Healthcare Safety Investigation Branch: An effective way to investigate medical harm?

29 March 2022

Formed in 2017, the Healthcare Safety Investigative Branch (HSIB) conducts independent investigations into patient safety incidents arising out of NHS-provided care across England and is funded by the Department of Health and Social Care and hosted by NHS England and NHS Improvement.

In January 2022, it was announced that a Special Health Authority will be established to continue the HSIB maternity investigation process, and that the national investigations programme will be carried out by the “Health Services Safety Investigations Body”

Rebecca Sellers, a specialist clinical negligence Solicitor in Shoosmiths medical negligence team, agrees there are certainly some positive aspects to the HSIB process:

“Investigations are conducted by a body independent of the Trust where the harm occurred and, ideally, the family is a part of the process as well as being given the opportunity to respond to a draft report. Depending on the outcome it could provide closure to families much sooner and could, it is hoped, result in improved patient safety.”

Working with patients, families and healthcare staff, HSIB reports never attribute blame or liability and its investigations focus on factors that have harmed or may harm patients. This provides a learning opportunity that prevent future patients coming to harm.  However, any recommendations for improvement that may be made are just that – recommendations -   without the force of legislative obligation to back them up. This raises questions as to just how independent investigators can be, despite a commitment to ‘independence, transparency and objectivity’, HSIB is, in effect, part of the NHS. Nonetheless, any additional safeguard for patient safety is always welcome.

Given her direct experience to date, Rebecca also notes some downsides to the system, especially where an HSIB report supplants local serious incident investigations. The process can be long and drawn out and result in delays, especially where multiple parties are involved:

“I am currently investigating a claim involving potential negligence where a baby was tragically born in a very poor condition and died at only six days old.  The HSIB report was delayed, and it was only when this was provided to the parents that they realised that there had also been serious problems with the way in which the baby’s resuscitation was managed. The Inquest was delayed until after the HSIB report was finalised and is yet to be listed, nearly 16 months later.” 

Rebecca also notes that many clients interpret an investigation that does not attribute blame or liability as not really being thorough in obtaining an explanation. Often, reports use terminology such as ‘may have impacted on the outcome’ or ‘did not impact on the outcome’ which does not give any certainty to families about what did actually happen.  

HSIB investigations are delivered through two programmes: national and maternity. There are differences in how they are carried out and how reports are published but the stated aims of both are to share learning and to make recommendations that improve patient safety at a national level.

HSIB investigations of national cases does not replace local serious incident investigations which take place within the Trust (or other NHS body) where the harm occurred. Rather, they are concerned with issues where there may be a wider, similar, risk across the entire NHS. In addition, any safety recommendations made on a national level are sent to the national bodies that should drive improvement, and not directly to the Trust being investigated.

Midwifery cases examined by the HSIB do replace local serious incident investigations within a Trust, who, in theory, abdicate their investigations to HSIB. Figures suggest that the HSIB midwifery team investigated 1,719 incidents between April 2018 and April 2021. In order to be investigated, referrals must first come from the Trust potentially under investigation, but anyone can refer something as long as it involves NHS funded care in England.

HSIB investigations are published on their website and bodies which are sent the reports, such as NHS England or NHS Resolution (NHSR), have 90 days to respond. One other process that impacts families and Trusts in these matters is the NHSR Early Notification Scheme. This is supposed to help speed up investigations into brain injury cases and also implement any learning to make midwifery and neonatal services safer. Where there has been a HSIB investigation involving a potential brain injury in an infant, it is referred to NHS Resolution, which is an enthusiastic supporter of the NHSR Early Notification Scheme.

Rebecca suggests therefore that, while no one doubts their good intentions, it would sometimes be unwise to rely entirely upon an HSIB investigation to get to the truth about what caused very serious harm or even a death:

“When making a civil claim, which will establish if an injury has been caused by negligence on the balance of probabilities, the family gets some degree of certainty with an independent clinical negligence expert. They will also have an opportunity to address all of their concerns with the Trust via their solicitors, not just those issues that a HSIB investigator deemed relevant. While a HSIB report may encourage an apology from a Trust, if negligence is found then a claim for damages can help a family face an uncertain future, insofar that compensation can ever put right any harm that has been caused.”



This information is for educational purposes only and does not constitute legal advice. It is recommended that specific professional advice is sought before acting on any of the information given. © Shoosmiths LLP 2024

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