Putting the statutory duty of candour into practice

Raindrops on cobwebIn my recent project with St George’s Healthcare NHS Trust, I have been helping them reflect on how they support patients and staff following patient safety incidents. In return, they have been helping me to understand the formidable practical challenges organisations face when they set out to do this well. Amongst other things, we have been thinking together about the impact of the new statutory duty of candour on organisations.

The new legal duty is set out in Regulation 20 of the Health and Social Care Act (Regulated Activities) Regulations, and apply only to England. The law came into effect for the NHS in England at the end of November 2014, and is expected to extend to bind all CQC registered providers in England by April 2015. The new duty  is similar in form to an existing contractual duty of candour, which was inserted into the NHS Standard Contract in 2013. What is significant about the new  duty is that breach could end up with provider organisations facing criminal sanctions.

When the Secretary of State announced the introduction of the statutory duty of candour in March 2014, Peter Walsh, the chief executive of Action against Medical Accidents, said it represented “potentially the biggest advance in patients’ rights and safety since the creation of the NHS”.  Whether it will achieve what we all want – to make care safer in the first place, and to help patients and professionals come to term with events when harm does happen – will depend on how well it is implemented.

The need for a legal duty of candour

There has of course long been a professional ethical duty to tell patients what has happened if they suffer harm during the course of their treatment. (In a rare display of unity, the UK health regulators recently issued a joint statement about this common professional duty.)

Doctors are also liable in negligence if they fail to tell patients that something has gone wrong, and the patient suffers further harm as a result (a principle established in the case of Gerber v Pines (1934) when a doctor did not tell the patient that a hypodermic needle fragment had been left inside). But legal action on these grounds is only available if a patient suffers harm as a consequence of the non-disclosure. And anyway, why should injured patients have to resort to costly legal action to get at the truth? (There is a cogent discussion of the legal background, and the threshold for the duty of candour, by surgeon and medico-legal expert Robert Wheeler here)

From 2015  the new statutory duty will require all CQC registered providers to ensure that patients who experience ‘significant harm’ are informed in writing, and receive an oral and written apology. The penalty for failing to do so is imposed on the organisation (albeit in the form of a rather feeble £10,000 fine) rather than on the individual health professional.

What health care events trigger the statutory duty of candour?

Before the statutory duty was introduced, there was some debate about what would trigger it. What sort of event will have to occur, to engage the new legal duty to disclose?

In a review carried out on behalf of the Secretary of State by Professor Sir Norman Williams (then President of the Royal College of Surgeons) and Sir David Dalton (Chief Executive of Salford Royal NHS Foundation Trust) the threshold for engaging the statutory duty of candour was set at ‘moderate harm or above’.

The review document is well worth reading for its wise and compassionate discussion of the culture of healthcare, and its argument that merely legislating a duty of candour into existence will not accomplish the cultural changes that patient and practitioners seek.

Notwithstanding, they set the threshold as follows.

    • Any patient safety incident that resulted in a moderate increase in treatment (return to surgery, unplanned readmission, prolonged episode of care, extra time in hospital) AND which caused significant but not permanent harm. Prolonged psychological harm would pass this threshold. Unfortunately, the subsequent legislation does not define ‘significant harm’.
    • Any patient safety incident that appears to have resulted in permanent harm (permanent lessening of bodily functions, sensory, motor, physiological or intellectual, including removal of wrong limb or organ or brain damage).
    • Any patient safety incident that directly resulted in the death (related to the incident rather than to the natural course of the patient’s illness or underlying condition) of one or more persons.

Because this threshold mirrors the existing contractual duty, St George’s Healthcare and other NHS care providers, can build on their experience of implementing the contractual duty.

A framework of ethical practices for restoring trust

In the work with St George’s I have been using the Restoring Trust framework (developed by myself and Murray Anderson Wallace) to examine all aspects of their response to patient safety events. There are seven practices in our framework (summarised in ‘Standards for Making Amends’ on this website). Each practice is accompanied by a number of ‘focal points’. These suggest key areas to consider, identified during our research and developmental work with NHS organisations.

Exploring how the duty of candour is implemented within this framework, we have become very conscious of the precarious balance that has to be created between organisational ‘moral commitment’ and organisational ‘compliance’. On the one hand, providers must signal that candour is a morally important part of compassionate care. At the same time they have to introduce systems designed to secure (the absolutely necessary) assurance that patient safety events are reliably reported, properly disclosed, and promptly managed. The challenge is to engage the hearts and minds of clinical staff at the same time as introducing essential organisational systems.  The danger of over-emphasising ‘compliance’ was anticipated in the Williams – Dalton review, and I return to it below.

Some worthwhile questions

This post can only introduce some of the questions we have found it useful to pursue during the St George’s project. Those below have opened up some fruitful lines of enquiry.

    • Who are the staff who most need to understand the new duty, and how can they be supported to enact it?

Most healthcare professionals will know to report incidents where serious harm occurs, but they may need to become more aware of the threshold for reporting lesser harms.

Medication errors and falls in hospital constitute a large proportion of ‘moderate harm’ patient safety incidents, along with pressure ulcers. Many – indeed probably, most – patient safety incidents subject to the duty of candour will therefore have to be identified, disclosed and reported by nursing staff.

Effective implementation of the duty of candour will rest on a wide group of front line nurses knowing the threshold at which the duty engages. Perhaps more importantly, it will also rest on members of nursing teams having the confidence to be open with each other when they think harm has occurred, and having the confidence and training to be open with patients.

    • What about harm to patients being cared for at home?

When care is provided in community settings and responsibility for care is shared between the provider, patient and/or carer, there is scope for uncertainty around when and how harm should be reported and disclosed.

Community nursing staff may, for instance, perceive a pressure ulcer to be a symptom of poor self-care or poor care from family members, as much as a ‘patient safety incident’.

And if it is recognised as a patient safety incident, ‘disclosure’ in this type of situation is potentially more complicated than in hospital settings. Disclosure in this case is about acknowledging that an evident problem is not just ‘unfortunate’ but should not have occurred; and explaining how it has come about. Explaining these things when care is provided by professionals on a hospital ward is one thing. Explaining them when responsibility for care is shared between professional and lay people is another. Patients may be finding it difficult to manage self-care, however hard they try. Carers may not be coping well with caring, and feeling  guilty about letting their loved one down or resentful about their caring role.  The disclosure discussion has to tread some fine lines: being clear about responsibilities, accepting blame if  professional providers are at fault,  avoiding blaming service users and carers, and separating explanation of what has happened in the past from advice for doing better in future.

Provision of  services in the community also raises interesting questions about how to evaluate and – if necessary – change the reporting and disclosure culture of professionals who spend much of their time working alone with patients.

    • Do staff treat materialisation of known risks as subject to the duty of candour?

When a known risk materialises, the patient is likely to be informed that it has happened or will be aware that something is amiss because it is obvious. The issue here is not whether they are told that something has happened, but whether they are told why it happened.

When patients suffer harm from a known risk of surgery, it can be tempting for a surgical team to conceptualise the case as a ‘complication’ rather than a ‘patient safety incident’. The MDU website has a useful case study illustrating how, when  bowel perforation (a known risk) occurred during an appendicectomy, it occasioned an appropriate disclosure under the duty of candour.

    • How far is disclosure managed as a process, not a one-off event?

When care goes wrong, patients and supporters can feel disorientated, fearful and let down. Honesty about what happened is an act of moral regard that helps patients make sense of events and regain equilibrium.

But poor disclosure can also lead to distrust, anger, hurt, and loss of confidence in the care provider. Effective disclosure is not just open. Openness can be satisfied by a brutal revelation of facts. Disclosure must also supportive of patients, helping them to make sense of the situation and cope with unexpected events.

Supportive disclosure is not a single event. Where an incident calls for investigation, an effective process is likely to include immediate disclosure, further care, patient involvement in the investigation, and further post-investigation disclosure.

Patients and supporters should feel that support is responsive to their practical and emotional needs, and is not time limited. They should know who besides them will be informed about events, and feel in control of what is communicated to others (including possibly media organisations). They should feel continuing contact with the organisation is welcomed, and know who is responsible for it. Where an investigation takes place, they should feel appropriately involved from an early stage.

One of the most difficult things to get right may be ongoing support. The timelines of those affected by harm are sometimes significantly at odds with those of the organisation, with patients and supporters unready to move on while organisations try to ‘close the book’ on an incident. Patients often seek a continuing relationship with the clinical team as they struggle to make sense of what has happened, but there may be little ‘clinically’ that the team can offer. Clinicians may be unable – or unwilling – to offer the sort of continuing counselling that patients need.

    • Who is caring for the caregivers?

Professional caregivers often experience the organisational response to harm as threatening, ostracising, and unsupportive. (This moving talk by former nurse Julie Thao describes just how harsh the institutional response can be.)

We all know that a blame culture is dangerous because it inhibits organisational learning. We now need to acknowledge that it is also cruel and unjust. It increases stress on professionals, demoralises and demotivates them, and contributes to the deterioration in clinical performance that sometimes follows unexpected outcomes.

When a patient suffers significant harm, caregivers are likely to experience a strong psychological reaction. In the immediate aftermath, they have to deal with their own response and also with disclosing the event to the patient. As time goes on, they find themselves having to contend with unfamiliar and often bewildering organisational processes, and experiencing the reactions of everyone around them with an interest in the case. This could include the patients’ supporters, professional colleagues, managers, regulators, insurers, lawyers, and perhaps the coroner or police.

To expect professionals to cope with all this without thoughtful support is both morally wrong and frankly dangerous. I will be discussing support for professionals more fully in a forthcoming post.

Remembering why we are doing this

The wisdom acquired through Norman Williams’s long career in surgical practice, and through David Dalton’s experience building a culture of safety at Salford Royal, inform every paragraph of their review of the duty of candour. The paragraph that follows is, to my mind, one of the most important of all.

“The obligations and challenges of candour serve to remind us that for all its technological advances, healthcare is a deeply human business. Systems and processes are necessary supports to good, compassionate care, but they can never serve as its substitute. It follows from this that making a reality of candour is a matter of hearts and minds more than it is a matter of systems and processes, important as they can be. A compliance-focused approach will fail. If organisations do not start from the simple recognition that candour is the right thing to do, systems and processes can only serve to structure a regulatory conversation about compliance. The commitment to candour has to be about values and it has to be rooted in genuine engagement of staff, building on their own professional duties and their personal commitment to their patients”

Image ‘Web of Deceit’ by Brendan Lally via flickr CC