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

8 Disclosable Events

8.1 The consultation document set out a definition for 'disclosable events' as follows: 'an unintended or unexpected event that occurred or was suspected to have occurred that resulted in death, injury or prolonged physical or psychological harm being experienced by a user of health and / or social care services'. The consultation document also provided a list of events that might be considered to be disclosable events. However, it was noted that definitions would be developed and informed through dialogue with health and social care professions. The following questions were asked:

Question 6a: Do you agree with the disclosable events that are proposed?

Question 6b: Will the disclosable events that are proposed be clearly applicable and identifiable in all care settings?

Question 6c: What definition should be used for 'disclosable events' in the context of children's social care?

Question 7: What are the main issues that need to be addressed to support effective mechanisms to determine if an instance of disclosable harm has occurred?

Definition of 'disclosable events' (Q6a)

8.2 Question 6a asked respondents if they agreed with the 'disclosable events' proposed in the consultation document. Altogether, 97 respondents replied to this question. Table 8.1 below shows that 59% agreed, and just over a quarter (26%) disagreed. Fifteen respondents (15%) neither agreed nor disagreed with the proposed 'disclosable events' and made comments which were unclear or which expressed mixed views on the issue.

Table 8.1: Q6a - Do you agree with the disclosable events that are proposed?

Type of respondent	Yes		No		Other		Total
	n	%	n	%	n	%	n	%
NHS organisations	14	58%	8	33%	2	8%	24	100%
Third sector organisations	16	80%	2	10%	2	10%	20	100%
Professional associations, support agencies and trade unions	7	44%	7	44%	2	13%	16	100%
Local government organisations	2	20%	7	70%	1	10%	10	100%
Scrutiny / regulatory bodies	4	50%	-	0%	4	50%	8	100%
Partnership bodies	6	86%	1	14%	-	0%	7	100%
Other organisational respondents	3	43%	-	0%	4	57%	7	100%
Individual respondents	5	100%	-	0%	-	0%	5	100%
Total	57	59%	25	26%	15	15%	97	100%

Percentages do not all total 100% due to rounding.

8.3 Most third sector respondents indicated agreement with the disclosable events proposed, while opinion was more divided among NHS organisations and professional associations, support agencies and trade unions. Most local government organisations did not agree with the events proposed.

8.4 Altogether, 80 respondents made comments at Question 6a. A number of recurring themes could be identified in these comments, and these were the same, irrespective of whether respondents had indicated agreement or disagreement with the question. People who answered 'no' to Question 6a expressed a range of concerns about the disclosable events proposed, and these same concerns were also raised by people who answered 'yes'. It is therefore not entirely clear from respondents' comments why some respondents agreed with this question and others did not.

8.5 Similarly, respondents whose comments were categorised as 'Other' in Table 8.1 above, frequently raised the same issues. This group suggested that they needed further clarification of the disclosable events before they could offer an opinion.

8.6 The key themes raised by all respondents are discussed below.

Aspects of the proposals with which respondents agreed

8.7 Those who indicated agreement at Question 6a often prefaced their comments by saying that they welcomed the basic principle of having a definition of a disclosable event. Moreover, they supported the threshold for a disclosable event being set at a high level. Respondents thought that it was important to have greater transparency and openness with patients; but at the same time they also believed it was important that services should not worry patients about every minor service failure or 'near miss'. Respondents were concerned that the introduction of a statutory duty of candour should not result in undermining public confidence in the care system.

8.8 Respondents welcomed the statement in the consultation document that definitions would be developed and informed 'through dialogue with health and social care professions, taking due recognition of the different context, nature and requirements of health and social care settings'.

Comments and concerns about definitions

8.9 However, irrespective of whether respondents ticked 'yes' or 'no' at Question 6a, they raised concerns about the definition given in the consultation document of a 'disclosable event'. While many comments focused on the specific examples of disclosable events set out in the consultation document, respondents also made more general comments, including that the definition of a 'disclosable event' was 'not clear', 'too vague', 'needed more detail', was 'subjective' and was 'open to interpretation'. It was also common for respondents to state that the examples given in the consultation document were 'too health focused', or 'too heavily weighted to medical, as opposed to social care, events'.

8.10 Respondents called for greater clarity in relation to the definitions of 'unintended', 'unexpected', 'prolonged', 'injury' and 'harm'. Concerns were particularly voiced about how 'psychological harm' would be defined in the context of adults who lack capacity and / or those suffering from a mental illness. However, the definition of 'harm', in general, was also thought to require further clarification, and some respondents suggested that the Scottish Government should consider the definitions of different types of harm set out in the Adult Support and Protection (Scotland) Act 2007. Others commented on the difficulty of identifying and measuring 'harm', particularly in relation to adults who lack capacity, which could often be the subject of differences of opinion between clinicians, patients and carers.

8.11 Respondents also acknowledged the inherent difficulty of defining a set of disclosable events that would be applicable across all branches of medicine, and in both health and social care services. There was also a particular concern raised about the possible implications for social care settings where appropriate risk-taking among service users is encouraged.

8.12 Some respondents argued that any definition of a disclosable event must 'make sense to service users', as the proposed duty of candour is primarily for the benefit of service users, not service providers.

Concerns and queries about the proposed disclosable events

8.13 In general, respondents 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.

8.14 There was a suggestion that the inclusion of a timescale associated with each event would be necessary, and that it would be clearer that the events listed in the consultation document were 'disclosable events' if each one included the phrase: 'resulting from clinical error' (e.g. 'Return to surgery resulting from clinical error').

Unintended consequences

8.15 Respondents were concerned about the possible unintended consequences of the proposals. (Most of these were already raised in relation to Question 1 - see Chapter 3 above.) These could include the following:

• Depending on the definitions adopted, there could be a large volume of disclosable events which far exceed current complaints.
• The proposals could create 'another layer of bureaucracy' on top of current processes and remove healthcare professionals from frontline care.
• The result will be a 'compliance and reporting culture' rather than the open, transparent culture which the duty of candour seeks to foster.
• Health (and social care) professionals might be blamed for events that are outside their control.

Other possible disclosable events

8.16 There were also some suggestions that the loss of personal data should be included as a disclosable event, and that disclosable events should not only include those that resulted in actual harm to an individual, but also those that were suspected of having caused harm, or that have the potential to cause harm. However, it was more common for respondents to say that the duty of candour should focus on 'high-threshold' events in which an individual suffered actual harm.

8.17 Finally, there was a question about whether 'neglect' (in the context of an inappropriate level of care provided to an older person at home) should be considered to be a 'disclosable event'.

Other suggestions

8.18 There was also a suggestion that a term other than 'disclosable event' should be used - to avoid confusion with the legal disclosure process in litigation, and to avoid implying that only certain events can be disclosed.

8.19 Finally, respondents saw the benefit of having a system to facilitate sharing of information about disclosable events between different areas, as this would support collective awareness and learning from these events.

Whether the disclosable events are applicable and identifiable in all care settings (Q6b)

8.20 Question 6b asked respondents if the disclosable events proposed in the consultation document would be clearly applicable and identifiable in all care settings. Altogether, 89 respondents replied to Question 6b. Table 8.2 shows that around a third (31%) agreed, but nearly half (47%) disagreed. A fifth of respondents neither agreed nor disagreed, or made comments which expressed mixed or unclear views.

Table 8.2: Q6b - Will the disclosable events that are proposed be clearly applicable and identifiable in all care settings?

Type of respondent	Yes		No		Other		Total
	n	%	n	%	n	%	n	%
NHS	10	42%	11	46%	3	13%	24	100%
Third sector	6	32%	6	32%	7	37%	19	100%
Professional associations, support agencies and trade unions	4	24%	11	65%	2	12%	17	100%
Local government organisations	2	20%	7	70%	1	10%	10	100%
Partnership bodies	1	17%	4	67%	1	17%	6	100%
Scrutiny / regulatory bodies	-	0%	1	33%	2	67%	3	100%
Other organisational respondents	2	40%	2	40%	1	20%	5	100%
Individual respondents	3	60%	1	20%	1	20%	5	100%
Total	28	31%	42	47%	18	20%	89	100%

Percentages do not all total 100% due to rounding.

8.21 While NHS and third sector respondents were divided in their views on Question 6b, professional associations / trade unions, local government organisations and partnership bodies tended to disagree.

Respondents' reasons for agreeing

8.22 Not all respondents who agreed that the proposed disclosable events would be clearly applicable and identifiable in all care settings provided further comment. Only 16 respondents in this group did so, and in most cases, these comments offered no additional information about the respondent's views or their reasons for agreeing with the question.

Respondents' reasons for disagreeing

8.23 Respondents who disagreed that that the proposed disclosable events would be clearly applicable and identifiable in all care settings generally made fuller and more detailed comments than those who agreed. These respondents gave a range of reasons for disagreeing, including that:

• The proposed disclosable events lacked clarity, and would be interpreted differently by different people.
• Not all of the proposed events would result in harm to a patient or service user and therefore would not require disclosure. Moreover, the same event could have varying effects on different people.
• The proposed events were too focused on acute healthcare services. Respondents thought that further work was needed to identify events relating to social care, primary care, other health services, and third sector or independent sector services.

Other comments on the definition and applicability of disclosable events

8.24 While a few respondents believed that 'when harm has occurred, this will be clearly identifiable' whatever the care setting, it was far more common for respondents (particularly those in local authority and NHS settings, as well as those who work with adults with incapacity) to highlight the difficulties of: a) identifying harm; and b) attributing harm to a single specific cause. Respondents pointed out that events such as unplanned hospital readmissions or delayed discharges can result from a number of interconnected issues involving a range of agencies. These respondents queried which organisation would have the duty of candour in such cases.

8.25 The predominant view among respondents was that it is unlikely to be possible to create a single, exhaustive list of all disclosable events which would apply across all care settings. Respondents generally believed that disclosable events would have to vary between care settings, and that 'context' would be an important factor in determining whether a disclosable event had occurred.

8.26 Several respondents queried whether and how the duty of candour would apply to care settings such as:

• Third sector, independent agencies and personal assistants delivering care at home (through self-directed support arrangements)
• Scottish Ambulance Service
• Single-handed GP practices, where the responsibility would fall on an individual rather than an organisation
• Dental practices
• Opticians
• Care homes (where service users are very frail and elderly and suffer from a range of complex conditions)
• Foster care and child-minding services.

8.27 One pharmacy respondent suggested that pharmacists could easily define adverse events for their own profession. However, other professions, such as radiology, would find it difficult because of the inherent 'error' that exists in certain areas of medicine.

8.28 There was also a question about who within an organisation would be responsible for deciding when a disclosable event had occurred.

Suggestions from respondents

8.29 As noted above, some respondents suggested that an attempt to develop a list of disclosable events would be impossible. There were suggestions that the definition of a disclosable event should be linked to processes that health and social care professionals were already familiar with - for example, (as previously noted) in health, this could be linked to 'adverse event' reporting, and in social care, it could be linked to notifications to the Care Inspectorate. The Mental Welfare Commission's notification guidance was also referred to as 'a useful example of how disclosable events may be consistently defined in relation to care and treatment delivered in different settings'.

8.30 Respondents thought it would be helpful if a 'decision tool' could be developed to assist with the process of identifying disclosable events.

'Disclosable events' in children's social care (Q6c)

8.31 Question 6c in the consultation document asked respondents for their views on what definition should be used for 'disclosable events' in the context of children's social care services. Around half of all respondents (n=54) answered this question, and there was disagreement among respondents about this issue.

8.32 Some thought that any such definition should be developed by professionals and other experts who work in this area (including Children's Panel members) - and with children and young people themselves. However, others argued that the same definition should be used for 'disclosable events' in adult and children's services. This latter group argued that many of the issues that arise in children's social care services are the same as those that arise in services for adults who lack capacity.

Defining 'disclosable events' in children's social care services vs defining principles

8.33 Some respondents attempted to define a set of disclosable events for children's social care services. For example:

• 'Services being slow to react, resulting in a child's exposure to neglect being prolonged'
• 'Undue delays in permanency planning and completion as a result of practice or resourcing decisions'
• 'Incomplete implementation of a child's plan resulting in serious harm'
• 'Physical, psychological and sexual abuse of children while in care'
• 'Any instance where the child is left feeling vulnerable - where there are breaks in care'

8.34 Others suggested a set of principles or criteria that could be used to determine whether a disclosable event had taken place. For example:

• 'Harm could be defined as anything not in the best interests of the child (where SHANARRI indicators are not being met)'^[5]
• 'The same criteria as for a significant case review… unintended or unexpected death of a child receiving health or social work services'^[6]
• 'Any incident which causes a child significant physical or psychological harm, or significant actual or anticipated material or other loss'
• 'Should focus on harm resulting from corporate culpability rather than on unintended consequences resulting from decisions taken in good faith'.

8.35 Respondents thought that any definition or guidance about disclosable events for children's social care services should take into account and be consistent with Getting it Right for Every Child (GIRFEC) and other child protection policies, children's rights (UN Convention on the Rights of the Child), and legislation related to the Protecting Vulnerable Groups (PVG) scheme.

Issues and concerns

8.36 Respondents raised a range of issues and concerns about the attempt to define 'disclosable events' in the context of children's social care services. In some cases, these echoed similar concerns expressed by respondents regarding disclosable events in other types of services. For example:

• There needs to be some consideration about whether disclosing information to the child - and / or their family - could result in an increased risk to the child's safety. There was a view that the child's opinion should be sought before disclosing certain information to parents / guardians.
• There are likely to be some difficulties in identifying any single cause for psychological trauma among children taken into care. There are also likely to be challenges in assessing pain in children who have communication difficulties, and the cause and effect of harm in children with serious long-term physical health problems.
• The proposed statutory duty of candour risks duplicating existing systems linked to child protection procedures.
• There was a question about which services the duty of candour would apply to, and a view that it would be anomalous if it applied to nurseries and after-school clubs, but not to primary or secondary schools.

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

8.37 Question 7 in the consultation document asked: 'What are the main issues that need to be addressed to support effective mechanisms to determine if an instance of disclosable harm has occurred'?

8.38 Altogether, 88 respondents replied to this question, with the following issues identified as needing to be addressed. It should be noted that much of this has already been discussed in detail in relation to earlier questions.

Need for clear definitions

8.39 First and foremost, respondents wanted greater clarity about the definition of a 'disclosable event'. It was suggested that definitions and processes should be consistent with those in existing legislation (both child and adult protection legislation).

Need for training and guidance for staff

8.40 Staff training and clear (written) guidance were both seen to be key in helping staff to feel confident to recognise when an event needs to be disclosed. Respondents thought that specialist training should be provided to staff involved in disclosing information to patients / service users, and to staff responsible for managing follow-up procedures. It was also suggested that guidance should include: examples of disclosable events, examples of exclusions, case studies, and a decision tree.

Need for advisors

8.41 Respondents thought it would be helpful to have an individual within their own organisation (for example, a senior clinician, senior manager or a designated 'Disclosable Harm Officer'), or an independent, external organisation (for example, the Care Inspectorate or Healthcare Improvement Scotland) to provide advice about whether a disclosable incident had occurred. The benefit of having an independent organisation acting in this capacity is that it would ensure that agreed definitions were being interpreted consistently across different areas.

8.42 There was a view that there may also need to be some form of arbitration - for example in cases where there was disagreement among staff / teams about whether a disclosable event had occurred.

Need for organisational policies and procedures to support the identification of disclosable events

8.43 Respondents thought that there would need to be robust systems and processes in place, which are integrated with existing adverse events and risk management policies. Methods for measuring the impact of a disclosable event on the patient (both the immediate and longer term impacts) were also thought to be needed.

8.44 There was a suggestion that it would also be helpful to have a framework to enable shared learning about disclosable events, both within and across organisations.

8.45 Respondents also raised issues about communication processes, since there is the possibility that a disclosable event could be identified, not by the service that caused the initial unintended harm, but rather by a different service. Respondents thought there would need to be mechanisms in place to ensure that communication with other relevant professionals takes place prior to the disclosure of the event. There was also a suggestion that the patient's GP should be informed about the event.

8.46 Finally, although not directly related to the question of mechanisms for determining if a disclosable event had taken place, respondents also thought there would be a need for standard systems and procedures for reporting disclosable events, as well as IT systems to support this. Several respondents referred to their experience of using the DATIX system for recording and reporting adverse events.

8.47 Related to the issue of reporting, respondents wanted clarification about who would have responsibility for reporting on disclosable events - i.e. which organisation and at what level of the organisation - particularly in the context of integrated services.

Need for organisational capacity and resourcing

8.48 Respondents commented that organisations would need to have both the capacity and the resources to ensure that disclosure takes place. The need for additional resources was identified - to develop and disseminate organisational policies on disclosable events, and to ensure that patient care does not suffer as a result of complying with the proposed duty of candour.

Need for a culture of transparency and of learning from mistakes

8.49 Respondents commented that an important factor in determining whether a disclosable event had taken place was the existence of a culture in which open and honest communication was the norm, and where there was no fear of disclosure. Some respondents suggested that a duty of candour would be part of a "Just Culture" ethos.^[7] The point was made that the establishment of such a culture would require support from management at the very top level of organisations.

8.50 However, there was also a contrasting view that the creation of legislation requiring professionals to demonstrate genuinely open communication would result in no more than 'a box-ticking exercise'.

Need to inform and raise awareness among patients / service users and carers

8.51 Finally, respondents saw a need for communication with members of the public. There were several aspects to this communication:

• Members of the public would need to be informed about the duty of candour
• There needs to be scope for service users to be involved in the process of identifying 'harm'.
• There needs to be some consideration about how to involve a service user's family or carers if the service user lacks capacity.
• Consideration will have to be given to continuity of care for individuals who have been inadvertently harmed if the individual does not wish to continue to receive care from the responsible healthcare professional.

8.52 There was a concern that communication with patients / service users about disclosable events would need to be done carefully, as there would otherwise be a risk of reinforcing a 'blame culture'.