Clinical Negligence

FAQs on Healthcare Safety Investigation Branch reports and the Early Notification Scheme

The Healthcare Safety Investigation Branch (HSIB) is an independent organisation funded by the Department of Health and Social Care which investigates standards of medical care in the NHS in England. Set up with the objective of improving patients’ safety, it is responsible for investigating and reporting on, among other things, safety concerns in relation to maternity incidents from 1 April 2018.

In order to accept a referral for a maternity investigation, HSIB needs to establish that the circumstances fall within the criteria taken from the Royal College of Obstetricians and Gynaecologists initiative Each Baby Counts which aims to reduce injuries that may in part have been caused by the standard of maternity care provided.

To be covered by the criteria for investigation, the baby has to have been born following labour at full term (meaning 37 + 0 weeks) where there has, very sadly, been:

  • a stillbirth;
  • an early neonatal death within the first week;
  • a baby who has been born with a potentially severe brain injury, diagnosed within seven days of life.

There are separate provisions relating to a maternal death investigation.

Once accepted, the HSIB maternity investigation team will review the incident using a number of sources. It will examine the medical records, cross-check and consider guidelines and protocols (both specific to the hospital and on a national level), interview staff and family members and also seek input from advisers where necessary.

The report will usually take between four and nine months to complete and then be sent, in draft form, to the family, trust and staff involved in the incident to ensure accuracy. It will not be published.

The investigation and report are independent, and therefore not specifically prepared for the benefit of the family or the trust. The main body of the final report will set out the facts, as found by HSIB, as to what happened prior to and during labour, delivery and following birth. There will be a section discussing key events and setting out findings and, if appropriate, making safety recommendations. Even if safety recommendations are not made directly, it is expected that the trust will review the findings and seek to implement areas of improvement.

HSIB confirms that although the report is not published, it will be used to identify themes and opportunities to improve systems and patient safety and avoid birth injury. A range of 'learning reports' have been published and can be found on the HSIB website.

In contrast the Early Notification Scheme (ENS), operated by NHS Resolution (formerly the National Health Service Litigation Authority), also investigates the circumstances where a birth injury has been sustained but does this, primarily, to assess if it will be responsible for paying compensation/damages. The documents produced in this internal investigation will be confidential and will not be disclosed.

The specialist birth injury team at Penningtons Manches Cooper regularly helps families who need to decide if they should agree to an investigation by the Healthcare Safety Investigation Branch when something has gone wrong around the time of birth. Our responses to some of the questions typically raised are set out below:

My baby was very unwell when she was born and we have concerns about the care provided. We have been asked if we will agree to an HSIB investigation. What does this involve? 

HSIB will undertake an independent investigation of the maternity care. Its aim is to learn and improve healthcare safety. A report will be prepared which will set out the facts, provide comments (findings) and can make safety recommendations. Where there appear to be systemic failures at a trust, HSIB investigators will be able to ask probing questions about them. The answers may not be so easily uncovered in an investigation undertaken by the trust which already has an understanding of how its processes work. HSIB can help to identify areas for improvement both at the trust in question and more widely.

Why has HSIB chosen to investigate our treatment?

It is likely that the hospital trust has referred your case. It is under an obligation to do so if, among other things, your baby was over 37 weeks and born with a potentially severe brain injury, and was:

  • diagnosed with grade III hypoxic ischemic encephalopathy (HIE);
  • therapeutically cooled; or
  • had a decreased central tone, was comatose and had seizures.       

Should we agree to the report?

It is up to you if you wish to agree to the report. The investigation cannot take place without your agreement, but many families think it is helpful to co-operate with the investigation and also want to do anything they can to stop a similar event happening to others.

The report will set out the facts as known based on the medical records and interviews with the staff and family and this can be helpful when you are trying to understand and obtain an explanation about what happened.

There will be an analysis of the information obtained including acknowledging where trust and national guidelines have not been followed and where safety issues have been identified. The report will acknowledge good practice as well.

You will be given an opportunity to review the draft report to comment on accuracy but, as this is an independent report, you cannot guarantee the conclusions will support the concerns that you may have about the cause of the birth injury.

Some clients involved have reported feeling reassured that an unbiased investigation has taken place because it has been undertaken independently.

What happens to the report after it has been completed?

When the report has been finalised, it will be sent to you and to the trust and it is hoped that the trust will act on any findings and safety recommendations. Themes from individual reports are included in learning reports and information distributed nationally to improve patient safety.

How does the Early Notification Scheme fit into the investigation? 

There is a separate Early Notification Scheme (ENS), set up in December 2017, which required a trust to notify NHS Resolution of a maternity incident 'with the potential to become a high value claim' within 30 days. It used the same criteria as HSIB (see above). The circumstances would then be investigated by NHSR lawyers to consider entitlement for compensation with review of evidence, expert witness reports and advice from counsel as thought appropriate. The outcome of the investigation would be notified to the family.

Since 1 April 2021, some requirements have changed and the trust is now under an obligation to report to HSIB initially (and not NHSR). HSIB will then investigate and prepare its report and will notify NHSR if there is potential eligibility under the ENS. The criteria for an ENS investigation has been narrowed so that it will now only take place if 'there is evidence of or the potential for brain injury'. Brain injury is stated to be in cases involving 'babies who have an abnormal MRI scan where there is evidence of injuries in relation to HIE', although some discretion is exercised. There is no guaranteed timeframe for the litigation investigation by NHSR or guarantees as to the outcome.

What should we do when we receive the HSIB report?

Once the report has been issued, you may be invited to a meeting with HSIB and/or the trust to discuss the findings and in some circumstances an apology may be given for failings in the care.

It is important to recognise that the aim of the report is to identify opportunities to learn and to improve patient safety rather than to determine if there has been a breach of duty of care or if compensation should be paid.

It is extremely unlikely that the report will have considered all issues relevant to a legal claim on behalf of your baby (or the mother), even though there may be an acknowledgement of some safety concerns.

We recommend that you review the report with a specialist clinical negligence solicitor who will be able to look beyond the findings and consider, for instance:

  • if any safety concerns are likely to amount to a breach of duty of care. The solicitor will also consider if there are other potential errors that have not been addressed in the report;
  • if any potential errors led to your baby's injuries;
  • what help your baby may need now and in the future, taking into account any difficulties that develop over time;
  • whether a claim for compensation is likely to succeed;
  • whether NHSR is likely to carry out an internal litigation investigation as part of the ENS and the action you may need to take as a result of this decision.

How we can help

If you have concerns about any aspects of care prior to, during or after your baby's delivery, one of the partners in our specialist birth injury claims team will be able to talk things through with you. We will discuss matters on a confidential basis with no commitment or charge. We appreciate that the prospect of bringing a legal claim can be daunting for many families. Our aim is to make this as smooth a process as possible.

For further information, please call us on 0800 328 9545, email or complete our online assessment form.


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