6. Communication and Engagement
173. Communication and engagement issues related to the escalation of the Health Board were extensively discussed in the Interim Report, and findings and recommendations were put forward (and set out again in the Summary above). The Final Report is considering another dimension of communications and engagement in the context of the infections: the Health Board's responsibilities (and duties) to review incidents where death or harm has occurred or could result from incidents.. Engagement is not simply about communications during an incident, but how the Health Board had reviewed what happened, its own actions and how patients and families are involved in such reviews of contributory factors. As the Scottish Government's guidance on the organisational duty of candour notes:
"Openness and honesty should be central to the actions of those providing care to others. It should be at the heart of every relationship between those providing, receiving and/or experiencing treatment and care. Trust and effective communication can be difficult to maintain and easy to lose when things have gone wrong."
174. The Oversight Board has a particular focus on the organisational duty of candour with respect to the infection incidents. Parents of some affected children and young people expressed concerns about the Health Board's duties and commitment to a person-centred approach to decision-making on reviews and the associated involvement, engagement and support provided to the children, young people and families through very difficult circumstances. It is important to understand how the Health Board deployed other review processes during these infection incidents, notably Significant Adverse Events Review and Mortality and Morbidity Reviews. They all form a critical part of NHS Scotland's strategic commitments to quality and improvement, both reflecting statutory and strategic obligations set out in underpinning legislation for NHS Scotland.
6.1 Organisational Duty of Candour
175. The organisational duty of candour procedure is a legal duty to support the implementation of consistent responses across health and social care providers where there has been an unexpected event or incident that has resulted in death or harm, or could result in death or harm, that is not related to the course of the condition for which the person is receiving care. Provisions in the Health (Tobacco, Nicotine etc. and Care) (Scotland) Act 2016 and the Duty of Candour Procedure (Scotland) Regulations 2018 set out the procedure that organisations providing health services, care services and social work services in Scotland are required by law to follow when such an incident has occurred. The provisions were enacted on 1 April 2018, and applied to information considered about earlier incidents that became available after enactment. Guidance setting out how those provisions should be implemented was published in 2018.
176. The organisational duty of candour legislation places a legal requirement on health and care providers, including Health Boards, to: review certain types of adverse events; meet personally with those affected to provide an account of the incident; provide an apology on behalf of the organisation; and provide an explanation of the actions that the organisation will take as part of the procedure. Under the duty of candour legislation, organisations must provide their employees with details of any services or support which may be able to provide assistance or support, taking into account the circumstances relating to the incident. Furthermore, organisations must provide patients and/ or their families with details of needs-based services or support, and through meetings and discussions, organisations should determine the impact of the incident on their health and wellbeing.
177. Organisations are required to apologise and to meaningfully involve patients and families in a review of what happened. When the review is complete, the organisation should agree any actions required to improve the quality of care, informed by the principles of learning and continuous improvement. They should tell the person who appears to have been harmed (or those acting on their behalf) what those actions are and when they will happen.
178. Given the vulnerability of the patient group who experienced these infections, the organisational duty of candour would be a highly relevant consideration here. It was actively considered by NHS GGC with respect to patients of the paediatric haemato-oncology service during the period under review. However, it was not formerly activated for any of the specific instances of infection, a concern raised by some of the families.
179. The decision not to activate was in line with NHS GGC policy in support of the organisational duty of candour, which the Oversight Board reviewed. However, the Health Board's policy does not fully reflect the legislation and guidance – primarily in respect of the reliance placed upon harm being viewed to be avoidable and/or related to acts of omission/commission by the organisation. It was focused on the concept of a 'patient safety incident' – which is not a concept set out in the legislation – and did not fully consider the legislative requirement to consider an unintended or unexpected incident that could result in harm (including actual or potential psychological harm). By this definition, a number of the incidents under review were clearly within the scope of the organisational duty of candour.
180. Work on developing how the organisational duty of candour should be implemented in relation to HAI had been initiated by ICDs in NHS GGC. This had identified the need for further action to consider complex interactions relating to the professional duty of candour obligations of clinicians, the organisational duty of candour and balancing related organisational duties relating to confidentiality. NHS GGC should identify the further actions required to address the issues identified by the Oversight Board relating to HAIs and organisational decision-making where concerns are expressed in respect of balancing organisational duties on candour and confidentiality.
181. While implementation of the organisational duty in these circumstances has particular challenges, it is clear that the legislation does not require a view on causation to be determined in deciding whether to activate the duty. This includes provision for unexpected or unintended events that have resulted or could result in outcomes included in legislation (including increases in treatment) to activate the relevant procedures. National work is progressing on this issue, and some of the issues faced by the Health Board are likely shared by other Health Boards. This work should inform the continuing improvement of the Health Board's policy, but steps should be taken sooner to address the issues set out here.
6.2 Significant Adverse Events Review Policy
182. In the complex systems and practices that underpin much of health and social care, adverse events can be expected to occur, despite the continuing efforts of staff and organisations to provide safe care. When such events do take place, it is essential that those affected most by those events – particularly patients and families – are given the opportunity to understand how they came about. It is equally essential that such events become opportunities for reflection to ensure that there is learning and improvement as a result.
183. For that reason, there is a national approach to reviewing significant adverse events across NHS Scotland. Guidance is provided through the National Framework by HIS, ensuring consistency in how they are conducted, recorded, how they are communicated, and how learning can be gathered and disseminated. As the Framework notes: "the national approach seeks to ensure that no matter where an adverse event occurs in Scotland: the affected person receives the same high quality response, organisations are open, honest and supportive towards the affected person, apologising for any harm that occurred."
184. Within NHS GGC, judgements are made on a case-by-case basis. For the patients affected by infection in the paediatric haemato-oncology services, incidents were reviewed by the local clinical teams as well as retrospectively by senior medical colleagues in a few instances.
185. NHS GGC recently updated its policy on how to handle these events in August 2020 (when it was approved by the Board). HIS was commissioned by the Oversight Board to review this policy in line with national guidance as part of its focus on communication and engagement issues.
186. The HIS review found that the revised policy was generally in line with national guidance. The definition and categorisation of adverse events was appropriate, and the system for conducting a review and reporting to the right parts of the governance structure were clear. Overall, the policy was robust, though there were areas of improvement that were highlighted, and which the Oversight Board recommends the Health Board addresses in reviewing its policy.
- The NHS GGC policy states that there is no requirement for the investigation team to be independent of the service in question. HIS recommends that this wording be reviewed in line with the National Framework which states that "the review team should be sufficiently removed from the event, have no conflict of interest (real or perceived) to be able to provide an objective view". It may be difficult to find the expertise to review cases appropriately in some smaller specialties – including the paediatric haemato-oncology service – but it remains important for Health Boards to strive actively for independence and objectivity as much as is possible.
- The involvement of patients and families in the process should be set out more clearly and explicitly. In particular, it would be helpful to include information in the policy about how patient/family feedback can be used to develop and improve the process. Moreover, families need to be clearly involved in the reviews.
- Further work in relation to assurance of the policy through clinical governance and committees/groups is worth testing to ensure that the right learning and communication to families is being undertaken.
- The language of adverse events is slightly out of alignment, in that NHS GGC refer to 'serious events', rather than the national practice of 'significant events', as instructed by the Cabinet Secretary for Health and Sport. This presents some scope for confusion given the mobility of patients and staffs across NHS Scotland.
6.3 Mortality and Morbidity Reviews
187. Mortality and Morbidity Reviews are key opportunities for learning from experience. In the Mortality and Morbidity Practice Guide produced by HIS, it states that such a review can be:
"a unique opportunity for caregivers to improve the quality of care offered through case studies. They provide clinicians and members of the healthcare team with a routine forum for the open examination of adverse events, complications, and errors that may have led to illness or death in patients."
They provide a systematic means to reviewing patient deaths or care complications with a view to improving patient care and professional learning. As has been stressed throughout the Oversight Board's reports, the complexity of the challenges arising from the infection incidents has given significant opportunities for such learning to be gathered.
188. Seventeen of the 19 cases examined in the Case Note Review were subject to the Morbidity and Mortality review process within NHS GGC. The other two cases were not reviewed locally as the patients had died in other Board settings – but in 2018, the review team changed its process so that all such cases would be discussed going forward.
189. NHS GGC has a number of key documents to support mortality and morbidity reviews. These include the following guidance and practice materials:
- Guidelines for Morbidity and Mortality Review Meetings;
- GG&C M&M Review Process;
- Morbidity and Mortality Meeting Analysis Prompts; and
- Morbidity and Mortality Principles for Practice/Code of Conduct.
190. NHS Education in Scotland (NES) was commissioned by the Oversight Board to review the Board's key documents against national practice guidance (though not the individual cases here). Overall, the NES review concluded: "the guidance content and learning approach advocated are good and are to be commended." Indeed, the Health Board demonstrated that "the importance of these meetings and processes in contributing to effective governance and improvement in care." Where comments were made, they were with a view to improving the approach in NHS GGC.
- In line with modern safety science approaches, it is advised that the concept of 'systems thinking' should be more explicitly incorporated within the guidance. The visible aim should be to better support recommendations for improvement of patient care and working practices at the systemic level rather than simply the individual level – in other words, individual actions and performance should not distract from opportunities for learning across the wider organisation.
- Given the time available, the selection of cases for review at meetings should arguably be informed by the greatest potential for learning and improvement – indeed, 'near-miss' events can often be overlooked but be equally and sometimes more important.
- Consideration should be given to weekly one-hour meetings to support up-to-date review of cases (including what works well and how it can be shared) and prevent backlog.
- Whilst the guidelines are noted for Morbidity and Mortality Review Meetings, there can be further emphasis in describing how these meetings are integrated into NHS GGC's wider governance process. Greater visibility of the learning arising from these meetings – particularly for the wider organisation – should be considered for relevant clinical oversight committees within the Health Board, with a particular view to considering standardising their format.
191. The Oversight Board also notes the Case Note Review comments on these Reviews with regard to infection incidents.
"The Paediatric Haematology Oncology service should ensure that Morbidity and Mortality reports are not restricted to a review of patients who die. Future Gram-negative environmental infections should be used as a trigger for an M&M (Morbidity and Mortality) review."
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