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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, out of a total of 1.4 million mostly low-harm or no-harm incidents annually. There were 338 recorded "never events" (such as wrong site surgery) during 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.
Patients and NHS staff deserve to have untoward 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. This requires strengthened investigative capacity locally in most of the NHS, supported by a new, single, independent and accountable investigative body to provide national leadership, to serve as a resource of skills and expertise for the conduct of patient safety incident investigations, and to act as a catalyst to promote a just and open culture across the whole health system.
We commend the Secretary of State for Health's determination to tackle the culture of blame and defensiveness which pervades much of the NHS, and which prevents lessons being learned and adopted following clinical failure. This is not to undervalue recent initiatives, such as those led by NHS England's Patient Safety Domain, which aim to promote patient safety. There are examples we found of good investigative practice in some areas. However, the processes for investigating and learning from 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. Many bodies promote safety in the NHS, including the Care Quality Commission and the Parliamentary and Health Service Ombudsman, and scores of bodies play a role in complaints and safety investigation. There is no systematic and independent process for investigating incidents and learning from the most serious clinical failures. No single person or organisation is responsible and accountable for the quality of clinical investigations or for ensuring that lessons learned drive improvement in safety across the NHS.
We therefore welcome the Secretary of State for Health's engagement with this inquiry and the fact that in response to our inquiry he has asked Dr Mike Durkin, Director of Patient Safety in NHS England, to look at the possibility of setting up a national independent patient safety investigation body. This must provide three key elements, which are currently lacking. First, it must offer a safe space: strong protections to patients and staff, so they can talk freely about what has gone wrong without punitive reprisals. Second, it must 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. Third, for transparency and accountability, and to drive learning and improvement, it must 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.
Our main recommendation is that the Secretary of State for Health should bring forward proposals, and eventually legislation, to establish a national independent patient safety investigation body. The cost of this body will be relatively small, compared to the costs and liabilities arising from clinical incidents at present. This will involve the development of a body of professionally qualified administrative and investigative staff, who, over time will be able to provide a substantial infrastructure in support of all investigation of clinical incidents. There should be formal examinations and qualifications similar to those formerly made by the Institute of Health Service Administration and the Association of Medical Records Officers. Experience in other safety critical industries demonstrates how resources devoted to investigating and learning to improve clinical safety will save unnecessary expense by reducing avoidable harm to patients. Investigations should 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. It must have its own substantial investigative capacity, so that it can lead by example, oversee local investigations and conduct its own investigations when necessary.
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. Therefore, the relevant provisions of the Coroners and Justice Act 2009 should be implemented, to create the post of Independent Medical Examiner in every local area. Dr Alan Fletcher became the first medical examiner in England and Wales in 2008 when a pilot scheme was established in Sheffield in response to the Shipman case, but few others have since been appointed. One should be appointed for every Clinical Commissioning Group, to examine hospital deaths, to keep families of the deceased informed, and to alert the coroner to cases of concern. In time, such Examiners should refer cases for investigation to the proposed new body.
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