Conclusions and recommendations
The investigative landscape in the NHS
1.It is clear from the evidence reviewed during the course of this inquiry that the investigative processes in the health service in England remain obscure and difficult to navigate for patients and families. As a result, patients and families are excluded by the system, which must become open and learning-focused if investigations are to lead to positive changes in the system. Families and patients should, as a matter of course, be included in investigations and should feel confident that lessons will be learned as a result of clinical incidents. (Paragraph 27)
HSIB and the learning culture
2.The intention for HSIB to share learning will not alone guarantee the improvement of investigations across the NHS in England. HSIB’s role as an exemplar can only be effective if its relationship to other bodies is clear. There must also be a well-defined process so that HSIB’s best practice is respected and shared across the system, including at local level. In order for this to happen, existing investigations and investigative bodies need to understand what to expect from HSIB when it starts operating, and how they are meant to respond to its findings. (Paragraph 35)
3.The Committee agrees that the ‘safe space’ established by the Secretary of State for Health’s Directions does not match what is provided for other incident investigators in aviation or rail safety. It neither provides sufficient protection for those participating in investigations nor for the information they share. They will continue to be vulnerable to any actions being taken against them. This undermines the ‘safe space’ principle and negates the intended role for HSIB as an independent investigator. (Paragraph 45)
4.While we were encouraged by the Minister’s clear assurance that HSIB will have discretion on what it investigates, we believe that unless HSIB’s independence is enshrined in primary legislation, its investigations remain open to external pressures and it will be seen as being part of the existing hierarchy. This perception is underscored by HSIB’s current position within NHS Improvement. The Directions set up by the Secretary of State for Health are not an adequate substitute for primary legislation formally enshrining HSIB’s independence. (Paragraph 46)
5.We agree with HSIB’s Chief Investigator that HSIB needs its own legislative basis in order to be independent and that the ‘safe space’ for its investigations is protected. We urge the Government to bring forward such legislation at the earliest possible opportunity. The Department of Health must cease to defy the consensus now established by Parliament, the HSIB, the Expert Advisory Group, and HSIB’s Chief investigator on the need for such legislation. If HSIB is asked to begin operations in 2017 without this legislation, there is a real risk it will fail to establish its authority, or to be effective in developing a learning culture in the health system. (Paragraph 47)
Learning and accountability: implementation of the ‘safe space’
6.The Committee believes the proposal to extend the safe space locally is indicative of confusion over how to balance learning from clinical incidents with accountability for their consequences. The rationale for HSIB to conduct protected ‘safe space’ investigations is clear: its role is to support system learning to improve patient safety. Locally, however, effective safety investigations should also provide the key information for settling complaints and legal claims. While these complaints and legal claims should, and often do, lead to wider learning, that is not their primary purpose. There is a wide variation in the quality and competence of local investigations. We therefore support the Chief Investigator of HSIB, Dr Keith Conradi, in his view that the ‘safe space’ should not be extended to the local level, at least for the time being. It would undermine trust in HSIB before HSIB has had a chance to acclimatise NHS bodies and the public to ‘safe space’ investigations. (Paragraph 54)
7.We recommend that the Government should not extend the ‘safe space’ to local investigations without the approval of HSIB. However, the government must establish the ‘safe space’ for HSIB through primary legislation so that this new body can acclimatise the health service to this new type of learning-focused investigation. (Paragraph 55)
A system-wide ‘just culture’
8.The Committee commends the Department of Health for articulating the need for the NHS in England to develop a learning culture. However, the NHS must embed the attitudes and behaviours that are necessary for a learning culture to develop. Achieving a ‘just culture’ within organisations requires the leadership to establish the appropriate balance between learning and accountability. In addition to this, as the next section sets out, the local investigative capacity and capability to conduct ‘safe space’ has not yet been established. (Paragraph 64)
9.PACAC endorses the HSIB Expert Advisory Group recommendation that a Just Culture Taskforce should be created, to help the leaderships of NHS England and NHS Trusts to embed the learning-focused culture within the NHS in England. In particular the Committee believes the taskforce should seek to establish a consensus on just culture policy across the whole of the NHS in England, expressed in the development of protocols between the legal, regulatory, and complaint handling bodies. Ministers should ensure that these protocols are drafted and communicated by 1 September 2017. (Paragraph 65)
Improving local competence
10.The Committee supports the recommendations made in the CQC’s report that training should be provided to staff across the health service in England on how to conduct investigations. Specifically, PACAC recommends that HSIB should work with national education bodies to ensure that training is effective in building up local investigative capacity. (Paragraph 72)
11.The Committee agrees that HSIB’s investigations will have the potential to produce valuable learning and information for regulatory and improvement agencies. However, we do not believe that HSIB setting good practice alone will adequately address the need to improve the capability to carry out investigations at the local level, which is where the vast majority will continue to take place. (Paragraph 78)
12.We have previously called for HSIB to assume unambiguous responsibility for standard setting and for playing a leading role in building the capability of local investigators in conjunction with other national bodies. While we appreciate that HSIB is still being established, we are disappointed at the lack of detailed strategic thinking from the Department of Health on how the quality of local investigations will be improved, and the role that HSIB will play in this. (Paragraph 79)
13.The Committee reiterates its previous recommendations, made in its June 2016 report ‘PHSO review: Quality of NHS complaints investigations.’ The government must stipulate in the HSIB legislation that, first, HSIB has the responsibility to set the national standards by which all clinical investigations are conducted; secondly, that local NHS providers are responsible for delivering these standards, according to the Serious Incident Framework; and thirdly, the Care Quality Commission should continue to be responsible as the regulator in assessing the quality of clinical investigations according to those standards at a local level. The government must also explain these functions to local Trusts and patients to ensure that confusion does not persist. (Paragraph 80)
14.There is an immediate need to improve investigative capability within Trusts and the coordination of multiple-body investigations. The Department of Health for England must take the lead by bringing together relevant national bodies, including NHS Improvement, NHS England, and Health Education England to determine how they will work with HSIB to improve local investigations. This should include a nationally accredited training programme, approved by HSIB, around investigative capability to raise standards, competence, and the confidence of staff involved in investigations. (Paragraph 81)
Measuring improvement
15.There are many different organisations and Ministers involved in delivering different aspects of the overall move towards a ‘learning culture’ in the NHS in England. This includes training and accreditation, awareness campaigns, reforming the investigations process, and the introduction of HSIB. From this, it is unclear who is to be accountable to Parliament for progress on moving towards a leaning culture. There is an acute need for the Department of Health to develop a strategic plan bringing all these initiatives together. PACAC recommends that Parliament should hold the Secretary of State for Health to account for the coordinated implementation of a cultural shift in the NHS in England. As such, PACAC will in future call the Secretary of State for Health to give evidence on the issues highlighted in this report. (Paragraph 84)
16.The Committee welcomes initiatives by NHS Improvement to work with Trusts on diagnosing and improving their cultures and on enabling clearer leadership. However, we are concerned at the relative dearth of knowledge and experience about how Trusts can develop more open cultures and particularly how Trusts, who are struggling to be more open and to learn from investigations, should develop practical strategies for improvement. (Paragraph 91)
17.The Committee notes that there is a range of initiatives taken by various bodies across the system in response to clinical incidents, but without proper evaluation, the NHS in England will never learn what works best. The SAM campaign leaflet to disseminate the lessons from the Sam Morrish case is a case in point; the impact of this initiative appears to have been negligible. HISB and other regulators need to have the powers to ensure that individuals are made accountable for taking forward such initiatives which reflect learning from investigations, or the implementation of larger scale initiatives arising from the introduction of HSIB will also fail. (Paragraph 92)
18.We recommend that the HSIB legislation give HSIB and NHS regulators the power to set out how plans to coordinate the various initiatives being taken across the health service with regard to improving the investigative culture. HSIB should evaluate the impact of resources being developed within the system, such as the culture toolkit launched by NHS Improvement with respect to organisational culture and clearer leadership. It should have the freedom to concentrate on Trusts that have been identified as inadequate in CQC’s “Well Led” domain. This should become part of a wider effort to structure the health service’s efforts to tackle the blame culture. This effort should result in a clear set of plans to communicate and coordinate the transformation of the culture at all levels of the health service, with particular reference to how HSIB will contribute to this. The Committee would expect the Department of Health to be able to report on significant progress in this regard by the time HSIB becomes operational in April 2017. Given the diffuse nature of Ministerial responsibilities in this area, PACAC feels that it is the Secretary of State for Health who must take on the coordination and evaluation of efforts to instigate a ‘learning culture’ in the NHS in England. (Paragraph 93)
27 January 2017