Draft Health Service Safety Investigations Bill: A new capability for investigating patient safety incidents Contents

5Scope of HSSIB and the additional 1,000 maternity cases

Maternity investigations

163.In November 2017, the then Secretary of State for Health and Social Care, Rt Hon Jeremy Hunt MP, announced that HSIB would be made responsible for investigating all cases of “stillbirth, neonatal death, suspected brain injury or maternal death”:

From next year, every case of a stillbirth, neonatal death, suspected brain injury or maternal death that is notified to the Royal College of Obstetricians and Gynaecologists’ ‘Each Baby Counts’ programme—that is about 1,000 incidents annually—will be investigated not by the trust at which the incident happened, but independently, with a thorough, learning-focused investigation conducted by the healthcare safety investigation branch.210

164.The HSIB has been required to undertake the additional 1,000 investigations as a consequence of directions made by the Secretary of State to the Trust Development Authority.211 We note that it was the HSIB’s present status that allowed the Secretary of State to instruct the HSIB to assume these responsibilities.212

165.The Government confirmed that the HSIB has been directed to conduct the maternity investigations outside of ‘safe space’.213 Highlighting the difference between a local serious incident investigation and a patient safety review which utilises ‘safe space’, William Vineall said that this decision had been made because the maternity investigations “are meant to be the single investigation that covers both the clinical uncovering of the information and satisfaction for the families.”214

166.Swift and satisfactory resolution of individual cases should be the priority of maternity investigations. We were struck by evidence submitted to us by Baroness Cumberlege and Prof Sir Cyril Chantler, Chair and Vice Chair of the NHS England Maternity Review, which outlined Rapid Resolution and Redress (RRR), a process for quickly resolving complaints related to injuries at birth. RRR is structured around an immediate no blame safety investigation when birth injuries occur.215 The priorities of the investigation are to establish the facts of the case for the family involved and to provide health professionals with certainty that they can be completely open without risk of action being taken against them. Baroness Cumberlege and Professor Chantler said in their evidence that this model has been applied successfully in Sweden where “a 50% reduction in avoidable serious birth injuries over a period of 6–7 years”216 had been recorded. The RRR model serves as an illustration of how investigations which do not seek blame can be central to improving patient safety.

167.Furthermore, the Government suggested that the draft Bill may be the vehicle by which non-‘safe space’ HSSIB investigations could be established in statute, saying the “intention is that these investigations should be reflected in the remit of the proposed new body and in the Bill more generally”.217 Evidence from NHS Providers, however, outlined the uncertainty and potential confusion that could arise within the existing system if HSSIB was required to carry out investigations which essentially replace those that would ordinarily be conducted by a trust:

if the HSIB is also carrying out local investigations in place of trusts—as it now is with serious incidents in maternity and neonatal care—there is a risk they could prevent trusts from fulfilling their current responsibilities following the occurrence of a serious incident. For an organisation to be properly governed and to be held accountable, it must have appropriate oversight and control of its operations. It must also have a role in coordinating these multiple processes, for the benefit of patients, their families and staff, as well as to reduce duplication and risk. The HSIB should not and, in our view, cannot take on that role, but neither can the trust properly do it if it is, at most, an observer (as the trust role is described in the maternity investigations).218

168.As well as proceeding without the core feature of an HSSIB investigation, namely ‘safe space’, we heard evidence that the maternity investigations will transform the resource required by HSSIB to discharge its duties. In addition to its annual budget of £4.1 million, HSSIB will be allocated £9.5 million219 to conduct maternity investigations and the organisation’s headcount will also expand. Keith Conradi said that HSSIB’s planned establishment had been for a team of 18 investigators to work on 30 investigations per year,220 but maternity investigations will more than quadruple the proposed workforce and compel HSSIB to develop a different staffing structure:

We are recruiting 126 maternity investigators in a regional set-up. We have already recruited about half of those. […] Most or a great majority are seconded from trusts.221

169.It is understandable that the former Secretary of State should have wanted to leverage the expertise and capability of the present HSIB for the maximum benefit of patient safety improvement in the NHS. However, the imposition of 1,000 local maternity investigations outside of ‘safe space’ risks completely misconstruing the function of the statutory HSSIB. This decision has the potential to distort the perception of what HSSIB is for, within the health sector. We are concerned that HSSIB should be understood across healthcare. Its purpose and function is the conduct of ‘safe space’ investigations of incidents without finding blame in order to promote patient safety and learning. It is not an organisation to be tasked by others to deliver local NHS investigations.

170.The confusion about HSSIB’s intended purpose created by the direction to oversee the investigation of 1,000 maternity cases underscores the importance of HSSIB’s independence. We regard the draft Bill as an opportunity to confirm the independent status of HSSIB and to secure it in statute.

171.We recommend that the conduct of the 1,000 maternity investigations should be recognised as the responsibility of NHS Improvement, which in legal terms it already is. Once established in statute, HSSIB can continue to provide advice and guidance to NHS Improvement so that best investigative practice can be applied to maternity, or any other, investigations. However, responsibility for the maternity investigations should remain with NHS Improvement and should not be transferred to the new body. It would risk creating confusion about its role and undermine clarity and trust in HSSIB. HSSIB’s funding should be adjusted to reflect the costs of providing advice to the NHS, but it should only have responsibility for conducting its own investigations.

172.We do not believe that the draft Bill should be recast to allow HSSIB to conduct investigations which do not have the protection of ‘safe space’.

173.In Chapter 7 we make further recommendations about the role of the Secretary of State in relation to HSSIB’s freedom to choose what to investigate.

Limitation to NHS services

Independent sector

174.By clause 2(1), the draft Bill applies only to incidents which occur during the provision of NHS services or at premises where such services are carried out. This means that an independent sector organisation providing NHS funded care will fall under HSSIB’s remit but privately funded care delivered by the same provider at different premises will not. In its 2015 report, PASC recommended that the investigating body should be able to investigate non-NHS funded healthcare as well:

In order to be able to carry out comprehensive investigations in all cases, it must be free to investigate non-NHS funded healthcare as well as the NHS. Exclusion of the independent sector from the jurisdiction of the new body would not be consistent with a whole system approach, which many witnesses regard as essential.222

175.A recent CQC report on the inspection of 206 independent hospitals found 41% “required improvement” in safety (and 1% were rated inadequate).223 In response, the Secretary of State wrote to leading independent healthcare providers seeking:

urgent assurances that you will get your house in order on safety, as well as a commitment to take rapid action to match the NHS’s world-recognised progress on transparency.224

176.One independent provider, Spire Healthcare, replied that they “would welcome the ability to refer our incidents to HSIB for investigation to ensure all relevant data is available to the healthcare system as a whole, regardless of the funding source”.225 The Independent Sector Complaints Adjudication Service said:

HSSIB will only command the confidence of patients and their families and healthcare professionals if it has a remit across healthcare, whether this is the NHS or in the independent sector. […]

… patients do not follow the funding boundaries established by governments, but increasingly choose care from different providers including NHS funded care in the NHS or independent sector, as well as through self-funded care or through insurance schemes in the independent sector.226

177.Witnesses representing a broad range of opinion all endorsed this view. Amongst others, organisations and representative bodies as diverse as the Royal College of Physicians, the Royal College of Surgeons, NHS Providers, the Equality and Human Rights Commission and the Clinical Human Factors Group all said that independently funded and provided care should be subject to HSSIB investigations.227

178.Niall Dickson supported the extension of HSSIB’s investigatory scope to privately funded and provided care, but noted that this raises a question as to how this aspect of HSSIB’s work will be funded.228 Dr Chaand Nagpaul of the BMA warned that “we cannot and should not have the NHS subsidising private providers”229 and Professor Brian Toft agreed that private providers should be charged for the work HSSIB undertakes in relation to the sector.230 Professor Charles Vincent warned that direct charges for investigations could create a conflict of interest and both he and Dr Carl Macrae were supportive of a general levy that could be applied to private providers.231 Dame Donna Kinnair of the Royal College of Nursing also said that a levy on private providers may be a suitable source of funding.232

179.Our evidence was clear that HSSIB’s remit should extend beyond just NHS-funded services to the whole healthcare system. We recommend that the draft Bill should be amended to extend HSSIB’s remit to the provision of all healthcare in England, however funded. Implementing this recommendation will demand consequential amendments, including reflecting it in the title of the Bill and the name of the investigative body. We recommend that the legislation should be called the ‘Healthcare Safety Investigations Bill’ and, consequently, it would establish the ‘Healthcare Safety Investigations Body’ (HSIB) in statute.

180.NHS funding should not be used to subsidise investigative work that will also apply to the private sector. We recommend that the Government should undertake a formal consultation to explore how private providers can make a proportionate contribution to the patient safety work undertaken by HSSIB. We do, however, warn against charging fees for investigations.

Social care

181.Not only is HSSIB’s proposed scope limited to NHS provided or commissioned care, there is also no provision in the draft Bill for HSSIB to extend its investigations into local authority or privately funded social care. Sir David Behan of the CQC said that HSSIB should “have the freedom to look at the whole system”.233 He explained how the integration of NHS services and other aspects of care, such as adult social care, has reshaped the environment for inspection and investigative bodies:

If we look at how people with complex co-morbid conditions are going to be served by health care and social care services in the future, it means that more than one agency needs to operate together. Where care breaks down, it is often in the hand-offs between different bits of the system.234

182.Chris Hopson of NHS Providers agreed that HSSIB should be able to look at the entirety of a patient’s journey through the health and social care system but cautioned against it becoming the investigatory body for adult social care:

we are saying that HSSIB cannot do its job unless it has the ability to follow that whole care pathway, but that does not mean that somehow it should become a body that is equally concerned about social care. Our view would be that the scope should allow it to follow the pathway, wherever the pathway goes.235

183.Offering a perspective on behalf of patients and the public, Imelda Redmond, National Director of Healthwatch England, highlighted the frustrations that patients and their families experience when complaints and investigation systems operate in their own institutional “silos” and do not follow the patient pathway.236 Discussing the limitations of HSSIB’s scope, the Minister said that HSSIB will only be able to follow a patient pathway “where care is funded by the NHS and a patient is taken into the social care sector.”237

184.We do not believe that the draft Bill reflects the integrated nature of modern healthcare. The development of NHS Vanguards, integrated care pioneers, sustainability and transformation partnerships, and integrated care systems (amongst many other initiatives) have all sought to bring together multiple NHS services with local authority commissioned social care. In many areas adult social care staff are now working in concert with NHS teams on a daily basis, be that in primary and community services or enabling discharge from secondary care.238

185.HSSIB investigations must not exist in an NHS ‘silo’ and should be able to explore all aspects of a patient journey and the interaction between services. HSSIB, however, should not be tasked or expected to be an investigatory body for social care. Nonetheless, we do recommend that the powers associated with HSSIB investigations and the protections of the ‘safe space’ be extended to social care so that investigations can analyse all aspects of the care pathway.

HSSIB’s territorial scope

186.Clause 38 of the draft Bill specifies that HSSIB’s remit is limited to England. There are no provisions in the draft Bill to deal with cross-border healthcare issues. Jennifer Benjamin emphasised that it is not within the gift of the Department for Health and Social Care to draft health legislation which applies to the devolved nations.239 HSSIB will, however, be able to provide assistance to the devolved Governments and their health systems, if requested. ‘Giving assistance’ is defined as:

(a) disseminating information about best practice in carrying out investigations;

(b) developing standards to be adopted in carrying out investigations;

(c) giving advice, guidance or training.240

187.We asked about the implications of HSSIB’s territorial limitations in relation to cross-border NHS care, which is commonplace in the UK, and the Department assured us that HSSIB’s remit should extend to any provider commissioned by the NHS in England to provide care and “there should not be a restriction in terms of geography.”241 Jennifer Benjamin acknowledged that whether or not a patient’s treatment is funded by the NHS in England is central to determining whether it falls within HSSIB’s remit.242

188.William Vineall said that, as the draft Bill stands, a patient from Scotland, Wales or Northern Ireland, who receives a component of their care in England, may not have all aspects of their patient pathway covered by HSSIB.243 The Minister added: “We can only really deal with complaints about care pathways that start in English hospitals”,244 but this does not address the key concern that problems connected to patient safety can often occur at the ‘hand-offs’ between different services.245 Therefore, a degree of uncertainty would remain for a patient whose GP service is based, for example, in Wales but who is receiving specialist secondary care in England.

189.Questions remain about HSSIB’s scope as it relates to investigating patient pathways that cross borders between the nations of the UK. In addition, there is a lack of clarity about the scope of HSSIB to investigate incidents which occur in satellite services of English trusts based in hospitals outside of England.246

190.How the devolved Governments will respond to the development of HSSIB is yet to be seen. The Minister told us that the Scottish Government is considering establishing an equivalent to HSSIB,247 but DHSC officials confirmed that there have been no discussions as to whether any devolved Government may wish to legislate to extend HSSIB’s remit to their nations. William Vineall emphasised the importance of respecting the devolution arrangements:

It is quite important that the devolved Administrations make their own decisions, because they are devolved Administrations. That is not just an official’s answer, it is a fact of the governance that we have.248

Discussing how HSSIB will tackle investigations which have a cross-border component, Keith Conradi said that the body had already engaged with the Welsh Government and that a pragmatic response to these challenges would be for HSSIB to operate in the devolved nations.249

191.It will be for the devolved nations to determine how they wish to respond to the development of HSSIB in England. Nonetheless, we expect the devolved health systems to develop mechanisms which allow for cross-border co-operation between HSSIB and appropriate bodies in Scotland, Wales and Northern Ireland when an HSSIB investigation includes aspects of cross-border care.

192.The Government should also clarify that HSSIB’s investigation functions can be conducted in relation to any incidents occurring in England, wherever a patient may originate from, including where any significant causative factor takes place in England.

193.To address the uncertainties that will remain around the provision of cross-border services we recommend that the draft Bill should be amended to:

a)enable reciprocal arrangements between HSSIB and the devolved health systems in cases of cross-border care; and

b)allow devolved administrations to choose whether HSSIB’s remit should be extended to their territory, if they so wish.

210 HC Deb, 28 November 2017, col 179 [Commons Chamber]

212 HSIB is part of the NHS Trust Development Authority, a special health authority subject to Secretary of State Direction which (together with Monitor) operates under the umbrella body, NHS Improvement.

215 NHS England National Maternity Review (SIB0053)

216 NHS England National Maternity Review (SIB0053), p 1

217 Department of Health and Social Care (SIB0034), para 12

218 NHS Providers (SIB0045), p 3

222 Public Administration Select Committee, Sixth Report of Session 2014–15, Investigating clinical incidents in the NHS, HC 886, para 136

225 Spire Healthcare letter to Secretary of State, 21 May 2018

226 ISCAS (SIB0033), paras 1.1–1.2

227 Royal College of Physicians (SIB0019), para 2; The Royal College of Surgeons of England (SIB0018), para 12; NHS Providers (SIB0023), para 3; Equality and Human Rights Commission (SIB0008), para 13; and Clinical Human Factors Group (SIB0017), p 3

238 Health and Social Care Integration, Briefing Paper 7902, House of Commons Library, October 2017

240 Clause 16(1)

Published: 2 August 2018