Business and Regulatory Impact Assessment (BRIA) for the Health (Tobacco, Nicotine etc. and Care) (Scotland) Bill

Part 2 Duty of Candour

PURPOSE AND INTENDED EFFECT

15. Background

15.1 The report of the Mid-Staffordshire NHS Foundation Trust Public Inquiry^[78], chaired by Robert Francis, QC included recommendations in support of an essential aim to ensure openness, transparency and candour throughout the health system about matters of concern. It was recommended that every healthcare organisation and everyone working for them must be honest, open and truthful in all their dealings with patients and the public. Organisational and personal interests must never be allowed to outweigh that duty to be honest, open and truthful. The Inquiry recommended that where death or serious harm has been or may have been caused to a patient by an act or omission of the organisation or its staff, the patient (or any lawfully entitled personal representative or other authorised person) should be informed of the incident, given full disclosure of the surrounding circumstances and be offered an appropriate level of support, whether or not the patient or representative has asked for this information.

15.2 The Berwick Report^[79] 'A promise to learn - a commitment to act' emphasised the importance of the requirement that patients or carers affected by serious incidents should be notified and supported. It recommended that where an incident qualifying as a serious incident occurs, the patient or carers affected by the incident should be notified and supported. The report cautioned against an automatic 'duty of candour' where patients are told about every error or near miss, highlighting that this will lead to defensive documentation and large bureaucratic overhead that distracts from patient care. The importance of providing patients with all the information they ask for was emphasised.

15.3 The Dalton Williams Review^[80] clearly outlined the expectations that all those involved in caring roles have a responsibility to be open and honest to those in their care. They noted that the evidence they heard reaffirmed what was already known; that when things do go wrong, patients and their families expect three things; to be told honestly what happened, what can be done to deal with any harm caused, and to know what will be done to prevent a reoccurrence to someone else. Health and care organisations have a responsibility to ensure that all of these are reliably undertaken.

15.4 It is internationally recognised that between 10-25% of episodes of healthcare (in general hospital, community hospital and general practice) are associated with an adverse event.^[81] However, it has been recognised that as few as 30 per cent of incidents resulting in harm are disclosed to people who have been affected. Denial and dismissal of mistakes often results in distress and people spending several years seeking the truth, accountability and an apology.^[82]

15.5 Adult social care providers already work within a well-developed framework for incident reporting. This involves a range of statutory reporting and practice arrangements that support engagement with an external reporting regime. This has driven a culture of candour in adult social care for some time. Adult social care providers are commonly already candid with people using their services when things go wrong. The less episodic nature of adult social care means that people are supported by social care providers for longer periods of time. The resulting establishment of longer term relationships tends to promote candour in practice, as something that is accepted as the 'right thing to do'.

15.6 There are a range of factors that have been consistently shown to facilitate disclosure of harm and some that impede disclosure. Known barriers to disclosure include fear, a culture of secrecy and/or blame, lack of confidence in communication skills, fears that people will be upset and doubt that disclosure is effective in improving culture.^[83] Factors that facilitate disclosure are an emphasis on accountability, honesty, restitution, trust and reduced risks of claims. Disclosure is inhibited by professional or institutional repercussions, legal liability, blame, lack of accountability and negative family reactions.^[84]

15.7 Improvements in arrangements to support the disclosure of harm, is a key element supporting a continuously improving culture of safety.^[85] There are several healthcare systems and organisations worldwide that have introduced initiatives or arrangements to support open disclosure of harm. For example, The Australian Open Disclosure Framework is a national initiative of the Australian national, state and territory governments, in conjunction with private health services, through the Australian Commission on Safety and Quality in Health Care. It is intended to contribute to improving the safety and quality of health care.^[86]

15.8 Ethically and morally, health and care professionals are already required to tell people about instances of harm. However of the eight UK wide professional regulatory bodies, only the General Medical Council (GMC) and Nursing and Midwifery Council's (NMC) standards explicitly require their registrants to be candid with people harmed by their practice. The General Pharmaceutical Council has a standard that requires their registrants to respond 'appropriately' when care goes wrong. However it does not specify that this involves being candid with the patient. The Professional Standards Authority has been overseeing the work of the professional regulatory bodies to reflect a common position on candour.

15.9 The General Medical Council and Nursing and Midwifery Council have recently consulted on a professional duty of candour.^[87] The new Code issued by the Nursing and Midwifery Council includes new content emphasising the professional duty of candour for nursing and midwifery registrants. Further guidance will be issued by the General Medical Council in summer 2015.

15.10 NHS Boards are required to implement the requirements outlined in 'Learning from adverse events through reporting and review: a national framework for NHSScotland'^{[88] [89]} and also the 'Can I Help You?' guidance in respect of feedback, comments, concerns and complaints received.^[90] This includes a requirement to submit annual reports on comments, concerns, feedback and complaints to the Scottish Government and the Scottish Health Council. The Scottish Health Council has published two reports following reviews of NHS Boards annual reports.^{[91] [92]}

15.11 'Learning from Adverse Events, through reporting and review: A National Framework for Scotland' (the National Framework) a document published by Healthcare Improvement Scotland is intended to provide an overarching approach, developed from best practice to support health and care providers to effectively manage adverse events.

The aims of the National Framework are to:

• learn locally and nationally to make service improvements that enhance the safety of our care system for everyone
• support adverse event management in a timely and effective manner
• provide a consistent national approach to the identification, reporting and review of adverse events, and allow best practice to be actively promoted across Scotland
• present an approach that allows reflective review of events which can be adapted to different settings, and
• provide national resources to develop the skills, culture and systems required to effectively learn from adverse events to improve services across Scotland.

The National Framework seeks to ensure that no matter where an adverse event occurs in Scotland:

• the affected person receives the same high quality response
• any staff involved are treated in a consistent manner
• the event is reviewed in a similar way and;
• learning is shared and implemented across the organisation and more widely, to improve the quality of services.

15.12 All care homes, care at home services, childminders, daycare of children, adoption and fostering services, housing support, secure care, school accommodation, nurse agencies, and offender accommodation are required to notify the Care Inspectorate of the death of a service user and the circumstances of the death under The Regulation of Care (Requirements as to Care Services) (Scotland) Regulations 2002. Additional requirements are placed on providers of care home services to notify the Care Inspectorate of any serious injury of a service user, accident or any allegation of misconduct by the provider or any person who is employed by the care service.

15.13 For care services registered on or after 1 April 2011, additional notification requirements are in place. These are not specified in legislation but are determined by the Care Inspectorate and includes accidents, incidents or injuries to a person using a service. The Care Inspectorate regards accidents requiring notification as unforeseen events resulting in harm or injury to a person using the service which results in a GP visit or a visit or referral to hospital. An incident is defined as a serious, unplanned event that had the potential to cause harm or loss, physical, financial or material. The Care Inspectorate also requires notification of allegations of abuse in relation to a person using a service. These additional notification requirements relate to all services regulated by the Care Inspectorate except child-minders.

15.14 Healthcare Improvement Scotland requires that independent healthcare providers notify them of serious injury or unintended death of a service user as part of their notification requirements.

16. Objective

16.1 The overarching aim of the duty of candour element of the Bill is to support the implementation of a consistent approach across health and social care settings when there has been an unexpected event or incident that has resulted in death or harm.

16.2 The Scottish Government believes that openness and transparency in relation to adverse events is increasingly recognised as an important element to establish a culture of continuous improvement in health and social care settings. The inclusion of the duty of candour in this Bill reflects the Scottish Government's commitment to putting people at the heart of health and social care services in Scotland, while also recognising and respecting the need of staff to feel supported when contributing to system review and learning.

17. Rationale for Government intervention

17.1 We want the people of Scotland to feel confident when they access our healthcare services and with the introduction of the duty of candour, the aim is to focus on satisfactory outcomes by dealing with the source of the disclosable event which has caused or could cause potential harm (either physically or psychologically). The duty of candour procedure will emphasise learning, change and improvement - three important elements that will make a significant and positive contribution to quality and safety in health and social care settings.

17.2 The decision to introduce legislation follows on from the introduction of a duty of candour by the Care Quality Commission in NHS England in 2014 which was extended in April 2015 to social care settings.

17.3 The new duty of candour on organisations, established by the Bill and subsequent regulations, will create a legal requirement for health and social care organisations to inform people (or their families/carers acting on their behalf) when they have been harmed (physically or psychologically) as a result of the care or treatment they have received. This will act as a powerful signal that when harm occurs, the focus will be on personal contact with those affected, support, and a process of review and action that is informed by learning and improvement. These proposals will have a positive effect on professional practice, patient and service user safety, and public confidence. There will be a requirement for organisational emphasis on staff support and training to ensure effective implementation of the organisational duty. Staff must feel they have the necessary skill and confidence if they are to be meaningfully involved in the delivery of duty of candour procedures.

17.4 The duty of candour reporting requirements will provide a way for organisations to outline the approaches that they adopt in responding to reports of unintended or unexpected events, resulting in harm. Public reporting will help people's understanding of the health and social care environment and empower them by providing information for those seeking care and treatment. It will also encourage organisations to involve people.

17.5 The introduction of the statutory duty of candour must not become a 'box-ticking' or 'form-filling' exercise. The concerns about the introduction of an unnecessary administrative burden will be addressed through clear guidance that supports integration with existing processes for responses to complaints, adverse event and incident reporting - emphasising the requirements for support, training and identification of learning and improvement actions.

17.6 The introduction of a statutory duty of candour contributes to one of the sixteen National Outcomes: we live longer, healthier lives

18. Consultation

Within Government

18.1 We have worked with internal health and social care colleagues to develop legislation around duty of candour. These include Primary Medical Services; Integration and Reshaping Care; and Children's Rights and Wellbeing.

Public Consultation

18.2 The public consultation ran for 12 weeks from 15 October 2014 to 14 January 2015 and a total of 109 responses were received. As table 3 illustrates, the majority of respondents were in favour of the introduction of a duty of candour.

Table 3: Response to consultation question: 'Do you agree that the arrangements that should be in place to support an organisational duty of candour should be outlined in legislation?'

Type of respondent	YES	NO	OTHER*
NHS	72%	20%	8%
Third sector	91%	0%	9%
Professional associations, support agencies, and trade unions	69%	19%	13%
Local government organisations	73%	27%	0%
Scrutiny/regulatory bodies	91%	0%	9%
Partnership bodies	86%	0%	14%
Other organisational respondents	75%	13%	13%
Individual respondents	86%	14%	0%
TOTAL	80%	12%	8%

*respondents who expressed mixed or unclear views
Source: Proposals to Introduce a Statutory Duty of Candour for Health and Social Care Services: Consultation Analysis, Scottish Government (2015)

18.3 Respondents who agreed with the introduction of a statutory duty of candour offered different explanations for their position, with some offering explicit support for the benefits of legislative action, while others expressed support for the underlying principles and policy aims which the legislation aimed to promote.

Main themes included:

• Legislation was seen to be a useful lever in bringing about changes in attitudes, practices and behaviour
• A legislative approach with detailed requirements and guidance would ensure that the principle of candour was embedded in all health and social care organisations, and that it was implemented consistently.

18.4 Respondents felt that the development of a culture of openness and honesty would be essential to ensuring safe, high quality health and social care services in Scotland.

19. Business

19.1 We met with a number of relevant organisations following our period of public consultation including care at home and care home providers, a dental practitioner, and representatives of two companies who run independent hospitals.

Some of the key concerns raised round the impact of the duty of candour procedure on organisations included:

• to ensure consistency is sustained by all health and social care
• organisations when reporting adverse events
• training for staff to deal with difficult conversations
• develop a culture of how complaints and learning is embedded
• communication skills for staff
• incident to resolution cost and
• what is to be disclosed

20. Options

Sectors and groups affected

20.1 Option 1: do nothing. Ethically and morally, most health and care professionals are already required to tell people about instances of harm. This duty would remain although there would be no statutory duty on organisations to ensure a culture and organisation that supports a consistent approach to disclosure of adverse events.

20.2 Option 2: to Introduce a statutory duty of candour for organisations providing health and social care. The duty, which is set out in the Bill with the procedure to be detailed in regulations, will require that an organisation acts in an open and transparent way with people when things go wrong. It will outline the minimum requirements that must be in place to support the duty of candour and require that reports are made to describe the implementation of arrangements.

20.3 Maintenance of the status quo in respect of there already being an existing professional duty of candour, guidance in relation to reporting, organisational responses to harm and established procedures in support of public protection was considered against the need for new statutory arrangements for organisations. The variation in implementation of current guidance and research that has highlighted the multiple organisational factors that influence optimal conditions for disclosure and learning from harm all suggest a need for alternative approaches to improve the current position across health and social care organisations in Scotland.

20.4 Healthcare Improvement Scotland has visited all NHS Boards in Scotland as part of the national programme supporting learning following adverse events. This confirmed that there is variation across the country in respect of the rigour and standard of open disclosure and support for families and staff when harm occurs.

Extracts from the review reports illustrate the variation that currently exists across the NHS in Scotland:

• "The three significant cases showed evidence of a consistent, robust approach to the involvement of patients and families throughout the process"
• "…there was no consistent approach for involving patients, families and carers in the incident investigation, or a systematic process for documenting these events."
• "Of the four cases we reviewed, only two documented some level of engagement with the family or relatives"
• "We were unable to identify from the policy how NHS Board X actually involves patients, families or carers in investigations of adverse events"
• "However the level of support provided to staff was sometimes variable"
• "The level of engagement with the patient or family varied across the six cases"
• "Most policies lacked guidance on how to involve stakeholders and there were significant inconsistencies in practice"

20.5 The observations made by Healthcare Improvement Scotland are consistent with observations from work that has shown that ethical and policy guidance has largely failed on its own to improve rates of disclosure.

20.6 In relation to health care, the Professional Standards Authority has published a summary of research that outlines that the existence of a professional duty might not always be sufficient to ensure that this is consistently delivered within organisations. Their review of research identified that there are factors that in some circumstances mean that staff might not always feel able to discharge their professional duty of candour - these relate to matters such as to diffusion of responsibility, divided loyalties, profession-specific cultures and concerns about career progression.

20.7 The Professional Standards Authority document makes a compelling case in support of the need to move beyond the current reliance on standards and guidance. They have outlined the marked mismatch that has been noted between people's attitudes and actual behaviours in relation to disclosure of harm and emphasised that disclosure in principle does not regularly translate into action. They outline the impact on health and social care professionals to exposure to stressful situations and heavy workloads, often linked with a requirement to process complicated information and focus on specific goals and targets. This 'stimulus overload' is cited as a potential contributor to unreliable implementation of best practice regarding a duty of candour. Normalisation of abnormal events as a way of coping with high risk situations has been noted and, in some circumstances, suboptimal situations become viewed as normal features of care. This can result in passive tolerance that leads to inaction following an unexpected event resulting in harm. Inter-professional tensions may also contribute to different approaches to disclosure of harm and a hierarchical approach to decisions about which profession is obligated to lead on disclosure.

21. Benefits

21.1 Option 1: do nothing. There would be no change to current policies and practice or to individual professional responsibilities. There would be no additional benefits.

21.2 Option 2: to introduce a statutory duty of candour for health and social care. The legislation aims to make providers of health and social care increase transparency and openness in the organisation, facilitating a culture in which staff is supported to report incidents where harm may have been caused. Staff will be encouraged to speak candidly to service users and /or relatives in the event of harm (including death) resulting from treatment.

22. Costs

22.1 Option 1: do nothing. Ethical, professional and policy guidance is generally insufficient in significantly improving rates of disclosure. Under current polices, there may be a lack of support for professionals from their employer organisations resulting in a reluctance or failure to support adverse events. This in turn means patients and service users are not fully informed, nor do individuals and organisations have the opportunity to learn from any adverse event.

22.2 Option 2: to introduce a statutory duty of candour for health and care services. Although ethically and morally health and care professionals are already required to tell people about instances of harm, by introducing an obligation on organisations which is intended to support a consistent approach to disclosure it is likely to result in an increased number of incidents disclosed. It is also likely to significantly enhance staff wellbeing as a result of improved support and training for disclosure.

22.3 There are likely to be a number of costs associated with the introduction of this legislation and any increase in reporting. The main elements of these costs are:

• apology and review; support, training and implementation; monitoring and finally publication of reports.

Table 4. Costs of disclosure, apology and review

	2016 - 17	2017-18	2018-19 onwards
	Non-recurring costs	Non-recurring costs	Non-recurring costs
Scottish Administration	£100,000	£75,000	£50,000
NHS	-	-	-
Local Authorities	-	-	-
Other bodies	-	-	-
Total	£100,000	£75,000	£50,000

There are no recurring costs.

22.4 The principles and approach that will be made explicit through the duty of candour provisions of the Bill, and Regulations made under those provisions, are consistent with current policy and strategies reflected through work in support of improvements in complaint handling, reporting and learning from adverse events. Current work programmes already established means that there will be no additional cost and additional funding will be made available to support the further training and implementation requirements.

22.5 The Scottish Government does not anticipate any additional cost on the NHS in Scotland arising from disclosure, apology and review of the duty. This element of the provisions is already mirrored in the guidance issued by Healthcare Improvement Scotland through its own Reporting and Learning from Adverse Events Framework.

22.6 Local Authorities already have mechanisms in place to support disclosure, apology and case reviews where there has been an unexpected incident resulting in harm.

22.7 The Scottish Government anticipates that some indirect costs may occur for smaller organisations that do not have existing systems and processes to support disclosure, apology and review of events resulting in harm. We will work with stakeholders to develop a suite of resources and guidance which are intended to support organisations through the process.

23. Savings

23.1 It is possible that there are some incidents that result in harm that would have traditionally been subject to complaints or claims procedures.

24. Support

24.1 The Bill, and regulations made using the powers in the Bill, will require organisations to ensure that support is provided to people who have been affected by unexpected incidents or events resulting in harm. Support will be provided through existing mechanisms and services which will therefore not result in direct costs as a result of this procedure. There may be direct costs where specific training tailored to specific clinical and care staff is needed. The nature of costs will depend on existing staff support services and the range of specialist psychological care provision that is already in place.

Table 5. Costs of Support*

	2016-17	2017-18	2018-19 Onwards
	Recurring Costs	Recurring Costs	Recurring Costs
Scottish Administration	-	-	-
NHS	£228,000	£230.280	£232,583
Local Authorities	£114,000	£115,140	£116,691
Other bodies	£114,000	£115,140	£116,691
Total	£456,000	£460,560	£465,965

There are no non-recurring costs

*Table 5 is based on the requirement for 10 whole time equivalent Band 6 staff who would be a counsellor/mental health nurse/therapist, allocated in a ratio of 50% to NHS Scotland, 25% to Local Authorities and 25% to other organisations - the ratio being determined by a review of the balance of incidents likely to fall within the duty of candour procedure

24.2 The Scottish Government does not anticipate any additional direct costs arising from the duty of candour procedure as a result of the requirement to provide support. Organisations will require advice and training to implement the support elements of the provisions - this advice and guidance will be developed as part of the wider guidance, training and implementation support costs.

24.3 The Scottish Government anticipates that in most cases the existing resources for support services through staff support and counselling, psychological care and specialist mental service will be sufficient to ensure that people who require support will access this through existing services. It is anticipated that in the cost on local authorities that most cases will be supported through existing services.

24.4 The Scottish Government anticipates that in most cases, for other bodies, individuals and businesses, there will be no direct costs in respect of the provision for support for people affected. Again, businesses and individuals will access existing services available through NHSScotland.

24.5 In terms of savings, it is likely that the early identification of support needs for staff and people affected by unexpected or unintended incidents resulting in harm will reduce the likelihood of more clinically significant emotional and psychological reactions developing, reactions which would otherwise have required more intensive clinical and care responses through the provision of specialist interventions and support.

Table 6. Cost of training and implementation

	2016-17		2017-18		2018-19 onwards
	Recurring	Non-recurring	Recurring	Non-recurring	Recurring
Scottish Administration	-	£182,000	£45,000	-	£25,000
NHS	-	-	-	-	-
Local authorities	-	-	-	-	-
Other bodies	-	£125,000	£15,000	-	£15,000
Total	-	£307,000	£60,000	-	£40,000

24.6 The Scottish Government recognises the importance of ensuring that all organisations which will be required to implement the duty of candour procedure have access to training and implementation support. Training and implementation support resources will be developed for use by all organisations that have to implement the duty. The costs of providing this training are based on training that was developed by NHS Education for Scotland on complaints handling and the power of apology training, which was delivered by workshops as well as DVDs.

24.7 The Scottish Government anticipates that NHS Boards, along with local authorities will be able to incorporate the requirements for the duty of candour procedure within their existing processes to support staff training and induction programmes.

24.8 However, the Scottish Government anticipates that smaller organisations are likely to have additional costs in relation to the requirement for training to be provided to those staff required to implement the duty of candour procedure. The development of training and implementation resources for these organisations will remove the requirement for organisations to deliver bespoke training.

25. Monitoring

25.1 The duty of candour procedure will require Healthcare Improvement Scotland, the Care Inspectorate and Scottish Government to implement arrangements to monitor the duty of candour procedure. We are working closely with both Healthcare Improvement Scotland and the Care Inspectorate to establish a monitoring group who will assist with this strand of work.

25.2 The Scottish Government does not anticipate any additional cost associated with monitoring of the implementation of the duty of candour provisions of the Bill. The existing procedures currently in place will be developed to incorporate the monitoring of the duty of candour procedure. The Scottish Government does not anticipate that NHS Scotland will incur any additional costs associated with monitoring of the duty of candour. NHS Boards are already required to collate and report information on specified incidents and events as part of procedures already in place as part of requirements such as the NHS complaints procedure and national framework for reporting and learning from adverse events.

25.3 In terms of Local Authorities the Scottish Government does not anticipate any additional costs as they already gather this information as part of public protection procedures. For other bodies, individuals and businesses, there will also be no significant costs of monitoring the duty of candour procedure as this will be incorporated within existing processes of organisations such as Healthcare Improvement Scotland and the Care Inspectorate.

25.4 For those organisations that are not currently regulated by Healthcare Improvement Scotland or the Care Inspectorate, a process will be required to submit a report on duty of candour procedures within their organisations on an annual basis to the Scottish Government. This would require a small amount of additional administrative time, but it is anticipated that some of this burden could be mitigated against by the introduction of an online resource with guidance and templates for producing the report.

26. Publication of Reports

26.1 The duty of candour provisions of the Bill would require that all organisations subject to the duty to submit and publish an annual report. Reports must cover the number and nature of incidents, an assessment of the extent to which the responsible person carried out the duty, information about policies and procedures, any changes to policy and procedure as a result of incidents to which the duty has applied and such other information as the responsible thinks fit.

26.2 The Scottish Government do not anticipate that there would by any significant additional costs for NHS Scotland. Boards are already required to produce reports for a range of monitoring, review and accreditation processes and will be expected to integrate duty of candour reporting within those processes. This will also be the requirement for local authorities.

26.3 Most other organisations which are covered by the duty of candour procedure are regulated by Healthcare Improvement Scotland or the Care Inspectorate and are already required to collate and report information in respect of incidents and complaints as part of their requirements of their registration. The Care Inspectorate collects annual data and information from organisations such as care homes. As part of existing processes, these bodies are required to report to the Care Inspectorate any incidents that occur with service users. The Care Inspectorate has indicated that there would be no additional cost as they would incorporate this as part of their statutory responsibilities.

26.4 The Scottish Government recognise that for some small organisations, this will require some additional administrative time, but is anticipated that some of this burden could be mitigated against by the introduction of an online resource with guidance and templates for producing the Report.

27. Scottish Firms Impact Test

27.1 The duty of candour procedure will reinforce existing mechanisms for reporting when incidents occur that result in harm. It is intended that the duty of candour provision of the Bill will be about openness, honestly and transparency along with learning and improvement.

During the consultation period there were specific points raised by respondents which include:

• The proposal would present difficulties for certain types of services/organisations (e.g. small community based organisations and prison health services).
• The new duty would need to operate in an integrated way across the health and social care sectors
• Respondents from pharmacy and dental sectors thought the requirement was not practicable or meaningful in small community-based settings and was more relevant to large organisations
• 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.

27.2 It was also determined that regulatory relationships with reporting bodies and businesses need to remain open to ensure advice and guidance from Healthcare Improvement Scotland and the Care Inspectorate can be easily accessed when required in order to deal with adverse events when they arise and effectively and thoroughly.

27.3 It will be important to have discussions about guidance and reporting mechanisms in order to support the duty of candour in the Bill. The Scottish Government along with Healthcare Improvement Scotland and the Care Inspectorate will work together with other key stakeholders to this end.

28. Competition Assessment

Will the proposal directly limit the number or range of suppliers?

The proposal will not directly affect the number or range of suppliers of health and/or social care. The legislation will apply to all health and care settings.

Will the proposal indirectly limit the number or range of suppliers?

The proposal will not indirectly affect the number or range of suppliers of health and/or social care. The legislation will apply to all adult health and care settings. It does not constitute a barrier to entry into the market.

Will the proposal limit the ability of suppliers to compete?

The legislation will apply to all adult health and care settings. Much of the activity covered will be within NHSScotland. It will have no impact on competition within the health and social care sector.

Will the proposal reduce suppliers' incentives to compete vigorously?

The legislation will apply to all adult health and care settings. Much of the activity covered will be within NHSScotland. Suppliers within the private sector will all be equally affected. There will be no impact on their ability to compete.

29. Test run of business forms

29.1 No new forms are anticipated

30. Legal Aid Impact Test

30.1 As the new duty of candour provisions do not create any offences, there will be no impact anticipated on the Legal Aid budget.

31. Enforcement, sanctions and monitoring

31.1 Annual reporting will be a requirement of the duty of candour procedure and will be monitored through existing mechanisms to scrutinise and review the quality of care. Our proposals not to introduce civil penalties or criminal sanctions were strongly supported.

31.2 The proposals are intended to make it clear to all those who use health and social care services and all those who provide them what is expected when harm has occurred. The duty of candour procedure will emphasise learning, change and improvement - three important elements that we know will make a significant and positive contribution to quality and safety in health and social care settings.

31.3 The proposals reflect the Scottish Government's commitment to putting people at the heart of our health and social care services in Scotland, while also recognising and respecting the need of staff to feel supported when contributing to system review and learning The duty of candour procedure in Scotland would also sit alongside a range of other activities already being pursued in this area.

31.4 We acknowledge that there are still some parts of our health and social care system where there is not yet a well-developed appreciation of the complexities and common contributors to harm when it happens and it is important that these complexities are managed in a candid manner ensuring all healthcare professionals learn from adverse events to ensure continued learning is adopted and sustained. However, the main consequence of a breach of the duty of candour should be the serving of a notice to a responsible person seeking relevant information and details of the incident and as specified in the notice. However, clear guidelines will be an essential component in terms of notification of incidents by the relevant person and for the purpose of compliance. This will require all relevant information about the incident to be submitted to the relevant organisational body within a specified time frame which will be set out in the serving notice.

31.5 It has been established that implemented guidance will be a key factor to ensuring that alignment, clarity and consistency is sustained and with the assistance from those with practical experience of the issues, we will be able to shape the guidance by on-going testing, learning and change as we identify what works best.

32. Implementation and delivery plan

32.1 The overarching aim of the duty of candour element of this Bill is to support the implementation of a consistent approach across health and social care settings when there has been an unexpected event or incident that has resulted in death or harm. Although there are existing mechanisms and processes currently in place to support the reporting of adverse events for health and social care settings, further development and guidance is needed in order to embed the new duty of candour procedure. This will also include adapting training programmes as well as to ensure staffs feels supported when dealing with difficult conversations as a result of a disclosable event.

32.2 The new guidance will be reviewed and monitored by the Scottish Government and key stakeholders to ensure they are having the desired effect and to ensure consistency is embedded into existing processes.

33. Summary and recommendation

Summary costs and benefits table

Option	Total benefit per annum: - economic, environmental, social	Total cost per annum: - economic, environmental, social - policy and administrative
1	No benefit	No cost
2	The duty (with the detail of the procedure to be set out in Regulations) will outline the minimum requirements that must be in place to support the duty of candour and require that reports are made to describe the implementation of arrangements. The legislation aims to make providers of health and social care increase transparency and openness in the organisation, facilitating a culture in which staff is supported to report incidents where harm may have been caused. Staff will be encouraged to speak candidly to service users and /or relatives in the event of harm (including death) resulting from treatment.	All healthcare professionals are already obligated to tell people about instances of harm, by introducing an obligation on organisations which is intended to support a consistent approach to disclosure; it is likely to result in an increased number of incidents disclosed. It is also likely to significantly enhance staff wellbeing as a result of improved support and training for disclosure. There are likely to be a number of costs associated with the introduction of this legislation and any increase in reporting. The main elements of these costs are: Apology and review, support, training and implementation, monitoring and finally publication of reports.

Table 7. Summary of costs of the duty of candour

	2016-17		2017-18		2018-19 onwards
	Recurring costs	Non-recurring costs	Recurring costs	Non-recurring costs	Eventual recurring costs	Total Non-recurring costs
Disclosure, apology and review	-	£100,000	-	£75,000	-	£50,000
Support	£456,000	-	£460,560	-	£465,965	-
Training and implementation	-	£307,000	-	£60,000	-	£40,000
Total	£456,000	£407,000	£460,560	£135,000	£465,965	£90,000
TOTAL	£863,000		£595,560		£555,965