Investigating NHS Patient Safety Incidents

20 Jul 2021 | Stephanie Prior

The HSIB (Healthcare Safety Investigation Branch) is an independent organisation made up of a team of investigators and analysts whose role is to conduct independent investigations of ‘patient safety concerns in NHS –funded care across England.’ The HSIB can only investigate patient safety concerns that happened after 1 April 2017.

The organisation is completely independent from the NHS insofar as their investigations are concerned. However, they are funded by the Department of Health and Social Care and hosted by NHS England and NHS Improvement.

The Government published a draft Health Service Safety Investigations Bill in September 2017 to recommend setting up a new body, the Health Service Safety Investigations Body (HSSIB) again to investigate any incident relating to patient safety in the NHS. The idea is that the HSSIB will be completely independent and will continue the work of the HSIB save for maternity investigations.

The proposed Bill will:

  • Establish the Health Service Safety Investigations Body (HSSIB), as a new independent arm’s-length body with powers to conduct investigations into patient safety incidents that occur during the provision of NHS-funded services;
  • Create a ‘safe space’ whereby participants can provide information to the HSSIB in the knowledge the information will not be shared with others, and only disclosed under certain limited circumstances as set out in legislation; and
  • Amend the Coroners and Justice Act 2009 to allow for NHS bodies, rather than local authorities, to appoint Medical Examiners; and place a duty on the Secretary of State to ensure enough Medical Examiners are appointed for England, are properly resourced and their performance monitored.

Who are the HSIB?

The team of investigators and analysts are led by Keith Conradi. He is the Chief Investigator with a plethora of experience in air accidents and a professional pilot for 40 years. Other members of his team are Dr Kevin Stewart who is the Executive Medical Director and Deputy Chief Investigator. He is a qualified Geriatrician; Lynne Spencer, Executive Director of Corporate Services who has worked in the NHS for 18 or so years in a corporate governance /risk management role and Dr Stephen Drage, the Executive Director of Investigations having previously worked as Deputy Medical Director at a large NHS Trust and still practising as an Intensive Care Consultant and Anaesthetist.

There are also sub groups of teams such as:

  • Intelligence Unit which is made up of 5 individuals who prioritise HSIB actions; manage the external Safety Awareness Notification System; manage the database of intelligence and expert advice.
  • National Investigation Team who are the core of the HSIB and oversee the investigations. The team is made up of a group of individuals with a wealth of experience in project management; serious case reviews; multi-agency investigations; management within the NHS; safety management; accident investigation; nursing; law; medicine and patient safety.
  • Maternity Investigation Team who are a team of obstetricians and midwives whose role is to investigate all maternity incidents with the NHS.
  • Senior Management Team who deal with issues pertaining to information management & technology; finance & performance; data compliance & information governance; communication; education, learning & development; policy, patient & public involvement etc.
  • Citizens’ Partnership and Delivery Group are a diverse mix of individuals who are internal and external members of the HSIB and they share their experiences and expertise in patient and public involvement to assist and raise the profile of the HSIB. Some of these individuals have experienced substandard NHS care themselves or lost a family member due to poor NHS care.

What do the HSIB do?

The crux of the reports prepared by the HSIB teams is to investigate any patient safety concern within the NHS.

The two main programmes are the National investigations and the Maternity investigations. Anyone can report a patient safety concern to the HSIB. Referrals can be made by patients; their family; NHS staff (and organisations) and the public

What is the purpose of an HSIB investigation?

The main purpose of the HSIB investigation is to carry out a thorough investigation of the circumstances pertaining to the patient safety issue and prepare a report.

The HSIB will not seek to investigate issues relating to blame or breaches of duty of care. It is not a legal investigation, however the final report is useful to you medical negligence lawyer.

The HSIB will involve the NHS Trust/healthcare professionals involved in the care; the patient and the family in the reporting process and all national investigations are published once the report is finalised.

Maternity investigations are not published but are shared with the family, NHS Trust and healthcare professionals who were involved with the patient safety incident in question.

The HSIB collates information from their investigations to enable them to identify themes with patient safety. Once they have completed a number of investigations relating to a particular NHS Trust they we hold a workshop with the NHS Trust concerned and this enables them to:

  • Minimise duplication and workload;
  • Develop feedback on common issues;
  • Raise actions that require immediate review to improve safety, in a quicker timeframe than waiting for our investigation reports to be completed.

Insofar as maternity investigations are concerned the HSIB have an agreement with the CQC in respect of sharing information relating to investigations. They also work closely with The Royal College of Obstetricians & Gynaecologists Each Baby Counts quality improvement programme and MBRRACE-UK (Mothers and Babies: Reducing Risks through Audits and Confidential Enquiries across the UK) and NHS Resolution.

How many investigations take place each year?

The HSIB carry out up to 30 investigations a year in relation to their National investigations and shockingly, as of December 2020, 1000 investigations a year in relation to their Maternity investigations. As at August 2020 there were 1,478 Maternity investigations commenced and 1083 concluded, working with 130 acute NHS Trusts in 14 regions of the UK including 10 NHS Ambulance Trusts. Not all families wish to engage with the HSIB and statistics reveal that 87% of families engaged in the Maternity investigations and slightly more at 89% engaged in the National investigation.

Has Covid-19 had an effect on HSIB investigations?

Apparently, between April 2019 – March 2020 there were 41 Maternal death referrals to the HSIB and yet between March – May 2020 there were 20.

A similar pattern emerged in respect of intrapartum stillbirth referrals; between April – June 2019 there were 24 referrals but during the period April – June 2020 there were 47, a 51% increase.

The HSIB investigations do not replace the Serious Untoward Incident Report/Root Cause Analysis report which is prepared internally by the NHS Trust involved in any serious incident. It is in addition to.

How will your medical negligence lawyer use an HSIB report?

At Osbornes law, our clinical negligence lawyers receive many HSIB reports. The information in these reports when collated with the information contained within the patient’s medical records and any other investigation reports is helpful in building the case. It does not replace any expert evidence that is required to prove a claim; or indeed the patient’s version of events. It is merely information that can be used in addition to other evidence.

Our lawyers specialise in maternity medical negligence claims and we have used HSIB reports when medical negligence has caused child injuries during birth, including cases of still birth claims and cerebral palsy claims. In the case of Gabriela Pintilie, where mistreatment tragically led to the death of a mother after giving birth, an HSIB investigation was carried out and the report formed part of our evidence against the NHS trust.

In view of the fact that many of our clients do not speak English as their first language and many are unable to understand what happened at the time of the incident in question, the HSIB are amenable to translating the HSIB reports into the client’s language so that they can fully understand the contents of the report. This is really helpful and our foreign language speaking legal team can go through these reports with the client in detail to ensure that they fully understand the content.

If you believe that a patient safety matter should be reported to the HISB or you would like to speak to a solicitor regarding any patient safety concerns; please contact Stephanie Prior. Stephanie  is head of Clinical Negligence at Osbornes. She is ranked as a leading medical negligence lawyer in London and is also accredited by AvMA, the leading charity championing patient safety.

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