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

5 Informing And Supporting People Who Have Been Harmed (Q3b And Q3c)

5.1 The consultation paper proposed there should be a requirement for organisations to inform people who have been harmed as a result of an adverse event. This requirement would involve: reporting the incident to the person harmed and / or their relatives; providing information on the steps to be taken to review the event; offering the opportunity to be involved in the related investigation; providing an apology; and providing a written record of the events and summary of the face-to-face meeting. It would also involve making an offer of reasonable support to the person who had been harmed, to their relatives and to staff involved in the event.

5.2 Two questions sought views on the proposed requirements, as follows:

Question 3b: Do you agree with the proposed requirements to ensure that people harmed are informed?

Question 3c: Do you agree with the proposed requirements to ensure that people are appropriately supported?

Views on the requirements to inform people who have been harmed (Q3b)

5.3 Altogether 100 respondents replied to Question 3b. Table 5.1 shows that 93% agreed that the duty of candour should require that people who are harmed are informed, while 2% disagreed. Five respondents (5%) neither agreed nor disagreed and made comments which expressed mixed or unclear views.

Table 5.1: Q3b - Do you agree with the proposed requirements to ensure that people harmed are informed?

Type of respondent	Yes		No		Other		Total
	n	%	n	%	n	%	n	%
NHS	24	100%	-	0%	-	0%	24	100%
Third sector	22	100%	-	0%	-	0%	22	100%
Professional associations, support agencies and trade unions	14	88%	1	6%	1	6%	16	100%
Local government organisations	10	91%	-	0%	1	9%	11	100%
Scrutiny / regulatory bodies	5	83%	-	0%	1	17%	6	100%
Partnership bodies	7	100%	-	0%	-	0%	7	100%
Other organisational respondents	5	63%	1	13%	2	25%	8	100%
Individual respondents	6	100%	-	0%	-	0%	6	100%
Total	93	93%	2	2%	5	5%	100	100%

Percentages do not all total 100% due to rounding.

5.4 Ninety (90) respondents made comments at Question 3b, as discussed below.

Agreement with the proposed requirement that people harmed are informed

5.5 In general, respondents supported the principle of informing people who had been harmed as a result of an adverse event. This was seen to be in line with an open and honest approach to service delivery and care and treatment.

5.6 It was argued that those harmed often wanted 'nothing more than an explanation of what had a gone wrong and to know that lessons had been learnt', and that providing information, offering an apology and providing reassurance about remedial steps taken all played a part in this.

5.7 Respondents also articulated a range of benefits for the individuals and families concerned, including providing them with:

• Help to deal with the after-effects of adverse events
• Assurance that identified failings were being addressed
• Information to allow them to make informed choices about their response to the event
• The opportunity to seek help, advice and support, and to participate in the review process.

5.8 Respondents also felt that informing those involved would have a positive impact on professional practice, patient and service-user safety, and public confidence.

5.9 Respondents often referred to existing arrangements in health and social care (professional, regulatory, organisational and legal) to inform those harmed as a result of an adverse event. The value of a consistent approach was stressed:

• There was a general view that a requirement to inform people harmed as a result of an adverse event was already included within professional duties and regulatory guidance, and that any new duty would need to reflect this.
• Several respondents cited policies and practices within their own organisations (e.g. local health boards) which already promoted good practice relating to disclosure. It was also suggested that local policies may need to be strengthened in the light of any new statutory requirement.
• Respondents emphasised the need to ensure alignment with: the Adults with Incapacity (Scotland) Act 2000, the Adult Support and Protection (Scotland) Act 2007 and the Patients' Rights (Scotland) Act 2011.

5.10 Respondents argued that the requirement to inform should be seen within a wider context of positive and ongoing communication between health and social care professionals and service users and patients.

Views on the specific requirements outlined

5.11 At a general level respondents offered two views on the requirements.

• Some argued for flexibility and proportionality. There was a view that the requirements should not be prescriptive but that there should be discretion in implementation to reflect the circumstances of any particular case.
• Others argued for the need for consistency across settings and across the country and sought clarity on a number of issues in order to achieve this.

5.12 These two views were not presented as mutually exclusive, with many seeking a degree of flexibility as well attaching importance to consistency.

5.13 In relation to exercising discretion, respondents highlighted cases where disclosure itself could be a source of harm and might not therefore in the best interests of the person affected. This was seen as a difficult issue requiring professional judgement and experience. Respondents generally agreed that any decision to not disclose should be the exception but felt it should be allowed for in the requirements. It was suggested that any such decision should be taken by a senior member of staff, and should be recorded, and open to scrutiny. It was also suggested that there should be provision to disclose to a 'nominated other' in some circumstances.

5.14 Respondents also commented on the specifics of the requirements outlined in the consultation paper as noted below.

Timing issues

5.15 Respondents thought the term 'as soon as reasonably practical' was open to interpretation and clarity was sought. They also queried the implied sequence of events, and the practicality of providing a step-by-step account of what had happened as part of the process of informing the person when this may not be possible until after an investigation had been carried out.

5.16 There were also questions about the extent of an organisation's obligation to inform in cases where the adverse event did not come to light immediately. It was noted that there may be difficulties in contacting people if a significant amount of time had elapsed and clarification was sought about the requirement for organisations to trace a person to carry out the disclosure. There was a suggestion of a time limit, beyond which disclosure would not be required.

The 'relevant person'

5.17 Respondents called for clarification as to who might be regarded as a 'relevant person' or who should be informed of harm in particular circumstances. They drew attention to incidents involving children and young people, those with reduced capacity (permanent or temporary), those with communication difficulties, and cases involving the death of a patient or service user. They also noted the importance of allowing provision for parents, appropriate adults, relatives, guardians or those with power of attorney to be regarded as relevant persons or to be present with the relevant person when disclosure took place. Respondents were clear that disclosure arrangements should meet the needs of all such groups.

5.18 A small number of respondents raised the issue of incidents involving harm to staff, and suggested that there may have to be provision for disclosure arrangements to encompass colleagues and managers.

Providing a written record / summary of the face-to-face meeting

5.19 Respondents called for more detail on what would be included in such a report, the form it would take and the point at which it would be provided. There was a specific view that the summary should record details of the adverse event and include information about available support, rather than just being a record of the disclosure meeting. There were calls for guidance to be provided or minimum standards to be prescribed. More commonly, though, respondents expressed concerns about the value, practicality and resource implications of providing such written reports in all cases.

5.20 There were also concerns about the implications of providing a written report (and apology - see below) should a case subsequently result in a complaint, or legal claim; the specific issue of criminal liability for pharmacists was also raised. However, there was also a view that protecting the rights of patients / service users and their families should always be the prime concern, and that the information provided should not be influenced by fear of a future claim.

Respecting the person's wishes

5.21 The consultation noted the need to respect the person's wishes with regard to how much information to provide. Respondents largely agreed, stating that while the presumption should be in favour of informing those harmed, people had a right not to be informed if that was their preference. However, it was also suggested that determining a person's wishes should not be regarded as a one-off event but should be kept under review, and there was a suggestion that a written record of the investigation should be maintained for anyone opting not to be informed, should they wish to access information later. The importance of seeking views and respecting people's wishes with regard to who should be informed (relatives, carers, etc.) was also noted.

The appropriate person to disclose the harm episode

5.22 Respondents emphasised the need for the person disclosing the episode to be adequately trained and supported in carrying out the task. More specific points focused on who the most suitable person might be in a particular case - there was support for the notion of flexibility and capitalising on existing staff / service-user or patient relationships. However, there was also a view that the senior professional in charge of the care and treatment should be responsible for disclosing the episode.

5.23 Respondents recognised the 'diverse nature of scenarios across health and social care which will come within the scope of the duty' and the implications this had for determining the appropriate person to disclose the episode of harm. They highlighted cases where care is delivered by a range of organisations and professionals; where the cause of any harm is difficult to pinpoint; or where the harm is attributed to an element of care and treatment such as radiology that involves little or no direct contact with the person concerned. All these circumstances, it was suggested, may give rise to difficulties in identifying the most appropriate person to disclose the harm.

Providing an apology

5.24 The proposed new duty would involve providing an apology. Although this was generally endorsed, respondents also had reservations. Most frequently there was a concern that an apology could be construed as an admission of liability, and respondents requested guidance on how this should be handled. It was suggested that the legislation should stipulate that an apology did not on its own equate to an admission of liability, and that this should be made clear to those involved.

Disagreement with the requirement to ensure people harmed are informed

5.25 Respondents who did not agree with the proposal thought it would be difficult to demonstrate compliance with the requirement; that the requirement would have significant resource implications; and it would risk undermining public confidence. Furthermore, since existing procedures related to adverse events already require people to be informed if they are harmed, the proposal would result in no further benefit to the individual or to the general public.

Views on the requirement to ensure people are appropriately supported (Q3c)

5.26 Question 3c asked respondents for their views about the proposed requirements to ensure that people who have been harmed are appropriately supported following the disclosure of harm. In total, 96 respondents replied to this question. Table 5.2 below shows that 93% agreed with the proposal and 2% disagreed. Five respondents (5%) neither agreed nor disagreed, but rather expressed unclear or mixed views.

Table 5.2: Q3c - Do you agree with the proposed requirements to ensure that people are appropriately supported?

Type of respondent	Yes		No		Other		Total
	n	%	n	%	n	%	n	%
NHS	22	96%	-	0%	1	4%	23	100%
Third sector	22	96%	-	0%	1	4%	23	100%
Professional associations, support agencies and trade unions	12	86%	1	7%	1	7%	14	100%
Local government organisations	10	100%	-	0%	-	0%	10	100%
Scrutiny / regulatory bodies	5	83%	-	0%	1	17%	6	100%
Partnership bodies	7	100%	-	0%	-	0%	7	100%
Other organisational respondents	5	71%	1	14%	1	14%	7	100%
Individual respondents	6	100%	-	0%	-	0%	6	100%
Total	89	93%	2	2%	5	5%	96	100%

Percentages do not all total 100% due to rounding.

5.27 Altogether, 83 respondents commented at Question 3c, as discussed below.

Views of those agreeing with the requirement

5.28 There was widespread agreement with the principle of ensuring that people were appropriately supported - some noted that providing support in such circumstances should already be part of organisational procedures and practice. Respondents noted that being involved in a disclosable event was a potentially traumatic or stressful experience for all involved - and the provision of support was variously described as 'vital' or 'essential'. It was further suggested that the obligation to provide support should also extend to carers and 'named persons'. There was a view that support should not only be offered, but that uptake should be encouraged.

5.29 The provision of support was seen as fulfilling a range of functions including: assisting with communication; helping people to understand the situation and participate in the process; and reducing the risk of the disclosure itself causing further harm. From an organisational perspective it was suggested that offering support may have the added benefit of reducing complaints as a result of improving the experience of those involved in adverse events, and allowing concerns to be dealt with more effectively.

5.30 At a general level, respondents thought people should be able to access good quality information, and both practical and emotional support. There was also a range of more specific views on the types of support which should be provided, with people wishing to see:

• An individualised approach and access to a range of options - recognising that different people would have different support needs
• The availability of support throughout - and beyond - the disclosure and investigation process, with requirement that this be kept under review
• Support for relatives and carers as well as patients / service users (albeit the individual's wishes regarding confidentiality should be respected).

5.31 Respondents also highlighted the particular needs of vulnerable groups, children and young people, and those with communication difficulties and mental disorders, and proposed the use of specialist staff and / or appropriate third parties (e.g. parents, guardians, or 'named individuals' reflecting the provisions of the Mental Health (Scotland) Act 2003). It was also suggested information should be provided in an appropriate format for such groups.

5.32 Although respondents often focused on the importance of specialist support services and emphasised the value of third-party independence, there was also another perspective which emphasised local solutions to providing support. Specifically, respondents highlighted the value of building on existing arrangements and relationships or the role that well-trained, sympathetic frontline staff could play in supporting people involved in adverse events.

Caveats and concerns

5.33 Respondents who agreed with the proposed requirement nevertheless expressed some concerns. These focused on: the need for clarity in the legislation; resource implications; and the application to community settings:

• There was a view that the consultation paper lacked clarity about the type of support to be provided, by whom and for how long. To aid consistency, respondents called for: clear parameters; prescribed minimum levels of support; and examples to help in the planning of services.
• Respondents highlighted the potentially significant resource implications of providing support (which may continue for some time in any one case) and noted that there could be costs for training internal staff, backfilling for staff involved in providing support, or funding support from third-party providers.
• Some respondents from the pharmacy and dental sectors thought the requirement was not practicable or meaningful in small, community-based settings and was more relevant to large organisations.

Views of those disagreeing with the requirement

5.34 Respondents who disagreed, or who did not indicate clear agreement or disagreement, generally echoed the concerns of those agreeing with the requirement. They did not think the requirement would add value to existing professional duties or good practice, or expressed concern that it would be open to interpretation, and so requested further guidance.