Providers of regulated healthcare need to start taking account of a slew of legislative changes affecting the governance of their organisation in the coming months, writes Tony Yeaman
We will shortly see the bringing into law of a number of recommendations around the need for greater transparency and accountability in the health sector, first in the NHS and later in the independent sector.
‘Failure to comply with the duty of candour is likely to have an impact on providers’ ratings under the CQC rating system’
There has been much debate and focus on a new statutory duty of candour, but with all the other changes they are coping with, there is a real danger that boards will have failed to have taken full account, or understood, the significance of a number of new provisions shortly to come into force.
These provisions, taken together, impose significant additional requirements and potential organisational and personal sanctions on boards in relation to good governance, openness and transparency.
It will be a real test for boards to ensure their organisations, their directors and staff are now ready, candid and fit for purpose. Getting it wrong could have significant implications for the patient, relevant director and organisation.
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Duty of candour
So what is happening? Well, in addition to an existing contractual duty of candour within the NHS contract and the longstanding ethical duty on healthcare professionals, we will see in the course of the next year a significant number of new statutory provisions, to be enforced by the Care Quality Commission. These will impact on providers of regulated healthcare.
The new provisions are to be found in the current draft regulations, snappily entitled the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, and in the Care Act 2014, which are expected to come into force in the coming months. They include:
- a new statutory duty of candour to report notifiable safety incidents (regulation 20);
- a fit and proper person test for directors including serious misconduct and mismanagement provision (regulation 5);
- a good governance provision in relation to systems and processes to ensure compliance with fundamental standards (regulation 17); and
- a new offence of providing false and misleading information (section 92).
Failure to comply with the duty of candour is likely to have an impact on providers’ ratings – particularly in relation to whether they are “well led” – under the CQC rating system.
Organisational staff support
The Department of Health has said that the 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”.
Boards, in doing this, will need to take a number of steps. A good starting point is the Being Open guidance – originally prepared by the National Patient Safety Agency, whose functions have now transferred to NHS England:
- Ensure the board, trust staff, and in a foundation trust, its governors, are fully apprised of and understand the new duty of candour provisions when they come into force, as well as implications for the trust.
- The board should make public commitments to implementing a policy of candour.
- Create or review and strengthen local policies to communicate with patients where there is a notifiable safety incident and ensure this is embedded within the organisation’s wider risk management processes.
- Providers should have named executive and non-executive leads.
- The new policy should be publicised to staff.
- Provide training support and advice to staff on managing patient safety incidents.
- Publicise information on the support available for staff affected by patient safety incidents.
- Ensure the board receives timely reporting of incidents and has a method for benchmarking, learning and review.
What is important for boards to grasp is that a duty of candour cannot be viewed in isolation as one new provision to comply with; it is part of a wider system/culture change, where the whole health economy becomes more open and transparent.
It is important for boards and their organisations to grasp this opportunity to not just review how and when they need to be candid, but also how they can learn and use this opportunity to become a more open, learning and patient-focused organisation.
This openness and opportunity, which is not new, is being embraced as a force for improving patient safety and learning, as exemplified by the NHS Litigation Authority.
‘The intention is to ensure providers are open and honest with service users when things go wrong’
Highlighted by its Saying Sorry leaflet, the authority promotes openness and transparency by encouraging healthcare organisations to create an environment in which all staff report patient safety incidents, say sorry and provide patients with an explanation when things go wrong.
The NHS LA has replaced risk assessments with a new safety and learning service to focus action on reducing harm by learning from claims.
A policy of being open, support for members and commitment to learning is at the heart of Sign up to Safety, a new national patient safety campaign that was announced in March by the health secretary.
A safer NHS
It is important that all healthcare organisations create the culture and environment in which members of staff are encouraged to report patient safety incidents, while feeling supported to counter the impact the incident may have had on them and the personal consequences of highlighting their own or others’ failures.
What is clear is that by placing in the hands of the CQC oversight and enforcement of this new raft of openness and governance provisions, the intention of the regulation is to ensure providers are open and honest with service users and other relevant persons when things go wrong. Boards, take note!
Some commentators fear the new obligations and criminal sanctions will do little to contribute to an open culture of learning from mistakes. That is clearly possible but needs to be countered by an engaged board building support for clinical staff and a culture of openness to support learning.
I believe that, taken together, and with the support of the board and proper engagement, training and support of staff, this will help deliver a safer NHS.
Tony Yeaman is national head of healthcare at Weightmans LLP