Queen Elizabeth University Hospital/ NHS Greater Glasgow and Clyde Oversight Board: final report

Annex B: Terms of Reference for the Case Note Review

Introduction

1. As a result of continuing problems arising from infection incidents on the Queen Elizabeth University Hospital (QEUH) campus, on 22 November 2019, the Scottish Government's Health and Social Care Management Board escalated NHS Greater Glasgow and Clyde to 'Stage 4' of its escalation ladder. That stage represents a level where there are "significant risks to delivery, quality, financial performance or safety, and senior level external transformational support [is] required." As a result, a new Oversight Board under the chair of the Chief Nursing Officer, Professor Fiona McQueen, has been set up to address two specific sets of issues that led to escalation: infection prevention and control and associated governance with respect to the QEUH; and communication and engagement with affected families.

2. As part of the work of the Oversight Board, the Cabinet Secretary for Health and Sport set out plans for a Case Note Review in Parliamentary statement on 28 January 2020. The Case Review team would review the case notes of paediatric haemato-oncology patients in the Royal Hospital for Children (RHC) and the QEUH from 2015 to 2019 who have had a Gram-negative environmental pathogen bacteraemia (and selected other organisms) identified in laboratory tests. The following note sets out the terms of reference for this work, specifically:

• its purpose and authority;
• the outputs/deliverables;
• key elements of its methodology, particularly the identification of cases for review, the use of the Paediatric Trigger Tool and the epidemiological review;
• communication and engagement of the Review and its outputs;
• key responsibilities;
• timelines for different phases of work; and
• risk management.

Purpose

3. The Case Note Review will review the medical records of all children diagnosed with qualifying infections (see definition below) and who were cared for at RHC between 1.5.15 and 31.12.19 to establish several key issues: the number of children – in particular, immunocompromised children – who were likely to have been put at risk because of the environment in which they were cared; and how that infection may have influenced their health outcomes. Such work will be vital in determining the number and nature of the children affected, providing assurance and identifying improvement actions, not just for NHS GGC, but more widely across NHSScotland, including Health Protection Scotland (HPS), and the Scottish Government.. It is also an important element in improving the communication and engagement with families and affected patients.

4. The Review will consider the following set of specific questions:

• How many children in the specified patient population have been affected, details of when, which organism etc?
• Is it possible to associate these infections with the environment of the RHC and the QEUH?
• Was there an impact on care and outcomes in relation to infection?
• What recommendations should be considered by NHS GGC – and, where appropriate, by NHS Scotland, more generally – to address the issues arising from these incidents to strengthen infection prevention and control in future?

5. Through Professor Marion Bain (see below), the Review will report directly to Professor Fiona McQueen as Chair of the Oversight Board.

Outputs/Deliverables

6. There are two specific sets of outputs, described in more detail below:

• reporting to the Oversight Board; and
• specific feedback to patients and families.

Reporting to the Oversight Board

7. The Expert Panel (see below) will be responsible for providing a Final Report to Professor Bain and the Oversight Board, which should include:

• a description of the approach and methodology to the Review;
• a description of the patients included in the Review;
• a description of the cases according to specified data types;
• analysis to answer the questions set out in the Purpose section above; and
• recommendations for NHS GGC and NHS Scotland, based on this analysis.

Individual case details will not be set out in the Report and the cases will be anonymised. The Final Report will be provided to the Cabinet Secretary for Health and Sport thereafter. The Final Report will be published by the Scottish Government.

8. Reporting on progress to the Oversight Board will be undertaken by Professor Marion Bain, which may include the provision of an interim report, subject to agreement between her and the Chair.

Reporting to Patients and Families

9. The Expert Panel will provide individual reporting to patients and families that request a description of the results of their individual patient case review. Patients and families will be invited to take up the offer of engagement with the Panel through Professor Craig White, Chair of the Oversight Board's Communication and Engagement Subgroup. The format of reporting will accommodate, as far as practicable, the wishes of the family, and will be decided in conjunction with the Expert Panel. All reporting will be carried out within three months of the submission of the Final Report to the Oversight Board.

10. Arrangements for engaging with patients and families, the format of individual reporting and the timetabling of any meetings will be determined by the Expert Panel with Professor Bain and Professor White.

Methodology

11. In its overall approach to developing a methodology for the Case Note Review, these terms of reference set out key elements for how the Review should be conducted. Its overarching principles will be:

• respect and sensitivity to individual patients and their families in the handling of data and the conduct and reporting of results;
• rigorous handling, recording and storage of data, respecting patient confidentiality and family sensitivity; and
• use of internationally-respected and clearly-explained methodological tools and data sources, which will be documented for the Final Report.

12. A range of information will need to be gathered for the Expert Panel analysis and reporting. This includes several key elements, described in more detail below:

• the epidemiological and clinical outcomes review;
• the use of the Paediatric Trigger tool; and
• the gathering of other key data.

Identification of Cases

13. HPS has undertaken an analysis of a variety of options to define the sample. The Expert Panel has agreed the following cohort definition, but will continue to review the sample as the Review progresses.

14. The cohort currently consists of 85 patients (and a larger number of infection episodes):

• patients with blood cultures of a Gram-negative environmental pathogen (including enteric pathogens associated with the environment) (there are 81 patients that meet this inclusion criteria);
• patients with a M. chelonae (Acid Fast Environmental) infection (there are 3 patients that meet this criteria – only 2 with bacteraemia, and 1 with a skin infection); and
• patients included for other reasons: this includes one child with a Gram-negative infection (not blood stream detected) and Aspergillus

Epidemiological and Clinical Outcomes Review

15. An epidemiological and clinical outcomes review of the cases is required to collect patient, outcome and risk data systematically using agreed definitions and for the findings to support the incident investigation. The objectives of this epidemiological investigation are to:

• determine a timeline for each of the cases;
• characterise the cases in terms of time, place and person:
  • time: describe the episodes of BSI over time and create a timeline for outbreak, including plotting of control measures against number of cases,
  • place: describe the location of patients (hospital, ward, bed/bay) and describe their movements in the hospital, and
  • person: characterise the patients with infection in terms of intrinsic and extrinsic risk factors; outcomes; antimicrobial prophylaxis and treatment; and individual infection prevention and control measures in place; and
• describe the cases in the context of environmental risks and incidents (where possible).

The epidemiological components of the review will be carried out by HPS staff and data items to inform clinical outcomes will be extracted in collaboration with the Clinical Team responsible for the Paediatric Trigger Tool work (see below). A full description of the agreed data set is provided in the separate Epidemiological and Clinical Outcomes Protocol.

Paediatric Trigger Tool

16. The review of the case notes is set against the background of Healthcare Improvement Scotland's document, 'Learning from adverse events through reporting and review – A national framework for Scotland: July 2018'. The aims of the national approach to learning from adverse events are to:

• learn locally and nationally to make service improvements that enhance the safety of the care system for everyone;
• support adverse event management in a timely and effective manner;
• support a consistent national approach to the identification, reporting and review of adverse events, and allow best practice to be actively promoted across Scotland;
• present an approach that allows reflective review of events which can be adapted to different settings; and
• provide national resources to develop the skills, culture and systems required to effectively learn from adverse events to improve health and care services across Scotland.

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;
• any staff involved are supported in a consistent manner;
• events are reviewed in a consistent way; and
• learning is shared and implemented across the organisation and more widely to improve the quality of services.

17. The intention of using an adapted Paediatric Trigger Tool (PTT) in the study of NHS GGC is not to determine preventable or non-preventable harm but to create opportunities to learn from the triggers and adverse events identified. It forms only part of the overarching case review process and it is anticipated the information from the PTT will underpin the epidemiological and clinical outcome review and the contextual organisational data and reports. The PTT methodology will examine harm in the processes of healthcare in the group of patients selected for case note review and its objectives are to contribute to the overall aim of the case note review by:

• identify all triggers and adverse events in the cohort of patients identified by the epidemiological review using an adapted PTT; and
• describe the rate and severity of harm occurring in hospitalised children in the cohort group.

18. Dr Pat O'Connor is adapting the PTT for use for this patient population, in coordination with Dr Peter Lachman, one of the Tool's creators.

Other Data Collection

19. The Epidemiological and Clinical Outcomes Review and the PTT may not provide all the data that the Expert Panel requires to conduct its work. The Expert Panel will review its data requirements on a continuing basis and request these through the Clinical and Support Team leads as well as Professor Bain as required.

Communication and Engagement

20. Communication and engagement is distinct from reporting, as described above. There are key 'audiences' whose communication needs should be supported through the work of the Case Note Review. Key among these are:

• patients and families, both those who will be part of the Case Note Review and those who may want to know more, or feel they should be part of the Review; and
• the staff of the relevant parts of the RHC and the QEUH.

More detailed work on communication and engagement will be reflected in the Programme Plan for the work.

Patients and Families

21. Initial communication with patients and families – setting out which cases would be reviewed – has now taken place. That set out the purpose and details of the Case Note Review, and invite any questions and issues to be raised through the signatories of the letters, Professor Bain and Professor McQueen.

22. Progress reporting on the Case Note Review as a whole will be conducted through the NHS GGC web pages and 'closed' Facebook page to the affected families.

23. Specific engagement with families wishing to discuss their particular cases will be handled on a case-by-case basis through Professor Bain and Professor White.

Staff

24. The medical, nursing and other relevant staff of the relevant parts of the RHC and the QEUH (including the NHS GGC Board and relevant committees) will want to be kept appraised of the progress of the Review. Professor Bain will organise:

• an initial overview session of the methodology/approach of the Review to reviewing the cases;
• regular progress reports from representatives of the Expert Panel, ideally delivered in face-to-face meetings; and
• a final 'debrief' of the key results and recommendations of the Final Report.

Key Responsibilities

25. As Executive Lead for infection prevention and control within NHS GGC, as appointed by Professor McQueen, Professor Bain will have oversight of the project as a whole. She will be responsible for its progress and reporting to Professor McQueen, including advice – provided by the Expert Panel and other members of the team below – for any necessary change in key elements of these Terms of Reference.

Expert Panel

26. The Expert Panel will be responsible for:

• agreeing, within the scope of these Terms of Reference, the definitions used to select patients for the review; the scope and direction of the data collection; and the methodological tools required;
• overseeing and interpreting the analysis of data obtained and developing the Final Report (and, in discussion with Professor Bain, the provision of any agreed interim reporting);
• progress reporting to relevant audiences, including the RHC/QEUH staff; and
• providing reporting to individual patients and families.

27. The Expert Panel consists of:

• Professor Mike Stevens (Emeritus Professor of Paediatric Oncology at the University of Bristol), who will be head of the Expert Panel and report to Professor Bain;
• Gaynor Evans (Clinical Lead for the Gram-negative Bloodstream Infection Programme at NHS Improvement England); and
• Professor Mark Wilcox (Professor of Medical Microbiology at the University of Leeds).

Clinical Team

28. The Clinical Team will be responsible for:

• undertaking the data collection, storage and submission of case note review material to the Expert Panel;
• resolving data/sampling issues with Professor Bain, the Support Team and the Expert Panel; and
• supporting the analysis and reporting of the Case Note Review through the Expert Panel.

All handling of patient data will be covered by relevant data-sharing agreements and protocols.

Epidemiology and Clinical Outcomes Review Team

• Dr Fiona Murdoch, Epidemiology and Clinical Outcomes Review Lead: March 2020-end of Review
• Jane McNeish, Epidemiology and Clinical Outcomes Review: May 2020-end of Review
• Shona Cairns, Epidemiology and Clinical Outcomes Review: January-March 2020

Paediatric Trigger Tool Review Team

• Dr Pat O'Connor, Paediatric Trigger Tool Review Lead: February 2020-end of Review
• Professor Peter Davey, Paediatric Trigger Tool Review: April 2020-end of Review

Advisers to Expert Panel

• Hayley Kane, Infection Control Manager, IPC (ICNet and Telepath) Review: September 2020-end of Review
• Dr Julie Aitken, Clinical Adviser to Expert Panel: September 2020-end of Review
• Linda Dempster, IPC Adviser to Expert Panel: October 2020-end of Review

Support Team

29. The Support Team will be responsible for:

• resolving practicalities and resourcing issues with Professor Bain, Professor Stevens and Dr O'Connor;
• undertaking key communication and engagement functions with Professor Bain;
• developing and maintaining the Review workplan;
• providing secretariat and related functions to the Expert Panel; and
• ensuring submission of Final Report to the Cabinet Secretary and publication.

30. The Support Team consists of:

• Diane Murray (Deputy Chief Nursing Office for Scotland), who will lead the Support Team;
• Lesley Shepherd (Professional Nurse Advisor to the Scottish Government), who will provide expert methodological advice and work with HPS;
• Professor Craig White (Chair of the Communication and Engagement Subgroup of the Oversight Board), who will work with Professor Bain in handling the communication and engagement with patients and families and provide the 'families' voice' in the development of key elements of the Review;
• Marie Brown (seconded Programme Manager from NHS National Services Scotland), who will develop and maintain the workplan and advise Diane Murray and Professor Bain of key delivery issues (role to be confirmed);
• Emma Mackay (seconded from NHS National Services Scotland); and
• Jim Dryden, Carole Campariol-Scott and Phil Raines: (QEUH Support Unit, Scottish Government), who will provide policy and practicalities support, and ensure timely progress updating to the Oversight Board and the Cabinet Secretary.

31. Additional key support will be provided by:

• Shona Cairns (Health Protection Scotland), who will head up the team responsible for final identification of patients to be included in the Case Note Review and leading the epidemiological component of the Epidemiology and Clinical Outcomes Review, working with Lesley Shepherd and reporting to the Expert Panel; and
• Professor Peter Lachman, who will supply consultancy advice on adapting the PTT for the particular patient population as one of the creators of the Tool, working with Dr Pat O'Connor.

Timelines

32. The timelines for the Review will be reviewed on an ongoing basis by Professor Bain in conjunction with the heads of the Expert Panel, the Clinical and Support Teams, and Professor McQueen. They will be encapsulated in the workplan to be developed and maintained by the Support Team. The Review is currently anticipated to provide a final report to the Oversight Board in 2020, but timelines will necessarily continue to be reviewed in light of the impact of Covid-19.