1. Statutory Duty of Candour
The Health (Tobacco, Nicotine etc. and Care) (Scotland) Act 2016
What does it mean for me?

2. Background Legislation in response to Francis Inquiry
Key recommendation for openness, transparency and candour, including a statutory duty.
Duty of Candour legislation introduced in England in 2014
Act passed in Scotland in April 2016.
Planned implementation date 1 April 2018
New law applies to all health and social care organisations

3. Duty of Candour as culture
Individuals want to be told when things have gone wrong.
Acknowledge. Apologise. Tell them the facts.
Tell them what steps will be taken to avoid this happening to someone else.
Remember the person behind the process.
An apology or other step taken in accordance with the duty of candour procedure does not of itself amount to an admission of negligence or a breach of a statutory duty

4. Who is responsible?
Many individuals within health and social care have a professional duty in their Codes Of Practice.
e.g. SSSC CoP 3.6- be open and honest with my employer, people who use services and carers when care has or may have caused physical, emotional, financial or material harm or loss.
New statutory duty for organisations
The ‘responsible person’ as defined in the act is not a person but the organisation/provider
Organisations will need to decide themselves who is responsible for taking the lead on this work

5. When does the duty apply?
When, in the reasonable opinion of a registered health professional, there has been incident that has resulted in unintended or unexpected harm to an individual receiving a health or care service.
A registered health professional who has not been involved with the provision of the care that the duty of candour procedure has been applied to should confirm that the activation of the duty of candour procedure is necessary.
The specific considerations that responsible persons will need to consider will be outlined in guidance

6. What do we mean by harm? death of the person
a permanent lessening of bodily, sensory, motor, physiologic or intellectual functions
an increase in the person’s treatment
changes to the structure of the person's body
the shortening of the life expectancy of the person
an impairment of the sensory, motor or intellectual functions of the person which has lasted, or is likely to last, for a continuous period of at least 28 days, .
the person experiencing pain or psychological harm which has been, or is likely to be, experienced by the person for a continuous period of at least 28 days
Or;
the person requiring treatment by a registered health professional in order to prevent-
(i)the death of the person, or .
(ii) any injury to the person which, if left untreated, would lead to one or more of the outcomes mentioned above.

7. What the duty requires
Organisations must follow procedure set out in regulations
Duty to produce an annual report including number and nature of incidents where the duty of candour has been implemented
The responsible person ( i.e. health board/ social work service/ organisation/ provider) is required to undertake training as stipulated in the regulations, and;
Provide training, supervision and support to any person carrying out any part of the procedure on behalf of the responsible person (i.e. knowledge of procedure, delivering an apology, having difficult conversations)
(draft regulations were developed with input from the sector and were circulated for comment in June Amendments are being made in light of feedback)

8. The procedure
The procedure is still being finalised (draft regulations were circulated in June 2017 for comment) but likely to include:
- how to record information
- when to offer support (to individuals and staff)
- nature of apology and explanation of events
- incident review and follow up
- actions required at and after a family meeting
(draft regulations were developed with input from the sector and were circulated for comment in June Amendments are being made in light of feedback)

9. Key stages of the procedure
The key stages of the procedure include:
(a) to notify the person affected (or family/relative where appropriate)
(b) to provide an apology
(c) to carry out a review the circumstances leading to the incident
(d) to offer and arrange a meeting with the person affected
(e) to provide the person affected with an account of the incident
(f) to provide information about further steps taken
(g) to make available, or provide information about, support to persons affected by the incident
(h) to prepare and publish an annual report on the duty of candour
Specific timescales will be included in the regulations

10. What do you need to report?
All organisations must publish annual report to show:
- number and nature of DoC incidents - assessment of extent to which the duty was carried out - information about DoC policies and procedures - any changes made to policies as a result of incidents
It is NOT a report for each incident
Support from Care Inspectorate and HIS on aligning existing recording systems with duty of candour requirements and style templates for annual reports
(draft regulations were developed with input from the sector and were circulated for comment in June Amendments are being made in light of feedback)

11. Education , training and support
E-learning module – case study and scenario based with knowledge check exercises and prompts to check local procedures
Webex sessions and webinars
Roadshows and ‘pop-up clinics’
Face-to-face training
Information and awareness raising materials including factsheets
Train the trainers pack including case studies, service user/ carer stories, presentation materials, signposting to other resources and tools
FAQs
(draft regulations were developed with input from the sector and were circulated for comment in June Amendments are being made in light of feedback)

12. What can you do now?
Understand how ready you are to respond – individually, within teams, organisation-wide
Align with existing reporting/recording/incident processes and procedures
Look at what training you have available and build on what you have embedding the new Duty and identify gaps
Consider who are the right people, with the rights skills to lead for your team/organisation
Engage with training materials and events
Relax, take a deep breath and don’t panic!!!!
(draft regulations were developed with input from the sector and were circulated for comment in June Amendments are being made in light of feedback)

13. The next steps Finalise regulations Develop guidance
Development of ‘Train the Trainers’ pack
Face to face and online engagement and information events
Development of information materials for people who use services and their families/carers
(draft regulations were developed with input from the sector and were circulated for comment in June Amendments are being made in light of feedback)

14. Further information Dedicated web page:
Includes a FAQs page
Any questions
(draft regulations were developed with input from the sector and were circulated for comment in June Amendments are being made in light of feedback)