What you need to know about The Maternity & Newborn Safety Investigations (MNSI) Programme.

You may have been referred to MNSI by the Hospital Trust, and wondering what rights you have when going through the process of investigating a birth injury to your child or fatal maternity incident.

The criteria are defined by Each Baby Counts – the Royal College of Obstetricians and Gynaecologists’ (RCOG) national quality improvement programme to reduce the number of babies who die or are left severely disabled as a result of incidents occurring during term labour.

These criteria are:

• • a baby born after 37 weeks gestation;
  • an intra-partum stillbirth (where the baby dies following the onset of labour);
  • early neonatal death (where the baby dies within the first six days of life);
  • evidence of a severe brain injury – usually defined as Grade I to III hypoxic ischaemic encephalopathy (HIE), who has received therapeutic cooling treatment and has decreased central tone and was comatose and has had seizures;
  • maternal deaths, usually at any stage of pregnancy or within around 42 days of giving birth.

The MNSI are usually given your contact details and will make telephone contact asking for your consent to take part and commence their investigation.

One question to consider is whether you have properly given consent to take part in their investigation. It is our view that there should be total transparency around not only their role but what will happen with their report when it is completed. As explained above, the report does form part of a later litigation triage system; there could therefore be legal implications regarding the evidence you provide them with in terms of any future clinical negligence claim.

The MNSI give information to families about the charity AvMA (Action Against Medical Accidents), and suggest families may wish to consult a specialist solicitor for support and guidance. They do not explain in their information leaflet that this forms a triage system in terms of the NHS assessing a potential admission of legal liability for injuries caused. It is important to bear this in mind.

Yes they do. The premise of the MNSI was always to be patient-led for the purposes of patient safety. They require your consent to undertake their detailed investigations.

If you refuse to consent to take part in the investigation then they are obliged to refer the matter back to the Trust involved so that they can investigate it internally, should they wish to do so.

Pre-April 2020 and the onset of COVID-19, the MNSI investigation would operate alongside the NHS Resolution Early Notification Scheme (ENS). The ENS is a separate pre-litigation scheme which considers (with the help of its panel experts and solicitors) an adverse incident with a view to making (where advised) an early admission of liability in a case. This is in an effort to avoid protracted legal investigations and reduce legal costs. The ENS scheme started in 2018 and had the same referral criteria as the MNSI. The ENS and MNSI schemes ran in tandem and were not inter-linked.

However after 1 April 2020 the ENS scheme was suspended and Trusts were no longer required to refer adverse incidents to them. This decision was made in an effort to re-direct limited NHS resources to front line services. In September 2020 it was confirmed that the suspension of this scheme will continue until at least March 2021 and has since been extended indefinitely.

The MNSI however did not suspend investigations, so they continued as before despite the demands of COVID-19 on resources.

Instead, the new system involves the MNSI receiving a referral from the Trust directly. The MNSI, on completion of their report, then send their findings to the Trust and also the ENS department at NHS Resolution.

The ENS has now formally adopted the MNSI report as a method by which to “triage” potential claims for them to consider taking further in terms of their own investigations. The ENS department will only further investigate cases where is there evidence of a hypoxic brain injury and will not do any of their own investigations until they have received the MNSI report. If the family refuses to allow an MNSI investigation then the ENS department will not proceed with any investigation of their own.

Yes it does. If a matter has been reported to MNSI then a Trust is no longer required to undertake it’s own Serious Untoward Incident Report (SUIR) or Root Cause Analysis Report (RCAR).

Some Trusts may opt to do so if MNSI confirm that they don’t intend pursue an investigation. MNSI reports are primary investigations of an incident which has occurred.

Yes, absolutely.

An internal complaint with the Trust who provided your care can still be undertaken. You should not have to do this before the MNSI investigations start, but there is no reason why you cannot do it whilst the MNSI investigations are ongoing or after they are completed.

The MNSI reports will very much focus on the standard of care you have been provided with, so will not usually look into ancillary issues such as issues around ward cleanliness, discharge arrangements, waiting times etc.

The Patient Advice and Liaison Service (PALS) will be able to assist you in making a complaint. You may also be invited to have a maternity “debrief” meeting with hospital staff (usually led by a Consultant Obstetrician) to discuss what went wrong, even while the MNSI investigation is still ongoing.

You should be sent an information leaflet from the MNSI explaining who they are and what they do. You will be asked, usually within the first four weeks after the birth or death of your child/partner, to take part in an interview with staff from the MNSI.

Yes, to a certain extent. The report does not identify the affected family nor the NHS Trust involved and the report itself is not published on the MNSI website. The MNSI will instead annually review all of its investigations and then prepare an annual summary report of its key findings and group errors into categories (e.g. poor management of the impacted fetal head).

The MNSI directions intended for all interviews and information sharing to be undertaken under the “safe space” principle so that everyone could feel free to report their views without fear; however the investigations into maternity incidents specifically removes this “safe space” principle. Therefore there is no true principle of confidentially of the information provided by either families or staff.

Notwithstanding this the staff involved have a “Duty of Candour” to be open and honest about the care they have provided, including any identified or potential failures. This is a now a legal requirement and failure to be honest may lead to fines under regulatory powers from the Care Quality Commission (CQC).

However it is important to note that when a completed MNSI report is sent to the Trust involved and the Early Notification Scheme of NHS Resolution, patient details will be identified so that they can link the report with the maternity and/or neonatal records and consider the findings themselves. So the reality is this process is not wholly confidential.

The MNSI aim to complete their reports within a four-to-six-month period. This has proved rather ambitious however and many reports are taking up to eight months to complete (or longer), especially those where there were significant failures in care or the circumstances were particularly complex.

You will first of all be sent a draft of the report and asked to check it for accuracy or provide feedback. Once this has been received from the family and staff involved, the report will be finalised and sent to the family, the Trust and the ENS team.

This report does not form part of your or your baby’s medical records. It is a document supplied to the Hospital Trust concerned as part of the overall safety governance process.

The MNSI report is not published on its website and will not be available for the public to read or review. The investigation will be formally completed and you will no longer be required to liaise with the MNSI.

The MNSI will however publish thematic reports looking at broader learning points, collating key findings noted across the board.

Any MNSI report which concludes a likely hypoxic brain injury occurred will also be sent to the Early Notification Scheme (ENS) to review and consider investigation for eligibility for financial compensation.

This does not mean you do not have a case for medical negligence.

The purpose of the MNSI report is to look at individual or systemic faults, it is not there to directly determine whether any of those faults made a difference to the outcome. Indeed the report may have failed to pick up certain failures, which would be discussed as part of a family’s legal investigation into a case, with the benefit of their own independent experts.

We would therefore advise that the MNSI report is reviewed by an independent solicitor afterwards, and especially if you have been told that the ENS team are considering the report.

If there has been an investigation into a neonatal or maternal death then the Coroner is most likely to await the outcome of the MNSI report before holding an inquest hearing.
The report, albeit anonymised, will likely be a fundamental part of the hearing and will be carefully considered by the Coroner as part of his or her inquiries in establishing how and in what circumstances the mother and/or child died.

Some Coroners may in fact seek disclosure of not only the report, but also all the interviews taken of staff which lie behind it. As the report and investigation documents are not legally privileged MNSI would be required to adhere to any request for disclosure. Therefore any evidence you give to MNSI after a fatality may form evidence as part of inquest proceedings.

It is very important to seek legal advice in respect of coronial proceedings and much more detailed information can be found on our inquest information pages.

In some cases MNSI may feel obliged to escalate their findings to another body, if their findings of failures are of serious concern or raise issues relating to general patient safety. They may choose to notify the Care Quality Commission, the General Medical Council, the Nursing and Midwifery Council or even the Police if they fear criminal action may be involved. You should be advised if this has taken place.

In theory, yes you should be sent the investigation documents if you request them. However this is likely to be met with resistance from MNSI.

As the MNSI Directives makes explicitly clear, the dominant purpose of their investigation is not to undertake a legal investigation into liability (civil or criminal) or fault. Therefore as the report does not come under the definitions of legal advice or litigation privilege the documents collated as part of the investigation should be disclosed to you if you request them.

However this right to information is very complex and muddied, and has been further complicated by the “blending” of the role of the MNSI as a triage service for the ENS body of NHS Resolution.

If you are refused disclosure of documents you have requested we would advise you consult further with a medical negligence solicitor.

In relation to all referrals from 1 April 2024 MNSI made changes to their investigation reports and process. The purpose of this change is to have improved learning on any system-wide issues and improve inclusivity and better inform safe maternity care.

The three main changes are:

The manner in which investigations will be undertaken also has a new focus, to interview staff in person and to visit the maternity units or settings in order to gain a better understanding of the clinical environment staff are working in. This may also include focus groups or a walk-through analysis to understand specific processes in the Trust. This gives a better understanding of the work systems in place at the time of the events, however will only be meaningful if investigations are done relatively contemporaneously.