Health bodies in England must comply with the statutory duty of candour – but many doctors remain unclear on how and when it applies. Dr Michael Devlin cracks the code.

You may be forgiven for wondering why a statutory duty of candour was considered necessary. Doctors have an ethical duty to be candid with patients when things go wrong, don't they? Yes, they do, and for over 50 years the MDU has been advising members to tell patients when things go wrong, to put things right and to apologise.

The ethical duty is explained in unambiguous terms in GMC guidance, Good medical practice (2013):

"You must be open and honest with patients if things go wrong. If a patient under your care has suffered harm or distress, you should:

  1. put matters right (if that is possible)
  2. offer an apology
  3. explain fully and promptly what has happened and the likely short-term and long-term effects."

There is good evidence that doctors understand this ethical duty. In 2014 the MDU surveyed over 8,000 members, and 677 responded. Around 99% of those doctors knew about their ethical duty to provide an explanation and apology to patients. The majority who had been involved in a recent incident (352) provided patients with an explanation and apology (341 and 326 respondents respectively). In most cases, the doctors also explained how they would try to put things right.

Statutory duty of candour

The new statutory duty of candour1 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 GP practices and independent practitioners 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.

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.

Key elements of the statutory duty

  • Care organisations 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. Recent joint GMC and NMC guidance, Openness and honesty when things go wrong (2015) gives further detail about how to approach saying sorry2.
  • 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.
  • 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

Doctors 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, doctors 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 are a hospital doctor or a GP. The differences and definitions are explained 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—

  1. 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
  2. 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 requires a moderate increase in treatment, and 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 (GP, private practitioner, etc)

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:

1. 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,
b. 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,
c. changes to the structure of the service user's body,
d. the service user experiencing prolonged pain or prolonged psychological harm, or
e. the shortening of the life expectancy of the service user; or

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

a. the death of the service user, or
b. 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 doctors 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 GPs and the practice 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 the CQC3, and these mirror exactly the duty of candour threshold for GPs and those in independent practice.  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 – a hospital obstetric unit

A consultant obstetrician is involved in the delivery of a woman where there were concerns that the fetus was growth-retarded. Labour was induced at 38 weeks following regular review of fetal growth in the third trimester. During labour, CTG changes suggested fetal distress and preparations were made for an emergency Caesarean section. At birth the baby was irritable and jittery, with a weak suck reflex but with normal tone and no seizures. After about 24 hours the baby was no longer in an irritable state and the sucking reflex was normal.

The consultant spoke to the baby’s parents as soon as was practicable after the Caesarean section to explain that the baby had shown some signs at delivery that could suggest brain hypoxia and ischaemia. The parents were told that the paediatric team would ensure that the baby had the best care possible to ensure the greatest chance that all would be well. In addition, the consultant explained that the case would be reviewed by the clinical team to see if the decisions made were optimal, or whether lessons could be learned. A detailed note of the discussion was entered in the clinical records.

Clinical governance procedures were followed, and the incident reported under hospital procedures. The case was subsequently discussed at a multi-disciplinary meeting and there was a difference in senior opinion as to whether the mother should have been offered an elective Caesarean section. 

The consultant had a discussion with the hospital manager responsible for the statutory duty of candour. They concluded that although the baby was now well, there was a small chance (less than 5%) that in the fullness of time evidence of hypoxic ischaemic encephalopathy could develop. If this did happen, it would be moderate or severe harm and therefore the duty of candour should apply.

As soon as could be arranged, the consultant spoke to the parents again, explaining that the case had been discussed, and some senior colleagues would have managed the delivery in a different way. She apologised that the outcome was not as good as had been hoped. Again, a careful note of the discussion was made in the clinical records.

Subsequently a letter was sent to the baby’s mother, summarising all that had happened at the delivery and the subsequent multi-disciplinary review. The apology was reiterated. Copies of the correspondence were kept by the trust manager.

Photo credit: Getty Images

Case example – a GP practice

A patient with forefoot pain attended his GP. He said that he had problems affecting his great toe with occasional tender swelling of the joint making it almost impossible to weight bear. It would normally settle over the course of a few days. The GP found tenderness on the plantar pad over the great toe metatarsophalangeal joint. He told the patient that he thought the problem was probably gout and arranged for some blood tests and prescribed a non-steroidal anti-inflammatory drug should it flare up again. The blood tests came back as normal.

Two months later the patient attended a different GP, who had a special interest in musculoskeletal disorders. The GP also elicited tenderness, and in particular thought that it was point tenderness overlying the sesamoids of the great toe. The GP also obtained a history that the patient was an avid runner, and had been for many years.  He considered that the patient may have sesamoiditis and referred him for an orthopaedic opinion. The patient was found to have a fractured sesamoid.

The second GP flagged up the incident using the practice’s clinical governance procedures, and it was also reported via the NRLS to NHS England. The second GP spoke to the patient to explain what had happened and apologised. As definitive treatment was under way at the hospital, no further action was required, but the patient was told that the practice would carefully analyse the incident to learn lessons. The discussion was followed up by a letter summarising the events and repeating the apology (which was on this occasion personally expressed by the first GP). Notes were made in the clinical records and the practice manager ensured a copy of the correspondence was kept on file.

At a significant event analysis meeting the staff thought it was an unusual presentation, but that the possibility of sesamoid pathology should be borne in mind, particularly given the history obtained by the second GP. The patient had suffered prolonged pain, and it was therefore agreed that it was correct to categorise the event as a notifiable safety incident, which obliged the practice to tell the patient under the statutory duty of candour.

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.
  2. The obligation to notify under the statutory duty of candour applies to the patient, not the CQC (although the regulator may seek evidence that the organisation has complied with its duty).
  3. However, in the case of non-NHS bodies (for example GPs), the threshold for the duty of candour mirrors that of a registration duty to tell CQC without delay of the incident. Therefore, for providers registered with CQC in primary care and independent practice 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 any harm or distress) will apply to all doctors, 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 MDU has for many years reassured doctors 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. Do 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 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 (see obstetric case example).
  11. Working out if the threshold applies can be complicated, so if there is doubt it is safest to assume that it does. MDU members can call the advisory helpline for assistance.

FOOTNOTES

  1. The 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).
  2. General Medical Council and Nursing and Midwifery Council (2015), Openness and honesty when things go wrong: the professional duty of candour (see paragraphs 13 to 16).
  3. Regulations 16 and 18 of the Care Quality Commission (Registration) Regulations 2009 (as amended).

This page was correct at publication on 12/08/2015. Any guidance 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.