The first reading of a Bill which will implement the NHS' long-term plan in England to establish an independent body to investigate serious healthcare incidents took place in the House of Lords last week.
This will give statutory powers to the Healthcare Safety Investigation Branch, an organisation which has been operational since April 2017 and is funded through the Department of Health and Social Care and hosted by NHS England and NHS Improvement. Should the Bill receive Royal Assent next year, it is proposed that the organisation will run in "shadow form" for around a year and then go fully operational in Autumn 2021. It will be known as the Health Service Safety Investigations Body (HSSIB).
The HSSIB will investigate serious incidents in healthcare. It will value independence, transparency, objectivity, expertise and learning for improvement and aim to create a safe space so NHS staff can raise concerns and speak out without fear of reprisal so patient safety can be improved. It is recognised that a culture in some parts of the NHS can deter staff from speaking out which can have a negative effect on both those who are brave enough to do so and patient safety.
The idea is that HSSIB will not attribute blame or liability against any individual; it will reflect the successful implementation of similar schemes in the air and marine industries. HSSIB will strive to improve the quality and effectiveness of local investigations by developing standards and providing advice, guidance and training to organisations. The expectation is the public will be given confidence in the independence of the HSSIB who will be trusted to carry out fair and unbiased investigations and provide potential system-wide learning for the NHS.
The "safe space" is to be achieved by independent investigating teams with a prohibition on disclosure of certain documentation held in connection with the investigation except in certain circumstances. Clearly if an offence has been committed then information can be disclosed to the police and it will also be possible to disclose information to other state bodies for the purpose of dealing with an identified risk. It may also be disclosed if misconduct has been identified.
A report must be published on the outcome of the investigation and this must include a statement of findings of fact made and recommendations as to actions to be taken. The report must focus on risks to patient safety and how those risks can be addressed. A draft of the report must be sent before being published to every person who participated in the investigation.
The Bill is designed to give HSSIB some teeth and so it will be granted the power to access public premises and require documents to be produced; a warrant can be applied for if necessary to gain access and there will be penalties for organisations who do not comply with requests for information. Trusts will need to be alive to this and ready to co-operate with the investigation teams or face hefty fines.
Part of the Bill deals with accreditation of Trusts so they can carry out both investigations of other Trusts and their own internal investigations to the standards of the HSSIB. This is of course something Trusts already have considerable experience in but any Trust wishing to be accredited will have to apply to the HSSIB and reach specified criteria. One of those criteria requires there to be procedures in place to involve patients and their families in the investigation process. Before Trusts can get accreditation to do their own internal investigations it seems they must have been accredited for external investigations and carried out a "sufficient" number of them to a "sufficiently high standard". It seems likely it will be some time therefore before Trusts will be carrying out their own investigations and it remains to be seen how many will apply to do it; it is not the case that any Trust will be accredited to do their own investigations just because they have previously carried out SUI investigations.
Unlike the content of a Trust's SUI report, an HSSIB investigation will not be admissible in the course of litigation arising from a patient's treatment unless a patient obtains an Order from the High Court. Such an Order may only be made if the interests of justice served by admitting the report outweigh the adverse impact on future investigations (it might deter persons from participating them or hamper improvement to NHS safety). This does not mean the patient at the centre of the investigation will not have seen the report – if they were involved in the investigation then they will have seen it and be alive therefore to any failings identified. Although the report could not be admitted as evidence it could still allow a claim to be constructed. In that respect perhaps the position is little different from now; it is widely accepted that transparency in healthcare investigations is important. The HSSIB aims to strike a balance between the importance of the general public seeing that investigations in serious incidents are carried out fairly and openly but still providing a safe space for staff to raise concerns without fear.
How much difference this will make to the day-to-day investigations carried out by Trusts will take time to emerge. It is however our view that Trusts should continue, at least for the time being, to carry out their own investigations irrespective of whether HSSIB are involved or not. If a claim is likely to be brought then statements need to be obtained as early as possible from relevant staff. To date the reports produced by HSIB have been relatively brief and focused on systems or generic issues and have not always been sufficiently detailed for the purposes of an inquest or legal claim. It may be sensible for Trusts to prepare a guide for their staff setting out what they should expect from HSSIB and the safe space that offers but also why the Trust's own record and investigations remain important.
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