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Patient Safety Incident Response Framework (PSIRF) Policy

Table of contents

1. Introduction, purpose, and aims

The Hearing People (THP), is committed fully to make Patient Safety its main priority, adhering to the principles of Duty of Candour by being open and transparent in a supportive environment.

The policy supports the requirements of the Patient Safety Incident Response Framework by NHS England. It is developed to demonstrate the company’s approach to developing and maintaining processes and procedures on how we would respond to patient safety incidents and issues for the purpose of improving patient safety and learning from it.

Our existing Serious Incident Response Framework will be replaced by an improvement- focused flexible system called the Patient Safety Incident Response Framework (PSIRF). Under PSIRF, the company will not be talking about the root cause of any serious incidents or about the investigation itself but in its place will be a system that will be a system focused flexible approach where the focus is on bringing improvements and engagement with patients, families and staff taking the center stage. The focus is to have resources, time and effort to solving and learning from it rather than putting efforts on delivering investigation reports. This policy advocates for a data driven and well-coordinated response to patient safety incidents. It prompts a significant cultural shift towards systemic patient safety management with major focus towards understanding and learning from how incidents occur rather than fostering a blame culture.

The policy is designed with four key aims:

  • An empathetic engagement and participation of all affected in patient safety
  • A systematic approach to learning from patient safety
  • Proportionate and considered responses to patient safety
  • A constructive oversight that is aimed at improving the performance and quality of response systems.

This policy is also designed to support the development of a new culture by ensuring appropriate training requirements set by NHSE compliance are met on human factors and systems approach in dealing with patient safety incidents. This will identify what needs to change (the changes need to be recorded and followed up in the system) to improve patient safety.

Executive summary
This PSIRF framework requires providers to implement new procedures, processes and systems in place to make sure that there in a culture where the greater focus is on improving and learning from incidents and a system in place where there is a better use of data using human factors to identify the improvement areas.

Scope of PSIRF
We identify that there are numerous ways to respond to any incident. This document will cover our approach to a response plan which is solely based on identification of systems- based improvement opportunity and learning. There is no remit within our PSIRF policy to create a blame culture or determine liability, prevention or identify cause of health safety incidents that take place. We strictly enforce and reinforce a ‘just culture’ and hold professional accountability for staff/patients/family members/care takers who use our service.

It is outside the scope of PSIRF for anybody to have a power to review situations in respect of complaints, HR issues, legal claims and inquests – which must be followed through relevant guidance and policies.

This policy describes the potential for systems - based learning from patient safety incidents. We will select incidents for review from sequelae aligned with nationally and locally defined patient safety priorities, which is detailed in the analysis later in this document.

System overview of The Hearing People
We have mapped our local system to see who works on patient safety activities throughout the company and what systems and mechanisms are in place to support them. All patient safety activities have been reviewed and close engagement with our network, including GP’s, pharmacists and audiologists, has taken place. The company consists of a Corporate Directorate. The company consists of a Corporate Directorate. The structure is led by a Chairman, with roles including the Chief Financial Officer (CFO), the Managing Director (MD), and a Non-Executive Chairman. The core Patient Safety Team is led by Head of NHS Services and supported by NHS Area managers, Quality and Governance Team, Clinical Effectiveness Team and the Legal Services Team.

The core patient safety activities we undertake are:

  • Patient Safety Strategy
  • Incident Response Framework in Patient Safety
  • Risk Management and Risk evaluation
  • Central Alert System (CAS)
  • Quality Improvement
  • Swarm Huddles
  • After Action Reviews

Another internal activity that informs patient safety is Structured Review meetings which takes place every month, Learning from incidents, complaints and feedback, legal claims and inquest responses.

A local governance and leadership team supports each ICB area with local expertise and advice on patient safety matters supported by the Corporate Team.

This new system has been designed to meet the needs of our patients, our services, and the structures in which we operate. This involves all key people & teams within the company who play an essential role in making our patient safety system, and our patient safety culture, a reality. This is not a static system, and our approach is to evolve and adapt further as we start our PSIRF journey.

Where the primary objectives of other processes diverge from those of a patient safety incident response they will be considered outside the remit of this policy, for example:

  • Complaints (No incident raised)
  • Professional standards investigations
  • Coronial inquests
  • Criminal investigations
  • Claims management
  • Financial investigation and auditing,
  • Safeguarding Incidents covered under Section 42 of the Care Act 2014

The information produced in a patient safety response process can be given over to those managing other forms of response – but there should be no impact from other processes on the remit of a patient safety incident response.

2. Responsibilities

a) The overall responsibility for ensuring implementation and PSIRF standards are met is the senior management. The Senior management comprising of Head of NHS Services supported by Managing Director are responsible and accountable for effective patient safety incident management. This includes supporting and participating in cross system/multi-agency responses and/or independent patient safety incident investigations (PSIIs) where required.

b) The PSIRF Executive lead (Learning Response lead) is the Head of NHS Services with the delegated following responsibilities:

  • Ensure the company meets the standards expected by the PSIRF.
  • The PSIRF Executive Lead, supported by the management, will oversee the development, review and approval of this policy and plan for patient safety incident response, ensuring that expectations set out in the patient safety incident response standards are met
  • Ensure that the PSIRF is central to the company’s overarching clinical and quality governance arrangements
  • Provide quality assurance and oversight of learning response to the management and Quality Assurance Committee
  • Ensuring the management has access to relevant information about the company’s preparation for and response to patient safety incidents, including the impact of changes following incidents. It is the PSIRF Executive Lead’s responsibility to ensure:
      • patient safety incident reporting and response data, learning response findings, safety actions, safety improvement plans, and progress are discussed at the Quality Governance Committee.
    • roles, training, processes, accountability, and responsibilities of staff are in place to support an effective response to incidents.
  • Ensure that mechanisms for the ongoing monitoring and review of the patient safety incident response plan, delivery of safety actions and improvement forms part of the overarching quality governance arrangements and that it is supported by clear financial planning to ensure appropriate resources are allocated to PSIRF activities and safety improvement.
  • Ensure the management will monitor the balance of resources going into patient safety incident response versus improvement. Repeat responses should be avoided when sufficient learning is available to enable the development and implementation of a safety improvement plan.
  • Ensure updates to the PSIRF policy and plan are made as required as part of regular oversight processes and that overall review of the patient safety incident response policy and plan will be undertaken within 12- 18 months, alongside a review of all safety actions
  • Ensure appropriate levels of training are delivered across the company, dependent on the roles assigned within the framework:
    • Level 1 - Essentials of Patient Safety, and 
    • Level 2 - Access to Practice
  • Quality assures learning response outputs - a final report should be produced for all individual PSIIs, and this reviewed and signed off as complete. The PSIRF Executive Lead is responsible for reviewing PSII reports in line with the patient safety incident response standards and signing off as finalized on behalf of the management. They may be supported by another executive colleague, Managing Director or subject matter expert.

Learning Response Lead (PSIRF Executive lead)
The Head of NHS Services, will serve as the Learning response lead. They will lead a learning response to a safety incident using system- based approaches to capture learning to inform safety actions for improvement and will:

  1. Be fully compliant with the relevant National PSIRF training requirements prior to undertaking any PSII
  2. Communicate developments and progress with the PSIRF, including any consultation exercise to respective corporate committees/groups
  3. Keep up to date with PSIRF developments and participate in local and national network meetings
    Participate in PSIRF learning and development events as a presenter or facilitator or attendee.

Patient Safety Group
The purpose of this group is to seek assurance on the implementation of patient safety arrangements in compliance with clinical best practice, regulatory and statutory requirements, and internal risk management and governance processes. This group will track the implementation of safety improvement plans.

Area Managers will:

  1. Foster an environment in which staff are encouraged to report incidents and discuss them constructively and openly. They will also serve as Risk managers and would be tasked to review patient safety incidents and gather further information required in relation to the incident reporting and investigation policy
  2. Refer to the Duty of Candour and Being Open policy to ensure requirements are met
  3. Escalate any incidents of concern (no and low harm incidents as well as moderate harm and above) to the PSIRF executive team.

Quality Assurance Committee (QAC)

This committee oversees all areas of patient safety from subgroups Committee which consists of Managing Director, Head of NHS Services, and the Quality and Compliance Officer.
The committee also provide assurance to the Board of Directors on the continuous and measurable improvement in the quality of services through the following key areas:

  • Patient safety and clinical risk
  • Clinical audit and effectiveness
  • Patient experience
  • Health and safety, and
  • Quality improvement
  • They report to the directorate board.

All staff
All staff have the responsibility to:

  • Report incidents in accordance with the company’s incident reporting policy and actively participate in PSIRF learning and development as required.

The following committees/groups oversee patient safety

  • Quality and Safety meetings
    Quality and Safety is a regular agenda item on the Governance meetings, providing assurance to the management on all matters relating to patient safety and risk, patient experience, clinical effectiveness, and quality improvement.
  • Incident Safety Huddle (ISH)
    The group provides bi-weekly incident governance and oversight, or when required. These incident review meetings are led by the Head of NHS Services, and Area Managers. It reports trends, learning and new investigations monthly to the company’s Quality Assurance Committee (QAC).
  • Integrated Care Board (ICB) and partnership working
    The company will keep ICB updated and review patient safety incidents in a timely manner.

3.  Definitions

THP

The Hearing People

NHS     

National Health Service

PSIRF   

Patient Safety Incident Response Framework 

ICB        

Integrated Care Board 

RIIT       

NHS England Regional Independent Investigation Team
 

PSIRF Incident Response plan
The companies ‘s local plan sets out how PSIRF will be carried out the locally including the list of priorities. These have been developed by analysis of local data, consideration of other safety priorities and consultation with stakeholders.

Patient Safety Incident Investigation (PSII)
A PSII is an in-depth investigation undertaken when an incident or near-miss indicates significant patient safety risks and potential for new learning. A PSII investigation uses the Systems Engineering Initiative for Patient Safety (SEIPS) framework to understand outcomes within complex systems and which can be applied to support the analysis of incidents and safety issues more broadly. Investigations explore decisions or actions as they relate to the situation. The method is based on the premise that actions or decisions are consequences, not causes, and is guided by the principle that people are well intentioned and strive to do the best they can.

4.  Policy specific content

a) The Hearing People's Safety Culture
The company is committed to creating an open and fair culture in which staff members are confident about reporting incidents and near misses. Evidence suggests that by creating a fair reporting culture, organisations can improve their ability to learn when things go wrong and improve patient safety.

In addition, the company has three Freedom to Speak Up Guardians and Speak Up Advocates, to support staff to highlight safety concerns and a Restorative culture.

b) Addressing Health Inequalities
The company recognises the importance of reducing the health inequalities of the population that are served by the company by ensuring services are designed around the needs of the local population, ensuring equality of access.

Under the Equality Act (2010), as a public authority, the company has statutory obligations for which there is commitment to deliver on. Data which identifies any possible patient safety risks or incidents which disproportionately affect certain cohorts of the population will be proactively gathered and analysed.

The company is committed to supporting effective communication by compliance with the Accessible Information Standard alongside use of supportive tools such as easy read, translation, and interpretation services. The companies’ Learning Response Leads and will engage with patients, families, and staff following a patient safety incident, for inclusion.

c) Engaging and involving patients, families and staff following a patient safety incident
Under the PSIRF there will be greater engagement with those affected by an incident, including patients, families, and staff ensuring they are treated with compassion and able to be part of any investigation.

Replacing ‘Being Open’ as the national standard for engaging those affected by a patient safety incident, the NHSE guidance ‘Engaging and involving patients, families and staff following a patient safety incident, 2022’ details advice on how to involve patients, carers, and staff in the incident response process. Aligned with this guidance, the company will ensure compassionate engagement and involvement through a process that enables patients, families and healthcare staff to contribute to a learning response and develop a shared understanding of what happened and potentially how to prevent a similar incident in the future. THP is committed to doing this.

d) Duty of Candour

The current Duty of Candour policy and practice legislation requires the company to ensure that when things go wrong which cause in moderate, severe harm, or death, patients and their families are informed. The company is currently required to:

  • Notify the patient in person that a notifiable safety incident has occurred and apologise.
  • Provide an account of all the facts known about the incident.
  • Advise the relevant person what further enquiries into the incident are believed to be appropriate.
  • Provide an offer of reasonable support to the patient.
  • Document the above in writing.
  • Follow up with a written notification confirming information provided and containing results of further enquiries (i.e. outcome or findings of any investigation) and apology.

Whilst previously under the Serious Incident Framework, a distinction was made between serious incidents and all other incidents, PSIRF seeks to cover all incidents which caused, or had the potential to cause harm with the focus on opportunities for learning. This change in approach will require careful communication and engagement with staff, patients, and their families to explain the reasons why an incident, which would have required an investigation previously, may not on this occasion be carried out, as other tools for learning will be adopted instead.

e) Patient Safety Incident Response Planning
The PSIRF enables the company to respond to incidents and safety issues in a way that maximises learning and improvement, rather than basing responses on pre-defined definitions of harm. Beyond nationally set requirements, the company will explore patient safety incidents relevant from the perspective of a local context, around the population which the company serves.

f) Patient Safety Incident Response Plan

The Patient Safety Incident Response Plan sets out how the company intends to respond proportionately to patient safety incidents, this will be reviewed every 12-18 months or more frequently as required to reflect changes in the company or patient safety priorities.

In developing and reviewing the plan, the PSIRF Implementation Group included key internal and external stakeholders to identify the company’s patient safety incident priorities.

g) Reviewing our patient safety incident response policy and plan

This covers how the company intends to respond to patient safety incidents over a period of 12 to 18 months however both the policy/ plan will be reviewed regularly at the Patient Safety Group to ensure efforts continue to be balanced between learning and improvement. This more in-depth review will include reviewing the response capacity, mapping the services, a wide review of organisational data (for example, patient safety incident investigation (PSII) reports, improvement plans, complaints, claims, inequalities data, and reporting data) and wider stakeholder engagement.

h) Responding to Patient Safety Incidents
Patient safety incidents are any unintended or unexpected incident which could have, or did, lead to harm for one or more patient’s receiving healthcare. The company is committed to creating an open and fair culture in which staff members are confident when reporting incidents and near misses. There is a clear procedure for reporting incidents, exploring and understanding the circumstances leading to events, and recording learning as well as monitoring processes which are set out in the incident reporting policy.

i) Patient safety incident reporting arrangements
All patient safety incidents will be recorded on the PSIRF log.

j) Patient safety incident response decision-making
The PSIRF supports the company to respond to incidents in a way that maximises learning and improvement rather than basing responses on arbitrary and subjective definitions of harm.

  • Quality and Risk Managers within each ICB area will review reported incidents and escalate any incidents of concern.
  • The Patient Safety Team will review incidents reported on the PSIRF log to agree the type of response required. This may include a learning response, patient safety incident investigation (PSII) or local management.
  • Incident Safety Huddle (ISH) group will discuss and agree the response to incidents, based on the following options described in the PSIRF and plan:
    • Contributory (system) factors not well understood - learning response indicated. These are aligned with the PSIRF toolkit for types of learning response.
      Safety issues well understood and/or improvement plans are in place and robust – consider not undertaking an investigation as no additional learning is likely to be identified
    • Unclear whether a learning response is required – the group will discuss and agree response based on information provided and opportunity for learning / improvement or present to the ISH for a decision
    • When potential patient safety incidents are identified through the complaints, clinical negligence or, learning from serious incidents reviews, or Legal Services teams, an incident review will take place and escalated as appropriate, for discussion and consideration at the ISH.
    • Resources will be allocated to support responses to emergent issues not included in the patient safety incident response plan on a case-by-case basis.

k) Hot Debriefs
Hot debriefs are short, focused discussions held immediately after an incident or near miss. They aim to capture initial perspectives and identify immediate actions to mitigate risks. The goal is to gather initial insights and facilitate prompt learning. 

Examples of when to conduct a Hot Brief:

  • After cardiac arrest/resuscitation
  • Following major trauma or critical deterioration
  • After patient death
  • After clinical errors or near misses
  • Following escalated conflict or aggressive incidents

Procedural steps:

  1. Identify the trigger – prompt debrief immediately after an event
  2. Assign a facilitator – Learning Response Lead
  3. Create a safe space – briefly check that all are ready and willing to participate
  4. Use a simple framework
    • What happened? 
    • Were there gaps in care? 
    • Could processes be improved? 
    • What immediate actions can be taken? 
  1. Record key themes – note learning points, ideas for improvement
  2. Escalate insights if needed – If serious issues arise, refer to formal PSIRF process

l) Swarm Huddles
Swarm huddles are a rapid response to a patient safety incident, involving staff "swarming" to the site. Swarms encourage prompt reflection and learning from incidents. 

Examples of when to use a swarm huddle:

  • Unexpected patient deterioration or death
  • Medication error or near miss
  • Falls, pressure ulcers, or safety breaches
  • Equipment failures impacting patient care
  • Escalation delays or communication failures

Procedural steps:

  1. Trigger identification – Incident occurs and staff or manager activates a swarm
  2. Gather core team – Include all involved disciplines
  3. Designate a facilitator – ISH, and QAC where necessary
  4. Set ground rules – "No blame, just facts", confidentiality, mutual respect
  5. Use a structured format
    • What happened?
    • What were the contributing factors?
    • What worked well?
    • What could have gone differently?
    • Are there any immediate changes or escalations needed?
  1. Document key learning – Note only themes, immediate actions, escalation needs
  2. Feedback & follow-up – Communicate outcomes to staff and governance

m) After Action Review (AAR)
AAR is a structured discussion focused on understanding the differences between expected and actual outcomes of an event. AARs can be applied to both positive outcomes and incidents, fostering shared learning among multidisciplinary teams. 

Procedural steps:

  1. Identify events for AAR – e.g. unexpected outcomes
  2. Assign a trained facilitator – Quality and Compliance team
  3. Gather the right participants – multidisciplinary staff directly involved in the event
  4. Use a structured format
    • What was expected? 
    • What actually happened? 
    • What was the difference? 
    • What is the learning?
  1. Document key learnings – record themes, learning points, and potential improvements
  2. Share and act on learning – disseminate key insights and implement any agreed changes
  3. Evaluate impact – monitor whether changes lead to improved safety or processes

n) Responding to Cross-System Incidents/Issues

  • The company has designed an oversight process in collaboration with stakeholders like GP practices and pharmacies where we operate our clinics to enable the company to demonstrate improvements in patient safety.
  • Local teams within each area will identify cross-system incidents or issues as they occur and escalate to the ISH for consideration.
  • Identified incidents presenting potential for significant learning and improvement for another provider will be sent directly to that provider’s patient safety team or equivalent. Where required, summary reporting can be used to share insight with another provider about their patient safety profile.
  • The Patient Safety Team will act as the liaison point for such working and will have supportive operating procedures to ensure that this is effectively managed.
  • All multi-agency incidents and those representing significant learning potential for the region or nationally, including all incidents of mental health related homicide, will be discussed with the RIIT (NHS England Regional Independent Investigation Team).

o) Timeframe for Learning Responses

  • Timescales should be set where possible, with a response being started as soon as practicable after an incident is identified. It should usually be completed within one to three months and no longer than six months, depending on the type and complexity of the incident.
  • The timeframe for completing a PSII should be agreed with those affected by the incident and this will form part of the terms of reference for the local response.
  • Should local responses undertaken by the company take more than six months or exceed the timeframes agreed, then the company will review the processes being followed to understand how timeliness can be improved.
  • In exceptional circumstances such as when a partner organisation requests an investigation to be paused, a longer timeframe may be needed to respond to an incident, and this will be agreed with all parties involved in the investigation.
  • Where external bodies or those affected by patient safety incidents, cannot provide information to enable the company to complete enquiries into an incident within six months or within the agreed timeframe, the learning response leads will work with the information, which is available, to complete the response to the best of their ability. Responses might be revisited if new information comes to light that indicates the need for further investigation.
  • The QAC will monitor timescales and progress of PSIIs and other learning responses.

p) Safety Action Development and Monitoring Improvement
The company will use the process for development of safety actions as outlined by NHS England in the Safety Action Development Guide (2022)

It will ensure that systems and processes are in place to design, implement and monitor safety actions. This will be part of the process of any learning response which might result in the identification of the company’s systems where change could reduce risk or potential harm.

Best practice advises that learning responses should not describe recommendations as this can lead to premature attempts to devise a solution. Any safety action devised in response to a defined area for improvement will be dependent on factors and constraints that sit outside of the scope of a learning response. Where needed an external subject matter experts in the area will be involved in the process.

q) Safety Improvement Plans

Safety improvement plans bring together findings from various responses to patient safety incidents and issues.

The company has in place:

  • A company-wide safety improvement plan summarising improvement work
  • Individual safety improvement plans that focus on a specific service, pathway or location
  • A system to review output from learning responses to single incidents when it is felt that there is sufficient understanding of the underlying, interlinked system issues
  • A safety improvement plan for broad areas for

Plans will be revised in response to any new learning, so they represent the latest and best approach to dealing with a particular patient safety issue. This includes revising improvement plans where evidence indicates that measures are not having the anticipated impact.

r) LfPSE
We are registered with LfPSE for reporting safety incidents where appropriate.

s) Making a complaint
A complaint can be made:

In person – Any staff member can receive a complaint

5.  Effectiveness criteria

To evidence compliance with this policy, the following elements will be monitored. 

What areas need to be
monitored?		 How will this be
evidenced?		 Where will this be reported
and by whom?
The document has been formatted to the agreed document template. Reviewing the policy. Document master list/QMS, Quality and Compliance Officer
This policy details the governance and oversight arrangements for the PSIRF framework

Operational oversight will be led by the ISH group, strategic oversight by QAC.

Various methods, such as incidents and harm levels, measures of learning and improvement and reduction in harm to patients.

Weekly oversight by ISH, Bi-monthly reporting to QAC. Annual review of PSIRF plan and priorities.

ISH – operational. QAC – Strategic.

The PSIRF standards have defined the competencies required for individuals leading on the implementation of PSIRF. All staff leading on the learning responses or being engagement leads or those with oversight roles will have undertaken the PSIRF stipulated training programmes. Resources have been allocated for this training which will be recurrent to meet need.

7. Appendix 1 – PSIRF process for reporting and escalating patient safety incidents

 
 
 
 
 
 
 
 
 
Patient Safety Incident Occurs
Immediate actions taken by staff
member to ensure patient/staff safety
  • Care for affected individuals
  • Mitigate ongoing risks
  • Report to their line manager via
    Teams call, and
  • Send a follow up email to the
    Patient Safety Group email address
The Patient Safety Group will
  • Complete the initial triage – does it
    meet PSIRF criteria? If ‘Yes’ log the
    incident in the PSIRF log
No
Yes
Manage through local reporting
process
PSIRF response planning with the
relevant teams involved
  • Learning Response Lead
  • Patient Safety Group
  • Quality Governance and Assurance
    Committee
The Learning Response Lead will
decide the best response, e.g. AAR, SII,
whilst keeping the other teams
regularly informed
The Quality Governance and
Assurance Committee will review
findings, and ensure the relevant
parties are kept up to date with
proceedings
  • Engage with patients, families and
    staff
  • Duty of candour
Share learning via governance, staff
meetings, reports, and externally (ICB,
LfPSE, UKAS)
Translating learning into
improvement
  • Implement Improvement Actions
  • Monitor progress
  • Evaluate effectiveness
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