Patient Safety Incident Response Plan (PSIRP)

1.0 Introduction

1.1 First and foremost, PSIRF is not an investigation framework but rather a learning and improvement framework.

1.2 PSIRF is a new approach to responding to patient safety events that aims to enhance the learning and improvement of patient safety in the NHS. It replaces the Serious Incident Framework (2015), which is the standard by which the NHS undertakes investigations, but it is recognised that this method was bureaucratic, inconsistent, and does not always achieve the main aims of learning from safety events and preventing harm.

1.3 One of the main benefits of PSIRF is that it focuses on understanding how incidents happen, rather than assigning blame or accountability. This allows us to learn from the system factors that contribute to incidents, and to implement effective actions to prevent them from recurring. PSIRF applies a range of system-based approaches to learning from incidents, such as human factors analysis, systems thinking, and safety-II principles. These methods help us to identify and address the underlying causes and influences of incidents,  rather than relying on a single root cause analysis method that may not capture the complexity and variability of healthcare.

1.4 Central to PSIRF is the principles of conducting fewer, but more comprehensive, investigations.

1.4.1 Clinical Partners believe in dedicating time and resources to performing systems-based investigations conducted by individuals trained in this specialised area. This plan, along with its associated policies and guidelines, is designed to outline the functioning of PSIRF and how it aligns with the NHS Patient Safety Strategy's call to rethink learning within healthcare organisations.

1.4.2 One potential challenge in successfully implementing PSIRF, is avoiding the pitfall of merely relabelling our previous investigation processes. Our goal is to integrate investigative practices into a broader, patient-centred response to safety incidents while embracing thematic learning from other patient safety insights. 

1.4.3 Within PSIRF, we recognise the significance of establishing robust support structures for both employee and patients affected by safety incidents. A key component of this support involves fostering a psychologically safe culture, evident in the conduct of our leaders and our reporting systems.

1.5 The transformational scale and aims of PSIRF mean that embedding all principles, processes, and cultural shifts cannot happen in a single step; changes to how we work, train, and learn will take time to mature. However, Clinical Partners is not at the start of this journey. We have previously commissioned PSIRF-aligned investigations using external expertise and have long recognised the importance of a systems-based approach to understanding patient safety events.

This Patient Safety Incident Response Plan therefore outlines how Clinical Partners will continue to respond to patient safety events over the next 12 to 18 months as we further embed PSIRF principles. It is not a fixed or restrictive set of rules: we will remain flexible, responsive to the circumstances of each incident or concern, and focused on meeting the needs of those affected. The continued implementation of PSIRF tools, resources, and training for key individuals will further strengthen the systems-thinking approach already present in our handling of incidents, complaints, and emerging issues.

1.6 Patient, families and carer engagement

1.6.1 Recognising the valuable contributions patients can make in identifying system failures, we actively encourage open communication with patients and families, including following the regulatory Duty of Candour. We understand the need to support patients’ families and carers to become equal partners in our patient safety responses and improvements.

1.6.2 Effective educational strategies and our PSIRF plan will enhance this further still to ensure we bring patients and their loved ones to the centre of how we manage safety incidents and future safety improvements.

1.6.3 To actively involve patients in safety processes and investigations, we will look to appoint Patient Safety Partners in the future and adopt proven engagement processes underpinned by quality research and development. Moreover, providing patients and carers with knowledge about the healthcare system empowers them to be active partners in their care and helps identify when prompt action is necessary.

1.7 A just and safe culture

1.7.1 Clinical Partners will prioritise the way we organise and manage governance and patient safety through cultural change that integrates quality improvement and patient safety to deliver safe patient care. We already encourage and expect all our employee to report safety events promptly and take immediate action when necessary.

1.7.2 Our focus is on fostering an open culture as transparency is vital for learning. We hold employee accountable for their actions while striving to create a safe and blame-free environment. Honest disclosure of information is encouraged, and we are committed to addressing issues fairly and justly.

1.8 Continuous learning and quality improvement

1.8.1 Clinical Partners place significant emphasis on learning and improving from incidents, complaints, and litigation but acknowledge we need to do more to recognise the value of sharing successful practices alongside errors (Safety II). Sharing knowledge is essential to prevent harm recurrence, and we will promote and develop mechanisms such as after-action reports, safety briefs, and huddles for effective local-level dissemination. The organisation commits to continuous review, transparency, and focused professional development for employee.

1.8.2 The introduction of the NHS Patient Safety syllabus and training modules aims to promote patient safety and human factors awareness among all employee. The skill and competence of our employee is crucial for providing safe, high-quality, and cost-effective care. Clinical Partners, acknowledge the way we work is very different to other organisations and as such brings different employeeing challenges and the importance of managing and monitoring safe employeeing effectively. Clinical Partners has created training on our in house training platform ‘FROG’ which is aligned with E-learning for healthcare’s Patient Safety Syllabus, Essentials for Patient Safety - Level 1 module. This training will form part of all employee mandatory training.

1.8.3 Clinical Partners will endeavour to create a more robust process for highlighting/reporting ‘good care’, in line with PSIRF. This has been added to the Organisational Learning and Improvement Plan (OLAP). 

1.9 Our Services:

1.9.1 Clinical Partners are one of the UK’s leading providers of mental health services who work both privately and with the NHS to help people and families experiencing mental and emotional difficulties to get the support they need.

1.9.2 Through face-to-face and online appointments, our services include specialist diagnostic assessments, general outpatient psychiatry, psychology, and psychotherapy for people of all ages.

1.9.3 Our priority is helping patients and meaningful others feel better. This means only using treatments and therapies that have been proven to work. Our clinicians all use an evidence-based approach that follows guidelines from the National Institute for Health and Care Excellence (NICE).

1.10 Incident Managements & Oversight:

1.10.1 Clinical Partners has a responsibility to ensure that it has in place systemic measures for the safeguarding of people, property, private and NHS resources and reputation. This includes a process for the timely reporting and investigation of incidents and near misses to ensure there is learning to minimise or prevent a recurrence.

1.10.2 All employee are required to report incidents using the organisations Incident reporting and management system and each investigation is assigned an investigator. All incidents are monitored throughout the organisation and robust reporting, and oversight processes are in place.

1.10.3 The Board has overall responsibility for incident reporting, investigation and analysis/improvement that forms an integral part of the organisations risk management policy. The Board will ensure that Clinical Partners complies with its statutory and mandatory obligations in this regard and any delegated responsibility should ensure these obligations are maintained.

1.11 Defining our Patient Safety Incident Profile

1.11.1 Clinical Partners operates an Exclusion Policy and a Triage Risk Assessment process to ensure that we only accept patients whom we can treat safely and effectively. These safeguards are designed to identify and manage risk at the point of referral. However, there may be occasions when a patient’s circumstances change or their mental health deteriorates, resulting in an increased risk profile that requires further review or alternative support.

1.11.2 Clinical Partners Safety Improvement Profile has been developed following:

Analysis of Patient incidents:

• Where an incident type is well understood because previous incidents of this type have been thoroughly investigated and national or local improvement plans, targeted at the contributory factors are being implemented and monitored for effectiveness. CP recognises that resources may be better directed at improvement rather than repeat investigation (or other type of learning response).

• Risks or broad patient safety issues may also be identified during patient safety incident response planning that could benefit from focussed improvement efforts rather than further incident responses.

• Clinical Partners may consider conducting a thematic review of past learning responses to inform the development of our safety improvement plan.

Complaints:

• Complaint themes are reviewed and a thematic analysis undertaken which was triangulated with other data sources such as dissatisfaction logs and Trust Pilot.

Analysis of Audit:

• Planned audit programme and responsive audits around relevant national, regional, and locally driven improvement and service transformation programmes are undertaken by CP. These may identify patient safety issues.

Patient and Stakeholder Feedback:

• A valuable source of information that may directly identify patient safety concerns or themes that indicate possible system errors.

1.12 System Reviews:

• Due to increased activity and pressure on operating platforms. Currently Clinical Partners argoing through an organisational and IT transformation project to improve services for patients and employee. Improved data availability and visibility to reduce risk. This will also include an updated/or new quality management system.

2 Risk Profile

Death by Suicide - Suicide is an immensely tragic occurrence, often without warning. Although its immediate onset may be unforeseeable, proactive and coordinated interventions can help create safer environments and reduce overall risk.

Overdose - Overdose events can be unpredictable. For safety reasons, we are unable to provide care for individuals who have recently overdosed, as they require a higher level of crisis support than our services can offer.

Prescribing Safety at Clinical Partners - Prescribing mistakes are very rare at Clinical Partners, but safety is our top priority. If something does go wrong, we act quickly to review what happened and make improvements. We’re committed to being open and transparent keep our patients and families informed about any actions we take to prevent similar issues in the future. All incidents are discussed at the weekly Clinical Incidents and Medications Errors meeting to ensure that any incidents are reviewed and associated risks mitigated promptly.

Feedback - Feedback sources are required to encompass complaints, safeguarding cases, employee suspensions, and data obtained through quality surveillance processes to ensure compliance with regulatory standards.

Maintaining a contemporaneous record of patient care - Maintain accurate, contemporaneous patient care documentation, including risk indicators, and guarantee secure, timely access for clinical employee.

Never Events - Never Events are rare but serious because they indicate a failure in systems designed to keep patients safe. Our organisation follows strict national standards and regularly reviews processes to ensure these events do not occur. If a Never Event does happen, we investigate thoroughly, learn from it, and take immediate action to prevent it from happening again.

As Clinical Partners continues to develop our Patient Safety Incident Response Plan, we will engage with stakeholders to review and further define patient safety risks.

2 Our Patient Safety Incident Response: National Requirements

3 Our Patient Safety Incident Response Plan: Local Focus

3.1.1 The planned responses detailed below set the expected approach to be taken. However, additional responses may be undertaken such as, a ‘debrief’ (for traumatic incidents), or a ‘Rapid review /72-hour report’ for incidents of significant harm. Alternative responses may also be undertaken due to specific needs of individual incidents and those affected.

3.1.2 The type of incident response deployed will depend on:

• The views of those affected, including patients and their families.

• Employeeing capacity/expertise available to undertake a learning response.

• What is known about the factors that lead to the incident(s)?

• Whether improvement work is underway to address the identified contributory factors.

• Whether there is evidence that improvement work is having the intended effect/benefit.

3.1.3 A chief aim of PSIRF is to undertake higher quality Patient Safety Incident Investigations (PSII) employing system review methodology to maximise effective and sustained learning and improvement. This will mean fewer but more significant investigations for the national and local priorities detailed in this plan.

4 Quality Improvement Plans

4.1 Clinical Partners has implemented several strategies to enhance patient safety and deliver improvement plans.

The Clinical Governance team has developed an organisational learning and improvement plan (OLAP), structured by source type, including:

• Reported incidents

• Audit findings

• Stakeholder engagement

These initiatives have informed the creation of targeted safety improvement plans for specific services, pathways, or locations. Plans may result from individual learning responses or thematic reviews where sufficient understanding of systemic issues exists.

5 PSIRF Transition Plan

5.1 As Clinical Partners further progresses with our PSIRF Plan, we recognise that in order to maximise the benefits and improvements the new framework will bring, we need to continue to enhance our patient safety initiatives and foster a culture of continuous improvement within our organisation. The following outlines our objectives and improvements to be continued and developed:

5.1 Training: Enhancing Knowledge and Skillsets

Patient Safety Incident Response Framework Introduction for Employee: Clinical Partners recognise the pivotal role that all employee members play in ensuring patient safety. To this end, we will introduce training on the Patient Safety Incident Response Framework. This training will equip our employee with a clear understanding of the framework's principles and procedures, ensuring a consistent and coordinated response to patient safety incidents.

Learning Response Leads Training. The quality of the investigation will be pivotal to ensuring a comprehensive and detailed response where the aims of PSIRF are achieved. To ensure that our employee are equipped to undertake a quality response, ongoing training will need to be provided to employee who will undertake the learning response lead function. This will need to be resourced and factored into the Governance and Compliance Team training agenda.

Expanding National Patient Safety Training Level 1: Recognising the importance of a well-informed workforce, we will expand our efforts to provide training on FROG which aligns with National Patient Safety Level 1 training across all employee within Clinical Partners. This training will empower our employee with the necessary knowledge and skills to contribute actively to patient safety.

Advanced Training for Patient Safety Specialists: Our commitment to excellence extends to Patient Safety Specialists. Currently within the NHS it is expected that every organisation has a Patient Safety Specialist. Clinical Partners has 3 Patient Safety Specialist within our organisation who have undertaken formal patient safety training. As an organisation we aim to refresh the PSP training and have our Clinical Leadership Team trained to level 3 and level 4 national patient safety training, ensuring they remain at the forefront of patient safety practices and innovations and this is recorded on our OLAP.

Patient Safety Partner: Currently Clinical Partners do not have any Patient Safety Partners, however this is something that the organisation aspires to have in the future as part of our Patient Safety Incident Response plan.

Safety II is an innovative approach that focuses on understanding how systems work effectively, rather than solely investigating failures. When implementing and enhancing the Patient Safety Incident Response Framework (PSIRF), it is important that safety II processes are factored into our learning response enquiry.

Understanding how the system works effectively will ensure that actions and areas for improvement envelope these proven solutions. More importantly, understanding what works well will reduce the risk that unproven actions devised in response to a safety event do not compromise existing and effective processes.

The SEIPS framework, in particular the tools which support ‘understanding how we work’ will enhance our knowledge of how systems work effectively. In addition, the implementation of a new reporting processes for patient events of ‘good care’ within our incident reporting and management system (mirroring the NHS expected reporting metrics) will also enhance the sharing of learning from where things work well in addition to when things do not.

6 Communication

6.1 Clinical Partners acknowledges that PSIRF is a relatively new approach to patient safety incidents but much of the requirements have been part of business as usual for some time especially the no blame culture and the systems-based approach. However, the implementation process will take time to progress and embed and will require regular review to ensure the organisation can demonstrate positive assurance in tangible improvements to the quality and safety of services with improved patient safety outcomes. To ensure the process is embedded within the organisation, a clear and detailed communication plan must be developed and implemented to ensure maximum engagement with both our internal and external stakeholders.

7 Implementing Standardised Alternative Responses

7.1 To enhance and expand our responses to patient safety events we need to broaden our response techniques used in Clinical Partners. The PSIRF promotes the use of undertaking responses that meet the needs of organisations to identify concerns and respond to them appropriately. To that end we will undertake a review of the available research and guidance for the following and develop a programme to implement these methods based on national standard (where available) and learning from partner organisations. A list of alternative response methods are found in Appendix 1.

8 Review

8.1 Every 12 to 18 months initially thereafter every two years on incident analysis

9 Patient Safety Incident Response Plan Definitions

A Just Culture: The fair treatment of employee supports a culture of fairness, openness and learning in the NHS by making employee feel confident to speak up when things go wrong, rather than fearing blame.

Supporting employee to be open about mistakes allows valuable lessons to be learnt so the same errors can be prevented from being repeated. In any organisations or teams where a blame culture is still prevalent, this guide will be a powerful tool in promoting cultural change.

Apology: a sincere expression of regret offered for harm sustained. This is not an admission of liability.

Being open: Being Open is a specific process of actions and behaviours that must be followed following any incident causing harm to a patient. These are determined by the Ten Principles of Being Open. The NPSA‟s Being Open policy does not require prevented patient safety incidents or “no harm” incidents to be reported to patients/relatives. Organisations are said to be “open” when the prevailing culture visibly encourages key behaviours. These include honesty, openness, appropriate sharing of information and a willingness to learn from experience to change how the organisation functions.

Clinical claim: a claim for compensation in respect of adverse clinical incidents, which led to personal injury or harm.

Complaint: an expression of dissatisfaction by one or more members of the public about Clinical Partners action or lack of action, or about the standard of a service, whether the action was taken by the organisation itself or by somebody acting on behalf of the organisation.

Duty of candour: A contractual and legal duty requiring Healthcare organisations to ensure that patients/families are informed of medical errors causing moderate, severe harm or death and provided with support. This includes receiving an apology, as appropriate, and the investigation findings and actions to prevent recurrence are shared.

Employer’s liability: claims for compensation for injury or ill health to employee arising out of work.

Harm: injury (physical or physiological), disease, suffering, disability, or death

Healthcare Professional: Doctor, Dentist, Nurse, Midwife, Pharmacist, Optometrist, Allied Healthcare Professional or registered alternative healthcare practitioner.

Incident: Patient safety incident, Health, and Safety Incident or, in reference to this plan only, a Complaint or Claim.

Injury: damage to tissues caused by an agent or circumstance

Investigation: A formal process of analysing an event and recording the findings.

Near Miss: An incident (clinical or non-clinical) that had the potential to cause harm or loss had intervention or evasive action not been taken.

Never Event: Serious incidents that are wholly preventable as guidance or safety recommendations that provide strong systemic protective barriers are available at a national level and should have been implemented by all healthcare providers.

Patient Safety Event: any unintended or unexpected incident, complaint or claim that lead to harm of any patient receiving healthcare within the organisation.

Patient Safety Incident Investigation (PSII): PSII is the process of systematically examining and analysing incidents that compromise patient safety within a healthcare setting. It aims to identify the root causes and contributing factors of such incidents to prevent their recurrence.

Patient Safety Incident Response Plan (PSIRP): PSIRP is a structured and documented strategy that outlines the actions and steps to be taken when a patient safety incident occurs in a healthcare facility. It provides guidance on how to respond, manage, and mitigate the impact of such incidents.

Patient Safety Partner (PSP): A PSP is an individual (not an employee), who will be appointed on a fixed term agreement to work in collaboration with the Clinical Partners to promote patient safety. They work in partnership with the safety team, and the governance and compliance team to provide and act as ‘the voice’ of the patient. Initially the individual may primarily sit on relevant quality/safety committees to provide insight and challenge in support of safety. Clinical Partners aspires to having Patient Safety Partners however at this current time has none.

Risk: The potential for suffering harm, loss, or damage to occur. Risk is the combination of likelihood and consequence of a risk/harm materialising.

Root cause analysis (RCA): a systematic approach in which contributing factors to any event are identified, and in which understanding of the underlying causes and environmental context of the event is sought.

Safety 2: Safety II is an approach to safety management that focuses on understanding how systems function successfully, rather than just analysing failures. It recognises that in complex systems, things often go right, and it aims to learn from these successes to enhance safety. This approach emphasises the importance of studying everyday work practices and the factors that contribute to positive outcomes, allowing organisations to proactively improve safety by building on what works well.

Severity Grade: A measurement of the actual or potential severity of harm.

Significant Incident: A “significant” incident would likely mean one with serious consequences for patients, employee, or the organisation, or one that triggers additional resources for a comprehensive response.

Table 1: Incident Grading Matrix (LFPSE)

Suffering: experiencing anything subjectively unpleasant. This may include pain, malaise, nausea and/vomiting, loss, depressions, agitation, alarm, fear, grief, or humiliation.

10 References

Patient Safety Incident Response Framework and supporting guidance [online]: NHS England » Patient Safety Incident Response Framework and supporting guidance

Care Quality Commission. 2019. Regulation 20: Duty of candour. Accessed online. https://www.cqc.org.uk/guidance-providers/regulations-enforcement/regulation-20-duty-candour

Health and Social Care Act 2008 (Regulated Activities) Regulation 2015: Regulation 20: Duty of Candour

Learn together Supporting involvement after safety events in healthcare. Learn-together.org.uk – Serious Incident Investigation resources

Mid Employeeordshire NHS Foundation Trust Public Inquiry [Francis report] (2013). Report of the Mid Employeeordshire NHS Foundation Trust Public Inquiry: Executive summary. London: The Stationery

Office [online] [Accessed 5 February 2013]

http://www.midemployeespublicinquiry.com/sites/default/files/report/Executive%20summary.pdf

NHS Improvement (2015) Serious Incident Framework [accessed 10 April 2019]

https://www.england.nhs.uk/wp-content/uploads/2015/04/serious-incidnt-framwrk-upd.pdf

National Patient Safety Agency (2009a) Being open: communicating patient safety incidents with patients, their families, and carers [online] [Accessed 20 December 2013].

http://www.nrls.npsa.nhs.uk/resources/?entryid45=83726&q=0%c2%acbeing+open%c2%ac

NHS Resolution (2017) Saying Sorry [online] [Accessed 22 January 2019]

https://resolution.nhs.uk/wp-content/uploads/2017/04/NHS-Resolution-Saying-Sorry-2017.pdf

NMC & GMC joint guidance (2015) Openness and honesty when things go wrong: the professional duty of candour. [Online] Openness and honesty when things go wrong: the professional duty of candour (nmc.org.uk), Openness and honesty when things go wrong: The professional duty of candour - professional standards - GMC (gmc-uk.org)