Adverse incidents for babies affected by oxygen deprivation at term birth: what changes have occurred to the NHS Early Notification Scheme’s and Healthcare Safety Investigation Branch’s investigations? An update

In a previous blog posted in early April 2020 I set out the parameters for the separate investigation processes undertaken by the Early Notification Scheme (ENS) and the Healthcare Safety Investigation Branch (HSIB). The ENS scheme is also aligned with the Clinical Negligence Scheme for Trusts (CNST) Maternity Incentive Scheme. As with many things, all of these Department of Heath schemes have been affected or changed in some way due to the COVID-19 pandemic having affected NHS services the UK in force from March 2020 onwards.

How the ENS system works

It is probably useful to summarise again briefly the current systems which the NHS have in place to investigate adverse outcomes in maternity care. These systems apply to hospital Trusts in England and Wales; systems differ in Scotland and Northern Ireland.

The systems in place comprise:

• an internal review by the hospital Trust by way of an “Adverse Incident Report” or a “Root Cause Analysis Report”;
• referral to the HSIB to investigate;
• referral to the ENS (which forms part of the litigation arm of the NHS, NHS Resolution).

The CNST Maternity Incentive Scheme is a separate, non-investigatory scheme. It requires individual Trusts to meet a certain list of 10 primary criteria to promote maternal safety. If a Trust can establish they have met this criteria then they receive a rebate of share of their CNST premium, which can be substantial for investment in their units. See my previous blog on this Scheme here.

If there has been an adverse outcome in maternity care and the below criteria are met, Trusts are then required to refer the matter to the HSIB for investigation:

• 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 II or III hypoxic ischaemic encephalopathy (HIE), who has received therapeutic cooling treatment and had decreased central tone and was comatose and had seizures.
• Maternal deaths, usually at any stage of pregnancy or within around 42 days of giving birth.

These criteria have been defined by Each Baby Counts (EBC)- 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.

If there has been a maternal or neonatal death then the death will also be referred to the local coroner for review to determine whether an inquest hearing is to be listed. If there has been a stillbirth then coroners are still not yet obliged to open inquest proceedings. For further information on coronial proceedings please see our inquests section.

The situation prior to April 2020

Pre-April 2020 Trusts were expected to report adverse incidents (as defined above) to both the ENS and to HSIB. Both organisations would then undertake their own investigations concurrently. Due to COVID-19 enormous strain was placed on NHS resources. It was determined a more efficient use of staff time and costs to remove the requirement for reporting to ENS and instead only reporting to HSIB was required.

In addition the CNST Maternity Incentive Scheme, including all the required actions as part of that scheme, was suspended from 01 April 2020.

The situation after April 2020

HSIB after 01 April 2020 now alone undertake a review of the maternity care provided and prepare a written anonymised report (anonymous for both the family affected and the Trust involved); this report alone is then disclosed to the family, the Trust and the ENS (NHS Resolution). It is at this point that ENS, having relied on the new HSIB “triage” system, will review the matter and consult their panel solicitors for advice on whether an admission of liability in causing harm should be made.

This new system was formally extended in September 2020; The RCOG, MBRRACE-UK, NHS Resolution and HSIB have worked together to reduce the obligation on Trusts to report cases which meet the EBC criteria. All maternal and infant deaths should still be reported to MBRRACE-UK, particularly for those who were COVID-19 positive at the time of death. The NHS is still focused on ensuring that the duty of candour is maintained, with openness to families where mistakes have been made and apologies offered when appropriate.

It is important to note that HSIB’s role is not to apportion blame or liability; it notes:

“It is not the function of the Investigation Branch in conducting investigations and publishing its findings, analysis and any recommendations, to identify civil or criminal liability in any matter, not to apportion blame or otherwise support fault-based legal or regulatory or other formal action against persons whose actions come under consideration as part of its investigation.”

The report does, however, now come under the litigation arm of the NHS as it is sent to NHS Resolution upon completion. Therefore consideration should be given by families when engaging with HSIB and reviewing their report as to whether they wish to seek their own legal advice from an independent medical negligence specialist solicitor. It will not necessarily follow that the ENS will liaise with a family following consideration of the HSIB report, if they are not of the opinion there was sub-standard care causative of any neurological injury.

Concerns regarding maternity services safety

It is of concern that the CNST Maternity Incentive Scheme was suspended in April 2020 and continues to be so. There is a risk that many Trusts will not be able, in the presence of strained resources and reduced staffing levels, to ensure standards of maternal safety on its delivery units. If Trusts do not seek to meet or cannot meet the safety actions as required under the scheme, will that in term affect maternal care?

One solution would be to adapt the safety actions to become more aligned with changed working practices in the presence of COVID-19, however initial plans to do so have not materialised.

For example, under Safety Action 6, there are five elements to the saving babies lives care bundle; these include monitoring of carbon monoxide levels in mothers who smoke, identifying fetal growth restriction, reporting reduced fetal movements, 90% of staff receiving fetal monitoring training and premature infants receiving steroids after birth.

Mothers are having much less frequent face to face visits with their midwives, affecting the opportunity to review health and discuss concerns. Fetal monitoring during labour is of the utmost importance and failures in this area are a leading cause of hypoxic injuries to babies. The high standard of staff training is imperative to maintaining knowledge and safety standards; questions must be asked as to whether staff are engaging in appropriate training?

It is of course to be welcomed that there is an independent body, HSIB, undertaking reviews of poor outcomes in maternal care; I doubt anyone could criticise its aims. However we are yet to be able to see whether this scheme is actual producing improvements in safety learning and lessons across the board in English and Welsh hospitals.

It is of greater concern that families may not have full transparency in understanding that HSIB reports are now the first “triage” method for NHS Resolution (the litigation arm of the NHS), and are not signposted to seek their own advice should they wish to do so.

In addition there must surely be anxiety that safety standards in maternity units post March 2020 with the arrival of COVID-19 are simply not what they were and have been adversely affected by under-staffing, strain, lack of equipment and a failure to maintain adequate training standards. We therefore hope that the questions asked in this article are answered soon.