The scale of the problem
The Secretary of State for Health estimates there are 12,000 avoidable hospital deaths every year. More than 10,000 serious incidents are reported to NHS England annually. There were 338 recorded "never events" (such as wrong site surgery) in 2013-14 and NHS England received 174,872 written complaints. The NHS Litigation Authority’s latest estimate of clinical negligence liabilities is £26.1 billion. The cost of the Francis Inquiry into the Mid Staffordshire NHS Foundation Trust was £13.6 million.
The huge numbers involved in the overall work of the NHS—15.8 million admissions to hospitals and 19.2 million A&E attendances in England the year to November 2014—put those figures in context but the overwhelming response PASC received to this inquiry is an indication of the devastating impact of clinical failures when things do go wrong, such as the patient Gina who had to have her leg amputated following an accidental injection of disinfectant during a routine angiography at Doncaster Royal Infirmary in 2013.
The current picture
Patients and NHS staff deserve to have clinical incidents investigated immediately at a local level, so that facts and evidence are established early, without the need to find blame, and regardless of whether a complaint has been raised. The Committee says there also needs to be a clear effective central system for disseminating the lessons learned from local incidents across the NHS nationally.
The current NHS processes for investigating and learning from untoward clinical incidents are complicated, take far too long and are preoccupied with blame or avoiding financial liability. The quality of most investigations therefore falls far short of what patients, their families and NHS staff are entitled to expect, and these failures compound the pain and distress caused to patients and their families by the original incident.
Many bodies promote safety in the NHS, including the Care Quality Commission and the Parliamentary and Health Service Ombudsman (PHSO), and scores of bodies play a role in complaints and safety investigation, but there is no systematic and independent process for investigating incidents and learning from the most serious clinical failures. The Committee also raises serious questions about the capacity and capability of the Parliamentary and Health Service Ombudsman—currently the 'court of last resort'—in relation to complaints involving clinical matters, because of the lack of timely, local, independent investigative capacity.
Features needed in the new body
The Committee says a new national independent patient safety investigation body must:
- be transparent and accountable directly to Parliament.
- offer a safe space with strong protections for patients and staff, so they can talk freely and without fear of reprisals about what has gone wrong.
- be independent of providers, commissioners and regulators, and so able to investigate whether and how the system as a whole was instrumental in contributing to clinical failure.
- have the power to publish its reports and to disseminate its recommendations. It should be for the Care Quality Commission and other executive, regulatory and commissioning bodies to ensure they are implemented
- have its own substantial investigative capacity, so that it can lead by example, oversee local investigations and conduct its own investigations when necessary.
Criteria for the new body
Experience in other safety critical industries such as aviation demonstrates how resources devoted to investigating and learning to improve clinical safety will save unnecessary expense by reducing avoidable harm to patients. Investigations should wherever possible be conducted locally, but local resolution is too often slow, conflicted, defensive and of poor quality. The new body must be primarily a centre of expertise and promoter of good investigatory practice and expertise.
The Committee says there will have to be clear criteria for deciding which incidents it should investigate, to avoid being overwhelmed by the large number that require routine investigation across the NHS. However, all untoward clinical incidents must be investigated: the only question is how and by whom.
Quote from the Chair
Bernard Jenkin MP, Chair of the Committee said:
"We are very pleased that the Secretary of State for Health has already appeared to have accepted the principle of our main recommendation. His engagement with this inquiry has been exceptional. The Shadow Health Secretary has also made a commitment to review all hospital deaths.
Ever since the MidStaffs hospital crisis and the Francis Report, it has been evident that the NHS has urgent need of a simpler and more trusted system for clinical incident investigation at both local and national level. This was again confirmed by the Kirkup report into the Morecombe Bay baby deaths. There needs to be investigative capacity so that facts and evidence can be established early, without the need to find blame, and regardless of whether a complaint has been raised. Our proposals for a new investigatory body will help transform the safety culture of the NHS and help to raise standards right across the NHS. This proposal is widely supported and it should be taken up early in the new Parliament.
We embarked on this inquiry because we are aware of the considerable anguish and disquiet where Parliamentary and Health Service Ombudsman investigations fail to uncover the truth, and of pain inflicted by the Ombudsman when it has been defensive and reluctant to admit mistakes. This underlines the need for improved competence and culture change around clinical incident investigation throughout the system, including in the PHSO but across the board.
That change is urgently needed. Some of the PHSO’s shortcomings are systemic and can only be addressed through legislation, which is needed early in the next Parliament. However, unhappiness with the Ombudsman underlines the need for improved capacity for clinical incident investigations in response to complaints, long before they reach the Ombudsman. To that end, we are calling for the establishment of this new, independent national patient safety investigation body, funded by the Department of Health.
The Secretary of State agrees that all serious clinical incidents in the NHS must be investigated thoroughly. The only question is: how and by whom. Nobody can argue that bearing this cost is unjustified, so the NHS must pay for better clinical investigations one way or another. We are calling on the Secretary of State for Health to start consulting on this proposal immediately after the election."