Duty of Candour

1. Duty of Candour Alexia Dawson, Associate, Ward Hadaway

2. Duty of Candour • What I am covering today • Brief background to the statutory duty of candour • The obligations under the new regulations • Guidance issued about the new regulations

3. Duty of Candour • Brief background to the statutory duty of candour • Duty of candour is not a new concept • The duty to be open already exists in the following:- • NHS standard contract (since 2013) • NHS Constitution • Being open framework • CQC registration requirements • Professional duty of candour

4. Duty of Candour • Francis Inquiry recommended the introduction of a statutory duty of candour on healthcare providers • Key dates post the Francis Inquiry • March 2013 – the initial Government response to the Francis Inquiry “Patients first and foremost”. The government accepted the need to introduce a Statutory of Duty of Candour for health and care providers. • June 2013 – CQC Consultation on the way it regulates, inspects and monitors care, which included issues concerning the planned Statutory Duty of Candour. • August 2013 – The Berwick Review. • January 2014 – Government response in “Hard Truths: The Journey to putting Patients First”.

5. Duty of Candour • The Department of Health obtained advice in relation to how improvements could be made to the reporting of patient safety incidents, the threshold for the Statutory Duty of Candour requirements, and what could be done to encourage compliance. • March 2014 – Dalton/Williams review. Sir David Dalton (Chief Executive of Salford Royal NHS Foundation Trust) and Professor Norman Williams (President of The Royal College of Surgeons) were asked to conduct a review of the threshold for the new Statutory Duty of Candour. • 26 March 2014 – Government consultation published – included a draft of the Regulations which will introduce the statutory duty of candour. • 25 April 2014 – consultation closed. • 7 July 2014 – Response to consultation published including amended draft regulations. • 25 July 2014 – 5 September 2014 – CQC consultation on CQC guidance for NHS bodies on the duty of candour.

6. Duty of Candour • Regulations and compliance • Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. • Statutory duty of candour set out at Regulation 20. • Regulation 20 came into force on 27 November 2014

7. Duty of Candour • CQC guidance issued on 20 November 2014 gives examples of what the CQC feels Trusts should do to comply with Regulation 20 – Trusts should ensure they are aware of the content of this guidance. • General duty in Regulation 20(1) – health service body to act in an open and transparent way in relation to care and treatment provided to service users.

8. Duty of Candour • Notification of notifiable safety incident-statutory duty only applies to incidents which fall within this definition • What is the definition of notifiable safety incident? • Issues to consider – • Moderate harm-what falls within this? • Could result in • Psychological harm – 28 days • Glossary to CQC guidance – clarification around cancelling treatment definition-where planned treatment is not carried out as a direct result of the notifiable safety incident

9. Duty of Candour • Notification of a notifiable safety incident • Regulation 20(2) – process starts as soon as reasonably practicable after a registered person becomes aware that a notifiable safety incident has occurred-when should this happen? • CQC guidance-analogy with NHS Standard Contract-must be within 10 working days of the incident being reported to local systems and sooner where possible • All staff to have responsibility to adhere to policies and procedures around duty of candour regardless of seniority and permanency • Being Open Framework provides guidance on good communication • Where the degree of harm is not yet clear but may fall within the definition the relevant person must be notified • No requirement to notify of a near miss

10. Duty of Candour • Registered person must – • Notify the relevant person of the incident in accordance with Regulation 20(2) – who is the relevant person? • Relevant person means the service user or a person lawfully acting on their behalf • on the death of the service user • if service user is under 16 and not competent • if the service user is over 16 and lacks capacity • Human elements?

11. Duty of Candour • Provide reasonable support to the relevant person – CQC guidance provides examples of what is reasonable support necessary to help overcome the physical, psychological and emotional impact of the incident including all or some of: • Being treated with respect, consideration and empathy • Being offered the option of direct emotional support during the notifications • Being offered access to assistance with understanding what is being said • Providing access to any necessary treatment and care to recover from or minimise the harm caused where appropriate

12. Duty of Candour • Providing the relevant person with details of specialist sources of practical advice and support or emotional support/counselling • Providing information about available impartial advocacy and support services, local Healthwatch and other relevant support groups • Arranging for care and treatment to be delivered by another professional, team or provider if this is possible should the relevant person wish this. • Providing support to access its complaints procedure • The Being Open Framework provides guidance on how to support patients, their families and carers following a patient safety incident

13. Duty of Candour • Form of notification given under regulation 20(2) • The notification must: • Be given in person by one or more representatives of the registered person • Provide an account of all the facts the registered person knows about the incident as at the date of notification • Advise the relevant person what further enquiries into the incident the registered person believes are appropriate • Include an apology, and • Be recorded in a written record which is kept securely by the registered person

14. Duty of Candour • CQC guidance about notification to be given under regulation 20(3) suggests the following: • A step by step account of all relevant facts known about the incident at the time is given in person by one or more appropriate representatives of the provider • Include as much or as little relevant information as the relevant person wants to hear • Should be jargon free and explain any complicated terms • Explain what further enquiries will be made • The account should be given in a manner that relevant persons can understand – consider if appropriate interpreters, advocates, communication aids etc but be mindful of confidentiality issues • Ensure a meaningful apology is given

15. Duty of Candour • Further requirements re notification • Regulation 20(4) states that the notification given must be followed by a written notification given or sent to the relevant person containing: • The facts as provided at the meeting • Details of any enquiries to be undertaken as discussed at the meeting • The results of any further enquiries into the incident; and • An apology • CQC guidance • Ensure that the written notification is given even though enquiries may not yet be complete • Further contact will be needed once enquiries are complete

16. Duty of Candour • What enquiries are to be undertaken? • Trusts will have a serious incident investigation policy • Will the SI report be sufficient enquiry? We would assume so • Include any concerns raised by relevant person

17. Duty of Candour • Additional issues around the drafting of SI reports • Balance between the need to produce reports in timescales required by Commissioners and need to involve the patient/family • The need for robust reports – these will be disclosed in whole or part of Statutory Duty of Candour process • The impact of poorly drafted SI reports • Claims • Inquests • Ensure reports are fair, balanced and represent what happened • Always consider issues of causation • Who may see an SI report?

18. Duty of Candour • Contacting the relevant person • Regulation 20(5) states if the relevant person cannot be: • Contacted in person; or • Declines to speak to the representative of the registered person • Then Regulation 20(2) to 20(4) do not apply and a written record should be kept of the attempts to contact the relevant person • CQC guidance-if the relevant person has died and there is nobody who can lawfully act on their behalf a record of this must be kept

19. Duty of Candour • Records to be kept • Regulation 20(6) – the relevant person must keep a copy of all correspondence with the relevant person under Regulation 20(4) • CQC guidance • A record of the written notification along with any enquiries and investigations and the outcome must be kept • Any correspondence from the relevant person must be responded to in an appropriate manner and a record kept

20. Duty of Candour • Other issues to consider • Apologies versus admissions • Be aware of the difference between an apology and an admission • An apology does not constitute an admission of liability • NHSLA letter about apologies – admissions to be made by the NHSLA • NHSLA leaflet-saying sorry-referred to in the CQC guidance • Compensation Act 2006

21. Duty of Candour • Sanctions for non compliance • CQC can move directly to prosecution without first serving a warning notice if a Trust fails to comply with the Regulations • Regulation 22(3) – it is an offence to fail to comply with Regulation 20(2)(a) and (3) but – • Regulation 22(4) – it is a defence if the Trust can prove they took all reasonable steps and exercised all due diligence to prevent the breach of any of those regulations that has occurred-importance of keeping all correspondence • The offence carries a maximum penalty of a level 4 fine on the standard scale (£2,500) • CQC guidance indicates that: • The CQC expects to mainly use the new Regulations to confirm or encourage good practice through the ratings given rather than to enforce them directly

22. Duty of Candour – and Effective Report Writing • The guidance will be key to deciding when prosecution is appropriate • The CQC will not shy away from using the full weight of their powers but anticipate that this will be in cases where they have evidence of deliberate withholding or manipulation of information • Other issues: • NHSLA – recent consultation • Care Act 2014 – offence re false or misleading information

23. Duty of Candour • What do Trusts need to do to ensure Trust and staff compliance with the Regulations? • CQC guidance suggests: • A board level commitment to being open and transparent • The culture of the organisation should encourage candour, openness and honesty at all levels as an integral part of a culture of safety that supports organisational and personal learning • Trusts to have policies and procedures in place to support a culture of openness and transparency • The Trust should take action to tackle bullying, harassment and undermining in relation to duty of candour and must investigate any instances where a member of staff may have obstructed another in exercising their duty of candour

24. Duty of Candour • The Trust should have a system in place to identify and deal with possible breaches of the professional duty of candour by staff who are professionally registered including the obstruction of another in their professional duty. This is likely to include an investigation and escalation process that may lead to referral to their professional regulator or other relevant body • The Trust should make all reasonable efforts to ensure that staff operating at all levels within the organisation operate within a culture of openness and transparency, understand their individual responsibilities in relation to the duty of candour and are supported to be open and honest with patients and apologise when things go wrong

25. Duty of Candour • Staff should receive appropriate training and there should be arrangements in place to support staff involved in a notifiable safety incident • If a relevant person (as defined in the Regulations) informs the Trust that something untoward has happened the Trust is to treat the allegation seriously, immediately consider whether this is a notifiable safety incident and take appropriate action

26. Duty of Candour • Existing Trust procedures • Do these new Regulations change anything? • Trusts will already have being open policies and serious incident investigation policies • Statutory Duty of Candour only applies to notifiable patient safety incidents • Serious incident reporting requirements are wider – eg include harm to visitors/staff or data security breaches • Being open policies are wider – notifications needed for less serious harm • Trusts should already be complying with most of the requirements and have procedures in place to deal with this • Issue is the need to ensure compliance with all elements of the Regulations to avoid sanctions • Important to have procedures and policies in place which ensure compliance • Staff to be aware of their obligations

27. Any questions?

28. Your speaker Alexia Dawson Associate | Healthcare E: alexia.dawson@wardhadaway.com T: 0191 204 4336