This article relates to the CQC key questions: Is your practice responsive to people's needs? and Is your practice well-led?
This article has been developed in consultation with the GPC and summarises CQC information on regulation 20: duty of candour.
The duty of candour came into effect for all non-NHS bodies registered with CQC (including all General Practices) from 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’ (people acting lawfully on their behalf) in general 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 an apology when things go wrong.
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.
Introducing Regulation 20 is a direct response to recommendation 181 of the Francis Inquiry report into Mid Staffordshire NHS Foundation Trust, which recommended that a statutory duty of candour be imposed on healthcare providers. This is in addition to the professional requirements for candour outlined in Good Medical Practice and applies to organisations rather than individual clinicians. In interpreting the regulation on the duty of candour, CQC uses the definitions of openness, transparency and candour used by Robert Francis 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.
Regulation 20 defines what constitutes a notifiable safety incident. Paragraph 9 of the regulation describes the harm thresholds and is consistent with thresholds for the existing CQC notification system for reporting deaths and serious injuries. These are:
- 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,
- 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,
- 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 to people who use services in the carrying on of a 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 of the duty of candour?
Once a notifiable safety incident has been identified which meets the requirements of Regulation 20, 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 provide support to them in relation to the incident, including when giving the notification.
- Provide an account of the incident which, to the best of the health service body’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 CQC regulate providers’ compliance with the duty of candour?
During our registration process we will test out with a provider that they understand the requirements of the regulation and ask them what systems they have in place to ensure that they will be able to meet these requirements.
The registration inspector will check that the provider has robust systems in place to meet the duty of candour regulation. This would include, but is not limited to:
- 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, we assess whether the provider is delivering good quality care. Specific key lines of enquiry (KLOEs) under the safe and well-led questions are relevant to the duty of candour in the inspection of General Practice. These are:
- S2: Are lessons learned and improvements made when things go wrong?
Prompt: Are people who use services told when they are affected by something that goes wrong, given an apology and informed of any actions taken as a result?
- W3: How does the leadership and culture reflect the vision and values, encourage openness and transparency and promote good quality care?
Prompt: Does the culture encourage candour, openness and honesty, with regular meetings and a culture of challenge and debate?
Illustrative Examples for General Practice which trigger the thresholds for duty of candour
- 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 5 days for monitoring and follow-up. It was noted on admission that the INR was 7.
Regulation 20 (9)(b)(i) Requires treatment by a health care professional in order to prevent the death of the service user.
- 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.
Regulation 20 (9)(a)(v) Shortening of the life expectancy of a service user
- A patient's discharge summary from a recent inpatient episode for pneumonia described how an x-ray showed signs of a 'suspicious lung lesion' requiring a follow-up with their GP. The GP practice carried out the appropriate further investigations – the results of which were normal. However the practice failed to follow normal processes for relaying the results to the patient and he was not informed for over one month. The patient consequently spent several weeks in a state of extreme upset, concerned about the possibility of cancer and developed symptoms of anxiety and depression which lasted more than 28 days.
Regulation 20 (9)(a)(iv) Prolonged psychological harm
- A patient is on a repeat prescription for morphine sulphate 10mg twice a day for chronic pain. The patient requests a prescription and, in error, a prescription is issued for morphine sulphate 100mg twice a day. The medication is dispensed and the patient’s wife, who looks after his medicines, gives her husband 100mg tablets of morphine sulphate. He takes 2 doses over the next day and then his wife is unable to rouse him in the morning. He is admitted to hospital where he has a cardiac arrest and dies.
Regulation 20 (9)(a)(i) Death of a service user.
A complete narrative example of how the duty of candour could be carried out
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. 10 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 7.
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 advisor and responsible officer at the CQC
More CQC resources
- View the full CQC Essentials series on Medeconomics
- CQC's recommended reading to help practices meet regulations and prepare for an inspection
Picture: JH Lancy