Proposals to Introduce a Statutory Duty of Candour for Health and Social Care Services: Consultation Analysis

1 Executive Summary

1. Between October 2014 and January 2015, the Scottish Government undertook a consultation on proposals to introduce a statutory duty of candour for health and social care services.

2. The duty would create a legal requirement for health and social care organisations in Scotland to inform people (and / or their families) when they have been accidentally harmed (physically or psychologically) as a result of the care or treatment they have received. The duty would relate to more serious events (those resulting in death, injury or prolonged harm) - referred to in the consultation as 'disclosable events'.

3. The proposals included that a duty of candour would involve: a review of the contributory factors to the event; efforts to put matters right; and the requirement to apologise. It would also include a requirement to provide training and support to staff in implementing the duty, and to offer support to those affected by an incident of harm. Finally, it proposed that organisations should publish a report outlining how the duty had been implemented, including the learning and improvements that have been identified and actioned.

4. The consultation paper contained nine questions, seeking views on a range of issues related to the requirements on organisations, the definition of 'disclosable events', and proposed monitoring arrangements. Around half of the consultation questions included a closed (yes / no, tick-box) component with space provided for further comments. The remaining questions were open.

The consultation respondents

5. The consultation received 109 responses - 7 from individuals and 102 from organisations. Organisational respondents included: NHS and local government organisations; third sector agencies; agencies responsible for the scrutiny and regulation of professional practice and / or services; and a range of organisations that support, train or represent health and social care professionals.

Views on the introduction of a statutory duty of candour (Q1)

6. Respondents were asked whether they agreed that the arrangements that should be in place to support an organisational duty of candour should be outlined in legislation. Eighty percent (80%) of respondents agreed and 12% disagreed.

7. Respondents who agreed with the proposal thought that legislation could be a useful lever in bringing about greater openness and transparency in services, and in addressing perceived failings associated with current arrangements based on ethical and professional codes. A legislative approach (and associated guidance) would also ensure that the duty was implemented in a clear and consistent way.

8. Respondents who disagreed with the introduction of a statutory duty of candour were generally supportive of the policy aims behind the proposals. However, this group felt that openness with patients and service users would be best achieved through other means (staff training, guidance and professional codes), rather than through legislation. This group also argued that a case had not be made for establishing a duty of candour in law, and that such legislation would not address the issues of organisational culture which currently inhibit disclosure. In addition, there was a concern that the duty and its associated reporting requirements would result in a (potentially) costly and bureaucratic burden upon organisations, and would undermine the learning opportunities which can result from identification of more minor events and 'near misses'.

Ensuring that staff have the required support, knowledge and skills to deal with disclosable events (Q2)

9. The consultation proposed that the statutory duty of candour should include an organisational requirement to ensure that staff involved in disclosable events have the necessary support, knowledge and skills to respond effectively and confidently. Respondents were asked if they agreed with this proposal. Views in relation to this proposal were nearly unanimous - with 98% of respondents saying that they agreed.

Informing and supporting people who have been harmed (Q3b and Q3c)

10. The consultation set out proposed requirements for informing people who have been harmed as a result of an adverse event, and for offering 'reasonable support' to the individual, their relatives and to staff involved. Respondents were asked for their views on the proposals.

11. Ninety-three percent (93%) agreed with the requirements for informing people who are harmed. The requirement to inform was seen to be consistent with an open and honest approach to care and treatment. However, respondents also argued for a degree of flexibility, and commented that there could be exceptional cases where the disclosure of harm itself could be a source of further harm, and may not be in the best interests of the person affected. Respondents wanted clarification about a range of issues related to how to fulfil this requirement in practice.

12. Those who disagreed with the requirement to inform people who had been harmed were concerned about the resource implications of the requirement, and whether it might result in undermining public confidence in services.

13. In relation to the proposal to offer support to people following the disclosure of harm, again, most respondents (93%) agreed, and there was a general view that support should not only be offered but that its uptake should be actively encouraged. Respondents suggested that the provision of support would assist with communication; help people to understand the situation and participate in the process; and reduce the risk of the disclosure itself causing further harm. However, there were concerns about the potential resource implications of the requirement and how it would apply to small services in community settings.

14. These concerns were echoed by those who did not agree with the requirement to provide support. This group also thought that such a requirement would not add value to existing professional duties or good practice, and they thought the requirement would be open to local interpretation.

Public reporting (Q3a and Q4)

15. The consultation sought views on the public reporting of disclosures which have taken place. Two questions were posed: the first sought views about the proposed requirement for public disclosure, and second about the appropriate frequency for such reporting.

16. Three-quarters of respondents (75%) agreed that organisations should be required to publically report on disclosures, while 13% disagreed. Irrespective of whether respondents agreed or disagreed, there was a call for clarity about the purpose of public reporting and the nature of any reporting (in relation to, for example, the intended audience, or the form and level of detail of reporting).

17. Those who had indicated agreement with the requirement for public reporting generally saw it as being in line with openness, transparency and accountability in public services. There was a view that to not have such a requirement would be 'at odds with a duty of candour'. However, respondents also expressed some concerns related to: the need to protect the rights and privacy of those involved; how the information might be misinterpreted or misused; and the possible resource implications associated with public reporting.

18. Those who disagreed with the requirement for public reporting echoed these concerns and also thought that public reporting would provide no additional benefit - either to those who had been harmed, or to organisational learning.

19. In terms of the frequency of public reporting, the majority of respondents (62% of those who commented) favoured annual (rather than more frequent) reporting, as this was seen to be 'manageable' and 'proportionate'.

Staffing and other resources (Q5)

20. Respondents were asked for their views on the staffing and resources required to support effective implementation of the duty of candour. In relation to staffing, respondents expected that a wide range of staff would need to contribute to meeting the obligations of the duty, and that this would have significant costs. They also identified needs in relation to: staff training; the resourcing of initial set-up activities (i.e. developing policies, procedures, etc.); the provision of support services for staff and for people affected by a disclosable event; and ongoing administrative support. There were concerns about the resource implications of the duty, particularly for small organisations.

Disclosable events (Q6)

21. The consultation document set out a definition for 'disclosable events' and provided a list of events as examples. Respondents were asked if they agreed with the events that were proposed, and whether these events would be clearly applicable and identifiable in all care settings.

22. A majority of respondents (59%) agreed with the disclosable events proposed. However, over a quarter (26%) disagreed. This latter group included most of the local government organisations. Respondents who disagreed expressed a range of concerns about the disclosable events proposed, and these same concerns were also raised by those who agreed. The main point made by both groups was that the definition of a 'disclosable event' was 'not clear' and 'needed more detail'.

23. Respondents also queried, or explicitly disagreed with, the examples of disclosable events given in the consultation document. Some went on to describe scenarios in which such events would not be considered to be adverse but, rather, would be reasonable and appropriate responses in a clinical context.

24. In relation to the question about whether the disclosable events would be clearly applicable and identifiable in all care settings, nearly half of respondents (47%) said 'no', while a third (31%) said 'yes'. Respondents suggested that it would be difficult to define a set of disclosable events that would be applicable across all branches of medicine, and in both health and social care services.

25. Those who thought the disclosable events would be clearly identifiable in all care settings generally qualified their support by saying, 'as long as they are clearly defined'. Those who disagreed thought that the proposed events were too focused on acute healthcare services. This group also reiterated their views that the proposed definition lacked clarity, and suggested that not all of the proposed events would necessarily result in harm to a patient or service user.

Disclosable events in children's social care (Q6c)

26. Respondents were asked for their views on the definition that should be used for 'disclosable events' in the context of children's social care services. There was disagreement among respondents about this issue. Some thought that any such definition should be developed by professionals and other experts who work in this area, while others argued that the same definition should be used for 'disclosable events' in adult and children's services.

27. Respondents thought that any definition or guidance about disclosable events for children's social care services should take into account and be consistent with the wider legislative and policy context in this area.

Supporting effective mechanisms to determine if disclosable harm has occurred (Q7)

28. The consultation document asked respondents their views about the main issues that need to be addressed to support effective mechanisms to determine if an instance of disclosable harm has occurred.

29. The main issues were the need for: clear definitions of 'disclosable event'; training and guidance for staff; access to advisors, both within and external to organisations; organisational policies and procedures to support the identification of disclosable events; adequate resourcing; an organisational culture that supports transparency and openness; and awareness-raising among patients, service users and their carers about the duty of candour.

Monitoring the statutory duty of candour (Q8 and Q9)

30. Respondents were asked their views about how the organisational duty of candour should be monitored, and what the consequences should be when it is discovered that a disclosable event had not been disclosed. The consultation document also described how the existing roles of the Scottish Government, Healthcare Improvement Scotland and the Care Inspectorate would relate to monitoring the implementation of the duty of candour.

31. In general, respondents agreed that monitoring should take place through existing systems. Respondents were concerned that if a new monitoring system was set up, it would cause duplication and confusion. However, there were concerns that Healthcare Improvement Scotland and the Care Inspectorate have slightly different functions, and this could result in inconsistency in the way the duty of candour is monitored in health and social care services.

32. In general, respondents thought that consequences for not disclosing a disclosable event should be in line with existing procedures and processes, with staff subject to existing disciplinary or regulatory proceedings and organisations being required to put improvement plans in place. Others thought that the consequences should depend entirely on the circumstances.

Cross-cutting issues

33. Across all the questions, there were a number of recurring themes in the responses which could be seen both in the comments of those agreeing with the proposals and the comments of those disagreeing. These included: support for the continuing development of a culture of openness and honesty in health and social care services; the importance of taking account of the needs of different equality groups in communicating incidents of harm; repeated calls for clarification in relation to certain aspects of the proposed duty (and particularly regarding the definition of a 'disclosable event').

34. Respondents also frequently expressed concerns about: the unintended consequences of the duty which could encourage a 'blame' culture in services and lead to risk-averse decision-making; and the resource implications of the proposals. There was a general view that, as much as possible, existing procedures and systems should be used for identifying and reporting events.