Patient Safety Incident Reporting Plan (PSIRP)

Many millions of people are treated safely and successfully each year by the NHS in England, but evidence tells us that in complex and dynamic healthcare systems things will and do go wrong, no matter how dedicated and professional the staff.

When things go wrong, patients and families are at risk of harm and many others may be affected. The emotional and physical consequences for patients and their families can be devastating. For the staff involved, incidents can be distressing and members of the clinical teams to which they belong can become demoralised and disaffected. Safety events also incur costs through lost time, additional treatment, and litigation. Overall, the majority of events are caused by system design issues, and not by individuals.

The Patient Safety Incident Response Framework (PSIRF) sets out the NHS’s approach to developing and maintaining effective systems and processes for responding to patient safety events for the purpose of learning and improving patient safety. It is recognised that there will need to be a shift towards systems-based approaches to a learning culture to allow GOSH to effectively respond to and learn from events, with the purpose of reducing the risk of avoidable harm as low as reasonably possible.

The Serious Incident Framework (SIF) outlines a suggested list of events which require a full investigation, with external oversight and approval. The introduction of PSIRF provides GOSH with more autonomy and flexibility in our approach to patient safety events.

Patient safety events can be defined as:

“Any unintended or unexpected incident which could have, or did, lead to harm for one or more patients’ receiving healthcare”.

Compassionate engagement is a key fundamental of PSIRF. Clear communication with those affected by patient safety events to determine the focus of any review is vital to ensure that the voice of the patient, families/carers, and staff is at the heart of any response and learning. Documentation of clear communication and engagement is vital.

It should be acknowledged that PSIRF is a new framework for the identification and response to patient safety events, however the aims and ethos have been adopted within healthcare for some time. The implementation process will take time to progress and embed and will require regular review to ensure that GOSH can demonstrate positive assurance in improvements and safety. Enhancing data quality and agility will need to be at the heart of the implementation process to ensure continuous progression.

Effective introduction and ongoing development of PSIRF will be achieved through identifying key themes, patterns, and trends from the data, identifying opportunities for learning and ensuring there are organisational improvement plans in place, over the medium and long term. These will be reviewed, by internal and external agencies, to provide assurance that GOSH can demonstrate effective learning, supported by sustainable improvements in the quality and safety of services and improved care for people who use our services.

The application of System Engineering Initiative for Patient Safety (SEIPS) methodology, to identify the safety actions that need to be considered, is new within the trust. As such, it is recognised that those leading on learning responses may benefit from support from either a more experienced practitioner, or a trained peer who has the same level of experience, as a “buddy”. It is possible that this expertise/support may be sought from an external source (e.g., another healthcare provider learning response lead from within North Central London Integrated Care Board (NCL ICB) or GOSH may be requested to provide “buddy” support.

The GOSH profile, however, must be flexible in its approach to risk and learning, and therefore, where there is either significant risk, opportunities for significant new learning, or opportunities to explore systems and processes for the purpose of learning, the Trust will remain flexible and consider specific individual circumstances and/or emerging themes alongside the implementation of this plan. Events for escalation to a PSII will not be graded by severity of harm, but rather the opportunity to understand what happened and the opportunity for learning and improving care.

A Patient Safety Incident Response Plan (PSIRP) is required for all services provided under the NHS Standard contract. This applies to all services provided by GOSH.

This PSIRP sets out how GOSH will respond to patient safety events reported by staff, patients, families, and carers to allow for continuous improvement of the quality and safety of the care we provide. The PSIRP will be reviewed bi-annually following the initial review to be carried out in June 2025.

PSIRF has four main aims upon which this plan is based.

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To meet the requirements for the National Standards for Patient Safety Responses, we will

Develop a body of expertise within the Patient Safety Team, and the wider organisation, to conduct learning responses which ensure compassionate engagement and involvement for all affected.

Undertake system-based approaches which support directorate, cross-directorate, and organisational learning, which has a positive impact on providing safer care for patients and families.

Ensure patients, families/carers and staff affected by patient safety events are compassionately engaged with at the earliest opportunity and are involved, as much as they wish to be, in the review and learning processes to allow for change which reflects the needs of people who use our services.

Assign an appropriately trained member of the Executive Team to oversee delivery of the PSII standards and support the approval of all PSIIs.

The Organisational Learning and Assurance Forum, will oversee, manage and provide assurance all learning responses and local improvement across GOSH, sharing and embedding learning.

Use Quality Improvement (QI) methodology and improvement science approaches to develop learning and implement improvements in care.

Great Ormond Street Hospital (GOSH) is an international centre of excellence in child healthcare. Since its foundation in 1852, the trust has been dedicated to children’s healthcare and to finding new and better ways to treat childhood illnesses.

GOSH receives around 242,694 outpatient visits and 42,112 inpatient visits per year, and approximately 750 children and young people per day2.

There are over 60 clinical specialities across the Trust and GOSH is the largest paediatric centre in the UK for:

- Paediatric Intensive Care

- Cardiac Surgery

- Neurosurgery

- Paediatric cancer services

- Nephrology and renal transplants

- Tracheal Surgery

- Children treated from overseas and privately within our International and Private Care (I&PC) wing

- Research and Innovation

- Tier four inpatient CAMHS mental health care

The trust has the following directorates:

- Heart and Lung

- Blood, Cells and Cancer

- Sight and Sound

- International and Private Care

- Brain

- Body, Bones and Mind

- Core Clinical Services

- Medical Director's Office

- Research and Innovation

GOSH has strengthened existing governance processes and will continue to review existing processes to ensure that they meet the PSIRF standards and to deliver the key aims of PSIRF. Patient safety is a key purpose and it essential there is effective learning from incidents.

Incident themes and trends will be reviewed at directorate Risk Action Groups (RAGs). The purpose of this forum is to review all safety events, with an emphasis on incidents across the directorate, or sub-directorate, to identify patterns. This allows for local learning and improvement to take place with the aim of minimising events and preventing avoidable harm. Patterns and events of concern can be escalated to the SERG for review by members of the senior leadership team.

The Safety Events Review Group (SERG) will continue to review incidents which:

- Meet the national or Trust priorities.

- Where there are identified patient safety themes.

- Emerging themes which impact on patient safety.

- Provide a forum for review and sign off of PSIIs.

Learning from events, PSII and learning responses will be undertaken in the Organisational Learning and Assurance Forum (OLAF) where there will be consideration for directorate, organisational and system-wide learning. PSII safety actions, themes from learning responses and local learning initiatives will be reviewed by this forum with recommendations for sharing learning and assurance that learning is being embedded.

OLAF will work collaboratively with the Quality Review Group (QRG) to identify and commission specific quality improvement projects to address learning from events. The QRG will ensure that clinical and corporate directorates provide robust assurance on quality improvement, in accordance with the Trust Quality Strategy.

Findings from individual PSII and other PSIRF learning responses will be collated and compared to identify themes in modifiable factors upon which quality improvement initiatives can be developed to support organisational learning.

The trust will apply the principles of patient safety science and improvement methodology to

identify:

- What improvements are recommended and prioritisation of quality improvements.

- Plans for implementation and involving stakeholders.

- Measuring the impact of the changes or identifying alternative changes where the desired impact is not achieved.

- Engage QI teams to ensure services have the resource to embed and sustain improvement.

- Hospital-wide Safety Transformation Programme.

The trust has the following safety improvement plans underway:

- Deteriorating patients Working Group

- Complex Patient Working Group

- Medicines Safety Committee

- Total Parenteral Nutrition (TPN) Improvement Group

Clinical effectiveness processes such as clinical audits, Horizon Scanning and Learning from Death data will continue to be monitored to ensure any new patient safety trends and risks are identified and acted upon in a timely manner. This data will also be used to inform the Trust’s patient safety event risk profile.

All forums listed above will report to the Quality, Safety, Outcomes and Compliance Committee (QSOCC).

The Trust completed a thematic analysis approach to determine our patient safety priorities. Thematic analysis is a method of identifying, analysing, and reporting patterns (themes) within data.

The data sources used to define the trust profile are outlined below. The analysis of data was undertaken by subject matter experts for each area to provide expert knowledge of trends and priorities and inform how the trust will respond to events. The review period was between 01 April 2020 to 31 March 2023 to ensure that the data was reflective of pre- and post-COVID data. This included careful consideration of safety improvement opportunities and plans and interventions already in place.

To determine the focus and priorities for PSII, engagement sessions to agree and finalise the Trust priorities were undertaken. This plan has also been reviewed by our Patient Safety Partners (PSPs).

We have determined six patient safety priorities that will be the focus for the next 18 months. These patient safety priorities have been developed from a review of the data listed above, and where the specified level of harm, or negative impact has occurred, will be subject to a Patient Safety Incident Investigation (PSII) using system-based methodology. Root Cause Analysis (RCA) methodology is not recommended for safety investigations.

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For events which do not meet the threshold for a PSII as outlined in the six priorities, an alternative, proportionate learning response will be identified and undertaken, involving staff, patients, families/carers, and where identified, a patient’s wider support network.

PSII, and other learning responses, are completed for the purpose of learning to and gain an understanding of system contributors about events. This will allow for improvements to be made to systems to make care safer for people who use services.

The selection of patient safety incidents investigations will be selected based on:

- Actual and/or potential impact of the incident outcome on harm to people, service quality, reputation of the Trust etc.

- Likelihood of recurrence

- High potential for new learning regarding:

- Incident causing factors

- Improving system efficiency and effectiveness

- Opportunities to greatly influence wider system improvement.

A full outline of national defined priorities which require referral for review by another agency or requiring a PSII can be found in the Patient Safety Incident Response Policy and Appendix A.

The table outlined below will guide how we will respond to the identified priorities and local investigations, including the governance arrangements to ensure we have meaningful learning which can be implemented across the Trust with the aim of reducing avoidable harm.

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PSII should ordinarily be completed within 3 months of their start date. The expected date of completion, including executive member sign off should be agreed at the commissioning of the investigation; patient and/or family and/or carer involvement, unless expressed otherwise, should be involved in determining completion dates. Once a date has been agreed with all involved, all efforts should be made to ensure completion of PSIIs are undertaken within this timeframe.

A balance will be drawn between conducting a thorough PSII, the impact that extended timescales can have on those involved in the incident, and the risk that delayed findings may adversely affect safety or require further checks to ensure they remain relevant.

Where the processes of external bodies delay access to information for longer than six months, a PSII can be completed and subsequently reviewed when the information becomes available; a completed PSII can be reviewed to determine whether new information indicates the need for further investigative activity.

Once an incident has been identified that meets the Statutory Duty of Candour threshold, which the trust outlines are moderate harm and above, then the legal duties as outlined in Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 will be carried out in full.

Duty of Candour is regulated by the Care Quality Commission (CQC).

A culture of openness is crucial to improving the safety of patients, families, and staff; thus improving the quality of healthcare. Duty of candour involves apologising and explaining what happened to patients who have been harmed as a result of their care or treatment.

An overview of duty of candour can be outlined in 3 steps:

- Conversation: Apologise in person as soon as we become aware that something has gone wrong.

- Candour Letter: Send a letter with a summary of the conversation and outline plans as to how GOSH will respond to this patient safety event (within 10 working days).

- Completion: Arrange for the learning from the response and if there are areas where GOSH will work to improve care and systems

All patient safety events will have a learning response, however, often engagement and learning are best achieved through a proportionate learning response.

Many patient safety events will not require PSII but may benefit from a different type of response to gain further insight or address queries from the patient, family, carers, or staff. A clear distinction is made between the activity, aims and outputs from reviews and those from PSIIs.

Different response techniques can be adopted, depending on the intended aim, and required outcome to identify learning.

GOSH will use the following response methods:

Immediate safety actions

To take urgent measures to address serious and imminent:

- discomfort, injury, or threat to life

- damage to equipment or the environment.

‘Being open’ conversations

To provide the opportunity for a verbal discussion with the affected patient, family, or carer about the incident (what happened) and to respond to any concerns.

Case record and note review

To determine whether there were any problems with the care provided to a patient by a particular service.

Safety huddle

A short multidisciplinary briefing, held at a set time and place and informed by visual feedback of data, to:

- improve situational awareness of safety concerns

- focus on the patients most at risk

- share understanding of the day’s focus and priorities

- agree actions

- enhance teamwork through communication and collaborative problem-solving

- celebrate success in reducing harm.

To provide a detailed documentary account of an incident (what happened) in the style of a ‘chronology’.

After-action review

A structured, facilitated discussion on an incident or event to identify a group’s strengths, weaknesses, and areas for improvement. This usually takes the form of a facilitated discussion following an event or activity. It enables understanding of the expectations and perspectives of all those involved, and it captures learning, which can then be shared locally, organisationally and system wide.

As part of World Patient Safety Day 2023, we engaged patients, families/carers, and staff about what makes them feel safe.

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The Patient Safety Incident Response Framework (PSIRF) recognises that learning and improvement following a patient safety event can only be achieved if supportive systems and processes are in place. A Restorative Just and Learning Culture is essential when reviewing or investigating incidents, and there is a need to ensure psychological safety to encourage openness and transparency to support colleagues reflect upon processes and actions taken during care delivery to allow for learning and improvement and facilitate closure for those affected.

GOSH recognises the significant impact patient safety events can have on patients, their families and carers, and our staff.

Getting the right level of involvement from those affected and listening to the voice of people is crucial in developing systems for meaningful learning.

At GOSH, we are in the process of developing an engagement framework for those affected by patient safety events which will focus on the areas below:

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GOSH offer support for staff affected by patient safety events through the following channels:

- Access to Employee Assistance and Wellbeing services (Care First).

- Debrief services via PEERS

- Trauma Risk Management Services (TRiM)

Incidents must be reported to the local organisation’s named professional/safeguarding lead manager and director of nursing for review/multi-professional investigation.

For further information see incidents in screening programme.

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