{"id":80,"date":"2021-10-20T14:09:56","date_gmt":"2021-10-20T13:09:56","guid":{"rendered":"https:\/\/blog.bham.ac.uk\/lawresearch\/?p=80"},"modified":"2022-10-03T15:12:16","modified_gmt":"2022-10-03T14:12:16","slug":"the-health-services-safety-investigations-body-and-the-health-and-care-bill-2021-safe-spaces-or-a-worrying-lack-of-candour","status":"publish","type":"post","link":"https:\/\/blog.bham.ac.uk\/lawresearch\/2021\/10\/the-health-services-safety-investigations-body-and-the-health-and-care-bill-2021-safe-spaces-or-a-worrying-lack-of-candour\/","title":{"rendered":"The Health Services Safety Investigations Body and the Health and Care Bill 2021: Safe Spaces or a worrying lack of candour?"},"content":{"rendered":"

The Health Services Safety Investigations Body and the Health and Care Bill 2021: Safe Spaces or a worrying lack of candour?<\/strong><\/p>\n

The Health and Care Bill 2021 is currently before the House of Commons in Committee stage. It is\u00a0 wide ranging Bill covering \u00a0a myriad of issues including\u00a0 major NHS reorganisation, public health powers, provisions concerning use of patient information\u00a0 and\u00a0 hospital food safety standards \u00a0This blog focuses upon one part of the Bill \u2013 Part IV and Schedules 13 and 14 of the Bill which concerns the establishment of the Health Services Safety Investigations Body. \u00a0Concerns 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]<\/a>, 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]<\/a> to more recent events such as the deaths of women and babies highlighted in the Morecambe Bay Inquiry.[3]<\/a>\u00a0 \u00a0One 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. \u00a0It wasn\u2019t however until 2014 before this recommendation- taken up in subsequent reports- was finally enacted.[4]<\/a> At the same time it was seen that health care professionals themselves should be able to \u201cspeak up\u201d and if needed blow the whistle on poor patient care.[5]<\/a>\u00a0 \u00a0But 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 \u201csafe space\u201d 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]<\/a> This was though a non-statutory body with no powers for example, to compel evidence.<\/p>\n

The proposals to\u00a0 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 \u00a0from the original proposals in Part IV and schedules 13 and 14 of the Health and Care Bill 2021.\u00a0 The Bill which applies to England establishes the Health Services Safety Investigations Body (HSSIB), a non-Crown Body.[7]<\/a> The HSSIB can investigate \u201cqualifying incidents\u201d 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]<\/a> 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]<\/a> The HSSIB\u2019s 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]<\/a> Rather, as with the existing non-statutory body, the intention is for \u201cgeneral lessons\u201d to be drawn and for these to be utilised to prevent patient safety incidents in the future.[11]<\/a> This approach is also reflected in \u00a0that while a Final Report will be produced as a result of\u00a0 an investigation \u00a0the 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. \u00a0Section 106 \u00a0sets out what the Explanatory Notes refer to as being the \u201csafe space provision\u201d \u00a0This is the \u00a0statutory 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. \u00a0Specific criminal offences in relation to disclosure of information obtained in HSSIB investigations are also set out in section 108.<\/p>\n

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 \u201cthe interests of justice served by admitting the report outweigh<\/p>\n

(a) any adverse impact on current or future investigations by deterring persons from<\/p>\n

providing information for the purposes of investigations, and<\/p>\n

(b) any adverse impact on securing the improvement of the safety of health care<\/p>\n

services provided to patients in England.[12]<\/a>\u201d<\/p>\n

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 \u201cnecessary to address a serious and continuing risk to the safety of any patient or to the public\u201d, they \u201creasonably 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]<\/a> 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<\/p>\n

\u201cif it determines that the interests of justice served by the disclosure outweigh<\/p>\n

(a) any adverse impact on current and future investigations by deterring persons from<\/p>\n

providing information for the purposes of investigations, and<\/p>\n

(b) any adverse impact on securing the improvement of the safety of health care services<\/p>\n

provided to patients in England.\u201d[14]<\/a><\/p>\n

How precisely this will work in practice of course remains to be determined \u2013what is critical is that the interests of justice themselves are not fundamentally undermined by this provision.\u00a0 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 \u201clisted bodies\u201d 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]<\/a> It remains unclear as to precisely how these investigations will operate. \u00a0Concerns 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]<\/a> \u00a0Moreover as Sir Robert Francis QC formally chair of the Mid Staffordshire Inquiry noted in evidence at Committee stage in September 2021<\/p>\n

\u201cas a lawyer, I would be very hesitant on the advice I would give to someone on<\/p>\n

the basis of the Bill as it stands, because there is no certainty that what goes into the safe space stays there.\u201d[17]<\/a><\/p>\n

Some final thoughts. \u00a0First, is the HSSIB is actually needed at all? As Lord Foulkes in the debates in the previous iteration of the legislative proposals asked<\/p>\n

\u201cDo 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?\u201d[18]<\/a><\/p>\n

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?\u00a0 One of the first references in a NHS report to the airline accident investigation model- that of the Chief Medical Officer\u2019s Report \u201cAn Organisation with a Memory\u201d 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]<\/a> \u00a0Thirdly, what about all this concern to exclude blame- going back to \u00a0\u00a0\u201cAn Organisation\u00a0 with\u00a0 a Memory\u201d the need to\u00a0 hold individuals to account was \u00a0noted in that Report. This too is perhaps something else this organisation has forgotten.<\/p>\n

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 \u2013 frankness and transparency owed to patients and the approach taken here concerning safe space.[20]<\/a> 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]<\/a>\u00a0 After all the years it took to get statutory recognition of the duty of candour itself it is a matter of concern \u00a0as whether\u00a0 this new\u00a0 \u201csafe space\u201d introduced with the aim of improving patient safety could ultimately simply undermine\u00a0 it and\u00a0 have a chilling effect on transparency and accountability in healthcare.<\/p>\n

 <\/p>\n

 <\/p>\n

[1]<\/a> \u00a0Professor Sir Ian Kennedy Learning from Bristol<\/em>, Cm 5207, London: 2001 The Stationery Office,<\/p>\n

[2]<\/a> R.\u00a0 Francis, Report of the Mid Staffordshire NHS Foundation Trust Public<\/em> Inquiry, HC 898, 3 volumes, London: 2013 The Stationery Office. Page 10. (2013, Vol 1)<\/p>\n

[3]<\/a>\u00a0 B.Kirkup The Report of the Morecambe Bay Investigation <\/em>(2015) The Stationary Office.<\/p>\n

[4]<\/a>\u00a0 Section 81 Care Act 2014 implemented in Regulation 20 of The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.<\/p>\n

[5]<\/a> R. Francis, Freedom to Speak Up. An independent review into creating an open and honest reporting culture in the NHS<\/em>. Report. (2015).<\/p>\n

[6]<\/a> https:\/\/www.hsib.org.uk\/<\/p>\n

[7]<\/a> \u00a0Section 93 and Schedule 13 Health and Care Bill 2021.<\/p>\n

[8]<\/a>\u00a0\u00a0 Explanatory Notes, para 8.31.<\/p>\n

[9]<\/a> Sections 102 and 103 Health and Care Bill 2021.<\/p>\n

[10]<\/a> Section 94, Health and Care Bill 2021.<\/p>\n

[11]<\/a> Explanatory Notes, para 8.33.<\/p>\n

[12]<\/a> Section 101(5) Health and Care Bill 2021.<\/p>\n

[13]<\/a> Schedule 14(4).<\/p>\n

[14]<\/a> Schedule 14(5)(4)<\/p>\n

[15]<\/a> Section 110.<\/p>\n

[16]<\/a>\u00a0 Baroness Thornton suggested in the debate in House of Lords on Health Service Safety Investigations Bill 29th<\/sup> October 2019.<\/p>\n

[17]<\/a> Committee stage in the House of Commons on 7th September 2021.<\/p>\n

[18]<\/a> Debate in House of Lords on Health Service Safety Investigations Bill 29h October 2019.<\/p>\n

[19]<\/a> CMO An organisation with a memory. Report of an expert group on learning from adverse events in the NHS <\/em>chaired by the Chief Medical Officer, London: \u00a02000, DH<\/p>\n

[20]<\/a> J.V. McHale \u201cPatient Safety, the safe space and the duty of candour\u201d in J. Tingle, C. O\u2019Neill and M. Shimwell (eds) Global Patient Safety Law Policy and Practice<\/em> (Routledge 2018).<\/p>\n

[21]<\/a> F. McNamara. \u201c Care Quality Commission issues fine to Bradford Teaching Hospitals NHS Foundation Trust \u201c 18th<\/sup> January 2019, Telegraph and Argus<\/em> https:\/\/www.thetelegraphandargus.co.uk\/news\/17366089.care-quality-commission-issues-fine-to-bradford-teaching-hospitals-nhs-foundation-trust\/<\/a>; S. Lintern \u201cNHS trust fined over lack of honesty with family after mother\u2019s death\u201d\u00a0 20th<\/sup> July 2021 https:\/\/www.independent.co.uk\/news\/health\/cqc-candour-doncaster-death-nhs-b1887175.html<\/p>\n","protected":false},"excerpt":{"rendered":"

In this blogpost, Professor Jean McHale examines pertinent provisions of 2021 health and Care Bill, currently progressing through the legislative process<\/p>\n","protected":false},"author":1299,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[11],"tags":[],"class_list":["post-80","post","type-post","status-publish","format-standard","hentry","category-health-care-law"],"_links":{"self":[{"href":"https:\/\/blog.bham.ac.uk\/lawresearch\/wp-json\/wp\/v2\/posts\/80","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blog.bham.ac.uk\/lawresearch\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blog.bham.ac.uk\/lawresearch\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blog.bham.ac.uk\/lawresearch\/wp-json\/wp\/v2\/users\/1299"}],"replies":[{"embeddable":true,"href":"https:\/\/blog.bham.ac.uk\/lawresearch\/wp-json\/wp\/v2\/comments?post=80"}],"version-history":[{"count":4,"href":"https:\/\/blog.bham.ac.uk\/lawresearch\/wp-json\/wp\/v2\/posts\/80\/revisions"}],"predecessor-version":[{"id":84,"href":"https:\/\/blog.bham.ac.uk\/lawresearch\/wp-json\/wp\/v2\/posts\/80\/revisions\/84"}],"wp:attachment":[{"href":"https:\/\/blog.bham.ac.uk\/lawresearch\/wp-json\/wp\/v2\/media?parent=80"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blog.bham.ac.uk\/lawresearch\/wp-json\/wp\/v2\/categories?post=80"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blog.bham.ac.uk\/lawresearch\/wp-json\/wp\/v2\/tags?post=80"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}