Report of the public inquiry into children's heart surgery at the Bristol Royal Infirmary

The report of the public inquiry into children's heart surgery at the Bristol Royal Infirmary (BRI) 1984-1995, chaired by Professor Sir Ian Kennedy, was published on 18 July 2001. The terms of reference for the inquiry were to:

• investigate the care of children receiving complex cardiac surgery at the BRI between 1984–95
• consider the adequacy of the services provided
• establish what action was taken to deal with concerns about the surgery
• identify any failure to take appropriate action
• make recommendations with the aim of securing high-quality care across the NHS.

Regulation (or the lack thereof) was a central theme of the inquiry report. Kennedy defined regulation as the processes for assuring safety and quality at a professional and institutional level. The report strongly suggested that the Department of Health's role should be increasingly strategic, with regulators being de-politicised to maintain public confidence, regarding which the report noted that:

'The regulation of the NHS in this broad sense must not, in our view, be in the day-to-day control of the Department of Health. While it is the proper role of government to establish the regulatory framework to ensure safety and promote quality, that framework must be as independent as possible of the Department of Health. This is quite simply because it is not in the interests of the public or of patients that the monopoly provider should also set and monitor the standards of care. Instead, these functions must be carried out by independent bodies within a statutory regulatory framework. The regulatory bodies, embracing, as we have said, matters to do with safety, quality and standards as well as the competence of healthcare professionals, must themselves be coordinated and their efforts aligned by some overarching system. Duplication must be reduced. Equally, holes in the system must be stopped. Only in this way will the fragmentation and lack of clarity about responsibility for regulating the quality of healthcare, which was such a feature of Bristol, be addressed. And by insisting on independence from government, the systems to ensure safety and promote the quality of healthcare will be made secure from the vagaries of passing political pressures.'

Kennedy recognised that the government had proposed the creation of NICE and the Commission for Healthcare Improvement (CHI), but suggested that they needed greater autonomy and independence from central government. He also suggested the establishment of an overarching body to integrate and coordinate the activities of all organisations involved in safety and quality.

Regarding professional regulation, Sir Ian suggested the establishment of a Council for the Regulation of Healthcare Professionals. This would coordinate the activities of the disparate bodies involved at the time with professional regulation (such as the Nursing and Midwifery Council and the General Medical Council – a similar body had been proposed by the government in the NHS Plan).

Sir Ian additionally noted the lack of professional appraisal and continuing professional development. He suggested a process of revalidation for all healthcare professionals. It was suggested that there was no systematic mechanism for monitoring the clinical performance of institutions or individual clinicians and in the future there should be a system of independent surveillance to monitor patterns of good and failing care.

Kennedy also noted that there had been a lack of transparency over the data provided to patients and the public and in the future patients should be able to gain access to information at a hospital, service or consultant level. He also suggested that healthcare staff should have a duty of candour to patients.

Government response

The government responded to the report the following year, on 17 January 2002, accepting the broad principles of the report. While the government accepted the majority of recommendations, a number were rejected, including recommendations to:

• specify the minimum level of regular clinical practice necessary to provide good quality care
• give the National Patient Safety Agency (NPSA) additional independence
• make the National Institute for Clinical Excellence (NICE) the only body permitted to issue national clinical standards to the NHS
• validate and revalidate trusts at an organisational level.