Do you know your duties of candour? Part 1

This is Part One of a case-based quiz that explores the scope of the professional-ethical and statutory duties of candour. I’m currently working with a number of organisations to improve patients’, carers’ and colleagues’ experiences of 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, including Peter Walsh at AvMA, for the stimulating discussions that underpin the cases.

Background

All health professionals have a professional-ethical duty to tell patients when something goes wrong with their treatment or care. In 2014 this duty was reiterated in a joint statement by the eight UK health professions regulators. The ethical duty on professionals as individuals is reinforced by legal duties of candour that bind organisations. For NHS organisations, a statutory duty of candour came into force in November 2014. (See Regulation 20 of The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.) A similar duty came into force for independent sector providers, including GP practices, in April 2015. (See the amended Regulation 20). The statutory duty is a duty on organisations to ensure that notifiable incidents are properly disclosed to patients. The duty is enforced by the Care Quality Commission and failure to comply could, ultimately, result in an organisation incurring criminal penalties.

For NHS Trusts a notifiable incident is any unexpected or unintended incident that causes moderate harm or worse. For GP practices and independent sector providers a notifiable incident is also one that is unexpected or unintended but thereafter the definition of the harm threshold becomes rather more complex (see subsection 5 of the amendment to Regulation 20 and discussion below). The threshold is roughly similar to moderate harm and in many cases the outcome will be the same – but not always.

To be absolutely accurate, it should also be noted that when care that is commissioned under an NHS contract – whether from an NHS Trust, independent sector provider or GP practice – the contract includes a further contractual duty of candour on organisations. This contractual duty is enforced by Clinical Commissioning Groups. The NHS Standard Contract adopts the phrasing of the statutory duties, so that the threshold for a notifiable incident under the contractual duty also differs according to whether the provider is an NHS Trust or a private organisation.

The statutory and contractual duties of candour require organisations to disclose information about harm to patients in a specific manner. (These requirements are the same for all providers.) The most important are to give patients or their supporters a prompt verbal explanation and apology, provide appropriate support, and follow up with a further written explanation and apology.

Being open about things that go wrong is important whatever the level of harm. It is morally right, and it helps to maintain trust in healthcare providers and healthcare professionals. But the statutory and contractual duties also require organisations to be able to demonstrate that they have acted properly in the circumstances that trigger the duties. It is therefore important to understand the threshold at which the duties apply.

Quiz

Each case is followed by an answer including reference to both NHS and private care. To encourage self-assessment and discourage peeking I’ve separated the two with some inspiring images. If you are unfamiliar with Regulation 20 or its amendments you may want to look at those before you start the quiz. There is also a summary of the NHS duty thresholds in this post on my site.

Case 1  –  A perforated bowel

A patient suffered a perforation of bowel during complex surgery. He had been advised of this risk during the consent process. Although the team were working carefully and attentively, the perforation was not noticed at the time. The perforation led to septicaemia and necessitated a return to surgery for repair.

Is this a notifiable incident under the statutory duty?

  1. No, because it does not satisfy the harm thresholds
  2. Yes, because it satisfies the harm thresholds
  3. No, because the patient consented to the risk
Answer

In the NHS this is a notifiable incident. It is a straightforward example of an event which meets the moderate harm threshold, taken from guidance published several years ago in the National Reporting and Learning Service Seven Steps to Patient Safety. If the perforation had been immediately noticed, washed out, and antibiotics administered it would count as LOW harm. Septicaemia and a return to surgery constitutes MODERATE harm. If a temporary colostomy and subsequent major operations were required, it would constitute SEVERE harm. No. 2 is therefore the correct answer.

This is also a notifiable incident if the procedure took place in the Independent Sector. Here a ‘notifiable incident’ is defined as an ‘unexpected or unintended incident’ that:

(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 in sub-paragraph (a).”

A perforated bowel clearly satisfies (b)(ii) and also appears to be an instance of (a)(iii), although I confess I find the meaning of ‘changes to the structure of the service user’s body’ somewhat obscure. In social and domiciliary care, where this definition has been the basis of their reporting system for many years, ‘change in the structure’ of the body tends to be viewed as a very serious harm such as amputation.

Case 2  –  A broken screw

During an orthopaedic procedure the tip of a screw sheared off leaving a screw fragment lodged in the patient’s bone. The screw was sterile, and it would have been impossible to remove without disrupting metal work already in place and causing further injury. The team decided that the least harm would be caused by leaving it behind.

Does the statutory duty of candour require you to tell the patient?

  1.  Yes, because the patient might perceive this as meeting the harm thresholds
  2. No, the patient need not be told as it does not satisfy the harm thresholds
  3. No, the statutory duty does not require you to tell the patient but the NHS ‘never events’ framework does
 Answer

This is not a notifiable incident under Regulation 20 in either the NHS or private sector, because it does not meet the harm thresholds. However, the professional duty of candour promoted by the GMC and the Royal College of Surgeons expects that patients will always be told ‘when something has gone wrong’, so the professional duty clearly applies in this case. This is reflected in the NHS ‘never events’ framework, which classifies this type of incident as low harm but also stipulates that the patient should be told about it. This was a bit of a trick question, because as described this incident would not actually be classed as a ‘never event’. This is because the team made a considered choice to leave the ‘retained foreign object’ in situ before the patient left theatre. The correct answer is no.3

Case 3  –  A fall and a cut

A patient fell in an older people’s mental health unit, and had a laceration to her forehead. She was transferred by ambulance to A&E, where she needed a single suture.

Does the statutory duty of candour apply to this event?

  1.  No, a fall is a daily hazard for older people and is not unexpected
  2. Yes, the event was unintended, and resulted in moderate harm
  3. No, although the patient had to be transferred to a different care area so this was in increase in treatment, a cut that requires one suture does not amount to significant harm    
Bottle of sodium amytal

‘Sodium Amytal’ (truth serum) Science Museum / Wellcome Trust CC BY 2.0

Answer

If the event occurred in an NHS mental health unit the correct answer would be no. 2. This example is taken from Woodward’s Briefing for the Duty of Candour Threshold Review Group, where it was used to illustrate moderate harm. According to Regulation 20 ‘moderate harm’ is something that requires a moderate increase in treatment, and causes significant, but not permanent, harm. What is a ‘moderate increase in treatment’ then? It is defined as 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.

What if the fall occurred in a private provider’s mental health unit? It would be notifiable if it satisfied the (b)(ii) threshold, something which if left untreated could end up as an (a)(iii) change to the structure of the service user’s body. Again, we are left to grapple with the meaning of ‘change to the structure of the service user’s body’ and also with trying to imagine what would happen if the wound were left untreated. My informants in social care tell me that they would not normally view this kind of injury as a ‘change to the structure’ of the body. But maybe they should, if it is notifiable as a moderate harm in the NHS?

As well as illustrating the rather confusing nature of the private sector definition, this example shows the importance of a notifiable incident being either “unintended or unexpected”. A fall is undoubtedly unintended, so fits clearly into the definition. It is interesting to ponder what ‘unexpected’ means in the Regulation though. Falls are unfortunately more frequent than we would wish, so in common parlance we could say they are not ‘unexpected’. The same could be said of pressure ulcers. The important point is that both are avoidable, and thus should not be ‘expected’ to arise during the course of good care. (You can test yourself on a case concerning community acquired pressure ulcers in the Part Two of the quiz.)

Case 4  –  A troubling mastectomy

A patient has been referred to you because she is worried about a possible recurrence of breast cancer. She had a mastectomy in an independent sector hospital four years ago. When you examine her it appears to you that the mastectomy was either grossly incompetent or unorthodox, because a great deal of excess breast tissue remained. This created an increased risk of local relapse and metastasis. Your investigations reveal a recurrence of the local cancer, and surgery will be required.

Does the statutory duty require you to ensure the patient be informed there were issues with the original surgery?

  1. Yes, because the case satisfies the harm thresholds
  2. No, because the cancer might have recurred anyway
  3. No, because it was done by another provider
Answer

This case was suggested by Professor Sir Ian Kennedy’s report on the case of Ian Paterson, who carried out what he called “cleavage-sparing mastectomies” on women in both the NHS and independent sector. In this example, the unorthodox approach has resulted in relapse. It therefore satisfies the harm threshold in both the NHS (severe harm) and independent sector (see above, the (b)(i) or (ii) definition)

But as it was carried out by a consultant working for another provider, is there any obligation to disclose it? The CQC’s Guidance on Regulation 20 makes plain that the provider who discovers an incident must take appropriate steps to ensure that it is disclosed, whether this is best done by themselves or by the original care provider. The correct answer is therefore no. 1.

This case example also raises the question whether harm that occurred prior to the introduction of the statutory duty of candour is covered by it. If Regulation 20 is to be consistent with the law on clinical negligence, it must be the date of discovery of harm that is important, not the date the harm originally occurred. So, anything freshly discovered now should be disclosed irrespective of when it originally occurred.

The principle that the date of discovery is what is important would apply equally to harm identified through activities such as internal audit or case note review.  It would therefore be prudent to have a protocol in place for disclosing harm discovered in the course of retrospective review of cases.

If you enjoyed testing your understanding in this Part One of the quiz, have a go at Part Two. And if you need to develop your organisation’s capability to respond to healthcare harm, do get in touch.