- 3 Oct 2018
Roles and 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 covers 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?
Organisations must ensure that the registered health professional who is involved in determining harm following an unintended or unexpected incident is not someone who was involved in the incident. They could, however, work for the same organisation.
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.
In a GP practice, who is the responsible person? Is it the practice manager or the Board?
GP practices should contact the duty of candour lead at their Board to determine which approach is being taken locally.
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?
The duty of candour procedure is the legal responsibility of the organisation who provided a health service, care service or social work service where the incident occurred. Other health and social care providers may have been involved in the provision of care and services, but they are not responsible persons (organisations) in respect of that incident.
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 outlines 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.
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.
What is the procedure start date?
The procedure start date is the date that the organisation receives confirmation from a registered health professional that, in their reasonable opinion, an unintended or unexpected incident appears to have resulted in, or could result in an outcome listed above and that relates directly to the incident rather than to the natural course of the relevant person's illness or underlying condition.
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 legislation does not require this to be a detailed and comprehensive analysis (though this will of course often be required given the nature of the incidents that activate the duty) of the incident to form an opinion about contributory factors. The requirement is for someone not involved in the incident to provide a view to inform a decision about activating the duty of candour procedure (which includes a review process).
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.
Defence organisations and unions often advise clinical staff not to apologise - how will this be addressed?
Education, training, implementation and related support materials 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?
Education, training, implementation and related support materials 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.
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 and 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 other review processes?
Organisations must carry out a review of the circumstances which they consider led or contributed to the unintended or unexpected incident. The legislation does not specify the manner in which the review is undertaken, but it is likely that this will be one of a range of review processes that are already undertaken such as an adverse event review, a significant case review of the sort undertaken by child, adult and public protection committees or a morbidity and mortality review.
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?
Whilst it would not be appropriate for an organisation to try to prevent the relevant person from making a claim, organisations can suggest to relevant persons that they may wish to wait until the duty of candour procedure has concluded, when their case will have been investigated; they will have received an apology; the facts will have been established and any actions to improve the quality of care and/or learning will have been identified.
If a relevant person mentions that they are considering making a claim, the duty of candour procedure should continue. If a relevant person makes a claim (i.e. the organisation receives formal notification of commencement of legal proceedings), then some elements of the duty of candour procedure may need to be paused until the legal process reaches a conclusion. For example, internal reviews could still proceed and organisations should still try to identify any potential improvement and learning actions.
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).
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?
Is there a timescale which dictates when the review must be completed?
In the case where the review is not completed within three months of the procedure start date, the organisation must provide the relevant person with an explanation of the reason for the delay in completing the review.
Why did the duty of candour legislation not prescribe a role for an individual as exists in other legislation such as the Health and Safety at Work Act where a “duty holder” is specified; or in the fire safety legislation where there is reference to “responsible person” and “competent person”; or “prescribed person” under Public Interest Disclosure Act?
The policies that informed this legislation focused on a range of responsibilities and accountabilities across the system, recognising that several of these are already set out in legislation. Sir Robert Francis, who conducted the Mid Staffordshire Inquiry, recognised that an organisational response rather than an individual response is often required when unintended or unexpected incidents that result in harm or death happen.
Within a Health Board, the role of chief executive is conferred by virtue of the National Health Service (Scotland) Act 1978. The provision of advice to the Board on the proper discharge of its functions are set out in the Functions of Health Boards (Scotland) Order 1991(SSI 1991/570).
The National Health Service (Scotland) Act 1978 requires that each Health Board, Special Health Board have arrangements for the purpose of monitoring and improving the quality of health care which it provides to individuals. The effective implementation of the statutory organisational duty of candour forms an integral part of NHS Board fulfilment of it’s statutory duty of quality conferred by the National Health Service (Scotland) Act 1978.
This also includes the provision that every Health Board and Special Health Board put and keep in place arrangements for the purposes of –
- improving the management of the officers employed by it;
- monitoring such management;
These ‘staff governance’ provisions for NHS Boards span the arrangements in place for all of the statutory obligations of NHS Boards – meaning that the actions of officers employed by the NHS Board in respect of the implementation of the organisational duty of candour fall within the scope of the arrangements referred to above.
Training education, advice, guidance and publicity
How will training/education resources from NES and SSSC be rolled out to organisations?
Each organisation must ensure that all staff who carry out the procedure on its behalf are aware of the duty of candour procedure.
An E-Learning resource has been produced by NHS Education for Scotland, The Scottish Social Services Council, The Care Inspectorate and Healthcare Improvement Scotland. Relevant staff should be encouraged to complete the module which takes no longer than an hour. It is available on the following web-sites:
- NHS learning systems, such as learnPro;
- The Care Inspectorate;
- Scottish Social Services Council;
- Little Things make a Big Difference;
Factsheets are available on the Little Things make a Big Difference website.
How can we ensure that staff have both the theoretical knowledge and the practical lived experience of applying the duty of candour procedure?
Organisations must ensure that all such employees receive relevant training and guidance on the duty of candour procedure, and any services and support which may be available to relevant persons.
Can we have a template apology letter that does not acknowledge fault or blame?
Guidance includes 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”.
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.
Have you implemented any training yet to help medical staff with their reflective practice given they do not have legal privilege?
Regulation 8 specifies that:
The responsible person must ensure that all employees who carry out the duty of candour procedure on its behalf—
a) are aware of the duty of candour procedure;
b) can provide relevant persons with the information mentioned in regulation 7(5)(c); and
c) receive relevant training and guidance on the duty of candour procedure and any services and support which may be available to relevant persons.
The responsible person must provide an employee who is involved in an incident with details of any services or support of which the responsible person is aware which may provide assistance or support to any such employee, taking into account—
a) the circumstances relating to the incident; and
b) the employee’s needs.
What does the Act actually require in terms of reporting?
The Act sets out that a responsible person that provides a health, care, or social work service during a financial year must prepare an annual report, as soon as reasonably practicable after the end of that financial year. 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.
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.
What level of detail should go into a report?
The 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. Sample report templates have been produced as illustrative examples for responsible persons.
Are organisations still required to publish a report when there has been no duty of candour incidents throughout the year?
When there are no duty of candour incidents, organisations are still required to publish a null 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 and 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. .
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.
Who checks that learning and improvement actions are actually implemented?
The Act sets out that a responsible person that provides a health, care, or social work service during a financial year must prepare an annual report, as soon as reasonably practicable after the end of that financial year.
The report must include:
- information about the number and nature of incidents to which the duty of candour procedure has applied in relation to a health service, a care service or a social work service provided by the responsible person;
- an assessment of the extent to which the responsible person carried out the duty of candour;
- information about the responsible person's policies and procedures in relation to the duty of candour, including information about procedures for identifying and reporting incidents, and support available to staff and to persons affected by incidents;
- information about any changes to the responsible person's policies and procedures as a result of incidents to which the duty of candour has applied;
- such other information as the responsible person thinks fit.
The report must not mention the name of any individual, or contain any information that could identify any individual.
The report must be published in a manner that is publicly accessible. For instance, on an organisation's website.
The implementation of the statutory duty of candour forms part of the scrutiny and inspection processes operated by Healthcare Improvement Scotland and the Care Inspectorate.
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 legislation does not require this to be a detailed and comprehensive analysis of the incident to form an opinion about contributory factors (though this will of course often be required given the nature of the incidents that activate the duty).
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.