What are investigation reports – and how do they work?

When something has gone seriously during a birth, there may be an investigation. There are so many types of investigation report, however, that it can feel confusing. Maria Repanos and Elizabeth Maliakal of Hudgell Solicitors explain what you need to know if you find your birth is being investigated  

Healthcare providers are required to be open and transparent with patients and their families when things go wrong with their healthcare. This often comes in the form of an NHS investigation report. These include:  

  •  Patient Safety Incident Investigation reports

  • ·Root Cause Analysis reports

  • ·Serious Untoward Incident reports

  •  Serious Incident Investigation reports

  •  Patient Safety Incident Investigation reports

  •  Duty of Candour letter/reports

  • Health Services Safety Investigation Body (HSSIB) reports

  • Maternity and Newborn Safety Investigations (MNSI)

When there has been an adverse event or near miss threatening patient safety, NHS staff are required to record it on a system called Datix. This allows hospitals to collect data on recurring problems and learn from mistakes.

Where a baby has been born with a brain injury, the hospital is required to refer the circumstances of the birth to the NHS Early Notification Scheme (ENS) and prepare an Early Notification Scheme report. The purpose of the scheme is to investigate specific brain injuries at birth and to determine whether they have been caused because of negligence. The scheme does not include cases relating to stillbirth or maternal death.

All investigation reports now fall under the Patient Safety Incident Response Framework (PSIRF), which aims to promote a culture of learning and focusing on understanding why mistakes happen. 

Below we answer some commonly-asked questions about investigation reports.

What is an investigation report? 

Broadly speaking an investigation report will be prepared when the care and treatment provided is thought to have gone wrong. The decision as to which type of investigation is carried out is determined by criteria set by each organisation.

Who carries out an investigation?

This depends on the type of investigation:

  • An MNSI investigation is independent of the NHS. However, their reports are sent to the Hospital Trust where care was provided.

  • An Early Notification Investigation is carried out by NHS Resolution, the legal arm of the NHS.

  • Serious Untoward Incident reports or Root Cause Analysis reports are usually prepared by the Hospital Trust where the care was provided.

In what circumstances is an investigation report prepared? 

There is no definitive list of incidents that require an investigation report, but they are often prepared when there is an unintended or unexpected incident which could have, or did, lead to harm for a patient receiving healthcare. This could include an unexpected or avoidable death, or unexpected or avoidable injury.  

Since 2014 there has been a statutory duty, known as the duty of candour, which means that staff must be open and honest where lapses in care may have occurred during treatment resulting in moderate harm, severe harm or death.

Sometimes families are not made aware that an investigation report is underway. If you have concerns about the treatment you or a family member received, we recommend you approach the healthcare provider to ask whether an investigation is being undertaken, and if yes, to ask for a copy of the investigation report.

How long will an investigation report take to complete?

There is no set timescale for completing investigation reports. The healthcare provider should keep you informed about what stage the investigation is at and when they are likely to complete their report. Some reports can take time, depending on whether expert opinions are being sought from outside the healthcare setting, the number of clinicians involved in the treatment, the seriousness of any injury sustained and any resourcing issues.  

Why are investigation reports important?

Investigation reports can be useful to patients and their families to explain what happened during their treatment, why it happened, whether there were any lapses in care and what the healthcare provider intends to do to prevent future lapses in care.

The aim is to identify where treatment went wrong and to inform patients openly and transparently about such treatment, and where possible to learn from mistakes, improve treatment and patient safety and reduce avoidable harm across the NHS.  

Investigation reports can provide an explanation of where treatment went wrong and, where appropriate, an apology, but they do not lead to payment of compensation.

What can I expect from an investigation report? 

Most investigation reports will contain information about who prepared the report, a brief introduction, a description of the incident investigated, terms of reference, the scope of the investigation, a list of documents/information used to compile the report, a list of contributors, any information/involvement from the patient or their families, an analysis of the incident, a background and summary, findings, conclusions, recommendations and an action plan.

The healthcare provider should contact a patient or their family to invite them to be involved in the investigation into the care provided. The aim of an investigation report is not necessarily to blame healthcare professionals but to identify opportunities to learn. The report will not necessarily pick out the actions of any specific individual.

Sometimes there will be a decision not to complete a Patient Safety Investigation Report after an initial review by the hospital. Families and patients can ask why this decision was made.

Can I still complain and/or make a legal claim while an investigation is ongoing? 

Yes, you can.

If you’re making a legal claim, the outcome of the investigation will be relevant and important to the claim. Your solicitor may advise you that they will undertake their own investigations once the investigation report is available. The outcome of the investigation will be used as evidence in any claim.  

Even if the investigation report finds that there are no concerns about the standards of care provided, this shouldn’t stop you seeking legal advice if you think there were failings in care.

Similarly, you can still make a complaint. Investigations look only at standards of care, but you might want to complain about other issues, such as staff attitudes, discharge arrangements or levels of hygiene. 

What can I do if I don’t agree with an investigation report? 

While NHS investigation reports are informative and can be helpful, patients or their families may disagree with aspects of the report. Some patients or their families may be disappointed in the outcome of an NHS investigation report for several reasons including: the patient or family’s account was misunderstood; not all the relevant healthcare professionals involved in a patient’s treatment were included in the report; or the conclusions reached in the report are not accepted.

Sometimes patients and their families are not made aware of the investigation or are not involved in the investigation. They may feel the report is not robust either failing to be sufficiently objective or comprehensive.

In these circumstances we recommend that you put your concerns in writing to the author of the report and if you believe that avoidable harm has been caused by failures, that you seek legal advice. The Birth Trauma Association’s Trusted Legal Partners are happy to help you to understand the content of an investigation report and decide on your next steps.

You will not need to take any further action if you are satisfied with the outcome of the investigation report.

If you are unhappy with the outcome of the report or do not understand the contents, we recommend that you obtain independent legal advice at the earliest opportunity.

Hudgell’s are one of our Trusted Legal Partners. You can find out more about them here.  

 

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