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

Conclusions and recommendations


1.The Government should implement the technical recommendations listed in the final column of Appendix 3. (Paragraph 18)

Purpose of HSSIB

2.We welcome the clarity about HSSIB’s role. It is intended that HSSIB will be a wholly new statutory and independent capability, separate from the rest of the healthcare system, for conducting investigations into patient safety incidents. HSSIB will not be part of the complaints system. HSSIB may undertake individual investigations, but not because patients and families are dissatisfied with the outcomes of existing processes. Equally, as the Chief Investigator makes clear, HSSIB will not act as a regulator or an enforcement agency as either responsibility would compromise its role and independence from the system it is meant to be investigating. (Paragraph 29)

3.The NHS in England employs over 1.2 million people. It is not a single organisation but a complex system composed of multiple cultures across varied organisations and geographies. By the term, culture, it is important to understand that we are talking about attitudes and behaviour. Culture change is about changing attitudes and behaviour; encouraging the right attitudes and behaviour, and discouraging the wrong ones (such as bullying). This is the responsibility of every individual in healthcare and, in the NHS in particular, clinical and system leaders must take responsibility for demonstrating attitudes and behaviour consistent with a just culture. (Paragraph 42)

4.It is impossible for any single organisation to change the established values and habits prevalent within the NHS. We also recognise the work already being done by trusts—and through initiatives such as Freedom to Speak Up Guardians—to improve the culture within the NHS. HSSIB should not, on its own, be expected to achieve culture change; but, as a new and independent capability, it can provide leadership and demonstrate behaviour which will lead to a healthier and more open culture in healthcare. (Paragraph 43)

5.HSSIB investigations will operate in the ‘safe space’ which will reduce the fear of talking openly. The objective of HSSIB investigations is not to find blame. Other investigatory activity in healthcare will still focus on making assessments of responsibility and accountability for errors. In the long–term, HSSIB’s contribution to culture change will be by demonstrating to patients, clinicians, providers, regulators and other investigators the value of patient safety investigations which examine context, focus on learning, and which do not find or apportion blame. In doing so, HSSIB can influence the development of a just culture where learning is paramount and errors are understood within the context of ‘human factors’ and the environment in which individual health professionals provide care. (Paragraph 44)

The ‘safe space’ (the prohibition on disclosure)

6.We are persuaded by patients, and their representative organisations, that there is nothing unreasonable about injured patients seeking compensation or other redress. Therefore, this Bill and HSSIB should place nothing in the way of patients and their families’ ability to seek compensation. The importance of this principle is reflected in the recommendations we make. (Paragraph 54)

7.We also have been guided by a second principle, namely that the primary and overriding purpose of this Bill is to put in place arrangements that will lead to learning and improvement arising from objective and comprehensive analysis of the causes of clinical mistakes and incidents, leading to better and safer outcomes for users of the healthcare system. We do not think this second principle is incompatible with obtaining justice in individual cases, which may and should be pursued by other means. (Paragraph 55)

8.It is in the wider public interest, and in the interest of patients and everyone in healthcare, that procedures be pursued that will assist in improving patient safety. Subject to the reservations set out below, we are therefore supportive of the proposal to provide for ‘safe space’. (Paragraph 56)

9.The experience in other safety critical industries is that ‘safe space’ investigations will encourage professionals to be more open with investigators, but only time will tell how effective this will be in the healthcare sector. The ‘safe space’ approach is based on a better understanding of what people feel when they are under scrutiny. It also supports patients who do not want their information shared more widely. Although initially only introduced on a limited scale, this approach is an innovation for the healthcare sector which presents great possibility for positive evolution of the attitudes and behaviour people have tended to adopt towards patient safety incident investigations. (Paragraph 63)

10.Assuming the Government accepts our recommendation regarding the accreditation of trusts, nothing about the ‘safe space’ would prevent patients (or regulators, the police, or the public) from acquiring anything to which they currently have access. We are absolutely clear that the sole purpose of the ‘safe space’ is to facilitate gathering evidence for HSSIB’s ‘no-blame’ investigations. It does not interfere with any other investigation or inquiry procedure which already exists. (Paragraph 69)

11.Patients will not be supplied with the new evidence that HSSIB will obtain or compile. That is not the purpose of HSSIB. But we expect HSSIB to provide sufficient detail in its reports for patients and their families to understand, in clear terms: what happened, what went wrong, why, and what should be done to make sure it does not happen again. In our view, this is the purpose of HSSIB. At the same time, we recognise that some patients may not wish their information or testimony to be shared with others. (Paragraph 72)

12.We are reassured that the draft Bill will require HSSIB, before it publishes a report, to send a draft of the report to everyone who participated in the investigation, and to notify them that they have the opportunity to comment on the draft. (Paragraph 73)

13.We agree with The Patients Association that it will be very helpful to engage with patients to help them better understand what ‘safe space’ means, why it is important, and how such investigations will be conducted. It is not clear to us whether HSSIB will have the resources to sustain this important role, which is vital for patient and public confidence in HSSIB. We recommend that the Department for Health and Social Care and HSSIB engage with patients and families, and their advocates or representatives, to ensure that the ‘safe space’ is widely understood by them. (Paragraph 75)

14.While the evidence of the effect of the duty of candour on changing the culture in the NHS may be mixed, we believe it is contributing to positive change. It is clear that HSSIB, and only HSSIB, is prevented from disclosing information under the draft Bill’s prohibition on disclosure (clause 28). The healthcare professional’s duty of candour is not diluted by the ‘safe space’ in any way. Nor would other contributors to an investigation, such as patients, be barred from sharing with others the evidence they gave to HSSIB. (Paragraph 80)

15.It would not be right for this draft Bill to restrict information which is freely available at present and, in respect of HSSIB investigations, it does not do so. HSSIB’s purpose is not to provide a hiding place for uncomfortable truths, but—in the interests of patient safety—to provide the greatest possible assurance that its investigations will have no negative consequence for participants. We look at accreditation in Chapter 4, but this provides an initial, and compelling, reason why we do not support the accreditation of trusts to conduct ‘safe space’ investigations. (Paragraph 83)

16.As the Bill is drafted, it is clear that the prohibition on disclosure (by HSSIB or an accredited trust) goes much further than just witness statements. Nevertheless, and in the light of our conclusion in paragraph 63, we conclude that this blanket ban on HSSIB disclosing the evidence that it gathers or generates—with specific exceptions—is the solution most likely to achieve the aim of getting to the truth, in the interests of patient safety. (Paragraph 88)

17.We recommend that the ‘safe space’ protection be extended, so that the prohibition on disclosure in clause 28 covers any information and material disclosed to HSSIB (other than by the Secretary of State or a healthcare provider) which HSSIB reasonably considers to have been provided for the purpose of promoting patient safety, or of inviting HSSIB to investigate a matter relevant to patient safety, whether or not it leads to an investigation. (Paragraph 91)

18.The question is under what circumstances HSSIB should be allowed or obliged to disclose information and evidence protected by the ‘safe space’. We draw a consensus from our evidence. HSSIB should only be expected to disclose such information as is necessary to address a serious and continuing risk to the safety of a patient, or to the public. This is consistent both with the Government’s stated aim for the exceptions and with the principle that HSSIB should be about learning not blaming. (Paragraph 102)

19.We recognise that problems associated with mental wellbeing can affect all professional groups in healthcare, all of whom play a critical role in ensuring patient safety. We believe that the protections afforded by the ‘safe space’ will be important to health professionals who are under stress from patient safety investigations or complaints, or who may be managing mental health problems. They will be able to speak more freely in the ‘safe space’ about the nature of their work, its impact on them, and the consequences for patient safety. (Paragraph 103)

20.We conclude from the evidence that the risk of patients having to give their account twice should be minimised by practical co-operation between the regulators and HSSIB; perhaps an agreed format or set of questions for obtaining a patient’s account, with a copy retained by the patient. We discuss how HSSIB should operate in order to address this later in this Report. (Paragraph 107)

21.We have considered the concern that there is a risk of conflicting accounts rendering evidence unreliable. But we are assured it is unfounded. Any account provided to HSSIB would be protected by the ‘safe space’. Healthcare professionals will remain subject to their professional duties, not least the duty of candour. The ‘safe space’ will have no impact on these duties. (Paragraph 108)

22.We see no reason for HSSIB to disclose evidence it has received, unless it believes there is a serious and continuing risk to the safety of a patient, or to the public. The Chief Investigator of the present HSIB does not think it would be appropriate otherwise. The regulators rightly want greater certainty about what will be disclosed and this should be made clear in the Bill. (Paragraph 109)

23.We recommend that the Government amend clause 29 to permit HSSIB to disclose to police, regulators, and/or trusts:

a) solely on the grounds that there is a serious and continuing risk to the safety of a patient, or to the public; and,

b) no more than the information necessary to enable the recipient of the information to set in train its own enquiries. (Paragraph 110)

24.We are satisfied with the provision in clause 30 setting out the power of the High Court to order HSSIB to disclose information, and the test it is to apply. The High Court will only be able to do so if it determines that the interests of justice served by disclosure outweigh any adverse impact on the ability of the Secretary of State to improve the safety of NHS services, or on people’s willingness to participate in future HSSIB investigations. This should only be in the most exceptional circumstances. (Paragraph 112)

25.To avoid any perceived dilution of the ‘safe space’, and to put the question beyond doubt, we recommend that the Bill expressly prohibit both the Parliamentary Commissioner for Administration and the Health Service Commissioner for England from having access to the information and material in clause 28 of the draft Bill, regardless of their entitlement under any other legislation. These bodies are well used to conducting their own investigations without access to HSSIB material. In this respect, the introduction of HSSIB has no impact on them whatsoever, except that they will be able to draw upon the reports and other material published by HSSIB. (Paragraph 117)

26.We recommend that the draft Bill be amended to put beyond any possible doubt that the ‘safe space’ cannot be compromised save in the most exceptional circumstances, and therefore that the prohibition on disclosure applies equally to disclosure to coroners. (Paragraph 119)

27.In the light of the two preceding recommendations and for the avoidance of any doubt, we recommend that the Government clarify, both in public statements and in the legislation, that the prohibition on disclosure is of application in all circumstances, except as provided for in the Bill itself. (Paragraph 120)

28.HSSIB needs the freedom (but should not be under any obligation) to release factual information during an investigation which could be of benefit to patient safety. We note that this reflects the way the HSIB currently operates. We therefore recommend the Bill be amended to allow disclosure, where in the view of HSSIB there may be a benefit to patient safety, to regulators, NHS bodies, suppliers, manufacturers, or the Secretary of State, of the information HSSIB deems of potential benefit, but not including

a)statements taken from any person in the course of an investigation, or submitted to HSSIB for the purpose of inviting it to investigate;

b)any information likely to reveal the identity of—

i)an individual who has given evidence, or

ii)any individual involved in an incident; or

c)drafts of interim or final reports. (Paragraph 124)

29.The Government should consider whether some of the other categories of material ought to be added to the above list of exclusions, and it should be guided by EU air accident investigation provisions. (Paragraph 125)

30.We understand the concern of some patient groups that they will not be able to use the information published by HSSIB to obtain justice or compensation. However, this does not prevent anyone from using knowledge gained from HSSIB published material to inform the framing of a case for legal redress. As previously stated, we are committed to the principle that this Bill should do nothing to restrict patients’ ability to seek redress. We are satisfied that it does not do so. (Paragraph 130)

31.There is no difficulty with coroners using reports from HSSIB and, where appropriate, hearing from its investigators to avoid duplication of investigations. (Paragraph 133)

32.We recommend that any evidence given to the coroner by HSSIB, including that given by investigators in oral evidence, be subject to the same test for admissibility in other proceedings as are reports of HSSIB, so that evidence given to the coroner does not become a ‘back door’ means of using in court information that was shared in the ‘safe space’. (Paragraph 134)

33.We raised with the Government the question of the draft Bill’s compatibility with data protection legislation (including EU law). There should be no question that the ‘safe space’ could be subject to any data access or freedom of information requests. We are satisfied with the Government’s assurance that ‘safe space’ information would be exempt from access requests under data protection legislation and invite the Government to give us the same assurance in relation to freedom of information requests. (Paragraph 138)

‘Safe space’ investigations by accredited NHS trusts

34.Accreditation of NHS trusts to undertake ‘safe space’ investigations risks creating conflicts of interest, since trusts have an interest in the information held in the ‘safe space’. An NHS trust may be the employer of those who are subject to the investigation, and may be subject to civil or even criminal proceedings. These conflicts would undermine public trust that the principle of ‘safe space’ was being used solely in the interest of patient safety, and this would damage the whole perception of ‘safe space’ investigations. (Paragraph 156)

35.NHS trusts have an obligation to continue to investigate complaints and patient safety incidents in a transparent and open way, but they cannot be as objective and independent as HSSIB will be. If ‘safe space’ investigations prove as valuable as we expect, and there is demand for more capacity for such investigations, accrediting trusts to conduct them is not a credible solution. The Government would have to choose whether or not to grow the capacity of HSSIB to do more. There is no other option. (Paragraph 157)

36.Furthermore, accreditation of trusts to conduct ‘safe space’ investigations will turn HSSIB into the de facto regulator of accredited trusts. HSSIB should not be a regulator in any sense or there will be confusion about its primary function. HSSIB represents a new capability for investigating patient safety incidents, and that is all. We established in Chapter 2 that the purpose of HSSIB is to be an independent investigatory body. (Paragraph 158)

37.HSSIB does, however, have an important role to play in promoting better standards for local investigations, which trusts and other bodies will continue to conduct without the ‘safe space’ We believe that improvements to patient safety can be best achieved by HSSIB working with providers to:

a)model best practice and develop methodologies which enhance the quality and consistency of local investigations conducted by trusts;

b)train local investigative staff in conducting investigations which find fact and identify learning but do not apportion blame; and

c)support the development of a curriculum, courses, examinations, and qualifications so that a new profession is developed, namely one of professional medical investigators.

In doing this HSSIB could help lead progress towards the wider culture change that witnesses to our inquiry have called for, but it will require additional resources. (Paragraph 159)

38.We believe that accreditation of trusts to conduct ‘safe space’ investigations is wholly misconceived. As has been noted, it would be like allowing an airline to investigate their own air accidents in place of the Air Accident Investigation Branch of the Department of Transport. Accredited trusts could not be objective. Accredited trust ‘safe space’ investigations would also risk undermining public confidence in the whole idea of ‘safe space’ investigations. (Paragraph 160)

39.We recommend Part 3 of the draft Bill (Investigations by accredited foundation or NHS trusts) be removed altogether. The Government’s policy should not be for HSSIB to accredit ‘safe space’ investigations at local level but to support HSSIB in improving the quality of all local investigations. We recommend that the Government should also be ready to grow the capacity of HSSIB once the value of ‘safe space’ investigations is established, and if there is demand for HSSIB to do more. (Paragraph 161)

40.All of the recommendations set out in this Report are predicated on the Government accepting our recommendation to remove the accreditation of NHS trusts from the draft Bill. (Paragraph 162)

Scope of HSSIB and the additional 1,000 maternity cases

41.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. (Paragraph 169)

42.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. (Paragraph 170)

43.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. (Paragraph 171)

44.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’. (Paragraph 172)

45.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. (Paragraph 179)

46.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. (Paragraph 180)

47.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. (Paragraph 184)

48.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. (Paragraph 185)

49.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. (Paragraph 189)

50.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. (Paragraph 191)

51.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. (Paragraph 192)

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

a)enable reciprocal arrangements between HSSIB and the devolved health systems in cases of cross-border care; and (Paragraph 193.a))

b)allow devolved administrations to choose whether HSSIB’s remit should be extended to their territory, if they so wish. (Paragraph 193.b))

Powers and procedures of HSSIB

53.As we have already made clear, it is vital that healthcare professionals and others feel able to use the HSSIB ‘safe space’ to report any matters of concern about patient safety, whether or not an incident has actually occurred. We have considered whether to go further: whether there should be a requirement on healthcare providers to report serious incidents directly to HSSIB. We are cautious about adding to the reporting burden on healthcare professionals—who are already obliged to report patient safety incidents, including ‘near misses’—particularly since this is unlikely to increase the amount of useable information available to HSSIB. (Paragraph 196)

54.HSSIB will require access to existing reporting systems as well as full and practical co-operation with the bodies already collecting and categorising information, but this should not require legislation. It is up to HSSIB to promote itself as an organisation to which healthcare professionals should feel they can turn, in complete confidence, when they need to raise a patient safety issue which is not being addressed satisfactorily elsewhere. (Paragraph 197)

55.While noting the concern some witnesses expressed at the lack of a clear definition of ‘qualifying incident’, we do not consider that any such definition should be inserted in the draft Bill. HSSIB should be able to determine what incidents it investigates according to specified patient safety benefit criteria. Based on the approach taken by the current HSIB, we are confident that HSSIB will endeavour to communicate these clearly to the public and other investigatory bodies to maximise certainty and manage expectations. (Paragraph 202)

56.We are content that the draft Bill is sufficiently flexible to enable HSSIB to investigate any patient safety issue, including by initiating thematic reviews without there necessarily being a ‘qualifying incident’. (Paragraph 204)

57.We agree that HSSIB should consult as widely as possible in developing the criteria, principles and processes for its investigations, in order to benefit from a broad range of experiences and expertise. However, we are not convinced there is value in being prescriptive about this in the legislation. We are content that clause 3(6) as drafted will facilitate appropriate consultation with all relevant stakeholders, and expect this to include patients and families, or their representatives. (Paragraph 207)

58.We recommend that clause 4 be amended to include the requirement that HSSIB must inform any person who has, or may have, been harmed by the incident (or their families), as far as reasonably practicable, before deciding whether to investigate a qualifying incident. (Paragraph 209)

59.We endorse the HSIB’s open and transparent approach to engaging with patients, their advocates, families and carers, and welcome the draft Bill’s particular focus on the involvement of patients and families with regard to the investigations that will be undertaken by the new body. (Paragraph 217)

60.In addition to the moral imperative to be open with patients, their families, and patient advocates, we agree with witnesses to this inquiry that engaging with patients and families will be critical to ensuring HSSIB investigations capture the ‘whole picture’ of events in any given incident. We are satisfied that the provisions outlined in clause 3 will facilitate this. (Paragraph 218)

61.It will also be essential to ensure that the processes developed to determine the involvement of patients, families and carers in HSSIB investigations are as simple and accessible as possible, so that no additional burden is placed on them during an already difficult and distressing time. (Paragraph 219)

62.We agree that co-operation, and the establishment of effective working relationships, with other investigative bodies will be essential to ensure co-ordination during parallel investigations, and for HSSIB to be able to fulfil its functions. Nonetheless, we are concerned about the implications of imposing a statutory duty to co-operate on HSSIB given the fundamental importance—as emphasised by Keith Conradi and earlier in this report—of the body’s independence and separation from the existing system. Consequently, we recommend that clause 15(2) be removed from the draft Bill. (Paragraph 232)

63.We consider that article 12(3) of Regulation (EU) No 996/2010 could be usefully adapted for the draft Bill, to provide for the development of MOU between HSSIB and relevant bodies. We therefore recommend that a requirement similar to that in Article 12(3) be inserted into clause 15 of the draft Bill. (Paragraph 234)

64.We are content that, if our recommendation is accepted, the Bill will facilitate the necessary levels of co-operation between HSSIB and other investigative bodies. As noted in Chapter 3, we call on all parties involved to develop appropriate processes to minimise the burden of participating in parallel investigations on patients, families and healthcare professionals. (Paragraph 235)

65.We believe HSSIB should have power to compel individuals. Clause 7 as drafted probably gives it this power, but we think it should be put beyond doubt. The experience of equivalent bodies in other safety critical industries is that it will almost certainly never be needed, but its existence will help to establish the authority of HSSIB and make clear that assisting it is not optional. It is, as was put to us, the quid pro quo for affording people who work in healthcare a ‘safe space’. (Paragraph 241)

66.We recommend that the Government should amend clause 7 to reserve to HSSIB the power to issue a summons to compel individuals to answer its questions (Paragraph 242)

67.Clause 5(3)(d) could be interpreted by HSSIB to exclude an interviewee’s representative or supporting colleague. That does not appear to be the intention of HSSIB, and we think it unlikely investigators will do so, other than in rare circumstances, if they want to secure the co-operation of a witness. Nonetheless, we think that an interviewee’s right to be accompanied should be expressed in the legislation. (Paragraph 244)

68.It is imperative that HSSIB be seen as a body with which individuals and bodies must co-operate. Despite recent moves away from criminal prosecution, strong powers of coercion are, in this instance, appropriate. We sincerely hope that such powers will never need to be exercised. (Paragraph 249)

69.We recommend that non-compliance with clause 7 be made a criminal offence, punishable by a fine or imprisonment of up to three months, as is the case with safety investigation bodies in other safety critical industries. (Paragraph 250)

70.If the Government does not make non-compliance a criminal offence, we recommend that the First-tier Tribunal be given jurisdiction to entertain an appeal against a penalty notice as a complete rehearing. (Paragraph 253)

71.There seems little justification for requiring HSSIB to obtain a warrant before entering premises (other than residential premises) or inspecting, copying or seizing things, or interviewing witnesses. The requirement for a warrant would invite people to misconstrue HSSIB as a prosecuting authority, rather than an organisation that is investigating without finding blame. Although the current Chief Inspector of HSIB does not seek the power to enter residential premises, we think it would be better—subject to appropriate safeguards—to have this power and not use it than to need it but be powerless to act. Indeed, there may well be cases in which healthcare services are provided from premises which are used mainly as a private dwelling, and an investigation could be hampered without access. In these cases, the requirement for a warrant would respect the significance of forcing entry to a private dwelling. (Paragraph 258)

72.The Government should remove from the Bill the need for HSSIB to obtain a warrant before taking an action under clause 5(1) or (3) to which the relevant person does not agree. Instead, investigators should be allowed to carry out an action in clause 5(1) or (3) where, in the opinion of the investigator-in-charge, it is necessary for the purposes of the investigation. HSSIB’s inspectors should have the power to enter residential premises, provided they obtain a warrant before doing so. (Paragraph 259)

73.The Government should ensure that any provision in the revised Bill dealing with the issue of a warrant specifies:

a)that a Justice of the Peace may issue the warrant; and

b)of what the Justice of the Peace must be satisfied (and whether on oath) before issuing the warrant. (Paragraph 261)

74.Clause 31 of the draft Bill requires HSSIB to report findings of fact from its investigations and an analysis of those findings, and to identify what actions should be taken as a result, by whom and when. It also provides that HSSIB must circulate a draft of its report to all organisations and individuals who participated in the investigation, seeking their comments by a set deadline and, if it did not take their comments into account in the final report, it would have to explain why. We consider that the provisions in clause 31 are satisfactory. (Paragraph 265)

75.We have already stated our view that, not least to avoid confusion over its role, HSSIB should not be responsible for ensuring implementation of its recommendations. (Paragraph 269)

76.We recommend that the Care Quality Commission incorporate the implementation of HSSIB recommendations into its quality standards, so that there will be assurance about their implementation. (Paragraph 269)

Governance and accountability of HSSIB

77.We do not consider that the current provision requiring HSSIB to “consider” representations or requests made by the Secretary of State about investigations amounts to a direction by the Minister. Confidence in the ability of HSSIB to say “No” to such representations or requests will be increased, however, if it has clearer independence from the Secretary of State. (Paragraph 274)

78.While the draft Bill provides for HSSIB to regulate its own procedures (in paragraph 10(1) of schedule 1), it makes no such provision in respect of what it investigates. HSSIB should decide its priorities objectively and on the basis of what will best serve the interest of patient safety. We recommend that the Bill be amended expressly to preserve HSSIB’s independence of judgement in this regard. We also recommend that clause 4(1) be amended to remove the reference to the Secretary of State. (Paragraph 275)

79.Although we accept that there is no intention to use this power to intervene frequently in HSSIB’s activities, this clause gives a broad-based authority to the Secretary of State. HSSIB’s ‘functions’ might be held to include how it carried out its investigations, or the substantive content of its reports or recommendations. It will be for the Secretary of State to determine what a ‘proper’ exercise of these functions might be. We therefore consider that the power in clause 18 should be limited to prevent the Secretary of State from directing how HSSIB should investigate, or the content of its reports or recommendations. (Paragraph 277)

80.We note that the Chief Investigator will be appointed by the non-executive members of the board, with the consent of the Secretary of State. The non-executive members of the board will also be appointed by the Secretary of State. While we acknowledge that the Chief Investigator must be responsible to the Secretary of State for the expenditure of public money and the general exercise of his or her responsibilities, we consider that there should be wider accountability, through Parliament. We recommend that both the chair of HSSIB’s board and HSSIB’s Chief Investigator be subject to pre-appointment scrutiny by the Commons Health and Social Care Committee. (Paragraph 283)

81.We note that HSSIB will be required to make an annual report, which will be presented to Parliament. This will afford an opportunity for the Commons Health and Social Care Committee to scrutinise the quality of HSSIB’s investigations and reports, and their effect on patient safety. (Paragraph 285)

82.We recommend that the legislation establishing HSSIB be subject to a post-legislative review, three years after HSSIB starts its work (rather than three years after enactment). (Paragraph 286)

Published: 2 August 2018