While the statutory Duty of Candour has been in force for NHS bodies for over six months, it was extended to non-NHS providers in April 2015.

The CQC has now issued further guidance for all providers which includes some helpful worked examples.

In addition, we had been awaiting final guidance from the GMC and NMC on how they expect the duty to apply to individuals, known as the professional Duty of Candour. Jonathan Heap explains these developments.

CQC update

The CQC has produced a separate, detailed guidance on each of the changes implemented by the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. In addition, they have recently issued specific information for all providers specific to the statutory Duty of Candour, which is Regulation 20.

As well as explaining what they are looking for when inspecting or registering providers, the document contains a concise overview of the Duty of Candour itself and is worth keeping close to hand. Two aspects in particular are worthy of mention:

Different criteria for health service and non-NHS providers

The harm thresholds in operation for health service bodies since implementation in November 2014 remain as:

  • Death of the service user
  • Severe harm
  • Moderate harm
  • Prolonged psychological harm                                                                                                                                                                                       Regulation 20(8)

Whereas the harm thresholds for non-health service bodies, such as primary medical and dental practices, adult social care and independent healthcare providers, (which came into force later, on 1 April 2015) are:

  • Incidents which appear to have resulted in any of the following:  
    • The death of the service user.
    • Impairment of the sensory, motor or intellectual functions of the service user which has lasted, or is likely to last, for a continuous period of at least 28 days.
    • Changes to the structure of the service user’s body.
    • The service user experiencing prolonged pain or prolonged psychological harm.
    • Shortening of their life expectancy.
  • Incidents which require treatment by a health care professional in order to prevent:
    • the death of the service user; or
    • any injury to the service user which, if left untreated, would lead to one or more of the outcomes listed above                                                                                                                                            Regulation 20(9)

The logic behind this distinction is to reflect existing reporting criteria which providers are subject to under the NRLS and CQC notification system respectively. However, the difference has drawn criticism from patient groups concerned about a ’two-tier’ system, culminating in a recent threat of judicial review. In response, the government has in the last week agreed to consult on whether the distinction should remain. Watch this space for further updates …

Worked examples

We have handled numerous queries from clients as to where the lines should be drawn and, in particular, what constitutes a ’notifiable safety incident’ which will trigger the statutory Duty of Candour, assuming one of the harm thresholds has been met. The CQC had committed to providing some illustrated examples of the sort of incident which will trigger the duty in various settings and these are now available, with the document to be updated periodically.

The examples are broken down by service and include:

  • Surgery
  • Medicine
  • General practice
  • Mental health
  • Maternity
  • Dentistry
  • Adult social care

Providers should familiarise themselves with these precedents and consider the issues which will crop up in their own services. We recommend that these are then incorporated into local policies to ensure consistency across your organisation.

GMC/NMC guidance ‘openness and honesty when things go wrong: the professional Duty of Candour’

The GMC and NMC have this week jointly published a guidance document  for healthcare professionals on how they should apply the Duty of Candour on an individual basis.

This advice will assist clinicians in complying with their own professional responsibilities as well as understanding what part they should play to ensure compliance with the existing contractual and statutory duties. A draft version of the guidance was issued for consultation in October 2014 and, thankfully, the final document is very similar.

The first page summary confirms the professional duty as follows:

"Every healthcare professional must be open and honest with patients when something that goes wrong with their treatment causes, or has the potential to cause harm and distress. This means that healthcare professionals must:

  • tell the patient (or, where appropriate, the patient’s advocate, carer or family) when something has gone wrong.
  • apologise to the patient (or, where appropriate, the patient’s advocate, carer or family).
  • offer an appropriate remedy or support to put matters right (if possible).
  • explain fully to the patient (or, where appropriate, the patient’s advocate, carer or family) the short and long term effects of what has happened.

Healthcare professionals must also be open and honest with their colleagues, employers and relevant organisations, and take part in reviews and investigations when requested. They must also be open and honest with their regulators, raising concerns where appropriate. They must support and encourage each other to be open and honest, and not stop anyone from raising concerns".

It is important to note the distinction between this professional duty, which rests on individuals and the statutory duty, which organisations are required to meet. The principle is the same but the professional duty is more pervasive and, for example, is not restricted to certain harm thresholds.

The guidance goes on to describe how professionals should apply this in practice. It is separated into two sections:

1. Being open and honest with patients, and those close to them, when things go wrong, including:

  • Discussing risks before treatment.
  • The circumstances in which professionals need to apologise, i.e. where something goes wrong with their care and they suffer harm or distress as a result.
  • When you should speak to them and what to say.
  • What to do if people don’t want to know the details.
  • Saying sorry.
  • Speaking to those close to the patient.
  • Dealing with near misses.

2. Encouraging a learning culture by reporting errors (i.e. candour with colleagues, employers and other organisations:

  • Relationship with other reporting systems.
  • Additional duties for those with management responsibilities or senior/high profile clinicians.
  • The organisational duty of candour – the need to support staff to report adverse incidents.

There is no substitute for a careful reading of the guidance itself.

It is vital that all organisations update their policies and train their staff on the implementation of the duty.