1.1. This consultation invites views on proposals to introduce legislation that will require organisations providing health and social care in Scotland to tell people if there has been an event involving them where the organisation has recognised that there has been physical or psychological harm as a result of their care or treatment.
1.2. "Transparency - especially when things go wrong is increasingly considered necessary to improving the quality of health care. By being candid with both patient and clinicians, health care organizations can promote their leaders' accountability for safer systems, better engage clinicians in improvement efforts, and engender greater patient trust"
1.3. However barriers to being open after serious safety incidents have been identified to include fear, worry, embarrassment and lack of institutional support.
1.4. Although much of the international evidence and current practice in this area has focussed on health services, it is proposed that in Scotland this duty will apply to providers of both child and adult social care services as well as health services.
2.1. The Berwick Report emphasised the importance of the requirement that people affected by serious incidents should be notified and supported.
2.2. 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. However, it has been recognised that as few as 30% 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.
2.3. Improvements in arrangements to support the disclosure of harm, is a key element supporting a continuously improving culture of safety. There are several healthcare systems and organisations worldwide that have introduced initiatives or arrangements to support open disclosure of harm. For example:
- In early 2002, the Michigan Healthcare System changed that way that it responded to instances of patient harm and injury. The public declaration on the requirement for honesty and transparency was subsequently associated with a steady reduction in the numbers and costs of clinical claims being made. When claims were made, the time taken for processing or settlement of such claims was reduced. It has been suggested that this may also impact positively on psychological and physical recovery.
- The Australian Healthcare System has a National Open Disclosure Standard that requires all adverse incidents to be disclosed.
- In the USA, Baystate Health and the Veterans Health Administration are two further healthcare systems who have implemented systems that required disclosure.
2.4. 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. The duty of candour will also apply to adult social care services in England from April 2015.
2.5. We want 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 resulting in harm. It will also require training and support to be provided for staff involved with disclosure and support to be available to people who have been affected by an instance of harm.
2.6. The introduction of a statutory duty of candour would support a move toward a planned, co-ordinated and consistent approach that supported respectful disclosure of episodes of harm. This is a central element of good practice for adverse event management. Research in this area has identified that there is a gap between that which is regarded as good practice in respect of disclosure and reality. Statutory reform has been recognised as an important element that is likely to support improvements.
2.7. Any new duty will need to be reflective of and aligned with existing disclosure requirements. For example, social care services already work within a framework where statutory reporting requirements (e.g. for child protection, vulnerable adults) necessitate reporting of harm episodes. In addition people accessing social care services tend to have established longer term relationships with professionals that support candour in practice.
2.8. It has been recognised that disclosure of harm requires advanced communication skills. 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. The content of these programmes is equally relevant and applicable to other care professionals.
2.9. Healthcare professionals have raised concerns that schemes supporting disclosure may undermine their professionalism. Others have expressed concerns that introduction of requirements for candour to legislation would cause fear among healthcare professionals that would not be conducive to their work to improve the quality and safety of services. There are a range of factors that have been consistently shown to facilitate disclosure of harm and some that impede disclosure. The most commonly reported factors are outlined below:
Known Barriers to Disclosure
Culture of secrecy and/or blame
Lack of confidence in communication skills
Fears that people will be upset
Doubt that disclosure is effective in improving culture
Factors Facilitating Disclosure
Reduction re Risk of Claim
Factors Inhibiting Disclosure
Professional or institutional repercussion
Lack of confidentiality
Negative family reaction
3. Proposals in this consultation paper
3.1. 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 an organisational duty. The introduction of this duty will form a further dimension of the arrangements already in place to support continuous improvements in quality and safety culture across Scotland's health and care services.
3.2. This consultation paper invites views on proposals that are intended to support a consistent approach to disclosure of events that have resulted in physical or psychological harm to users of health and social care services. In particular the proposals build on the progress made through the implementation across NHSScotland of the 'Learning from adverse events through reporting and review: A national framework for NHSScotland' The testing that is currently ongoing within NHSScotland on 'Being Open' guidance is also likely to be helpful in framing stakeholder engagement and the further development of proposals. There are also elements of the review of significant case reviews in Scotland regarding disclosure and involvement of families that will inform the scope and detail of proposed legislation.
3.3. This paper has been divided into the following chapters:
Chapter 1 - Existing approaches regarding candour
Chapter 2 - Proposed requirements on organisations
Chapter 3 - Disclosable events
Chapter 4 - Monitoring of the statutory duty of candour
Chapter 5 - Responding to this consultation paper
Chapter 6 - The Scottish Government consultation process
Email: Professor Craig A White