Knowing your duties of candour, Part 2

This is Part Two of a quiz that explores the scope of the statutory duty of candour. I’m working with a number of organisations to improve patients’, carers’ and colleagues’ experiences in the aftermath of healthcare harm, including helping front line staff and senior managers understand their duties of candour. I’m grateful to all of them for the stimulating discussions that underlie the cases in both Part One and Part Two of the quiz.

If you’ve not already tested yourself on the first four cases in Part One, please take a look there first. This is not because I want to be bossy. It’s because I discuss in the introduction to Part One how the professional-ethical duty to tell patients when anything goes wrong is the cornerstone of good disclosure practice. The statutory duty augments this professional-ethical duty and applies when harm meets a certain threshold. This threshold is different for NHS Trusts and private providers. Because breach of the duty could lead to CQC action or even criminal proceedings, it is important to be able to identify the threshold at which the statutory duty applies. This quiz aims to help you do so.

Here is Regulation 20 and its amendments if you want to check the wording. Each case is followed by a big picture, below which you’ll find the answer. No peeking! And if you’d like to talk about building your organisation’s capability for responding to healthcare harm, do get in touch.


Case 5  –  A GP misses a DVT

A patient had pain and swelling in her lower leg. She was due for a GP appointment to discuss several aspects of her chronic care needs, and the possibility of a DVT was overlooked. Over the next two days the patient experienced increased pain and swelling, and difficulty walking. When she contacted the GP again, DVT was diagnosed. However, the late diagnosis meant she needed a short spell of inpatient treatment rather than outpatient management. After she had left hospital, she saw her GP who said she was sorry she had missed the DVT first time around.

Should this event be treated as a notifiable incident under the statutory duty of candour?

  1. No, the statutory duty of candour does not apply to GP practices
  2. No, this event does not satisfy the harm threshold
  3. Yes, but the GP has already fulfilled the duty by apologising

This case is based on an example provided in Woodward’s Briefing for the Duty of Candour Threshold Review Group and would satisfy the moderate harm threshold if the patient had been seen by a General Practitioner employed in an NHS Trust.

But does it meet the threshold for the statutory duty on independent GP practices? We would look first at Part (a) of the definition for independent providers. Here the closest match is injury that impairs ‘the sensory, motor or intellectual functions…for a continuous period of at least 28 days’ or by ‘prolonged pain or psychological harm’. But as the patient’s injury did not amount to this level of severity,  the requirements of part (a) are not met. Part (b) of the definition applies to an injury that a professional believes ‘requires treatment’ to prevent injuries in part (a) occurring. As our lady has already recovered well after her inpatient treatment, part (b) is not met either. If this were an independent GP practice the correct answer would be no.2.

This example leads to the rather unsatisfactory conclusion that there is a statutory duty to be candid about the late diagnosis if the patient saw a GP who was working as part of an A&E department; but not if she saw a GP working in an independent practice.

Case 6  –  A baby suffers cardiac arrest during induction of anaesthesia

A baby needed an operation to correct a complex heart defect. Infants with this condition are very sensitive to induction of anaesthesia. If they suffer cardiac arrest during induction, they are at risk of hypoxia with possible neurological damage. Unfortunately the baby did arrest. Cardiac massage was carried out until he was on cardiopulmonary bypass. There was no undue delay, but this inevitably took some time. The rest of the operation went to plan and the baby appeared to recover reasonably well.

 Is this a notifiable incident?

  1.  No, there appears to be no harm done
  2. No, the possibility of a cardiac arrest was a known complication
  3. Yes, hypoxia could have resulted in harm that is not yet apparent

If it were to happen in an NHS Trust this case would be an example of an incident that is notifiable because, in the words of Regulation 20, “in the reasonable opinion of a health care professional, [it] could result in” moderate or severe harm. If an incident occurred which could cause harm, but the harm has not yet materialised or is not yet apparent, it is nevertheless notifiable under the NHS providers’  statutory duty of candour. The correct answer would therefore be no. 3. Cases are notifiable even where known risks materialised, because the incident is still ‘unintended’. Be aware that the definition of the threshold for NHS providers has potential to cause confusion here – “could result in” does not mean that near misses are notifiable.

What if this procedure had been carried out in the independent sector? Unfortunately, this incident would not appear to be covered by the definition that currently applies to them. Part (a) of the independent sector definition states that incidents are notifiable if they appear to have resulted in certain types of harm. In this case, no harm is yet apparent. Part (b) states incidents are notifiable if treatment is required in order to prevent death, or to prevent the harms set out in Part (a) from occurring. The problem is that if baby seems to have recovered this not an injury that needs treatment to prevent death; and if developmental delay materialises in the future it is not a condition that can be treated so as to prevent the harms in Part (a) from materialising.

Case 7  –  A lady suffering from dementia experiences a medication error

A patient suffering from dementia was admitted from residential care to an inpatient ward in the hospital. Unfortunately a medication error was made by the hospital. Luckily, she did not suffer any pain or lasting physical effects. However, the error resulted in her scheduled procedure being delayed, so that her stay in hospital was extended by three days. Being out of her usual care environment in a hospital ward was particularly distressing for this patient, because dementia heightened her anxiety and confusion.

Is this a case where the statutory duty of candour applies?

  1.  Yes, the cancelled procedure and extra days in hospital satisfy the threshold requirements
  2. No, although there was a moderate increase in treatment the patient did not suffer significant harm
  3. No, it doesn’t apply to patients who lack capacity

This case study divides opinion among health professionals.

If the incident occurred in an NHS Trust, the starting point would be that the extra days in hospital certainly amount to a moderate increase in treatment. But is the second limb of the definition in Regulation 20, the requirement for ‘significant harm’, also satisfied? Some professionals answer yes, because they view the additional distress of hospital admission that is suffered by patients with dementia, to amount to a significant harm. I am inclined to agree, and so suggest that no. 1 is the best answer. An additional point in this case study is that mental capacity is irrelevant. If this patient can understand a simple explanation of what happened, then disclosure should be made to her. If she cannot, disclosure should be made to another relevant person. This might be for instance her next of kin, or someone holding a healthcare power of attorney. This example is inspired by the film ‘Barbara’s Story’, produced by Guy’s & St Thomas’s NHS Foundation Trust. One aim of Barbara’s Story is to make apparent how particularly distressing and confusing hospital treatment can be for people with dementia.

If the case occurred in an independent sector hospital, we would look first to Part (a) to see whether the harm is one of those listed. Part (a) does not include an increase in treatment in its list, and it would require a ‘prolonged period’ of ‘psychological harm’ to trigger the duty. Part (b) does not address these circumstances either. So once again, it looks as though the statutory duty would not be triggered if the error was made by a private provider.

Case 8  –  Shared care results in a pressure ulcer

You are a member of a district nursing team that has been providing long term care in his home for a severely disabled man with complex care needs. Care is shared with family carers. Unfortunately, despite the steps you have taken to avoid it, your patient has developed a grade 3 pressure ulcer. In discussion with his family you expressed your regret, and in response they admitted they had been switching off the pressure relieving air mattress at night because they were worried about the cost of electricity.

You are going to raise this in your team in any event. But should you also flag it as a notifiable incident?

  1. Yes, because a grade 3 pressure ulcer meets the threshold requirements
  2. No, because responsibility for care is shared with the family
  3. No, because they have already been offered a verbal explanation and apology

I think this quite a difficult case to classify. First, if we look at the wording of the statutory duty on NHS providers, there is no doubt that the pressure ulcer constitutes moderate harm. It is also an injury that requires treatment to prevent further injury, so it would meet the private provider threshold. But is it the result of an “unintended or unexpected incident that occurred in respect of a service user”? It is perhaps stretching the concept a bit to describe the pressure mattress being regularly switched off, by carers who did not appreciate the consequences, as an ‘unexpected or unintended incident’.

Looking at it a bit differently, we could ask what the intention of Regulation 20 is. It is clearly to ensure that a prompt explanation is given, and a formal apology offered, when care provision has gone wrong. This does not initially appear to be a situation for which a formal apology – as opposed to a generalised expression of regret – is warranted.

Of course, if there were other care-related factors that had also contributed to the pressure ulcer, there could be something for which an apology ought to be offered. So we need to consider a third approach to classification, which focuses on organisational assurance processes. Patients, carers, colleagues and leaders all need be assured that, when appropriate, incidents will have been disclosed. The risk in not flagging this case as notifiable is the possibility that there may be other contributory factors that the team member is unaware of and which call for disclosure, apology, and organisational learning.

On balance, it seems prudent to treat this as notifiable and select no.1 as the best answer. Coming to this conclusion highlights a problem that several organisations have already started to identify. This is a degree of ‘precautionary creep’ in the classification of incidents. If front line staff are worried about the consequences of failing to register notifiable incidents, the natural tendency will be to notify more.