As of 27 November 2014, all health service Providers must comply with a new statutory duty of candour. This is separate to the contractual duty of candour which took effect from 1 April 2013.
The new duty was implemented by Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. It applies to all CQC registered Providers (whether providing NHS, Local Authority or privately-funded care).
The duty is likely be extended to all the above Providers beyond the NHS from 1 April 2015.
Reminder of Contractual duty of Candour
As a brief reminder, the duty of candour took effect in contractual form by way of being included in the NHS Standard Contract (Specific Condition 35). This requires all NHS and non-NHS providers of services to patients to comply with the duty of candour under contract.
The contractual duty of candour is triggered by individual patient safety incidents that result in moderate or severe harm or death. Once triggered, Providers are under a duty to carry out the following actions:
- report the incident as soon as possible and in any event within 10 days;
- implement a full investigation into the incident as soon as possible;
- inform the relevant person (ie, service user, family or carer) that the incident has occurred, or is suspected to have occurred, within 10 days. This should take place in person by a representative of the Provider and should include, where possible, the clinician responsible for the episode of care;
- provide the relevant person with a step by step explanation of events or circumstances surrounding the incident. Regular updates should be provided throughout the investigation;
- provide the relevant person with a copy of the investigation report within 10 days of completion;
- maintain full written records of any meeting or contact with the relevant person.
Statutory Duty of Candour
What is the duty?
Looking to the NHS, the new duty aims to ensure openness and transparency by a health service body with people who use their services and / or relevant persons (this term explained below) in relation to care and treatment provided to service users in carrying out a regulated activity. In particular, the duty ensures that when things go wrong with care and treatment, service users or relevant persons are provided with reasonable support, truthful information and an apology.
When is the duty triggered?
The statutory duty of candour arises where there is, believed or suspected to be, a "notifiable patient safety incident".
Regulation 20 defines this as "any unintended or unexpected incident that occurred in respect of a service user…that in the reasonable opinion of a healthcare professional, could or 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;
- Severe harm, moderate harm, or prolonged psychological harm to the service user/patient.
Briefly, these are defined as follows:
- Severe harm – a permanent lessening of bodily, sensory, motor, physiologic or intellectual function that is directly related to the incident and not related to the natural course of the patient's illness or underlying condition;
- Moderate harm – harm that requires a moderate increase in treatment and significant but not permanent harm. This could be an unplanned return to surgery, an unplanned readmission, a prolonged episode of care, extra time in hospital or as an outpatient, cancelling of treatment, or transfer to another treatment area such as intensive care (all of which fall in the definition of a moderate increase in treatment);
- Prolonged psychological harm – psychological harm which a service user has experienced or is likely to experience, for a continuous period of at least 28 days.
How is Compliance Achieved?
Providers are expected to carry out the following actions to be compliant with the new duty:
- As soon as reasonably practicable after becoming aware that a notifiable patient safety incident has occurred, the health service body must:
- Notify the relevant person that an incident has occurred;
- Provide reasonable support to the relevant person in relation to the incident, including when notifying them. This notification must:
- Be given in person by one or more representatives of the health service body;
- Provide an account which is true of all the facts to the best of the health service body's knowledge about the incident at the time of the notification;
- Advise the relevant person what further enquiries into the incident the health service body believes are appropriate;
- Include an apology;
- Be recorded in a written record which is kept securely by the health service body.
- The initial notification must then be followed by a written notification. This must contain:
- All of the information given at the notification meeting;
- Details of any enquiries into the incident;
- The results of any further enquiries into the incident or an update on those enquiries; and
- An apology.
- The health service body must keep a copy of all correspondence with the relevant person;
- The results of any investigation (ie RCA) must be provided to the relevant person in a timely way.
Who is the Relevant Person?
This is the service user, or a person lawfully acting on their behalf in circumstances in which the service user;
- has died (such as the next of kin or personal representative);
- is under 16 and is not competent to make a decision in relation to their care and treatment (such as an individual with parental responsibility);
- is 16 or over and lacks capacity in relation to their care and treatment (such as a person appointed by way of Lasting Power of Attorney for health and welfare, or the person to be consulted in the service user's best interests under the Mental Capacity Act 2005. The Provider is not required to liaise with all potential persons identified who could meet that best interests role, but should identify key persons.)
What if the Relevant Person cannot be contacted or declines to engage with this process?
The health service body must keep a written record of all attempts to contact or speak to the relevant person and their response, whether by silence or otherwise, to each attempt.
What form should the Apology take?
The apology should be an appropriate and sincere expression of sorrow or regret for the harm which resulted from the incident. The apology should be based on the facts known at the time. It is always prudent to explain to the individual that new information may emerge as an investigation takes place, and to provide reassurance that the person will be kept updated throughout the investigation.
Providers may have understandable concerns about making an apology, including a fear of being seen to "admit liability" or affecting any claim that may be made against the Provider.
Firstly, it is important to remember that an apology is not a legal admission of liability. Secondly, the NHSLA has confirmed that it would "never withhold cover for a claim because an apology or explanation has been given."
Who is responsible for monitoring compliance and how will this be done?
The CQC will be the lead monitor for compliance of the duty of candour. This will be undertaken by inspection, and therefore this could have an effect on a hospital's inspection rating.
As part of their inspection, it is anticipated that the CQC will sample records of notifiable patient safety incidents to determine whether:
- the notification was given by a representative of the Provider;
- the relevant person received (to the best of the Provider's knowledge) a true account of the incident to date;
- the Provider explained what further enquiries were being made and kept the person updated;
- the Provider included an apology;
- that the compliance requirements outline above where achieved;
- the action taken was appropriately recorded in writing and kept securely.
What are the consequences of breaching the duty?
When CQC identifies a breach of Regulation 20, it will assess the impact and decide whether it needs to take regulatory action. CQC have indicated however:
- We expect to mainly use the new regulations on candour to confirm or encourage good practice through the ratings we give, rather than to enforce them directly.
- Criminal sanctions have a role to play, but by themselves are unlikely to be the strongest driver for promoting a culture of openness in providers.
- We will develop the processes that our inspectors will use to inspect and enforce the duty of candour, and ensure that our approach is proportionate, for example taking account the degree of harm.
- We will not shy away from using the full weight of our powers, but we anticipate that this will be in cases where there is evidence of deliberate withholding or manipulation of information.
Overall whilst doctors and nurses will not be personally liable in terms of any criminal sanctions; where CQC identifies a breach, it is open to it to prosecute that organisation should it feel that the breach is serious enough. Consequently it is entirely possible for an organisation to be prosecuted for failing to meet the statutory requirements of Regulation 20.
It was the case that where an organisation failed to meet the requirements of a Regulation, a warning notice was issued with a timescale for compliance. If that organisation then failed to comply, CQC may decide to bring a prosecution. If the organisation did comply, then no prosecution could be brought. This has now changed with the implementation of Regulation 20 so that if an organisation is not meeting its obligations in terms of its statutory duty of candour, it is open to the CQC to immediately prosecute. Clearly this is only likely to happen in the most serious of cases (ie where there are a lack of systems for example), but it is something to bear in mind.
The implications of a successful prosecution are a fine (£2,500). Whilst this may not seem very much, it is more about the impact on public reputation which has the more serious consequence.
In addition, it is also worth noting that in terms of personal liability a Director or Senior Manager can also be prosecuted, with criminal sanctions imposed if the organisation's serious failure to meet statutory requirements of the duty of candour stem from actions done with consent, or as a result of neglect, or the failure should have been reasonably known, for example.
A Candour Culture
Organisations should take steps to act in an open and transparent way.
- There should be a board level commitment to being open and transparent in relation to care and treatment;
- The culture of an organisation should encourage candour, openness and honesty;
- The Provider should have policies and procedures to support a culture of openness/candour and ensure these are followed by all staff;
- The Provider should take action to tackle bullying or harassment and must investigate any member of staff who may be obstructing duty of candour;
- The Provider should have a system in place to identify and deal with breaches of professional duty of candour.
Practical ways in which Providers can ensure a commitment to the duty of candour includes:
- Ensuring a suitable policy is fully implemented throughout its organisation;
- Carry out a Root Cause Analysis investigation for incidents to discover underlying causes;
- Ensure there is a system of accountability throughout all levels of the organisation;
- Provide a programme of continuous learning and audit.
Staff should be reminded to:
- Familiarise themselves with policies;
- Report any "near misses" appropriately in line with their own professional duties of candour;
- Report notifiable incidents within the meaning of Regulation 20 as soon as possible;
- Co-operate fully, honestly and openly with any investigations;
- Participate fully in staff training so that there is ongoing organisational and personal learning.
In summary, the key issues to consider are:
- Has there been a potential "notifiable patient safety incident" within the meaning of Regulation 20?
- Has the requisite standard of harm been triggered, or could it be triggered in the future as a result of this incident?
- If so, the Provider is under an obligation to carry out certain steps in order to comply with the statutory duty of candour.
- Staff should be encouraged to report notifiable incidents as soon as possible so that the necessary steps can be taken.