ROLES & RESPONSIBILITIES
Who will be the identified duty of candour lead in each organisation – what is the Scottish Government's expectation?
This will be for organisations themselves to determine. Guidance will cover the issues organisations need to consider to support leadership and management actions required to implement the organisational duty.
Who will be the registered health professional involved in determining harm?
This will be determined by the local arrangements in place within organisations. Guidance will outline some of the issues that will need to be considered in deciding for individual incidents who this might be within different organisations.
How is Duty of Candour going to work in primary care?
The implementation of the duty of candour procedure should operate in primary care settings in the same way that it will be implemented across other health and social care providers. It will be up to the responsible person (the organisation) to develop and implement processes and systems that support the activation of the procedure and to report on it effectively. Discussions are commencing with primary care contractors about ways that the duty of candour procedure could operate as an integral part of existing contractual, legislative and/or reporting arrangements.
In a GP practice, who is the responsible person? Is it the practice manager or the Board?
This will be for the GP practice to determine who will be the responsible person. Discussions with Scottish Government Primary Care Division and stakeholders will inform guidance about approaches to be taken in respect of GP practices and NHS Boards.
When a local authority organisation refers to another organisation such as CAMHS, and psychological harm occurs over a long period of time, who would be responsible for activating the Duty of Candour?
The responsibility for duty of candour activation will depend on local decision-making that takes account of the sequence of events relating to the incident that is regarded as unintended or unexpected and results in one of the outcomes outlined in the Act.
When hospice staff, GPs and NHS Scotland are involved in providing care, who is the responsible person if an unexpected incident occurs?
This will depend on the events and the nature of the unexpected or unintended incident. Regulations and guidance will make it clear how multiple responsible persons can work collectively to implement individual statutory duties.
In a patient’s journey where harm/death may have occurred – where does the duty sit – which organisation is best placed to implement the duty – and who will decide that?
Organisations involved with the provision of care impacting upon the outcomes for an individual will need to have mechanism to consider the specific ways in which they will liaise and discharge their individual responsibilities in respect of the duty of candour procedure. Guidance will include reference to common scenarios and best practice in this area.
In a Health and Social Care Partnership, who is the responsible person? Does the IJB decide?
Depending on where and when the incident that resulted in death or harm took place it is for the services within the Health and Social Care Partnership to decide whether the NHS Board or Local Authority is the responsible person and will activate the duty of candour procedure
Will the provisions of the duty of candour apply to NHS Health Scotland?
Will NHS Education for Scotland (NES) be required to report on Duty of Candour?
NES is not covered by the Act as it is not a provider of health and/or social care. The provision of health and/or social care by staff linked to NHS Education for Scotland training programmes will be subject to the duty of candour obligations of the organisations that they work within (which are themselves subject to the Act. )
Are we talking about an intervention that has gone wrong when we are defining a duty of candour incident?
Possibly, though the primary determinant of an organisation activating the duty of candour procedure will be their local discussions and decision-making in respect of whether an unintended or unexpected incident has resulted in one of the outcomes outlined in the Act.
Will the duty of candour apply to near misses ? If not, why not and isn’t this a missed opportunity for learning ?
The Duty of Candour procedure will not be activated for near misses.. This is because no death or harm (as defined by the Act) will have occurred and so the statutory nature of the procedure cannot apply. Some organisations already have established processes to review near misses. The duty of candour procedure should not stop organisations from reviewing near misses as part of an established learning system within their organisation.
What definitions will be provided for staff to consider whether the duty of candour should be applied?
Guidance will outline the range of issues to be considered in support of the local decision-making that will need to be applied to consider, on a case by case basis, whether the duty of candour procedure will be activated for an incident.
Will the regulations outline definitions?
No. Guidance will outline the issues that will need to be considered by organisations implementing the procedure.
How is an apology defined in relation to the Apologies (Scotland) Act 2016?
Section 23 of the Act defines ‘apology’ in relation to the duty of candour provisions and subsection (2) provides that any apology or other steps taken which are in accordance with the duty of candour procedure set out in regulations made under section 22 cannot be taken by itself to be an admission of negligence or a breach of a statutory duty. This means that there is not to be taken to be a link between giving an apology (or otherwise following the duty of candour procedure) in relation to an incident and acknowledgment of any wrong-doing. This does not prevent individuals affected from taking further action in relation to an incident.
Section 3 of the Apologies (Scotland) Act 2016 provides that an apology is a statement (which could be written or oral) made either by the person who is apologising (whether a natural person, or a legal person such as a company), or by someone else on their behalf (e.g. a spokesperson or agent). The core element is an indication that the person is sorry about, or regrets, an act, omission or outcome. Where the statement includes an undertaking to look at the circumstances with a view to preventing a recurrence, that qualifies as part of the apology itself. The definition of apology for the purpose of the Act does not include statements of fact or admissions of fault. In any statement that includes both an apology and a statement of fact and/or admission of fault, only the apology is inadmissible as evidence of liability.
Definitions of harm – in the guidance can broad definitions be given or will the definitions in the Act be the only reference point? Will they be similar to the descriptions of harm within an Adult/Child Support & Protection Act?
Guidance will outline the sorts of issues that organisations will need to consider when considering whether to apply the duty of candour procedure.
What does reasonably practicable mean as outlined in the Act?
This will be considered in the process to develop regulations and guidance.
When there has been a death and further information is required to determine whether it was unintended or unexpected eg a toxicology report - at what stage should Duty of Candour procedure be activated?
It is for responsible persons/ organisations to determine when they will activate the procedure, acknowledging that information from external agencies investigating the circumstances of some deaths will often determine organisational decision-making in respect of whether it is regarded as unintended or unexpected.
The Act states in the reasonable opinion of a registered health professional- if harm occurs in social care or social work setting does this mean the duty cannot be triggered without a health assessment? Does it need to be a formal assessment or just verbal feedback doing treatment? Who is expected to do the assessment? If a GP – what are the implications if they will not come to the service or makes a judgement call over the phone – will that be sufficient?
A registered health professional who has not been involved with the provision of the care that the duty of candour procedure has been applied to should confirm that the activation of the duty of candour procedure is necessary. The specific considerations that responsible persons will need to consider will be outlined in guidance.
How will conflicting opinions about whether the duty of candour applies be handled ?
It is for organisations themselves to determine, with the input of a registered health professional providing a view based on individual circumstances, whether a sequence of events is regarded as an incident for which the duty of candour procedure should be activated. It will also be for organisations to put in place a process to ensure that the procedure is activated consistently in all cases. National and local training and education resources will need to be put in place to support staff to carry out their duties around duty of candour activation and procedure. All organisations have received a letter alerting them to the need for local planning in advance of implementation.
Defence organisations and unions often advise clinical staff not to apologise - how will this be addressed?
Education, training, implementation and related support materials will emphasise that this advice is not consistent with best practice, nor reflective of the provisions of the Act.
This work needs to take account of the fact that there are still organisations that focus less on human factors and systems and more on individual conduct and blame – how will this work be implemented to address this issue?
The implementation toolkit and guidance will reflect the need for duty of candour procedures to be implemented in accordance with best practice – which emphasises local learning systems and how these inform continuous improvement. The duty of candour procedure is not related to organisational conduct or capability arrangements in any way.
Is there a risk that being open and honest with some groups of patients or service users could be counterproductive, and in some cases actually cause harm?
Yes, we acknowledge that it may not always be in the best interests of the individual to be told about what has happened, and organisations will be required to consider this carefully and ensure that they do not have a one size fits all approach to disclosing information. The Scottish Government’s implementation advisory group will consider this issue as part of its remit.
Additionally, we will consider this in the context of the regulations that will set out the duty of candour procedure, to include requirements to ask individuals if they want to be given information about what has happened.
How will the duty of candour deal with the fact that is well established in medicine that there are known risks and complications ? There are some events that occur entirely predictably during the course of medical interventions and procedures – it is completely impractical to suggest that an organisational duty of candour might be applied to these surely ?
Duty of candour is very specific and only applies where there has been an unexpected or unintended consequence that causes harm or death to an individual (as defined by the Act) that is not as a consequence of the condition for which they are being treated.
If a person is expecting a natural birth and unexpected circumstances lead to them having a C-section, ie ‘an increase in the person’s treatment’. Does this activate Duty of Candour?
It is for organisations themselves to determine, with the input of a registered health professional carrying out an assessment and taking into account individual circumstances, whether a sequence of events is regarded as an incident for which the duty of candour procedure should be activated. A decision to carry out a C-section is not in itself likely to constitute an unintended or unexpected incident for a pregnant woman. It is possible however, that a team may consider that the overall episode of care that led to this decision had other aspects which were unintended or unexpected.
If a person is expecting a C-section and it is no longer needed. They then have a natural birth then develop Posttraumatic Stress Disorder (PTSD). Does this activate Duty of Candour?
It is for organisations themselves to determine with the input of a registered health professional carrying out an assessment and taking into account individual circumstances, whether a sequence of events is regarded as an incident for which the duty of candour procedure should be activated. The assessment should consider the impact of changes in maternity/obstetric care plans, the sequence of events and the outcomes for individual patient (as outlined in the Act). A diagnosis of Posttraumatic Stress Disorder would constitute psychological harm as outlined in the Act.
If an unexpected or unintended incident which results in one of the outcomes in section 21 (4) of the Act happens before the 1 April 2018, should the Duty of Candour procedure be activated?
The Duty of Candour procedure should be activated for incidents that the responsible person becomes aware of after 1 April. For example, after 1 April 2018, if the responsible person becomes aware of unexpected psychological harm that occurred because of care provided to the relevant person in 2015, the Duty of Candour procedure should be activated.
OTHER PROCEDURES & LEGISLATION
Health and social care professionals already have a professional duty of candour so why do we need an organisational duty?
Some professional regulatory bodies already require registrants to have a duty of candour. The General Medical Council (GMC) and Nursing and Midwifery Council (NMC) have issued specific additional guidance on duty of candour. Research evidence collated by the Professional Standards Authority and observations from national visits to NHS Boards would suggest that there are several factors that contribute to unacceptable variation in organisational approach to candour. The statutory duty on organisations would help to establish a robust and consistent approach to candour across health and social care, complementing professional duties already in existence.
How do Rapid Alerts feed into duty of candour incidents?
They don’t specifically, though organisations who generate or use rapid alerts as part of their local learning systems may wish to consider how the learning from duty of candour reviews inform any alerts to be issued within local or national organisations.
Where does Duty of Candour fit with adverse event reviews?
Some incidents that are currently investigated through adverse event review processes are likely to require activation of the duty of candour procedure.
When a mortality and morbidity review takes place, will the Duty of Candour process create additional burden?
The interface and impact of linkages across other organisational procedures is a matter for responsible persons/organisations. Leadership and management should ensure that there are effective arrangements in place to support links between all review processes and their duty of candour obligations.
If an organisation is subject to litigation- will organisations be expected to stop the Duty of Candour procedure part way through or carry on given that litigation takes primacy?
No as litigation is focused on the determination of causation and liability – whereas the duty of candour procedure relates to a review of the contributory factors to harm.
If the Duty of Candour procedure has been applied will that be seen as a mitigating factor in any litigation cases and award of damages – and conversely, if not, then will it be an aggravating factor if not carried out when it should have been?
It will be for those involved in determining causation, liability and the awarding of compensation to determine how an organisational response to an incident will be considered as part of separate processes such as a claim. It is likely that the activation of the duty of candour procedure will, in some cases, avoid the need for a claim or legal process (particularly those where previously the legal process has been used to seek assurance that learning from the event and changes to processes will reduce the likelihood of recurrence for other people).
There is other legislation that needs to be taken into account and which care providers cannot ignore and may take primacy in some circumstances – such as the Adults with Incapacity Act or the Mental Health Care and Treatment Act.
Guidance will explain how the duty of candour procedure should be implemented in accordance with a range of related statutory provisions including local procedures for the management of unintended or unexpected incidents and harm.
How will a concern raised through whistleblowing policies relate to the duty of candour provisions?
This will depend on what the concern is and whether the information provided through this regarded to be an unintended or unexpected event resulting in harm. It is and has not been reported elsewhere, an organisation may decide to activate the duty.
Will this sort of work be included within the self-assessments that organisations have to do?
There are already definitions of reportable events for the care sector, for independent healthcare and for adverse events in NHS Scotland. How will the duty of candour work impact upon this?
Guidance will encourage organisations to consider the ways in which existing approaches can be aligned with local decision making on the duty of candour procedure. Where possible national support programmes and guidance will also be aligned to the duty of candour provisions.
TRAINING, EDUCATION, ADVICE, GUIDANCE & PUBLICITY
How will training/education resources from NES and SSSC be rolled out to organisations?
NHS Education for Scotland and the Scottish Social Services Council will be making these available through the existing networks and communication channels they use.
Scottish Government often talk about new legislation and the importance of education and training but do not provide resources for the care sector. Will resources be provided?
Resources have been allocated already by NHS Education for Scotland and the Scottish Social Services Council to support training and awareness. Using and targeting existing resources will also be an important element of implementation support planning for the Duty of Candour.
How can we ensure that staff have both the theoretical knowledge and the practical lived experience of applying the duty of candour procedure?
Organisations should support a range of approaches to the planning, delivery and continuous improvement of their processes for applying the duty of candour procedure.
Have you got a timescale for when the implementation support toolkit will be available?
Where do Independent Contractors go for support if they need further advice?
Healthcare Improvement Scotland, Care Inspectorate, Scottish Social Services Council, NHS Education for Scotland and The Scottish Government have agreed to work together to provide support for any responsible person who wishes to contact them to discuss this in this pre-implementation phase.
How will we be informing patients/service users about the new Organisational Statutory Duty of Candour – will there be a national publicity campaign?
The Education and Training Sub-Group will be considering whether any specific awareness raising targeted at the public might be required to complement the awareness raising targeted at health and care professionals.
Can we have a template apology letter that does not acknowledge fault or blame?
Guidance will include information to support organisations consider how best to communicate apologies as part of the duty of candour procedure. The Act states at Section 23 that “An apology or other step taken in accordance with the duty of candour procedure under section 22 does not of itself amount to an admission of negligence or breach of a statutory duty”.
How well is the duty working in England? Can we have case studies/speakers from England come and speak about how it works, how they have implemented it to alleviate people’s fears?
Some concerns have been expressed in England about the implementation of the duty. The lessons learned about preparations and implementation support planning have informed the approach being taken in Scotland.
What have you learned from other countries and how has this influenced the duty of candour in Scotland ?
From work to review the effectiveness of the duty of candour in England, we have learned that training and education is an essential component of implementation planning. Resources on open disclosure from Australia are being used to inform guidance and work from Denmark on adverse event reporting has informed our policy position promoting local organisational ownership in reviews of incidents.
Can it be made clear in guidance if failure to act resulting in harm is applicable and if delayed discharge is also applicable?
Guidance will cover a range of scenarios. These will include circumstances in which acts of omission are contributory to harm and also when delays to anticipated discharge date result in harm.
What does the Act actually require in terms of reporting?
The Act requires the responsible person to report annually on the implementation of the duty of candour procedure. This report is to include information on the number and nature of incidents in which the duty was invoked and any changes to policies and procedures that resulted from the incidents. This will capture the learning and improvement actions arising from the review of unintended incidents or events resulting in death or harm.
What are the benefits of reports being published and submitted on the duty of candour?
Evidence and experience suggests that organisations that embrace transparency and candour regarding harm incidents can evidence improvements in the learning culture within their organisation as a result this greater openness.
Will the duty of candour reporting requirements align with the incident reporting requirements of the Care Inspectorate for the regulated care sector?
Can the duty of candour report not replace existing reporting arrangements? What will its impact be on the annual Chief Social Worker Report?
It is for each individual responsible person to determine the way in which duty of candour reporting requirements can best be implemented for them. This will include decisions about the most appropriate way to report how the duty of candour procedure has been applied within an organisation during a year.
There are various other reporting systems. Will a new I.T. project be required?
It is possible that organisations will want to make amendments to existing incident reporting systems. No specific national ‘IT project’ is envisaged.
Will there be similar codes identified for input to Datix – to apply to duty of candour; Adverse Events; Complaints?
Organisations will need to determine which changes might need to be made within their local systems such as Datix and equivalent systems to support these organisational processes across health and social care providers.
After the Duty of Candour procedure has been activated, is it reported immediately or in a single report at the end of the year?
The duty of candour procedure outlined in the Act requires the submission of an annual report detailing how the procedure has been applied.
What level of detail should go into a report?
The Scottish Government will be producing guidance example templates detailing the sort of information that could feature in an Annual Report.
Could we be “marked down” in an inspection if there are large amount of Duty of Candour incidents?
The number of times an organisation decides to activate the duty of candour procedure will not, in and of itself, form a criterion that will be reviewed in isolation from other data as part of any future scrutiny or quality of care review processes.
MONITORING & COMPLIANCE
How will the duty of candour be monitored?
Monitoring arrangements will be insofar as possible aligned to existing regulatory arrangements. In our discussions with stakeholders this was highlighted as an important factor in preventing the duty from becoming burdensome.
What does the SG think that success will look like – and how will that be monitored and measured?
At a national level one of the indicators of success will be more information being widely available on the ways in which organisations have implemented the duty of candour procedure and how reviews have resulted in learning and improvements.
How will The Scottish Government/Healthcare Improvement Scotland/The Care Inspectorate ensure each organisation complies with the duty?
Annual reports will be reviewed to consider progress with implementation of the duty of candour procedure.
How will the Scottish Government ensure organisational compliance?
Reports outlining how the duty has been applied by organisations will be considered by Scottish Government, Healthcare Improvement Scotland and the Care Inspectorate as part of their existing arrangements for reviewing the quality of health and social care delivery in Scotland.
What sanctions, penalties and policing will be in place in respect of the duty of candour ?
Monitoring arrangements will be, insofar as possible, aligned to existing regulatory arrangements. In our discussions with stakeholders this was highlighted as an important factor in preventing the duty from becoming burdensome. In addition, annual reports from each organisation will be reviewed by Healthcare Improvement Scotland (HIS), the Care Inspectorate (CI) and the Scottish Government to ensure learning and changes to systems and processes is taking place.
If organisations have not applied the duty of candour procedure when it appears they could or should have, then this will be reviewed through the range of existing mechanisms for reviewing and supporting improvements in the quality of care. The Act outlines at Section 24(6) that a notice may be served to require the organisation to provide information about any matter relating to their implementation of the duty of candour procedure. Healthcare Improvement Scotland, Care Inspectorate and the Scottish Government are currently considering recommendations from the Monitoring and Reporting Sub-Group.
What is SG, HIS, CI going to do with the information gained from reports? If trends or lack of resources are identified will SG respond to this in terms of dedicated resource or budget?
The information within reports will be used as part of the range of quality monitoring, planning and improvement activities of these organisations. If organisations identify that resources were causal or contributory to harm outcomes then, in the first instance, it will be for these provider organisations to consider as part of financial planning.
Where can 3rd sector organisations go to apply for funding to implement Duty of Candour?
Funding discussions in respect of the provision of health and/or social care by third sector organisations are a matter for them and the organisation that they are contracting with. Healthcare Improvement Scotland, Care Inspectorate, Scottish Social Services Council, NHS Education for Scotland and The Scottish Government have agreed to work together to provide support for any responsible person who wishes to contact them to discuss this in this pre-implementation phase.
Have the resource implications on GPs (given their existing heavy workload) been taken into account, if it is their opinion that is to be sought about incidents?
It will generally be the view of another health professional within the organisations where the unintended or unexpected incident resulting in harm has occurred that is sought to provide this opinion, rather than a GP. It is possible that in organisations with no registered health professional that GPs will be asked for their view on the incident and the specific outcomes that trigger the duty of candour procedure. The practical implications of this arrangement are being considered as part of implementation planning.
What will happen if organisations try to use the new arrangements to show resources are the main issues contributing to harm ?
If information is presented that lack of resource within an organisation contributes to harm incidents that activate the duty of candour procedure - these should be reviewed by organisations themselves initially to determine where resources could be used more effectively..
Will more resources be made available by the Scottish Government if new complaints and duty of candour processes demonstrate that more resources are needed?
The Scottish Government uses a range of sources of information to determine resource allocation in support of the range of initiatives supporting the delivery of quality health and social care services in Scotland. After initial assessment and planning by the organisation themselves to determine if resources can be allocated more effectively, this information from responsible persons may inform future allocation processes.