The Government's latest Consultation Response sets out its revised thinking on the proposed statutory duty of candour and, in doing so, makes a distinction between NHS services and services in the independent healthcare and adult social care sectors.
For NHS providers (NHS Trusts and FTs) the statutory duty of candour commences in October 2014 whereas, for independent healthcare and adult social care providers, the duty is not implemented until April 2015.
The Government also proposes to differentiate between NHS providers, and independent healthcare and adult social care providers in terms of the definition of "notifiable safety incidents" which trigger the duty. Whereas the Government's initial proposal was to have different definitions of "notifiable safety incidents" in the healthcare and social care sectors, the revised proposal is to have a different definitions for the NHS from that which will apply to the independent healthcare and adult social care sectors.
For NHS bodies the definition of a "notifiable safety incident"
which will trigger the duty of candour is one which, in the
reasonable opinion of a health care professional, results in death,
severe harm, moderate harm, or "prolonged psychological
harm". The definitions of "moderate" and "severe" harm are
consistent with those used within the NHS for reporting under the
NRLS and the existing contractual duty under the NHS Standard
Contract. However, the inclusion of "prolonged psychological
harm" means that candour notifications will need to be given when a
service user has experienced, or is likely to have experienced,
psychological harm for a continuous period of at least 28 days.
For the independent healthcare and adult social care sectors, the Consultation Response makes it clear that they will use the existing CQC notifiable patient safety incident harm definitions (under regulation 18 of the Care Quality Commission (Registration) Regulations 2009) to identify when a disclosure under the duty of candour is required.
It is helpful, therefore, that for all sectors, the thresholds for when the statutory duty of candour is triggered will be based on definitions already in use in the sectors.
Strangely, although the pre-consultation draft regulations set out to the proposed wording of the duty of candour for both the NHS and the independent sector, the revised draft Regulations only include a duty for health service bodies. Further regulations will, therefore, need to be introduced in order to implement the statutory duty for the independent healthcare and adult social care sectors.
One further significant change as a result of the consultation is that the maximum sanction, upon conviction for breach of the statutory duty of candour has been reduced from a potentially unlimited fine to a fine of level four on the standard scale (currently £2,500).
It is helpful that the thresholds for notifiable incidents are to be set at levels which should already be familiar to providers in all sectors.
For those providers already subject to the contractual duty of candour under the NHS Standard Contract, the substance of the proposed duty of candour is very similar. Private healthcare providers should also have existing practices around making candid disclosures to patients due to the professional duties of candour on healthcare professionals. It seems that the impact of the new duty will be felt most, therefore, in the adult social care sector. However, even for providers already subject to the contractual duty of candour, the introduction of the statutory duty means they will now be liable to enforcement (including possible prosecution) by CQC for failure to comply; such failures are also likely to have an impact upon providers' ratings (particularly in relation to whether they are 'Well-led') under the new CQC rating system.
Suggested course of action
The Consultation Response makes the point that provider organisations will need to ensure they have appropriate policies, procedures and systems in place. However, as Dalton and Williams commented in their review of the duty of candour "making a reality of candour is a matter of hearts and minds more than it is a system of systems and processes" and the Government's Response indicates the importance of ensuring candour through education and training of staff in provider organisations.
It is also important for providers to ensure there is appropriate advocacy support for service users to assist them through the candour process; indeed one of the requirements of the duty, in the draft Regulations is to provide "reasonable support".
The Response discusses the question of apologies and reiterates the point made in the recent NHSLA guidance 'Saying Sorry' that an apology is not the same as an admission of legal liability. However, although the Consultation Response states that the apology is to be "for the harm that has arisen" the wording of the draft Regulations, themselves defines an apology as being an expression of sorrow or regret in respect of the "incident". There is a risk, therefore, that in making apologies, and providing explanations, for incidents, providers will make admissions of fact which may influence the question of liability in any claims.
The Department of Health state that CQC will "require providers to be taking steps to ensure that there is good organisational management and leadership in place to encourage and support staff to be open with service users and to drive a culture change towards more openness and transparency". As an example of good practice, the Department refers to the National Patient Safety Agency's 'Being Open' guidance which suggests providers should take the following steps to implement a policy, and culture, of candour:
- Create or review and strengthen local policies identifying how to communicate with patients where serious injury or death has occurred; and ensure this policy is embedded with the organisation’s wider risk management processes
- Boards should make public commitments to implementing a policy of candour
- Providers should have named executive and non-executive leads responsible for candour
- Publicise the new policy with staff and provide advice and training to staff on managing patient safety incidents
- Publicise information on the support systems currently available for staff distressed by patient safety incidences
How can Bevan Brittan help?
We can provide assistance and support on a wide range of issues relating to candour including:
- Investigations and responses to specific incidents
- Liaison and disclosures between providers, commissioners and regulators
- Drafting and reviewing candour and related quality governance policies and procedures
- Training throughout organisations (from Boards and Executive
Teams to front-line staff)