In April 2016, the Care Quality Commission announced that it is carrying out a review of how NHS trusts identify, report, investigate and learn from deaths of people using their services. The findings will be published in a national report by March 2017.
This review was prompted by the Government response to the independent Mazars report into failures by Southern Health NHS Foundation Trust to investigate and learn from the deaths of patients particularly in its older people’s, learning disability and mental health services.
As part of the review, CQC will be writing to all acute, community and mental health trusts seeking information about the number of deaths in their services, how they decide which of these should be investigated and how they then carry out those investigations. CQC have identified that important areas for them to review are how the findings of investigations are used to make improvements and how families are involved in the investigation process. CQC aim to find out how well NHS trusts support and engage with the families of people who have died.
Following their January 2016 inspection of Southern Health NHS Trust, CQC identified that there remained uncertainty amongst some staff as to how to involve families in the investigation of deaths.
The issue of the involvement of and engagement with families in the investigation process relates to a live issue for Providers which is the question of whether the duty of candour requires Providers to disclose to relevant persons the investigation reports produced following serious incidents, (the death of a service user being a serious incident).
The statutory duty of candour is set out in regulation 20 of the Health and Social Care (Regulated Activities) Regulations 2014 (as amended) “the 2014 Regulations”.
There is also a contractual duty of candour inserted in to the NHS Standard Contract (SC35) which incorporates compliance with the obligations contained within regulation 20 of the 2014 Regulations in respect of notifiable safety incidents.
Additionally, individual Registrants of the professional regulatory bodies such as the General Medical Council (GMC), the Nursing and Midwifery Council (NMC) and the General Dental Council (GDC) are subject to a professional duty of candour.
Since 1 April 2015 the statutory duty of candour contained within regulation 20 has required all registered Providers to ensure that they act in an open and transparent way with relevant persons’ in relation to care and treatment provided. To comply with regulation 20, in summary, all registered Providers are required to:
· Tell the relevant person that a notifiable safety incident has occurred and provide support In relation to that incident;
· Provide an account which is true to the best of the Provider’s knowledge, of all the facts known about the incident at the time of notification;
· Advise the relevant person what further enquiries the Provider believes are appropriate;
· Provide an apology;
· Provide this information and the apology in writing and give details of the enquiries to be undertaken and the results of any further enquiries into the incident;
· Keep a written record of communications with the relevant person.
What is not clear is whether the requirement to provide written notification to relevant persons of the account of the incident and the results of any further enquiries requires disclosure of the full investigation report following a serious incident. That is not explicitly covered by regulation 20 or the related guidance. A reading of the regulation would appear to suggest that correspondence providing a summary of the details of the enquiries and the results of them would suffice.
However, NHS Providers must exercise caution in this regard since, in addition to the duty of candour, they are contractually obliged to comply with the requirements for incident reporting set out in the NHS Standard Contract (SC33). This provision of the Standard Contract requires that NHS Providers must comply with the NHS Serious Incident Framework and the Never Events Policy Framework, and must report all Serious Incidents and Never Events in accordance with the requirements of those frameworks.
In relation to involving those affected in the investigation of serious incidents, the NHS Serious Incident Framework sets out that those involved must also have access to the necessary information and should:
· be given access to the findings of any investigation, including interim findings ; and
· have an opportunity to respond/comment on the findings and recommendations outlined in the final report and be assured that this will be considered as part of the quality assurance and closure process undertaken by the commissioner;
This would suggest that investigation reports may require to be disclosed however, the Serious Incident Framework goes on to acknowledge that this may “disclose confidential personal information for which consent has been obtained, or where patient confidentiality is overridden in the public interest. This should be considered by the organisation’s Caldicott Guardian and confirmed by legal advice, where required.” Issues of patient confidentiality will be particularly relevant here since the definition of ‘those affected’ for the purposes of the Serious Incident Framework appears wider than the definition of ‘relevant persons’ for the purposes of Regulation 20.
Accordingly, pending national guidance from NHS England on this issue which is in development, legal advice on disclosure of investigation reports into serious incidents should be sought on a case by case basis. Meantime providers should continue to ensure that they provide communication to relevant persons in line with their obligations under regulation 20 of the 2014 Regulations.