On 26 March 2014 the DoH published its consultation paper "Introducing the Statutory Duty of Candour – A consultation on proposals to introduce a new CQC registration regulation" ("the
On 26 March 2014 the DoH published its consultation paper "Introducing the Statutory Duty of Candour – A consultation on proposals to introduce a new CQC registration regulation" ("the Consultation"). The deadline for responses is 25 April 2014.
At present, there is a contractual Duty of Candour on organisations that provide services under the NHS Standard Contract. One of the key recommendations to come out of the Mid-Staffordshire NHS Foundation Trust Pubic Inquiry (the Francis Inquiry) was the need for a statutory Duty of Candour, breaches of which will be a criminal offence. The duty will apply to all Healthcare and Adult Social Care providers registered with CQC (thus affecting NHS Hospitals, Private Hospitals, GP surgeries, Dentists and Care Homes) and would be enforced by the CQC. It appears highly probable that a statutory duty will be introduced and the purpose of the consultation is to address some of the specifics of the proposed duty in relation to harm thresholds. The Consultation also seeks comments on the costs and benefits associated with the Duty of Candour and any equality impacts.
Organisations that provide care will have a general duty to be open and transparent with their service users or people acting on their behalf. The draft Regulations do not intend place a Duty of Candour on individual staff providing care (although separately this is being considered by the professional regulatory bodies). In addition to the general duty, the draft Regulations impose a more specific and detailed duty on all registered providers where any harm to a service user arises from their care or treatment where the harm is above a certain "harm-threshold" (currently defined as a "notifiable safety incident" under the draft Regulations).
The proposed harm-threshold for Healthcare will be reached when:
This is the same harm-threshold used in the current contractual Duty of Candour, save for the addition of prolonged psychological harm. The definitions for "moderate" and "severe" harm are taken from the existing National Learning and Reporting System (NLRS).
The proposed Harm-Threshold for Adult Social Care will be reached when, in the reasonable opinion of a health care professional, an incident:
As soon as practicable after becoming aware that the harm threshold has been breached the registered provider must:
The mandatory requirement to give an apology as soon as reasonably practicable after the service provider becomes aware of an incident triggering the Duty of Candour has the potential to be contentious and it will be interesting to see what the status of such an apology is where issues of liability may still be in question and where there is potential for negligence claims and/or regulatory action.
DoH's aim is that, subject to Parliamentary approval, the draft Regulations (together with various other new registration requirements) will become part of a consolidated package of regulations to be introduced in October 2014. We will stay abreast of the responses to the Consultation; any significant opposition could impact on the Government's tight timescale for introducing the Duty of Candour by Autumn this year.
At present, there is a contractual Duty of Candour on organisations that provide services under the NHS Standard Contract. One of the key recommendations to come out of the Mid-Staffordshire NHS Foundation Trust Pubic Inquiry (the Francis Inquiry) was the need for a statutory Duty of Candour, breaches of which will be a criminal offence. The duty will apply to all Healthcare and Adult Social Care providers registered with CQC (thus affecting NHS Hospitals, Private Hospitals, GP surgeries, Dentists and Care Homes) and would be enforced by the CQC. It appears highly probable that a statutory duty will be introduced and the purpose of the consultation is to address some of the specifics of the proposed duty in relation to harm thresholds. The Consultation also seeks comments on the costs and benefits associated with the Duty of Candour and any equality impacts.
Organisations that provide care will have a general duty to be open and transparent with their service users or people acting on their behalf. The draft Regulations do not intend place a Duty of Candour on individual staff providing care (although separately this is being considered by the professional regulatory bodies). In addition to the general duty, the draft Regulations impose a more specific and detailed duty on all registered providers where any harm to a service user arises from their care or treatment where the harm is above a certain "harm-threshold" (currently defined as a "notifiable safety incident" under the draft Regulations).
The proposed harm-threshold for Healthcare will be reached when:
- in the event of death, if the death relates to the incident of harm rather than to the natural course of the service user's illness or underlying condition; and
- in the event of harm where the harm is classified as moderate or severe or where there is 'prolonged psychological harm'.
This is the same harm-threshold used in the current contractual Duty of Candour, save for the addition of prolonged psychological harm. The definitions for "moderate" and "severe" harm are taken from the existing National Learning and Reporting System (NLRS).
The proposed Harm-Threshold for Adult Social Care will be reached when, in the reasonable opinion of a health care professional, an incident:
- appears to have resulted in death arising from the incident (rather than the natural course of the service user's illness or underlying condition), serious injury, some moderate harm, prolonged pain or psychological harm, or a shortening of life expectancy; OR
- requires treatment by a health care professional to prevent death or injury or which if left untreated would lead to one or more of the above outcomes.
As soon as practicable after becoming aware that the harm threshold has been breached the registered provider must:
- Notify the service user, including provision of a truthful account of all the facts the registered provider knows about the incident at the time of the notification;
- Provide advice and, if possible, agree with the service user (or a person lawfully acting on their behalf) what further enquiries into the incident are appropriate;
- Provide an apology;
- Provide a written copy of the notification, including the apology, and the result of any further enquiries into the incident.
The mandatory requirement to give an apology as soon as reasonably practicable after the service provider becomes aware of an incident triggering the Duty of Candour has the potential to be contentious and it will be interesting to see what the status of such an apology is where issues of liability may still be in question and where there is potential for negligence claims and/or regulatory action.
DoH's aim is that, subject to Parliamentary approval, the draft Regulations (together with various other new registration requirements) will become part of a consolidated package of regulations to be introduced in October 2014. We will stay abreast of the responses to the Consultation; any significant opposition could impact on the Government's tight timescale for introducing the Duty of Candour by Autumn this year.