The time may be right for a radical rethink of how professional regulation can contribute better to patient safety, writes Sir Robert Francis

The regulatory regime overseeing the fitness to practise (FTP) of doctors and nurses is intended to serve the public interest by protecting patients and maintaining confidence in the professions.

The General Medical Council logo proclaims that it is “working with doctors, working for patients”. Fitness to practise regimes are not intended to be punitive, although it is accepted that the steps necessary for the protection of the public may have a punitive effect.

There is an increasing awareness that protecting patients from harm is not a simple matter of identifying medical error and finding a professional to blame. The question arises as to how professional regulators can best contribute to patient safety and what role fitness to practise proceedings have in this context.

Human cost

While the volume of FTP business has increased exponentially, the proportion of complaints not leading to an outcome involving a sanction is striking.

In 1992 the GMC had only 91 sitting days on such cases, but 651 in 2002. Today there are multiple panels sitting in Manchester for most working days of the year. The NMC concluded 1,732 hearings in 2014-15. Yet of the 8,269 complaints received by the GMC in 2015, 65 per cent were closed immediately. Ninety-two per cent of complaints about clinical competence from the public resulted in no sanction.

In the same year 69 per cent of concluded 2,808 investigations were closed with no further action, a mere 7 per cent resulted in a sanction of suspension or erasure and 6 per cent in conditions or undertakings. The picture at the Nursing and Midwifery Council is similar: of 5,183 new referrals to it in 2014-2015, 35 per cent were closed at screening and 53 per cent of the rest were not referred to a hearing after investigation. Fifty per cent of their cases coming to final adjudication in that period resulted in erasure or suspension.

’Twenty-eight suicides or suspected suicides by doctors under investigation were identified as occurring between 2005 and 2013. It is reasonable to suppose that many more suffer stress related illness’

FTP processes are expensive. Financed out of fees paid by registrants, the NMC spent £57.3 million on this in 2014-15 and the GMC £63.2 million [including the cost of the MPTS] in 2015. To that must be added the costs incurred by defence organisations, unions, complainants, witnesses and employers.

Then there is the human cost. In a review bravely commissioned by the GMC, 28 suicides or suspected suicides by doctors under investigation were identified as occurring between 2005 and 2013. It is reasonable to suppose that many more suffer stress related illness. The pressures are easily imagined and come on top of the already high suicide rates of doctors generally.

Sleep deprived

Safety remains a problem in the NHS. This year’s Care Quality Commission State of Care report shows that in acute hospitals the largest proportion of “inadequate” and “requires improvement” ratings relate to safety. It has been suggested that one in 20 NHS (England) hospital deaths may be preventable.

Staff and trainee surveys continue to indicate cause for concern about the stressors, such as unpaid overtime, physical violence and bullying. The latest GMC survey suggests that 50-60 per cent of junior doctors work beyond their allocated hours and 25 per cent found their working patterns left them sleep deprived.

The support offered to the development of a learning culture by the duty of candour and the measures supporting the freedom to speak up assume ever greater importance

The picture with regard to incident and complaint investigations is also concerning. In the 2015 NHS staff survey only 68 per cent of NHS staff surveyed felt secure in raising concerns. The Parliamentary Health Service Ombudsman recently reported that 40 per cent of the investigations they looked at were inadequate to find out what happened.

A Royal College of  Obestetricians and Gynaecologists review found that 27 per cent of 204 local reviews obtained insufficient information to determine whether different care would have affected the outcome.

Against this background the support offered to the development of a learning culture by the duty of candour and the measures supporting the freedom to speak up assume ever greater importance.

It is therefore encouraging to see the Department of Health’s support for an independent patient safety investigation and a “safe space” designed to encourage professionals to discuss openly and honestly their experiences by the introduction of a statutory requirement that information generated in a safety investigation will not be generally shared outside the investigation.

Radical rethink

However, professionals will still be deterred from cooperation if they fear that it will lead to evidence obtained by other routes and subsequent dismissal and FTP processes. To be effective, safe space protection needs to be extended to local incident investigations, not just those conducted by a national service.

The time may be right for a radical rethink on how professional regulation can contribute better to patient safety. At the moment its processes do not meet public expectations and only affect a very small minority of registrants, at huge financial and human cost. A more risk based, supportive approach might be more effective than punitive action. Regulators could consider changing their approach in a number of ways, some requiring little change to the current legislative framework. For example:

  • Alternative means of resolving complaints, such as mediation, could be considered.
  • Complaints about one person could prompt a wider investigation into others who appear to have been involved.
  • Systemic deficiencies contributing to concerning incidents and behaviour should always be looked for and taken into account.
  • Joint or coordinated action could be taken between relevant regulators, for example when nurses and doctors are involved in the same event.
  • Any potential association between an allegation and a history or the registrant raising safety or probity issues should be taken into account.
  • Staff who raise honestly held concerns with regulators should be supported and recognised and the behaviour of the employer should be monitored.
  • The focus should be on supporting the development of learning and insight, not blame for errors and incidents. True accountability is found in recognition of the need for change and its implementation.
  • Conventional professional disciplinary process in relation to clinical accidents should be avoided unless there is provable criminal conduct, gross neglect not brought about by systemic deficiencies, repeated error indicating irremediable lack of competence, or a failure/refusal to acknowledge and address proven deficiencies.

Such changes require the trust and understanding of the public. To achieve this a number of other steps are likely to be required, including:

  • A radically improved complaints system in which complainants are genuinely involved in all stages, complaints are promptly and effectively investigated and learning is demonstrated;
  • Appropriate personal redress without recourse to litigation;
  • Regulation of senior healthcare managers on the same basis as the reformed supportive system for clinicians. It is questionable whether the current fit and proper person regulatory process can achieve a level playing field between all healthcare leaders.

This article is based upon a presentation delivered to the Scottish government’s ninth Annual Regulation Conference in Edinburgh on 31 October 2016.

Sir Robert Francis QC is a non-executive director of the Care Quality Commission, but the views expressed in this article are his personal ones and do not necessarily reflect the views of the CQC.

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