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Press Round-Up: Regulatory and Professional Discipline – August and September 2025
Imogen Roberts
Where there has been a concern surrounding medical care at an NHS Hospital, an internal investigation may be carried out and a written report produced to assist with learning from the incident. From a patient perspective, the report can be helpful in understanding more about the event and what, if anything, went wrong.
Such incident reports have been given different names over the years. Some people will have heard of terms such as Root Cause Analysis Report (RCA), Serious Incident Report (SIR) and Serious Untoward Incident Report (SUI). However, in 2022, a new framework was introduced in relation to patient safety (Patient Safety Incident Response Framework – PSIRF) and an internal investigation into a safety incident is now known as Patient Safety Incident Investigation (PSII).
Here I look at some key questions about internal NHS investigations that may help those who are concerned about their care and are considering a legal claim for medical negligence.
Will there be an investigation?
According to the PSIRF the definition of a patient safety incident is: ‘unintended or unexpected incidents (including omissions) in healthcare that could have or did lead to harm one or more patients’.
It is noteworthy that safety issues within NHS Trusts can be reported by staff using a web-based system called DATIX. Following an event being highlighted, the relevant NHS Trust will then decide whether an investigation is necessary.
An investigation does not have to be undertaken every time there has been an apparent problem with patient care - even where there has been a serious incident and a patient has been harmed. The PSIRF does not prescribe what types of incidents must be investigated. Instead, Hospital Trusts have to make decisions based on local and national priorities. However, there are some events which 'require a specific type of response as set out in policies or regulations'. For example, according to NHS England guidance, incidents meeting the Never Events Criteria require a PSII.
What should I expect from a PSII?
If there is an internal investigation, the Hospital Trust should contact the patient or their family to enable them to be involved in the process. They may invite the patient to a meeting to discuss the incident. They should explain the process of the investigation, who is leading it, and provide a timeframe for when they expect to complete this and provide a report.
During an investigation there usually will be a review of the relevant medical records and statements may be taken from members of staff.
Where something was found to have gone wrong, the Hospital Trust must be upfront with patients – they have a duty of candour.
Will an investigation report help me to bring a clinical negligence claim?
The PSII report template provided by NHS England sets out that ‘PSIIs focus on improving healthcare systems; they do not look to blame individuals’.
It is important to realise that if an internal investigation report finds failings or problems with medical care, it does not mean that any such failings will necessarily meet the legal standard for medical negligence. Equally, if a report does not identify failings in care, this does not necessarily mean that no legal claim for negligence can be made. The reports invariably do not deal with what is needed to prove a compensation claim – as this is not the purpose of them. They do not use phrases such as “breach of duty of care”. They often fail to deal with what might have happened if the adverse event had not occurred. We see reports which frequently use expressions such as “… but it is not known if the outcome would have been different”.
Without doubt an investigation report can be a very helpful and important document if you are considering a legal claim for compensation. The specialist clinical negligence team at Kingsley Napley will be able to assist with reviewing the report and advising as to whether there may be a case. Such reports are often key evidence when assessing the potential for a claim. Time limits exist in clinical negligence claims and therefore it is important to seek legal advice as soon as possible.
We assist our clients to understand any internal investigation processes that are ongoing once we are instructed. It is also worth noting that an internal investigation report can be particularly important once a claim is underway since it may provide helpful evidence to be considered by medical experts.
If you have received an internal investigation report in relation to your medical care, or that of a loved one, and are seeking advice, please contact our team of specialist lawyers.
About the author
James is the head of our Medical Negligence and Personal Injury practice and joined the firm in 2023 from Hodge, Jones & Allen. He has undertaken medical negligence and personal injury cases for over 30 years.
We welcome views and opinions about the issues raised in this blog. Should you require specific advice in relation to personal circumstances, please use the form on the contact page.
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