1. Background to the Case Note Review
The events that have occurred since the move of the Children’s Hospital from its previous site at Yorkhill, to its new home on the QEUH campus in the summer of 2015 have been numerous and complex. The concern that infections in children and young people under the care of the Paediatric Haematology Oncology service have arisen from microbiological contamination of the hospital environment is a story that derives from many interwoven threads. It is not our task to create a comprehensive historical account but we are cognisant that much of what has gone before bears on the presentation and interpretation of the data we have sought to evaluate in the course of our Review.
Section 1.1 is a timeline of dates that has helped the Panel understand the evolving story, before and through, the period of the Review. We recognise that there have been other elements to this story which carry a sense of greater or lesser importance to other stakeholders depending on their perspective of the events.
We have also reviewed the timeline document prepared for the Oversight Board and published in the annex to its Final Report which provides a narrative timeline from January 2015 to 2019 (in fact this also includes data collected up to March 2020). This is a timeline of the infection incidents which occurred in Wards 2A and 2B in RHC and latterly in the QEUH (Wards 4B and 6A only). It was created to assist in the understanding of the sequence of incidents that occurred, the control measures put in place and the various hypothesis that were investigated to identify the source of the incidents. The timeline also considers incidents which occurred in other wards in the RHC (as patients could be temporarily accommodated in other parts of the RHC due to the severity of their illness) but also to demonstrate exactly where all of the incidents reported actually occurred. The timeline does not cover any such incidents reported in the QEUH other than following the transfer of patients to Wards 6A and 4B.
The report published by Health Protection Scotland (HPS) in November 2019 provides an insight into the creation of an agreed microbiology definition for the cohort selected for our review. We comment further on this report in Chapter 8 (section 8.2.3).
We also recognise that blood stream infection in Paediatric Haematology Oncology patients is a known hazard that derives from several factors relating both to disease and its treatment. It seemed relevant, therefore, that we should incorporate a brief summary from published literature to set the scene about what is already known and understood in this area. This is set out in section 1.2.
1.1 Timeline of key dates leading up to the Case Note Review
27 January 2015 Handover of QEUH and RHC buildings to NHS GGC
10 June 2015 Move from Royal Hospital for Sick Children (Yorkhill) to Royal Hospital for Children (Govan).
7 July 2015 Having previously identified concerns about the safety of the new environment for patients (adults and children) undergoing stem cell transplantation, the Infection Control Doctor resigned over the approach being taken to their resolution.
February 2016 Infection of a child with Cupriavidis pauculus. Investigation linked the infection to a sink in the aseptic pharmacy suite.
March 2017 Concern emerging within NHS GGC about increased bacteraemia rates in Paediatric Haematology Oncology patients. The first Problem Assessment Group (PAG) for a Gram-negative environmental bacteraemia is convened.
Concern also emerged about incidence of Aspergillus spp. infections at the same time.
Quality improvement group established to work on reducing CLABSI (Central Line Associated Blood Steam Infection) rates.
September 2017 Microbiology staff raised concerns about the facilities in the QEUH and RHC and the structure of IPCT Service in NHS GGC. (SBAR in October 2017).
March 2018 Health Facilities Scotland (HFS) and HPS were asked by NHS GGC to investigate ongoing issues with the water supply.
2 March 2018 Water Incident Management Team IMT convened.
26 March 2018 CNO invoked the National Framework: this offers additional support to to NHS Boards in responding to HAI incidents/outbreaks and ensures assistance from HPS.
26 September 2018 All services from RHC Wards 2A and 2B are transferred to QEUH Ward 4B and Ward 6A due to concerns over facilities.
Autumn /Winter 2018/19 Additional chlorination of the water supply implemented.
22 January 2019 Paediatric Haematology Oncology patients transferred out of Ward 6A due to concerns relating to Cryptococcus and the sealant used in the ensuite shower rooms (they were returned on 11 February 2019).
22 January 2019 The Cabinet Secretary for Health and Sport announced in Parliament plans for an Independent Review.
22 February 2019 HPS publish its report: Summary of Incidents and Findings of the NHS Greater Glasgow and Clyde: Queen Elizabeth University Hospital/Royal Hospital for Children Water Contamination Incident and Recommendations for NHS Scotland.
March 2019 HFS finalised (although never published) its report: Water Management Issues Technical Review: NHS Greater Glasgow and Clyde - Queen Elizabeth University Hospital/Royal Hospital for Children.
5 March 2019 Drs Fraser and Montgomery appointed to lead the Independent Review.
2 August 2019 Admissions to Ward 6A restricted and new patients diverted to other NHS Boards due to concerns over facilities.
29 August 2019 SBAR issued by Consultant Microbiologists raising persisting concerns about the microbiological safety of Ward 6A: subsequently reviewed at IMT 6.9.2019 and options for resolution were discussed (also in relation to the refurbishment of Ward 2A).
September 2019 Closed Facebook group established for patients and families associated with the Paediatric Haematology Oncology service.
4 October 2019 Cabinet Secretary for Health and Sport appoints Professor Craig White to review concerns articulated by families and liaise with families as appropriate.
21 November 2019 Ward 6A re-opened to new admissions.
22 November 2019 Scottish Government’s Health and Social Care Management Board escalated NHS GGC to ‘Stage 4’ of its escalation ladder and a new Oversight Board, led by the CNO, Professor Fiona McQueen, was established.
26 November 2019 HPS published its report: Review of NHS GG&C Paediatric Haematology Oncology Data (see section 1.2 for further commentary).
28 January 2020 The Cabinet Secretary for Health and Sport announced in Parliament the plans for a Case Note Review.
24 February 2020 The Case Note Review commenced.
June 2020 Independent Review report published.
15 June 2020 ToR published for the Independent Inquiry into the construction of the QEUH, Glasgow and the Royal Hospital for Children and Young People and Department of Clinical Neurosciences (RHCYP/DCN), Edinburgh.
21 December 2020 The QEUH/NHS GGC Oversight Board published its Interim Report.
January 2021 Completion of the review of cases and episodes within the Case Note Review.
March 2021 Case Note Review Overall Report and QEUH/NHS GGC Oversight Board Final Report both published.
1.2 Blood Stream Infections in Paediatric Haematology Oncology patients
Long-term survival of children with cancer has improved dramatically due to multiple medical advances, including the delivery of intensive chemotherapy. This aggressive therapy alongside disease-related bone marrow aplasia, prolonged courses of high-dose steroids, treatment induced mucositis and the requirement for long-term central venous access, puts children with cancer at increased risk of blood stream infections (BSI) and severe sepsis. Sepsis is the leading cause of Paediatric Intensive Care Unit (PICU) admission, morbidity and mortality among children with cancer,,.
Overall mortality from febrile neutropenia (the commonest side effect after most forms of chemotherapy) is frequently quoted as less than 1%. Bacteraemia is, however, identified in 5-38% of all paediatric cancer patients with febrile neutropenia and the early use of broad-spectrum antibiotics is crucial to prevent harm,,. The mortality rate from severe sepsis in children with cancer ranges from 8% to as high as 41%, reported in a recent multinational study.
One study demonstrated that 45% of all Paediatric Haematology Oncology patients required at least one admission due to concerns about sepsis and 8% of those admitted required paediatric intensive care of whom, 34% of those with severe sepsis developed multiple organ dysfunction and/or died. Children with leukaemia and related diagnoses were more likely to require intensive care treatment than those with other types of cancer, however the type of diagnosis did not affect the ultimate outcome3.
Other studies have demonstrated a lower overall intensive care mortality rate but also showed that this was significantly higher in patients with a history of haematopoietic stem cell transplantation (HSCT) and varied depending on the causative pathogen, greater for fungal sepsis than for Gram-negative bacterial sepsis,.
BSI in Paediatric Haematology Oncology patients are most commonly associated with indwelling central venous access devices, most commonly Hickman lines. Prospective surveillance studies report overall incidence rates for central‐line associated infections per 1000 central venous catheter (CVC) days, and rates of about 1 BSI/1000 CVC days are where best practice should aim to lie.
Bacterial BSI are also more common in those who have undergone HSCT, occurring in 20 to 45% of patients in some series, with the majority of infections occurring prior to engraftment. Post transplant BSI remains a risk and may be associated with a higher mortality depending on confounding factors such as the presence of graft versus host disease and extended use of steroid therapy.
The profile of microorganisms causing BSI in children with cancer has evolved over the years. In the early years of modern therapies, Gram-negative organisms were the predominant concern. This was followed by a sustained increase in Gram-positive infections but, more recently Gram-negative organisms are re-emerging, accounting, in some reports, for approximately half of all BSI.
Gram-negative bacteria are associated with significantly higher mortality rates and there is growing concern about antibiotic resistance. Particular concerns have been raised in several studies about extended-spectrum β-lactamase (ESBL) producing Enterobacteriaceae, fluoroquinolone-resistant Gram-negative bacteria, carbapenem-resistant Pseudomonas aeruginosa and multidrug resistant organisms [4,12].
A systematic review of risk factors in the development of antibiotic resistant Gram-negative bacteriaemia in children with cancer concluded that hospitalisation for 48 hours or more increases the probability of antibiotic resistance as does recent antimicrobial exposure, including prophylaxis with ciprofloxacin, which may increase the risk of developing antibiotic resistant Gram-negative bacteraemia14. Consensus guidelines about antibiotic prophylaxis in this setting have recently been published.
Antimicrobial resistance and the paucity of new antibiotics could be a particular threat to Paediatric Haematology Oncology patients with severe sepsis in future. Prevention remains key and it is recommended that infection control ‘bundles’ are adapted alongside the careful oversight of antibiotic use. Knowledge of the local epidemiology of pathogens and patterns of antibiotic resistance is essential to guide management.
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