The Early Notification Scheme (ENS) and Healthcare Safety Investigation Branch (HSIB)

Our birth injury specialists explain what you need to know about the Early Notification Scheme (ENS) and the Healthcare Safety Investigation Branch (HSIB)

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On 1 April 2017 the NHS launched the “Early Notification Scheme” (ENS). This required NHS Hospitals to report to the ENS legal team (part of NHS Resolution) within 30 days all incidents where babies (who were born at term and following a labour) had a potential severe brain injury diagnosed within the first week of life.

These babies were categorised as those who:

  • were diagnosed with grade II hypoxic ischaemic encephalopathy (HIE); or
  • were therapeutically cooled (active cooling only); or
  • had decreased central tone AND were comatose AND had seizures of any kind.

The intention was that, with early notification, the NHS could begin their own investigations as to what may have gone wrong at a much earlier stage.

It is important to note that this scheme is not designed to award families directly with monetary compensation, it is designed to try to ascertain whether an early admission of liability and an apology should be made for having caused the baby a brain injury.

In the event that an apology is made to a family it is not clear what further advice is then given to parents. It is hoped that families will be suitably directed to an independent organisation such as AvMA (Action against Medical Accidents), who could give further information and advice about seeking monetary compensation.

Following the outbreak of COVID-19 from 1 April 2020, NHS Resolution have stated it is no longer a requirement to report these cases to the ENS. It had been expected that the scheme would resume in October 2020, however the current non-reporting requirements have now been extended indefinitely. All births which are categorised for reporting as above do however still require reporting to the Healthcare Safety Investigation Branch (HSIB). The HSIB investigation will now form a “triage” system for ENS in investigating adverse outcomes. From April 2021 this process was further streamlined by NHS Resolution so that:

  • No steps will be taken by the ENS scheme to investigate a eligibility for compensation until HSIB have completed their report. Where the family have refused to allow an HSIB investigation to take place there will be no ENS investigation undertaken.
  • The criteria for an investigation by the ENS scheme as run by NHS Resolution will be narrowed to only those cases where there is evidence of or the potential for a brain injury; namely those cases which may attract a high value compensation award.

How do the ENS investigate the maternity incident?

Put simply the ENS have their own legal team who will review each case individually. In doing so they will commission the opinion of obstetric and midwifery experts (we presume on their panel of experts) to review the medical records and the “liability risk assessment report” provided by the hospital themselves. The ENS team will instruct a firm of solicitors (who act only for Hospital Trusts) to review the evidence and provide them with a report. In theory the family should be provided with a copy of this report.

Is this investigation properly independent?

It is not the view of this firm that the investigation is properly independent because:

  • The parents cannot directly participate in the investigation.
  • There is a lack of transparency as to how the investigation is actually undertaken and the nature and level of detail involved. For example the quality of interviews of the medical staff involved, the potential lack of a full set of medical records being made available to the expert as examples.
  • The solicitors instructed by the ENS only work for hospitals and never act on behalf of families.
  • The experts instructed are selected by the ENS or the instructed solicitors and are not part of any independently assessed or approved panel. It is unlikely the medical opinions would be disclosed to the families.
  • If an apology is made, it is not at all clear what advise parents are given regarding their legal options to seek full financial recompense on behalf of their child for their injuries.

What if you are told there was no fault by medical staff?

Not all reviews will result in an apology; just because there is no apology does not mean that there is no claim for negligent care.

The ENS scheme is very unlikely to investigate a case in the same way Claimant lawyers would and in particular, if there is any issue regarding the potential cause of the brain injury then they are likely to come to a negative conclusion.

We would strongly recommend in the event that a conclusion of no fault is returned by the ENS that you seek a second opinion by instructing a specialist clinical negligence solicitor to review the evidence. It may well be that alternative medical experts will form a very different conclusion.

What are the key themes which have come out of ENS investigations?

There have been some common threads in terms of failures identified by the ENS Scheme, these include:

  • Failures to adequately respond to warning signs from the fetal monitors (the CTG belt around the mother’s stomach during labour). There were failures to realise the trace of the baby’s heart rate was pathological, that is demonstrated that the baby was in extreme distress (due to lack of oxygen) and required urgent delivery.
  • Difficulties in caesarean sections with delivery of the baby’s head because it has become impacted against the mother’s pubic bone during labour.
  • Failure to respond to a mother who is critically unwell in labour.
  •  Failures to promptly and properly undertake resuscitation of a new born who is delivered in a critical condition.

The Healthcare Safety Investigation Branch

The Healthcare Safety Investigation Branch Maternity Investigation system was set up in 2018 and is a relatively new way whereby the NHS investigates adverse outcomes for mothers and babies in particular circumstances. This body is not generally well known and therefore we have information on many frequently asked questions about HSIB below, please click on the one that you wish to have answered or scroll through the guide to see them all.

Is HSIB family-focused?

HSIB have made great effort to fully involve, and to make a focus, the families of those affected by adverse medical events. They published a report in September 2020 with their updated aims; this can be found here.

Their key principles are to be:

  • timely
  • respectful
  • personalised
  • open and transparent
  • accessible and inclusive.
What are the referral criteria to HSIB?

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 6 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.
Does the HSIB need our consent to investigate?

Yes they do. The premise of the HSIB 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.

How does the HSIB work with the Early Notification Scheme (ENS)?

Pre-April 2020 and the onset of COVID-19, the HSIB 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 HSIB. The ENS and HSIB schemes ran in tandem and were not inter-linked.

However after 01 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 HSIB however did not suspend investigations, so they continued as before despite the demands of COVID-19 on resources.

Instead, the new system involves the HSIB receiving a referral from the Trust directly. The HSIB, 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 HSIB 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 HSIB report. If the family refuses to allow an HSIB investigation then the ENS department will not proceed with any investigation of their own.

Does the HSIB investigation replace a Trust’s internal investigations?

Yes it does. If a matter has been reported to HSIB 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 HSIB confirm that they don’t intend pursue an investigation. HSIB reports are primary investigations of an incident which has occurred.

Can I still do the normal Trust complaints procedure?

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 HSIB investigations start, but there is no reason why you cannot do it whilst the HSIB investigations are ongoing or after they are completed.

The HSIB 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 HSIB investigation is still ongoing.

What will the HSIB ask of me?

You should be sent an information leaflet from the HSIB 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 HSIB.

Since the COVID-19 pandemic face to face interviews have stopped, so you will be invited to take part in an interview online (normally via zoom). Following this, the HSIB may prepare a written statement for you to review and for you to confirm its accuracy.

When do I consent to take part?

The HSIB 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 HSIB currently do not signpost families to the charity AvMA (Action Against Medical Accidents), nor 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.

What if I am concerned about the accuracy or content of the report?

If you consider any of the factual evidence you want to give is controversial or it seems to contradict the account of events given by staff then it may be sensible to seek legal advice early on. You will be sent a draft copy of the HSIB report to review before it is finalised; this will give the opportunity to raise any concerns that you have about its accuracy.

You may be concerned that the report will prejudice any later legal action you want to consider if you agree to its contents. If this is a real concern of yours then it would be important to seek the advice of your own independent solicitor.

Will the HSIB report be anonymous and confidential?

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 HSIB website. The HSIB 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 HSIB 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 HSIB 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.

When will I get the HSIB report?

The HSIB 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.

What happens after I get the HSIB report?

The HSIB 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 HSIB.

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

Any HSIB 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.

The HSIB review reports can be found on their website here.

HSIB reports and Coroner’s inquests

If there has been an investigation into a neonatal or maternal death then the Coroner is most likely to await the outcome of the HSIB 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 HSIB would be required to adhere to any request for disclosure. Therefore any evidence you give to HSIB 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.

HSIB reports and escalation of their findings

In some cases HSIB 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.

Can I get the information the medical staff provided to HSIB?

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

As the HSIB 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 HSIB 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.

Should I seek my own legal advice?

This is a very personal decision; there is no direct requirement to do so. The HSIB investigations are not in themselves a legal process and lawyers for the Trust and for the family cannot participate or contribute to this process.

However, given that the HSIB forms part of the triage system for the NHS considering admission of liability in any later claim for monetary compensation, families may be wise to seek legal advice early on. This is the case even if simply for reassurance, peace of mind and being fully informed of the system and their options.

What if the HSIB report does not conclude the cause of a death or my child’s brain injury was as a result of failures?

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

The purpose of the HSIB 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 HSIB report is reviewed by an independent solicitor afterwards, and especially if you have been told that the ENS team are considering the report.

How does the HSIB investigate a critical maternal incident?

The HSIB is not designed to apportion blame, it is more a fact finding exercise in order to ascertain whether there are key types of failures in maternity care that would enable general learning and teaching of maternity staff to improve.

The views of the family are very much taken into account as are the accounts from the staff involved in the critical incident. The clear premise of these maternity investigations is to enable lessons to be learnt and allow for sharing of knowledge so that hopefully systems in place can change to prevent similar incidents recurring.

Families may wish to seek legal advice and general support from a specialist clinical negligence solicitor as part of this process, albeit that lawyers cannot be directly involved or contribute to the report.

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