Statutory patient safety investigations a step closer?

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Statutory patient safety investigations a step closer?

Published 2 agosto 2018

As the national drive to improve patient safety continues apace, moves to create a statutory patient safety investigations system through the Health Service Safety Investigations Body (HSSIB) have taken another step forward with the publication of a Joint Committee report on the Draft Health Service Safety Investigations Bill.

The three main pillars of the draft bill - (a) setting up a new, independent statutory patient safety investigations body (HSSIB), (b) creating a 'safe space' for those investigations by protecting information from disclosure and (c) accrediting some Trusts to carry out 'safe space' investigations themselves - have come under close scrutiny by the Joint Committee, with some game-changing recommendations now made.

Headline recommendations for changes to the draft bill include:

  • Extending the HSSIB's remit to the independent sector;
  • Giving HSSIB greater powers - e.g. to compel witnesses to provide evidence in investigations;
  • Further strengthening the 'safe space' provisions;
  • Removing the concept of certain Trusts being accredited to do safe space investigations;
  • Dropping the idea of HSSIB carrying out 'non-safe space' maternity investigations.  

We look at what the Joint Committee has said and what happens next.

Recap on the draft bill

The Draft Health Service Safety Investigations Bill was published in September 2017 and its central provisions are:

  • HSSIB - The central idea of the draft bill is to build on the existing Healthcare Safety Investigation Branch (which would be replaced) by setting up a more powerful, independent statutory patient safety investigations body - the Health Service Safety Investigations Body (HSSIB) - to investigate and identify wider learning from incidents occurring in the context of NHS-funded care. HSSIB investigations would be modelled on the 'learning not blame' principles that have been successfully applied within air accident investigations.

  • Safe Space - The draft bill creates a 'safe space' for those investigations by prohibiting disclosure of information held by HSSIB except in certain limited circumstances - i.e. if one of the statutory exceptions apply (relating to the commission of an offence, continuing and serious risks to patient safety or serious misconduct) or the High Court orders disclosure (where the interests of justice served by disclosure would outweigh any adverse impact on future investigations).

  • Trust accreditation - The current draft bill proposes the introduction of an accreditation scheme, which would allow NHS Trusts to apply to HSSIB to be accredited to carry out 'safe space' investigations at other Trusts and - if they demonstrate they can do this effectively - within their own Trust.

The proposals under scrutiny

As part of pre-legislative scrutiny of the draft bill, a Parliamentary Joint Committee (consisting members of the House of Lords and House of Commons) has heard evidence from a wide range of sector contributors, exploring key elements of the wording and impact of the draft bill. DAC Beachcroft contributed evidence via Clinical Risk partner, Matthew McGrath on a number of areas, in addition to written evidence on a broad range of legal and strategic issues raised by the committee.

The Joint Committee has today published its report delivering findings on whether the bill is likely to achieve its objective of improving patient safety and how well it would work in practice.

Questions explored by the Joint Committee included:

  • Does the draft bill give HSSIB enough power to deliver effective investigations or does it go too far?

  • Is a legally protected 'safe space' necessary for healthcare investigations and will it encourage people to speak freely?

  • Should HSSIB's remit extend to private healthcare?

  • Will the pubic have confidence in Trusts to carry out their own 'safe space' investigations?

Key findings/recommendations 

HSSIB

The principle of establishing the HSSIB to improve patient safety by conducting 'no blame' investigations into incidents selected for their learning potential is supported by the Joint Committee, although its report makes a number of recommendations about changes to the remit and powers of the proposed HSSIB.  

  • Extending remit to independent sector - Currently, the draft bill applies only to incidents occurring during provision of NHS services or at premises where such services are carried out, meaning that an independent sector organisation providing NHS funded care would fall under HSSIB's remit, but privately funded care delivered by the same provider would not.   The Joint Committee heard evidence that excluding the independent sector from the jurisdiction of the HSSIB would not be consistent with a whole-system approach. Its report therefore recommends that the draft bill should cover all healthcare in England, however funded. The report also recommends that HSSIB should be able to look into social care where this forms part of the patient journey/interaction between services (although it is emphasised that HSSIB will not be expected to be an investigatory body for social care).

    The Joint Committee further recommends that the government should undertake a formal consultation to explore how independent sector providers can make a proportionate contribution to HSSIB's patient safety work. In line with these recommendations, the report suggests dropping the reference to 'health service' in the title of both the bill and the resulting investigations body.

  • Choosing cases for investigation - Although some who gave evidence to the Joint Committee wanted more clarity on what would constitute a 'qualifying incident' for investigation, the report finds that it should be left to the HSSIB to decide which incidents it investigates according to specified patient safety benefit criteria.   It suggests, however, that HSSIB should consult as widely as possible in developing those criteria.

  • Strengthening HSSIB's powers - In the Joint Committee's view, it is imperative that HSSIB is seen as a body with which individuals and organisations must cooperate. In line with this, the report recommends making non-compliance with HSSIB requests for information a criminal offence (rather than just subject to a financial penalty as proposed in the draft bill), as it is for other safety-critical industries.   It also recommends amending the draft bill to give HSSIB a power to issue a summons to compel witnesses to give evidence to the investigation (making it clear that assisting is mandatory) and enabling HSSIB to enter premises, interview witnesses and inspect/copy/seize documents or other items without a warrant (except residential premises, which would need a warrant). It is unclear where the duplication of powers/effort between the Care Quality Commission conducting investigations into clinical events (and holding these powers already), and HSSIB, will settle.

  • HSSIB's investigation reports - The Joint Committee says HSSIB will be expected to provide sufficient detail in its reports for patients and their families to understand in clear terms what happened, what went wrong and why, and what should be done to make sure it does not happen again. Despite concerns expressed by some about the impact on rights of redress, the Joint Committee believes that the provisions in the draft bill about not being able to use HSSIB reports as evidence in proceedings to determine civil or criminal liability should remain. In fatal cases, the committee suggests that, because inquests are in principle non-adversarial, there should be no difficulty with coroners using HSSIB reports to avoid duplication of investigation.

  • Enforcing HSSIB recommendations - To avoid confusion over its role, the Joint Committee suggests that HSSIB should not be responsible for ensuring implementation of its recommendations. Instead, the report recommends that the CQC incorporates the implementation of HSSIB recommendations into its quality standards. The practical application and frequency of this is unclear, but as a minimum we would assume the intention is to ensure CQC Key Lines of Enquiry include having regard to learning outputs from the HSSIB, to enable inspection against those recommendations when issued within the sector, in the same way as NICE guidance or professional standards are benchmarked.

  • Maternity investigations - The Joint Committee is strongly of the view that the circa 1,000 maternity investigations per year which are currently to be carried out by the Healthcare Safety Investigation Branch outside the 'safe space' provisions (under the direction of the former Secretary of State for Health and Social Care) are inconsistent with the intended HSSIB's statutory function. HSSIB's role will be to carry out 'safe space' investigations to promote wider learning. It is not an organisation to be tasked by others to deliver local NHS investigations.  As such, it is recommended that these investigations be recognised as the responsibility of NHS Improvement moving forward. Once HSSIB is established in statute it can provide best investigative practice to maternity, or any other, investigations.

'Safe Space'

A key focus of the Joint Committee report is on the proposed 'safe space' provisions which would protect information provided to HSSIB from disclosure except in limited circumstances to be set out in the legislation.

Despite concerns expressed by various organisations that the 'safe space' concept will hide information which would otherwise be disclosed, the Joint Committee supports this as being an essential component of the proposed new system.   Its report emphasises that HSSIB investigations will be additional to - not a replacement for - the investigations already carried out by others (e.g. Trusts, CQC and the Health Service Ombudsman), which 'safe space' will have no impact on.   Linked with this, the Joint Committee's view is that the Duty of Candour is not diluted by the HSSIB's 'safe space' provisions in any way, despite the risk of tension between being open in one setting and being protected in another. 

 The Joint Committee also asked itself: 'How safe is the safe space?' and has identified recommendations for changes to the draft bill which would further strengthen this, as follows:

  • HSSIB should be permitted to disclose information to the police, regulators and/or the relevant Trust where the incident arose, solely on the grounds that there is a serious and continuing risk to the safety of a patient or to the public and, even then, it should disclose no more than the information necessary to enable the recipient of the information to set in train their own enquiries;

  • In relation to the test to be applied by the High Court when considering whether to order disclosure in a particular case, the draft bill should be amended to emphasise that the 'safe space' should not be compromised save in the most exceptional circumstances. It should also be made clear that the prohibition on disclosure applies equally to the Parliamentary and Health Service Ombudsman and, crucially, to coroners.

What about the impact of this in the context of clinical negligence claims? The report makes clear that the restricted disclosure under 'safe space' principles attaches only to HSSIB, and all contributors to the investigation (e.g. patients and healthcare professionals) can share the evidence they provided if they so wish. Whilst HSSIB reports would not be available to use in court under these provisions, the Joint Committee states that this does not prevent use of the knowledge gained from the report to 'inform the framing of a case for legal redress', which is of course to be expected.  We suspect, however, that there will continue to be much debate on this issue as the bill progresses through the legislative process.

Trust accreditation

The report says that many who gave evidence to the Joint Committee raised serious concerns about the idea of Trusts being accredited by HSSIB to carry out 'safe space' investigations into their own and other Trusts.

Taking into account the potential for conflicts of interest and the difficulties around objectivity, this proposal is described as 'wholly misconceived' and the Joint Committee recommends removing it from the bill completely.

However, the Joint Committee does think HSSIB should be funded to help improve the quality of investigations conducted across the health system - e.g. by training local investigators and supporting the development of courses/exams/qualifications to develop a profession of 'medical investigators'.

What next?

As the Joint Committee says, its report is just the start of parliamentary and public debate on this.

The next step will be for the government to consider the Joint Committee's recommendations (which it may or may not accept) and to produce a further version of the bill which will then be formally laid before Parliament for further scrutiny.

How we can help

Our national teams of healthcare regulatory and clinical risk lawyers have extensive experience of supporting and advising health and social care providers on a wide range of matters relating to patient safety, and the impact of the new HSSIB, including:

  • Clinical governance scrutiny to assess the effectiveness of incident investigations, organisational learning and board leadership/culture on learning;

  • Duty of Candour requirements;

  • Terms of Reference for investigations into serious incidents;

  • Reviewing draft serious incident investigation reports/actions plans;

  • Representation and support in relation to further investigations which may be linked to incidents/patient deaths, including inquests and CQC/HSE or police investigations.

Authors

Corinne Slingo

Corinne Slingo

Bristol

+44 (0)117 918 2152

Matthew McGrath

Matthew McGrath

Winchester

+44 (0)1962 705 548

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