4. Governance and Risk Management
102. In recent years, NHS Scotland has clearly articulated the principles and practice of good governance in Health Boards. In February 2019, DL (2019)2 was published, setting out requirements for Health Boards to adopt the Blueprint for Good Governance. The Blueprint drew on current best practice to ensure all Health Boards assessed and developed their corporate governance systems. As the Blueprint described: "Good governance is essential in addressing the challenges the public sector faces and providing high quality, safe, sustainable health and social care services depends on NHS Boards developing robust, accountable and transparent corporate governance systems."
103. Amongst other responsibilities, good governance should:
- identify current and future corporate, clinical, legislative, financial and reputational risks; and
- oversee an effective risk management system that assesses level of risk, identifies mitigation and provides assurance that risk is being effectively treated, tolerated or eliminated.
This is reflected in the responsibilities of individual Board Members, which include:
- providing effective scrutiny, challenge, support and advice to the Executive Leadership Team on the delivery of the organisation's aims, objectives, standards and targets; and
- contributing to the identification and management of strategic and operational risks.
104. The principles outlined above are clearly essential with respect to IPC issues. In order for the Oversight Board to address one of its key questions – is the governance structure adequate to pick up and address infection risks? – it was necessary to consider how infection management and risk was addressed by the Health Board. Against this baseline of the Blueprint, the following sections in this chapter review:
- the framework for governance around IPC – in effect, how the system was set out 'on paper';
- how that system worked in action, by examining key incidents in this period of escalation; and
- how the risks around these infection incidents were captured and managed.
4.1 Principles of Governance and Risk Management for Infection Prevention and Control
105. It is vital for a Health Board to have a clear description of its governance and risk management. Such a description should not be expected to be static, but adapting to improve practice within a clear governance and assurance structure. Before examining whether NHS GGC practice in governance and risk management met national expectations in the context of these infection incidents, it is important to consider how the Health Board articulated its approach to management and escalation of incidents in general.
106. In implementing the Blueprint for Good Governance, NHS GGC explicitly set out its principles in the Governance and Quality Assurance Framework for Infection Prevention and Control Services (described in more detail in the box below). Moreover, the approach to IPC sits within a wider, robust approach to governance and risk management. Within NHS GGC, assurance on the structure of governance and risk has been actively sought by the Board: it has been reviewed by external organisations (such as Price Waterhouse Cooper and Scott Moncrieff).
Governance and Quality Assurance Framework for Infection Prevention and Control Services
NHS GGC's Governance and Quality Assurance Framework for IPC Services brought together a number of earlier documents to provide a complete statement of responsibilities and checks on IPC within the Health Board. It described how the Board sets and delivers its strategic aims, the risk management process and how it gives stakeholders and the public assurance that the service is delivering for patients, staff and the organisation. It also described how the Board uses information from the point of care to the NHS Board to improve outcomes for patients and how it reports incidents and outbreaks that may affect the health of patients, staff or visitors.
The framework clearly set out the role of the Chief Executive of the Health Board, which is to ensure that there is successful prevention and control of infection throughout the NHS Board area. The accountabilities of this role are outlined in the Healthcare Improvement Scotland Standards for HAI and have been further emphasised within the NHS HIS report on the second review of these standards. The framework included details on the structure and responsibilities of key elements of the governance structure and how escalation should take place, including: IPC Senior Management team; the sector-based IPC teams the NHS GGC Board Infection Control Committee; and the Acute Infection Prevention and Control Committee.
107. The Oversight Board welcomes the creation of this Framework document. The Framework has not yet been published, and has been maintained in draft form – 'version 5', dated November 2019, was shared with the Oversight Board and was clearly a work in progress. The document should be finalised as soon as possible and published to support transparency in the governance of IPC.
108. The IPC and Governance Subgroup reviewed the document. It found that IPC issues and escalation would be treated in the Health Board with clear lines of responsibility through the ICM through the HAI Executive Lead to the Chief Executive. In terms of Committees, the structure is also clear and logical, and there is evidence that it has been used appropriately throughout this period. In particular:
- Infection incidents (including actions taken) have been reported to the Acute Board Infection Control Committee (which has responsibility for supporting local infection control teams in their responsibilities and reporting upwards on IPC issues that have wider implications), and then onto the Board Infection Control Committee (chaired by the Medical Director, and which provides leadership and support to the IPC services 'from ward to Board').
- The Board Infection Control Committee has reported directly to the Chief Executive, and the Board Clinical Governance Forum, and regular HAI reports have been provided to the Board.
109. In addition, incidents have been reported through the Clinical and Care Governance Committee, which reports directly to the Board. Handling of infection incidents are relevant to the Committee, not least in the context of its remit to "ensure the clinical and care governance arrangements are effective, including interactions with other organisational arrangements, in improving and monitoring the quality of clinical care" and "provide assurance to the Board that NHS GGC meetings its statutory and mandatory obligations relating the NHS Duty of Quality". In effect, it allows an additional line for key incidents, risks and their handling to be addressed within the Health Board.
110. The IPC and Governance Subgroup did make a number of recommendations about this document which should be included as part of a final revision of the Framework.
- There is no mention of how IPC should be 'everyone's responsibility', a clear theme of the recent Silver Command work. It would be useful to see the service leads, senior managers and other key roles mentioned in terms of responsibilities for IPC.
- While escalation from the IPC Team is clearly described, there would be value in describing how escalation should take place within the Team as well.
- The role of Infection Control Nurses should be set out in the context of the full description of responsibilities.
- The IPC Senior Management Team would benefit from a clear description of the involvement of the Lead ICD and the new role of Director of IPC.
- Routine reporting of IPC activity and incidents/outbreaks should be explicitly set out, rather than just the escalation of issues.
- The document should be clear about other key links, particularly between the IPC Team and the Board Infection Control Committee with other key groups/functions, including the Water Safety Group, Decontamination Committee, Facilities and Cleaning, Built Environment and Ventilation.
- Linking with the discussion of how national IPC standards and practice are reflected in the Health Board, the Framework would benefit from a clear designation of responsibilities for monitoring and overseeing compliance with what is set out in the National IPC Manual, not least with respect to the IPC Team.
- The issues relating to how infection risks are captured as part of the Health Board's approach to risk management are detailed further below.
- As noted earlier, the Oversight Board believes governance would be strengthened if HAI Executive responsibilities for IPC were concentrated in a new permanent post (potentially the proposed Director of IPC). That individual should be clearly given the responsibility for overseeing the implementation of the Framework and any updating of its contents.
111. As part of the Gold Command work put in place by the Chief Executive, there has been recent review and revisions to the governance framework. These are set out in Annex E, and show how the Gold and Silver Command programmes of work fit into the IPC governance and assurance framework. The Oversight Board supports the changes and the new structure.
112. This structure has allowed for infection issues to be highlighted in a number of different places and for action to be taken and monitored, before being brought ultimately (and as appropriate) to the full Board to act in its role of providing assurance that the right steps have been taken. The Oversight Board found significant evidence that infection incidents were regularly brought before the relevant Committees, particularly from the 2018 'water incident' onwards. As the Executive lead on IPC for the Board, the Medical Director actively led on the reporting of infections to these Committees, and indeed the full Board itself. HAIRTs (and outbreak reports) were systematically provided to the Board Infection Control Committee and the Board. The issues were clearly being made visible to senior governance as soon as their seriousness appeared to be recognised through IMTs.
113. This can be clearly seen in the meetings that took place in 2018. For example:
- the Board Infection Control Committee was informed at meetings on 28 March (including a paper discussing the water testing results and the draft terms of reference of the new Technical Water Group), 23 May and 25 July (when it was notified of the closure of the incident and the plans for widespread chemical dosing);
- the Clinical and Care Governance Committee was updated on the 'water incident' at its 12 June meeting through a paper that set out the incidents in wards 2A and 2B, the steps taken to address and the risk of wider water contamination, and the closure of the incident at its 4 September meeting; and
- the full Board was appraised of the incident and developments on 17 April, 19 June and 21 August – as noted in the 19 June minutes:
"Dr Armstrong advised that following the bacteria in the water system incident at Queen Elizabeth University Hospital (QEUH) and the Royal Hospital for Children (RHC), a number of immediate actions had been undertaken to address the issue including domestic cleaning, cleaning of equipment, hand hygiene, the installation of end of tap filters and the installation of new drain spigots. The longer term plan was to chemically dose the water supply and then replace taps in high risk units."
In addition, the full Board received a regular update on infection matters via the Medical Director's HAIRT reports.
4.2 Key Incidents in Escalation
114. The Blueprint emphasises an active role in good governance for senior leaders to show prioritisation, challenge and assurance of what the organisation as a whole is doing. In the context of infections, this raises a series of fundamental questions: when did different parts of the relevant part of the governance structure know about the infections (and were these the right points for escalation); was their understanding of the implications of the infections (and any pattern) appropriate and timely; and did they provide the right challenge and enforce the right accountability about the actions being taken in response.
115. An important way to understand these issues is to review the organisation's response when evidence of potentially significant risks associated with the infections were appropriately raised in line with guidance and good practice. It is important to acknowledge that the infection issues presented a complex, not easily comprehensible set of challenges, though that complexity was itself a risk that was not captured in risk registers. Over the period under review, there were a myriad of meetings and issues that can be traced in terms of incident response and review. To illuminate the effectiveness of governance, the Oversight Board has examined a handful of key points in that period in greater detail. Significant shortcomings of governance at these points would raise critical issues about governance as a whole in the context of the escalation of the Health Board to Stage 4. In effect, the test is whether these specific issues, once identified by staff (or raised by families), were reviewed and, given their significance, escalated, scrutinised and acted upon appropriately at the right level of governance.
116. The Oversight Board considered several relevant instances in the period under review:
- the 2015 DMA Canyon water testing report (one of the clearest early indications of potential water contamination);
- the October 2017 SBAR by a number of clinicians and microbiologists at the QEUH (the point at which a number of concerns about environmental risk were formally raised);
- the development of the 'water hypothesis' through IMTs and the Technical Water Group in 2018 (the point at which an understanding of environmental risk prompted a range of major actions by the Health Board, including installation of a comprehensive water dosing system); and
- the decision to de-cant Wards 2A and 2B in 2018 (a major milestone in how the issues were addressed, with huge implications for the affected children, young people and families).
2015 DMA Canyon Report
117. In April 2015, a water specialist consultant (DMA Canyon Ltd) undertook a water risk assessment of the QEUH for the handover of the water system, with a particular focus on the risks associated with Legionella. The report highlighted a number of significant concerns with the system at that point, including temperature control of the water system, installation of flexi-hoses (and the risks associated with bacterial growth) and the lack of effective management, notably with respect to the communication and control of contractor activity at the point of handover. The risks clearly had significant implications for IPC within the new hospital complex, and given the serious issues outlined, it would have been expected to have not only been actioned 'locally' but that higher levels of governance would have been alerted in line with the principles of the committee structure and infection risk management set out above. Indeed, it is exactly the kind of scenario that the governance/risk management structure for IPC was designed to address to ensure that relevant action and assurance is taking place within the Health Board.
118. The report was an internal Health Board report, commissioned of an external company, and was not disclosed publicly until November 2019. What was a particular concern was the absence of action on this report until 2018 – indeed, the lack of record of how the report was received and considered. Action was not taken within the Health Board on the report between 2015 and 2018, and that the report was not considered by the relevant committees. It did not seem to have been brought to the attention of relevant staff within IPC, particularly through the relevant IMTs through 2018. Indeed, when the external company undertook a follow-up report in 2017, the same issues and recommendations – and similar high risks – were identified.
119. The Oversight Board understands that the reports only 'surfaced' as part of the review of historical documentation to be provided to HPS and HFS for their reviews of water system and infection issues in March 2018. At that point, the Health Board took rapid action with an action plan drawn up and monitored to address the specific issues set out in the reports, as well as an internal investigation into how the report had not been picked up before. Mitigating actions to address both 2015 and 2017 reports were subsumed within action plans addressing issues arising from the HPS reports (and as of September 2019, had all been completed).
120. While it is clear that these reports were taken 'seriously' at that stage – admittedly in the context of more recent assessments and surveys of water issues, such as the HPS and HFS reports – it was not clear to the Oversight Board the extent to which the implications for governance were shared with IMTs or discussed by the relevant committees, although an internal review was conducted by the Health Board in 2018 on what had happened to the 2015 report (and later in 2018, a new SOP was introduced on how to handle DMA reports). Moreover, issues of transparency remained even on the 'discovery' of the reports during 2018, as the Oversight Board understands that the reports were not shared with relevant IPC staff and microbiologists or IMTs at that stage– somewhat surprising given that the reports were provided to the external review bodies, HFS and HPS. As the contents of the report seemed directly relevant to considering the source of infections during 2018, this apparent omission raises questions about the rationale for withholding this material and what consideration was given to the implications for IPC staff and microbiologists to fulfil their responsibilities for patient safety and care.
121. The Independent Review has addressed the issues with respect to the handover of the building following completion of work, and so this aspect of this issue is not reviewed by the Oversight Board. Nevertheless, the receipt of the 2015 DMA Canyon report should have alerted senior management within the Health Board at that time to the fact that there were potentially serious issues with the water system with respect to infection risks. The report seemed to be lodged within the Facilities and Estates service at a local level and not properly considered, nor was it escalated through the appropriate governance. The failure was a local one and relevant managers – not least in IPC – did not seem to have been made aware of the report.
122. Such reports would not normally be considered by the higher levels of governance; there were intended to be considered and acted upon by those with local operational responsibilities. However, that failure to consider and act should have been a matter of concern at different levels of governance when the reports came to light. While the steps to redress that operational failure within Facilities and Estates were monitored appropriately in the Health Board – notably by the Facilities Planning and Performance Committee – a more systematic questioning of how such relevant environmental information was being conveyed within the organisation (and indeed, escalated) seems warranted, but absent. In essence, this can be characterised by the question: was the right information being provided to the right point in the governance of IPC to allow assurance to take place?
123. The failure in governance is a significant oversight. Wider awareness and consideration of the 2015 report – in conjunction with the issues raised by a number of staff, as described below – would most likely have raised the level of urgency around potential environmental risks at an earlier stage and more forcefully. It would have presented a different context to the isolated infection incidents that occurred before 2018 and may have resulted in preventative course of action being pursued earlier.
124. While the failure to escalate the reports may have largely arisen from limited, and by now, historical, weaknesses in Facilities and Estates, the later discovery of the reports should have prompted more formal and visible reflection by relevant committees, and indeed, by the full Board itself. As noted, the Chief Executive commissioned a series of reports as part of a review of a number of concerns at the QEUH, which were presented to the full Board in December 2019 – an exercise that the Oversight Board commends. However, a 'lessons learned' exercise that ensured all the key failures in governance related to the 2015 DMA Canyon report had been identified and addressed has not taken place, not least the impact of not being pro-active in sharing the reports with relevant services internally. There is a need for such learning to be transparent and comprehensive to provide suitable assurance about appropriate information sharing and escalation.
2017 SBAR on Potential Environmental Risks
125. From before the formal handover of the new building, concerns had been raised by some clinicians about emerging environmental risks arising from its design and construction. The history of concerns – particularly among microbiologists at the QEUH – is not detailed here, but provides an important backdrop to the second spotlight incident considered in the context of governance: the October 2017 SBAR. While the raising of concerns was not new, the manner in which it was raised and considered within IPC governance was.
126. This SBAR was produced by several clinicians and microbiologists in the QEUH at the request of the Medical Director. It drew attention to a range of risks to patients arising from infection control issues in the hospital. The issues were drawn from discussions with colleagues as well as weekly meetings among the consultants. They included:
- delays and scope of water testing;
- lack of consistent reporting of sewage leakage issues (in the Institute of Neurosciences and Spinal Unit);
- lack of remedial action to address inadequate decontamination facilities in paediatric and adult respiratory clinics;
- the insufficient standard of the Positive Ventilated Lobbied rooms, as they did not provide appropriate airborne protection to patients and the absence of HEPA filters in key locations, as well as other ventilation issues;
- concerns around some cleaning arrangements;
- roles within the IPC team being unclear, including ICDs not being informed of HAI-SCRIBE meetings and incidents in a timely manner; and
- lack of resources to investigate infection outbreaks, and a particular gap in experience and knowledge arising from the then-Lead ICD's absence at the time.
The SBAR was accompanied by several clinicians and microbiologists raising their concerns through Step 1 of the whistleblowing process.
127. In this instance, action was quickly taken. A meeting was held that same month with the Medical Director to discuss these concerns, and an action plan was produced. The action plan was ratified by the Clinical and Care Governance Committee at its 5 December 2017 meeting, demitted to the Board Infection Control Committee for ongoing oversight and noted by the full Board in February 2018. The Oversight Board has been informed that work has been substantially completed on the action plan, but the most recent version of the action plan seems to be dated to January 2019 (with several actions shown as still in progress); a further update (and closure) of the action plan should be put forward and reviewed by the Clinical and Care Governance Committee.
128. It is unclear how (and indeed, whether) all of the original authors of the SBAR were fully engaged in the development of the action plan, as differing accounts were presented to the Oversight Board about the quality of this engagement. Nevertheless, the incident does show the Health Board taking action in response to the raising of concerns – even if the effectiveness of the response remains disputed –and appropriate governance being applied in that context.
Development of the 'Water Hypothesis'
129. The cluster of infection incidents in 2018 prompted a prolonged search for the sources of infection, drawing in concerns that had been raised by some clinicians and microbiologists previously and resulting in continuing debate and review of the overall environmental risks of the QEUH by the IPC service and microbiologists through 2019 to the present. This was not the first time a supposition of water contamination was considered within the Health Board, but the cluster brought a more sustained and widespread focus on water contamination as a potential source, and a move towards supplementing existing infection strategies focused on endogenous bacteria towards actions that targeted the environment, particularly the water system.
130. The earlier section on IPC discussed how an understanding of water contamination emerged and evolved through IMTs by 2018. This section focuses on how the implications of the 'water hypothesis' were considered within NHS GGC governance, not least as those implications had major consequences not just for the paediatric haemato-oncology patient group, but potentially the hospital as a whole. That the source of infections related to water was evident in the succession of hypotheses examined by IMTs and followed through with the actions, including the presence of biofilm in taps and other elements of water infrastructure and the testing undertaken by Intertek in 2018 on taps, sinks and drains in Wards 2A and 2B. However, the extent to which this contamination was lodged within the wider water system – and could have arisen from issues relating to building and handover of the hospital – remains a hypothesis over which different views continue to be held. As the Health Board set out for the Oversight Board: "after investigation, various hypotheses may be considered, with certain findings informing what might be considered the most probable source of contamination, but it is simply not possible to prove beyond doubt what the exact source might have been." Indeed, in its response to a series of questions on the environmental risks of the hospital, posed by families of paediatric haemato-oncology patients in July 2020 on the 'closed Facebook page' (which is described in more detail in the Interim Report), the Health Board cited the HPS reports not finding a single source for the infection and that any more systemic contamination of the water system had not been proven, as well as the Independent Review's overall conclusion that there was no conclusive evidence that failures of the environment could be directly attributable to deaths arising from the infection incidents. However, as the Independent Review also noted: "the design, construction, stewardship and early maintenance of the water system is of sufficient concern to make strong enough links, merit decisions and actions that have resulted in taking substantial precautionary measures to repair and replace parts of the water and drainage systems, maintain the water system with extra chlorination."
131. One important milestone was the HPS report in November 2019. The retrospective analysis of infection data by HPS has been seen by the Health Board as an important document in supporting the view that what was happening was not 'unusual' when compared to other hospitals. Of course, the report would not have directly influenced actions being taken or analysis by the Health Board before that date. However, it has been cited as supporting the Health Board view about assumptions about what might be taking place in the QEUH and RHC.
132. In October 2019, HPS was asked to provide independent support to review the data being used to inform their risk assessment and decision making in relation to Wards 6A and 4B at the QEUH and RHC. This request resulted in the HPS report, 'Review of NHSGG&C paediatric haemato-oncology data'. The report concluded that there was no evidence of a single point of exposure causing the bloodstream infections. For the period June 2015 to September 2019 as a whole, it compared the rate of positive blood cultures with those in two other hospitals – the Royal Aberdeen Children's Hospital (NHS Grampian) and Royal Hospital for Sick Children (NHS Lothian) – and found that there was no difference in the rates of the Gram-negative group. Moreover, internal work was done to examine infection rates and was presented to the December 2019 meetings of the Clinical and Care Governance Committee and the Board, concluding that: "in the last year following the move to QEUH (October 2018 – September 2019), there was no difference in the rate for Gram-negative group, environmental including the enteric group or environmental group [and] no single source of 'exposure' to specific micro-organisms which may cause infections had been identified across the six year period." At that Clinical and Care Governance Committee meeting, it was concluded that infection rates were within range or better than other Health Boards, and that the steps being taken had been sufficient.
133. However, the Oversight Board does not believe the HPS analysis demonstrates that there was nothing 'unusual' occurring with infection incidents in the RHC and QEUH. The report principally focused on a review of data quality and datasets. While it clearly set out some findings on comparisons with other hospitals, it equally caveated its work by noting the different sample sizes of the patient groups in each hospital (for example, the Aberdeen and Edinburgh hospitals did not have bone marrow transplant units in this analysis). There were numerous 'breaches' of the upper control limits, showing spikes in infection rates throughout the period. Ultimately, the report did not comment on the issue of water contamination, or offer a view about what kind of action should or should not have been taken in response to the infection incidents being identified.
134. Moreover, the Case Note Review – undertaken in parallel with this Oversight Board's work (and published at the same time) – concluded that there was a likelihood of links between infection and the environment in several cases. It found that 28 percent of the infection episodes it examined were 'probably' or 'strongly probably' linked to the environment, and a further 50 percent were 'possibly' or 'strongly possibly' so. This was on the basis of the existing documentation and case note files within the Health Board. Indeed, the Case Note Review concluded:
"We are surprised that the evidence for an excess of Gram-negative environmental bacteraemia in the Paediatric Haematology Oncology patients was challenged by some within the organisation. By 2018, we suggest that simple observation should have identified a disturbing pattern characterised by the occurrence of bacteraemias caused by some very unusual microorganisms and apparent clusters of some of those more commonly
encountered. The widespread contamination of the water system seems to have been accepted and NHS GGCs response, notably its decision to close and relocate an entire clinical unit in September 2018, must be interpreted as evidence of the organisation's acceptance that the environment presented a risk of serious infection to a vulnerable group of patients. Although the investigations undertaken to that date had failed to identify a single cohesive hypothesis for the origin of many of the infections, the approach taken to surveillance thereafter did not appear to match the severity of what had already occurred."
135. What this should demonstrate is the significant uncertainty that the Health Board faced in examining for a pattern of infection. The lack of a consensus view suggests that what may be more important in this context is the balance of risk and how that informs decisions, not certainty regarding source. Indeed, within the Health Board itself, grounds for urgency were being raised about the need to respond to the risks of water contamination. Clinical staff in the March IMTs were questioning whether the IMT was able to cope with the apparently escalating environmental risks. The 'water hypothesis' was being raised internally throughout 2018:
- On 23 March, the possibility of contamination of water points at the time of commissioning was explicitly noted by Facilities staff at the IMT meeting.
- On 28 March, the Board Infection Control Committee (minutes and special paper) noted the hypothesis that the problem could have originated in water outlet commissioning actions.
- On 27 April, the Acute Infection Control Committee noted the hypothesis that biofilm could have been present in the water system since the building's commissioning and dispersed by outlet flushing.
- By May 2018, in a paper to the Clinical and Care Governance Committee, IPC staff were highlighting that "it became evident from further water testing that the problem with water contamination was more extensive and involved both RHC and QEUH".
- On 21 August, the full Board was updated on the actions being taken and noted that a possible link to contaminated water system was made early in the incident.
Lastly, as well as the HPS February 2019 report, the accompanying HFS technical report – 'Water Management issues Technical Review: NHS Greater Glasgow and Clyde – Queen Elizabeth University Hospital and Royal Hospital for Children' – which was available in final draft by August 2018, noted the probability of a system-wide contamination of the water from 2015 onwards.
136. As has already been noted, significant action was being taken on what appears to be the presumption of widespread water contamination, notably the installation of point-of-use filters and the water dosing system. What is not apparent is any systematic investigation of the implications of the 'water hypothesis' for the hospital as a whole. While the introduction of point-of-use filters was applied to other vulnerable groups as well as the paediatric haemato-oncology group and water testing was conducted throughout the complex, the focus remained on addressing the immediate issues in the affected wards rather than a more comprehensive review of what this might mean to different parts of the hospital and different patient groups. The risk of water contamination has several different dimensions:
- clinical risk to the range of different patient groups (not just those in the paediatric haemato-oncology service);
- infrastructure implications, not just in terms of the short-term actions such as the use of filters, but wider ones about a programme of remedial work to identify and resolve problems through the hospital's water infrastructure;
- a thorough approach to water sampling and testing based on the water contamination risk;
- the financial and public assurance consequences arising from this; and
- the implications for staff working in such an environment and addressing patient and family concerns.
While many of these actions were taken forward, there did not appear to be a strategic overview that considered all these risks and responses to water contamination as a whole, not least their inter-dependencies. Such an approach would have necessarily spanned the whole governance framework of the Health Board.
137. This kind of approach was not being requested of the Health Board by those working with it nationally, but it seems equally clear that it was not actioned internally. Throughout the period, the governance system was active in addressing and containing the individual incidents, taking impressive actions of redress, but there did not appear to be consideration of the wider risks that the incidents suggested and which the succession of outbreaks demanded. It was not just a question of the 'long view' of the succession of incidents, but the 'wider view' of what that might mean across the Health Board's operations. Again, there is learning here not just for NHS GGC, but for all Health Boards.
Decision to De-cant Wards 2A and 2B
138. The decision to de-cant Wards 2A and 2B in 2018 remains one of the most significant actions taken by the Health Board in response to the series of infection incidents. Moving children and young people into the QEUH building itself allowed substantial works to be undertaken on the RHC wards. To date, refurbishment work has not been completed and paediatric haemato-oncology patients continue to be treated in Wards 6A and 4C within the QEUH.
139. The decision was taken relatively quickly. At the Board meeting on 21 August 2018 and the Clinical and Care Governance Committee meeting on 4 September, the minutes do not show that there might be a need to de-cant, reflecting the understanding that the issues were under control following the closure of the earlier incident and the actions set in motion as a result. The de-cant took place on 26 September. How communication of the event took place with children, young people and families has already been reviewed in the Interim Report. The relevant wards were inspected and made ready for patients with a programme of repairs and full deep cleans. Weekly IMT meetings continued to monitor the de-cant, and no issues were initially raised about the move. An update on the de-cant was provided to the Board Infection Control Committee, where some concerns at the clinical risks of the move were expressed. The full Board was updated at its meeting on 26 October, where the decision to close the RHC wards was formalised.
140. The rapid decision and follow-up action here shows that NHS GGC was capable of responding quickly when urgent action was required. However, the move was not without its own series of risks, given that the children and young people were being transferred to wards that had not been specifically designed for their needs. While a risk assessment of different options was undertaken, concerns were brought forward by clinicians and microbiologists when a new series of infection incidents occurred in Ward 6A and a new IMT was established in June 2019. This led to a SBAR in August, produced by seven microbiologists, outlining a number of concerns including: issues about air changes and pressure; use of HEPA filtration; infection risks from chilled beam technology; existence of pathogenic fungi; exposure of the children and young people to unfiltered water; risk from toilet plume; the absence of 'solid' ceilings; and the lack of play area. This SBAR argued that what was originally considered a short-term de-cant had become longer term, owing to the greater scale of issues uncovered in the original wards as part of the refurbishment; as a result, it was necessary for a new, longer-term risk assessment and appraisal to be carried out of the 'temporary' wards, particularly 6A. Indeed, the SBAR concluded that this was a matter of significant public safety, as it concluded: "6A should be considered to have significant unacceptable levels of infection risk for the immune compromised patients due to the built environment."
141. What gives particular significance to the August 2019 SBAR was not just the number of microbiologists who set out their concerns, but the implications for NHS GGC senior managers of an argument that Ward 6A (in particular) was not a 'safe' place for this patient group. In many respects, the alternative choices facing the Health Board were more limited and stark than those in the original decision to de-cant from the RHC, so this provides a significant test of how the issues were assessed and addressed within the governance structure. While the evidence is strong throughout 2019 that there was considerable discussion and reporting of the measures being taken to mitigate the infection issues in Wards 6A and 4B, including discussions at the Clinical and Care Governance Committee and the Board itself (via the regular HAI reports), it is important to understand how these more fundamental concerns about the long-term appropriateness of the QEUH wards were being considered.
142. The issues and responses to the August 2019 SBAR was discussed at the first IMT meeting in September, but it was not clear what further action/consideration was to be taken forward. The Oversight Board was aware that several of the authors of the SBAR sought a formal response to their SBAR, but there is no indication that a formal action plan was created (or that the issues were incorporated into an existing action plan). Indeed, IMT minutes in September following the internal discussion on the SBAR's points held an action point for the IMT's views and responses to be communicated back to the authors of the SBAR; this was raised again at a subsequent meeting, where it was confirmed that such a response had been provided. Nevertheless, several of the SBAR's authors have reported that no such confirmation was made.
143. The Oversight Board is not aware that the issue was formally raised or discussed with any of the relevant committees/groups in the subsequent period. The December 2019 meeting of the Clinical and Care Governance Committee noted that whistleblowing concerns had been raised by some clinicians and microbiologists and noted that the relevant processes were being followed. It also set out actions that addressed some of the issues raised in this SBAR, such as cleaning focused on the chilled beams. The lack of clarity and formal recording of considering and acting on the SBAR is surprising in light of the continuing issues with infection at the QEUH.
144. Alongside these concerns about the appropriateness of Ward 6A for this vulnerable group of patients, there was internal speculation on why Gram-negative bacterium were continuing to appear despite the chemical dosing regime. Such actions can take significant periods of time to prove effective (and indeed levels of bacteria had reduced, as seen by the water testing results), but questions were raised about whether resistance to chlorine dioxide might be present. At its meeting on 16 July 2019, the Acute Infection Control Committee was informed that while the QEUH chlorination system had been fully fitted and Gram-negative counts had fallen, the mycobacteria issue had recently re-emerged despite the dosing. Such concerns posed risks to the strategy being pursued by the Health Board to addressing potential environment risks. On 29 July, similar concerns were noted at the Board Infection Control Committee, but no specific action seems to have been taken.
145. While such discussions may have taken place among senior managers, these risks do not seem to have been discussed at formal meetings. Instead, the emphasis seems to have principally been on assurance that immediate measures to address concerns – such as the provision of taps or cleaning regimes – were in place. The high level of uncertainty over continuing safety to the children and young people, environmental risk did not make decision and action easy. However, the complexity of these issues did not seem reflected fully to more senior levels of governance, and there was insufficient recognition of the concerns around environmental risks – not least with respect to the de-canted wards in the QEUH – continually raised by some clinicians.
146. Issues about escalation were also apparent in the handling of Mycobacterium Chelonae cases within the hospital – Gram-positive bacterium, but related to the environment and just as potentially threatening to this vulnerable patient group. The National IPC Manual does not refer specifically to MC in its list in Appendix 13, and it is an unusual organism. It was reported in May 2018 in Ward 2A in the RHC, although it did not feature in the HAIRTs provided later to the full Board. A second incident occurred in June 2019 in Ward 6A in the QEUH; that incident was reported to the full Board's October meeting in the HAIRT, but there was no reference to the earlier 2018 incident in that report. While the issues were discussed in other Committees (and reported to HPS, including the earlier 2018 case), it may have been useful if this had been reported to the full Board for consistency and to give an adequate profile to the occurrence of an unusual organism (again in the context of the risks of water contamination). The Board did report this to HPS at the time and following active consideration by the ICD, the organism was excluded as not meeting the case definition. Further national guidance on reporting would be helpful to support Health Boards in future.
147. In the Oversight Board's view, both instances warranted being brought to the full Board's attention in a consistent manner that noted the issue of apparent recurrence. IPC governance in a Health Board as large and complex as NHS GGC depends on issues being addressed at the appropriate place and relevant reporting being undertaken to higher levels of governance. In the view of the Oversight Board, this was not consistently done in the period under review.
148. IPC governance also depends on higher levels of governance seeking assurance of the system as a whole. The Oversight Boarded noted that targeted internal audits of IPC governance did not appear to take place during the period under review. Such action should also be considered as part of wider work on reviewing governance within the Health Board described below (and indeed, as part of wider work on audit and governance for NHS Scotland as a whole).
149. In reviewing how IPC governance handled the infection incidents, the Oversight Board found governance as a whole was fulfilling many of its primary responsibilities. No obvious 'weak links' in a chain of good IPC governance were identified. Infection incidents were, for the most part, reported at different committees, up to and including the full Board, and actions were reported and largely monitored and followed up. Indeed, there are several examples of good governance in action. For example, following reporting of the Cryptococcus incident in January 2019, the Board requested regular updates on air sampling at subsequent meetings. Improvements in Wards 2A and 2B. The improvements in Facilities and Estates operations were given proper and commendable attention by the Facilities Planning and Performance Committee through 2019. In this, the different Committees were fulfilling a clear role on assurance, particularly of the infection issues being raised and the actions taken.
150. However, the Oversight Board is not satisfied that the full Board was appraised of all the relevant issues. In part this may reflect what was presented to these Committees, and the absence of important information (such as the loss of the DMA Canyon reports). There was also no systematic review of the implications of water contamination presented to – or indeed, requested by – the full Board. Arguably these are issues that can only have been brought together at the level of the full Board, where the work of different Committees looking at different dimensions to the QEUH issues came together. The lack of some information and of a cross-cutting review of the implications of water contamination may have hindered the Board's ability to fulfil the key elements of its role in assurance: seeing the 'big picture' in full; and providing challenge. It also highlights another key aspect of how IPC governance should have addressed the infection incidents: risk management.
4.3 Risk Management
151. Risk is not the responsibility of any one part of the organisation; while more senior parts of the governance system have clear roles on overall oversight, it should be mainstreamed through all levels and services. As stated to the Oversight Board: "[NHS GGC] believe that the provision of high standards of health, safety and welfare within a risk management framework is fundamental to the provision of high standards of health care". The Board itself retains ultimate corporate responsibility for the risk management strategy and ensuring that corporate risks are properly captured and addressed, as well as assuring itself that all parts of the organisation are managing risk appropriately.
152. Relevant risk registers – not least the Corporate Risk Register – do reflect infection risks, and are necessary to ensure there is a systematic approach to considering and taking action on the right issues. However, the environmental infection risks increasingly apparent from 2018 onwards were not reflected in the Health Board's risk record. While infection incidents were reported individually to oversight committees within NHS GGC (as noted above), the significance of potentially widespread water contamination was not quickly raised within the governance structure.
153. As risk should be mainstreamed throughout the organisation, an appreciation of risk management should not be limited to what was and was not discussed at formal meetings. In its discussions with the Oversight Board, the Health Board noted that issues of risk were consistently being discussed and addressed by senior managers outside of formal meetings, and indeed, for some groups, such as the Technical Water Group, it clearly shaped the urgency and work programme to address risks. However, the abiding impression from the formal reflection on these matters within NHS GGC – not least by the Board itself – was of the senior levels of governance simply noting actions and not demonstrating a more active approach to seeking assurance around the risks. This is a view echoed by the Independent Review, which concluded: "There is little evidence in the [Board Infection Control Committee] or Board papers of a strategic approach to IP&C but rather of a responsive approach to exceptions that otherwise demonstrates good compliance with activities and standard."
154. Recording of risk is a key part of risk management. As the Blueprint for Good Governance sets out: "Assessing risk requires that the Board should… identify current and future corporate, clinical, legislative, financial and reputational risks [and] oversee an effective risk management system that assesses level of risk, identifies mitigation and provides assurance that risk is being effectively treated, tolerated or eliminated." The Oversight Board found that capture of the infection risks relating to the QEUH was scant.
155. A dedicated IPC risk register exists, which has been regularly reviewed and submitted to the Board Infection Control Committee for approval – its highest rated risks are then submitted to the Corporate Risk Register. The risk register for 2019 noted key risks that are clearly of relevance to the incidents in the QEUH, for example: "failure to provide appropriate infection control advice and support in the assessment and reduction of risks associated with new builds and renovation projects" (rated in the 2019 document as 'moderate'); and "failure to adequately engage with public and service users" (rated in 2019 as 'low'). However, the description of the risk and mitigation focuses on improved processes – such as the links with key groups and the production of relevant SOPs – rather than any operational set of risks arising from the continuing infection issues in the QEUH.
156. Moreover, the risks of water contamination were not reflected in the Corporate Risk Register. The latter did include a recurring risk of "failure to comply with recognised policies and procedures in relation to infection and control", but this does not relate specifically to the environmental and other associated risks. Indeed, the only reference in the Corporate Risk Register was in June 2019: "there is a reputational risk in respect of the recent issues and concerns expressed to the QEUH, including facilities and environmental issues, capacity flow across the south sector, and intense media scrutiny regarding patient care." This focus on 'reputational risk' does not include a wider sense of the patient safety and financial consequences of systemic water contamination.
157. Apart from a reference to the issue of cladding in the QEUH in the Corporate Risk Register, facilities/environmental risks did not feature significantly. This might reflect the way that risks are phrased and an assumption that more 'operational' risks are captured elsewhere (though where infection does feature, it does reflect operational granularity, as in the focus on maintaining good hygiene strategies to reduce MRSA/MSSA (Methicillin-resistant Staphylococcus aureus/ Methicillin-sensitive Staphylococcus aureus) rates). Given that these issues have proven so damaging to the affected children and young people and families, as well as staff and indeed, the Health Board itself (not least with the escalation to Stage 4), risk management in NHS GGC – at least with respect to IPC and in the context of corporate risks – had not prepared the Health Board properly. This is not to suggest that more visible and systematic capturing of these risks in relevant risk registers would have necessarily led to different courses of action – the lack of reference in the Corporate Risk Register, for example, did not affect the commendable approach to implementing the water dosing system in 2018. But risk management must aim at providing systematic assurance that such responsiveness is neither assumed nor simply dependent on local competence or expertise. Indeed, this does raise difficult questions about whether risk management in NHS GGC as a whole is performing its required role in enabling the Health Board to fulfil its duties, at least with respect to infection issues.
158. Overall, it presents a picture of a Health Board that did not fully – or at least overtly – appreciate the risks and issues arising from the QEUH incidents and act appropriately to address the issues as a result. Such a picture may not, of course, do justice to the commitment and actions of individual staff and services in addressing the huge challenges of the infection incidents. However, at the very least, it should represent a key challenge that the full Board itself should review, not least in the context of the review of governance and assurance in IPC captured in the Gold and Silver Command programme of work.
159. The Oversight Board recognises that the full Board has initiated work to address wider governance, and that this work has the potential to improve some of the issues identified here. As part of work to embed the Blueprint of Good Governance in the Health Board, it is taking forward a three-stage project to improve its governance and assurance. It has adopted the national principle of ''Active Governance', which requires NHS Boards to have not only a clear and accurate picture of what is happening within the organisation at a given point in time, but also regard to the wider strategic and policy context in which the Board operates. This is described as:
- ensuring the right things are being considered by the correct individuals/committees;
- ensuring there is a review of the right information and support given to ensure understanding and context; and
- facilitating an appropriate response by committees/Board and thus assessment of scrutiny and assurance can be elicited and governance active ensured.
160. The application of these principles to IPC is not clear at this stage, but early indications show that such links are being made. One of the early steps in this work is defining corporate objectives and allocating them clearly within the governance structure: there is a clear designation of the corporate objective "to provide safe and appropriate working practices that minimise the risk of infection, injury or harm to our patients and our people" to the Clinical and Care Governance Committee as lead. Moreover, in his letter of 3 December 2020 to the Cabinet Secretary for Health and Sport, the Health Board Chair noted that the Health Board's 2020/21 winter priorities included "the issues around the design, build and maintenance of the QEUH campus, including the legal case and the liaison with the Oversight Boards and the Public Inquiry". He also noted that a comprehensive review of the existing risk management system has now been commissioned, which will include both corporate and operational risk management. A Senior Risk Officer has been appointed as part of this activity.
161. The Oversight Board welcomes the approach and recommends that the principles are applied to ensuring that IPC strategic and operational risks are captured within this system, and relevant information escalated more effectively, as soon as possible.
162. In addition, the Oversight Board draws attention to whether the Gold and Silver Command programme of work has been considered under the Health Board's obligations under Part 1, Section 2 of the Children and Young People (Scotland) Act 2014. This places obligations on organisations such as Health Boards to report every three years on the steps they have taken to secure better or further effect of the requirements of the United Nations Convention on the Rights of the Child (UNCRC). Typically this would entail the use of children's rights and wellbeing impact assessments on key policy and service changes that affect children and young people. Given the range of UNCRC rights likely to have been engaged by this work, the use of an impact assessment and highlighting of the results in the next three-yearly report would be strongly advised, not least as an active part of risk management going forward.
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