When an unexpected event occurs in maternity care before, during, or after delivery, there are a number of investigations that can take place. Two important types of investigations fall under the Maternity and Newborn Safety Investigations (MNSI) programme, and the Early Notification Scheme (ENS) respectively.
Although linked, these two investigations differ in their purpose. The MNSI programme is designed to independently review maternity incidents, understand what exactly took place, and consequently make recommendations, with the ultimate goal of improving future healthcare safety. An ENS investigation, meanwhile, is conducted for the purposes of determining if, legally, compensation is owed as a result of the maternity care received.
This article provides information on the two types of investigations, and answers some FAQs typically asked by families approached over a maternity investigation.
In April 2018, the Healthcare Safety Investigation Branch (HSIB), an independent organisation funded by the Department of Health and Social Care, became responsible for investigating and reporting on safety concerns in relation to maternity incidents. Since then, in October 2023, responsibility for the maternity programme has transitioned to the Maternity and Newborn Safety Investigations Special Health Authority, hosted by the Care Quality Commission (CQC).
The purposes of the transformed maternity investigations are stated to be: ‘to provide independent, standardised and family focused investigations of maternity cases for families; to provide learning to the health system via reports at local, regional and national level; analyse data to identify key trends and provide system wide learning; be a system expert in standards for maternity investigations; and collaborate with system partners to escalate safety concerns’.
An incident is investigated if the parents agree and the circumstances fall within the relevant criteria.
The baby has to have been born following labour at full term (37+ weeks) where there has been:
There are separate provisions relating to a maternal death investigation.
The investigation team will examine the medical records, 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 maternity investigation and report should be independent and are not prepared for the benefit of the family or the trust. The main part will set out the facts about what happened prior to and during labour and delivery, and following birth. There will be sections discussing key events and findings, safety recommendations and areas for improvement.
The report will be sent, in draft form, to the family, trust, and staff involved in the incident, and NHS Resolution (NHSR), the organisation responsible for paying compensation. It will not be published.
A meeting is then held with the family, CQC and the trust to discuss next steps.
Although the report is not made public, 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 to date.
The review for 2022/23 noted that (amongst other things):
Of particular note is the fact that racial differences in maternity outcomes have been identified and a racial equality group has been formed as a result of this. Twelve themes were identified in 2022/23 and these included issues relating to clinical assessment and oversight, fetal monitoring, risk assessment and escalation. The report sets out how this information is distributed to the seven NHS England regions.
In contrast, the Early Notification Scheme is operated by NHS Resolution, the organisation responsible for paying compensation. This investigation is undertaken for the benefit of NHSR which is provided with a copy of the maternity investigation report. Eligibility for the scheme is more limited and it will only review those cases where there is a hypoxic brain injury which could potentially result in compensation, and there are concerns about the care provided. An in-house investigation will not be instigated, even if the more limited criteria are met, if the parents have declined the MNSI investigation, unless a request is made directly via the trust.
Our specialist birth injury team can provide support at an early stage when there are concerns about maternity services and treatment provided for a baby or mother. Parents often require advice and assistance when they are asked to agree to a maternity investigation.
If you need help and have questions about this process, we will be happy to quickly arrange for you to speak to a partner in the team who can discuss your individual circumstances.
It may also help to consider our general responses to some of the questions that are typically raised. These are set out below:
The trust may propose its own investigation but it is more likely that the CQC investigation will replace any local investigation. 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, investigators will be able to ask probing questions about them. This can help to identify areas for improvement both at the trust in question and more widely.
It is likely that the hospital trust has referred your case. It is under an obligation to do so if, amongst other things, your baby was over 37 weeks, born with a potentially severe brain injury and was:
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 parents involved have reported feeling reassured that an unbiased investigation has taken place. Others have been frustrated by delays and conclusions reached. There is no doubt however that the report will provide a better understanding of some aspects of the care.
When the report has been finalised, it will be sent to you and to the trust and the trust should act on any findings and safety recommendations. Themes from individual reports are included in anonymous learning reports and the information distributed nationally to improve patient safety.
NHSR will be provided with a copy of the report and will consider whether a further legal investigation (ENS) should be started if errors identified may have led to an injury which will result in compensation being paid.
There is a separate Early Notification Scheme, set up in December 2017, which required a trust to notify NHSR of a maternity incident 'with the potential to become a high value claim' within 30 days. If a CQC maternity investigation is proceeding, then NHSR will await the final report before its lawyers are asked to review as part of the ENS.
The focus of the ENS is different to the maternity investigation by the CQC because it is considering if compensation should be paid. The legal investigation is likely to include obtaining expert witness reports which are commissioned by NHSR and are confidential, and advice on the potential claim from a barrister. The conclusions of the investigation should then be notified by letter to the family.
There is no guaranteed timeframe for the ENS investigation or guarantees as to the outcome. Our experience is that there can be very significant delays in concluding the investigation (at least a year and often longer). On occasions there is a full admission meaning NHSR accepts that compensation will be paid for the injury caused. On other occasions the claim is denied.
However, more often than not, the outcome is inconclusive because only some of the potential errors in treatment are acknowledged and/or there is a dispute about the cause of the injuries in any event. This means that the parents will need to continue or commence their own investigation separately.
Once the maternity investigation report has been issued, you may be invited to a meeting with the CQC and/or the trust to discuss the findings, and in some circumstances an apology will be given for failings in the care. However, 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.
Similarly, if a letter is received about the findings of the ENS, legal advice should be obtained either to proceed with assessment of the value of compensation if an admission has been made in full, or to evaluate the conclusions and next steps.
We recommend that you review the outcome of these investigations with a specialist clinical negligence solicitor who is a panel member of the charity Action against Medical Accidents (AvMA) or the Law Society, and who will be able to look beyond the findings and consider:
If you have concerns about any aspects of the medical care around the time of your child’s birth, you can speak directly to one of the partners in our specialist birth injury claims team, who will be able to talk things through with you. We will discuss matters on a confidential basis and help wherever we can.
For further information, please contact:
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