Following the publication of Professor Don Berwick’s review of the Mid Staffordshire tragedy, the headlines have focussed on the creation of a criminal offence to deter wilful or reckless neglect or mistreatment, with the much campaigned-for duty of candour seemingly side-lined. In fact, a closer reading of Don Berwick’s review indicates support for the creation of a duty of candour through regulations and related recommendations aimed at promoting openness within the NHS. However, when it comes to shaping the duty of candour, the necessarily succinct Berwick review leaves many questions unanswered and the Secretary of State, Jeremy Hunt, will therefore need to carefully assess the recommendations and evidence contained within Sir Robert Francis QC’s final report to ensure the duty of candour is properly – and thoughtfully – implemented.

One of the central reforms proposed by Sir Robert’s final Report of the Mid Staffordshire Public Inquiry was the creation of a statutory duty of candour, the key plank of which requires that where harm has been caused to a patient, resulting in serious injury or death, he or she (or if the patient is deceased, a relative) should be informed of the incident and provided with full disclosure and support. Linked to this duty were recommendations that:

  • Full and truthful answers must to be given to questions reasonably asked by patients about their treatment.
  • Any statement made by a healthcare organisation to a regulator or commissioner performing statutory duties must be completely truthful.
  • Duties are placed on both healthcare providers and registered medical practitioners and nurses who believe or suspect that treatment or care provided by them to a patient has caused injury to the patient, to: (a) inform the patient, and (b) in the case of individual practitioners, report concerns to their employer.

Crucially, the Berwick review supports Sir Robert’s key recommendation, stating, “Where an incident qualifying as a Serious Incident (as defined by NHS England) occurs CQC [the Care Quality Commission] regulations should require that the patient or carers affected by the incident be notified and supported.”  In linking the duty to an incident which qualifies as a Serious Incident, a relatively wide range of circumstances will in fact be caught. Patients and relatives will fall to be notified of unexpected or avoidable deaths, serious injury, alleged abuse and so-called ‘never’ events, such as wrong site surgery. However, in line with Sir Robert’s recommendations, the Berwick review adopts the same view that the duty should not be extended to events categorised as “near misses”. 

The linked duties are also supported by the Berwick review, with agreement that patients should be given all information they ask for and, critically, that the Government should make it an offence for a healthcare organisation to withhold or obstruct the provision of relevant information to a commissioner, regulator, inspector, coroner or other person with a legitimate duty in relation to the quality and safety of care.

The latter recommendation may cause anxiety amongst NHS executives, but is an important reflection of the parlous approach to the provision of information at Mid Staffs, where the Trust made inaccurate statements about its mortality rate based on a non-existent report, failed to pass information to the regulator about serious concerns, made exaggerated claims of success to the public and failed to disclose a report critical of patient care to a coroner. It also reflects the situation more generally in the healthcare sector that at an organisational level, a fundamental change of approach to information provision is needed – we need only reflect on the recent allegations that executives of the CQC themselves supressed a critical internal review linked to its inspections of the maternity unit at Morecambe Bay NHS Foundation Trust.

Where Don Berwick and Sir Robert part company is in respect of the creation of a statutory duty on registered medical practitioners and nurses, requiring them to report their beliefs or suspicions about Serious Incidents to their employer. It is apparent that Professor Berwick agrees with the principle of reporting, but that he believes that the duty is adequately addressed in professional codes of conduct and guidance. Whilst his analysis is strictly speaking correct, it is somewhat superficial and does not address the strength of the professional codes of conduct already in place, and whether their influence is capable of addressing the ‘culture of denial’ apparent in many NHS Trusts, and which was particularly virulent at Mid Staffs (the Department of Health publicly recognised the former as early as 2006 in its report Safety First). 

The remit given to Professor Berwick and his advisory group was to study the various accounts of Mid Staffs, including Sir Robert’s recommendations, and to distil for the Government and NHS the lessons learned, and specify the changes needed. The distilled nature of the review therefore, by necessity, leaves many specific questions unanswered. For example questions such as: Who will shoulder direct responsibility for notifying patients or relatives of Serious Incidents – the medical team, or a designated individual within the organisation? Relatedly: If the latter, what reporting requirements and mechanisms need to be put in place within organisations? Yet a further question: What does ‘notification’ actually mean? Presumably, it means full disclosure of the circumstances of the Serious Incident together with disclosure of any relevant documentation – but this is not clear on the face of the Berwick review. All these questions and more will require careful consideration.

In answering these questions and bringing the duty of candour to life, Jeremy Hunt will therefore need to carefully assess the more detailed recommendations and underlying evidence contained in the Mid Staffs Inquiry final report. If done properly, a thoughtfully implemented duty of candour is not something anyone should fear, rather it should become a duty which reflects the ‘organisational maturity’ of the NHS, and which will allow it to take ownership of the inevitable human errors which take place, and to utilise them to develop exemplary patient safety practices.