Babies who meet the criteria to be reported to us by NHS Trusts include term babies born following labour (at least 37 completed weeks of gestation) who have had a potential severe hypoxic brain injury confirmed on an MRI scan. Babies who are born by elective caesarean section, and babies who have sadly died within the first week of life (0-6 days) will not be eligible for review under the EN scheme.
A potential severe brain injury is diagnosed in the first seven days of a baby’s life, and is when the baby:
Was therapeutically cooled (active cooling only), or
Has been diagnosed with moderate to severe encephalopathy, consisting of altered state of consciousness (lethargy, stupor or coma) and at least one of the following:
hypotonia;
abnormal reflexes including oculomotor or pupillary abnormalities;
absent or weak suck;
clinical seizures
(We have amended the wording on our family pages to give a simplified version of the above criteria).
The EN Scheme investigates a specific type of brain injury which meets NHS Resolution’s clinical MRI criteria.
We investigate cases involving therapeutically cooled babies where there is evidence of ongoing neurological injury. This would usually mean that to meet our criteria to be considered for investigation there will be a brain MRI scan showing evidence of intrapartum hypoxic ischaemic encephalopathy (HIE) (a type of brain injury that occurs when there is a disruption in supply of oxygen to the brain).
Cases reported in will be triaged to confirm if there is evidence of hypoxic injury on the MRI scan. Those cases confirmed as meeting the EN criteria will receive a preliminary review by NHS Resolution’s clinical team who consider whether there are any initial concerns about the care provided and whether that care may have caused injury to the baby. Where there are potential concerns about the care provided that may have caused injury to the baby, we will complete a full legal investigation. If the baby was born on or after 1 October 2023, NHS Resolution will ask the family’s permission to do this and ask for a signed form permitting us to access additional medical records.
Trusts are required to report all incidents that meet the Maternity and Newborn Safety Investigations (MNSI) programme criteria to MNSI and NHS Resolution. The criteria for an investigation by NHS Resolution’s Early Notification Scheme is narrowed to those cases reported to MNSI, where there is evidence of changes in relation to intrapartum hypoxic ischaemic encephalopathy (HIE).
The functions of MNSI and the EN scheme differ. There is some overlap between the organisations in that they both undertake investigations where a baby born at term has sustained severe brain damage following a delivery where there was labour. However, the EN criteria differs from the MNSI criteria as EN scheme will not investigate intrapartum stillbirths, maternal deaths or early neonatal deaths (within the first week of life (0-6 days).
It is important to note that whilst there is some overlap in the investigations undertaken by both organisations the purpose of MNSI and EN scheme investigations differ. MNSI investigations and reports are prepared with a view to making recommendations with the aim of improving healthcare systems and processes and reducing risk of harm to patients. NHS Resolution employs a litigation lens to the incident to assess the standard of medical care provided, which is different to the assessments made by MNSI investigators.
MNSI carry out their safety investigation and once completed NHS Resolution overlays an investigation to identify cases that satisfy the legal requirements for financial compensation. So, whilst the two organisations may review and investigate the facts of the same incident the remit and purposes of the two organisations are distinct.
* Due to extreme circumstances caused by the Covid-19 pandemic crisis data sharing arrangements were put in place between MNSI and NHS Resolution to ease extreme work pressures faced by Trusts during this period. With the end to the pandemic the data-sharing arrangements put into place have expired and we have now reverted to pre-Covid reporting requirements.
The EN scheme has strict entry criteria, so where MNSI may review and report on an incident due to family or Trust concerns, the EN scheme will not investigate cases where there is a normal MRI (because they do not meet the minimum entry requirements for the EN scheme).
In such circumstances, Trusts may wish to signpost families to the ‘support organisations’ section of the EN scheme family and carers webpage where there are details of organisations that may be able to provide them with legal advice and specialist support. You can also signpost them to our ‘Advice for claimants’ webpage where the family can find more information about how to make a claim where an EN investigation isn’t taking place.
In circumstances where the EN scheme criteria has been met but the family decline an MNSI investigation, they can still request an EN review independently of MNSI.
In these circumstances the Trust should:
notify the EN team by reporting the matter via the Reporting Claims Wizard
mark the EN report form to reflect the families’ wish for an EN review where they have declined an MNSI investigation
provide the relevant documents to enable NHS Resolution to conduct a preliminary triage (MRI report and child’s condition at discharge in the first instance). The EN team will be in touch to request other medical records or documents if needed.
Please note this is the only exception to the rule that all EN cases must be reported to the EN scheme with the relevant MNSI reference.
Trusts are reminded that the EN preliminary criteria stipulates that as a minimum the baby must survive to day seven and beyond. Unfortunately, babies that die within the first week (zero to six days) fall outside of the EN scheme.
If an incident initially meets the EN criteria and is reported to NHS Resolution and the child subsequently dies (some time beyond day seven) this does not preclude the case from proceeding under the EN scheme.
Trusts are reminded that in circumstances where a child subsequently dies or there are other significant clinical developments after a case is reported to the EN team we expect that this information is reported to the EN team case manager as soon as possible and without delay. It is of paramount importance that we have all of the relevant up to date information relating to a case provided to us and recorded on the file. This will minimise the risk of causing unnecessary distress or upset to the family when we are in contact with them.
Initially where the MNSI criteria are met but they subsequently decline to investigate the matter because there is a normal MRI the incident is not reportable to the EN scheme. In these circumstances, please follow your Trust’s framework for responding to patient safety incidents for the purpose of learning and improving patient safety.
Unfortunately, we are unable to amend the Reporting Wizard as this is a portal used by members to report different types of claims to NHS Resolution not just the EN scheme.
To avoid rejection of the case when reporting EN matters please ensure that:
the MNSI reference is set out in the ‘Any other comments’ box on the Reporting Wizard AND
We have listed the following steps to outline when to notify ENS:
Step one
Please report qualifying incidents to MNSI as per the MNSI criteria.
Step two
Case is deemed eligible and/or is accepted for investigation by MNSI.
Babies who meet the criteria to be reported to us by NHS Trusts include term babies born following labour (at least 37 completed weeks of gestation) who have had a potential severe hypoxic brain injury confirmed on an MRI scan. Babies who are born by elective caesarean section, and babies who have sadly died within the first week of life (0-6 days) will not be eligible for review under the EN scheme.
A potential severe brain injury is diagnosed in the first seven days of a baby’s life, and is when the baby:
Was therapeutically cooled (active cooling only), or
Has been diagnosed with moderate to severe encephalopathy, consisting of altered state of consciousness (lethargy, stupor or coma) and at least one of the following:
hypotonia;
abnormal reflexes including oculomotor or pupillary abnormalities;
absent or weak suck;
clinical seizures
(We have amended the wording on our family pages to give a simplified version of the above criteria).
The EN MVAG was established to provide external stakeholders, in particular families and their representatives, with a forum through which they can advise and support future service developments within the EN scheme.
MVAG currently includes representatives from Campaign from:
It is our ambition that the group will become a forum for the NHS Resolution EN team and key stakeholders to:
Work creatively to co-produce solutions together such as EN patient facing products or materials
Use patient experience data and insight to inform future development of the EN Scheme
Evaluate and provide opportunities for continuous quality improvement through shared learning from incidents.
For Trusts wishing to direct staff members involved in an incident towards further support and advice there is also some guidance and information as well as a list of organisations that may be able to provide them with further assistance within Appendix 1 of the Early Notification Second Report.
In such circumstances the Trust may wish to signpost families to a charity called Peeps H.I.E. which provides support and advice to families affected by babies born with hypoxic ischaemic encephalopathy (HIE).
You may also wish to direct families to the EN family facing page as we list several other organisations that may be able to provide them with specialist legal advice and support.
If the incident does not meet the EN entry criteria it will fall outside of the EN scheme. Trusts can direct families to the EN family facing page where we provide a list of support organisations that may be able to provide them with specialist legal advice and support.
The EN scheme recognises that any time an adverse outcome occurs it affects the patient and family but can also be emotionally difficult and stressful for the staff involved. NHS Resolution is unable to provide support directly to individual staff members, therefore staff support should be provided at a local level in the first instance. Our ‘Being Fair’ report promotes a just and learning culture within organisations and illustrates how staff should expect their organisation to support them. Improved support for affected staff members was also one of the recommendations contained within the EN scheme’s first and second reports and within Appendix 1 of the EN Second Report we list some further resources that may assist staff members involved in an adverse incident at work.
In the meantime, the EN scheme aims to make the EN investigation and process as stress free as possible for staff members. EN scheme clinical and legal team members are available to discuss staff member queries relating to the EN scheme and investigation process via email or telephone (nhsr.enteam@nhs.net or 020 7811 6263).
Trusts are reminded that Safety Action Ten of the Maternity Incentive Scheme mandates all qualifying incidents to be reported to MNSI and the Early Notification Scheme.
Please check the EN entry criteria for more information on qualifying incidents.
Please note that the EN scheme does not investigate maternity incidents where there was an elective caesarean section.
The EN requirement regarding labour aligns with the MNSI’s criteria for labour which is defined as follows:
Any labour diagnosed by a health professional, including the latent phase (start) of labour at less than 4cm cervical dilatation.
When the mother called the maternity unit to report any concerns of being in labour, for example (but not limited to) abdominal pains, contractions, or suspected ruptured membranes (waters breaking).
Induction of labour (when labour is started artificially).
When the baby was thought to be alive following suspected or confirmed pre-labour rupture of membranes.
The EN investigation may involve the instruction of Panel solicitors (specialist healthcare lawyers who are instructed to act on behalf of NHS Resolution and their Member Trusts). These lawyers will go on to instruct medical experts who provide independent opinions on the care provided.
The types of experts instructed will vary but often include a midwife, an obstetrician (doctor specialising in pregnancy and labour), a neonatologist (doctor specialising in looking after infants who are unwell after their birth) and a neuroradiologist (doctor specialising in the interpretation of brain scans). In addition, some cases will also have a paediatric neurologist instructed (doctor specialising in diagnosing and managing neurological disorders in children).
An expert’s duty is to the Court and their purpose is to provide neutral opinions which are independent from the Hospital Trust or NHS Resolution. They advise on the standard of the care provided and whether, if the care provided had been different, the infant would have been less unwell following birth.
An EN expert summit is a forum where multiple EN cases can be considered at a single point in time. This allows for discussions between medico-legal experts, a senior barrister, the instructed panel solicitor and NHS Resolution as well as representatives from the member trust. The discussions remain subject to legal privilege as they are primarily for the purposes of obtaining information and advice in the context of reasonably contemplated litigation. Key information is captured, tested and considered to allow counsel and solicitors to set out a road map towards providing an open and considered letter of explanation to the family. This includes early admissions of liability and apologies where appropriate. Where further investigation is identified, then further actions will be agreed between the parties at the Expert Summit.
Trust representatives will normally be invited to attend an expert summit. It is often very useful to have clinicians in attendance at expert summits because they frequently provide many helpful factual insights in discussions between experts and the senior barrister which may otherwise not be known.
Panel firms and NHS Resolution will coordinate summits and arrange the date and time for these. Some months prior to the summit the EN case manager and panel lawyer will take a view as to whether trust clinicians should be invited to attend. Panel will liaise with the Trust legal team to invite either the treating clinicians or someone more senior who may be able to provide information or necessary approvals. If clinician attendance is required, we will contact the Trust legal team to arrange this.
Documents produced when giving or receiving legal advice are protected under a principle called “legal privilege.” This means we will not be able to give the family copies of the expert reports or other documentation created during the investigation. Legal privilege also applies if the family instruct their own lawyers.
If the EN investigation identifies substandard care that has caused an injury, and negligence is determined, the injured child will be entitled to compensation, and we will strongly advise the family to obtain independent legal advice from a solicitor who specialises in these type of clinical negligence claims.
The next stage will be to carry out further investigations to establish the amount of compensation to be paid. It can be difficult to assess the level of financial support a child will need as they are still developing, and the extent of their disability may be unknown, as their needs are changing. It may take several years before a final settlement can be agreed but in the meantime the courts may award what is known as an ‘interim payment’ to cover the costs of items which are required immediately or in the near future. The family and their representative will be invited to attend a meeting shortly after they have received the outcome letter (this can be in person or virtual/remote depending on circumstances). The aim of this meeting will be for us to better understand your child’s current condition, whether there are any needs which are currently unmet, and to gain further information which can assist us in making early interim compensation payments.
