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The HSIB; a new approach or a lost opportunity?

Published 1 July 2016

Healthcare Safety Investigation Branch

On 1 April 2016, the legislation which provides for the establishment of the Healthcare Safety Investigation Branch (HSIB) came into force. The National Health Service Trust Development Authority (Healthcare Safety Investigation Branch) directions 2016 sets out the functions of the HSIB and details the role of the chief investigator to ensure that it is in a position to commence activity by April 2017.

The background to the creation of this new body goes back to March 2015, when the Public Administration Select Committee (PASC) published a report titled ‘Investigating clinical incidents in the NHS’. The committee called for:

‘a new, single, independent and accountable investigative body to provide national leadership, to serve as a resource of skills and expertise for the conduct of patient safety incident investigations, and to act as a catalyst to promote a just and open culture across the whole health system.’

The government response, Learning not blaming, in July 2015 agreed that there should be a new, national independent patient safety investigation service offering support and guidance to NHS organisations on investigations as well as carrying out certain investigations itself. The guiding principles for the new body being objectivity, transparency, independence, expertise and learning for improvement.

An Expert Advisory Group (EAG) was set up to advise on the purpose, role and operation of the new body. Their report, published on 12 May 2016, made recommendations to improve the quality of clinical investigations across the NHS in England. These included proposals for how to: guarantee its independence; ensure its aim is not to apportion blame or liability; allow patients, families and staff, to be active participants in the process; use the branch to drive system-wide improvement; and create a just culture of trust, honesty and fairness.

The directions set out the function of the HSIB and its chief inspector:

The HSIB will investigate incidents or accidents which evidence risks affecting patient safety, ascertain and analyse the facts and identify improvements in services or the conduct of other functions for the purpose of the health service. Such risks may include those resulting in repeated preventable or common occurrences, those indicating a systemic problem with significant impact in more than one setting, or those involving new or novel forms or risks of harm.

The Department of Health has stated that HSIB will conduct 30 investigations a year with an annual budget of £3.6 M.

The directions explicitly state that it is not the function of the HSIB to identify civil or criminal liability, nor to apportion blame or support fault –based legal, regulatory or other formal action. The directions also set out a ‘safe space principle’. This is based on the view that investigations are best informed by comprehensive and candid contributions, which are more likely to be made where there is confidence that they will be used not to apportion blame but to identify improvements. So the directions state that disclosure of material gathered by the HSIB should be avoided unless there is an overriding public interest or legal compulsion to do so- and disclosure of any material outside the HSIB requires the approval of the chief investigator.

The directions do not provide the level of independence called for by the PASC, requiring only that reasonable steps must be taken to protect the independence of the HSIB from the other activities of the Trust Development Authority (replaced and renamed by NHS Improvement).

In June 2016, the Public Administration and Constitutional Affairs Committee (which has replaced the PASC) published the report of their inquiry into the Parliamentary and Health Service Ombudsman’s critical review of 150 NHS investigations from December 2015. The committee describes the government’s decision to locate HSIB within NHS Improvement, as ‘both disappointing and unacceptable’. It calls on the government to bring forward the primary legislation necessary to secure HSIB’s independence and to create a ‘statutory safe space’ with protection for all those involved in HSIB’s investigations can speak honestly and openly without fear of blame.

Endorsing the appointment of Mr Keith Conradi as first Chief Investigator of HSIB, the PACAC concluded that his experience as Chief Inspector of the Air Accidents Investigation Branch and proven ability to run independent safety investigations will enable him to strengthen the independence of HSIB’s operations. However, the Committee concludes:

“We remain deeply concerned that HSIB has been established without the necessary primary legislation to assure the independence of the new body and create a statutory ‘safe space’ and that it has been established inside an existing NHS regulator rather than as an independent body. The government must take seriously the need to provide HSIB with a legislative base that will enable it to carry out its functions to full effect and to establish it as an independent body. The government should bring forward appropriate primary legislation without delay.”

There is much to be done to turn aspiration into reality and this is an occasion for turning to the strong arm of the law. Our next blog about the HSIB will look in more detail at how the branch can have the greatest impact on learning from safety incidents.

The HSIB; a new approach or a lost opportunity?

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