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The duty of candour regulation and general practice

Professor Nigel Sparrow explains practices' obligations under the new duty of candour regulation and how the CQC will assess compliance.

Prof Sparrow: 'Practices must promote a culture that encourages candour, openness and honesty at all levels' (Picture: Pete Hill)
Prof Sparrow: 'Practices must promote a culture that encourages candour, openness and honesty at all levels' (Picture: Pete Hill)

The duty of candour came into effect for GP practices on 1 April 2015. This is Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, which sets out fundamental standards.

It aims to ensure that providers are open and transparent with people who use services and other ‘relevant persons’ in relation to care and treatment. It also sets out some specific requirements that providers must follow when things go wrong with care and treatment, including informing people about the incident, providing reasonable support, providing truthful information and a written apology. 

The duty of candour regulation was recommended by the Francis Inquiry report into Mid Staffordshire NHS Foundation Trust. This is in addition to the professional requirements for candour outlined in Good Medical Practice and applies to organisations rather than individual clinicians.  

It means that practices must promote a culture that encourages candour, openness and honesty at all levels. This should be an integral part of a culture of safety that supports organisational and personal learning. There should also be a commitment to being open and transparent at board or partnership level.

What does duty of candour mean for practices?

In interpreting the regulation on the duty of candour, the CQC uses the definitions Robert Francis listed in his report:

  • Openness – enabling concerns and complaints to be raised freely without fear and questions asked to be answered.
  • Transparency – allowing information about the truth about performance and outcomes to be shared with staff, patients, the public and regulators.
  • Candour – any patient harmed by the provision of a healthcare service is informed of the fact and an appropriate remedy offered, regardless of whether a complaint has been made or a question asked about it.

The new regulation defines what constitutes a notifiable safety incident. These are:

  • the death of the patient, where the death relates directly to the incident rather than to the natural course of the service user’s illness or underlying condition, 
  • an impairment of the sensory, motor or intellectual functions of the patient, which has lasted, or is likely to last, for a continuous period of at least 28 days, 
  • changes to the structure of the service user’s body, 
  • the service user experiencing prolonged pain or prolonged psychological harm, or
  • the shortening of the life expectancy of the service user 
  • Requirement for additional treatment to prevent one of the harms described above.

Regulation 20 applies to providers when they are providing care and treatment for CQC-regulated activity only. The identification of clinical situations which meet these thresholds remains the professional judgement of the clinicians involved in the incident.

What must an organisation do to meet the requirements?

Once a notifiable safety incident has been identified a registered provider must:

  • Make sure it acts in an open and transparent way with relevant persons in relation to care and treatment provided to people who use services in carrying on a regulated activity.
  • Tell the relevant person in person as soon as reasonably practicable after becoming aware that a notifiable safety incident has occurred, and support them in relation to the incident, including when giving the notification.
  • Provide an account of the incident which, to the best of the organisation’s knowledge, is true of all the facts the body knows about the incident as at the date of the notification.
  • Advise the relevant person what further enquiries the provider believes are appropriate.
  • Offer an apology.
  • Follow this up by giving the same information in writing, and providing an update on the enquiries.
  • Keep a written record of all communication with the relevant person.

How will the CQC regulate providers’ compliance? 

During the registration process we will test whether providers understand the requirements of the regulation and ask them what systems they have in place to ensure that they will be able to meet them. 

The registration inspector will check there are robust systems in place. This would include:

  • training for all staff on communicating with patients about notifiable safety incidents
  • incident reporting forms which support the recording of a duty of candour notification
  • support for staff when they notify patients when something has gone wrong
  • oversight and assurance.

During the inspection process, the CQC assesses whether the provider is delivering good quality care. Specific key lines of enquiry (KLOEs) under the safe and well-led questions are relevant to assessing duty of candour in practice inspections – see here for more detail on the CQC's key lines of enquiry.  

Examples that trigger the thresholds for duty of candour

Example 1: A patient was prescribed an antibiotic by the practice which is known to interfere with warfarin levels went without INR monitoring for several weeks. The patient had an upper GI bleed and was admitted to hospital for five days for monitoring and follow-up. It was noted on admission that the INR was 7. 

Example 2: A patient who is a heavy smoker with a persistent cough is noted to have a suspicious lesion on a chest x-ray. The GP messages the practice reception to arrange an urgent appointment with the patient, although there is no answer on the patient’s home telephone as he is on holiday. The message to follow up is missed. Nine months later the patient presents with shortness of breath and haemoptysis. He is admitted to hospital via MAU and is diagnosed with lung cancer. 

How the duty of candour could be carried out in practice

A patient taking warfarin for stroke prevention from atrial fibrillation presented with a cough and shortness of breath and was given antibiotics for chest infection. His INR was normally stable and he only attended the warfarin clinic at the GP practice for INR monitoring on a monthly basis.

Ten days passed, during which his chest symptoms recovered. He then slipped at home and hit his leg, and developed an uncomfortable haematoma. He attended the GP practice for an INR check and his INR is found to be seven.

The GP who prescribed the antibiotics explained that it was likely that the antibiotic treatment had increased the anticoagulant effect of the patient’s usual warfarin dose. Although the patient had been warned of the risk of bleeding when he started treatment with warfarin several years before, the GP apologised for what had happened.

The GP gave the patient vitamin K, and withheld the warfarin for that day. The patient recovered without further bleeding, but had to reattend the surgery every day for several days to recheck his INR value and modify his warfarin dose, until the INR value stabilised.

The GP invited the patient into the surgery for a meeting and reiterated his apology. He made sure that the patient understood what he had been told. The GP made a detailed note of what had been discussed in the patient’s medical record.

The GP notified the practice manager responsible for duty of candour arrangements in person and followed the practice’s clinical governance procedures for reporting patient safety incidents.

Referring to CQC guidance, the manager and GP agreed that it was a notifiable patient safety incident, and that the discussions that had taken place were appropriate and sufficient under the statutory duty of candour obligations.They agreed the GP would write to the patient, summarising what had happened.

The GP wrote a letter to the patient, summarising all that was known about what had happened, and which repeated the earlier apologies. The GP made a final note in the clinical records of the discussion, relaying this to the manager so that the practice’s notification process was complete.

  • Professor Nigel Sparrow is senior national GP adviser at the CQC

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