A breach of the duty of candour will be a criminal offence, so it is imperative that you and your organisation know how to deal with an incident of patient harm or complaint. Jonathan Heap explains how

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The statutory duty of candour is one of the fundamental changes arising from the Francis report.

It introduced a requirement for providers of health and social care to be open with patients and to apologise when things go wrong.

Since April 2013 a contractual duty of candour has been in operation that requires healthcare providers under the NHS standard contract to disclose cases of “moderate harm”, “severe harm” or death.

Latest developments

The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 have now been published and will be implemented as follows:

  • The statutory duty of candour and new “fit and proper persons requirement” for directors were introduced for NHS bodies on 27 November.
  • Both will be extended to all Care Quality Commission registered providers from April 2015.
  • The remaining fundamental standards will be introduced for all providers in April 2015.

Criminal penalties

As expected, the statutory duty will apply to organisations registered with the CQC rather than individuals. The CQC published guidance for NHS bodies on 27 November and the General Medical Council and Nursing and Midwifery Council have issued draft guidelines for consultation to reinforce this at an individual level.

Providers are expected to implement the duty across the organisation, requiring the education and training of staff. Policies and systems need to be revised to ensure that harm is identified and reported. 

The duty is engaged where there is a notifiable patient safety incident resulting in death, severe harm or moderate harm. This includes prolonged psychological harm, as described by the Dalton review. The exact definitions have been the subject of debate but are confirmed as follows:

  • Notifiable patient safety incident: Any unintended or unexpected incident that occurred during the provision of a regulated activity that did or could result in death or harm.
  • Moderate harm: Harm that requires a moderate increase in treatment, or significant harm which is not permanent.
  • Moderate increase in treatment: An unplanned return to surgery, an unplanned re-admission, a prolonged episode of care, extra time in hospital or as an outpatient, cancellation of treatment, or transfer to another treatment area, such as ICU.
  • Severe harm: A permanent lessening of bodily, sensory, motor, physiologic or intellectual functions, including removal of the wrong limb, organ or brain damage. 
  • Prolonged psychological harm: Psychological harm experienced for a continuous period of at least 28 days.

In any case, the injury must result from the incident, rather than being related to the natural course of the illness or underlying condition.

The duty will be overseen by the CQC and enforcement will be against the service provider, rather than patients having a direct right of redress.

A breach of the duty of candour will constitute a criminal offence, carrying a maximum penalty of a level 4 fine (currently up to £2,500). The real cost will be reputational.

Where the patient has died, lacks mental capacity or is under 16, and is not competent to make treatment decisions, the notification must be given to a “relevant person”, who can be anyone lawfully entitled to act on their behalf.

An apology must be provided in any case, even where there has been an “honest error”. 

Apart from the requirement for the initial response “as soon as reasonably practicable” there are no deadlines in the regulations. However, you need to comply with the contractual duty deadlines and it is good practice if local policies set out time limits to work to.

Notifiable safety incident procedure

  1. As soon as reasonably practicable, a representative must notify the relevant person that the incident has occurred. Include an account of what is known already, further enquiries to be undertaken, and an apology. The response should be recorded and kept securely.
  2. There is no formal requirement for third party advocacy to be provided but organisations must give  “reasonable support” to service users following an incident.
  3. Follow with a written notification containing the above information, the results of any further enquiries and repeating the apology.
  4. If the relevant person cannot be contacted or declines to speak to the appointed representative then no further action is required save that a written record must be kept of all attempts to contact or speak to them. 

Saying sorry

The NHS has long advocated the need to apologise when things go wrong, providing a full explanation of what happened. The latest guidance from the NHS Litigation Authority, Saying Sorry, includes useful advice for healthcare providers on when and how apologies should be made.

“Saying sorry when things go wrong is vital for the patient, their family and carers, as well as to support learning and improve safety. 

“Of those that have suffered harm as a result of their healthcare, 50% wanted an apology and explanation. 

“Patients, their families and carers should receive a meaningful apology – one that is a sincere expression of sorrow or regret for the harm that has occurred.”

How to apologise

Where mistakes have been made, start with a clear explanation and a prompt verbal apology.  A written apology should also be given that clearly states that the organisation is sorry for the suffering and distress caused.

Where possible this should include details of the learning which will be implemented to improve services and prevent errors from recurring. 

This is what patients want to know. 

Who should apologise?

Staff should feel supported throughout any investigation process, not forgetting that they too can be traumatised by their involvement. Training on the duty of candour and your “being open” policy is important.

Staff need guidance about who should talk to patients and what they should say. They may be concerned that they will cause upset, exacerbate the situation or create a legal liability.  

‘Staff should feel supported throughout any investigation process, not forgetting that they too can be traumatised by their involvement’

Local policies should explain how you identify the right person to lead in each case. Remember to consider seniority, relationship to the patient, experience and expertise when making this decision. 

Frontline staff must feel empowered to communicate effectively with patients and families where something has gone wrong. 

It is often appropriate for the clinician involved to provide the apology and explanation. However, care should be taken when deciding whether those involved in the treatment should attend meetings with patients. 

On occasion, the patient may prefer that a particular professional is not present. In that case, a personal written apology is often valuable.

10 tips to comply with the duty of candour

  1. Managing expectations starts with a good consent process. Are consent forms audited to ensure they include enough detail on risks and benefits? Do you conduct post-operative feedback on whether expectations are met?
  2. Simple things can make a big difference: check that you are writing to the correct person, at the right address and that spelling is checked. Be aware of the timing, particularly around a birthday or anniversary of deceased patients.
  3. The patient should be given a single point of contact for any questions or requests they might have. Make sure their questions are answered and the timescale for doing so is kept. Stay proactive.
  4. The language should be pitched appropriately for the recipient. Do they require additional support, such as an independent patient advocate or a translator?
  5. When meeting patients, speak clearly and slowly, maintaining eye contact. Give them plenty of time to respond. Avoid medical jargon or acronyms.
  6. The more you can include about lessons learned the better. Your response will be more meaningful if you can highlight changes in practice or other tangible improvements. What steps have been taken to stop this happening to another patient?
  7. Who does the patient want the apology from? Whom do they trust?  The clinicians will be best placed to say what has changed “on the ground”’.
  8. A joined up approach is essential. What has already been said? What if the incident occurred at another healthcare provider? Your policy should include channels for reporting to them and shared learning.
  9. Avoid vague or overly formal language which does not actually admit anything, such as “I am sorry you think…” If there has been a mistake, we should accept it and apologise in clear terms. An apology followed by an excuse is not an apology.
  10. Good documentation is key. Discussions around the time of an incident should be recorded in the patient records. Any subsequent meetings should be minuted and followed up by letter.

Should you act differently if the patient makes a formal complaint or claim?

No. A patient is entitled to bring a complaint. Patients should be informed of their ability to bring a complaint and given appropriate support to do so.

The decision to take legal action may be determined not only by the original injury, but also by insensitive handling and poor communication. This can be avoided by an early apology given in a truthful and open manner. 

Is an apology the same as an admission?

No. An effective and meaningful apology can be given without amounting to an admission of legal liability.  

The Litigation Authority are clear that saying sorry “is not an admission of legal liability; it is the right thing to do”. Their guidance confirms that they will not withhold cover for a claim because an apology or explanation has been given.

Using information gathered from incidents

Providers are obliged to monitor incidents and identify patterns of poor care.

Boards should scrutinise incidents, share learning and use that information for service improvement. This will require a coherent approach to collate information gathered from incidents, complaints, inquests and claims.

Robust board leadership, oversight and insistence on visibility of patient and staff feedback will support the NHS to create a safety and learning culture.

Jonathan Heap is partner at Hill Dickinson