You may be forgiven for wondering why a statutory duty of candour was considered necessary. Dentists have an ethical duty to be open and honest with patients, don't they? Yes, they do, and for many years the DDU has advised dental professionals to tell patients when things have gone wrong, to apologise and to try and put things right. Dental professionals understand this ethical duty, and that having an open dialogue with patients is not something to be afraid of. 

The GDC, along with other healthcare regulators, recognises a common professional duty to be open and honest when things go wrong1. The professional duty of candour means that, when something goes wrong with patients' treatment or care and which causes (or could cause) harm or distress, dental professionals must:

  • tell the patient (or their representative) when something has gone wrong;
  • apologise to the patient;
  • offer an appropriate remedy or support to put matters right, if that is possible; and
  • explain fully to the patient the short- and long-terms effects of what has happened.
The duty of candour is one of the fundamental standards of quality and safety

Statutory duty of candour

The new statutory duty of candour2 was introduced for NHS bodies in England (trusts, foundation trusts and special health authorities) on 27 November 2014. The statutory duty is in addition to the contractual duty of candour required of organisations whose services are commissioned under a post-April 2013 standard contract. 

From 1 April 2015, it was extended to all other CQC-registered care providers (such as dental practices in England). The duty of candour is one of the fundamental standards of quality and safety – these are the standards below which care must not fall and which the CQC will investigate during an inspection to make sure they are being met in all registered healthcare organisations.

Key elements of the statutory duty
  • Dental practices have a general duty to act in an open and transparent way in relation to care provided to patients. This means that an open and honest culture must exist throughout an organisation. 
  • The statutory duty applies to organisations, not individuals, though it is clear from CQC guidance that it is expected that an organisation's staff will cooperate with it to ensure the obligation is met. 
  • As soon as is reasonably practicable after a notifiable patient safety incident occurs, the organisation must tell the patient (or their representative) about it in person. The organisation has to give the patient a full explanation of what is known at the time, including what further enquiries will be carried out. Organisations must also provide an apology and keep a written record of the notification to the patient. 
  • A 'notifiable safety incident' has a specific statutory meaning, but its exact nature depends on whether the healthcare organisation is an NHS body or not. In other words there are two statutory definitions of notifiable safety incidents, and these are summarised below.  Dental professionals working in an NHS trust setting, such as hospital or community dental services, will need to apply the "NHS body" threshold of moderate harm (or prolonged psychological harm) or worse. Conversely, dental professionals in general dental practice will need to apply the other threshold, which in the main applies to serious incidents and prolonged psychological harm.
  • There is a statutory duty to provide reasonable support to the patient. Reasonable support could be providing an interpreter to ensure discussions are understood, or giving emotional support to the patient following a notifiable patient safety incident. 
  • Once the patient has been told in person about the notifiable patient safety incident, the organisation must provide the patient with a written note of the discussion, and copies of correspondence must be kept.
The threshold for reporting

Dentists are likely to be their organisation's representative under the statutory duty of candour. They will be the individuals who will know the patient and their family, and have a rapport with them. Because they have an ethical duty to act with candour when things go wrong and the patient is harmed, dentists will also find it quite natural to tell patients what happened and to apologise for what went wrong.

The tricky bit of the statutory duty is trying to work out if the threshold of a notifiable safety incident is met, and as explained above this will be different depending on whether you work in general dental practice (with or without NHS patients) or in hospital or community dental services, which are normally part of an NHS body. The differences and definitions are explained in the box below.

Notifiable patient safety incident

NHS body (trust, foundation trust, etc)

In relation to a health service body, a notifiable safety incident means any unintended or unexpected incident that occurred in respect of a service user during the provision of a regulated activity that, in the reasonable opinion of a health care professional, could result in, or appears to have resulted in—

a. the death of the service user, where the death relates directly to the incident rather than to the natural course of the service user's illness or underlying condition, or
b. severe harm, moderate harm or prolonged psychological harm to the service user.

'Severe harm' means a permanent lessening of bodily, sensory, motor, physiologic or intellectual functions, including removal of the wrong limb or organ or brain damage, that is related directly to the incident and not related to the natural course of the service user's illness or underlying condition.

'Moderate harm' means harm that 

a. requires a moderate increase in treatment, and 
b. significant, but not permanent, harm.

'Moderate increase in treatment' means an unplanned return to surgery, an unplanned re-admission, a prolonged episode of care, extra time in hospital or as an outpatient, cancelling of treatment, or transfer to another treatment area (such as intensive care).

'Prolonged psychological harm' means psychological harm which a service user has experienced, or is likely to experience, for a continuous period of at least 28 days.

Non-NHS body (dental practices)

In relation to a registered person who is not a health service body, a notifiable safety incident means any unintended or unexpected incident that occurred in respect of a service user during the provision of a regulated activity that, in the reasonable opinion of a health care professional:

a. appears to have resulted in—

i. the death of the service user, where the death relates directly to the incident rather than to the natural course of the service user's illness or underlying condition,
ii. an 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,
iii. changes to the structure of the service user's body,
iv. the service user experiencing prolonged pain or prolonged psychological harm, or
v. the shortening of the life expectancy of the service user; or

b. requires treatment by a health care professional in order to prevent—

i. the death of the service user, or
ii. any injury to the service user which, if left untreated, would lead to one or more of the outcomes mentioned above.

'Prolonged psychological harm' means psychological harm which a service user has experienced, or is likely to experience, for a continuous period of at least 28 days.

'Prolonged pain' means pain which a service user has experienced, or is likely to experience, for a continuous period of at least 28 days.

To reiterate, the statutory duty of candour applies at the organisational level, rather than to individuals. But inevitably dental professionals will be called on to advise managers in a trust on whether a patient safety incident meets the threshold described above, or in primary care settings such discussions are likely to take place between dentists and the practice owner(s) or manager. 

Practical guidance and case examples

Therefore, on a practical level, the processes of clinical governance and duty of candour are likely to be most effective when they are closely linked. For example, in all the situations where the statutory duty of candour is likely to apply, the incident should already have been reported through the organisation's clinical governance procedures, and investigated accordingly.  A notification to NHS England's National Reporting and Learning System is also likely to have been made. 

In addition, certain specified incidents are already required to be reported without delay to CQC3, and these mirror exactly the duty of candour threshold for dental practices. What is important is that these processes are joined up in such a way that both the obligation to tell the patient about what has gone wrong, and to learn from it, happen automatically. This might be achieved by the use of flowcharts, checklists, and so on.

Case example – dental practice

A dentist planned to extract a patient's carious LL6. The adjacent teeth, although also carious, were to be restored with amalgam fillings. The patient was very anxious and the dentist made particular efforts to talk to and reassure him as the extraction progressed.

There was no problem technically with the extraction, and the patient was fine. The dentist showed the extracted tooth to the patient. In doing so he realised, to his horror, that it was plainly not as diseased as he was expecting. He immediately checked the dentition and realised that in error he had extracted the wrong tooth.

The dentist told the patient immediately, and apologised. He explained that the diseased tooth would still need to be extracted, which he could do straight away should the patient agree. The patient was shocked and said he didn't want any further dental treatment that day. He was given an appointment for the following week.

The dentist reported what had happened to the practice owner and to the practice manager, and relevant notifications were made under the NRLS reporting scheme and to CQC, as it was an unanticipated serious incident that had led to an irreversible change in the structure of the patient's body. The matter was also discussed with the other dentists in the practice and it was agreed that it was an incident where the statutory duty of candour applied. It was also agreed that it would be discussed as a significant event at the next staff meeting which, as it happened, was two days later.

At the staff meeting the conclusion was that the dentist's concentration had been affected by the need to control the patient's anxiety. In such circumstances it was as important as ever to check basic parameters, such as adequacy of local anaesthesia and identification of the correct tooth.

The patient attended the following week and the dentist explained what had happened, reiterating a sincere apology. The dentist also explained that they had discussed it as a practice to see what lessons could be learnt, and told the patient about the conclusions reached. 

The patient said that he accepted that mistakes could happen, and that he appreciated the dentist being open and honest. He would have the other tooth extracted but said that he would be more comfortable if that could be undertaken by one of the other dentists. This was duly arranged.

The dentist followed up the meeting with a letter, taking the opportunity to apologise in writing and setting out what had gone wrong, and what had been learnt from it. Copies of the correspondence were retained on file.

Summary

The statutory duty of candour has introduced complex definitions that will apply to determining when the threshold is reached. Some practical thoughts are set out below.

  1. Don't forget that the statutory duty of candour only applies in England to organisations registered with the CQC, but the GDC's requirement to be open and honest with patients applies across all of the UK.
  2. The patient should be told as soon as possible after something has gone wrong, causing harm, which meets the relevant threshold of the statutory duty of candour.
  3. Bear in mind that in dental practices the threshold for the duty of candour mirrors that of a registration duty to tell CQC of the incident without delay. Therefore, for providers registered with CQC in primary dental care there will be a parallel process of notification, to both patient and CQC. It should also be borne in mind that even in NHS bodies, an incident categorised as serious harm or death will almost always trigger the obligation to tell CQC without delay.
  4. Remember that the ethical duty of candour (which has a low threshold – an incident causing, or having the potential to cause, any harm or distress) will apply to all dental professionals, in all parts of UK, in all circumstances.
  5. Don't delay. As soon as reasonably practicable, tell the patient what has happened and what further investigations are required.
  6. Do apologise. The DDU has for many years reassured dental professionals that a frank and sincere apology to a patient when something goes wrong is the right thing to do.
  7. Although the statutory duty of candour is not particularly bureaucratic, it is nevertheless necessary to keep a written record of discussions with the patient and of correspondence with the patient.
  8. Link your clinical governance procedures closely to assessing whether an incident has reached the threshold for the statutory duty of candour.
  9. Remember that the statutory duty of candour is not assessed against whether your organisation is at fault, or has been negligent, or whether there has been a complaint. It is whether the specific statutory threshold for a notifiable safety incident has been met – an unexpected or unanticipated incident resulting in a defined level of harm - and this may occur in the absence of a complaint or negligence. 
  10. If you work in a trust or foundation trust, bear in mind that a notifiable safety incident may occur where the patient does not currently show evidence of moderate harm or worse, but where this may occur in the future.
  11. Working out if the threshold applies can be complicated, so if there is doubt it is safest to assume that it does. Members can call the advisory helpline for assistance. 

FOOTNOTES

1Joint statement from the Chief Executives of statutory regulators of healthcare professionals, 13 October 2014

2The statutory duty of candour and its obligations (as well as the 11 other regulations defining the fundamental standards of quality and safety) are set out in regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (as amended).

3Regulations 16 and 18 of the Care Quality Commission (Registration) Regulations 2009 (as amended).


This article was correct at publication on 07/09/2015. It is intended as general guidance for members only. If you are a member and need specific advice relating to your own circumstances, please contact one of our advisers.

Rupert Hoppenbrouwers

Senior dento-legal adviser

Rupert Hoppenbrouwers (BDS LDSRCS) was head of the DDU until his retirement at the end of 2015. He is a former general dental practitioner and was director of the School of Dental Hygiene at University College Hospital, London, from 1980 to 1986. He has lectured and written widely on risk management and dento-legal matters, has previously chaired the UK Dental Law and Ethics Forum, and has a particular interest in complex ethical and legal issues affecting dental members.

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