The CQC has introduced a new regulation that makes it a statutory duty to have systems in place that capture patient safety incidents.
The new regulation, or fundamental standard, is the duty of candour (regulation 20).
You must now act in an open and transparent way and ensure you have:
- systems in place to capture notifiable safety incidents
- processes to inform patients and provide support.
Although the statutory duty applies to organisations, not individuals, an organisation's staff must co-operate with it.
What is a notifiable safety incident?
The regulation states that there are two meanings of a notifiable safety incident; one for a health service body, the other for registered persons – registered persons being GPs and primary care dental practitioners.
According to the regulation: “In relation to a registered person who is not a health service body, “notifiable safety incident” means any unintended or unexpected incident that occurred in respect of a service user during the provision of a regulated activity that, in the reasonable opinion of a health care professional –
(a) appears to have resulted in –
- 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; or
(b) requires treatment by a health care professional in order to prevent –
- the death of the service user, or
- any injury to the service user which, if left untreated, would lead to one or more of the outcomes mentioned in sub-paragraph (a).
What should you do?
After a notifiable patient safety incident has occurred, practices must:
- Inform the patient (or their representative)
- Provide an account of the incident and apologise
- Inform the patient what further enquiries are to be undertaken
- Provide support to the patient
- Keep a written record of all discussions.
Follow these steps to make sure you comply with the regulation. You should:
1. Promote incident reporting and ensure that staff are aware of the reporting requirements.
2. Make sure staff understand the consequences of non-compliance and that the duty sits alongside existing professional responsibilities, eg, GMC Good medical practice, NMC The Code.
3. Ensure staff are able to raise concerns and understand the part they play.
4. Have robust systems for investigating the causes of patient safety incidents, eg, using significant event audit and root cause analysis.
Need advice on dealing with the CQC?
MPS has created a tailored resource for practices advising them on the CQC’s requirements. Visit the new section
CQC, Guidance for providers on meeting the regulations (March 2015)
The CQC’s new duty of candour essential standard launches on 1 April. Practices have to provide evidence of an open and honest culture.
MPS’s online Safety Culture 360 survey takes just ten minutes to complete and can provide you with evidence of a positive safety culture in your practice.
You can register for Safety Culture 360 online or call our education team on 0113 241 0359.
(This is free for Practice Xtra Gold members* and £99 for other practices with MPS members).