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

Annex A Partial Business and Regulatory Impact Assessment

Title of Proposal

To Introduce a Statutory Duty of Candour for Health and Social Care Services

Purpose and intended effect

• Background

Improvements in arrangements to support the disclosure of harm, is a key element supporting a continuously improving culture of safety.^[23] There are several healthcare systems and organisations worldwide that have introduced initiatives or arrangements to support open disclosure of harm. The Berwick Report^[24] emphasised the importance of the requirement that a patient or carer affected by serious incidents should be notified and supported.

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.^[25] However, it has also 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 apology^[26]

Healthcare Improvement Scotland have 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 rigor and standard of open disclosure and support for families and staff when harm occurs.

The Scottish Government wants to introduce an organisational duty of candour in Scotland. This will require services to make sure that they are open and honest with people when something has gone wrong with their care and treatment.

• Objective

The Scottish Government intends to introduce a statutory requirement on organisations providing health and social care to have effective arrangements in place to demonstrate their commitment to disclose instances of physical or psychological harm. The proposals have been intentionally focused on organisational duties and specifically developed to ensure that this includes all of the elements that will need to be in place to support continuous improvements in quality and safety culture across Scotland's health and care services.

Ethically, morally and professionally health and care professionals are already required to tell people about instances of harm. The clear requirement for candour in professional standards and codes of conduct are complementary to the proposed introduction of a duty on organisations.

From November 2014 the Care Quality Commission in England will include the duty of candour among the standards to be met by healthcare providers in England. These will form part of the inspection and monitoring regime operating in England. This includes a range of new enforcement powers, including civil penalties and criminal proceedings for repeated failures. From April 2015 this will be extended to providers of adult social care services.

• Rationale for Government intervention

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^[27]. There has been strong support for the benefits of improving organisational arrangements for disclosure of harm in recent years.

The 2013 Health and Care Survey^[28] asked respondents whether they believed a mistake was made in their treatment or care by their GP practice. 6% of respondents believed such a mistake had been made in their treatment or care. Of those that felt a mistake had been made in their treatment or care:

7% indicated that it did not require a response

Of those that required a response:

19% were completely satisfied with how it was dealt with
44% were satisfied to some extent
38% of those where were not satisfied

The Dalton-Williams review^[29] recommended that there should be a statutory duty on organisations and that this would provide a powerful signal of what is considered essential and this should act as an important catalyst for care organisations to improve their systems and commit to a learning culture for their staff.

The Scottish Government has five strategic objectives that underpin its core purpose - to create a more successful country, with opportunities for all of Scotland to flourish, through increasing sustainable economic growth. This proposal will contribute to the strategic objective of "healthier" by increasing the quality of health and social care that individual's experience.

Consultation

The legislation will be developed in a collaborative way involving colleagues from across and outside the Scottish Government.

• Within Government

We are working with colleagues across the Scottish Government to develop this legislation. This includes, but is not restricted to the following teams: Primary Medical Services; Pharmacy, Integration and Reshaping Care; Children's Rights and Wellbeing; Chief Medical Officer, Chief Social Work Adviser, Chief Dental Officer and Chief Nursing Officer's Directorates. The nature and scope of the proposals have been shaped through dialogue with policy colleagues. This has also directly influenced the consultation questions that will be asked.

• Public Consultation

The formal consultation will run for a period of 12 weeks from 15 October 2014.

• Business

We will identify relevant organisations to meet with during the consultation period and update this section at Final BRIA stage.

Options

Option 1: do nothing. Ethically, morally and professionally, 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.

Option 2: to Introduce a Statutory Duty of Candour for organisations providing Health and Social Care The statutory duty will require that an organisation must act 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.

Requirements for Health and Social Care Organisations

1. As soon as it is reasonably practicable after becoming aware that there has been adverse event resulting in harm, the organisation must ensure that the relevant person is notified that this has happened. This will involve the provision of a step by step account of the facts of the event, including as much or as little information as the person has expressed their wish for.

2. There must be an offer of reasonable support provided to the patient, relatives and staff who have been involved with the event. The person undertaking the disclosure may be different for each disclosure episode.

3. The responsibility will rest with organisations to ensure that all staff who are asked to be involved with disclosure have access to the relevant training, supervision and support before, during and after their involvement with disclosure communications.

4. The notification that is made to the relevant person should be given in person by a suitably trained representative of the organisation and should include an account of all of the facts known at the time of disclosure and the plans for the event to be reviewed. It will be for the organisation to determine who is most appropriate to disclose the harm episode.

5. The relevant person must be informed of the further steps to be taken to review the event and be given the opportunity to have their questions considered by the review process.

6. The organisation must provide an apology and must confirm all of the actions taken in a written record, the contents of which will inform the quarterly report.

7. The relevant person must also receive a written summary of the face to face meeting.

Reporting on Disclosure Arrangements

1. All organisations would be required to report publically on a quarterly basis the nature of adverse incidents that have been disclosed to people and confirm that requirements of the organisational duty of candour have been met.

2. Organisations would also be required to report on the way in which they had supported staff in the development and maintenance of the skills required to ensure respectful disclosure by staff who are required to be involved with this.

3. Organisations should also publish annually their policies and procedures to support openness and transparency, this must include the arrangements in place to support staff training and development in these advanced communication skills. These reports should be submitted to the relevant organisation (which will differ for each organisation).

4. Organisations would be required to ensure that they have arrangements in place to ensure that if any adverse event is reported that this is considered and a decision made whether this is a disclosable event.

5. Organisations would also be required to include a summary in their reports of the support that is available to patients, families and staff following an disclosable event. They would also need to describe the provision to ensure that training and development support has been implemented to ensure best practice in disclosure.

Sectors and groups affected

The statutory duty of candour would apply to health and care services provided by NHS Boards, Local Authorities, all organisations providing services regulated by the Care Inspectorate, independent hospitals, independent hospices, General Practices, community pharmacies, dental practices and optometry practices.

Any or all patient/clients, and their families, treated in a formal healthcare setting could be affected. As this is an organisational duty, it would not apply to individuals providing services, for example, childminders.

Benefits

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.

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 are 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.

This will reduce the level of distress and frustration that people experience when they do not receive the information that they're seeking. This benefit is unquantifiable.

It is anticipated that, initially, there will be an increase in the level of reporting of incidences, providing an increase in learning opportunities. This should result in increased awareness of patient safety and ultimately a reduction in avoidable incidences of harm. This benefit is difficult to quantify.

Overall, a requirement which encourages openness and honesty across all organisations within the health and social care sector may increase both staff and patient satisfaction. This benefit is difficult to quantify.

Costs

Option 1: do nothing
Ethical, professional and policy guidance is generally insufficient in significantly improving rates of disclosure. Under current policies there may be a lack of support for professionals from their employer organisations resulting in a reluctance or failure to report 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.

Option 2: to Introduce a Statutory Duty of Candour for Health and Social Care

Although ethically, morally and professionally 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.

Although 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^[30] and it has been recognised that as few as 30 per cent of incidents resulting in harm are disclosed to people who have been affected, it is not possible to quantify how many additional disclosures of harm this legislation might generate in Scotland .

There are likely to be a number of costs associated with the introduction of this legislation and any increase in reporting.

Scottish Government

The Government will need to consider whether it wishes to undertake a public education campaign to make people aware of any change in the law. There would also potentially be costs involved in providing literature/guidance for care providers including care homes and the range of health professionals. It is likely that this could be part of work to emphasise policy commitments on quality, safety and improvement work in health and social care.

SG/NHS Boards/providers: training

It has been recognised that being candid is an advanced communication skill. Programmes have been developed to improve the preparation of doctors to make such disclosures, and to deal with emotional elements that are linked with this task.^[31] The Scottish Government in collaboration with NHS Education for Scotland (NES) would need to consider if and how to introduce any additional staff training. This might involve adding to existing training packages both for staff in training and those already qualified. Information on possible training content and focus will be obtained from stakeholders during the consultation period.

Within the NHS alone, there are approx 104,000 employees involved in delivering care (this excludes admin, support and health science workers) and there are over 192,000 employed in delivering social care services^[32] across public, private and voluntary sectors. Different types/levels of training may be appropriate for different staff groups. For example although it will be everyone's responsibility to identify and report when an adverse event occurs, it may be appropriate to target training to particular senior staff groups who would then communicate with patients/clients.

All Providers

All health and social care providers will have to ensure that they have policies and procedures in place that reflect the statutory duty imposed to disclose adverse events. These will need to be communicated to staff. There will be a resource cost involved particularly in developing and disseminating these policies for the first time. These may be defined as transitional costs. It is anticipated that these activities would form part of routine management responsibilities.

Increased numbers of disclosure may result in an increased need for additional training for staff on specific issues. These will only be identified once incidents are reported.

There may be a small risk of increased litigation from an increased number of disclosures of adverse events although international evidence is that a statutory duty on disclosure results in a reduction in the number and costs of medical claims^[33].

All organisations would be required to report publically on a quarterly basis the nature of adverse incidents that have been disclosed to people and confirm that requirements of the organisational duty of candour have been met. Although this is an additional requirement it is assume that this could be incorporated into existing routine reporting.

Organisational Support for staff

For both staff who report incidents and those who communicate these to patients/carers it will be necessary for organisations to ensure that there are adequate supports in place and that staff are made aware of these. It is possible that additional resources will be required for larger organisations who might wish to enhance staff support available through specialists in psychological care, counselling and/or occupational health. Smaller organisations could incur costs associated with the provision of access to such support if this is not already in place.

Support for patients/clients/carers

There is evidence that honesty, openness and apologies are important to patients when there has been an error in treatment and that it may make them less likely to seek recompense through the courts. However it is important that not only are they given the information by an appropriately trained professional but that there is support available to them, should it be required, to deal with the information and any implications associated with that information. Additional demands for access to clinical psychologists, specialist nurses and/or counsellors could be made. Demands are likely to be met within existing services, though this will depend on the extent of service provision in place. This will be considered during the consultation period.

Monitoring & enforcement

It is proposed that the Scottish Government, Healthcare Improvement Scotland and the Care Inspectorate are involved in monitoring and enforcing. Although these would be additional responsibilities the Scottish Government considers that it would be a small increase in workload when integrated with existing monitoring, reporting and inspection arrangements and it is not anticipated that this would require significant additional staff or resource. Further information on this will be obtained throughout the consultation period.

Scottish Firms Impact Test

Throughout the formal consultation period officials will meet with a range of stakeholders, including organisations, businesses and patients/clients who are likely to be affected by any proposed legislation. The outcome of these meetings will be analysed and presented as part of the full BRIA.

Competition Assessment

Will the proposal directly limit the number or range of suppliers?
No, the proposal will not limit the range of suppliers within the market. It does not restrict the right to supply services in any way.

Will the proposal indirectly limit the number or range of suppliers?
No, the proposal will increase the standards of care expected but is not expected to indirectly affect the number of suppliers.

Will the proposal limit the ability of suppliers to compete?
No, the proposal will apply equally to all providers of health and social care.

Will the proposal reduce suppliers' incentives to compete vigorously?
No, it will reduce informational asymmetry between patients/clients and healthcare providers. Where a market exists, it will increase competition.

Test run of business forms

There are no new forms for businesses planned.

Legal Aid Impact Test

As part of the on-going development process we will liaise with the Scottish Government Legal Systems Division to gauge whether any proposals will have an impact on the legal aid system. This will be detailed within the full BRIA

Enforcement, sanctions and monitoring

Option 1: this option would require no additional monitoring or enforcement.

Option 2:
Monitoring and enforcement: organisations will be expected to report quarterly on all disclosable events including information on the arrangements in place to deliver duty of candour and the learning and improvement subsequent to these events.

It is intended to use the existing regulatory mechanisms within Scotland available through the Scottish Government, Healthcare Improvement Scotland and the Care Inspectorate. Particular sections of the health and social care market would report to assigned agencies. These proposed arrangements for reporting and monitoring are part of the consultation and the Scottish Government would welcome comments on these.

Sanctions: a decision on possible sanctions and/or penalties has yet to be reached. The Scottish Government invites, through the consultation, suggestions on possible sanctions for non-compliance with a duty of candour.

Implementation and delivery plan

15 October 2014 - 14 January 2015

• Consultation launch
• Publication of Partial BRIA & EQIA with consultation document October 2014
• Engagement with stakeholders including health professionals, health boards, care home providers

• Post-implementation review
  Any review process will be considered as the legislation is developed.

Summary and recommendation

Option 2: to Introduce a Statutory Duty of Candour for Health and Social Care is the Scottish Government's preferred option. The Scottish Government is committed to improving the quality of all health and social care. This includes ensuring a culture in which staff are supported to report incidents where harm may have been caused. The statutory duty will complement the existing professional responsibilities of healthcare professionals. It will provide the structures in which staff can be supported to give clear explanations of events to patients/clients/carers and support providers to use the lessons learned.

• Summary costs and benefits table
  This information will be detailed in the full BRIA and financial memorandum that accompanies detailed proposals.

Declaration and publication

I have read the Business and Regulatory Impact Assessment and I am satisfied that, given the available evidence, it represents a reasonable view of the likely costs, benefits and impact of the leading options. I am satisfied that business impact has been assessed with the support of businesses in Scotland.

Signed:

Date: 13 October 2014

Minister's name Michael Mathieson
Minister's title Minister for Public Health

Scottish Government Contact point: Craig White, Divisional Clinical Lead,

The Quality Unit

EQUALITY IMPACT ASSESSMENT

The purpose of carrying out an Equality Impact Assessment is to aid the Scottish Government in discharging its Public Sector Equality Duty under section 149 of the Equality Act 2010. The Scottish Government is required to assess the impact of applying a new or revised policy or practice against the needs in the public sector equality duty - to eliminate unlawful discrimination, to advance equality of opportunity and to foster good relations.

The protected characteristics that must be profiled against the policies are:

Age
Sex
Pregnancy and maternity
Disability
Race
Religion or belief
Gender Reassignment
Sexual Orientation

To help inform our Equality Impact Assessment of the policy proposals to reform FAI legislation, it would be helpful if you could answer the following question.

Please tell us about any potential impacts, either positive or negative, you feel any or all of the proposals in this consultation may have on a particular group or groups of people.