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

9 Monitoring The Statutory Duty Of Candour

9.1 The consultation document stated that the proposed duty of candour would apply to all providers of health and social care, and would be monitored through existing performance monitoring, regulation and / or scrutiny arrangements that apply to organisations. These differ for different organisations.

9.2 The consultation document then set out the existing roles of the Scottish Government, Healthcare Improvement Scotland and the Care Inspectorate as these would relate to monitoring the implementation of the duty of candour.

9.3 Respondents were asked two questions on these issues.

Question 8: How do you think the organisational duty of candour should be monitored?

Question 9: What should the consequences be when it is discovered that a disclosable event has not been disclosed to the relevant person?

How should the duty of candour be monitored? (Q8)

9.4 Altogether, 91 respondents replied to Question 8, and in general, respondents agreed that the monitoring of the duty of candour should take place through existing arrangements. Respondents described this proposal as 'pragmatic' and 'proportionate', and suggested that it 'would avoid additional burdens being placed on the health and social care sector or taxpayers'. Respondents were also concerned that if a new monitoring system was set up, it would cause duplication and confusion.

9.5 However, respondents also highlighted some issues in relation to this proposal. In particular, there were concerns that Healthcare Improvement Scotland (HIS) and the Care Inspectorate (CI) 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. There were calls for greater clarity about how, exactly, the proposed monitoring function would fit within the remit of HIS specifically. There were a few respondents who thought it would be preferable to have a single organisation responsible for monitoring across health and social care (to ensure consistency).

9.6 The response from the Care Inspectorate raised a concern that the process of monitoring compliance with the duty of candour could have the potential to be very onerous for the organisation. Therefore, it was suggested that the requirement to monitor compliance should not be necessary at every inspection of a care service. There was also a concern that the CI may not be currently equipped or resourced to make judgements about the range of complex medical issues that might be raised in monitoring compliance with a statutory duty of candour.

9.7 Some respondents suggested that other bodies should also (or instead) have a role in monitoring the duty of candour, including: the relevant regulators for each professional body, and a new body with representation from both professional and lay people. Finally, it was suggested that the role of the national Adult Protection Coordinator could be enhanced to assist with the task of monitoring.

9.8 Respondents made a range of suggestions about other ways in which the duty of candour could be monitored. These included:

• Through existing organisational governance arrangements, including adverse event reporting, performance management reporting, and through published (publicly accessible) reports - the development of a national audit tool was also suggested
• Through staff appraisals and development reviews, and through regular anonymised staff surveys
• Through patient / service user feedback, including the record of the discussion with patients / service users in adverse event reviews
• Through the establishment of an external independent agency to whom dissatisfied patients / families could refer concerns about incidents of harm which had not been disclosed, or concerns about an organisation's handling of a disclosed event.

9.9 There were also suggestions about how compliance with the duty of candour could be measured, for example, through:

• Evidence of staff being trained and adequately supported
• Having a named individual (or named individuals) with responsibility for ensuring compliance
• Audits of random samples of complaints, claims and incident reports
• Investigations into alleged breaches of the duty.

9.10 Finally, there was a view that it would be helpful if there could be an initial period of allowing organisations to become familiar with applying the duty of candour before any monitoring / enforcement arrangements are put in place.

Concerns about monitoring compliance with the duty of candour

9.11 Respondents raised a number of concerns about the monitoring and enforcement of the duty of candour. These largely related to the practicalities of enforcement, and the potential for unintended consequences

9.12 Some respondents suggested that the duty of candour would be difficult to enforce, and / or difficult to enforce consistently - particularly given the very wide range of 'disclosable events' proposed in the consultation document, and the requirement for a subjective assessment about whether harm had occurred.

9.13 Others felt that the statutory duty of candour had the potential to be counter-productive: that it would become a 'box-ticking exercise', that the task of monitoring and reviewing would result in the creation of 'a new industry' that would divert funds away from clinical services; and that it would undermine openness, transparency and candour because of the fear of possible negative consequences (sanctions or penalties) to individuals and organisations.

9.14 As noted previously in the discussion on Questions 6 and 7, there were also repeated requests for clarification about who the duty of candour would apply to in relation to: a) commissioned services delivered by the third or private sector; and b) integrated services delivered jointly by health and social care.

The consequences of NOT disclosing a disclosable event (Q9)

9.15 Question 9 asked respondents for their views on what the consequences should be when it is discovered that a disclosable event had not be disclosed to the relevant person. Altogether, 89 respondents answered this question.

9.16 In general, respondents thought that consequences for not disclosing a disclosable event should be in line with existing procedures and processes. Where an individual member of staff was responsible for a breach of the duty, it was thought that the individual should be subject to the organisation's disciplinary procedures and, if a registered health or social care professional, referred to the appropriate professional regulator. It was thought that organisational accountability should be at chief executive / director level.

9.17 There was a view that, if it was discovered that a disclosable event had not been disclosed, then there should be an immediate disclosure (even if it relates to an historical event); a senior manager should meet with the relevant person or relatives; and an apology should be given.

9.18 It was less common for respondents to explicitly suggest that some form of investigation should take place, although this idea may have been implicit in the views of respondents who thought that existing procedures and processes should be followed. In general, those who discussed the idea of a formal investigation were concerned that there may be a deliberate attempt to hide or 'cover up' a disclosable event.

9.19 Respondents generally thought that the main consequence of a breach of the duty of candour should be for an improvement plan to be put in place - that the incident should be treated as a learning opportunity, and remedial action taken to address the reasons for the failure to disclose. Some of those who suggested this course of action felt that the focus should be on the factors contributing to the breach of duty (i.e. inadequate staff training and support), rather than on the individual's failure to comply.

9.20 There was also a relatively common view that there should be increasing sanctions for persistent non-compliance - and moreover, that these sanctions could apply both to the organisation (i.e. fines, or cuts in public funding), or to the individual (criminal or civil penalties, loss of registration, etc.).

9.21 Other respondents thought that the consequences should depend entirely on the circumstances. For example, was this a one-off failure, or was there evidence of repeated and persistent non-compliance? Was the breach of the duty due to inadequate training and knowledge among staff, or was it a deliberate withholding of information?

9.22 Some respondents argued that the use of sanctions - either against the individual or the organisation - would be unhelpful and 'illogical'. This group thought that fines or other financial sanctions against the organisation would only disadvantage patients and risk safety. Similarly, the threat of legal action against individuals for a failure to comply with a duty of candour would be unlikely to encourage greater openness and transparency.