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

CHAPTER 3: Disclosable events

9.1. In order for organisations to implement effective arrangements for disclosure of episodes of harm, they need to be clear about the definition of harm that will be used to decide when disclosure is appropriate. The statutory duty of candour legislation would include a nationally agreed definition of the types of harm that would trigger the organisational duty of candour. These definitions need to be developed and informed through dialogue with health and social care professions, taking due recognition of the different context, nature and requirements in health and social care settings.

Definitions of Adverse Events Resulting in Harm

9.2. In healthcare, the National Framework for Adverse Events has proposed that it is possible to define episodes of harm considering events in accordance with the impact on the person who has experienced the event. The following definitions were proposed:

9.3. Category I - Events that may have contributed to or resulted in permanent harm, for example death, intervention required to sustain life, severe financial loss (£>1m), ongoing national adverse publicity (likely to be graded as major or extreme impact on NHSScotland risk assessment matrix, or category G, H or I from National Co-Ordinating Council for Medication Error Reporting (NCCMERP) index).

9.4. Category II - Events that may have contributed to or resulted in temporary harm, for example initial or prolonged treatment, intervention or monitoring required, temporary loss of service, significant financial loss, adverse local publicity (likely to be graded as minor or moderate impact on NHSScotland risk assessment matrix).

9.5. These definitions rely on reference to the NHSScotland Risk Assessment Matrix and NCCMERP Index. These definitions are wider in scope than that proposed for the new legislation, for example an 'Extreme' event in the Risk Assessment Matrix would include an event that attracted national media coverage - which may not necessarily reflect that there had been an episode of physical or psychological harm. Equally these definitions may not work intuitively for social care provision.

9.6. It is recognised that there is not a consistent approach to definition of what constitutes an adverse event where disclosure should take place. We have also recognised that each instance must be considered on its individual merits, taking account of the specific clinical and care elements of individual care episodes.

9.7. Organisations would require to demonstrate through their reporting that they have arrangements in place to consider events in relation to the agreed definition of physical or psychological harm, and that when they have determined harm has not occurred the decision-making process that has informed this decision.

9.8. The issues that will need to be taken into account in considering what constitutes a disclosable event are outlined in this chapter. This will need to encompass the different contexts that influences safety and harm incidents within health and social care services.

Disclosable event

9.9. Disclosable events would be defined as unintended or unexpected event that occurred or was suspected to have occurred that resulted in death, injury or prolonged physical or psychological harm being experienced by a user of health and/or social care services.

9.10. Disclosable events in relation to health care would involve the death of someone receiving care where the death relates to the event itself (as opposed to the natural course of their illness or underlying condition).

9.11. Events involving harm that involve the permanent lessening of bodily, sensory, motor, physiological or intellectual functions (including removal of the wrong limb or organ or the occurrence of brain damage) would be disclosable.

9.12. Returns to surgery, an unplanned re-admission to hospital, a prolonged episode of care, extra time in hospital or as an out-patient, cancellation of treatment or transfer to intensive care should also be included within the scope of events that result in harm.

9.13. Prolonged pain and prolonged psychological harm also needs to be taken into account when framing definitions (e.g. prolongation for a continuous period of 28 days).

9.14. The shortening of the life expectancy of someone using social care services would be disclosable. If a user of social care services required treatment by a healthcare professional in order to prevent death this should come within the scope of the duty to disclose. The occurrence of an injury that, if left untreated would lead to death, impairment, harm or shortened life expectancy would also be within the scope of disclosable events for social care providers. This would not include a shortening of life expectancy as a result of a long-term condition where this is an expected outcome.

9.15. Children's social care services, alongside keeping children safe, are primarily focused on a child developing as well as it can and reaching his or her full potential. Decisions taken to that effect, such as taking children into care, may have unintended consequences, though it may not always be possible to attribute trauma to any particular action.

Question 6a: Do you agree with the disclosable events that are proposed ?

Question 6b: Will the disclosable events that are proposed be clearly applicable and identifiable in all care settings ?

Question 6c: What definition should be used for 'disclosable events' in the context of children's social care?

Question 7: What are the main issues that need to be addressed to support effective mechanisms to determine if an instance of disclosable harm has occurred ?