Self-help guide
What is the PSIRF?
The Patient Safety Incident Response Framework (PSIRF) is the way in which anyone who provides services under an NHS contract is expected to respond to patient safety incidents.
It is important to know that the investigation and subsequent report are prepared for the purpose of learning and improving — not for the purpose of identifying whether the care provided was of an acceptable standard.
PSIRF sets out how certain NHS organisations should respond to a patient safety incident. There are four phases to a PSIRF investigation:
- planning,
- information gathering,
- synthesis, and
- interpreting and improving.
When will the PSIRF be introduced?
The PSIRF should be used whenever a patient safety incident is investigated, but it is important to note not all patient safety incidents will be investigated under this. The PSIRF investigation process was to have been put in place by autumn 2023, however at the time of writing this guide (February 2024) it appears that some NHS providers are still in the process of adopting it.
Where the patient safety incident meets the definition of a notifiable patient safety incident, it should be dealt with by following the duty of candour.
Who does the PSIRF apply to?
Anyone who provides services under an NHS standard contract must adopt the PSIRF. That includes providers of acute care, ambulance services, mental health, and community healthcare providers. The PSIRF also applies to maternity and specialised services, although when it comes to maternity investigations other frameworks such as the Maternity Newborn Serious Investigations (MNSI) process may be used instead of PSIRF.
It should be noted that the MNSI only investigates certain types of maternity incidents, details of which can be found on their website. If an incident does not meet the MNSI investigation criteria, the PSIRF may then apply.
Primary care providers can adopt the PSIRF if they wish to, but they are not required to do so. A primary care provider is a service which provides the first point of contact in the healthcare system, sometimes referred to as the “front door” of the NHS. GP services, community pharmacy, dental, and optometry (eye health) services are typical examples of a primary care service.
The duty of candour
Regardless of whether a patient safety incident occurs which is to be investigated under the PSIRF or any other investigation such as MNSI, providing the patient safety incident is considered a “notifiable safety incident”, the duty of candour must always be followed.
Commonly asked questions
Q: Who does the duty of candour apply to?
A: The duty of candour applies to every health and social care provider regulated by the Care Quality Commission (CQC).
Q: What is the duty of candour?
A: To be open and transparent with the patient (or their family/loved ones) when a notifiable safety incident has occurred. Reasonable support should be provided and a written record of the incident should be sent to the patient including an apology (often referred to as a duty of candour letter).
Q: What is a notifiable safety incident?
A: It is any unintended or unexpected incident which in the healthcare professional’s opinion could, or appears to have resulted, in the service user’s death, severe or moderate harm, or prolonged psychological harm.
Q: When does the duty of candour apply?
A: The duty to be open and transparent applies as soon as practicable after the healthcare provider becomes aware that a notifiable safety incident has occurred. See above for definition of a notifiable safety incident.
Q: What information should be included in a duty of candour letter?
A: A duty of candour letter is the written notification provided by or on behalf of the healthcare professional treating the patient about the notifiable patient safety incident which occurred. The letter should contain or be followed up with correspondence which:
- provides a true written account of all the facts known to the health service body at the time they notify the patient in writing,
- explains what further enquiries are considered to be appropriate,
- includes an apology,
- provides details of any enquiries to be undertaken, and
- provides the results of any further enquiries into the incident.
The serious incident reporting (SIR) process
Under the previous serious incident reporting (SIR) process, an investigation would be carried out when a recognisable trigger occurred. The triggers were that there had been:
- an unexpected or avoidable death,
- an unexpected or avoidable injury resulting in serious harm,
- a ‘never event‘, or
- an allegation of abuse.
Any patient safety incident which could be categorised as one of the above gave rise to a serious incident investigation. The SIR process sets out when and how to investigate a patient safety incident; PSIRF takes a different approach.
Have SIRs ceased?
Depending on when your incident occurred, an SIR may still be underway. If the patient safety incident occurred after autumn 2023n the investigation is likely to fall under the PSIRF. All providers of NHS healthcare were expected to have adopted the PSIRF approach to patient safety by autumn 2023, but in practice some practices will be quicker than others to do so.
If the NHS provider has not yet introduced PSIRF, they will be using the old SIR model of investigations. The SIR is being phased out, so increasingly the patient safety investigation will be carried out according to the PSIRF.
What is the difference between a SIR investigation and the PSIRF?
The PSIRF differs from SIR in that it is much more flexible. PSIRF investigations do not occur because an incident triggers the need for an investigation — rather, the investigation is introduced because it is required to establish learning and improvement. This means that not every patient safety incident will be subject to an investigation under the PSIRF. If a trust believes it know what went wrong and why this occurred, it may not investigate further.
What triggers the PSIRF?
The PSIRF is triggered by a patient safety incident. The PSIRF expects that where an incident has occurred, this will be explained to the patient and/or family, with a description clearly set out. Where an investigation is to take place under the PSIRF, the terms of reference should be discussed and shared with you. Please see below for more information on the terms of reference.
What is the PSIRF definition of a patient safety incident?
Patient safety incidents are any unintended or unexpected events (including omissions) in healthcare that could have, or did, lead to harm for one or more patients. Examples of such incidents include never events and deaths thought to be due to problems in care. Each patient safety incident will be considered against the facts and circumstances of the case.
It is important to note that the PSIRF uses the above definition of a patient safety incident, whereas the duty of candour applies in cases where a “notifiable safety incident has occurred”.
Why has the PSIRF been introduced?
The PSIRF has been designed to enable organisations to use their incident response resources for improvements, “rather than repeatedly responding to patient safety incidents based on subjective thresholds and definitions of harm”. The PSIRF enables NHS trusts and others to take a “proportionate approach to responding to patient safety incidents”
But what does this mean in practice for members of the public who are concerned that a patient safety incident has occurred? There is no one easy answer to this question — under the PSIRF, each NHS trust is responsible for its own patient safety response process, including what to investigate and how. Please see the paragraph below, When is a PSIRF investigation carried out?
What can I expect from the PSIRF?
The framework aims to prioritise compassionate engagement and involvement of those affected by patient safety incidents. This principle applies to NHS staff as well as the person or patient to whom the incident occurred, their family, close relations, partners, siblings, children, guardians, carers, and anyone else with a direct and close relationship to the patient.
The PSIRF recognises the following aspects:
- Needs: That people who have been affected by a patient safety incident may have a range of needs, including clinical needs as a result of the incident. These must be met where possible.
- Engagement: This enables the NHS understanding of what happened and potentially to prevent a similar incident in the future. Engagement describes everything an organisation does to communicate with and involve people affected by a safety incident in a learning response.
- Support: Compassionate engagement and involvement include providing practical advice. Support in this context requires staff to consider if the person affected and their family have the correct support mechanisms available to them. If they do not, they should be referred or signposted to appropriate agencies or groups.
Support can mean assistance or comfort which aims to assist people in coping with a variety of issues according to their individual needs. Support is broadly interpreted and may mean physical/psychological support, information, and advice or advocacy needs. Support can be provided in a variety of ways:
- by the healthcare provider,
- by the person’s own family, friends, or networks,
- by independent organisations, or
- by individuals specialising in different forms of support.
The framework is also committed to preventing the harm being compounded through the investigation process. Compounded harm is not defined, but includes things like additional harm caused by potential erosion of trust in the organisation and a feeling that the duty of care has been removed.
The core principles of the PSIRF
There are nine core principles in the PSIRF, which are flexibly applied. They are flexible because the extent to which they apply will vary according to the different needs of the individuals affected. The core principles are:
- Apologies are meaningful.
- Approach is individualised. The approach should be adapted to reflect an individual’s changing needs whether practical, physical or emotional.
- Timing is sensitive. This means you can expect the level of engagement to reflect the needs of the person affected.
- Treatment of person raising concern. Those affected must be treated with respect and compassion.
- Guidance and clarity are provided on the investigation process. This means explaining what a patient safety incident is, why it is being investigated, or what the learning response entails. All communication should be clear, describe the process and its purpose, and not assume any prior understanding.
- Those affected are heard. This is about being listened to and providing the opportunity to share your experience
- Collaboration. Approach to the investigation is collaborative and open.
- Subjectivity is accepted. This is about acknowledging that different people will experience the same incident in different ways — no one person’s experience should be prioritised over anyone else’s, and sources of information should be viewed as credible.
- Strive for equity. Recognising that an appropriate response for a family may be different to what an organisation or member of staff considers to be appropriate, the need to learn from an incident should be weighed against the needs of those affected by the incident.
When is a PSIRF investigation carried out?
The PSIRF applies when a patient safety incident has occurred, but this does not mean an investigation will automatically follow. An investigation is more likely to take place if it will provide learning and an opportunity for improving systems. It will depend on the nature of the incident and what is known about it. Not every patient safety incident will have an investigation, but the organisation must be able to say why it has decided to investigate or not.
There may be times when other investigation processes, such as when an inquest is being held, where it might be more appropriate to see what is covered by the coroner’s inquiry before carrying out a PSIRF investigation.
If a PSIRF investigation is carried out, the organisation should:
- Be familiar with the facts of the incident. Where a family or staff member informs the organisation that something has gone wrong, they should be taken seriously.
- Explain the patient safety incident in appropriate language.
- Describe any immediate actions taken in response to the incident.
- Describe how the organisation intends to respond, advise if a learning response is planned, whether improvement work is already underway, and whether a review will be conducted to understand if further learning is required.
What you can expect if there is a PSIRF investigation
Where an investigation is to be carried out, the organisation should:
- notify you that this has been triggered,
- ask you if you need any particular support,
- explain and provide information about the process (you should also be given an opportunity to ask any questions about the process),
- give you the opportunity to set out your concerns and queries,
- Give you a copy of the terms of reference (you should be given a draft copy of the terms of reference and be able to comment on it),
- offer a suggested timetable for investigation and explain any likely delays,
- make time to answer any questions or concerns you may have and ensure everyone has an equal opportunity to engage in the process,
- Always apologise for the patient safety incident occurring at the earliest opportunity (meaningful apologies should be provided where appropriate; they should not be contingent on the outcome of any investigation which may take place), and
- Provide you with information on other redress, e.g. formal complaint.
About the PSIRF terms of reference
Where an investigation into a patient safety incident takes place, the nature and extent of the investigation should be clearly set out in writing and explained to the patient and/or their family. The terms of reference are important as they set out what the investigation will look at and identify the questions that need answering during the investigation.
The organisation should explain how the terms of reference were identified. You should have the opportunity to set out any questions not covered by the terms of reference which you think are relevant to the investigation.
How Avma may be able to help
Avma may be able to assist you with explaining the terms of reference and support you in identifying what issues the investigation should cover. We can also advise on the duty of candour and what is expected under the new PSIRF investigation system. If you would like assistance from us, please submit a case and one of our specialist workers will get back to you.