The Health Services Safety Investigations Body and the Health and Care Bill 2021: Safe Spaces or a worrying lack of candour?

Published: Posted on

In this blogpost, Professor Jean McHale examines pertinent provisions of 2021 health and Care Bill, currently progressing through the legislative process

The Health Services Safety Investigations Body and the Health and Care Bill 2021: Safe Spaces or a worrying lack of candour?

The Health and Care Bill 2021 is currently before the House of Commons in Committee stage. It is  wide ranging Bill covering  a myriad of issues including  major NHS reorganisation, public health powers, provisions concerning use of patient information  and  hospital food safety standards  This blog focuses upon one part of the Bill – Part IV and Schedules 13 and 14 of the Bill which concerns the establishment of the Health Services Safety Investigations Body.  Concerns about NHS patient safety are nothing new. This is an area characterised by damning report after damning report over decades- from the Bristol Royal Infirmary Inquiry Report into the deaths at the cardiac paediatric unit at that hospital published in 2001[1], through to the widespread investigation into the litany of failures of care and deaths of patients at Stafford Hospital in the Mid-Staffordshire Inquiry[2] to more recent events such as the deaths of women and babies highlighted in the Morecambe Bay Inquiry.[3]   One of the very many recommendations of the Bristol Royal Infirmary Inquiry Report in 2001 was that of the establishment of a duty of candour- an obligation to be frank and honest and to admit mistakes to patients where these had occurred.  It wasn’t however until 2014 before this recommendation- taken up in subsequent reports- was finally enacted.[4] At the same time it was seen that health care professionals themselves should be able to “speak up” and if needed blow the whistle on poor patient care.[5]   But there was also another thread of policy rooted in the concern that the invasive nature of investigations leading to public condemnation of individuals for mistakes could deter effective learning when things went wrong. Instead of incidents being identified early and problems addressed the prospect of litigation could inhibit effective learning. It was suggested that for effective safety investigations health care professionals needed a “safe space” in which to be able to come forward and frankly admit mistakes which could then feed into the safety learning process, without sanction a model operational in areas such as civil aviation. This led to a call for specific legislation to enable the establishment of an investigative structure where individuals could come forward subject to statutory protection and to initially draft legislation followed by the Health Service Safety Investigations Bill in 2019 which got to second reading in the House of Lords. In the meantime a non-statutory body the Healthcare Safety Investigations Branch had been established which had undertaken a number of investigations produced reports highlighting problems arising and broad lessons to be learnt from incidents but not pinning blame on individuals.[6] This was though a non-statutory body with no powers for example, to compel evidence.

The proposals to  create a new statutory investigative body which can investigate and individuals can disclose to under the security of safe space are now back in Parliament with some amendment  from the original proposals in Part IV and schedules 13 and 14 of the Health and Care Bill 2021.  The Bill which applies to England establishes the Health Services Safety Investigations Body (HSSIB), a non-Crown Body.[7] The HSSIB can investigate “qualifying incidents” which took place when healthcare services were provided with the intention of identifying patient safety risks and also improvements which can be undertaken as a result to the healthcare system.[8] This applies to both NHS and independent sector provision and is a change from the original Bill which excluded the independent sector. It raises the question as to the extent to which private sector services should be subject to such safe space protection as well as the NHS. Its investigatory powers include powers of investigation, entry and seizure and to require information.[9] The HSSIB’s scope is expressly limited to exclude any assessment or determination of blame, civil or criminal liability, or as to whether a regulatory body should take action regarding a particular individual.[10] Rather, as with the existing non-statutory body, the intention is for “general lessons” to be drawn and for these to be utilised to prevent patient safety incidents in the future.[11] This approach is also reflected in  that while a Final Report will be produced as a result of  an investigation  the Report is to focus on those patient safety risks and exclude assessment/determination of blame or liability in criminal or civil law or whether specific action needed to be taken by a regulatory body. In addition such Reports will not be admissible in civil or criminal proceedings, employment tribunals or regulatory bodies.  Section 106  sets out what the Explanatory Notes refer to as being the “safe space provision”  This is the  statutory prohibition on disclosure by the HSSIB or individuals connected with them to disclose information/documents and other materials which are concerning HSSIB investigations and which have not already been made available to the public.  Specific criminal offences in relation to disclosure of information obtained in HSSIB investigations are also set out in section 108.

The Bill however sets out various exceptions to the prohibitions on disclosure. First, the High Court can order disclosure of the Report in subsequent proceeding but only if it decides that the “the interests of justice served by admitting the report outweigh

(a) any adverse impact on current or future investigations by deterring persons from

providing information for the purposes of investigations, and

(b) any adverse impact on securing the improvement of the safety of health care

services provided to patients in England.[12]

There are other exceptions to disclosure of information obtained during investigations provided for in the legislation. For example, the Chief Investigator can disclose material if it is “necessary to address a serious and continuing risk to the safety of any patient or to the public”, they “reasonably believes that the person is in a position to address the risk, and finally this disclosure is limited to what is necessary for that person take the requisite steps to address the risk.[13] An individual may also apply to the High Court for disclosure of information obtained in the investigation. This will involve an interesting balancing exercise. Schedule 14 provides that the High Court can only make an order

“if it determines that the interests of justice served by the disclosure outweigh

(a) any adverse impact on current and future investigations by deterring persons from

providing information for the purposes of investigations, and

(b) any adverse impact on securing the improvement of the safety of health care services

provided to patients in England.”[14]

How precisely this will work in practice of course remains to be determined –what is critical is that the interests of justice themselves are not fundamentally undermined by this provision.  Going forward there is also the question as to how the HSSIB will relate to other bodies which may be contemporaneously undertaking investigations. There is provision for co-operation by “listed bodies” in relation to investigations and there are a wide range of bodies from NHS Trusts to regulatory bodies such as the Human Fertilisation and Embryology Authority.[15] It remains unclear as to precisely how these investigations will operate.  Concerns have been expressed that the legislative exceptions could ultimately increase rather than reduce litigation costs if successive actions are brought before the court seeking disclosure under the legislation.[16]  Moreover as Sir Robert Francis QC formally chair of the Mid Staffordshire Inquiry noted in evidence at Committee stage in September 2021

“as a lawyer, I would be very hesitant on the advice I would give to someone on

the basis of the Bill as it stands, because there is no certainty that what goes into the safe space stays there.”[17]

Some final thoughts.  First, is the HSSIB is actually needed at all? As Lord Foulkes in the debates in the previous iteration of the legislative proposals asked

“Do we really need this additional body? It will take over from its non-statutory predecessor, set up in April 2017 Was that body really considered insufficiently independent? Was its work really hampered by lack of statutory powers?”[18]

Two years on these points surely still have force- has the case for this new body really been made? Is there really overwhelming evidence that the HSSIB is fettered by lack of statutory powers? Secondly, there has been much stress on the idea of the safe space model working well in aircraft accident investigations. But are these really comparable?  One of the first references in a NHS report to the airline accident investigation model- that of the Chief Medical Officer’s Report “An Organisation with a Memory” in 2001 highlighted a range of factors which had impacted on improvements in Aviation Safety- the safe space while listed was only part of a much more complex picture.[19]  Thirdly, what about all this concern to exclude blame- going back to   “An Organisation  with  a Memory” the need to  hold individuals to account was  noted in that Report. This too is perhaps something else this organisation has forgotten.

Ultimately as I suggested after the original proposals were advanced for the HSSIB in 2017 there is and remains an inevitable tension between the emphasis on the importance of the duty of candour – frankness and transparency owed to patients and the approach taken here concerning safe space.[20] This is particularly worrying at a time where there is a growing number of prosecutions of NHS bodies who have failed to comply with the duty of candour.[21]  After all the years it took to get statutory recognition of the duty of candour itself it is a matter of concern  as whether  this new  “safe space” introduced with the aim of improving patient safety could ultimately simply undermine  it and  have a chilling effect on transparency and accountability in healthcare.

 

 

[1]  Professor Sir Ian Kennedy Learning from Bristol, Cm 5207, London: 2001 The Stationery Office,

[2] R.  Francis, Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry, HC 898, 3 volumes, London: 2013 The Stationery Office. Page 10. (2013, Vol 1)

[3]  B.Kirkup The Report of the Morecambe Bay Investigation (2015) The Stationary Office.

[4]  Section 81 Care Act 2014 implemented in Regulation 20 of The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.

[5] R. Francis, Freedom to Speak Up. An independent review into creating an open and honest reporting culture in the NHS. Report. (2015).

[6] https://www.hsib.org.uk/

[7]  Section 93 and Schedule 13 Health and Care Bill 2021.

[8]   Explanatory Notes, para 8.31.

[9] Sections 102 and 103 Health and Care Bill 2021.

[10] Section 94, Health and Care Bill 2021.

[11] Explanatory Notes, para 8.33.

[12] Section 101(5) Health and Care Bill 2021.

[13] Schedule 14(4).

[14] Schedule 14(5)(4)

[15] Section 110.

[16]  Baroness Thornton suggested in the debate in House of Lords on Health Service Safety Investigations Bill 29th October 2019.

[17] Committee stage in the House of Commons on 7th September 2021.

[18] Debate in House of Lords on Health Service Safety Investigations Bill 29h October 2019.

[19] CMO An organisation with a memory. Report of an expert group on learning from adverse events in the NHS chaired by the Chief Medical Officer, London:  2000, DH

[20] J.V. McHale “Patient Safety, the safe space and the duty of candour” in J. Tingle, C. O’Neill and M. Shimwell (eds) Global Patient Safety Law Policy and Practice (Routledge 2018).

[21] F. McNamara. “ Care Quality Commission issues fine to Bradford Teaching Hospitals NHS Foundation Trust “ 18th January 2019, Telegraph and Argus https://www.thetelegraphandargus.co.uk/news/17366089.care-quality-commission-issues-fine-to-bradford-teaching-hospitals-nhs-foundation-trust/; S. Lintern “NHS trust fined over lack of honesty with family after mother’s death”  20th July 2021 https://www.independent.co.uk/news/health/cqc-candour-doncaster-death-nhs-b1887175.html

Share:

Leave a Reply

Your email address will not be published. Required fields are marked *