Support for NHS trusts or member organisations

About the Early Notification (EN) scheme

The Early Notification (EN) scheme is a key initiative towards achieving the delivery of safer maternity care, providing a more rapid, caring response to families in cases of severe harm, supporting a learning culture.

The scheme proactively investigates specific brain injuries at birth for the purposes of determining if negligence has caused the harm. We do this by requiring our Clinical Negligence Scheme for Trusts (CNST) members to notify us of maternity incidents which meet a certain clinical definition.

Early Notification criteria

i) 1 April 2017 to 31 March 2020

In line with the criteria used by the Each Baby Counts programme of the Royal College of Obstetricians and Gynaecologists, the EN criteria included all babies born at term (≥37 completed weeks of gestation), following labour, that had a potentially severe brain injury diagnosed in the first seven days of life and:

Was diagnosed with grade III hypoxic ischaemic encephalopathy (HIE) or
Was therapeutically cooled (active cooling only) or
Had decreased central tone AND was comatose AND had seizures of any kind.

ii) 1 April 2020 to 31 March 2022

During the pandemic period, there were two key improvements to the investigation process:

NHS Resolution decided that no steps will be taken to investigate eligibility for compensation until the Healthcare Investigation Branch (HSIB) had completed a safety investigation.

The intention was to reduce duplication and enable trusts to focus on liaison with HSIB and the family. Instead, on receipt of the HSIB report on relevant cases, NHS Resolution overlaid an investigation into legal liability. Where families had declined an HSIB investigation, no EN investigation took place, unless the family had requested this.

The criteria for an investigation by NHS Resolution was narrowed to those cases where there is evidence of or the potential for a hypoxic brain injury. This ensured that the scheme remained focused on those cases where there is potential for a high value compensation payment.

We apply the following definition to cases: “Babies who have an abnormal MRI scan where there is evidence of changes in relation to intrapartum hypoxic ischaemic encephalopathy (HIE)”.

iii) From 1 April 2022

We will continue to apply the following clinical definition to cases: “Babies who have an abnormal MRI scan where there is evidence of changes in relation to intrapartum hypoxic ischaemic encephalopathy (HIE)”.

Babies whose MRI findings fall outside of the clinical definition of a brain injury could still be accepted by the EN scheme. For these babies, a multidisciplinary clinical review will take place to understand the extent of the MRI changes. If necessary, further information may be sought from the trust to help us decide whether an investigation into compensation entitlement should proceed.

Reporting requirements

i) 1 April 2017 to 31 March 2020

During this period, our Clinical Negligence Scheme for Trusts (CNST) members were required to report all maternity incidents of potentially severe brain injury to NHS Resolution within 30 days.

ii) 1 April 2020 to 31 March 2022

During this period, trust reporting to NHS Resolution was paused in order to support trusts during the pandemic. Trusts continued to report all eligible EN cases meeting the above criteria to HSIB for learning investigations to take place. HSIB then reported potential eligible EN cases to NHS Resolution for further consideration from a legal perspective.

iii) From 1 April 2022 onwards

During the pandemic period NHS Resolution and the Healthcare Safety Investigation Branch (HSIB) were able to reduce reporting requirements with qualifying Early Notification (EN) cases being reported to NHS Resolution via HSIB. This was enabled by the Control of Patient Information (COPI) notice which allowed data-sharing between NHS and public bodies. This is due to expire at the end of March 2022.

With effect from 1 April 2022, trust legal teams are to notify NHS Resolution, via the Claims Reporting Wizard, of qualifying EN cases once they have been confirmed by HSIB as under investigation. Trusts will be required to continue to report their maternity incidents to HSIB via their electronic portal.

Key actions for trusts:

Trusts’ legal teams to report incidents to NHS Resolution only where HSIB have confirmed they are investigating. These will concern cases where a baby has clinical or MRI evidence of neurological injury
When reporting incidents to NHS Resolution, please include the HSIB reference in the ‘any other comments’ box
Please select Sangita Bodalia, Head of Early Notification at NHS Resolution on the Claims Reporting Wizard
Undertake statutory duty of candour conversations and inform families of the EN process.
Please upload the final HSIB report to the corresponding CMS file when you have received this via DTS.

Communication with families

The statutory duty of candour requires Trusts to inform families of all investigations into their care and it is vital that families involved in HSIB and EN investigations are fully informed by NHS Trusts of all processes underway and of the outcome reached.

Please note that Trusts are encouraged to continue with their initial 72 hour reviews to ensure that any learning is identified and actioned in a timely manner. 72 hour reports and investigations can be shared with NHS Resolution should a liability investigation take place.

To support the EN process we have created a dedicated web pages to provide support for patients, families or carers.

What happens once a case proceeds to an EN investigation?

Once we receive the HSIB investigation report, NHS Resolution will undertake a clinical triage to confirm whether the clinical criteria for an investigation under the Early Notification Scheme are met.

We will instruct our specialist medical lawyers to start early investigation into the potential for a compensation payment on of behalf of the NHS trust. They will work alongside trust legal and clinical teams to review relevant evidence. If needed, they will instruct expert witnesses to give their views on the standard of care provided by the organisation and apply the appropriate legal tests to determine potential eligibility for compensation. This may require a conference with counsel to take place to consider the issues.

Once the investigations have concluded, we will work with trusts to inform the family of the outcome and any next steps. This will likely include an apology (if one hasn’t already been made), signposting the family to legal support and advice and, where appropriate, making any legal admissions and offers of compensation.

Please note that investigation notes and documents will be confidential and covered by legal privilege.

All information will be handled sensitively and securely, and any learning from the EN process will be shared on an anonymised basis. To learn more about how NHS Resolution will use this information, please see our privacy policy.