In October 2023, a ground-breaking step will be taken to support learning culture around patient safety investigations in healthcare generally, and in the NHS in England in particular.¹

For the first time, safety investigations undertaken by the newly established Health Services Safety Investigations Body (HSSIB) will have legal privilege, also often referred to as 'safe space'. This means that findings of the HSSIB's safety investigations will not be admissible evidence in legal proceedings.

This is already accepted and exists for other safety critical industry investigations such as those undertaken by the UK's transport investigation branches. Through changes brought by the Health and Care Act 2022, from October 2023 the protections for witness statements will also apply to national patient safety investigations in England carried out by HSSIB, the body that will replace the current Healthcare Safety Investigation Branch (HSIB).

The General Medical Council's 'Good medical practice' (2013) gives clear recommendations on safety - "You must promote and encourage a culture that allows all staff to raise concerns openly and safely" (para 24) . However, the fear of blame and paranoia in the NHS regarding safety investigations remains widespread, most recently reinforced by the NHS national staff survey feedback. While 74.9% of staff in the 2022 survey "would feel secure raising concerns about unsafe clinical practice" is an improvement, it still leaves more than a quarter who would not.

Investigations in healthcare

Following the pattern of establishing an investigation branch following a disaster, the Healthcare Safety Investigation Branch (HSIB) was established in 2017 after the independent inquiries into Mid Staffordshire NHS Foundation Trust and Morecombe Bay NHS FT. HSIB carries out national investigations into incidents that pose a systemic risk to patient safety, and which indicate "a problem with significant impact in more than one setting."

These national investigations - up to 30 a year - are in addition to any local investigation and are published on the HSIB website. They produce recommendations at 'system' rather than local level; to national bodies that have the power to change policies and processes that shape how care is delivered. This recognises that work as imagined is often different to what is realistic and achievable within the environmental and operational conditions experienced at the frontline.

It was an important distinguishing feature that 'safe space' would apply for these national investigations, to ensure that investigation witnesses could speak freely about the problems they faced - practical, cultural, managerial - in delivering safe care. However, the necessary legislation was significantly delayed and only passed in spring 2022. The Health and Care Act 2022 has delivered some significant and important changes, and will result in the establishment of the Health Services Safety Investigation Body (HSSIB) for national investigations from October 2023. It also formalises the legal privilege or 'safe space' for these national investigations.

In 2018 HSIB's remit was expanded to include maternity investigations as part of a national plan to make NHS maternity care safer. HSIB maternity investigations are into the most serious maternity incidents as defined by RCOG's Each Baby Counts programme as well as HSIB criteria for maternal deaths. They replace the local investigations, are written for the trust and the family, are not published publicly and number approximately 1,000 per year. After October 2023, maternity investigations will move to a special health authority, maternity and newborn safety investigations (MNSI) and will not be subject to legal privilege/'safe space'.

Safe space

'Safe space' will prohibit the disclosure of any information, document, equipment, or other item held by HSSIB in connection with an investigation, apart from certain limited circumstances. These would be if there was evidence of committing an offence, a continuing serious risk to patient safety, or serious misconduct. The High Court may also order disclosure of information if it determines the interests of justice outweigh any adverse impact on future investigations by HSSIB.

However, there is clear precedent of the High Court supporting safe space in the transport investigation branches. As an example, after the Shoreham Air Show crash, Sussex police applied to the High Court for interview evidence held by the AAIB, and this was refused as it was obtained in 'safe space'.

It is important to reiterate that the protections for HSSIB investigations do not impede or prevent any other necessary investigation processes or interviewing of witnesses - it simply ringfences the HSSIB investigation materials so they can only be used for safety learning.

If an HSSIB investigation is launched into a matter involving potential criminality, relevant legal processes would need to take precedent. As we know though, the likelihood of wilful criminal conduct in patient safety incidents is vanishingly small, and increasingly likely to be picked up through processes such as the independent medical examiner process, which will soon apply to every single non-coronial death in England.

Powers and authority

There are some other changes in the authority that HSSIB will have in carrying out its investigations, including the powers of entry, inspection and seizure and the power to require information. In practice this means that HSSIB investigators will have the authority to enter premises, inspect any equipment or documents and take copies or remove any item, as long as doing so does not pose a risk to the safety of any patient. Secondly, HSSIB investigators may, by notice, require a person to attend an interview and answer questions directly related to the investigation.

Clearly, the professional duty held by many of those involved in an investigation means that these powers are unlikely to be necessary. However, it is worth considering the motive and reason for these powers. The Francis report of the Mid Staffordshire NHS Foundation Trust Public Enquiry and the Ockenden report into maternity services at the Shrewsbury and Telford Hospital NHS Trust both found that some staff were anxious and scared to raise concerns.

Therefore, the power to compel staff to take part in a safety investigation may alter the dynamic from a staff member being a whistleblower to someone being compelled by HSSIB investigators for information.

A fairer future?

These changes in the law supporting HSSIB patient safety investigations are ground-breaking in healthcare - currently, only Norway and Denmark now offer a similar approach, although more countries are showing interest in learning from the UK's lead.

They offer powerful impetus to the drive towards a learning culture in patient safety and moving away from a culture of blame and paranoia for staff. However, they may be met with caution and concern from both healthcare professionals and the public, even though the same principles underpinning safety investigations in transport are generally highly regarded as being fair. The culture of blame is not just present amongst some staff but also often expressed in the media and by the public. This is reinforced by a legal system of fault-based compensation.

It may therefore take some time for the public and media to trust that 'safe spaces' for healthcare professionals and investigations will achieve greater transparency and insight about why harm happens during healthcare, rather than less. For healthcare staff who have worked in a culture of blame, it may also take some time to trust that these powers will increase fairness for staff and patients instead of impeding it.

Some may rightly say that this only applies to HSSIB investigations - with up to 30 a year, they make up a tiny fraction of all patient safety investigations in healthcare. Many will also cite the case of Dr Bawa-Garba, whose reflective note was used in evidence when she was convicted of gross negligence manslaughter in a tragic case where there were many systems issues involved.

However, this is a crucial step in changing the culture of safety investigations in healthcare, and HSIB is proud to be at the forefront of greater fairness and learning to support improved patient safety.

The views expressed in this article are those of the authors and do not necessarily reflect those of the MDU.