Understanding Maternity and Newborn Safety Investigations (MNSI)

The days immediately after the birth of a baby can be difficult. They may be even more difficult if you are concerned that you and/or your baby has experienced an injury as a result of the birth.

There are investigation processes which may take place if there are concerns about care given. This guide has been produced to help families understand more about the Maternity and Newborn Safety Investigation (MNSI) process and to let you know that Avma can support you through this.

Overview of investigation processes

Mothers and families whose baby was born at an NHS hospital after 1st April 2018 who may be concerned that their baby sustained a brain injury at birth may be going through an investigation process. You may feel confused about why an investigation is taking place and what is being investigated. This is understandable, as there are at least two possible investigations which might take place in these circumstances (and some families go through both).

The first investigation which might occur is the MNSI investigation. The other investigation process is NHS Resolution’s Early Notification Scheme (ENS). Check our dedicated ENS guide for more information on this scheme.

It is important to remember that thankfully, most women who have their babies on the NHS have good, safe outcomes. Sometimes, however, an NHS hospital may suspect or be concerned that the medical care provided to a mother during her labour was not as it should have been and as a result baby may have experienced a severe brain injury. If the NHS hospital concerned think the care they provided caused this injury, it must report this to the MNSI.

The MNSI is an independent organisation separate from the NHS. Please see the section What is the MNSI and what do they do? for more information. The MNSI will investigate if the definition of a brain injury meets the Royal College of Obstetricians and Gynaecologists’ (RCOG) Each Baby Counts guidelines. The RCOG definition of severe brain injury is set out below.

The MNSI will also investigate other areas of obstetric and neonatal injury and some deaths, not just where a potential brain injury has been identified. For more information, see How are maternity investigations carried out? below.

Definition of a severe brain injury

The MNSI has largely adopted RCOG’s Each Baby Counts definition: that the baby must have been born at 37 weeks gestation or beyond, and that within seven days following their birth they had one or more of the following:

• diagnosed with moderate to severe encephalopathy consisting of an altered state of consciousness such as lethargy, stupor or coma (as well as this, the baby must also be showing one of the followings signs: hypotonia (decreased muscle tone), and/or abnormal reflexes, and/or absent or weak suck reflex, and/or (iv) clinical seizures, or
• actively therapeutically cooled and showing signs of neurological injury.

Since 2020, the MNSI will not routinely investigate cases involving therapeutically cooled babies where there is no ongoing neurological injury. However, they will investigate these cases if it can be shown that the baby was therapeutically cooled and there is still evidence of injury, for example: “Babies who have an abnormal MRI scan where there is evidence of changes in relation to intrapartum hypoxic ischaemic encephalopathy (HIE)”.

It is important to stress that babies who meet the definition of severe brain injury may not go on to have a significant long-term disability, although it is often not possible to know until the child is of school age.

If after reading this guide you are still unsure about the process and want some support, please submit a written case to Avma. Our advice is given free of charge, without obligation, and in complete confidence. Once you have submitted your case, one of our caseworkers will email you within two days to offer an appointment at a convenient time for you.

Frequently asked questions

What is a moderate to severe encephalopathy?

An encephalopathy is damage or disease which affects the brain. The type of encephalopathy likely to be found in babies within the first seven days of life is hypoxic ischaemic encephalopathy (HIE). HIE is a term doctors use to refer to a brain injury caused by not enough oxygen reaching a baby’s brain when it is being born. It can also be referred to as intrapartum asphyxia.

What is therapeutic cooling?

Therapeutic cooling involves taking a baby as soon as possible after birth (but in any event usually within six hours of birth) and putting them in a controlled environment which will bring their body temperature down as low as 33.5°C. The baby may be kept in these conditions for about 72 hours before a gradual rewarming process is started. This process has been shown to reduce the risk of serious brain injury.

Since April 2020, you have to show not only that the baby was therapeutically cooled, but that despite cooling they show signs of neurological injury.

My baby was therapeutically cooled after their birth, what sort of signs might indicate neurological injury?

If your baby has undergone an MRI scan of their brain which shows signs of actual or possible damage to the brain, this may indicate neurological injury. If your baby has not had an MRI scan, they may have other signs such as not meeting their usual milestones when they are expected to — for example, your baby may not be holding their head up when they are supposed to.

Other signs might include abnormal body movement, not walking or crawling when they ought to be, long-term feeding difficulties (e.g. weak or absent ability to suck), and decreased levels of consciousness and/or clinical seizures.

These are just examples; it is not an exhaustive list. Just because you think your baby might be showing one or more of these signs, this does not necessarily mean your baby does have a neurological injury. If you have concerns, we urge you to discuss these with your GP as soon as possible.

What is labour?

The MNSI considers that labour has commenced when 37 weeks gestation has been completed and one of the following has occurred:

• labour has been diagnosed by a health professional — this includes at the start of labour when cervical dilation is less than 4cm,
• the mother calls the maternity unit reporting abdominal pains, contractions, or that her waters have broken (examples of concerns which might be reported which suggest labour has commenced),
• labour has been started artificially, such as induction of labour, or
• the baby is thought to have been alive after suspected or confirmed rupture of membranes (waters breaking).

Am I allowed to see the MNSI investigation records?

In principle, yes. MNSI investigations are carried out under the principle of duty of candour, which is about being open with families. There are some investigations which are carried out under the principle of safe space, which does restrict the investigating body’s ability to share information, but this does not apply to MNSI. However, in practice MNSI is very protective of the NHS staff interviews and any investigation reports it has access to as part of its MNSI investigations, so it may not voluntarily disclose this information.

What is the MNSI and what do they do?

The MNSI came into being in October 2023 — the programme was previously known as Health Safety Investigation Branch (HSIB) maternity investigations. The MNSI is funded by the Department of Health and Social Care and hosted by the Care Quality Commission, but is an independent investigative body.

MNSI investigations do not look at establishing criminal or civil liability or carry out investigations from a legal or litigation perspective. They do not seek to place blame or investigate individual members of NHS staff. They do not investigate under safe space principles, which means that information from investigations can be shared.

How are maternity investigations carried out?

The MNSI has a specific investigation programme for maternity-related issues which include potential severe brain injuries in babies that meet the definition of a serious brain injury (see above). The MNSI also investigates intrapartum stillbirths, neonatal deaths, and maternal deaths which meet their criteria. You can find out more on their What we investigate webpage.

In investigations into potential brain injuries at birth, intrapartum stillbirths and early neonatal deaths, the following criteria apply:

• the baby must have been born in England,
• the baby must have been born following labour, and
• the birth must have been after 37+ complete weeks of gestation.

For investigations into potential brain injuries at birth, the baby must have experienced a potential severe brain injury (explained in the sections above) which is diagnosed within the first seven days of life.

For investigations into intrapartum stillbirth, the baby must meet the definition of an intrapartum stillbirth (where they were believed to be alive at the start of labour, but were ultimately born with no signs of life).

For investigations into early neonatal deaths, the baby must have died at between zero and six days of age. The death can be due to any cause.

The MNSI will conduct investigations into maternal deaths of women while pregnant or within 42 days of the end of pregnancy. These may be direct or indirect deaths:

• Direct deaths: A direct death is one that arises as a result of obstetric complications of pregnancy or labour, or after the birth. The death must be related to surgical interventions, omissions in medical care, incorrect treatment, or events which arise from any of these things.
• Indirect deaths: Indirect deaths occur due to previous existing disease or as a result of disease that develops during pregnancy. The death will have been brought on by the physiological effects of pregnancy in the perinatal period — that is, the period of time between the pregnancy and giving birth and up to 42 days after the end of the pregnancy.

The MNSI will not carry out any investigation in situations where:

• the baby was born outside of England,
• the baby was born before 37 complete weeks of gestation,
• the baby was not born following labour (e.g. where a caesarian section was performed before the mother started having contractions or ruptured her membranes),
• the baby was cooled at birth and does not show signs of neurological injury,
• the baby is thought to have died before labour started or was induced,
• a maternal death was caused by suicide, or
• the death or injury to baby or mother occurred before 2018.

Do families have to consent to an investigation?

If you want the investigation to proceed, you should consent to the MNSI accessing the mother’s and baby’s relevant medical records.

It is unlikely that MNSI could investigate and produce a report where a family does not give their consent for MNSI to access the medical records. Most families do consent to the process.

How does the MNSI know an incident meeting their criteria has occurred?

Where an NHS trust considers that a potentially severe brain injury has occurred and any other maternity incidents which meet the MNSI criteria have occurred (including where a baby has been therapeutically cooled and there is no evidence of ongoing neurological injury), the trust:

• is required to report this to the MNSI — NHS trusts have a designated electronic portal called HIMS to help with this reporting process,
• is expected to inform the family that a referral has been made to MNSI and provide information about the MNSI to them,
• is expected to ask the family to give their consent for the MNSI to contact them about the investigation, and
• will then confirm to the MNSI whether that consent has been given.

The MNSI process

Once the MNSI receives notification from an NHS hospital trust that a baby meets the definition of a severe brain injury, they will contact you within five days. The MNSI will then introduce you to their named investigator who will keep you updated on the investigation. The MNSI will:

• explain the process
• ask you for permission to seek the mother’s and baby’s medical records (it is unlikely that the investigation will take place without consent),
• discuss how and to what extent you wish to be involved,
• ask you to tell them what happened and your experience,
• ask you questions to understand your individual needs and how they can support you and where you can go for support,
• involve you in the investigation,
• discuss the terms of reference of the investigation,
• with your agreement, arrange an initial meeting between you and the investigators,
• interview both the hospital staff involved in providing the maternity care and the family (interviews can be in person or by video, but if you prefer to engage on the phone or in writing please let them know; a lawyer cannot usually attend such meetings), and
• seek expert medical advice from a panel of experienced clinicians.

How long does the MNSI process take?

An MNSI investigation takes about six months to complete, although it can be longer than this. The MNSI will discuss this with you and should update you on when you can expect their investigation to be completed.

Although the MNSI may make safety recommendations, the responsibility for putting them into action rests with the trust.

Other than the report, it does not provide any additional information it may have gathered as part of its investigation. NHS Resolution will also receive a copy of the MNSI report. The report belongs to the family and the trust.

What can I do while the MNSI investigation is being carried out?

Where the MNSI agrees to carry out an investigation, the hospital does not need to carry out its own internal investigations as well.

If the MNSI does not investigate, the patient safety incident must be considered under the Patient Safety Incident Response Framework (PSIRF) which has taken over from serious incident reporting (SIR) investigations. Please see our guide on the PSIRF for more information. The trust remains responsible for complying with the duty of candour.

You are still entitled to use the NHS complaints process, details of which can be found in our guide to NHS complaints. You are entitled to seek independent legal advice at any point — you do not have to wait for the MNSI to complete their investigation.

Please contact Avma if you need support or advice. We can explain the pros and cons of using other avenues of redress while the MNSI or ENS investigation processes are underway. Submit a written case for support.

Is there a connection between the MNSI and the Early Notification Scheme (ENS) process?

The short answer is no, there is no connection between the MNSI and the ENS process, which is run by NHS Resolution. The MNSI investigation is completely separate from the ENS investigation process — they are two separate investigation processes, run by separate organisations, with separate aims.

MNSI investigations are independent of the NHS and aim to identify where safety improvements should be made. The ENS investigation is designed by NHS Resolution, primarily to establish whether the trust will be liable in a legal claim for birth injuries arising because of negligent treatment. However, ENS investigations do also look to support a learning culture within the NHS with a view to delivering safer maternity care.

NHS Resolution will not consider whether a case is to be investigated under ENS until the MNSI report is available to them. Under the ENS investigation process, you will not be entitled to see any of the medical reports, statements or other documents prepared as part of the ENS investigation.

Please see our dedicated guide to ENS investigations for more information.

How can Avma help me?

Now you have read our guide, you may feel that you would like to speak to one of our specialist advisors. Avma can:

• provide advice and assistance on a wide range of issues relating to concerns you may have about your labour and your baby/child’s development,
• explain the ENS and MNSI processes to you in more detail,
• advise you on other routes for investigation such as the NHS complaints process, and health professional fitness to practise procedures if you feel that a doctor or midwife is unfit to practise,
• help you understand an MNSI investigation, with what questions to ask, support you through the investigation, and help formulate any additional questions you may have because of the report, and
• put you in touch with a specialist accredited solicitor who has the experience and expertise to assist you in this highly complex area of medicine and law.

Avma’s advice and information services are available to the public without charge or obligation, although if you phone our helpline you will be liable to pay your telephone providers tariffs.