2 Investigation Leads

To ensure that patient safety investigations under the Patient Safety Incident Response Framework (PSIRF) are carried out to a consistent and high standard, all staff who act as investigation leads must complete appropriate training. Training is aligned with the national PSIRF competency framework and reflects the complexity and proportionality of different levels of investigation.

Level 1 Investigation Lead

Scope: Suitable for leading proportionate, lower complexity investigations such as After Action Reviews (AARs), rapid reviews, or local learning responses.

Training Requirements:

-          Completion of PSIRF introductory training.

-          Competence in Just Culture principles, systems thinking, and human factors awareness.

-          Skills in facilitating open discussions with staff and capturing learning points in a structured format.

Role: Level 1 leads ensure that lower-level investigations remain learning-focused, timely, and proportionate, and that staff and patients are engaged respectfully throughout the process.

Level 2 Investigation Lead

Scope: Suitable for leading full Patient Safety Investigations (PSIs) and thematic reviews, often where harm is more significant or the issues are complex.

Training Requirements:

-          All Level 1 requirements.

-          Completion of accredited PSIRF Level 2 Investigator training, including:

-          Root cause analysis and systems-based methodologies.

-          Conducting interviews and evidence gathering.

-          Analysis of contributory factors and system gaps.

-          Report writing that is clear, balanced, and focused on learning.

-          Involving patients, families, and carers meaningfully and compassionately.

Role: Level 2 leads ensure investigations are robust, impartial, and proportionate. They coordinate multi-disciplinary input, manage sensitive information, and deliver recommendations that lead to sustainable improvement.

Ongoing Development and Support

All investigation leads will be offered supervision, peer support, and opportunities to review case studies to build confidence and capability.

Refresher training will be provided at least every three years or sooner where national guidance changes.

The Patient Safety Specialist (PSS) will maintain a register of trained investigation leads and ensure that only those appropriately trained are allocated to lead investigations.

Complaints

Held Health recognises that complaints are an important source of insight into patient and family experience and may highlight potential safety concerns. Complaints will therefore be considered within the Patient Safety Incident Response Framework (PSIRF) as part of our learning system.

Principles

Respect and openness: All complaints are treated with seriousness, compassion, and transparency.

Integration: Where a complaint indicates a potential patient safety incident, the Patient Safety Specialist (PSS) will work closely with the Complaints Team to ensure coordinated handling.

Learning focus: Complaints are not viewed as isolated grievances but as opportunities to identify system weaknesses and to prevent recurrence.

Just Culture: Staff involved in complaints will be supported, with an emphasis on fairness, reflection, and improvement rather than blame.

Processes

Screening: All complaints received are reviewed to determine whether they also constitute a patient safety incident under PSIRF.

Dual pathways

If the complaint relates only to service quality, it will be managed solely under the Held Health Complaints policy and procedures.

If it raises safety concerns, a PSIRF response will also be initiated.

Coordination: A single point of contact (Complaints Manager or PSS) will be allocated to ensure complainants are updated and to avoid duplication between the complaints process and the patient safety investigation.

Involvement of complainants: Patients and families will be invited to contribute their perspective to the patient safety investigation, in line with PSIRF principles of meaningful involvement.

Learning dissemination: Lessons identified through complaints linked to patient safety incidents will be shared through PSIRF governance structures, reported to the Quality and Safety Committee, and fed back to patients, families, and staff.

Oversight: The Complaints Manager and the Patient Safety Specialist will jointly review complaint themes quarterly. Shared learning will be triangulated with incident reports, claims, and other intelligence sources to ensure a comprehensive understanding of safety risks.

LeDeR

Learning from Lives and Deaths – People with a Learning Disability and Autistic People (LeDeR)

The organisation is committed to ensuring that the care and outcomes of people with a learning disability and autistic people are reviewed, understood, and improved in line with national LeDeR requirements. LeDeR is a statutory programme designed to support local areas in reviewing the deaths of people with learning disabilities and autistic people, with the purpose of identifying service improvements and tackling health inequalities.

Principles

Equity: People with learning disabilities and autistic people have the right to the same quality of healthcare and outcomes as the wider population.

Integration with PSIRF: All relevant deaths will be subject to the LeDeR review process, and where potential patient safety issues are identified, a PSIRF investigation will also be initiated. The two processes will be coordinated to avoid duplication and ensure shared learning.

Family and carer involvement: Families, carers, and advocates will be meaningfully involved in reviews and investigations, with sensitivity, transparency, and compassion.

Just Culture: Staff engagement in LeDeR and PSIRF will be supported in a fair and open environment that encourages reflection and learning.

Processes

Notification: All deaths of people with a learning disability or autistic people will be notified to the LeDeR programme in accordance with NHS England guidance.

Screening: The Safeguarding Lead or nominated LeDeR coordinator will ensure each case is screened to determine whether a patient safety incident investigation under PSIRF is required.

Coordination: Where both LeDeR and PSIRF processes apply, a joint plan will be agreed between the Patient Safety Specialist (PSS), LeDeR reviewer, and Safeguarding Lead.

Roles and responsibilities will be clearly defined.

Families will be given a single point of contact.

Investigation: A systems-based approach will be used to explore contributory factors, including diagnostic overshadowing, access to care, reasonable adjustments, and communication barriers.

Learning and Dissemination:

LeDeR findings will be triangulated with PSIRF outputs to generate system-wide learning.

Themes and recommendations will be reviewed at the Quality and Safety Committee and reported through the Integrated Care Board (ICB).

Wider learning will be shared with staff, patients, families, and partner organisations.

Oversight

The Executive Lead for LeDeR will have responsibility for ensuring compliance with LeDeR requirements. Progress on LeDeR reviews and related patient safety learning will be monitored through PSIRF governance structures and reported to the Board.

Patient Safety Partner

Held Health recognises the value of working in genuine partnership with patients, families, and carers in improving safety. Patient Safety Partners (PSPs) are individuals with lived experience who work alongside staff at all levels of the organisation to support the delivery of the Patient Safety Incident Response Framework (PSIRF). Their role is central to ensuring openness, transparency, and meaningful patient and public involvement in safety improvement.

Principles

Collaboration: PSPs are equal partners in safety governance and improvement.

Transparency: Their involvement strengthens the openness of incident response processes and demonstrates accountability to the public.

Diversity of perspective: PSPs bring lived experience that enhances organisational understanding of patient safety risks and priorities.

Just Culture: PSPs contribute to creating a fair, supportive environment that values honesty, reflection, and learning from incidents.

Roles of PSPs within PSIRF

PSPs will:

Contribute to the design and oversight of the organisation’s patient safety incident response plan.

Sit on relevant governance committees to provide independent challenge and assurance.

Support the development of policies, patient information, and staff training relating to PSIRF.

Provide a patient and family perspective on themes and learning arising from investigations.

Help ensure patient and family involvement in individual investigations is meaningful, compassionate, and accessible.

Recruitment, Training, and Support

PSPs will be recruited through open and transparent processes in line with NHS England guidance.

They will receive training in PSIRF principles, patient safety science, and safeguarding to enable effective participation.

Ongoing support, supervision, and expenses will be provided to sustain their role and wellbeing.

Oversight

The Executive Lead for Patient Safety will be responsible for ensuring PSPs are fully embedded in PSIRF governance. Progress will be reviewed quarterly through the Governance Committee, with an annual report on PSP involvement and impact shared with the Board and published publicly.

Cross Organisation Learning

Patient safety incidents frequently arise in complex pathways that cross organisational boundaries. To ensure learning is maximised, this organisation will actively engage in cross-system collaboration as part of its implementation of the Patient Safety Incident Response Framework (PSIRF).

Principles

Shared responsibility: Where care spans more than one provider (e.g. private sector, primary care, acute, mental health, ambulance services, community, or social care), responsibility for patient safety learning is collective, not confined to one organisation.

Transparency: All organisations involved in a patient’s care pathway will be informed of incidents where their service is implicated and will be invited to contribute to the response.

Consistency: The Just Culture principles will be upheld across organisations, ensuring staff can participate openly and without fear of disproportionate blame.

Timeliness: Information will be shared promptly, enabling learning to be acted on quickly and reducing the risk of recurrence.

Processes

Notification: When an incident indicates cross-organisational factors, the Patient Safety Specialist (PSS) will ensure that relevant partners are notified at the earliest opportunity.

Joint Scoping: The lead organisation will coordinate a scoping discussion with all parties to agree:

The lead for the patient safety investigation

Roles and contributions of each partner

How findings will be shared and disseminated

Investigation: Each organisation will provide information relevant to their service, such as records, policies, or staff interviews. A systems-based approach will be applied to ensure contributory factors are fully explored.

Learning Dissemination: Final reports will be shared across all organisations involved, with clear identification of:

System issues requiring joint solutions

Organisation-specific improvements

Recommendations for integrated pathways of care

Feedback: Findings will be cascaded to frontline staff across all organisations, and where relevant, shared with patients and families.

Governance and Oversight

Cross-organisation learning will be monitored through the Integrated Care System (ICS) Patient Safety Collaborative and reviewed by the Governance Committee. Themes and actions will be shared with NHS England and other national bodies where applicable to inform wider learning.

Example Application

An incident involving delayed diagnosis in a patient moving between Held Health (private sector), primary care and specialist services (eg CAMHS) would trigger a joint investigation led by Held Health but including contributions from the GP practice and CAMHS. Learning might highlight communication gaps in referral processes and lead to system-wide improvements, such as a standardised handover protocol.

Sharing of Learning Externally

Held Health is committed to transparency and to maximising the impact of patient safety learning by sharing it beyond organisational boundaries. Patient safety incidents often highlight system-wide issues that extend across care pathways, and improvement is most effective when learning is disseminated at local, regional, and national levels.

Principles

Openness: Patient safety learning will be shared externally in a transparent manner, consistent with our duty of candour and with the principles of a Just Culture.

Collaboration: We will engage actively with Integrated Care Boards (ICBs), regulators, professional networks, and partner providers to promote shared understanding of risks and solutions.

Proportionality: Learning will be shared in a way that is timely, accessible, and proportionate to the nature and scale of the incident.

Confidentiality: All external sharing will comply with information governance, data protection, and safeguarding requirements, ensuring individuals cannot be identified unless explicit consent is provided.

Processes

Identification of wider learning: During patient safety investigations, the Patient Safety Specialist (PSS) will highlight themes and findings that are relevant beyond the organisation.

Approval for sharing: Summaries of learning will be reviewed through PSIRF governance processes before being shared externally.

Routes for external sharing

Integrated Care Board (ICB): to support system-level safety improvements.

National reporting systems: including NHS England and other national programmes (e.g. LeDeR, Maternity and Neonatal Safety).

Peer networks: such as regional collaboratives, specialty safety groups, or professional forums.

Public transparency: where appropriate, learning will be shared in public Board papers, newsletters, and on the organisational website.

Feedback loop: Where learning is shared externally, the organisation will also seek to receive learning from other providers and incorporate this into local improvement work.

Oversight

The Patient Safety Specialist will maintain a log of all externally shared learning, including recipients, format, and feedback received. Oversight will be provided by the Quality and Safety Committee, which will review the impact of shared learning and ensure actions are embedded both internally and across the system.

Communication and Duty of Candour

Held Health is committed to transparency and honesty with patients and families. Where harm has occurred, we will provide timely explanations, apologies, and updates in line with the Duty of Candour.

Governance and Oversight

Effective governance and oversight are central to the delivery of the Patient Safety Incident Response Framework (PSIRF). Held Health is committed to ensuring that patient safety incident response is transparent, learning-focused, and embedded within wider quality governance structures.

Board-Level Accountability

The Board has ultimate accountability for patient safety.

The Executive Lead for Patient Safety, the Clinical Director, is responsible for ensuring the organisation complies with PSIRF requirements.

The Board will receive regular reports on incident response activity, learning, and improvement actions.

Patient Safety Specialist (PSS)

Provides expert leadership and coordination of PSIRF implementation.

Ensures that proportional, systems-based responses are undertaken.

Acts as the link between frontline teams, governance committees, and external partners.

Committees and Groups

Governance Committee: Provides assurance to the Board on all aspects of patient safety incident response, including oversight of investigations, thematic reviews, and learning dissemination.

Safeguarding Committee: Works in partnership with the PSG to ensure safeguarding issues identified through PSIRF are addressed and statutory duties are met.

Patient Safety Partners (PSPs): Participate in governance forums to ensure transparency, provide challenge, and contribute lived experience to decision-making.

Monitoring and Reporting

Incident response activity will be tracked using the patient safety incident management system

A quarterly PSIRF report will be presented to the Governance Committee, including:

Number and type of responses undertaken.

Timeliness of investigations.

Key themes and system learning.

Progress on improvement actions.

Evidence of patient and family involvement.

Annual PSIRF outcomes will be published publicly in the Quality Account to demonstrate transparency and accountability.

External Oversight

The organisation will share relevant themes and learning with the Integrated Care Board (ICB), NHS England, and other partners where appropriate.

Participation in regional and national safety collaboratives will ensure that local learning contributes to wider system improvement.

Monitoring and Review

This policy will be reviewed annually or sooner if national guidance changes. Learning outcomes will be monitored, and progress reported quarterly to the leadership team.