Plans for a new statutory patient safety investigations system took another step forward this week with the publication of the Health Service Safety Investigations Bill.
By way of headlines, once the Bill becomes law, it will:
- Establish the new Health Service Safety Investigations Body (HSSIB), which will be a more powerful, statutory version of the existing Healthcare Safety Investigation Branch (HSIB);
- Enable HSSIB to investigate incidents (which meet the criteria it sets) involving NHS services, including services provided by the independent sector under NHS contracts;
- Give HSSIB wide powers of entry/seizure and make it a criminal offence to fail without reasonable excuse to answer questions/provide information to HSSIB as requested;
- Create a 'safe space' for HSSIB investigations by prohibiting HSSIB from disclosing any information it holds except in very limited circumstances.
We look at the Bill's key provisions and what to expect next.
What's the context of this?
The idea of creating a fully independent body with statutory powers to investigate patient safety incidents (along the lines of the Air Accidents Investigation Branch) has been on the cards for some time, with the draft version of the new Health Service Safety Investigations Bill having been published over two years ago.
The idea set out in the draft bill of NHS Trusts potentially becoming accredited to do their own 'safe space' investigations has been completely dropped in the Bill itself, but plans for the new independent investigations body - the Health Service Safety Investigations Body (HSSIB) - remain broadly along the lines envisaged in the draft.
The new HSSIB will replace the existing Healthcare Safety Investigation Branch (HSIB), which has completed around 15 investigations into a wide range of patient safety incidents since it became operational in April 2017 and has a number of investigations ongoing, including investigating all adverse outcomes (babies born compromised) in maternity cases in England.
What will HSSIB be able to investigate?
Under the Bill, HSSIB's function will be to investigate 'qualifying incidents' that occur during the provision of NHS services or at premises where NHS services are provided.
Although a recommendation (made by the Joint Committee examining the draft bill) to extend HSSIB's reach to privately funded healthcare has not been taken up in the Bill, services provided by independent sector providers under NHS contracts will come within HSSIB's remit.
Decisions about what counts as a 'qualifying incident' will be made by HSSIB in line with criteria which it will set and publish.
In carrying out its function of investigating incidents to identify and address risks to patient safety, HSSIB will not be allowed to assess/determine blame, civil or criminal liability or whether action needs to be taken by a regulatory body in relation to any individual.
Will organisations/individuals have to cooperate?
In short - yes - because HSSIB will have strong legal powers to require them to do so.
As well as a power to enter and inspect premises and to seize and remove any document or equipment which an HSSIB investigator deems necessary for their investigation, investigators will have the power to give notice to any person requiring them to attend at a specified time and place and answer questions (i.e. be interviewed) and/or requiring them to produce any document, equipment or other item specified by the investigator.
Apart from legally privileged information (which would not have to be provided), the only grounds for resisting such requests would be if answering the questions/handing over the information would risk the safety of any patient or if it might incriminate the person being asked.
Importantly, failure to cooperate with HSSIB could have serious consequences because the Bill stipulates that anyone who intentionally obstructs an HSSIB investigator, fails (without reasonable excuse) to comply with a notice to attend to answer questions and/or provide documents or knowingly provides HSSIB with false/misleading information will be committing a criminal offence.
To what extent will HSSIB be able to pass on information obtained for its investigations?
One of the key drivers behind the creation of HSSIB is the idea that the best way to maximise learning from incidents is to focus on systems not individuals and to create a 'safe space' for people to be open/frank about what they think went wrong without fear that this will lead to them being penalised. Although the phrase 'safe space' does not appear in the Bill itself, this concept is central to the tight limitations placed on the extent to which HSSIB will be able to share the information it gathers in the course of its investigations.
Under the Bill, information/documents/equipment etc held by HSSIB in connection with its investigations are classed as 'protected material' and the HSSIB is prohibited from disclosing this except in very limited circumstances, which are (1) if the Chief Investigator reasonably believes the disclosure is necessary to address a serious and continuing risk to the safety of any patient or the public (in which case disclosure can be made to any person believed to be in a position to address the risk) or (2) if an application for disclosure is made to the High Court and a judge decides that the interests of justice served by disclosing the protected material outweigh any adverse impact on current and future investigations by deterring people from participating in them and any adverse impact on the ability of the Secretary of State to secure improvement in the safety of NHS services.
Disclosure in breach of this prohibition will be a criminal offence.
The above restrictions apply even to organisations which would otherwise have a statutory power to require production of documents (e.g. professional regulators, CQC). The only exception relates to coroners, with the Bill providing that the HSSIB can disclose protected material to a coroner but the coroner cannot then pass on that information without first obtaining an order from the High Court (as above).
What about HSSIB investigation reports?
When HSSIB completes an investigation, it must publish a report on the outcome, including findings of fact/analysis and recommended actions.
Before publishing a report, HSSIB must send a draft to anyone HSSIB reasonably believes could be adversely affected by the report once published. Reports will not include the name of any participant in the investigation without that person's consent.
HSSIB reports will not be admissible in any civil, criminal or regulatory body proceedings, unless the High Court makes an order that the interests of justice in admitting the report outweigh the adverse impact of doing so.
Will HSSIB's recommendations have teeth?
Yes, some. Recommendations in the report must identify the person(s) who is to take each specified action and set a deadline for them to provide a written response to HSSIB. The written responses must set out the actions which will be taken and HSSIB may publish those responses.
How will the HSSIB's investigation 'assistance' function work?
In addition to its investigation function, the Bill provides that - if asked - HSSIB must give assistance to specified NHS bodies (including NHS Trusts and CCGs) in relation to incident investigations. Under the Bill, this 'assistance' can cover disseminating information about best practice, developing standards to be adopted and giving advice, guidance or training (unless HSSIB deems it impractical to do so).
The Bill also enables HSSIB to give assistance regarding investigations to any person not falling within the list of specified bodies (e.g. to an independent sector provider), although HSSIB would be able to charge on a commercial basis for doing so.
The legislation required to bring the new HSSIB into existence has now started on its journey through Parliament. With the Bill having been introduced in the House of Lords this week, its second reading is scheduled for 29 October 2019. Once it has proceeded through various stages of scrutiny and amendment in the House of Lords, the Bill will go through a similar process in the House of Commons, until eventually receiving Royal Assent and becoming law.
Whilst we cannot know at this stage exactly when that will happen, organisations could start considering now how they plan to ensure that their Board and staff are fully aware of HSSIB's functions and powers, which will be important when the time comes, especially given the potential criminal offences for non-compliance created under the Bill.
In the meantime, the existing HSIB will carry on its work and healthcare providers should ensure they continue to take on board the national learning/good practice recommendations arising from those investigations.
How we can help
Our national teams of healthcare regulatory and clinical risk lawyers have extensive experience of supporting and advising healthcare 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.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.