Since the Mid Staffordshire NHS Foundation Trust public inquiry under Sir Robert Francis QC reported in 2013, there has continued to be a number of high-profile reviews into incidents where patients have suffered serious harm. There is no doubt that avoidable risks to patient safety in UK health care are commonplace and widespread. In 2015, the House of Commons Public Administration Select Committee (PASC) reported that there are 12,000 avoidable hospital deaths every year. More than 24,000 serious incidents are reported to NHS England, out of a total of 1.4 million mostly low-harm or no-harm incidents annually. In order to improve patient safety, the Government accepted PASC’s central recommendation to establish a new body to conduct patient safety investigations into a small number of incidents, so that the system can learn from common failures, whether in procedures, or the training or management of staff, or in technology or policy. A shadow form of this body, the Healthcare Safety Investigation Branch (‘the present HSIB’), was established in April 2017. It is under the control of NHS Improvement, and lacks the necessary powers and independence to make it fully effective. However, it is intended to lead to the creation of a wholly new capability, separate from the rest of the healthcare system, for conducting investigations into patient safety incidents.
We have been given the task of examining the draft legislation to establish the Health Service Safety Investigations Body (HSSIB). Its independence and powers will be underpinned by statute, like the safety investigation bodies in other safety critical industries, so it can obtain the necessary information to make wide-ranging ‘system safety’ recommendations, including in such areas as staffing levels. HSSIB investigations will not seek to apportion blame, but will prioritise the consideration of ‘human factors’ as causes of the failures it identifies in the provision of healthcare.
At present, there are many pressures which can deter healthcare professionals from alerting the authorities to potential safety problems, or being frank about failings in patient care. These include: a lack of confidence in their own judgement; a culture of deference to senior staff or management; a bullying atmosphere; fear of the damage that may be done to their career if they admit failings; or, a perception that their concerns will be ignored. A common feeling is that it is not safe or prudent to speak out, despite existing obligations to be open, such as the duty of candour.
To obtain the best and most comprehensive information about patient safety incidents, HSSIB’s investigations will be able to operate in a ‘safe space’ for those taking part in them. The vital element of the ‘safe space’ is the confidence it provides that information given to HSSIB will not be unfairly used to expose any individual, but instead will help to produce factual conclusions and recommendations to improve patient safety.
One of the main purposes of the draft Bill is to set up the ‘safe space’: to protect information given to HSSIB. Various organisations were concerned that this will hide information which should otherwise be disclosed. We have listened with particular care to these concerns, since suspicion about HSSIB would undermine its effectiveness. Nonetheless, we are convinced by the evidence that the ‘safe space’ will only protect information held by HSSIB. The ‘safe space’ will have no effect whatsoever on any information or evidence already available, or which can still be acquired and made available by existing healthcare bodies and non-HSSIB patient safety investigations. HSSIB’s reports will be additional to, not a replacement for, the investigations carried out by trusts, professional regulators, the Care Quality Commission and the Health Service Ombudsman. These assurances address these understandable concerns.
The Government also wants to improve the quality of local investigations, so it proposes that HSSIB accredit some NHS trusts and foundation trusts to undertake ‘safe space’ investigations themselves. They would carry out investigations into other trusts and, eventually, into incidents taking place in their own trust. Many of those who gave evidence to us raised serious concerns about this proposal. We listened carefully to their arguments and we are convinced that this idea is wholly misconceived. It represents too great a conflict of interest for the accredited trusts and would risk damaging confidence in the safe space concept itself. We recommend that this proposal be dropped from the Bill. HSSIB should be funded to help to improve the quality of the many thousands of investigations that are conducted across the health system through advising, assisting and providing training, but not by accrediting others to conduct ‘safe space’ investigations. HSSIB must be a new, independent and separate capability. Making it also a regulator of accredited trusts would confuse its role, and make it part of the system it is investigating.
The new HSSIB’s role has also been confused by the then Secretary of State’s understandable decision to direct the present HSIB to investigate all cases of stillbirth, neonatal death, suspected brain injury or maternal death. These 1,000 or so investigations are taking place outside of the ‘safe space’, and replace the local serious incident investigations conducted by trusts. The Government has suggested that the draft Bill might be amended to allow HSSIB to carry out such non-‘safe space’ investigations more widely. We also reject this idea. Much of the concern about HSSIB arises from a fear that it will undermine the duties of trusts, professional regulators, and the courts to investigate harm and provide accountability. There must be a clear distinction between HSSIB’s role—focussing on learning lessons of general relevance without finding blame—and that of the investigations run by other bodies: providing accountability for individual incidents and, if necessary, finding fault.
HSSIB will need to co-operate closely with trusts, NHS Improvement, the Care Quality Commission, the Health Service Ombudsman and professional regulators, to avoid conflicts over the timing of inquiries and to ease the practical burden on those who may have to give evidence to several different inquiries. However, we recommend that no statutory duty to co-operate should be imposed on HSSIB, as this would cast doubt on its independence from existing structures.
The draft Bill limits HSSIB’s remit to incidents which occur during the provision of NHS services, or at premises where such services are carried out. It also limits HSSIB’s remit to England, as healthcare is a devolved matter. We believe that both of these limitations pose potential problems as they do not recognise the complex interactions of health and social care, private and public healthcare, and the fact that many patients cross borders within the UK to receive aspects of their care under different administrations. We recommend that HSSIB’s remit should be extended to cover all healthcare in England, however funded. We recognise that HSSIB itself cannot be expected to take on responsibility for social care as a whole but suggest that its powers and the protections of safe space be extended, so that HSSIB investigations can analyse all aspects of the care pathway. With regard to cross-border care, we are clear that the devolution settlements must be respected but recommend that the draft Bill should be amended to enable reciprocal co-operation arrangements between HSSIB and the devolved health systems, and to give devolved administrations the choice of participating in HSSIB, if they so wish.
We considered the linked issues of the independence, governance and accountability of HSSIB. Our witnesses emphasised that—to win the confidence of patients, healthcare practitioners and other bodies with responsibility for patient safety—HSSIB had to be, and be seen to be, independent of existing healthcare structures, including the Department of Health and Social Care. We have made several recommendations intended to increase HSSIB’s independence, including to reinforce its accountability to Parliament.
We believe that HSSIB will play an important role in improving patient safety, and look forward to the introduction of this legislation as soon as possible.
Published: 2 August 2018