Over the summer, CQC issued new guidance on the interpretation of the Duty of candour. However, although the guidance, itself, states that it “clarifies” how providers should determine whether an incident is an “unintended or unexpected incident” which should be treated as a ‘notifiable safety incident’ (“NSI”) for the purposes of the duty of candour, the new guidance in our view creates further uncertainty in an area which has been the subject of some confusion since the introduction of the statutory duty.
Given the importance of the duty of candour, and the significant consequences for providers if they fail to comply, it would be extremely helpful if CQC were to provide further clarification of its expectations in this area.
When the statutory duty of candour was launched there was some confusion as to the type of incidents which constituted NSIs to which it applied. At the time of its roll out to independent sector providers in March 2015, CQC’s press release announced the duty as a requirement on providers about being open about “mistakes” when they happen.
However, later that year CQC’s Board clarified that the duty “applies not just to incidents caused by ‘mistakes’ or ‘failings in care’ but to all notifiable safety incidents that result in harm, even if these arise from known risks”.
CQC 2015 Guidance
This approach was subsequently confirmed by CQC in its guidance ‘Regulation 20: Duty of candour’ published in March 2015 (the “2015 Guidance”). ThIs confirmed that the prescriptive steps to be taken in relation to NSIs are required “when things go wrong with care and treatment”. The language used throughout the 2015 Guidance is that the duties to notify patients/ families of NSIs arise (subject to the requisite harm threshold being reached) “when things go wrong with care and treatment”.
Although the 2015 Guidance did not elaborate further on what is meant by “when things go wrong”, Appendix C to that guidance set out a number of illustrative examples of incidents that would be NSIs. These included the following:
An elderly patient undergoes a coronary artery bypass operation. The patient is appropriately consented for the risks of the operation, including stroke and death. Unfortunately, the patient sustained a large stroke during the operation, and subsequently died as a result.
This would be an example where an incident resulted in death (regulation 20 (8) (a)
The 2015 Guidance was clear therefore that, as long as they met the harm threshold, NSIs could arise regardless of whether the incident constituted a failing in the care provided or was a recognised complication of the procedure which occurred without any shortfall in the care provided.
This resulted in an increased burden on providers, particularly healthcare providers, who would be under a duty to follow the prescriptive steps of the duty of candour even in relation to matters which were clearly recognised complications of procedures in respect of which the patient had been fully informed at the time of giving consent. However, at least there was clarity as to the requirement.
The 2022 Guidance
However, on 30 June 2022, and with little fanfare, CQC issued revised guidance on the Duty of candour (the “2022 Guidance”).
This 2022 Guidance states that providers should identify whether a situation is a NSI, not by reference to whether the service user has suffered harm which is “unintended or unexpected”, but by reference to whether an “unintended or unexpected” incident (resulting in the requisite level of harm) has occurred during the course of the care and treatment.
The area where this causes greatest confusion is in relation to recognised complications of procedures and whether (assuming they result in the requisite level of harm) these constitute NSIs. As an illustrative example, the 2022 Guidance uses the same scenario as is in the 2015 Guidance (referred to above), but this time states as follows:
“An elderly woman undergoes a coronary artery bypass operation. The operation is carried out according to plan, with no unexpected or unintended incidences. But the woman suffers a large stroke during the operation and dies soon after.
Does this qualify as a notifiable safety incident?
Did something unintended or unexpected happen during the care or treatment? No. In this case, nothing unexpected or unintended occurred during the course of treatment.
… So, this does not qualify as a notifiable safety incident.”
On the face of it, therefore, the 2022 Guidance totally contradicts the 2015 Guidance as to whether this scenario is a NSI. In terms of an explanation of its new approach on this, the 2022 Guidance states as follows:
“You should interpret "unexpected or unintended" in relation to an incident which arises in the course of the regulated activity, not to the outcome of the incident. … if the treatment or care provided went as intended, and as expected, an incident may not qualify as a Notifiable Safety Incident, even if harm occurred.
This does not mean that known complications or side effects of treatment are always disqualified from being Notifiable Safety Incidents. In every case, the healthcare professionals involved must use their judgement to assess whether anything occurred during the provision of the care or treatment that was unexpected or unintended.”
This explanation is confusing and there is a risk that, without greater clarity, providers will not know whether or not they should be treating recognised complications which eventuate as NSIs and responding to them accordingly. Given that failure to comply with the duty of candour in relation to NSIs carries criminal sanctions for providers, this lack of clarity in the 2022 Guidance is concerning.
What does this mean?
Having reflected on the 2022 Guidance at some length, it occurs to us that the only way to make sense of this new approach to recognised complications, in the context of the duty of candour, is by starting from the premise that there are effectively two types of recognised complications that can arise from treatment:
- On the one hand, there are poor outcomes which are known to arise from certain interventions despite everything being done by the clinicians as planned, for instance due to the physiological and chemical differences in human bodies (eg certain people do not recover so effectively from surgery, or suffer known side effects of medication). In such cases, although the harm is obviously unintended, there has been no actual “unintended or unexpected incident” and therefore this is not a NSI; whereas
- On the other hand, there are situations where the harm is caused by an act of the clinician but where it is recognised that the complexity of the procedure means it is possible that that act may occur and cause harm, without there being any shortfall whatsoever in the standard of care provided (eg a surgeon causing a perforation during an endoscopy). In such cases, the perforation is an “unintended incident”, albeit not an “unexpected incident”, and should be treated as a NSI.
As we say, this seems to us the only way to make sense of the 2022 Guidance. However, this interpretation, itself, is not straightforward and, if followed, could lead to surprising outcomes in some cases. Consider, for example, the following situation:
A patient is undergoing an orthopaedic procedure involving the insertion of a prosthetic implant into a joint. As it happens, this patient’s bone structure is particularly frail. As a consequence, when, during the procedure, the surgeon is hammering in the prosthetic implant, this causes the patient’s bone to fracture resulting in the need for surgical repair of that bone and the patient having an extended stay in hospital, the need for further post-operative treatment, a prolonged period of post-operative pain, and a poorer outcome.
The level of harm suffered by the patient in this case, clearly crosses the threshold for NSIs. However, the 2022 Guidance states that providers should not interpret whether or not something is "unexpected or unintended" by reference to the outcome of the incident, but by considering “whether anything occurred during the provision of the care or treatment that was unexpected or unintended”. Clearly the outcome (the harm suffered by the patient) is unintended. But if one has to disregard that, then, in terms of what was done during the course of the treatment, it would appear that there was no “unexpected or unintended incident”; the surgeon acted entirely as they intended, it is just that those intended acts caused the patient to suffer harm.
On our interpretation of the 2022 Guidance, therefore, this would suggest that this event is not a NSI, and that the provider would not be required to follow the prescriptive steps of the duty of candour. This might, however, be somewhat surprising to the patient. This is particularly the case given that the provider would be under a separate obligation to notify the event to CQC under regulation 18 of the Care Quality Commission (Registration) Regulations 2009, as those notifications are triggered merely by the level of harm arising regardless of whether there was an unexpected or unintended incident.
As can be seen, therefore, the consequences of our interpretation of the 2022 Guidance are not without difficulties and it may be that CQC has an alternative approach to this issue.
One alternative, and far more straight forward, approach, would be to proceed on the basis that an incident is not a NSI, and the prescriptive steps of the duty of candour do not need to be followed, if it is something about which the patient has been informed as part of the consenting process; i.e. a consented for complication of the treatment or care which can occur despite everything being done by the clinicians as planned. Such an approach would be patient centred and still achieve the purposes of openness and transparency, as patients would still be appropriately notified. They would either be notified in advance (during the consenting process) of things which could go wrong (and, in some cases, the patient’s understanding of what may occur in the course of their care would then, unfortunately materialise). Or, they would be notified after the event (by way of the duty of candour process) of (other) things which have gone wrong. However, it needs to be stressed that this is expressly not the approach the CQC guidance takes to date.
Providers are therefore left in the unenviable position of having to interpret this difficult issue with a risk of either treating issues as NSIs unnecessarily (and having to follow the various prescriptive steps in circumstances where this is not required), or failing to treat issues as NSIs with the consequent risk of facing regulatory enforcement action. It is essential that the regulator should be clear in terms of the approach it expects providers to take and, unfortunately, the latest guidance leaves uncertainty on this issue.
In summary, there is a risk that the 2022 Guidance simply adds to the confusion in this area. This is highly unsatisfactory as, if providers are to scale back on what they define as NSIs (particularly in relation to recognised complications), there needs to be a clear basis for doing this, given that a breach of the duty of candour can constitute an offence. It would therefore be extremely helpful if CQC would engage further with providers as to the intention behind the latest guidance, and clarify that intention, as soon as possible.