7. Case Note Review
192. A Case Note Review was established in January 2020 to examine individual cases of infections. Undertaken by a Panel of independent external experts, the Case Note Review team has examined the case notes of those children and young people in the paediatric haemato-oncology service in the RHC and the QEUH from 2015 to 2019 who had a bacteraemia caused by a Gram-negative environmental microorganism (and selected other bacteria, as identified in laboratory tests). The terms of reference are set out in Annex B. While its Overview Report is published separately to this Final Report, the following digest summarises its findings on several of the wider, systemic issues relating to IPC in NHS GGC, and has been prepared for inclusion in this report.
193. As part of its work, the Panel confirmed that 84 patients, with 118 infection episodes, fell within the scope of its review. This included the following:
- One patient had two episodes of infection, the first of which was a Stenotrophomonas spp. bacteraemia, but this was excluded as it occurred prior to the transfer of the hospital to its new site in 2015. This patient remained in the Review because of a second eligible episode.
- One patient had a single episode of bacteraemia within the period of the review, but this was not caused by a Gram-negative environmental (GNE) microorganism; on that basis, both the patient and the episode were excluded from the analysis.
- There was one further patient, who experienced four infection episodes, whose parents did not wish their child to be included in the Review.
194. The Case Note Review final report will review these issues and the individual cases in more detail. This chapter draws out key Expert Panel findings as they relate to the Oversight Board's scope of work, focusing particularly on the availability and use of data within the Health Board, and how potentially hospital (environment) related infections were identified, mapped and responded to.
7.1 Data Issues
195. In examining the microbiological, environmental and clinical data relating to the individual cases, the Expert Panel reached conclusions on a number of issues relating to how NHS GGC has collected, organised and use key data in the infection incidents.
196. Environmental data did not appear to be organised as well as it should have been. The data initially provided to the Expert Panel by the Health Board about water and surface samples were incomplete and without adequate place location identifiers. Samples and their locations were inconsistently labelled and the format in which they were presented rendered cross tabulation with individual patient records almost impossible. This raised questions about how the Health Board was able to make use of such data in its continuing investigation of the bacteraemias.
197. Typing of bacterial organisms is key to understanding whether or not isolates from different patients or from the environment may be closely related/ indistinguishable (ie. evidence for potential common/environmental sources). Reference was found in clinical notes for individual cases in IMT records and in the ICNet and Telepath systems to samples being sent from the isolates identified in patients in the review to a reference laboratory (normally outside NHS GGC). However, this was not done consistently and on many occasions no results were recorded or only a simple statement provided that the bacterial strain in question was described in the lab report as 'unique'. This latter statement is meaningless unless it is clear to how many and which other strains the index strain has been compared.
198. Following discussion with NHS GGC, it became apparent that a database recording all typing data for the cases included in the Review, and contemporaneous environmental samples, did not exist. Indeed, an electronic laboratory record system for typing data appears to have been created only towards the end of the period covered by the Review; prior to this, reports had been received from the reference lab as individual pdf files and filed as such. In order to provide this information to the Panel, NHS GGC had to request resubmission of original data from the external laboratory (Public Health England (PHE) Colindale). In the process of discussing the availability and format of these data with NHS GGC, the Panel reached the conclusion that, notwithstanding concern about, and investigation of GNE bacteraemias in paediatric haemato-oncology patients within NHS GGC over a period of five years, and even by 2020, systems had not been created for the collection, collation, storage or analysis of data in a manner readily available to optimise internal investigations and decision making, either in real time or retrospectively.
Use of Data Systems
199. Telepath is the laboratory information management system used in NHS GGC. The Panel found that it generally provided good evidence of frequent engagement between the microbiology and clinical teams in sharing information, including about the identification of infecting organisms and their susceptibility profiles to guide optimal antibiotic therapy choices.
200. The ICNet system relies on data being transferred from Telepath when an organism is identified for which a pre-set alert exists. The National Infection Prevention and Control Manual (NIPCM) provides a nationally-agreed minimum list of alert organisms/conditions. The purpose of this list is to alert NHS Boards of the occurrence of these organisms/conditions, which may require further investigation. The guidance states: "the list is not exhaustive and specialist units, for example those managing patients with Cystic Fibrosis, will also be guided by local policy regarding other alert organisms not included within these lists". However, the Panel found little evidence, even as late as 2019, that the NHS GGC alert list had been modified in light of the evolving experience with GNE bacteraemias. This resulted in frequent absence of alerts being triggered within ICNet, and the subsequent absence of IPC input in episodes of GNE bacteraemia in the cases reviewed.
Patient Location Records
201. The locations of patients during hospital attendance and inpatient stays were obtained from Trackcare. Whilst a specific bed was identified for almost all inpatient stays, the system did not provide locations to the level of a specific bed space when patients were receiving day care in Ward 2B or, subsequently, in Ward 6A. This limited the capacity of the Panel to assess specific locations of care as risk factors for infection.
202. One unexpected issue was the continuing coding of haemato-oncology day care patients as attending Ward 2B after the date both Wards 2A and 2B were closed in September 2018. This occurred inconsistently within individual records and, although the Panel was made aware that Ward 2B was used for the RHC pre-assessment service from 29 April 2019 to 15 November 2019, it was assured that no haemato-oncology patients attended that area during this period. It seemed self-evident for the benefit of tracking purposes that patients should never be coded to an area other than that which they physically attended.
203. It was often difficult to identify from the clinical records in which operating theatre surgical procedures took place. It was also likely that procedures (for example, bone marrow sampling and lumbar puncture procedures) were undertaken in anaesthetic rooms, also without a record of the location.
204. The NHS GGC Clinical Portal stored scanned copies of written inpatient medical notes which should be dated to the day of discharge. For the episodes included in the Review, complete written notes were found for 65 percent of cases, incomplete notes for 18 percent and no written notes for 16 percent. Of the episodes identified with written notes, 61 percent were filed under the date of discharge, but written notes for other episodes were found to have been filed up to 14 months after the date of discharge.
205. The Clinical Portal also contained digital inpatient medical records for some patients. These records include Generic Continuation notes. These were not linked to specific admissions and contained diverse inpatient and outpatient records from different professions and specialties. If the Generic Continuation was labelled Paediatrics, then it usually contained digital inpatient medical notes. These were detailed and fully electronic, which enabled word searching. However, these notes might cover several admissions and the median length of records for patients in the review was 12 months (maximum 35 months). These structural issues made the searching for data from records in the clinical portal very difficult at times.
7.2 Addressing Bacteraemia Clusters
206. The Panel also examined how bacteraemia clusters (possible outbreaks) were investigated. In the initial stages of investigation, thresholds for calling a PAG or subsequently proceeding to an IMT did not appear to evolve during the period of the review, despite the continuing existence of concern about GNE bacteraemias over several years. There seemed to have been little recognition that the use of standard definitions of an outbreak may be less useful in a situation where unusual infections emerge in relatively small numbers within a small subset of the overall hospital population (as was the case in paediatric haemato-oncology). Some IMT minutes and other internal reports seen by the Panel that have analysed data about infection trends may also have provided inappropriate reassurance from the use of SPC methodology without accurate ascertainment of an appropriate baseline.
207. There were examples of PAG meetings being called separately for clusters/outbreaks of different microorganisms despite the fact that they were all GNE bacteria occurring within a closely-related timeframe. There were also examples where, contrary to the Panel's expectation, an IMT appeared to be either never called or terminated prematurely. In other situations, IMTs were called to investigate bacteraemias caused by specific organisms, but did not always recognise and document the concurrent emergence of other GNE infections. Opportunities for seeing the wider picture were likely lost by this approach.
208. Distinctions between hospital-acquired and healthcare-associated infections sometimes appeared to have been considered important in discussion of the significance of a reported bacteraemia. Yet it was clear that the utility of these definitions was less informative in a clinical setting where patients are attending for day care or outpatient appointments at the very high frequency seen in this patient group.
209. Root Cause Analysis (RCA) methodology was only agreed as the basis for future IMT investigation in late 2019 and applied prospectively in two patients in the Review. The template subsequently created to support RCA goes beyond the HPS Outbreak/Incident Data Collection Tool provided as an appendix to the NHS GGC outbreak SOP.
210. A requirement (or even recommendation) for the use of RCA did not feature in the NHS GGC 2020 Outbreak SOP and it is hard to see why, given the experience of repeated GNE bacteraemias over five years, this would not have been introduced earlier or more generally. The Panel noted, however, that recommendations for use of a structured approach to the investigation of infection using RCA methodology did not feature nationally in the NIPCM.
211. IMT minutes were not always easy to understand in retrospect – patients may not have been identified in a way that would allow them to be tracked across a series of meetings; staff were not identified by their role; the structure of the documents varied and the style was sometimes informal; actions were not presented or summarised in a consistent way; and recording of progress in following up on previously agreed actions was inconsistent (including whether these were implemented and/or sustained).
212. IMT action logs were rarely apparent either within the minutes or separately, which must have limited the ability to track completion or evolution of actions from one meeting to the next either within an IMT sequence or between consecutive IMT sequences. This suggested a fragmentation of approach and risked lack of learning for the future.
213. The Panel did not see 'hot debrief' or full reports at the close of a series of IMT meetings relating to cases included in the review despite this being mandated in the NHS GGC outbreak SOP. Examples of such documents had been provided to the Panel from IMTs in other clinical areas within NHS GGC, raising questions about consistency in practice across the organisation.
214. The SOP also indicated that these reports should be signed off by members of the IMT and sent to the Acute Infection Control Committee from where upward reporting was expected to the Board itself. There was little or no documented evidence that IMT members were asked to approve such reports, even if they existed.
215. Whilst it was evident from NHS GGC Board papers that reports about the problems encountered within Wards 2A/B and subsequently 6A were provided at Executive level, the significance and scale of what was happening might not have been adequately expressed. By way of example, the HAIRT report made to the NHS GGC Board on 17 October 2017 stated only the following:
"Two cases of Stenotrophomonas maltophilia bacteraemia were identified over an 8-day period in July. A Problem Assessment Group (PAG) was held on the 26.07.17. HPS were notified and a Healthcare Incident Infection and Outbreak Reporting Template (HIIORT) was completed. No further cases were identified and the two cases were later confirmed to be different types".
It was not why it was important for the Board to hear that there had been two infections, that they had been appropriately reported and that they were considered to be of different types but not to be told that one of the children had died. The Expert Panel was told by NHS GGC that the infections and the death were reported at the Board Infection Control Committee but that, as the full Board was a public meeting, there was a need to ensure awareness of infections but no requirement to discuss individual patient details (for patient confidentiality and Data Protection reasons). However, the Expert Panel noted that the occurrence of another bacteraemia, caused by the same organism, earlier in the same year, following which the child also died, was not reported to the Board. This showed an inconsistency in the process and purpose of reporting and could represent an organisational culture which promoted a focus on process (ie. that a report was received) rather than being clear what the cause or consequences were.
216. There were occasions when the minutes record that clinicians presented at an IMT directly questioned if the environmental risks had been reported to senior management within NHS GGC; this was mainly in 2018 and 2019, but there was also an unsubstantiated suggestion that this could also have been in 2017 (the Panel did not see written evidence for this). It was interesting to hear, at a meeting with RHC clinicians in February 2020, the IMT process described as "lacking integration and fails to recognise patterns". This simple statement reflected the overall impression of the Panel.
217. The Expert Panel was less able to form a view of the overall effect on the clinical service although it was obvious that disruption was substantial, particularly in relation to the decisions to close Ward 2A and 2B in September 2018, to move patients out of Ward 6A for a short period at the beginning of 2019, and to limit admissions to Ward 6A in the summer and early autumn of that year. Throughout the Review, the Expert Panel saw few documents prepared by the clinical team, NHS GGC management or the Managed Service Network that set out an analysis of how these decisions affected the overall delivery of paediatric haemato-oncology care. Measures that would have been of interest were, for example: timeliness in delivering planned chemotherapy; deferral of planned treatment (eg. surgery, radiotherapy, stem cell transplantation); use of shared care; and transfers to other units.
218. Two documents were provided. One was an audit of admissions with bacteraemia from 1 July 2017 to 31 August 2018, which looked at characteristics of patients affected by age, gender, diagnosis and the profile of the microorganisms causing infection and their antibiotic sensitivities. The main focus of the audit seemed to be on defining the optimal choice of empirical antibiotics: it did not attempt to look at the observed frequency of bacteraemia against that which might have been expected. The second document was an analysis of episodes of care transferred to other wards/hospitals/Health Boards for delivery of chemotherapy. It related to data collected from 29 July 2019 to 4 November 2019, during the period when there were restrictions on admission to Ward 6A. Short-term adjustment to patient flow is expected under such circumstances and it was good that these transfers were able to take place to limit delay to treatment. It seems, however, that there may also have been some more permanent change to shared care activity as a result of the impact of these infections. The wider development of shared care with local hospitals may have been helpful to individual families in offering more care closer to home, but appropriate structures and processes are needed to ensure that a shared care network is both supported and safe. Evidence was not provided that the issues that arose at NHS GGC were supported by any action from the Managed Service Network.
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