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Clinical Research in Southampton
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Vulnerable with capacity
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Are there situations where a capacitous patient is nonetheless vulnerable to adverse decision making?
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/HealthProfessionals/Clinical-law-updates/Vulnerable-with-capacity.aspx
Records management policy
Description
Records Management Policy Date Issued: Review Date: Document Type: 9 May 2018 19 April 2021 Policy Version: 6 Contents Paragraph 1 2 3 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 4 5 6 7 8 9 Appendices Appendix A Appendix B Appendix C Executive Summary Introduction, Scope and Purpose Definitions Details of Procedure to be followed Regulatory and legal framework The Records Information Lifecycle Record Creation Handling and Using Records Record Closure and Retention Appraisal Disposal Additional Guidance on Specific Record Types Roles and Responsibilities Related Trust Policies Communication Plan Process for Monitoring Compliance/Effectiveness of this Policy Arrangements for Review of this Policy References Page 2 3 4 5 5 6 6 7 9 10 11 11 13 14 14 15 15 15 Page 17 21 22 Record Creation and Filing Procedures Medical Record Keeping Standards List of Record Types listed in NHS retention Schedule Document Status This is a controlled document. Whilst this document may be printed, the electronic version posted on the intranet is the controlled copy. Any printed copies of this document are not controlled. As a controlled document, this document should not be saved onto local or network drives but should always be accessed from the intranet. Page 1 of 26 Executive Summary 1. There is a need to manage Trust records efficiently and effectively to support day to day operational and business activity and meet certain legal requirements. As we create and collect increasing amounts of information about our patients, staff and business activities it is vital that are able to organise, securely store and retrieve this information when required. 2. As we manage the incremental change from traditional/paper based record keeping to electronic/ digital systems we encounter new challenges, however the key principles of records management outlined in this policy continue to apply to these new storage mediums. Where different or additional guidance is required this is provided. 3. This policy is structured to provide staff with guidance on managing records through their life cycle from creation to disposal. Adherence to this guidance will support all aspects of Trust business and help the Trust comply with its duties as a public body subject to the Public Records Act (1958) and the Freedom of information Act (2000). 4. The Records/Information Life Cycle describes a regime designed to ensure information is managed from the point that it is created to the point that it either destroyed or permanently preserved as being of historical or research interest. The cycle is illustrated in this diagram: 5. In summary this policy: Defines duties and responsibilities in regard to records management in the Trust Outlines the key legal obligations and statutory provisions that apply to records created and used within the Trust Provides a procedural Framework with guidance to encourage best practice in records management within the Trust Describes the `Information Life Cycle' and highlight best practice to be followed at each stage of the cycle from creation to disposal. Page 2 of 26 1. Introduction, Scope and Purpose 1.1 Introduction 1.1.1 Records Management is the process by which an organisation manages all the aspects of records whether internally or externally generated and in any format or media type, from their creation, all the way through to their lifecycle to their eventual disposal The Trust's records are its corporate memory, providing evidence of actions and decisions and representing a vital asset to support daily functions and operations. Records support policy formation and managerial decision-making, protect the interests of the Trust and the rights of patients, staff and members of the public. They support consistency, continuity, efficiency and productivity and help deliver services in consistent and equitable ways. Adherence to the guidance provided in this Policy will provide the Trust with a number of benefits including: better use of physical and server space; better use of staff time; improved control of valuable information resources; compliance with legislation and standards; and reduced costs. This document sets out a framework within which Trust records can be managed and controlled effectively, and at best value, commensurate with legal, operational and information needs. 1.1.2 1.1.3 1.1.4 1.2 Scope 1.2.1 This policy applies to Trust records held in any format including: Paper Photographs slides and other images Microform microfich and microfilm Audio and video tapes, cassettes CD ROM etc Computerised records Scanned records Text messages and social media Websites and intranet sites that provide key information to patients The majority of Trust members of staff will create records during the course of their day to day activity. Aspects of this policy will therefore apply to most members of staff, with specific responsibilities applying to department heads and managers for the management of local records created stored or held in their areas of responsibility. At the time of publication of this policy preparations are being made to ensure the Trusts compliance with the implementation of the European Union General Data Protection Regulation (GDPR) in May 2018. To date no direct impact on the records procedures outlined in this policy has been identified as a consequence of the introduction of GDPR. As these preparations progress any identified changes required to records management policy and procedure will be made. The Trust is also in the process of changing to a digital format of medical record recording and storage using the Onbase Electronic Document Management System (eDMS). An incremental roll out of the system to care groups has started but is at an early stage. 1.2.2 1.2.3 1.2.4 Page 3 of 26 1.2.5 1.2.6 This policy makes an occasional reference to this significant change and the key principles for records management outlined in this policy (storage, retention etc) still apply to the records created and stored in Onbase. As the incremental roll out of Onbase eDMS progresses and operational procedures are finalized this policy will be reviewed and the need for changes to be made or additional operational policies and procedures to be published will be agreed and implemented. 1.3 Purpose 1.3.1 The purpose of this policy is to: Define duties and responsibilities in regard to records management in the Trust Outline the key legal obligations and statutory provisions that apply to records created and used within the Trust Provide a procedural Framework with guidance to encourage best practice in records management within the Trust Describe the `Information Life Cycle' and highlight best practice to be followed at each stage of the cycle from creation to disposal. Definitions 2. Term Records Management Meaning Applied in this Policy A set of activities required for systematically controlling the creation, distribution, use, maintenance, and disposition of recorded information maintained as evidence of business activities and transactions. Record Information created, received and maintained as evidence and information by an organisation and person, in pursuance of legal obligations or in the transaction of business. (ISO Standard 154891:2016). General Data Protection European Union Directive which will replace the Data Protection Act Regulation (GDPR) (1998) in UK law, enforceable from 25th May 2018. Designed to harmonise data protection regulation across the European Union. Electronic Document A software program/system that manages the creation, storage and Management System control of documents electronically. (eDMS) Information Life Cycle A term that describes a controlled regime in which information is managed from the point that it is created to the point that it either destroyed or permanently preserved as being of historical or research interest. Public Authority An organisation within the categories listed in Schedule 1 to the Freedom of information Act defined as `a body that appears to be exercising functions of a public nature or who are providing, under contract with a public authority, any service whose provision is a function of that authority. The Trust is a Public Authority. Metadata Data that describes information about other data. e.g. author and creation date of a record are elements of its metadata. Record Classification Means by which a record keeping system arranges or organises Scheme records to enable appropriate management controls to be applied and support accurate retrieval of information. e.g. a filing index. Page 4 of 26 Public Records Administrative and departmental records belonging to Her Majesty, in the UK or elsewhere, in right of Her Majesty's Government, and in particular records of or held in any government department and records of offices, commissions or other bodies under HMG in the UK. (Public Records Act 1958). All Trust records are public records subject to the Public Records Act (1958) Data Subjects An individual who is the subject of personal data. Patient Administration Electronic system used to hold non clinical details about Trust System (PAS) patients (demographics, GP details, contacts etc). Electronic Clinical A module of the Trust PAS used to record the movement of patient Record Tracking (eCRT) Health Record Folders within UHS and partner organisations. Record closure The process followed to make a record inactive when it has ceased to be in active use other than for reference purposes. Record retention The process of keeping a record for a period of time for administrative, legal, fiscal, historical, or other purposes. Record appraisal The process of deciding what to do with a record when the business use has ceased. The outcome of record appraisal will be either: destroy/delete, retain for a further period or transfer to a Place of Deposit. The National Archives A non-ministerial department, and the official archive and publisher (TNA) for the UK Government, and for England and Wales. TNA publishes advice and guidance on information and records management. Place of Deposit (POD) Record Archive storage location appointed by the Secretary of State for Culture Media and Sport. Usually a public archive service provided by a Local Authority. Corporate Records Records of business processes such as accounting, procurement, staff management and estates maintenance. In NHS organisations this term covers all records that are not patient/care records. Permanent preservation A process followed to place a record in an archive storage location allowing public access to records of historical administrative or local importance. Record Disposal The destruction, deletion or transfer for permanent preservation of a closed record British Standard 10008- The British Standard that outlines best practice for the 2014 Evidential Weight implementation and operation of electronic information and Legal Admissibility management systems, including the storage and transfer of of Electronic Information information. Information Governance An umbrella term relating to the processes and systems used by organisations to manage the information they hold. In the context of the NHS, it specifically refers to the processes and procedures used to ensue confidentiality, security and accuracy of information. 3. Details of Procedures to be Followed 3.1 Regulatory and Legal Framework 3.1.1 Under the terms of the Public Record Act 1958 all records created in the Trust are regarded as public records. The act imposes a statutory duty on the Trust to make arrangements for the safe keeping and eventual disposal of records. The ownership and copyright of records created within Trust lies with the Trust and not the individual who has created them. Page 5 of 26 3.1.2 3.1.3 3.1.4 As a Public Authority subject to the Freedom of Information Act the Trust has a duty to follow the Code of Practice for Records Management published by the Lord Chancellor in accordance with section 46 of the FOIA. The code provides guidance to public authorities on keeping, managing and destroying records. The Data Protection Act sets in law how personal and sensitive information may be processed and largely influences the way we handle care records. Further guidance on the confidentiality aspects of record keeping is provided in the NHS Confidentiality Code of Practice and the Trust Data Protection and Confidentiality Policy. The Records Management Code of Practice for Health and Social Care 2016 provides records management guidance for NHS and Social Care organisations based on current legal requirements and professional best practice. The Trust is committed to following the guidance issued in the code of practice and the procedures outlined in this policy are largely based on the guidance included in this Code of Practice. 3.2 The Records Information Lifecycle 3.2.1 The records or information lifecycle is a term that describes a controlled regime in which information is managed from the point that it is created to the point that it either destroyed or permanently preserved as being of historical or research interest. The cycle is illustrated in figure 1 Figure 1. The Information Lifecycle 3.2.2 Procedural guidance associated with each stage of the cycle is included in subsequent sections 3.3 Record Creation 3.3.1 ISO 15489-1:2016 Information and Documentation � Records Management describes the characteristics of `Authoritative Records' as being authentic, reliable integral and useable. Table 1 below expands on these definitions. Page 6 of 26 Table 1. Record Characteristics Record Characteristic Authentic How to Evidence It is what it purports (claims) to be To have been created or sent by the person purported to have created or sent it and To have been created or sent at the time purported. Full and accurate record of the transaction/activity or fact Created close to the time of transaction/activity Created by individuals with direct knowledge of the facts or by instruments routinely involved in the transaction /activity. Complete and unaltered Protected against unauthorised alteration Alterations after creation can be identified as can the persons making the changes. Located, retrieved, presented and interpreted The context can be established through links to other records in the transaction/activity. Reliable Integrity Useable 3.3.2 3.3.3 3.3.4 3.3.5 By organising records in a file system or classification scheme elements of `Metadata' are associated with each record which helps maintain the characteristics described above. Metadata in its simplest form would identify the creator, creation date and subject of a record but can be expanded to include additional information such as destruction date, identifiers and accessibility. Classification schemes can be a simple arrangement of files and folders on a Network drive increasing in sophistication up to a full blown Electronic Document and Records Management System such as the Onbase edMS being introduced to store patient records in the Trust. All Trust records should be stored within an appropriate classification/filing system after creation. This will ensure they remain secure and accessible from the outset and be available to support Trust business activity. A more comprehensive guide for users covering the creation and filing of records is attached at Appendix 1. 3.4 Handling and Using Records 3.4.1 Record Keeping 3.4.1.1 When completing entries in or creating any form of records the following general guidance should be applied: Be factual, consistent and accurate Write clearly and in such a way that text cannot be erased Write in such a way that any alterations or additions are dated, timed and signed in such a way that the original entry can still be read. Page 7 of 26 3.4.1.2 Healthcare professionals may be subject to additional record keeping codes of practice set by their professional bodies. The Academy of Medical Royal Colleges has published a set of generic medical record keeping standards which are reproduced at Appendix 2. All entries in Trust care records should conform to these standards. 3.4.1.3 Rights granted to members of the public by the Freedom of Information Act and to patients and staff under the Data Protection Act can result in copies of corporate records being placed in the public domain and data subjects obtaining copies of records containing information about them. Providing record entries are factual and accurate and personal records do not include any unnecessary and/or derogatory comments record disclosure should not create any additional issues. 3.4.2 Confidentiality and Access 3.4.2.1 All Trust records are public records and thus are subject to a number of statutory provisions regarding confidentiality, access and disclosure. Patients entrust the NHS or allow it to gather sensitive information relating to their health and other matters as part of their seeking treatment. They do so in confidence and they have the legitimate expectation that staff will respect this trust. It is essential, if the legal requirements are to be met and the trust of patients is to be retained, that the NHS provides, and is seen to provide, a confidential service. 3.4.2.2 Specific guidance on patient confidentiality issues is provided in the Trust Data Protection and Confidentiality Policy. Further advice on all aspects of patient confidentiality and the application of the Data Protection Act (1998) on the way we handle records in the Trust can be obtained from the Trust Information Governance Manager. 3.4.2.3 The Data Protection Act (1998) makes provision in law for `data subjects' (e.g. patients and members of staff) to obtain copies of otherwise gain access to information held about them. The Trust Access to Records Policy covers this aspect of records management and further advice on the procedure can be obtained from the Trust Information Governance manager. 3.4.2.4 In 2000 the government introduced the Freedom of information Act providing members of the public with the general right of access to recorded information held by a wide range of bodies across the public sector. The effect of this legislation is to make it possible for people to obtain copies of a wide range of Trust records that in the past would have remained confidential. The Trust Freedom of Information Policy covers this aspect of records management and further advice on the procedure can be obtained from the Trust Information Governance manager. 3.4.3 Record Tracking 3.4.3.1 Ideally the movement and location of all records should be controlled to ensure that a record can be retrieved at any time and there is an auditable trail of record transactions. This is best achieved using some form of record tracking system to record the movement of records between locations. 3.4.3.2 It is the policy of the Trust that patient health record folders are tracked using the PAS record tracking component (electronic casenote record tracking e-CRT.) Users are provided with training to use e-CRT prior to being granted access to the system. 3.4.3.3 While electronic records do not require tracking as such, control must be exercised when hard copies are produced. If separate clinical casenotes are produced from electronic systems to form a filing system individual record movements should be tracked to aid retrieval and avoid loss of data. 3.4.3.4 For most areas, where movement of records is restricted, paper based systems may be employed, using registers or tracer cards to record the relevant information. Page 8 of 26 3.4.3.5 When making arrangements to move records which contain personal or sensitive information to destinations external to the Trust (including archive storage) consideration needs to be given to security and confidentiality and a means of dispatch chosen that affords an adequate level of security. (See Trust Data Protection Policy for further guidance.) 3.4.4 Record Storage 3.4.4.1 When not required for operational purposes records should be kept in a secure storage area. Records in current use should ideally be stored close to the point of use while records no longer in current use can be transferred to secondary or archive storage more remote from the operational area. 3.4.4.2 Records should be stored in an appropriate environment to ensure they remain fit for purpose during their expected period of retention. When evaluating the suitability of a location for record storage the following points should be considered: Environment. Is the location suitable for the type of material being stored? Is the area free from hazards that may cause the records to deteriorate or place at risk staff that may need to access the records? i.e. excessive dust, damp, restricted access. Security. Is the level of security offered by the location acceptable for the type of record being stored? Ease of Access. Can records be easily located and retrieved? Some restrictions on access may be acceptable for records that are not frequently recalled. Layout. Consideration should be given to the design of the storage location to ensure the most cost effective use is made of the space available. 3.4.4.3 External storage companies provide an alternative to local storage and in the short term can prove a cost effective alternative in areas where record storage space is at a premium. The Trust has negotiated a contract for external record storage with a Restore, a national provider with storage premises located a few miles East of Southampton. Advice on external storage options and alternative strategies such as archiving records to digital formats can be obtained from the Trust records manager. 3.4.4.4 A comprehensive record should be maintained of any records sent for commercial storage including a proposed date for review/destruction. A mechanism for reviewing these records for disposal should be developed and implemented to ensure records are not retained longer than necessary. 3.4.4.5 Digital information should be stored in such a way that throughout the lifecycle it can be recovered in an accessible format. Over time such changes as migration to new formats can cause links to other documents and embedded documents to fail to open impacting the integrity of the record. Any changes to the electronic storage systems used to hold Trust records should only take place after full consideration of the impact on the records held and successful testing of retrieval of transferred records from the new version/system. 3.5 Record Closure and Retention 3.5.1 A record should be closed when the business use for that record ceases. Following closure NHS records are subject to a minimum period of retention. The length of the retention period varies by record type and is based on legal and regulatory requirements and the assessed importance of and likely need to access the type of record. Certain types of corporate records (e.g. finance, meeting records etc) will follow annual cycles with existing records closed following year end and new records created for the new year (calendar or financial). 3.5.2 Page 9 of 26 3.5.3 3.5.4 3.5.5 3.5.6 3.5.7 3.5.8 3.5.9 Paper record folders should be clearly marked with the date of closure and planned review/disposal date. Closed records in electronic storage systems should hold this information as part of the record's metadata and/or the record moved to another area of the system reserved for closed records. For patient care records the recognised date of record `closure' is normally the date of the patient's last attendance for treatment. Where a patient has died subsequent to treatment at the Trust the retention period applicable to deceased patient records (8 years) may be applied from the date of death, if this results in a shorter retention period. Minimum retention periods for NHS and Social Care records are set out in Appendix 3 of the Code of Practice which can be accessed via this link: https://digital.nhs.uk/codes-of-practice-handling-information Periods of retention between 6 months and 20 years are listed for NHS record types organised by functional groups. A list of the NHS record types with minimum retention periods listed in the Code of practice is reproduced at Appendix 3. The majority of adult patient health records are subject to a minimum retention period of 8 years. Health records for Children, Obstetric records, mental health (including psychology) records, and records recording treatment for cancer are all subject to longer periods of retention. The period of retention is measured from the start of the calendar year following the record closure date. e.g. record closed 1 July 2017 subject to 5 year retention period. Period starts 1 Jan 2018 and ends 31 Dec 2022. The code of practice lists minimum periods of retention and in most cases it will be appropriate to destroy records immediately once the period has expired. Retention beyond the recommended period is permitted with good reason but if personal data is held `longer than necessary' the Trust may breach a provision of the Data Protection Act. The Public Records Act 1958 states no public record can be retained after closure for a period in excess of 20 years without permission from the Sec of State for culture Media and Sport. However, a legal exemption applies for individual NHS staff and patient records to meet the extended (20 years plus) periods of retention listed for these records in the Code of Practice. 3.6 Appraisal 3.6.1 When the minimum retention period for a record or set of records has passed it should be subject to an appraisal. The purpose of the appraisal process is to: Identify records of public interest worthy of permanent preservation by transfer to The National Archives or a local Place of Deposit. Identify records to be retained for a longer period To confirm that records not meeting above criteria should be deleted or destroyed. A small percentage of Trust records will meet the criteria for selection for permanent preservation. The preservation of a small subset of key records is designed to enable the public to understand the working of the Trust and the impact on the population it serves and to preserve information likely to have long term research value. The Code of Practice includes guidance on the records that should be considered for preservation in the schedule of minimum retention periods. The suggestions for consideration include Trust Board and other key committee papers, key policies and strategies and records of major building works. 3.6.2 3.6.3 Page 10 of 26 3.6.4 3.6.5 The process of selection of key corporate records for permanent preservation will be managed by the Trust Records manager and the Director of Corporate Affairs who will agree with the Trust's local Place of Deposit (POD), Southampton City Archives, which Trust records merit transfer. Clinical records are problematic to preserve permanently in an archive and due to confidentiality issues personal health records cannot normally be accessed by the public for considerable periods of time following transfer. This does not prevent appropriate sets of clinical records being considered for permanent preservation and the Code of Practice provides some specific guidance on this process. 3.7 Disposal 3.7.1 Following appraisal any records not selected for permanent preservation or a longer retention period should be disposed of. No information should be destroyed if it is the subject of a request under the DPA and/or FOIA or any other legal process, such as an inquest following a death. Paper records should be destroyed securely through a local process of cross cut shredding or using the Trust confidential waste disposal service or other similar secure disposal service. Destruction of digital information is more challenging. At present there are two ways of permanently destroying digital information and these are either: overwriting the media a sufficient number of times or the physical destruction of the media. Further advice about the destruction of digital records can be obtained from the Trust Informatics service. Where decisions are made to destroy/dispose of a series or bulk number of Trust records a record of the decision and the details of the records disposed of should be maintained. 3.7.2 3.7.3 3.7.4 3.8 Additional Guidance on Specific Record Types 3.8.1 E-Mail 3.8.1.1 Personal e-mail accounts tend to be structured according to personal preference and the data stored is not searchable and organised in a systematic way, making e-mail accounts unsuitable for record storage purposes. 3.8.1.2 E-mail accounts should not be used to file records on a permanent basis but should be regarded as transient storage areas for working documents. E-mails or documents distributed by e-mail that need to be retained as Trust records should be copied to the appropriate paper or electronic registered file system and the e-mail copy destroyed as soon as practicable. 3.8.1.3 Where email is declared as a record or as a component of a record, the entire email must be kept including attachments so the record remains integral - for example an email approving a business case must be saved with the business case file. Emails that are the sole record of an event or issue, for example an exchange between a clinician and a patient, should be copied in to the relevant clinical record rather than being simply deleted. 3.8.2 Scanned Records 3.8.2.1 Where paper records are scanned, the main consideration is that the information can perform the same function as the paper counterpart did, and like any evidence, scanned records can be challenged in a court. This is unlikely to be a problem provided it can be demonstrated that the scan is an authentic record and there are technical and organisational means to ensure the scanned records maintain their integrity, authenticity and usability as records, for the duration of the relevant retention period. Page 11 of 26 3.8.2.2 Complying with the standard, `BS 10008 Electronic Information Management Ensuring the authenticity and integrity of electronic information' provides one method of ensuring and demonstrating that electronic information remains authentic. The scanning of Trust patient records for inclusion in the Onbase eDMS patient record system is being carried out in accordance with this standard. 3.8.2.3 For smaller scale local record scanning projects compliance with the full scope of BS 1008 will not be the appropriate methodology. Methods that can be employed to ensure that scanned records can be considered authentic include: A written procedure outlining the process to scan, quality check and any destruction process for the paper record Evidence that the process has been followed An audit trail or secure system that can show that no alterations have been made to the record after the point they have been digitised Fix the scan into a file format that cannot be edited such as Portable Document Format (PDF). 3.8.2.4 Providing scanning is carried out to an acceptable standard with an element of quality assurance included in the process it is Trust policy and normal practice that original documents should be destroyed after scanning. This prevents issues with two versions of the same record existing (original and scanned) and maximises the benefits accruing from scanning paper records. 3.8.2.5 There may be some local exceptions to this practice with appropriate justification. 3.8.3 Staff Records 3.8.3.1 Staff records should hold sufficient information about a staff member for decisions to be made about employment matters. The nucleus of any staff file will be the paperwork collected through the recruitment process and this will be expanded over time with additional material added by line managers. 3.8.3.2 Upon termination of contract, records must be held up to and beyond the staff member's statutory retirement age. On contract termination line managers should return the employees file to HR department for retention until the employee's 75th birthday or 6 years after leaving whichever is the longer. To reduce the burden of storage a summary record may be prepared and held. 3.8.4 Records of non NHS Funded Patients 3.8.4.1 Records of individuals who are not NHS funded held in the Trust record keeping systems must be kept for the same minimum retention periods as other records outlined in this Code. The same levels of security and confidentiality will also apply. 3.8.5 Adopted Persons Health Records 3.8.5.1 The records of adopted persons can only be placed under a new last name when an adoption order has been granted. Before an adoption order is granted, an alias may be used, but more commonly the birth names are used. 3.8.5.2 Depending on the circumstances of the adoption there may be a need to protect from disclosure any information about a third party. Care must be exercised when disclosing records of adopted patients because of the heightened risk of accidental disclosure. 3.8.5.3 It is important that any new records, if created, contain sufficient information to allow for a continuity of care. At present the patients GP will initiate any change of NHS number or identity if it was considered appropriate to do so, following the adoption. The Trust would then make changes to its own records in line with that initiated by the patient's GP. Page 12 of 26 3.8.6 Health Records of Transgender Patients 3.8.6.1 Patients considering or undergoing gender identity change may ask for changes to their name they are known by to be made and in most cases the Trust will agree to such a request. 3.8.6.2 A patient can request that their gender be changed in a record by a statutory declaration, but this does not give them the same rights as those that can be made by the Gender Recognition Act 2004. 3.8.6.3 The formal legal process (as defined in the Gender Recognition Act 2004) is that a Gender Reassignment Certificate is issued by a Gender Reassignment Panel. At this time a new NHS number can be issued and a new record can be created, if it is the wish of the patient. 3.8.6.4 Except in a limited set of circumstances it is an offence under the gender recognition act to disclose without consent information that would identify that a person has undergone a gender identity change. 3.8.6.5 The key to the successful management of records in these circumstances is to discuss with the patient their choices and agree what they wish to happen in respect to their health record. If a new health record is being created there is a need to identify which records are moved into the new record and to discuss how to link any records held in any other institutions with the new record. 4. Roles and Responsibilities 4.1 Chief Executive 4.1.1 As accountable officer the Chief Executive is responsible for the overall leadership and management of the Trust and its performance in terms of service provision, financial and corporate viability, ensuring that the Trust meets all its quality and safety, statutory and service obligations and for working closely with other partner organisations. The CEO delegates aspects of this responsibility to relevant Executive Directors according to their organisational portfolios. 4.2 Director of Transformation and Improvement 4.2.1 The Director of Transformation and Improvement is the appointed Executive Director with responsibility for Information Governance including records management and is the Trust Senior Information Risk Owner (SIRO). The SIRO is responsible for managing information risk in the Trust and will implement and lead the NHS Information Governance risk assessment and management processes within the Trust and advise the Board on the effectiveness of information risk management. 4.2.2 4.3 Caldicott Guardian 4.3.1 The Trust Caldicott Guardian is the Director of Nursing who has a particular responsibility for reflecting patients' interests regarding the use of patient identifiable information. The Trust Caldicott Guardian is responsible for ensuring patient identifiable information is shared in an appropriate and secure manner. The duties and responsibilities of the Trust Caldicott Guardian are outlined in the Trust Confidentiality and Data protection Policy. 4.3.2 Page 13 of 26 4.4 Trust Records Manager 4.4.1 The Trust Records Manager is responsible for ensuring that this policy is implemented and that the records management system and associated processes are developed, co-ordinated and monitored. The Trust Records Manager is also responsible for the overall development and maintenance of health records management practices and promoting compliance with this policy in such a way as to ensure the easy, appropriate and timely retrieval of patient information. 4.4.2 4.5 Local Managers 4.5.1 The responsibility for local records management is devolved to divisional, care group and department heads whom retain overall responsibility for the management of records generated by their activities, i.e. for ensuring that records created within their unit are managed in a way which meets the aims of the Trust's records management policy and associated procedures. 4.6 Clinical Leads and Matrons 4.6.1 Clinical leads in all professions have a responsibility to ensure clinical staff they manage who contribute to patient health records are adequately trained in record keeping and are aware of and adhere to the standards for record keeping outlined in this policy. 4.7 All Staff 4.7.1 Members of Staff who create, receive and use records have records management responsibilities. In particular all staff must ensure that they keep appropriate records of their work in the Trust and manage those records in keeping with this policy and with any guidance subsequently produced. Staff who make entries in medical records should do so in accordance with the clinical record keeping standards published in this policy. In addition Royal Colleges and other professional bodies publish record keeping guidance for clinical staff and it is the responsibility of clinical staff to ensure they keep up to date with and adhere to relevant legislation, case law and national guidance. Related Trust Policies 4.7.2 5. 5.1 The following Trust policies overlap with or relate to matters covered in this policy Information Governance Policy Data Protection and Confidentiality Policy Freedom of Information Policy Access to Records Policy Subject Access Policy IM&T Security Policy Incident Management Policy Patient Information and Corporate Identity Policy Web Publishing Policy 6. Communication Plan Page 14 of 26 6.1 The publication of this updated policy will be highlighted to staff via an article on the news section of `Staffnet', the Trust intranet. The article will draw attention to the key changes made to the previous policy version. 6.2 A copy of this policy will be available for staff to access via the policies section of Staffnet and links to the policy will also be provided within the records management section of the Information Governance pages of Staffnet. 6.3 Elements of record training and procedure form part of the annual training for information governance (now known as data security training) which forms part of the Trusts annual mandatory training requirement. 7. Process for Monitoring Compliance and Effectiveness 7.1 The purpose of monitoring is to provide assurance that the agreed approach is being followed � this ensures we get things right for patients, use resources well and protect our reputation. Our monitoring will therefore be proportionate, achievable and deal with specifics that can be assessed or measured. Key aspects of the procedural document that will be monitored: What aspects of compliance with the document will be monitored Compliance with Record handling best Practice and guidance What will be reviewed to evidence this How and how often will this be done Detail sample size (if applicable) Who will coordinate and report findings (1) Which group or report will receive findings Incidents reported with record related cause codes Medical records procedures for retrieval and tracking Medical Record Keeping Standards Sample or record movements recorded on Trust PAS Entries in sample of Trust inpatient medical records Ongoing monitoring carried out by local governance leads and Trust Records Manager Quarterly audit carried out by Medical Records Manager Annual Audit as part of Trust Clinical Audit programme. N/A Local governance leads and Trust Records Manager Serious breaches will be reported to the Information Governance Steering Group 25 records per quarter Medical Records Manager Information Governance Steering Group 100 records plus Audit managed by Trust Clinical Audit Manager and local Divisional audit leads Clinical Effectiveness Steering Group Where monitoring identifies deficiencies actions plans will be developed to address them. 8. Arrangements for Review of the Policy 8.1 This policy will be subject to formal review three years after publication unless significant changes in legislation or NHS guidance dictate an earlier review. Minor updates will be made as and when required. Page 15 of 26 8.2 If as a result of the full adoption of GDPR legislation into UK law on the 25th May 2018 a further amendment to this policy is required then this will be carried out. See para 1.2.3 above. 9. References Public Records Act (1958) Freedom of Information Act (2000) Data Protection Act (1998) General Data Protection Regulation Records Management Code of Practice for Health and Social Care 2016 Academy of Medical Royal Colleges' Standards for the clinical structure and content of patient records Chancellor's Code of Practice on the management of records issued under section 46 of the Freedom of Information Act (2000). The National Archives BS 10008 Electronic Information Management - Ensuring the authenticity and integrity of electronic information Appendices A. B. C. Record Creation and Filing Procedures Medical Record Keeping Generic Standards Categories of Records listed in NHS Retention Schedule Page 16 of 26 Appendix A to Records Management Policy User Guide to Record Creation Introduction 1. This guide primarily covers records created for non care purposes as the procedure for creating and filing patient records is part of the training given to users of the Patient Administration System. The key principles apply to all records however. 2. Although most records in the Trust are created and stored electronically some paper based record keeping systems are still in use. Most of the guidance provided in this document can be applied to both forms of records but where this is not the case users will need to exercise judgment when applying the guidance. 3. Common types of documents such as letters, meeting minutes, Job Descriptions etc should be always be created using the Trust Word Templates set up for these document types. When creating documents staff should take note of the guidance about document style contained in the Trust Patient Information and Corporate Identity Policy available on the Trust Intranet. 4. All records created in the Trust should be included in a record keeping filing system and be given a unique title or name to identify it. When creating records users need to consider the need for privacy markings and version control. The guidance set out in the following sections addresses these requirements and provides guidance in their application. Record Filing Systems 5. Records created in both electronic or paper form should be organised in some form of registered fling system so they can be easily located when needed and documents of a similar or linked nature are kept together. Filing systems can be created and organised using a variety of methods. Probably the most common method is a simple alphanumeric system whereby records are grouped together in folders that are given unique names. The folders are then organised/ordered in alphanumeric fashion in draws/cabinets (paper records) or within Trust HQ/Divisional/Care Group hard Drives (electronic records) 6. When designing and developing filing systems the following points should be considered: a. b. c. Retain control and continuity by restricting the number of staff who can create new folders in the system. Organise folders and sub folders in a logical manner that will make sense to those who need to access records within them. e.g. organised by function or teams. Give each folder a clear title that describes the contents within. e.g. `MeetingsDiv Board2009', `ComplaintsPatients200804to200906. Avoid names like `General', `Miscellaneous' or personal titles like `Jane's Folder'. (See next section for more details on file names) Within folders records are normally filed in chronological order by date of creation or receipt. It is good practice to clearly stamp on the front or all documents received the date of receipt. Folders in hard copy filing systems should be marked with the date the folder was opened and when closed the date of closure. When files are closed the date when the folder should be reviewed prior to disposal (usually at the end of the minimum retention period) should be added. In electronic filing systems these pieces of information can often be added to the metadata for the folders created. d. e. Page 17 of 26 f. g. A regular programme of reviews should be established to consider the need for closure and disposal of records/folders. The frequency of these reviews will largely depend on the size and growth rate of the filing system. A summary of the responsibilities, organisation and conventions used for each filing system should be set out in a document that is made available to all those who access the system. Folder and File Naming/Referencing Conventions 4. Names for folders and documents should be kept as short as possible whilst also being meaningful. Long file names create long file paths and links which increase the likelihood of error and are more difficult to remember. Avoid using personal names and codes and abbreviations that are not commonly understood. e.g. use `H&SCtteeTOR.doc' in preference to `Health_&_Safety_Comittee_Terms of_Reference.doc' 5. When creating sub folders and files within electronic filing systems there is no need to include in the file name descriptive information already contained in the parent folder as this will already form part of the filename/file path. e.g. use: not: `/.../DivBoard/agenda20100210' `/.../DivBoard/DivBoardagenda20100210 6. Avoid using spaces and underscores in file names. Some software packages have difficulty recognising file names with spaces. Use capital letters to delimit words. e.g. use `AuditMeetingsAgendas.doc' in preference to `Audit_Meetings_Agendas.doc' 7. When using a number in a file name always give it as a two digit number so that when it is displayed in the file directory in alphanumeric order it will be ranked in the correct order. Organised alphanumerically `ab2' will be listed after `ab10'. e.g. V01, V02, V03 etc not V1, V2, V3. 8. If using a date in the file name always state the date `back to front' and use four digit years, two digit months and two digit days: YYYYMMDD or YYYYMM or YYYY or YYYYYYYY. Writing dates in this way will present the records in chronological order in the file list with the latest record at the end of the list. e.g. use `20100201agenda.doc' not `1Feb2010Agenda.doc' 9. The elements of the file name should be ordered in the most appropriate way to retrieve the record. If records are retrieved by date the date element should appear first, if retrieved according to description then this should appear first. e.g. `20100201agenda.doc' (date retrieval) or `agenda20100201' (subject retrieval). Protective Marking of Documents 10. The NHS has agreed a scheme of classification using two privacy markings; Page 18 of 26 a. NHS CONFIDENTIAL. This classification should be used for paper and electronic documents containing personal identifiable clinical or NHS staff information and other sensitive information the compromise of which could lead to serious consequences for the Trust. The marking should be included at the top centre of every page of the document and documents so marked should be held and transported securely at all times. (The term NHS CONFIDENTIAL should never be used on correspondence to a patient.) b. NHS RESTRICTED. This classification should be used to mark all other sensitive information. Documents marked NHS RESTRICTED may also be endorsed with a suitable descriptor indicating the reason for the classification. A list of these descriptors is shown in the table below. The marking should be included at the top centre of every page of the document and documents so marked should be kept in lockable containers. 11. When classifying documents regard should be paid to the requirements of the Freedom of Information Act 2000. Careful consideration should be given to classifying documents that would be normally be published or disclosed on request.. Protective markings should wherever possible only be applied to documents that would be exempt from disclosure. Table 1 Categories of NHS RESTRICTED Documents Category Appointments Barred Board Commercial Contracts For Publication Management Personal Policy Proceedings Definition Concerning actual or potential appointments not yet announced Statutory prohibition on disclosure exists or disclosure would constitute contempt of court. Documents considered by an organisation's Board of Directors, initially in private. Where disclosure would be likely to damage a third party commercial undertaking's processes or affairs Concerning tenders Where it is planned that the information will be published at a future date. Concerning policy and planning affecting the interests of a groups of staff Concerning matters personal to the sender or recipient Issues of approach or direction on which the organisation needs to take decision. Information the subject of or concerned in a legal
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/Media/UHS-website-2019/Docs/Policies/Records-management-policy.pdf
UHS AR 22-23-6
Description
2022/23 Incorporating the quality account University Hospital Southampton NHS Foundation Trust Annual Report and Accounts 2022/23 Presented to Parliament pursuant to Schedule 7, paragraph 25(4)(a) of the National Health Service Act 2006 © 2023 University Hospital Southampton NHS Foundation Trust Contents Welcome from our chair and chief executive 6 Overview and performance 8 Performance report 9 Overview 10 Accountability report 33 Directors’ report 34 Remuneration report 57 Staff report 71 Annual governance statement 91 Quality account 106 Statement on quality from the chief executive 107 Priorities for improvement and statements of assurance from the board 110 Other information 188 Annual accounts 222 Statement from the chief financial officer 223 Auditor’s report 224 Foreword to the accounts 230 Statement of Comprehensive Income 231 Statement of Financial Position 232 Statement of Changes in Taxpayers’ Equity 233 Statement of Cash Flows 234 Notes to the accounts 235 5 Welcome from the Chair and Chief Executive Officer University Hospital Southampton NHS Foundation Trust (‘UHS’ or the ‘Trust’) experienced another challenging year during 2022/23. Nonetheless, the Trust and its staff have continued to deliver for patients and the wider system in which it operates. Trust highlights from 2022/23 include: • Delivering an 8% increase in activity (compared to 2019/20) under the elective recovery programme, which places us as one of the top performing trusts in England. • Being recognised in the NHS staff survey as the seventh highest trust for recommendation as a place to work nationally and the best performing trust in opportunities for career development. • Celebrating 50 years as a medical school with the University of Southampton and continuing to pioneer UK and world-first research studies. • Enhancing the reputation of our specialist care – for example our bone marrow transplant team at UHS have the best patient outcomes in Europe. However, as was the picture across the country, UHS had an extremely challenging winter with attendances at our emergency department often in excess of 400 a day. This was driven in part by high prevalence of streptococcus A (strep A) in the community along with other seasonal illnesses such as influenza and high incidences of COVID-19 at times. Moreover, the lack of availability of care home beds and other care packages in the community has resulted in challenges in discharging patients who are ready to leave hospital and therefore we have been operating at or near to capacity throughout the year. At the time of writing, there continues to be operational pressures due to industrial action by the Royal College of Nursing and British Medical Association. Throughout the disputes, we have attempted to balance the right of our staff to strike with the need to minimise the impact on the Trust’s operations and patients and ensure that safety was not compromised. Our leadership team has engaged proactively with the unions to agree, where possible, derogations (i.e. services that will continue to be staffed during strikes) to ensure that the running of our hospitals can continue and that patients remain safe. We would like to express our thanks to all staff who have gone over and above during these periods of industrial action by being willing to do different work to usual, often at anti-social times of the day. While we cannot influence national negotiations, we are focusing on what we can control within UHS. Our people strategy published last year sets out how we will grow and deploy our workforce of today and the future as part of a thriving community to deliver world-class patient care. Building on this, we have recently launched our inclusion and belonging strategy so that as a leadership team we can deliver what is required for all our workforce to feel they can belong and thrive at UHS. The Trust achieved its Cost Improvement Plan (CIP) target of £45.6m for 2022/23, the highest in our history but despite this, ended the year with a deficit of £11m. The deficit was driven by a combination of factors including a substantial increase in energy prices, higher costs of medicines and equipment and temporary staffing costs as well as changes in recent years in respect of the NHS funding infrastructure, which adversely impacted the Trust relative to others during the year. In terms of the broader context, the Hampshire and Isle of Wight Integrated Care System, in which the Trust operates, reported an overall deficit for 2022/23 driven in part by a significant increase in staffing numbers when compared to 2019/20 as well as structural factors. 6 We have continued to make progress on our estates strategy, building new theatres and carrying out improvements to existing facilities, as well as opening a new park and ride for staff at Adanac Park and progressing plans for a new innovation campus there. During 2022/23 we invested over £88m of capital expenditure to meet our ambition of increasing capacity and improving services in order to manage the increasing demand. All development is underpinned by our green plan, which sets out areas of focus for decarbonising UHS and achieving the net zero target set by the NHS. The Trust has continued to support the Hampshire and Isle of Wight Integrated Care System, which was formed on 1 July 2022 to facilitate integration and collaboration across health and social care partners in the region. In particular, UHS has worked closely with the Integrated Care Board and other providers in the development of the operating plan for 2023/24. We have also continued to work with other partners in the region, including local authorities and the University of Southampton. The 13,000 staff of UHS are our greatest asset and we would like to express our gratitude to them for continuing to go above and beyond to put patients first under very challenging circumstances. Without our staff, we would be unable to fulfil our ambition to be a world-class organisation with world-class people delivering world-class care. Jenni Douglas-Todd Chair 26 June 2023 David French Chief Executive Officer 26 June 2023 7 PERFORMANCE REPORT Performance report Introduction from the Chief Executive Officer The Trust experienced another challenging year with the need to balance the delivery of quality patient care with a significant increase in demand for the Trust’s resources and the need to do so whilst maintaining a sustainable financial position. The Trust saw the number of patients on a waiting list under the 18-week referral to treatment pathway increase to just over 55,000 patients at the end of the year. Despite this, however, the Trust was successful in reducing the number of patients waiting more than 104 weeks to nil and in reducing the number of patients waiting more than 78 weeks to 14 by the end of the year. In addition, the Trust’s performance under the elective recovery programme placed it as one of the topperforming trusts in the country. Demand for non-elective care also significantly increased during the year with the emergency department seeing more than 400 attendances per day at some points, especially during the winter months. The industrial action seen in the latter part of 2022/23 placed further pressure on the Trust and resulted in a need to cancel elective procedures and outpatients appointments. However, on balance, the Trust was able to manage these events through effective planning and the engagement and support of its staff. Although the Trust was successful in recruiting to substantive roles, especially in terms of reducing the number of Health Care Assistant vacancies, the anticipated reduction in use of bank and agency staff was not seen. This, among other factors, such as the substantial increase in energy costs and the rate of inflation, posed a significant challenge in terms of the Trust’s financial position. Despite achieving savings of £45.6m, the Trust reported a deficit of £11m for 2022/23. 9 Overview About the Trust Our services University Hospital Southampton NHS Foundation Trust is one of the largest acute teaching trusts in England with a turnover of more than £1 billion in 2022/23. It is based on the coast in southeast England and provides services to over 1.9 million people living in Southampton and south Hampshire and specialist services, including neurosciences, respiratory medicine, cancer care, cardiovascular, obstetrics and specialist children’s services, to more than 3.7 million people in central southern England and the Channel Islands. The Trust is also a designated major trauma centre, one of only two places in the south of England to offer adults and children full major trauma care provision. As a leading centre for teaching and research, the Trust has close working relationships with the University of Southampton, the Medical Research Council, National Institute for Health and Care Research (NIHR), Wellcome Trust and Cancer Research UK. The Trust is consistently one of the UK’s highest recruiting trusts of patients to clinical trials and one of the top nationally for research study volumes as ranked by the NIHR Clinical Research Network. Every year the Trust: treats around 160,000 inpatients and day patients, including about 75,000 emergency admissions sees over 650,000 people at outpatient appointments deals with around 150,000 cases in our emergency department delivers more than 100 outpatient clinics across the south of England, keeping services local for patients The Trust provides most of its services from the following locations: • Southampton General Hospital – the Trust’s largest location, where a great number of specialist services are based alongside emergency and critical care and which includes Southampton Children’s Hospital. • Princess Anne Hospital – located across the road from Southampton General Hospital and providing maternity care and specialist care for women with medical problems during pregnancy and babies who need extra care around birth across the region. • Royal South Hants Hospital – although the Trust does not operate this site near the centre of Southampton it provides a smaller number of services from this location. • New Forest Birth Centre – located at Ashurst on the edge of the New Forest and run by experienced midwives and support staff it acts as a community midwifery hub. The services provided by the Trust are commissioned and paid for by the Hampshire and Isle of Wight Integrated Care System (ICS) and, in the case of more specialised services (such as treatments for rare conditions), by NHS England. Trust services are supported by clinical income, of which 55% is paid for by NHS England and 43% by the Hampshire and Isle of Wight Integrated Care Board. These are provided under a standard NHS contract, which incorporates ongoing monitoring of the Trust and the quality of the services provided. 10 Our structure UHS gained foundation trust status on 1 October 2011. A foundation trust is a public benefit corporation providing NHS services in line with the core NHS principles: that care should be universal, comprehensive and free at the point of need. The Trust is licensed as a foundation trust to provide these services by NHS England and the healthcare services we provide are regulated by the Care Quality Commission. Since 1 July 2022, the Trust has been part of the Hampshire and Isle of Wight Integrated Care System (ICS) when this was established through the Health and Social Care Act 2022. Each ICS has two statutory elements: an integrated care partnership (ICP) and an integrated care board (ICB). The ICP is a statutory committee jointly formed between the NHS integrated care board and all uppertier local authorities that fall within the ICS area. The ICP will bring together a broad alliance of partners concerned with improving the care, health and wellbeing of the population, with membership determined locally. The ICP is responsible for producing an integrated care strategy on how to meet the health and wellbeing needs of the population in the ICS area. The ICB is a statutory NHS organisation responsible for developing a plan for meeting the health needs of the population, managing the NHS budget and arranging for the provision of health services in the ICS area. The establishment of ICBs resulted in clinical commissioning groups (CCGs) being closed down. The Trust has been a university teaching hospital since 1971. The diagram below provides an overview of the overall organisational structure of the Trust. Division A Surgery Critical Care Opthalmology Theatres and Anaesthetics Public and foundation trust members Council of Governors Board of Directors Executive Directors Division B Division C Division D Cancer Care Emergency Medicine Helicopter Emergency Medical Services Medicine and Medicine for Older People Pathology Specialist Medicine Women and Newborn Maternity Child Health Clinical Support Cardiovascular and Thoracic Neurosciences Trauma and Orthopaedics Radiology Trust Headquarters Division 11 Our values Our values describe how we do things at UHS and act as a guide to all staff working with colleagues to deliver high quality patient care and a great patient experience every day. Our values are: Patients, their families and carers are at the heart of what we do. Their experience of our services will be our measure of success. Partnership between clinicians, patients and carers is critical to achieving our vision, both within hospital teams and extending across organisational boundaries in the NHS, social care and the third sector. We will ensure we are always improving services for patients through research, education, clinical effectiveness and quality improvement. We will continue to incorporate new ideas, technologies and create greater efficiencies in the services we provide. 12 Our strategy 2021-25 The Trust’s strategy was updated during 2020/21 to take account of everything our staff had experienced during the COVID-19 pandemic and what we had learnt from this. The vision for UHS is to become an organisation of world class people delivering world class care. Our strategy is organised around five themes and for each of these it describes a number of ambitions we aim to achieve by 2025. Theme Ambitions Outstanding patient outcomes, • We will monitor clinical outcomes, safety and experience of our experience and safety patients regularly to ensure they are amongst the best in the UK By 2025 we will strengthen our and the world. national reputation for outstanding • We will reduce harm, learning from all incidents through our patient outcomes, experience and proactive patient safety culture. safety, providing high quality care • We will ensure all patients and relatives have a positive experience and treatment across an extensive of our care, as a result of the environment created by our people range of services from foetal and our facilities. medicine, through all life stages and conditions, to end-of-life care Pioneering research • We will recruit and enable people to deliver pioneering research in and innovation Southampton. We will continue to be a leading teaching hospital with a growing, reputable and innovative research and development portfolio • We will optimise access to clinical research studies for our patients. • We will enable innovation in everything we do, and ensure that ‘cutting edge’ investigations and treatments are delivered in Southampton. that attracts the best staff and efficiently delivers the best possible treatments and care for our patients. World class people • We will recruit and develop enough people with the right Supporting and nurturing our knowledge and skills to meet the needs of our patients. people through a culture that values • We will provide satisfying and fulfilling roles, growing our talent diversity and builds knowledge and through development and opportunity for progression. skills to ensure everyone reaches • We will empower our people, embracing diversity and embedding their full potential. We must provide compassion, inclusion and equity of opportunity. rewarding career paths within empowered, compassionate, and motivated teams. Integrated networks and collaboration We will deliver our services with partners through clinical networks, collaboration and integration across geographical and organisational boundaries. • We will work in partnership with key stakeholders across the Hampshire and Isle of Wight integrated care system. • We will strengthen our acute clinical networks across the region, centralising when necessary and supporting local care when appropriate. • We will foster local integration with primary and community care as well as mental health and social care services for seamless delivery across boundaries. • We will build on our successful partnership with University of Southampton (UoS), growing our reputation as a national leading university teaching hospital. 13 Theme Foundations for the future Making our enabling infrastructure (finance, digital, estate) fit for the future to support a leading university teaching hospital in the 21st century and recognising our responsibility as a major employer in the community of Southampton and our role in broader environmental sustainability. Ambitions • We will deliver best value to the taxpayer as a financially efficient and sustainable organisation. • We will support patient self-management and seamless care across organisational boundaries through our ambitious digital programme, including real time data reporting, to inform our care. • We will expand and improve our estate, increasing capacity where needed and providing modern facilities for our patients and our people. • We will strengthen our role in the community as an employer of choice, a partner in delivery of services to our population and by leading the Greener NHS agenda locally. During each year of the strategy the Trust sets out a more detailed series of objectives to achieve and progress towards the delivery of its ambitions. In 2022/23 these objectives included: Outstanding patient outcomes, experience and safety Pioneering research and innovation World class people Integrated networks and collaboration Foundations for the future • Recovery, restoration and improvement of clinical services • Introducing a robust and proactive safety culture • Empowering and developing staff to improve services for patients • Always Improving strategy • Delivering a high-quality experience of care for all • Delivery of year two of the research and innovation investment plan • Strategy and partnership working • Growing, developing and innovating our workforce • A great place to work, develop and achieve • Compassionate and inclusive workplace for all • We Work in partnership with Integrated Care System and Primary Care Networks • Integrated Networks and Collaborations • Establishing Southern Counties Pathology Network • Establishing the Wessex Imaging Network • Develop Collaborations strategy • Creating a sustainable financial infrastructure • Making our corporate infrastructure fit for the future to support a leading university teaching hospital in the 21st century • Recognising our responsibility as a major employer in the community of Southampton and our role in delivering a greener NHS Performance against these objectives will be monitored and reported to the Trust’s Board on a quarterly basis. 14 Principal risks to our strategy and objectives The Board has identified and manages the principal risks to the delivery of its strategy and objectives through its board assurance framework. The principal risks to the delivery of its strategy and objectives identified by the Trust during 2022/23 were that: • There would be a lack of capacity to appropriately respond to emergency demand, manage the increasing waiting lists for elective demand, and provide timely diagnostics, that results in avoidable harm to patients. • Due to the current challenges, the Trust fails to provide patients and their families with a high-quality experience of care and positive patient outcomes. • The Trust would not effectively plan for and implement infection prevention and control measures that reduce the number of hospital-acquired infections and limit the number of nosocomial outbreaks of infection. • The Trust is unable to meet current and planned service requirements due to unavailability of qualified staff to fulfil key roles. • The Trust fails to develop a diverse, compassionate and inclusive workforce, providing a more positive experience for all staff. • The Trust fails to create a sustainable and innovative education and development response to meet the current and future workforce needs identified in the Trust’s longer-term workforce plan. • The Trust does not implement effective models to deliver integrated and networked care, resulting in sub-optimal patient experience and outcomes, increased numbers of admissions and increases in patients’ length of stay. • The Trust is unable to deliver a financial breakeven position and support prioritised investment as identified in the Trust’s capital plan within locally available limits (capital departmental expenditure limit (CDEL)). • The Trust does not adequately maintain, improve and develop its estate to deliver its clinical services and increase capacity. • The Trust fails to introduce and implement new technology and expand the use of existing technology to transform its delivery of care through the funding and delivery of the digital strategy. • The Trust fails to prioritise green initiatives to deliver a trajectory that will reduce its direct and indirect carbon footprint by 80% by 2028-2032 (compared with a 1990 baseline) and reach net zero direct carbon emissions by 2040 and net zero indirect carbon emissions by 2045. During 2022/23, the Trust continued to experience the impact of the COVID-19 pandemic. The need to ensure a safe environment for patients through stringent infection control processes impacted the Trust’s capacity due to the need to isolate patients with COVID-19 in separate areas of the hospital. In addition, outbreaks of norovirus during the winter months placed further pressure on hospital capacity. The impact of the pandemic continued to be felt in terms of staff absence due to becoming infected with COVID-19 as well as the significant impact on staff mental health. The higher than normal (i.e. pre-COVID) levels of staff absence placed additional strain on the Trust’s operations and led to increased expenditure due to the requirement to enlist bank and/or agency staff to maintain safe staffing levels. 15 Performance overview The Trust monitors a broad range of key performance indicators within its departments, divisions, directorates and through Trust executive committees. On a monthly basis, the Board and executive committee receives a performance report containing a variety of indicators intended to provide assurance in respect of the Trust’s strategy and that the care provided is safe, caring, effective, responsive and well-led. This report also includes the Trust’s performance against the national targets set by NHS England. The performance reports include a ‘spotlight’ section, which provides more detailed analysis of a particular area. Typically, this is one of either the national targets or the Trust’s performance against the expectations set out in the NHS Constitution. The monthly performance report is also published on the Trust’s website. The Chief Executive Officer provides a regular report on performance to the Council of Governors, which includes a range of non-financial and financial performance information. Capacity The pressures of the COVID-19 pandemic led to increases in the waiting times for patients and the number of patients waiting for more than a year increased significantly. During the year, the Trust achieved its goal of no patients waiting more than 104 weeks by July 2022 and finished the year with only 14 patients waiting for more than 78 weeks. However, the length of time patients are waiting for treatment remains one of the key risks for the Trust. This situation was compounded by the sustained demand for non-elective activity, which saw attendances at the emergency department rise to over 400 patients per day during some periods of 2022/23 and was consistently higher than previously was the case. The significant increase in referrals, often requiring more complex treatment, has seen the number of patients on a waiting list under the 18-week referral to treatment pathway increase to just over 55,000 patients at the end of the year. In addition, the industrial action during the year placed further strain on the Trust’s ability to both provide urgent care and manage its elective recovery programme. Quality and compliance Furthermore, difficulties in obtaining care home beds and other care packages in the community has resulted in challenges in discharging patients who are ready to leave hospital and therefore the Trust has been operating at or near to capacity throughout the year. The Trust continued to monitor the quality of care delivered throughout 2022/23. The Trust continued its focus on infection prevention and control, which had proven successful during the COVID-19 pandemic. The Trust progressed its Always Improving strategy and successfully supported the identification and implementation of 84 quality improvement projects. In addition, the Trust continued to implement the patient safety incident response framework as well as taking other steps to drive a safety culture within the organisation. Furthermore, the Trust conducted further trials of shared decision making between clinicians and patients and is a leading site nationally for shared decision-making principles. Further information can be found in the Quality Account. 16 Partnerships The new arrangements for integrated care systems were implemented in July 2022 with the Trust becoming part of the Hampshire and Isle of Wight Integrated Care System. As such, the Trust’s senior management frequently meets with peers from across the system to consider and agree matters of wider concern across the system. In addition, the Trust worked with the Integrated Care Board in order to develop its financial and capital plans for 2023/24 and beyond. The Trust also attends the Southampton Health and Wellbeing Board at Southampton City Council and in the Hampshire and Isle of Wight Acute Provider Partnership Board. During 2022/23, the Trust continued to progress research activities and opportunities with the University of Southampton and Wessex Health Partners. Workforce In addition, work continued in the development of an elective hub at Winchester with Hampshire Hospitals NHS Foundation Trust, which will provide the Trust with additional capacity to carry out its elective programme. The Trust’s key areas of focus during 2022/23 were in respect of increasing the substantive workforce and reducing staff turnover. Although the Trust was successful in recruiting to substantive posts, the expected reduction in reliance on bank and agency staff did not materialise, which meant that the Trust was 1,068 whole-time equivalents above its plan for 2022/23. Included in this figure is the TUPE transfer of genomics staff from Salisbury. A particular area of focus was the recruitment of Health Care Assistants where the Trust was successful in reducing the number of vacancies from 27% to 18%. Whilst the Trust was successful in reducing staff turnover from 14.9% in 2021/22 to 13.5%, it remained above the 12% target. However, the Trust did experience a reduction in staff absence from 4.7% in April 2022 to 4.3% in March 2023, and initiatives to improve staff wellbeing were an area of focus during the year. Estate Innovation and technology The industrial action in late 2022 and early 2023 posed significant challenges for the Trust, including in terms of the need to engage additional temporary staff to ensure patient safety. The Trust continued to invest in and develop its estate during 2022/23 including successful completion of the Paediatric Intensive Care Unit project, which delivered single rooms and specialist accent lighting alongside delivery of a ‘twin care’ room. There were a number of other significant projects during the year, including refurbishments of wards and work on creating new theatres as well as projects to improve staff wellbeing. These were part of over £88m of capital expenditure in 2022/23 that also included equipment, digital and the backlog maintenance programme. The Trust continued to promote research and development during 2022/23, including through partnerships with the University of Southampton and Wessex Health Partners. Furthermore, the Trust continued to examine ways to make use of technology to improve its service delivery. In particular, the Trust has promoted the use of MyMedicalRecord, which gives patients the ability to co-manage their healthcare online and through an app. 17 Sustainable financial model The Trust did not achieve breakeven status at the end of 2022/23 and reported a deficit of £11.037m at year-end. This was due to a number of factors, including the Trust’s underlying deficit as well as the increase in energy prices. The Trust was more exposed than most to fluctuations in the wholesale price of gas due to its reliance on a gas-powered energy supply. In addition, the Trust’s 8% uplift in elective activity when compared to 2019/20 was not fullyfunded, which placed further pressure on the Trust’s existing financial resources, which had been used to ensure a breakeven position in 2021/22. The continued use of bank and agency staff as well as the costs of industrial action in late 2022 and early 2023 further eroded the Trust’s financial position. Notwithstanding the above, the Trust did succeed in obtaining a number of sources of nonrecurrent funding during the year, including a successful bid for £29.4m of funding through the Public Sector De-Carbonisation Fund, which will be used to fund green initiatives as part of the Trust’s capital programme. The financial outlook across the NHS continues to appear very challenging during 2023/24 and the Hampshire and Isle of Wight Integrated Care System is forecasting one of the highest deficits in England. 18 Performance analysis COVID-19 Impacts Although the pandemic has ended and serious cases of COVID-19 have reduced significantly, the Trust continued to be impacted by COVID-19 during 2022/23. Heightened infection prevention control measures in respect of patients with COVID-19 placed additional stress on the Trust’s capacity due to the need to isolate those patients and there was a consequential reduction in the Trust’s ability to make most efficient use of its available spaces. Furthermore, the ongoing impact on the Trust’s staff has led to higher staff absence than was the case prior to the pandemic, particularly due anxiety, infectious diseases and colds and flu. • The Trust experienced an average number of 98.7 patients per day who tested positive for COVID-19. During the winter months, this number increased substantially to nearly 200. • During the year, an average of 3.6 intensive care/high-dependency beds per day were occupied by COVID-19 patients. However, at times this increased to as much as ten. • Although staff sickness rates remained higher than pre-pandemic, the Trust saw a decrease in the absence rate from 4.7% at the beginning of 2022/23 to 4.3% by the end of the period. COVID-19 Cases UHS average number of confirmed COVID-19 patients in bed (08:00 census) 250 200 150 100 50 0 4/1/20225/1/2022 6/1/20227/1/2022 8/1/2022 9/1/202210/1/202211/1/202212/1/2022 1/1/2023 2/1/20233/1/2023 Intensive care/higher care beds UHS average number of confirmed COVID-19 patients in an ICU/HDU bed (08:00 census) 12 10 8 6 4 2 0 4/1/20225/1/2022 6/1/20227/1/2022 8/1/2022 9/1/202210/1/202211/1/202212/1/2022 1/1/2023 2/1/20233/1/2023 19 Number of patients Emergency access through the emergency department The Trust continued to experience high demand from patients presenting to receive care in the emergency department throughout the year above that seen prior to the COVID-19 pandemic. In particular, during the period between January and March 2023, the Trust averaged 352 attendances per day compared to 301 during the same period in 2019/20, an increase of 17%. The Trust also saw a significant increase in attendances during December due to both seasonal illnesses, but also due to the prevalence of streptococcus A in the community with attendances sometimes over 400 per day. Furthermore, the industrial action during the latter part of 2022 and early 2023 placed further pressure on the Trust’s ability to deliver services. In addition, the difficulties in discharging patients in need of care either at home or in another setting resulted in reduced flow from the emergency department to the relevant ward(s), which placed further strain on the Trust’s performance. During the year, in order to reduce emergency department attendances, the Trust trialled using General Practitioners to triage and see more straightforward patients who would otherwise have presented to the emergency department. Although this trial did result in a slight reduction in terms of number of patients and waiting times in ambulatory majors and majors, the affordability and value for money of this scheme is under review. Number of patients presenting to the emergency department 16,000 14,000 12,000 10,000 8,000 6,000 4,000 2,000 0 Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-22 Oct-22 Nov-22 Dec-22 Jan-23 Feb-23 Mar-23 As a result of the increase in demand upon the emergency department, there continued to be a significant adverse impact on timeliness of care. The Trust failed to meet the national target of 95% of main emergency department/type 1 attendances seen within four hours, achieving 64.5% in March 2023, although this performance was above average in England. 20 % standard met Emergency access 4hr standard UHS vs NHSE average Type 1 performance 70% 0 10 60% 20 50% 30 40 40% 50 Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-2 2 Oct-22 Nov-22 Dec-22 Jan-23 Feb-2 3 Mar-23 UH S NHSE average UHS rank amongst NHSE trusts Rank Ambulance handovers are an area of focus for NHS England, with a target of all handovers having to take place within 15 minutes and none waiting more than 30 minutes. The Trust performed well in this area with an average handover time of 17 minutes, having made the conscious decision to ensure that patients did not queue in ambulances at the expense of patients being queued within emergency department majors – thus impacting the Trust’s four-hour target, but meaning that ambulances were not queued outside the hospital as was seen in other areas of the country. Elective Waiting times Demand The year saw a continuation of the trend of increasing elective referrals experienced in 2021/22 following the pandemic, and referral rates continued to be above those seen prior to the pandemic. UHS Accepted Referrals 30,000 25,000 20,000 15,000 10,000 5,000 0 Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-2 2 Oct-22 Nov-22 Dec-22 Jan-23 Feb-2 3 Mar-23 Number of accepted referrals 21 Activity The Trust experienced significant increases in terms of the number of hospital appointments, diagnostic tests and elective admissions during the year, exceeding levels in previous years. The Trust was one of the top performing trusts in terms of its elective recovery programme, achieving an 8% increase in its elective activity during the year when compared to 2019/20. However, performance in this area and in terms of outpatients appointments was negatively affected by the industrial action by nurses, junior doctors and other members of staff, which took place in late 2022 and early 2023 due to the need to cancel non-urgent procedures and appointments in favour of maintaining safe staffing levels in areas such as the emergency department. In addition, the continued presence of COVID-19 as well as other illnesses such as influenza and norovirus placed significant pressure at times on the Trust’s capacity due to the need to implement appropriate infection prevention control measures. Furthermore, difficulties in discharging patients fit to be discharged, but in need of a care package, placed additional strain on the Trust’s capacity. Elective admissions (including day case) Post-COVID-19 pandemic Elective (including day case) recovery (% of same month compared between March 2019 – February 2020) 105% 100% 95% 90% 85% 80% 75% Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-22 Oct-22 Nov-22 Dec-22 Jan-23 Feb-23 % recovery Outpatient attendances Post-COVID-19 pandemic outpatient seen recovery (% of same month compared between March 2019 – February 2020) 140% 0 90% 10 20 40% 30 Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-22 Oct-22 Nov-22 Dec-22 Jan-23 Feb-23 UH S UHS rank amongst NHSE trusts % recovery Rank 22 Diagnostics The Trust measures performance on a total of 15 frequently used diagnostic tests. In March 2023, 22% of patients were waiting more than six weeks for diagnostics compared with the national target of less than 1%. Patients waiting for a diagnostic test to be performed (sum of 15 different frequently used tests) UHS diagnostic waiting list volume 12,000 11,500 11,000 10,500 10,000 9,500 Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-2 2 Oct-22 Nov-22 Dec-22 Jan-23 Feb-2 3 Mar-23 Diagnostic waiting list volume Percentage of patients waiting over 6 weeks for a diagnostic test to be performed Diagnostic 6 week wait performance UHS vs. NHSE average 35% 30% 25% 20% 15% 10% 5% 0% Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-22 Oct-22 Nov-22 Dec-22 Jan-23 Feb-23 Mar-23 UH S NHSE average % standard met 23 Referral to Treatment The Trust continued to see an increase in the number of patients being referred for treatment during 2022/23 with just over 55,000 patients on a waiting list under the 18-week referral to treatment pathway at the end of the year. Averaged across the year, the volume of referrals exceeded the Trust’s theoretical capacity by around 3.5%. Due to this significant demand, the Trust only achieved 63.2% of patients being treated within 18 weeks of referral in March 2023 compared with the monthly target of more than 92%. However, despite this, the Trust remained in the top quartile when compared to other teaching hospitals, reflecting that this growth in demand continues to be a national challenge. During 2022/23, the national target was to ensure that there were no patients waiting over two years for treatment by July 2022, and that there were no patients waiting more than 78 weeks by the end of March 2023. Long-waiting patients were an area of particular focus for the Trust during the year with no reported two-year waits since November 2022 and only two between the period June-November due to patients choosing to delay their treatment. This was a significant improvement compared to the peak of 171 patients reported in December 2021. Similarly, the Trust made progress in reducing the number of patients waiting over 78 weeks for treatment. In February 2023, the Trust reported 84 patients in this category compared to the peak of over 900 patients in September 2021. By the end of March 2023, the Trust had managed to further reduce this number of patients to 14, with those in breach of the target all due to the complexity of the cases. UHS referral to treatment waiting list 56,000 54,000 52,000 50,000 48,000 46,000 44,000 Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-22 Oct-22 Nov-22 Dec-22 Jan-23 Feb-23 Mar-23 24 Number on waiting list % standard met Percentage of patients waiting up to 18 weeks between referral and treatment RTT 18 week performance UHS vs. NHSE average 70% 65% 60% 55% 50% Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-22 Oct-22 Nov-22 Dec-22 Jan-23 Feb-23 Mar-23 UH S NHSE average Percentage of patients waiting more than 52 weeks between referral and commencement of a treatment for their condition Number of patients Rank UHS Referral to treatment patients waiting more than 52 weeks 3,000 0 2,500 10 2,000 20 1,500 30 1,000 40 500 50 0 60 Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-22 Oct-22 Nov-22 Dec-22 Jan-23 Feb-23 Mar-23 UH S UHS rank amongst NHSE trusts % of RTT patients RTT % of patients waiting more than 52 weeks UHS vs. NHSE average 5.0% 0 4.5% 20 40 4.0% 60 3.5% 80 Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-22 Oct-22 Nov-22 Dec-22 Jan-23 Feb-23 Mar-23 UH S UHS rank amongst NHSE trusts Rank 25 % standard met Cancer Waiting Times The Trust is one of 12 regional cancer centres in the UK offering treatment for rare and complex cancers as well as cancer in children and brain cancer. The Trust has historically been in the upper quartile, relative to teaching hospital peers. Due to loss of key members of staff and industrial action, the Trust’s performance has slipped over the year with 72.5% of patients seen within two weeks in March 2023 following referral by a General Practitioner for suspected cancer (national target: > 93% per month). Cancer waiting times - 2 week wait performance UHS vs NHSE average 100% 0 80% 50 60% 100 40% 150 Apr-22May-22 Jun-22 Jul-22 Aug-22 Sep-22 Oct-22 Nov-22 Dec-22 Jan-23 Feb-23Mar-23 UH S NHSE average UHS rank amongst NHSE trusts Rank Referrals for January to March 2023 were at the highest for that month for the past five years and overall referral volumes in 2022/23 averaged 2,049 patients per month, 8% higher than in 2021/22 and 28% higher than in 2019/20. The national target was for 96% of patients to commence treatment within 31 days of diagnosis. However, in March 2023, the Trust only achieved 87.9%, but this figure hides considerable variation dependent on the tumour site and type of cancer with a range of 100% for haematology and children’s cancers to 71% for skin. The high rate of referrals led to a significant backlog in terms of patients waiting longer than 62 days for treatment. However, the Trust took steps to reduce this backlog by more than 50% through a dedicated recovery programme. In March 2023, the Trust treated 54.8% of patients within 62 days of referral compared to the target of more than 85%. Treatment for Cancer within 62 days of an urgent GP referral to hospital Cancer waiting times 62 day RTT performance UHS vs. NHSE average 80% 60% 40% 20% 0% Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-22 Oct-22 Nov-22 Dec-22 Jan-23 Feb-23 Mar-23 UH S NHSE average % standard met 26 First definitive treatment for cancer within 31 days of a decision to treat % standard met Cancer waiting times 31 day RTT performance UHS vs. NHSE average 95% 90% 85% 80% 75% Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-22 Oct-22 Nov-22 Dec-22 Jan-23 Feb-23 Mar-23 UH S NHSE average Quality priorities The Trust set eight quality priorities in 2022/23, which were aimed at ensuring it continued to deliver the highest quality of care. The quality priorities were shaped by a range of national and regional factors as well as local and Trust‐wide considerations. The Trust recognised the overriding issues of significant operational pressures being felt right across the health and social care system, including those associated with the previous two years of the COVID-19 pandemic. The challenge was to deliver the best quality care in the context of these operational pressures, and the Trust set its quality priorities accordingly. Out of the eight priories set, the Trust achieved five and partially achieved three. Priority One: Enhancing capability in Quality Improvement (QI) through our Always Improving strategy The transformation team has grown to over thirty team members including project support officers, project managers, benefit realisation managers. This has allowed the Trust to develop that systematic organisational approach to guide and support its staff in their QI projects. The Trust originally set a target of delivering fifty quality improvement projects but have successfully supported a total of 84 (55 local and 29 flow improvements). These are local change projects which were identified, proposed, led, and delivered by the people who do the work. To date over 1500 people have been trained in the Trust’s improvement approach, which exceeds the original target of 500. The Trust also developed a QI project register and held an Always Improving conference. Priority Two: Developing a culture of kindness and compassion to drive a safety culture The Trust only partially achieved this priority as plans to fully deliver training were affected by operational pressures. However, during the year a variety of communication platforms were used to make sure staff understood the Trust’s vision and were kept up to date with plans and progress. The Trust worked to develop and embed a ‘just culture’ allowing staff to speak up and ask, “what happened and how do we learn?” and developed ‘stop for safety’ staff huddles. Priority Three: We will improve mental health care across the Trust including support for staff delivering care The Trust only partially achieved this priority as several key quality improvement projects have not yet been delivered, and the mental health strategy not yet been finalised. However, a training needs analysis was completed and significant staff training and an education scheme were introduced in response to the findings of the analysis. Mental health champion training has been delivered to 153 staff and IT systems have been improved to help capture vital data to help shape the Trust’s service. 27 Priority Four: Recognising and responding to deterioration in patients During 2021/22 the Trust successfully introduced national Paediatric Early Warning System (nPEWS) into its Southampton Children’s Hospital and UHS is now part of the national test and trial of nPEWS which is assessing the usability of the scoring system. The Trust has also explored how nPEWS can be adapted for children with complex medical conditions requiring interventions (including non-invasive ventilation) as part of their normal care. A daily heat map of escalation times over a 24-hour period was piloted in 2022 and will be rolled out across all adult’s inpatient areas during 2023. The Trust has also performed well with its cardiac arrest audits, and training and education programmes have consistently been delivered. September 2022 saw the implementation of a 24-hour paediatric outreach service. There is a deteriorating patient group and several successful QI projects have been introduced. Priority Five: Improving how the organisation learns from deaths The Trust only partially achieved this priority as it has been unable to establish a learning from deaths steering group. The Trust has introduced a mortality governance coordinator/analyst and grown its bereavement care service. Priority Six: Shared Decision Making (SDM) The shared decision models started at UHS in 2021/22 and have continued to grow with investment in pilot roles to expand these models, which include several advanced nurse practitioner roles, models in paediatrics bringing Shared Decision Making to patients who are transitioning from paediatric to adult services, while in maternity we have introduced SDM in birth planning. When assessing delivery of SDM against NICE guidelines, UHS performs well, especially in targets related to Trust buy-in, governance and practices of pilot areas. This year the Trust has implemented training through key platforms and expanded patient involvement in the project. As a leading site nationally for SDM principles, UHS have worked with NHS England on creating materials for others to learn from. Priority Seven: Working with our local community to expose and address health inequalities During the year the Trust refocused its efforts on making sure that its involvement and participation activities support the health inequalities agenda, while also working to deliver responsive information and advice to patients, carers, and families. Priority Eight: Ensure patients are involved, supported, and appropriately communicated with on discharge During the year the Trust has focused on improved patient, carer and family involvement, and improved communication during the discharge process as well as prompting a more collaborative working between social and health care staff. Strong partnership working with external agencies has been developed to support a system approach to hospital discharge, develop digital solutions, develop the patient hub to support discharge and delivered education to UHS staff. More information can be found about how the Trust delivered and measured its quality priorities, including feedback from patients and staff and improvement aims and quality priorities for 2023/24, in the Trust’s Quality Account for 2022/23. 28 Financial performance The Trust delivered a deficit of £11 million from a revenue position of over £1.2 billion, once items deemed as “below the line” by NHS England, such as the financial position of the Southampton Hospitals Charity, were removed. The Trust was unable to deliver the planned breakeven position. Several material cost pressures were incurred, including unfunded high-cost drugs costs and energy prices. These were unable to be off set in full by a savings programme, despite delivery of £45.6m of efficiencies (2021/22: £15m). Trust operating income rose by £64m from the previous financial year, most notably funding the NHS pay award, as well as additional elective recovery funding. Income reduced from the prior year in relation to ending a nationally funded project regarding testing for COVID-19. The Trust has however been successful in increasing funding for research and development. Trust operating expenditure rose by £78m, incorporating funded inflationary costs as well as the cost pressures outlined above. The Trust has also continued its reinvestment of surplus cash into infrastructure for the Trust, with capital investmen
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ANNUAL REPORT AND ACCOUNTS 2018/19 incorporating the quality account 2018/19 Presented to Parliament pursuant to Schedule 7, paragraph 25 (4) (a) of the National Health Service Act 2006 University Hospital Southampton NHS Foundation Trust Annual report and accounts 2018/19 incorporating the quality account 2018/19 Presented to Parliament pursuant to Schedule 7, paragraph 25 (4) (a) of the National Health Service Act 2006 3 ©2019 University Hospital Southampton NHS Foundation Trust 4 TABLE OF CONTENTS Overview and performance report Welcome from our Chair 7 A word from the chief executive 8 Overview of the Trust Statement of purpose and activities 9 History of UHS 9 Our executive team structure 10 Structure of our services 11 Our vision and values 12 Our priorities, key issues and risks 13 Performance report Going concern disclosure 16 Reporting structure 16 Key performance indicators 17 How we monitor performance 18 Detailed analysis and explanation of the development and performance of UHS 18 Regulatory body ratings 23 Environmental matters 24 Social, community, anti-bribery and human rights issues 25 Accountability report Members of the Trust Board 27 Trust Board purpose and structure 31 Board meeting attendance record 2018/19 32 Well-led framework 33 Strategy and finance committee 34 Quality committee 34 Audit and risk committee 35 External auditors 36 Governance code 36 Performance evaluation of Trust Board and its committees 36 Remuneration 36 Countering fraud and corruption 36 Independence of external auditor 37 Internal audit service 37 Better payment practice code 37 Statement as to the disclosures to auditors 37 Disclosures 37 Income disclosures 38 Governance disclosures 38 Approach to quality governance 38 Council of Governors 40 Annual remuneration statement 49 Remuneration and appointments committee 52 Governors’ nomination committee 54 Staffing report 58 Staff survey results 62 Trade union facility time 66 Statement of chief executive’s responsibilities as the accounting officer 69 Annual governance statement 70 Voluntary disclosures Equality, diversity and inclusion 78 Environmental sustainability and climate change 80 Southampton Hospital Charity 84 Developments in informatics 85 Leading research into better care 85 Investing for the future 86 Quality account and quality report 2018/19 Chief executive’s welcome 88 Our approach to quality assurance 90 Our commitment to safety 90 Duty of candour 91 Our commitment to staff 91 Freedom to speak up 94 Our commitment to education and training 95 Our commitment to staffing rota gaps 96 Our commitment to technology to support quality 97 Our commitment to the Care Quality Commission 98 Our commitment to improving the environment for our patients 100 Review of quality performance 101 Clinical research 101 Review of services 102 CQUIN payment framework 103 Data quality 103 Participation in national clinical audits and confidential enquiries 104 How we are implementing the priority clinical standards for seven day hospital services 105 Learning from deaths 106 Progress against 2018/19 priorities 109 Priorities for improvement 2019/20 128 Conclusion 132 Responses to our quality account 133 Statement of directors’ responsibilities 138 Independent auditor’s report 139 Quality account appendix Appendix 1: Our quality priorities 2019/20 143 Appendix 2: Quality performance data 144 Appendix 3: CQUIN data 151 Appendix 4: Clinical audit and confidential enquiries data 154 Appendix 5: British Society of Urogynaecology 156 Appendix 6: National clinical audit: actions to improve quality 157 Appendix 7: Local clinical audit: actions to improve quality 161 Appendix 8: Shared decision making 173 Appendix 9: Registration with the Care Quality Commission 174 Annual accounts Statement from the chief financial officer 177 Foreword to the accounts 178 Independent auditor’s report 179 Financial accounts and notes 186 5 OVERVIEW AND PERFORMANCE REPORT OVERVIEW AND PERFORMANCE REPORT Welcome from our chair 2018/19 was a year of change in the leadership of UHS. Following the departure of Fiona Dalton in March 2018 to run a hospital group in Canada, David French took on the role of interim chief executive officer. On behalf of the Trust Board I would like to thank David for agreeing to do so and also for doing such an outstanding job. During the year we welcomed three new non-executive directors to the Trust; Jane Bailey, Professor Cyrus Cooper and Catherine Mason. Catherine’s talents were also recognised by Solent NHS Trust and she has since left to help lead their organisation as chair. We were delighted to welcome Paula Head as chief executive in September after a rigorous and robust recruitment process. Paula’s experience as chief executive of Royal Surrey County Hospital NHS Trust and, prior to that of Sussex Community NHS Foundation Trust, shone through and we were confident that under her leadership UHS would continue to develop, grow and improve. Demand for our services continues to rise rapidly as the result of a changing demographic and other factors, and at a rate far greater than our income. Despite this our staff continue to deliver exceptional care. I was delighted that this was recognised by the Care Quality Commission in their recent inspection when they again rated us as Good. The revised NHS Long Term Plan will inevitably require us to adapt to the changing pattern of healthcare, but we do so with enthusiasm. This year has shown just how adept we are as an organisation at responding positively to change, not only rising to the challenges it presents, but thriving with it. This is evident in the significant investments we have made in the Trust’s estate this year. Phase one of our new children’s emergency department is complete thanks to the continued support of the Murray Parish Trust. We also approved one of the largest capital investments in our history with the updating and expansion of our general intensive care unit. We recognised that it was as crucial to invest, not just in the physical environment within which we provide healthcare, but within the digital environment too, acknowledging that UHS is an NHS digital exemplar. We have invested significantly in information technology to enhance accessibility and improve both patient and staff experience. We look forward with confidence to helping lead the NHS into a new phase of delivering health and care for the United Kingdom into 2019/20. Peter Hollins Chair 7 OVERVIEW AND PERFORMANCE REPORT A word from the chief executive Since arriving at UHS to take up my position as chief executive officer, I have heard and witnessed some incredible achievements by staff at the Trust. Dr Joanne Horne was named biomedical scientist of the year at the Advancing Healthcare Awards for her work in histopathology; Dr Beth McCausland, quality improvement fellow in dementia care, was named foundation doctor of the year by Royal College of Psychiatrists; Sarah Charters, consultant nurse and mental health lead for the emergency department was awarded an MBE for services to vulnerable adults and her vulnerable adult support team were also winners of a Nursing Times Award in the emergency and critical care category. The medicine for older people therapy team led by Hannah Wood was named most inspiring team at the national #EndPJParalysis awards while Marie Nelson, matron in research and development, and senior research sisters Jane Forbes and Kirsty Gladas won the silver award for clinical research site of the year at the PharmaTimes International Clinical Researcher of the Year Awards. Jean Piernicki, senior nurse manager in occupational health, was awarded the title of Queen’s Nurse in recognition of her high level of commitment to patient care and nursing practice. Fiona Chaâbane, a senior clinical nurse in neurosciences was named winner of the nursing and midwifery award at the BBC’s The One Show Patients Awards. The medicines advice service, led by Dr Simon Wills, picked up the HSJ Value Award for training and development for its medicines learning portal and Matthew Watts, head of news, was named operational services support worker of the year for the south of England at the Our Health Heroes Awards 2018. We were also delighted that the energy and sustainability team collected the clinical NHS Sustainability Award for its green wards project. These are just a few of the individual and team successes achieved this year. Our entire organisation can also be incredibly pleased and encouraged by the outcome of the recent Care Quality Commission (CQC) inspection, which rated UHS ‘good’ overall, with many individual areas being recognised as outstanding by the CQC. You can find full details of the inspection on page 98 of the quality account. Such positive inspection results link to equally positive staff survey results which saw UHS ranked as the second highest acute trust for staff satisfaction and fifth highest for staff recommending the Trust as a place to work and receive treatment. It’s made me incredibly proud to be able to say that I am part of such a driven team and it’s clear that the UHS team share my drive and determination to improve things for patients and staff every day. This is evident in both the successes I have already mentioned, but also in the pioneering work that is taking place across every department. Informatics has been pioneering new digital initiatives which they recently shared with Hadley Beeman, chief technology adviser to the secretary of state and social care. Surgeons Bhaskar Somani and Stephen Griffin have created a ‘twin surgeon’ model that has revolutionised the treatment of kidney stones in children. Dr John Paisey, consultant cardiologist, and his team were among the first in the world to implant and programme a pacemaker using Bluetooth technology. They performed four of the first five procedures in the world. While Professor Mike Grocott and his team created ‘surgery school’ which is transforming the fitness of patients prior to their operations and thereby reducing length of stay. These are by no means the entirety of our achievements this year and I would like to take the opportunity to thank every single member of staff at the Trust who continues to make UHS one of the leading trust’s in the UK. Paula Head Chief executive officer 8 OVERVIEW AND PERFORMANCE REPORT Overview of the Trust Statement of purpose and activities UHS is a large teaching hospital located on the south coast of England. We have a tripartite mission to provide clinical care, educate current and future healthcare professionals, and undertake research to improve healthcare for the future. Our clinical care encompasses local acute and elective care for 680,000 people who live in Southampton, the New Forest, Eastleigh and Test Valley. We also provide care for the residents of the Isle of Wight for many services. As the major university hospital on the south coast, UHS provides the full range of tertiary medical and surgical specialities (with the exception of transplantation, renal services and burns) to over 3.7 million people in central southern England and the Channel Islands. UHS is a centre of excellence for training the doctors, nurses and other healthcare professionals of the future. We work with the University of Southampton and Solent University to educate and develop staff at all levels, including a large apprenticeship programme, undergraduate and post-graduate education. Our role in research, developed in active partnership with the University of Southampton, is to contribute to the development of treatments for tomorrow’s patients. This work distinguishes us as a hospital that works at the leading edge of healthcare developments in the NHS and internationally. In particular we have nationally-leading research into cancer, respiratory disease, nutrition, cardiovascular disease, bone and joint conditions and complex immune system problems. We are one of the largest recruiters of patients into clinical trials in the country. Over 11,900 people work at the Trust, making it one of the area’s biggest employers. We also benefit from the contributions of over 1,000 volunteers. Our turnover in 2018/19 was more than £878m. History of UHS The Trust has its origins in the 1900s when the Shirley Warren Poor Law Infirmary was built on the site of what is now Southampton General Hospital. In the early half of the century, the site began to expand, including the opening of the school of nursing and the creation of the Wessex Neurological Unit. In 1971 a new medical school was opened in Southampton and the 1970s and 1980s saw a significant building programme encompassing the current footprint of Southampton General Hospital, Princess Anne Hospital and Countess Mountbatten House. During the 1990s, services were increasingly centralised at the general hospital, with the eye hospital and cancer services being relocated from elsewhere in the city. The Wellcome Trust funded a clinical research facility at the hospital in 2001 and this unit remains the foundation for much of the Trust’s groundbreaking medical research. In the last decade, development has continued with the opening of the North Wing Cardiac Centre in 2006, the creation of a major trauma centre with on-site helipad and the opening in 2014 of Ronald McDonald House for the relatives of sick children. Organisationally, Southampton University Hospitals Trust was formed in 1993, creating a single management board for acute services in Southampton. Eighteen years later, University Hospital Southampton NHS Foundation Trust (UHS) was formed (1 October 2011) when Southampton University Hospitals NHS Trust was licensed as a foundation trust by the then regulator, Monitor (now known as NHS Improvement (NHSI)). 9 OVERVIEW AND PERFORMANCE REPORT Our executive team structure Associate director of corporate affairs (interim) Charlie Helps Constitution; Council of governors; legal services; insurance; risk management; policy management; freedom of information (FOI) general data protection regulations (GDPR) Chief executive Paula Head Director of HR Steven Harris Employee relations; pay and reward; resourcing and temporary staffing; staff engagement; staff performance and appraisal; occupational health and wellbeing; childcare services; communications Medical director Dr Derek Sandeman MD for research & development; clinical effectiveness; clinical practices and outcomes; professional regulation & standards; GP relationships Director of nursing & organisational development Gail Byrne Chief financial officer & deputy chief executive David French Clinical governance & patient safety; education; patient experience; clinical practice & outcomes; professional regulation & standards; complaints/PALS; HR/workforce; voluntary services; fundraising Caldicott Guardian Financial management; financial strategy; investment & ROI; audit; procurement; capital programme management; estates; Commercial development Division A Surgery Cancer care Critical care & theatres Chief operating officer Caroline Marshall Major incident planning; security Division B Division C Emergency medicine Women & newborn Specialist medicine/ ophthalmology Pathology Child health Support services Director of transformation & improvement Jane Hayward Division D Cardiovascular & thoracic Neurosciences Trauma & orthopaedics Cost improvement & transformation; information technology; information governance; core platform systems; informatics development; strategy; commissioning; business & capacity planning Senior Information Risk Owner (SIRO) Radiology 10 OVERVIEW AND PERFORMANCE REPORT Structure of our services Our organisation is split into five areas, with our clinical services grouped into four divisions. Within each division there are care groups. Each division, with the exception of Trust headquarters, is led by a divisional management team consisting of: • divisional clinical director (DCD) • divisional director of operations (DDO) • divisional head of nursing/professions (DHN) • divisional research and development lead • divisional finance manager • divisional planning and business development (or strategy) manager • divisional education lead • division HR business partner • divisional governance manager (DGM) The diagram below outlines the five divisions and care groups/services within each. Each care group has a clinical lead, care group manager and matron/s for specific services as a minimum. Division A Surgery Cancer care Critical care Theatres Division B Emergency medicine Medicine for older people Pathology Specialist medicine and ophthalmology Genetics Division C Child health Women and newborn Support services Division D Cardiovascular and thoracic Neurosciences Trauma and orthopaedics Major trauma centre Radiology TRUST HQ Corporate affairs Communications Finance Human resources Informatics Patient support services Claims and litigation Cost improvement and transformation Estates and capital developments Research and development 11 OVERVIEW AND PERFORMANCE REPORT Our vision and values Our Forward vision outlines who we are and what we stand for, as well as describing the current challenges we face and our priorities for the future. It also provides an in-depth review of our three Trust values, which are summarised below: putting patien putting patien putting patien putting patien putting patien putting patien putting patien putting patien putting patien king together king together king together king together king together king together king together king together king together ts first ts firwsotr ts firwsotr wor ts first ts firwsotr ts firwsotr wor ts first ts firwsotr ts firwsotr wor always imparlwovaiynsg imparlwovaiynsg improving always imparlwovaiynsg imparlwovaiynsg improving always imparlwovaiynsg imparlwovaiynsg improving ts first ts first ts first wor wor wor putting patien putting patien putting patien king together king together king together always imparlwovaiynsg imparlwovaiynsg improving Patients and families will be at Our clinical teams will provide the heart of what we do and services to patients and are their experience within the crucial to our success. hospital, and their perception We have launched a leadership ofmtheeasTurruensgtop,aftwiesnuitlslcfbcnigreesptsaosti.euntrs fnigrsptatients first clsintrrikacintageltgomgyetahtnherkraianggtteoegmnetsehuernkrrintegstteoogaeumthresr are engaged in the day-to-day management and governance of the Trust. alw alw alw Our growing reputation in research and development and our approach to education and training will continue ays improtvoinagiyns icmoprropvionagrysaitmeprnoveinwg ideas, technologies and greater efficiencies in the services we provide tients first tients first tients first together together together mproving mproving mproving putti putting pa putti putting pa putti putting pa wo working wo working wo working always i always i always i 12 OVERVIEW AND PERFORMANCE REPORT Our priorities, key issues and risks Our top eight priorities 1 Promote and live our values. We will: • be clearer about the behaviours we expect from our staff • recruit, train and promote people who demonstrably share our values in everything they do 2 Improve safety, quality and productivity. We will: • Sign up to safety and deliver on our promises to patients as part of this campaign • Focus on improving outcomes by measuring and publishing clinical outcomes for all specialties • Focus on improving the whole patient experience, so that patients feel treated with compassion by all staff in every contact • Develop the concept of excellent administrative care, organising our services well so that the patient journey runs smoothly • Commit to productivity improvement across all areas • Develop innovative solutions that allow us to deliver services more efficiently while making better use of our capacity 3 Our staff and education mission. We will: • Attract the best staff by offering them a better deal and the best place to work • Continue to invest in education and training opportunities for our staff including leadership development • Ensure that our leaders and staff understand and deliver our equality and diversity agenda • Prioritise excellent communication that allows the voice of our staff to be heard and acted on • Focus on the staff of the future by developing our education and training capability for clinical and non-clinical staff • Work with our local education providers to offer excellent education opportunities and bring high calibre people into healthcare roles in our hospitals 4 Become a hospital without walls. We will: • Increase the number of patients we care for who are not inpatients within the hospital. Some of these will be cared for in another residential location or at home in partnership between ourselves and other organisations • Be clear about services where we wish to provide end-to-end integrated care, and those where we wish to work with partners to integrate care across organisations • Work with health and social care partners (public, private and third sector), where necessary using new organisational models, to ensure that patients are always cared for in the right setting • Work more closely with general practices and support innovation being led by primary care 13 OVERVIEW AND PERFORMANCE REPORT 5 Specialised services. We will: • Engage with commissioners to plan changes in service models according to national service specifications • Continue to plan and manage the ongoing drift of sub-specialist work particularly in paediatrics and complex surgical services • Maintain and develop the critical mass that is increasingly required to care for complex and specialist patients • Work with Salisbury NHS Foundation Trust, the University of Southampton and other partners to play our part in the genomic revolution, building on the Genomic Medicine Centre and seeking to become a Genomics Central Laboratory Hub for the region • Develop our clinical informatics ability to ensure that we can take advantage of new information available for the benefit of patients 6 Preventative care. We will: • Continue to expand our screening programmes as national policy and commissioning intentions develop • Take every opportunity to further support and improve the health of our staff • Ensure that our clinical translational research programme, much of which is directly relevant to health promotion, accelerates translation of research into benefit for the local population 7 Discovery. We will: • Develop a detailed plan to continue increasing the number of UHS patients who are offered access to clinical trials and maximise the impact of the research we undertake • Work with the University of Southampton to submit a strong bid for the next round of Biomedical Research Centre / Biomedical Research Unit funding opportunities • Support the University of Southampton to create an international centre for cancer immunology to accelerate the development of new immune therapies to treat cancer 8 All stages of life. We will: • Continue to expand our paediatric services in partnership with community and local acute paediatrics and develop the physical infrastructure of a modern children’s hospital as quickly as finances allow • Continue to improve transition and the care of teenagers and young adults • Develop elderly care services that are integrated across the acute and community sectors • Continue to develop our end of life care 14 OVERVIEW AND PERFORMANCE REPORT Key issues and risks 1 Failure to deliver national access targets, which impacts patient experience and patient safety. Whilst we are meeting some of the national constitutional standards in waiting times, we are not meeting them all. A number of actions have been taken in relation to improving responsiveness and working with local health and social care partners to reduce delayed transfers of care. The Trust will continue to work to reduce delayed transfers of care, as well as reviewing the efficiency of discharge processes during 2019/20. 2 Capacity and occupancy, which impacts on patient flow and the quality and timeliness of care. Operational risks have been identified across a number of services/specialties linking to issues around increasing referrals, system capacity and delayed transfers of care. We have mitigated this by implementing daily reviews to assess system capacity and escalation requirements aligning capacity plans with the wider system, developing plans to reduce length of stay with strong clinical leadership and oversight and working with local health and social care partners to reduce delayed transfers of care. 3 Staffing, both in terms of recruitment and retention. To mitigate this risk we will continue to focus on making UHS an attractive employer by: • developing band four posts and apprentices • leveraging the ‘Think UHS’ recruitment brand • continuing to recruit within Europe and further afield • working with universities to increase student nurses • enhancing medical overseas fellows posts • reviewing all junior doctor rotas in light of the new contract • using flexible and temporary staff when needed • creating different roles linked to our research agenda • reviewing training and education to enhance retention. 15 OVERVIEW AND PERFORMANCE REPORT Performance report Going concern disclosure After making enquiries, the directors have a reasonable expectation that the Trust has adequate resources to continue in operational existence for the foreseeable future. For this reason, they continue to adopt the going concern basis in preparing the accounts. Reporting structure As a large NHS university hospital foundation trust, UHS monitors performance within individual teams throughout the year with feedback processes in place to escalate issues to more senior management teams. At a corporate level we have an established executive reporting structure. Monthly Trust Board Public meeting where executive directors present high level summary to chairman and non-executive directors. For further information see page 31. Audit and risk committee Strategy and finance committee Quality committee Trust executive committee (TEC) Review performance/issues/risks in greater depth For further detail on role of these committees please refer to the annual governance statement section on page 70. Trust Board study sessions Trust Board members meet to focus on a specific issue. Performance meetings Operational management team (led by chief operating officer) and division and care group management teams focus on individual patient and service pathways to develop improvement plans. 16 OVERVIEW AND PERFORMANCE REPORT Key performance indicators (KPIs) The Trust publishes a monthly integrated KPI Board report on our website which provides both the Board and the public with an overview of our performance. This report is constantly evolving as new areas of monitoring are developed and new areas of national focus become apparent. For 2018/19 the format of the monthly report followed the five key Care Quality Commission (CQC) questions: • Are we safe? • Are we effective? • Are we caring? • Are we responsive? • Are we well-led? The monthly report features the following sections: • Overview – Aggregation of commentary supporting all sections of the report • Safe • Effective • Caring • Activity • Emergency access • Referral to treatment and diagnostics • Cancer waiting times • Flow • Staffing • Research and development • Estates • Digital This report also includes summary versions of quarterly reports submitted to the Trust executive committee, which go into greater detail about patient experience, patient safety, clinical effectiveness outcomes, and infection prevention. In addition, a separate finance Board report is submitted to Trust Board on a monthly basis. The Emergency Access, Activity and Flow section have several KPI’s that are relevant to the key risk of delivering the national access target. Some of the KPI’s are: • Number of attendances • Time to initial assessment • Hospital red/black alerts • Delayed transfers of care • Non-elective length of stay The Activity and Flow section have several KPI’s that are relevant to the key risk of capacity and occupancy. Some of the KPI’s are: • Length of stay • New referrals • Number of attendances • Bed occupancy • Hospital red/black alerts The Staffing (HR) section has several KPI’s that are relevant to the key risk of Staffing. Some of the KPI’s are: • Staff turnover • Nursing vacancies • Friends and Family Test – percentage of staff who recommend UHS as a place to work You can see full copies of the monthly report by visiting www.uhs.nhs.uk 17 OVERVIEW AND PERFORMANCE REPORT How we monitor performance In addition to reviewing the data submitted to the Trust Board in these papers, we have a suite of tools available to compare UHS performance to that of comparable trusts around the country. Depending on the measures being monitored, UHS has a number of peer groups to benchmark against including other local providers, major trauma centres and university hospital teaching trusts. Each NHS trust will service a different size and type of population and will offer a slightly different range of services so it is important to understand that this benchmarking provides an initial indication of performance rather than an absolute guide to our position nationally. In 2018/19 we continue to review the National Model Hospital data as it is published from NHS Improvement. The data and ability to compare our performance has helped to highlight areas of excellent practice and areas where there is potential to improve. The Trust is engaging with the model hospital team and has a member of staff on the ‘model hospital ambassador program’, as well as reviewing areas highlighted as having potential opportunities alongside finance and operational teams. Detailed analysis and explanation of the development and performance of UHS Activity, capacity and occupancy Over the past three years we have seen significant increases in all types of activity. This is linked to demographic growth, new specialist techniques and services transferring from other providers, including vascular services from Portsmouth. In addition, UHS now has responsibility for surgical services at Lymington. The graph and table below demonstrate this increase in activity. UHS growth in activity – 2016/17 to 2018/19 800,000 700,000 600,000 500,000 400,000 300,000 200,000 100,000 0 Inpatient spells (inc. day cases) 2013/14 2016/17 Outpatient appointments 2017/18 2018/19 ED attendances (type one) Referrals (excl March) Inpatient spells (inc. day cases Outpatient appointments ED attendances (type one) Referrals (excl March) 2016/17 160,000 630,045 99,273 189,194 2017/18 157,993 658,147 104,616 197,522 2018/19 168,791 695,343 110,771 207,209 Increase 2016/17 to 2018/19 5.5% 10.4% 11.6% 9.5% 18 OVERVIEW AND PERFORMANCE REPORT Hospital alert status The hospital alert status is decided by the operations centre after assessing the bed and staffing position, and is recorded twice daily at the Trust bed meetings (though the status may change at any time). Black alert is the highest level of alert and is issued when there are no empty beds available across the Trust with no expected discharges, the emergency department is full, and if actions are not taken several ambulances are likely to be delayed for long periods of time, stopping them from responding to 999 calls (this is based on a national definition of escalation). Red alert is when the majority of the hospital is under significant operational pressure and is likely to include a mismatch between supply and demand of beds and/or there are no beds available, with patients waiting more than three hours in the emergency department, and patients with a clinical decision for admission but no bed identified for them to move to. The Trust will undertake a wide range of actions in response to this, including the opening of additional overnight beds (usually within day wards), the redistribution of staff or bed capacity to support areas under most pressure, Trust-wide communication to request a focus on actions which will enable patients to be discharged or the admission avoided and the potential review of less urgent elective operations to maintain bed availability for patients with more urgent needs. In 2015/16 a black alert was recorded seven times at the twice daily bed meetings. In 2016/17 this was increased to eleven, in 2017/18 this increased to twenty, however in 2018/19 there were no black alerts. The chart below shows red alerts logged during 2018/19. Red alerts 2018/19 60 Number of AM and PM alerts 45 30 15 0 4/1/18 6/1/18 8/1/18 10/1/18 12/1/18 2/1/19 Contributing to this change has been an increase in day cases and an increase in length of stay (LoS) for elective patients linked to a more complex case mix. UHS delayed transfers of care 2018/19 The chart below shows the total bed days attributable to delayed transfers of care at UHS in 2018/19. 3,600 Percentage of bed days lost 3,200 2,800 2,400 2,000 April 2018 June 2018 August 2018 October 2018 December 2018 February 2019 19 OVERVIEW AND PERFORMANCE REPORT Referral to treatment (18 weeks) performance National target: 92% of all patients on 18 week pathway and not yet treated should have waited 18 weeks or less at the end of the month (incomplete pathways target). How did we do? UHS did not meet the target this year. Achievement of this target in 2018/19 should be set against a rise in patient referrals, which highlights the increased demands being placed on the Trust. The Trust has finished the financial year with no patients waiting greater than 52 weeks, and a total referral to treatment waiting list lower than in March 2018. Emergency department (ED) performance There are three types of emergency departments: Type Type Type ONE TWO THREE 3 24 hour with full resuscitation facilities 3 Consultant-led 3 Designated accommodation for patients admitted via ED 3 Single specialty emergencies (eye or dental) 3 Consultant-led 3 Designated accommodation 3 Minor injuries/walk-in centres 3 Doctor or nurse-led 3 Can be routinely accessed without appointment 3 May be co-located within an ED or sited in the community We run all three types of departments and all three types are subject to the national target and are therefore reflected in our figures. National target: The constitutional standard states that 95% of patients should be treated and either admitted or discharged within fours of arrival into ED. However, NHS Improvement set local targets for all NHS organisations with an ambition that the NHS would return to meet the 95% target by March 2019. The local targets set by quarter (to allow for seasonal variations) for UHS were: Quarter 1 - 90% Quarter 2 - 91.4% Quarter 3 - 90% Quarter 4 - 90-95% How did we do? 2018/19 was another challenging year for emergency patients for the whole Hampshire and Isle of Wight area. Whilst we had a positive start to the year achieving quarter 1 and 2 targets, we did not meet quarter 3 or 4 targets. We did, however, meet out local delivery system targets. 20 OVERVIEW AND PERFORMANCE REPORT The graph below shows our performance against the four hour target over the last year (including all UHS types and Lymington). National 4 hour access target – UHS performance 100% 95% 90% 87.1% 85% 80% 82.1% 82.3% 87.4% 87.4% 93.0% 90.5% 84.7% 82.9% 85.7% 90.7% 88.9% 84.8% 77.9% 81.1% 75% Jan 2018 Feb 2018 Mar 2018 Apr 2018 May 2018 June 2018 July 2018 Aug 2018 Sep 2018 Oct 2018 Nov 2018 Dec 2018 Jan 2019 Feb 2019 Mar 2019 The graph below shows our local delivery system performance against the four hour target over the last year (including all SGH types, Lymington and Southampton Treatment Centre). National 4 hour access target – Local delivery system 100% 95% 91.0% 90% 91.1% 95.1% 92.8% 88.7% 87.1% 89.2% 91.5% 85% 92.9% 88.4% 83.3% 85.9% 80% 75% Apr 2018 May 2018 June 2018 July 2018 Aug 2018 Sep 2018 Oct 2018 Nov 2018 Dec 2018 Jan 2019 Feb 2019 Mar 2019 21 OVERVIEW AND PERFORMANCE REPORT Cancer waiting times There are nine separate cancer waiting times standards (below), each of which can then be split into tumour site specific performance groups. Measures Urgent GP referrals seen in two weeks Breast symptoms referral seen in two weeks Treatment started within 62 days of urgent GP referral Treatment started within 62 days of referral (breast, cervical and bowel screening) 62 day consultant upgrades Treatment started within 31 days of decision to treat Second or subsequent treatment (surgery) started within 31 days of decision to treat Second or subsequent treatment (anti-cancer drugs) started within 31 days of decision to treat Second or subsequent treatment (radiotherapy) started within 31 days of decision to treat Target > 93% > 93% > 85% > 90% > 86% > 96% > 94% > 98% > 98% 18/19 YTD (up to and including Feb 19) 86% 50% 74% 80% Achieved 8 8 8 8 86% 3 93% 8 85% 8 100% 3 100% 3 The number of patients referred under the two week wait urgent suspected cancer protocol seen within two weeks of their referral, rose by 7.7% in 2018/19. The chart below shows the rise in demand for UHS cancer services over the past three years UHS growth in cancer actvity – 2016/17 to 2018/19 (up to and including month 11) 18,000 16,000 14,000 12,000 10,000 8,000 6,000 4,000 2,000 0 Two week waits 2016/17 up to and incl Feb 62 day target patients 31 day target patients 2017/18 up to and incl Feb 2018/19 up to and incl Feb For staffing performance, please refer to page 58. For financial performance please see page 177. Paula Head, chief executive officer 28 May 2019 22 OVERVIEW AND PERFORMANCE REPORT Regulatory body ratings Single Oversight Framework NHS Improvement’s Single Oversight Framework provides the framework for overseeing providers and identifying potential support needs. The framework looks at five themes: 1. Quality of care 2. Finance and use of resources 3. Operational performance 4. Strategic change 5. Leadership and improvement capability (well-led) Based on information from these themes, providers are segmented from one to four where ‘4’ reflects providers receiving the most support, and ‘1’ reflects providers with maximum autonomy. A foundation trust will only be in segments three or four where it has been found to be in breach or suspected breach of its licence. Segmentation During 2018/19 the Trust was confirmed as being placed within segment ‘2’. This segmentation information is the Trust’s position as at 31 March 2019. Current segmentation information for NHS trusts and foundation trusts is published on the NHS Improvement website. Finance and use of resources The finance and use of resources theme is based on the scoring of five measures from ‘1’ to ‘4’, where ‘1’ reflects the strongest performance. These scores are then weighted to give an overall score. Given that finance and use of resources is only one of the five themes feeding into the Single Oversight Framework, the segmentation of the Trust disclosed above might not be the same as the overall finance score here. Area Financial sustainability Financial sustainability Financial sustainability Overall scoring Care Quality Commission ratings: Metric Capital service cover Liquidity Income and expenditure margin Distance from financial plan Agency spend Q1 Q2 Q3 Q4 2 2 1 1 1 1 1 1 1 1 1 1 1 2 2 1 1 1 1 1 1 1 1 1 Overall rating for this trust Are services at this trust safe? Are services at this trust effective? Are services at this trust caring? Are services at this trust responsive? Are services at this trust well-led? Good Requires improvement Outstanding Good Requires improvement Good 23 OVERVIEW AND PERFORMANCE REPORT In December 2018, the CQC inspected four core services; urgent and emergency care, medicine, maternity and outpatients. It also looked at management and leadership, and effective and efficient use of resources. The CQC report (published on the 17 April 2019) rated the Trust as ‘good’ overall and ‘outstanding’ for providing effective services. “Our inspectors found a strong patient-centred culture with staff committed to keeping their people safe, and encouraging them to be independent. Patients’ needs came first and staff worked hard to deliver the best possible care with compassion and respect. Inspectors saw many areas of outstanding practice, with care delivered by compassionate and knowledgeable staff. Several teams led by example with a continuous focus on quality improvement. The Trust did face some challenges especially with the ageing estates. Some patient environments were showing significant signs of wear and tear – but again staff were doing their utmost to deliver compassionate care”. Dr Nigel Acheson Deputy chief inspector of hospitals (South) Environmental matters We recognise that the Trust’s business has an impact on the environment. As a large hospital we undertake a wide range of activities and use a large amount of resources, for example: • The Trust generates approximately 3,000 tonnes of waste yearly, half of which is clinical waste. If not properly treated this huge amount of waste can cause soil, water and air pollution depending on the disposal route. • Due to the large number of visitors and deliveries we attract every day, traffic congestion is regularly experienced on and around the site, which impacts the air quality around the hospital. We are committed to environmental sustainability and consider it as part of the business culture. We acknowledge that reducing waste and minimising the consumption of scarce resources is consistent with financial sustainability. Our sustainability disclosure section on page 80 provides greater detail on the steps we are taking to reduce our activities’ impact on the environment. 24 OVERVIEW AND PERFORMANCE REPORT Social, community, anti-bribery and human rights issues We recognise our responsibilities under the European Convention on Human Rights (included in the Human Rights Act 1998 in the UK), which are relevant to health and social care. These rights include the: • right to life • right not to be subjected to torture, inhuman or degrading treatment or punishment • right to liberty • right to respect for private and family life The Trust is committed to ensuring it fully takes into account all aspects of human rights in our work. At University Hospital Southampton we value our reputation for top quality care and financial probity and conduct our business in an ethical manner. The Bribery Act 2010 was introduced to make it easier to tackle the issue of bribery which is a damaging practice. Bribery can be defined as ‘giving someone a financial or other advantage to encourage them to perform their duties improperly or reward them for having done so’. To limit our exposure to bribery we have in place an Anti-Fraud, Bribery and Corruption Policy, a Standards of Business Conduct Policy and a Freedom to Speak Up (formerly Raising Concerns) Policy. These apply to all staff and to individuals and organisations who act on behalf of UHS. We also employ a local counter fraud specialist who will investigate, as appropriate, any allegations of fraud, bribery or corruption. The success of our anti-bribery approach depends on our staff playing their part in helping to detect and eradicate bribery. Therefore, we encourage staff, service users and others associated with UHS to report any suspicions of bribery and we will rigorously investigate any allegations. In addition, we hold a register of interest for directors, staff, and governors and ask staff not to accept gifts or hospitality that will compromise them or the Trust. The Board of Directors carries out its business in an open and transparent way. We are committed to the prevention of bribery as well as to combating fraud and expect the organisations we work with to do the same. Doing business in this way enables us to reassure our patients, members and stakeholders that public funds are properly safeguarded. There are no important events since the year end affecting the foundation trust. No political donations have been made. The Trust has no overseas branches. 25 FR STAND BODY ACCOUNTABILITY REPORT Members of the Trust Board Board member Name Title Paula Head Chief executive officer David French Deputy chief executive officer and chief financial officer Gail Byrne Director of nursing and organisational development Jane Hayward Director of transformation and improvement Biography Declarations Paula joined the Trust as chief executive in September 2018, having been chief executive at the Royal Surrey County NHS Foundation Trust in Guildford and before that at Sussex Community NHS Foundation Trust. She began her career as a pharmacist working in the community, hospitals and at health authorities before moving into general management and her first board position at Kingston Hospital. Since then she has spent time on the boards of commissioners and providers, including director of transformation at Frimley Park Hospital NHS FT. Paula lives in Hampshire and has a daughter studying medicine at the University of Southampton. Daughter is a medical student at University of Southampton; Member of Hampshire & Isle of Wight Sustainability and Transformation Partnership Executive Delivery Group David joined the Trust in February 2016 and led on finance, procurement, estates and commercial development until March 2018, when he became interim chief executive officer. He read Economics and Social Policy at the University of London before joining ICI plc, where he qualified as a chartered management accountant. David has extensive healthcare experience from the pharmaceutical industry, mostly Eli Lilly and Company where he held many commercial and financial roles in the UK and overseas. He joined the NHS in 2010 as chief financial officer of Hampshire Hospitals NHS Foundation Trust. He also serves as a non-executive director for Vivid Housing Limited, a social housing provider across Hampshire and the Solent. Non-executive director and chair of audit and risk committee, Vivid Housing Limited; Director, UHS Estates Limited, a wholly-owned subsidiary of UHSFT; Director, Southampton Commercial Estates Development Partnership (CEDP) Project Company Limited, a whollyowned subsidiary of UHSFT; Member of Solent Acute Alliance; Member of Hampshire & Isle of Wight Counter Fraud Board; Member of Hampshire & Isle of Wight Sustainability and Transformation Partnership Capital Planning Panel (from May 2018) Gail joined the Trust in 2010 as deputy director of nursing and head of patient safety. Prior to this, she has worked at the Strategic Health Authority as head of patient safety, and director of clinical services at Portsmouth Hospital. Gail has also worked in Brisbane, Australia as a hospital Macmillan nurse, and as general manager of a special purpose vehicle company for the private finance initiative at South Manchester Hospitals. Husband is a consultant surgeon in the Trust; Daughter is a midwife at UHS (from March 2019) Jane joined the Trust in 2000 as a clinical services manager for the cardiothoracic directorate after spending two years in Hertfordshire as director of performance and 11 years at Barts and the London Hospitals in various roles including planning, finance and commissioning. Jane has led on human resources, information management and technology, improvement and modernisation and has been chief operating officer. Jane joined the Trust Board in February 2008 and became director of transformation and improvement in January 2014. Director, UHS Estates Limited, a wholly-owned subsidiary of UHSFT; Father and mother are UHSFT simulated patients (voluntary position) Dr Derek Medical Sandeman director Dr Caroline Marshall Chief operating officer Derek was appointed to the Trust as a consultant physician in 1993 and went on to develop a regional endocrine service. Throughout his career he has had extensive clinical leadership experience, most recently serving eight years as clinical director. Derek’s leadership roles have also included programme director for postgraduate education and the Wessex Endocrine Royal College representative. He has a strong history of wider system engagement, working collaboratively with partners to improve systems resilience and pathways. Caroline joined the Trust in 1997 as a consultant hepatobiliary and neuroanaesthetist. She has held the posts of college tutor for the Royal College of Anaesthetists and UHS mentoring and coaching lead. In 2008, she became clinical service director for critical care, and then divisional clinical director for division A between 2010 and 2013. Caroline served as interim chief operating officer between January to December 2014, and was then appointed to the substantive post. Her portfolio includes the executive lead for cancer and the executive lead for major trauma. Director of UHS Pharmacy Limited, a wholly-owned subsidiary of UHSFT; Member of Hampshire & Isle of Wight Sustainability and Transformation Partnership Clinical Executive Group Daughter is employed within the emergency department at UHS (from 1 August 2018) 27 ACCOUNTABILITY REPORT Non-executive directors Name Title Peter Hollins Chair Simon Porter Senior independent director and deputy chair Dr Mike Non-executive Sadler director Biography Declarations Peter graduated in chemistry from Hertford College, Oxford. Joining Imperial Chemical Industries in 1973, he undertook a series of increasingly senior roles in marketing and then general management. Following three years in the Netherlands as general manager of ICI Resins BV, he was appointed in 1992 as chief operating officer of EVC in Brussels – a joint venture between ICI and Enichem of Italy. He played a key role in the flotation of the company in 1994, returning in 1998 to the UK as chief executive officer of
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ANNUAL REPORT AND ACCOUNTS 2019/20 Incorporating the quality account 2019/20 Page 2 University Hospital Southampton NHS Foundation Trust Annual report and accounts 2019/20 incorporating the quality account 2019/20 Presented to Parliament pursuant to Schedule 7, paragraph 25 (4) (a) of the National Health Service Act 2006 Page 4 ©2020 University Hospital Southampton NHS Foundation Trust Page 5 TABLE OF CONTENTS Overview and performance report Welcome from our chair A word from the chief executive Overview of the Trust Statement of purpose and activities History of UHS Our executive team structure Structure of our services Our vision and values Our priorities, key issues and risks Voluntary disclosures Equality, diversity and inclusion 92 8 9 Environmental sustainability and climate chan ge 95 Quality account 10 Chief executive welcome 101 10 11 Annual accounts 12 Statement from the Chief financial officer 183 13 Independent Auditors report 185 14 Foreword to accounts 192 Performance report Going concern disclosure 16 Reporting structure 16 Key performance indicators 18 How we monitor performance 19 Overview of performance of UHS 18 Regulatory body ratings 19 Environmental matters 23 Social, community, anti-bribery and human rights issues 23 Accountability report Members of the Trust Board 25 Trust Board purpose and structure 30 Board meeting attendance record 2018/19 31 Well-led framework 32 Finance and investment committee 34 Quality committee 33 Audit and risk committee 35 External auditors 36 Governance code 36 Performance evaluation of Trust Board and its committees 36 Remuneration 36 Countering fraud and corruption 37 Independence of external auditor 37 Internal audit service 37 Better payment practice code 37 Statement as to the disclosures to auditors 38 Disclosures 38 Income disclosures 38 Governance disclosures 38 Approach to quality governance 38 Council of Governors 41 Annual remuneration statement 51 Remuneration and appointments committee 54 Governors’ nomination committee 57 Staffing report 61 Staff survey results 65 Trade union facility time 68 Statement of chief executive’s responsibilities as the accounting officer 72 Annual governance statement 73 Page 6 OVERVIEW AND PERFORMANCE REPORT Page 7 OVERVIEW AND PERFORMANCE REPORT Welcome from our chair 2019/20 was another challenging year for University Hospital Southampton NHS Foundation Trust (UHS). Demand for our services continued to rise rapidly, partly because of the ageing of the population we are here to serve and partly because of challenges in the external environment, but also because of our ability to offer exciting innovations for a range of conditions. As a result, we were not always able to offer treatment as rapidly as we wished. A major challenge towards the end of the year was the need to prepare the Trust for the COVID-19 pandemic, resulting in the need to re-engineer services on an unprecedented scale. The response of UHS staff to these challenges has, from start to finish, been magnificent. We saw major innovation in improved patient pathways to accommodate rising demand, and the creativity of colleagues in readying the Trust for COVID-19 was truly breath-taking in its scope and energy. UHS has had a long record of effective financial management. By constantly seeking operational innovation and better value for money in procurement, the Trust has been able to generate the funds necessary to make a number of capital investments which will provide huge patient benefit in future. There has been rapid progress in our major project to refurbish and extend our general intensive care unit. Our £2.2m investment in our new urology unit was completed this year; it will transform our patients’ experiences. We have continued wherever possible to work with partners and we are delighted that work on the £5m Maggie’s Centre has started. Quite apart from the need to navigate our way through the COVID-19 crisis and into the world beyond it, the Trust needs to prepare to play its full role in the Hampshire and Isle of Wight healthcare system as it develops in a way consistent with the NHS Long Term Plan. The responsibility for this falls of course to the Trust Board and I believe that even after having had more change on the Board this year than for some time, we continue to have a strong and committed leadership team. Following the retirement of Caroline Marshall, our long-serving chief operating officer, in September 2019 we welcomed Joe Teape into the position. Joe had not been at the Trust long before we were thrust into the COVID-19 pandemic and got to grips with it impressively rapidly. During the year we said farewell to three non-executive directors (NEDs); Catherine Mason who left us to become chair of Solent Healthcare, Mike Sadler our clinical NED and Simon Porter. After a series of rigorous selection processes, we were delighted to welcome Dave Bennett, Dr Tim Peachey and Keith Evans as replacements. Simon had been both deputy chair and senior independent director (SID) and on his departure Jenni Douglas-Todd succeeded him in both roles. The work of the Board is supported, stimulated and, quite correctly, challenged by the Council of Governors (COG) whose enthusiasm is of huge value to the proper governance of UHS. All of the elections to the COG were competitive, in some cases by a multiplicity of candidates. Unfortunately, one of those vacancies resulted from the death of Edward Osmond. Although Edward had only recently been elected as a governor, he had shown huge commitment to the role and I am sure would have gone on to make a major contribution to UHS. We welcomed nine new governors and one new young governor. I look forward to working with them and all the other governors as we move through and beyond the COVID-19 world. Peter Hollins Chair Page 8 OVERVIEW AND PERFORMANCE REPORT A word from the chief executive My first full year as chief executive officer of UHS has been exciting, inspiring, and extremely rewarding but not, as you would expect, without a considerable degree of challenge! The pressures on the NHS have been well publicised as we strive to provide the highest possible standard of care at a time when demand for our services escalates rapidly. At the same time, at UHS we need to play our full part in working out how we shape and deliver the health and care provision for our community into the future. During the year we have done a great deal of work on how we turn our vision for the Trust, world-class care for everyone, into what happens on the front line every day. While the vision may be new it is built firmly on our long-standing values; patients first, working together, and always improving, which together describe who we are as an organisation. These values were central to the development of our new clinical and corporate strategy which sets out an exciting future for UHS over the coming decade. It includes how we will deliver the safest care, delivering the best outcomes, as well as how we will focus on improving the health of our population, supporting both health and wellbeing. The values also provided the basis for our CQC rating of ‘Good’ awarded during the year as were some other fantastic accolades. These included a prestigious British Medical Journal award for improving care for older patients with the development of our frailty unit and activity hub. Our women’s and maternity care at the Princess Anne Hospital was named as being among the best in the world. In addition, we adopted prehabilitation for cancer patients, a pioneering service. There are countless other examples of innovation which have sprung from the creativity and innovative spirit at UHS. Some of these have involved better outcomes for patients, some an improved patient experience and others simply lower the cost of doing things, liberating money which we can then invest in improving other services. I’d like to thank every one of our staff for creating the spirit of UHS which means that the extraordinary happens every day. The world of health and social care is changing dramatically and we continue to be integral to the Hampshire and Isle of Wight Sustainability and Transformation Partnership (STP). UHS will have a leading part to play in ensuring that, with our partners, we forge a pattern for the provision of healthcare across the local system and beyond, delivering the highest possible standards of care on an enduring basis. As we entered 2020, we began preparing to face COVID-19, the largest pandemic we have seen. Some areas of the hospital are truly unrecognisable as we have adapted to the fight against this virus. The loss of life as a result of COVID-19 has been utterly devastating and it has, I am sure, touched us all personally. It has also challenged the health and wellbeing of all our staff, but particularly our frontline staff, in a unique way. I am not sure whether I am prouder of the spirit with which our staff have responded to the challenge or of the fact that they made us by common consent one of the best prepared trusts in the country. Finally, I’d like to recognise the acts of kindness I see throughout the Trust on a daily basis. It is one of the things that has struck me the most as I have got to know this organisation and the people within it. I watch how they support one another through challenging times, how they support patients and visitors in their own time and in work time, and how they go above and beyond every day for the people they’re caring for. Every day they make me hugely privileged to lead this amazing organisation. Paula Head Chief executive officer Page 9 OVERVIEW AND PERFORMANCE REPORT Overview of the Trust Statement of purpose and activities UHS is a large teaching hospital located on the south coast of England. We have a tripartite mission to provide clinical care, educate current and future healthcare professionals, and undertake research to improve healthcare for the future. Our clinical care encompasses local acute and elective care for 680,000 people who live in Southampton, the New Forest, Eastleigh and Test Valley. We also provide care for the residents of the Isle of Wight for many services. As the major university hospital on the south coast, UHS provides the full range of tertiary medical and surgical specialities (with the exception of transplantation, renal services and burns) to over 3.7 million people in central southern England and the Channel Islands. UHS is a centre of excellence for training the doctors, nurses and other healthcare professionals of the future. We work with the University of Southampton and Solent University to educate and develop staff at all levels, including a large apprenticeship programme, undergraduate and postgraduate education. Our role in research, developed in active partnership with the University of Southampton, is to contribute to the development of treatments for tomorrow’s patients. This work distinguishes us as a hospital that works at the leading edge of healthcare developments in the NHS and internationally. In particular we have nationally-leading research into cancer, respiratory disease, nutrition, cardiovascular disease, bone and joint conditions and complex immune system problems. We are one of the largest recruiters of patients into clinical trials in the country. Over 12,000 people work at the Trust, making it one of the area’s biggest employers. We also benefit from the contributions of over 1,000 volunteers. Our turnover in 2019/20 was £912m. History of UHS The Trust has its origins in the 1900s when the Shirley Warren Poor Law Infirmary was built on the site of what is now Southampton General Hospital. In the early half of the century, the site began to expand, including the opening of the school of nursing and the creation of the Wessex Neurological Unit. In 1971 a new medical school was opened in Southampton and the 1970s and 1980s saw a significant building programme encompassing the current footprint of Southampton General Hospital, Princess Anne Hospital and Countess Mountbatten House. During the 1990s, services were increasingly centralised at the general hospital, with the eye hospital and cancer services being relocated from elsewhere in the city. The Wellcome Trust funded a clinical research facility at the hospital in 2001 and this unit remains the foundation for much of the Trust’s groundbreaking medical research. In the last decade, development has continued with the opening of the North Wing Cardiac Centre in 2006, the creation of a major trauma centre with on-site helipad and the opening in 2014 of Ronald McDonald House for the relatives of sick children. Organisationally, Southampton University Hospitals Trust was formed in 1993, creating a single management board for acute services in Southampton. Eighteen years later, University Hospital Southampton NHS Foundation Trust (UHS) was formed (1 October 2011) when Southampton University Hospitals NHS Trust was licensed as a foundation trust by the then regulator, Monitor (now known as NHS Improvement (NHSI)). Page 10 OVERVIEW AND PERFORMANCE REPORT Our executive team structure Executive team structure as at 31/03/2020 Page 11 OVERVIEW AND PERFORMANCE REPORT Structure of our services Our organisation is split into five areas, with our clinical services grouped into four divisions. Within each division there are care groups. Each division, with the exception of Trust headquarters, is led by a divisional management team consisting of: • divisional clinical director (DCD) • divisional director of operations (DDO) • divisional head of nursing/professions (DHN) • divisional research and development lead • divisional finance manager • divisional planning and business development (or strategy) manager • divisional education lead • division HR business partner • divisional governance manager (DGM) The diagram below outlines the five divisions and care groups/services within each. Each care group has a clinical lead, care group manager and matron/s for specific services as a minimum. Page 12 OVERVIEW AND PERFORMANCE REPORT Our vision and values Our vision outlines who we are and what we stand for, as well as describing the current challenges we face and our priorities for the future. It also provides an in-depth review of our three Trust values, which are summarised below: Patients first Patients and families will be at the heart of what we do and their experience within the hospital, and their perception of the Trust, will be our measure of success. Working together Our clinical teams will provide services to patients and are crucial to our success. We have launched a leadership strategy that ensures our clinical management teams are engaged in the day-today management and governance of the Trust. Always improving Our growing reputation in research and development and our approach to education and training will continue to incorporate new ideas, technologies and greater efficiencies in the services we provide Page 13 OVERVIEW AND PERFORMANCE REPORT Our priorities, key issues and risks Our goals 1. Improving patient journeys (system focus, integration) We will: • Write a strategic plan for integrated ‘front door; services to address capacity and demand mismatch and enable flow • Secure influence in primary care by establishing the hospital’s role in supporting primary care networks • Promote value-based healthcare, particularly: Introduce ‘advanced decision making’ • Redesign services to provide timely safe care and meet constitutional access trajectories • Deliver priorities relevant to UHS in the first year of the long-term plan including commissioning and long-term changes 2. Delivering value-based health and care We will: • Deliver the Trust financial plan and maximise any national funding • Prepare UHS for the new NHS financial regime • Deliver the Trust Quality Improvement plan to improve safety/experience and outcomes • Build capability for change by embedding quality improvement, innovation and transformation at a leadership level • Deliver the Cost Improvement Plan (CIP) without compromising on quality 3. Supporting health lives (prevention, wellbeing inequalities, outcomes and experience) We will: • Improve staff health and wellbeing • Improve population health, maximising the impact of UHS touch points • Develop an early warning tool to identify any deterioration in quality 4. Building an expert and inclusive workforce (diversity, engagement, leadership) We will: • Close the staffing supply gap in priority groups/services to provide high quality and timely care • Manage overall workforce cost to meet CIP challenge • Measure improvement in staff engagement by increasing participation in staff survey • Increase representation of diverse groups in leadership and decision making • Improve the staff engagement score 5. Being agile in meeting people’s needs (organisational elegance/design/flexibility) We will: • Reset organisational structure as necessary, responding to changes outlined in the NHS long-term plan • Leverage digital capability to support patient empowerment and self-care • Measure staff user satisfaction with the Trust IT systems and use this to support the digital strategy • Be agile in flexing resources, responding to fluctuating demand • Secure strategic influence by establishing UHS role in the transition from STP to ICS 6. Leading edge research, education and innovation (research and outcomes) We will: • Identify the capacity constraints to expand research and plan to address • Identify priority areas without a research base and set strategy • Improve quality and breadth of education and training programme Page 14 OVERVIEW AND PERFORMANCE REPORT The novel coronavirus (COVID-19) will continue to have a significant impact on public health, morbidity and mortality if adequate prevention and control is not in place. The Trust put rapid and robust arrangements in place early on to prepare for the potential surge in COVID-19 patients. As the government now announces the easing of the lockdown restrictions, the COVID-19 challenge continues to unfold and still represents a very significant future risk to the organization. Our response and mitigations will continue to evolve through 2020/21. Further details on our response to the COVID-19 challenge are in included in the Annual Governance Statement on page 73.. Key issues and risks 1. Inability to develop partnerships and redesign services innovatively renders the Trust unable to meet the expectations of the NHS long-term plan, our strategic plan, and sustainable elective and non-elective pathways. UHS continues to actively develop partnerships across the region and work within the Integrated Care System whilst promoting value-based healthcare and delivering priorities relevant to UHS in the first year of the longterm plan. 2. Failure to deliver regulatory requirements results in license breach and loss of local control with an enforced change in leadership, impacting on Goals 1 to 6. UHS continues to monitor progress against NHSI Performance framework at committee and Board level and build capability for change by embedding quality improvement, innovation and transformation at a leadership level. 3. Failure to achieve financial targets results in a shortfall in cash required to deliver the capital programme. A robust cost improvement programme is in place, continuously monitored through governance processes with a focus on delivery of the Trust’s financial plan. 4. Reduced access to resources compromises the quality of services. We will implement the Trust Quality Improvement plan to improve safety/ experience and outcomes. 5. Capacity and capability gaps in the workforce lead to an inability to provide safe and timely care. To mitigate this risk, we will continue to develop initiatives to improve staff health and wellbeing with proactive recruitment and retention initiatives in place. Staff engagement is monitored through staff survey and leadership and development training in place. 6. Lack of inclusion and diversity results in the failure to get the best from every individual. UHS has an equality, diversity and inclusion strategy, with established Trust networks and inclusive talent management programmes. Page 15 OVERVIEW AND PERFORMANCE REPORT Performance report Going concern disclosure After making enquiries, the directors have a reasonable expectation that the Trust has adequate resources to continue in operational existence for the foreseeable future. For this reason, they continue to adopt the going concern basis in preparing the accounts. Reporting structure As a large NHS university hospital foundation trust, UHS monitors performance within individual teams throughout the year with feedback processes in place to escalate issues to more senior management teams. At a corporate level we have an established executive reporting structure. Page 16 OVERVIEW AND PERFORMANCE REPORT Monthly Trust Board Public meeting where executive directors present high level summary to chairman and non-executive directors. Audit andrisk committee Finance and Investment committee Quality Committee People & Organisational Development Committee Trust executive committee (TEC) Review performance/issues/risks in greater depth For further detail on role of these committees please refer to the annual governance statement section. Trust Board study sessions Trust Board members meet to focus on a specific issue. Performance meetings Operational management team (led by chief operating officer) and division and care group management teams focus on individual patient and service pathways to develop improvement plans. Page 17 OVERVIEW AND PERFORMANCE REPORT Key performance indicators (KPIs) The Trust publishes a monthly integrated KPI Board report on our website which provides both the Board and the public with an overview of our performance. This report is constantly evolving as new areas of monitoring are developed and new areas of national focus become apparent. The format of the monthly report follows our six strategic goals: • Improve patient journeys • Value-based health and care • Healthy lives • An expert and inclusive workforce • Being agile in meeting people’s needs • Leading edge research, education and innovation The monthly report features the following sections: • Overview – Aggregation of commentary supporting all sections of the report • Safe • Effective • Caring • Activity • Emergency access • Referral to treatment and diagnostics • Cancer waiting times • Flow • Staffing • Research and development • Estates • Digital This report also includes summary versions of quarterly reports submitted to the Trust executive committee, which go into greater detail about patient experience, patient safety, clinical effectiveness outcomes, and infection prevention. In addition, a separate finance Board report is submitted to Trust Board on a monthly basis. The Emergency Access, Activity and Flow section has several KPIs that are relevant to the key risk of delivering the national access target. Some of the KPIs are: • Number of attendances • Time to initial assessment • Delayed transfers of care • Non-elective length of stay The Activity and Flow sections have several KPIs that are relevant to the key risk of capacity and occupancy. Some of the KPIs are: • Length of stay • New referrals • Number of attendances • Bed occupancy The Staffing (HR) section has several KPIs that are relevant to the key risk of Staffing. Some of the KPIs are: • Staff turnover • Nursing vacancies • Friends and Family Test – percentage of staff who recommend UHS as a place to work You can see full copies of the monthly report by visiting www.uhs.nhs.uk Page 18 OVERVIEW AND PERFORMANCE REPORT How we monitor performance In addition to reviewing the data submitted to the Trust Board in these papers, we have a suite of tools available to compare UHS performance to that of comparable trusts around the country. Depending on the measures being monitored, UHS has a number of peer groups to benchmark against, including other local providers, major trauma centres and university hospital teaching trusts. Each NHS trust will service a different size and type of population and will offer a slightly different range of services so it is important to understand that this benchmarking provides an initial indication of performance rather than an absolute guide to our position nationally. In 2020/21 we continue to review the National Model Hospital data as it is published from NHS Improvement. The data and ability to compare our performance has helped to highlight areas of excellent practice and areas where there is potential to improve. The Trust is engaging with the model hospital team and has a member of staff on the ‘model hospital ambassador program’, as well as reviewing areas highlighted as having potential opportunities alongside finance and operational teams. Overview of performance Improving patient journeys 2019/20 was a challenging year in which we made only modest progress against some objectives to ‘Improve Patient Journeys’, and deteriorated in performance against others. • Inpatient length of stay remained stable but didn’t reduce as significantly as we had intended. The percentage of bed days used due to ‘Delayed Transfers of Care’ to other settings increased to nearly twice the national target. This, combined with growth in non-elective admissions (2.8% YTD excluding M12), resulted in occupancy rates which often exceeded our target, and an increase in patients cared for as ‘outliers’ away from their own speciality wards. • Emergency Access Performance (patients spending less than four hours in the emergency department) remained below both the national and local targets, though performance did show modest improvement during the year. There has been a further substantial increase in the volume of emergency department attendances. • The number of ‘elective’ patients waiting for treatment, the percentage of patients waiting within 18 weeks, and also the waiting time for first outpatient appointments, deteriorated significantly during the year. This has, in part, been impacted upon by reduced availability of clinical capacity due to staff concerns about the impact of new pension/tax regulations. There are, however, good indications that service changes are being implemented to increase consultation capacity in an efficient way as we had aimed to. There has been a substantial increase in consultations provided through ‘non-face-to-face’ routes, and a small decrease in the number of more traditional face-to-face consultations. • Urgent GP referrals for suspected cancer seen within two weeks saw a substantial and sustained improvement compared to the previous year, exceeding that target. • Performance against treatment within 62 days measures also demonstrated modest improvement during the year. Significant improvement in cancer performance continues to be required in order for UHS to deliver the national targets for timeliness of treatment. Page 19 OVERVIEW AND PERFORMANCE REPORT Delivering value-based healthcare • Complaints about UHS care have remained low, with the percentage of complaints ‘closed’ within 35 days above target for the first 11 months of 2019/2020. • Pleasingly, the availability of nursing care to our inpatients (expressed as care hours per patient per day) has increased progressively through the year from 8.6 to 8.9. An active overseas nursing recruitment and induction process has supplemented domestic recruitment and training. • The Trust has formed a 50/50 joint venture company with Hampshire Hospitals NHS Foundation Trust called Wessex NHS Procurement Limited (WPL). From 1 December 2019, WPL is providing procurement, supply chain and materials management services to the Trust. The objectives of this innovative partnership include the consolidation of supplies purchases for both Trusts (combined revenue £1.4bn) to leverage better prices from suppliers and increased productivity through the elimination of previously duplicated procurement activity. Supporting healthy lives • There was very good performance on the Hospital Standardised Mortality Ratio. The standard is 100 and we are consistently below this (83 in December, results are reported nationally retrospectively). This measure includes all patients in England with the same condition and compares those who have died with those that have survived. Being below 100 is a strong indicator of good care. • We continue to receive feedback, which is largely positive, through the national ‘Friends and Family’ survey for both our inpatient and maternity care. • The Board monitors a range of quality indicators. Of these, exceeding the target number of patients infected with clostridium difficile by six is of some concern, we are pleased that the number of severe/moderate medication errors has been maintained well below our target level, and following an increase in the number of Serious Incidents Requiring Investigation (SIRI) that were reported to Board in the early part of the year both the number of SIRIs has reduced and the timeliness of investigation has significantly improved. • Staff sickness levels were on target through the summer months, but significantly in excess of this through the winter months. As a whole, this is a cause for some concern. Building an expert and inclusive workforce • Very pleasingly, nursing vacancies were reduced significantly during the year, from 18% to 15%. Though still a challenge, this supports increases in the treatment capacity we can make available in the Trust, in our ability to open additional bed capacity to reduce our inpatient occupancy rates, and increases the care hours provided per patient per day. • Turnover rates have been in excess of our target throughout the year and there has also been a reduction in the percentage of staff who would recommend UHS as a place to work, though we remain above our target of 76%. The percentage of non-medical appraisals taking place within 12 months remains below target and is declining. • We have made steady progress this year towards our target of 15% of staff at Band 7 and above being from Black and Minority Ethnic backgrounds by 2023 (above 9% in March 2020). Being agile in meeting people’s needs • 2019/2020 has seen further progress in the implementation of digital tools that enable patients and clinicians to review and discuss patient specific clinical information in new ways, for example, large increases in usage of ‘My Medical Record’ and ‘digi-rounds’, modest further progress in electronic requesting and acknowledgement of tests, and stable usage of other tools. Page 20 OVERVIEW AND PERFORMANCE REPORT Leading edge research, education and innovation • The majority of recruitment targets have been achieved during 2019/20. • In Q4 UHS ranked 13th for contract commercial study recruitment, which is the same position achieved in the previous year and thus did not achieve our target of Top 10, with a constraint on pharmacy research capacity being a contributing factor. • The proportion of commercial studies closing in the 2019/20 financial year on time and to recruitment target ended the year below the 80% target at 68%, though the year-end target for the proportion of non-commercial studies closing on time and to recruitment target was exceeded at 88% compared to 80% target. Details of UHS performance can be found in the Integrated Performance report which is available in the Trust Board papers section of our website www.uhs.nhs.uk. UHS performance is scrutinised by the Board on a monthly basis. Paula Head, chief executive officer 22 June 2020 Regulatory body ratings Single Oversight Framework NHS Improvement’s Single Oversight Framework provides the framework for overseeing providers and identifying potential support needs. The framework looks at five themes: 1. Quality of care 2. Finance and use of resources 3. Operational performance 4. Strategic change 5. Leadership and improvement capability (well-led) Based on information from these themes, providers are segmented from one to four where ‘4’ reflects providers receiving the most support, and ‘1’ reflects providers with maximum autonomy. A foundation trust will only be in segments three or four where it has been found to be in breach or suspected breach of its licence. Segmentation During 2019/20 the Trust was confirmed as being placed within segment ‘2’. This segmentation information is the Trust’s position as at 31 March 2020. Current segmentation information for NHS trusts and foundation trusts is published on the NHS Improvement website. Finance and use of resources The finance and use of resources theme is based on the scoring of five measures from ‘1’ to ‘4’, where ‘1’ reflects the strongest performance. These scores are then weighted to give an overall score. Given that finance and use of resources is only one of the five themes feeding into the Single Oversight Framework, the segmentation of the Trust disclosed above might not be the same as the overall finance score here. The Trust was on track to deliver a use of resources score of ‘2’. However, as a direct result of COVID-19 our staff were unable to take their full complement of annual leave. The Trust was required Page 21 OVERVIEW AND PERFORMANCE REPORT to allow for this additional cost, which was an unfunded cost pressure allowable by NHS Improvement. This had the impact of moving the distance from financial plan score to a ‘4’ and subsequently the overall use of resources score to a ‘3’. Area Financial sustainability Financial sustainability Financial sustainability Overall scoring Metric Capital service cover Liquidity Income and expenditure margin Distance from financial plan Agency spend Q1 Q2 Q3 Q4 Year 3 3 2 2 2 1 1 1 1 1 3 1 1 1 1 1 1 2 4 4 1 1 1 1 1 2 1 2 3 3 Care Quality Commission ratings: Overall rating for this trust Are services at this trust safe? Are services at this trust effective? Are services at this trust caring? Are services at this trust responsive? Are services at this trust well-led? Good Requires improvement Outstanding Good Requires improvement Good In December 2018, the CQC inspected four core services; urgent and emergency care, medicine, maternity and outpatients. It also looked at management and leadership, and effective and efficient use of resources. The CQC report (published on the 17 April 2019) rated the Trust as ‘good’ overall and ‘outstanding’ for providing effective services. All sites and services across the organisation are now rated as ‘good’ in the effective and caring domains, with Southampton General Hospital rated as ‘outstanding’ in these areas. The Well-Led section of this report provides further details of the inspectors’ findings. “Our inspectors found a strong patient-centred culture with staff committed to keeping their people safe, and encouraging them to be independent. Patients’ needs came first and staff worked hard to deliver the best possible care with compassion and respect. Inspectors saw many areas of outstanding practice, with care delivered by compassionate and knowledgeable staff. Several teams led by example with a continuous focus on quality improvement. The Trust did face some challenges especially with the ageing estates. Some patient environments were showing significant signs of wear and tear – but again staff were doing their utmost to deliver compassionate care”. Dr Nigel Acheson Deputy chief inspector of hospitals (South) Page 22 OVERVIEW AND PERFORMANCE REPORT Environmental matters We recognise that the Trust’s business has an impact on the environment. As a large hospital, we undertake a wide range of activities and use a large amount of resources. We are committed to environmental sustainability and consider it as part of the business culture. We continue to invest in energy saving initiatives and staff awareness campaigns that focus on promoting sustainability. We acknowledge that reducing waste and minimising the consumption of scarce resources is consistent with financial sustainability. Our sustainability disclosure section on pages 86 and 95 provides greater detail on the steps we are taking to reduce our activities’ impact on the environment. Social, community, anti-bribery and human rights issues We recognise our responsibilities under the European Convention on Human Rights (included in the Human Rights Act 1998 in the UK), which are relevant to health and social care. These rights include the: • right to life • right not to be subjected to torture, inhuman or degrading treatment or punishment • right to liberty • right to respect for private and family life The Trust is committed to ensuring it fully takes into account all aspects of human rights in our work. At University Hospital Southampton we value our reputation for top quality care and financial probity and conduct our business in an ethical manner. The Bribery Act 2010 was introduced to make it easier to tackle the issue of bribery which is a damaging practice. Bribery can be defined as ‘giving someone a financial or other advantage to encourage them to perform their duties improperly or reward them for having done so’. To limit our exposure to bribery we have in place an Anti-Fraud, Bribery and Corruption Policy, a Standards of Business Conduct Policy and a Freedom to Speak Up (formerly Raising Concerns) Policy. These apply to all staff and to individuals and organisations who act on behalf of UHS. We also employ a local counter-fraud specialist who will investigate, as appropriate, any allegations of fraud, bribery or corruption. The success of our anti-bribery approach depends on our staff playing their part in helping to detect and eradicate bribery. Therefore, we encourage staff, service users and others associated with UHS to report any suspicions of bribery and we will rigorously investigate any allegations. In addition, we hold a register of interest for directors, staff, and governors, and ask staff not to accept gifts or hospitality that will compromise them or the Trust. The Board of Directors carries out its business in an open and transparent way. We are committed to the prevention of bribery as well as to combating fraud, and expect the organisations we work with to do the same. Doing business in this way enables us to reassure our patients, members and stakeholders that public funds are properly safeguarded. There are no important events since the year end affecting the Foundation Trust. No political donations have been made. The Trust has no overseas branches. Page 23 OVERVIEW AND PERFORMANCE REPORT Page 24 ACCOUNTABILITY REPORT Members of the Trust Board Board member Name Title Paula Head Chief executive officer David French Deputy chief executive officer and chief financial officer Gail Byrne Director of nursing and organisational development Biography Paula joined the Trust as chief executive in September 2018, having been chief executive at the Royal Surrey County NHS Foundation Trust in Guildford and before that at Sussex Community NHS Foundation Trust. She began her career as a pharmacist working in the community, in hospitals and at health authorities before moving into general management and her first board position at Kingston Hospital. Since then she has spent time on the boards of commissioners and providers, including director of transformation at Frimley Park Hospital NHS FT. Paula lives in Hampshire and has a daughter studying medicine at the University of Southampton. David joined the Trust in February 2016 and served as interim chief executive officer from April to September 2018. He read Economics and Social Policy at the University of London before joining ICI plc, where he qualified as a chartered management accountant. David has extensive healthcare experience from the pharmaceutical industry, mostly Eli Lilly and Company where he held many commercial and financial roles in the UK and overseas. He joined the NHS in 2010 as chief financial officer of Hampshire Hospitals NHS Foundation Trust. He also serves as a non-executive director for Vivid Housing Limited, a social housing provider across Hampshire and the Solent. Gail joined the Trust in 2010 as deputy director of nursing and head of patient safety. Prior to this, she has worked at the Strategic Health Authority as head of patient safety, and director of clinical services at Portsmouth Hospital. Gail has also worked in Brisbane, Australia as a hospital Macmillan nurse, and as general manager of a special purpose vehicle company for the private finance initiative at South Manchester Hospitals. Declarations Daughter is a medical student at University of Southampton; Member of Hampshire & Isle of Wight Sustainability and Transformation Partnership Executive Delivery Group Non-executive director and chair of audit and risk committee, Vivid Housing Limited; Director, UHS Estates Limited, a wholly-owned subsidiary of UHSFT; Director, Southampton Commercial Estates Development Partnership (CEDP) Project Company Limited, a joint-venture company owned 50/50 by UHSFT and Prime plc; Member of Hampshire & Isle of Wight Counter Fraud Board; Member of Hampshire & Isle of Wight Sustainability and Transformation Partnership Capital Planning Panel; Director of Wessex NHS Procurement Limited (WPL), a joint venture company owned 50/50 by UHSFT and Hampshire Hospitals NHS Foundation Trust (from December 2019) Husband is a consultant surgeon at UHS; Daughter is a midwife at UHS (from March 2019) Dr Derek Sandeman Joe Teape Medical director Chief operating officer Derek was appointed to the Trust as a consultant physician in 1993 and went on to develop a regional Director of UHS Pharmacy Limited, endocrine service. Throughout his career he has had a wholly-owned subsidiary of extensive clinical leadership experience, most recently serving eight years as clinical director. Derek’s leadership roles have also included programme director for postgraduate education and the Wessex Endocrine Royal College representative. He has a strong history of wider system engagement, working collaboratively with partners to improve systems resilience and pathways. UHSFT; Member of Hampshire & Isle of Wight Sustainability and Transformation Partnership Clinical Executive Group Joe joined the Trust as chief operating officer in December Nil 2019. Previously he was deputy chief executive and director of operations of a large health board in Wales which managed integrated services across three counties including four district general hospitals as well as mental health, learning disability and community services. Prior to this, Joe worked in director roles across finance and strategy within provider acute trusts across the south west of England. Joe is passionate about providing leadership and support for all staff, whatever their profession, and contributing to excellent patient care. He is committed to open and ongoing engagement with the general public and often uses social media to engage with colleagues and with those who have an interest in healthcare. Page 25 ACCOUNTABILITY REPORT Non-executive directors Name Title Peter Hollins Chair Dr Tim Peachey Non-executive director David Bennett Non-executive director Biography Declarations Peter graduated in chemistry from Hertford College, Chair of CLIC Sargent Cancer Care Oxford. Joining Imperial Chemical Industries in 1973, for Children (a company limited by he undertook a series of increasingly senior roles in guarantee) (until December 2019); marketing and then general management. Following Council member of University of three years in the Netherlands as general manager of Southampton ICI Resins BV, he was appointed in 1992 as chief operating officer of EVC in Brussels – a joint venture between ICI and Enichem of Italy. He played a key role in the flotation of the company in 1994, returning in 1998 to the UK as chief executive officer of British Energy where he remained until 2001. From 2001, he held various chairmanships and non- executive directorships. In 2003, he decided to return to an executive role as chief executive of the British Heart Foundation in which post he remained until retirement in March 2013. He joined Southampton University Hospital Trust as a non- executive director in 2010, became senior independent director and deputy chairman of UHS in 2014, and was appointed chair in April 2016. Tim qualified as a doctor from Kings College Hospital Director, TP Medcon Ltd; Clinical School of Medicine in 1983. For nearly 20 years, he Safety Officer, Block Solutions Ltd; worked as a consultant anaesthetist at the Royal Free Non-executive director and Quality Hospital in London, specialising in pancreatic cancer Committee chair, Isle of Wight NHS surgery, liver surgery and liver transplantation. He also Trust developed an interest in medical leadership and management and has held positions such as clinical director, divisional director and medical director at the Royal Free. In 2012, Tim moved into full-time management as chief executive of Barnet and Chase Farm Hospitals NHS Trust until its acquisition by the Royal Free. He then worked as the London associate medical director at the NHS Trust Development Authority before moving to Barts Health NHS Trust as improvement director and subsequently became deputy chief executive. Tim now holds two NHS non-executive posts. In addition to his role at University Hospital Southampton, Tim also serves on the board for Isle of Wight NHS Trust as deputy chair. He is a practicing mediator specialising in the healthcare sector. He also consults for companies in the medical information technology industry. Dave graduated in chemistry from the University of Director, Davox Consulting Limited; Southampton before entering management consulting, Non-executive director, Faculty of becoming a partner in Accenture’s strategy practice. Leadership and Medical In 2003 he joined Exel Logistics (later bought by DHL), Management (from November managing the company’s healthcare business across 2019); Director Royal College of Europe and the Middle East. During this time, he General Practitioners (RCGP) established NHS Supply Chain, a UK organisation Enterprises Ltd and RGCP responsible for procuring and delivering medical Conferences Ltd (from November consumables for the NHS in England, as well as sourcing 2019) capital equipment. Dave joined the board of Cable & Wireless as sales director in 2008. He later set up his own strategy consulting practice serving the healthcare sector, completing numerous projects in the UK and the US. Dave has also served as a non-executive director at The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust between 2009 and 2016. He chaired the Trust’s quality committee. Page 26 ACCOUNTABILITY REPORT Board member Name Title Jenni DouglasTodd Senior independent director/deputy chair (from 01/02/2020) Biography Jenni is a former chief executive of Hampshire Police Authority and the office of the Hampshire police and crime commissioner. After beginning her career in the probation service, she was headhunted into the civil service, at the Home Office, where she spent four years before becoming director of policy and research for the Independent Police Complaints Commission. In the latter role she was responsible for establishing governance of the new police complaints system. She then spent two and a half years as a resident twinning adviser for the UK, based in Turkey to help set up a law enforcement complaints system before taking up the role of chief executive of the county’s police authority. During her three years in the post, she supported the authority in developing effective governance processes to increase accountability and transparency. She also helped the organisation deliver cost-savings whilst still improving performance and developing closer working relations with neighbouring forces. Declarations Independent chair, Dorset Integrated Care System. Managing director, Diversa Consultancy Limited; Member of the Judicial Conduct Investigative Office; Nonexecutive director, Hampshire Cricket Board; Trustee, NACRO; Member of English Cricket Board’s Regulatory Committee. Professor Non-executive Cyrus director Cooper In 2012, she became chief executive and monitoring officer for the Hampshire police and crime commissioner, where she led the development of the office’s vision, mission, values and organisational strategy. She took on the role of investigating committee chair for the General Dental Council in 2014 and, in April that year, founded the Diversa Consultancy, which supports organisations with changes in business, culture and behaviour. She is also a member of the Judicial Conduct Investigating Office, a public appointment. Cyrus Cooper is professor of rheumatology and director of the MRC Lifecourse Epidemiology Unit. He’s also vicedean of the faculty of medicine at the University of Southampton and professor of epidemiology at the Nuffield Department of Orthopaedics (rheumatology and musculoskeletal sciences, University of Oxford). He leads an internationally competitive programme of research into the epidemiology of musculoskeletal disorders, most notably osteoporosis. His key research contributions have been: • discovery of the developmental influences which contribute to the risk of osteoporosis and hip fracture in late adulthood • demonstration that maternal vitamin D insufficiency is associated with sub-optimal bone mineral accrual in childhood • characterisation of the definition and incidence rates of vertebral fractures • leadership of large pragmatic randomised controlled trials of calcium and vitamin D supplementation in the elderly as immediate preventative strategies against hip fracture. Director and professor of rheumatology, Medical Research Council (MRC) Lifecourse Epidemiology Unit; Vice-D
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Unwelcome photography in NHS hospitals
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Mr Wheeler discusses unwelcome photography in NHS hospitals - how the rights of both patients and staff can be protected and to what extent can we prohibit unwelcome photography.
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Disclosure for consent
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The DOLS regulations were enacted to ensure that incapacitated adults are not deprived of their liberty by NHS Trusts.
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UHS AR 23-24 Final
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2023/24 Incorporating the quality account University Hospital Southampton NHS Foundation Trust Annual Report and Accounts 2023/24 Presented to Parliament pursuant to Schedule 7, paragraph 25(4)(a) of the National Health Service Act 2006 © 2024 University Hospital Southampton NHS Foundation Trust Contents Welcome from our chair and chief executive 6 Overview and performance 8 Performance report 9 Overview 10 Accountability report 37 Directors’ report 38 Remuneration report 62 Staff report 75 Annual governance statement 95 Quality account 111 Statement on quality from the chief executive 112 Priorities for improvement and statements of assurance from the board 115 Other information 180 Annual accounts 207 Statement from the chief financial officer 208 Auditor’s report 210 Foreword to the accounts 217 Statement of Comprehensive Income 218 Statement of Financial Position 219 Statement of Changes in Taxpayers’ Equity 220 Statement of Cash Flows 221 Notes to the accounts 222 5 Welcome from the Chair and Chief Executive Officer This has been another busy and undoubtedly challenging year across the NHS and UK health and social care system, and much of what has impacted the national picture has been reflected in the operational focuses and patient and people priorities for University Hospital Southampton NHS Foundation Trust (‘UHS’ or the ‘Trust’) over the last year. Meeting and continuing to overcome the challenges we have faced has required an organisation-wide team effort, and looking back at the successes we feel incredibly proud of the achievements of our 13,000 staff. Particular highlights include: • In the top ten in the country (7th) against government targets for elective recovery performance with 118% of activity compared with 2019. • Top-quartile performance against most performance metrics compared to similar sized teaching hospitals, including Emergency Department access, long-waiting patients on Referral to Treatment pathways, Diagnostics and Cancer performance. • Significant investment in new capacity through building new wards and theatres and refurbishing existing areas of the hospital. • Delivery of our highest ever Cost Improvement Programme saving. These achievements place us among the best performing trusts in England in several areas and are even more remarkable against a backdrop of continued periods of industrial action and increasing demand for our services, with many people coming to us with higher levels of acuity than ever before. The Trust’s performance in terms of elective recovery places it as one of the best-performing trusts in England and demonstrates the impact of the Trust’s decision to invest in additional capacity in prior years by building new wards and theatres. The Trust’s Emergency Department performance in respect of its four-hour waiting target at the end of March 2024 has attracted additional capital funding as part of an incentive scheme. Some of this funding will be used to increase the department’s same-day emergency care capacity during 2024/25. From a financial perspective, balancing the complexities of today’s challenges alongside the need to protect and ensure the long-term stability and quality of our service provision, has required the Board to take a number of considered and crucial efficiency improvement actions this year. Whilst challenging, the Trust has seen significant progress in delivering on both its forecasted finance position for 2023/24 and productivity targets. Achieving long-term financial stability is key to us continuing to invest in much needed upgrades and improvements to the parts of our estate that are ageing, and to developing new state-of-the-art facilities and infrastructure that increases our capabilities and capacity into the future. In the last year parts of the hospital have been transformed, with the opening of new wards, theatres and a skybridge to link the estate. Construction of a sterile services and aseptics facility has begun at Adanac Park and the expansion of our neonatal department, where we treat and care for some of our most vulnerable babies and their families, is underway. The development of a new aseptic facility at Adanac Park will have capacity to serve other hospitals within the region and is a significant opportunity for improved system-wide working. 6 We have also worked with our people to design spaces where they can rest, relax and recharge - including a new wellbeing hub and rooftop garden on the Princess Anne Hospital site. In addition, 40 staff rooms across the site have been refurbished thanks to funding from Southampton Hospitals Charity. During the year, the Trust worked to establish the Southampton Hospitals Charity as a separate charitable company to improve its ability to both raise and spend funds. This process completed on 1 April 2024. Work was carried out to refurbish a children’s ward during the year in partnership with the charity. Our people are our greatest asset, and we are pleased to see improvements from the annual staff survey in several areas - such as how people can work more flexibly, access to learning and development and improved satisfaction in support from line managers. We recognise the pressures and demands that come with working in this environment and will continue to ensure everyone working here feels heard, encouraged and supported when raising concerns. At UHS, every opportunity is taken to recognise and celebrate the incredible things our people do here every day, including the return of our in-person annual awards ceremony, monthly staff recognition events and the first ever ‘We Are UHS Week’. These occasions are an important reminder that, even when faced with challenges, there is so much to be proud of and celebrate across the whole Trust. Working together, both within the Trust and across organisational boundaries, remains one of our core values. The partnership between UHS and the University of Southampton is as strong as it has ever been, with more than 250,000 individuals having now taken part in research studies in Southampton. As the lead partner member for Acute Hospital Services on the Hampshire and Isle of Wight Integrated Care Board, we are proactively working with other trusts and healthcare providers in the region to improve the health of the community we serve. In addition, the Trust has continued to work in partnership with other providers across the system to build a shared elective orthopaedic hub in Winchester. It is anticipated that the health and social care system will continue to be a challenging environment in 2024/25. We recognise that many of the big challenges we face can only be solved in partnership with wider local partners, and we are committed to actively playing our part in delivering system-wide solutions. Equally, we will continue to focus on improving whatever is within our internal control, and to work collaboratively with our people to ensure our patients’ experience, safety and outcomes remain central to our decision-making and the actions of everyone at UHS. Jenni Douglas-Todd Chair 19 July 2024 David French Chief Executive Officer 19 July 2024 7 PERFORMANCE REPORT Performance report Introduction from the Chief Executive Officer As with 2022/23, this was another challenging year with continued increasing demand for the Trust’s resources and the need to balance this with the need to deliver quality patient care and at the same time maintain a sustainable financial position. Demand for non-elective care continued to increase with an average of 375 attendances per day to our main Emergency Department. In addition, the number of patients on the 18-week Referral to Treatment pathway rose to 58,000. Patients having no clinical criteria to reside in hospital, but unable to be discharged due to the lack of funded care in a more suitable location, posed and continues to pose a significant challenge for the Trust. The number of patients within this category was as high as 270 at times and was consistently higher throughout the year when compared to 2022/23. Despite this the Trust continued to perform well when compared to other comparable organisations, achieving some of the best Emergency Department and elective recovery fund performance in England. The Trust’s financial position continued to be difficult, which required some difficult decisions in respect of spending controls and controls on recruitment. The Trust focused in particular on controlling spending on temporary and agency staff, but in view of the overall workforce numbers compared to the 2023/24 plan, further controls were implemented in respect of substantive recruitment. Due to the additional controls and the Trust’s best delivery to date on its Cost Improvement Programme (£63.4m), the Trust achieved an end of year deficit of £4.5m, compared to the deficit of £26m anticipated in its 2023/24 plan. 9 Overview About the Trust Our services University Hospital Southampton NHS Foundation Trust is one of the largest acute teaching trusts in England with a turnover of more than £1.3 billion in 2023/24. It is based on the coast in south east England and provides services to over 1.9 million people living in Southampton and south Hampshire and specialist services, including neurosciences, respiratory medicine, cancer care, cardiovascular, obstetrics and specialist children’s services, to nearly four million people in central southern England and the Channel Islands. The Trust is also a designated major trauma centre, one of only two places in the south of England to offer adults and children full major trauma care provision. As a leading centre for teaching and research, the Trust has close working relationships with the University of Southampton, the Medical Research Council, National Institute for Health and Care Research (NIHR), Wellcome Trust and Cancer Research UK. The Trust is consistently one of the UK’s highest recruiting trusts of patients to clinical trials and one of the top nationally for research study volumes as ranked by the NIHR Clinical Research Network. Every year the Trust: treats around 155,000 inpatients and day patients, including about 70,000 emergency admissions sees over 750,000 people at outpatient appointments deals with around 150,000 cases in our emergency department The Trust provides most of its services from the following locations: • Southampton General Hospital – the Trust’s largest location, where a great number of specialist services are based alongside emergency and critical care and which includes Southampton Children’s Hospital. • Princess Anne Hospital – located across the road from Southampton General Hospital and providing maternity care and specialist care for women with medical problems during pregnancy and babies who need extra care around birth across the region. • Royal South Hants Hospital – although the Trust does not operate this site near the centre of Southampton it provides a smaller number of services from this location. • New Forest Birth Centre – located at Ashurst on the edge of the New Forest and run by experienced midwives and support staff it acts as a community midwifery hub. The services provided by the Trust are commissioned and paid for by the Hampshire and Isle of Wight Integrated Care System (ICS) and, in the case of more specialised services (such as treatments for rare conditions), by NHS England. Trust services are supported by clinical income, of which 54% is paid for by NHS England and 43% by integrated care boards, predominantly the Hampshire and Isle of Wight Integrated Care Board (ICB). These are provided under a standard NHS contract, which incorporates ongoing monitoring of the Trust and the quality of the services provided. 10 Our structure UHS gained foundation trust status on 1 October 2011. A foundation trust is a public benefit corporation providing NHS services in line with the core NHS principles: that care should be universal, comprehensive and free at the point of need. The Trust is licensed as a foundation trust to provide these services by NHS England and the healthcare services we provide are regulated by the Care Quality Commission. Since 1 July 2022, the Trust has been part of the Hampshire and Isle of Wight Integrated Care System when this was established through the Health and Social Care Act 2022. Each ICS has two statutory elements: an integrated care partnership (ICP) and an integrated care board. The ICP is a statutory committee jointly formed between the NHS integrated care board and all upper-tier local authorities that fall within the ICS area. The ICP brings together a broad alliance of partners concerned with improving the care, health and wellbeing of the population, with membership determined locally. The ICP is responsible for producing an integrated care strategy on how to meet the health and wellbeing needs of the population in the ICS area. The ICB is a statutory NHS organisation responsible for developing a plan for meeting the health needs of the population, managing the NHS budget and arranging for the provision of health services in the ICS area. The Trust has been a university teaching hospital since 1971. The diagram below provides an overview of the overall organisational structure of the Trust. Public and foundation trust members Council of Governors Board of Directors Executive Directors Division A Division B Division C Division D Surgery Critical Care Opthalmology Theatres and Anaesthetics Cancer Care Emergency Medicine Helicopter Emergency Medical Services Medicine and Medicine for Older People Pathology Specialist Medicine Women and Newborn Maternity Child Health Clinical Support Cardiovascular and Thoracic Neurosciences Trauma and Orthopaedics Radiology Trust Headquarters Division 11 Our values The Trust’s values describe how things are done at UHS and act as a guide to all staff working with colleagues to deliver high quality patient care and a great patient experience every day. These values are: Patients, their families and carers are at the heart of what we do. Their experience of our services will be our measure of success. Partnership between clinicians, patients and carers is critical to achieving our vision, both within hospital teams and extending across organisational boundaries in the NHS, social care and the third sector. We will ensure we are always improving services for patients through research, education, clinical effectiveness and quality improvement. We will continue to incorporate new ideas, technologies and create greater efficiencies in the services we provide. 12 Our strategy 2021-25 The Trust’s strategy was updated during 2020/21 to take account of everything its staff had experienced during the COVID-19 pandemic and what had been learnt from this. The vision for UHS is to become an organisation of world class people delivering world class care. The Trust’s strategy is organised around five themes and for each of these it describes a number of ambitions UHS aims to achieve by 2025. Theme Ambitions Outstanding patient outcomes, • We will monitor clinical outcomes, safety and experience of our experience and safety patients regularly to ensure they are amongst the best in the UK By 2025 we will strengthen our and the world. national reputation for outstanding • We will reduce harm, learning from all incidents through our patient outcomes, experience and proactive patient safety culture. safety, providing high quality care • We will ensure all patients and relatives have a positive experience and treatment across an extensive of our care, as a result of the environment created by our people range of services from foetal and our facilities. medicine, through all life stages and conditions, to end-of-life care. Pioneering research • We will recruit and enable people to deliver pioneering research in and innovation Southampton. We will continue to be a leading teaching hospital with a growing, reputable and innovative research and development portfolio • We will optimise access to clinical research studies for our patients. • We will enable innovation in everything we do, and ensure that ‘cutting edge’ investigations and treatments are delivered in Southampton. that attracts the best staff and efficiently delivers the best possible treatments and care for our patients. World class people • We will recruit and develop enough people with the right Supporting and nurturing our knowledge and skills to meet the needs of our patients. people through a culture that values • We will provide satisfying and fulfilling roles, growing our talent diversity and builds knowledge and through development and opportunity for progression. skills to ensure everyone reaches • We will empower our people, embracing diversity and embedding their full potential. We must provide compassion, inclusion and equity of opportunity. rewarding career paths within empowered, compassionate, and motivated teams. Integrated networks and collaboration We will deliver our services with partners through clinical networks, collaboration and integration across geographical and organisational boundaries. • We will work in partnership with key stakeholders across the Hampshire and Isle of Wight integrated care system. • We will strengthen our acute clinical networks across the region, centralising when necessary and supporting local care when appropriate. • We will foster local integration with primary and community care as well as mental health and social care services for seamless delivery across boundaries. • We will build on our successful partnership with University of Southampton (UoS), growing our reputation as a national leading university teaching hospital. 13 Theme Foundations for the future Making our enabling infrastructure (finance, digital, estate) fit for the future to support a leading university teaching hospital in the 21st century and recognising our responsibility as a major employer in the community of Southampton and our role in broader environmental sustainability. Ambitions • We will deliver best value to the taxpayer as a financially efficient and sustainable organisation. • We will support patient self-management and seamless care across organisational boundaries through our ambitious digital programme, including real time data reporting, to inform our care. • We will expand and improve our estate, increasing capacity where needed and providing modern facilities for our patients and our people. • We will strengthen our role in the community as an employer of choice, a partner in delivery of services to our population and by leading the Greener NHS agenda locally. During each year of the strategy the Trust sets out a more detailed series of objectives to achieve and progress towards the delivery of its ambitions. In 2023/24 these objectives included: Outstanding patient outcomes, experience and safety Pioneering research and innovation World class people Integrated networks and collaboration Foundations for the future • Increasing the number of reported Shared Decision-Making conversations. • Increasing the number of specialities reporting outcomes that matter to patients. • Rolling out the Patient Safety Incident Reporting Framework across the Trust. • Working with patients as partners to improve patient satisfaction. • Treating patients according to need but aiming for no patient to wait, other than through patient choice, more than 65 weeks for treatment. • Delivering national metrics for site set-up time to target for clinical research studies. • Improving the Trust’s position against peers. • Delivering year three of the Trust’s research and innovation investment plan. • Developing the five-year research and development strategy implementation plan and delivery of the first year. • Strengthening and broadening the partnership between the Trust and the University of Southampton. • Supporting delivery of the Trust’s workforce plan for 2023/24. • Reducing turnover and sickness absence rates. • Increasing overall participation in the NHS staff survey and maintaining overall staff engagement score. • Increasing the proportion of appraisals completed. • Delivering the first year objectives of the Inclusion and Belonging strategy. • Working in partnership with acute trusts to agree and implement the acute services strategy. • Producing and embedding an internal framework for network development. • Working with the local delivery system on vertical integration to reduce the number of patients without criteria to reside. • Working with system partners to open a surgical elective hub. • For the Trust to be seen as an ‘anchor institution’ in the local area. • Delivering the Trust’s financial plan for 2023/24. • Engaging the organisation in the challenge to manage demand so that capacity and demand are in equilibrium. • Delivery of the Always Improving strategy priorities. • Delivering the Trust’s capital programme in full. • Entering into a new energy performance contract and delivering the first year of the Public Sector Decarbonisation Scheme. Performance against these objectives was monitored and reported to the Trust’s Board on a quarterly basis. 14 At the end of 2023/24, the Trust had met the objectives set as follows: Corporate Ambition Outstanding patient outcomes, safety and experience Pioneering research and innovation World class people Integrated networks and collaboration Foundations for the future Totals Number of Objectives 5 5 5 5 5 25 Achieved in full 4 3 2 3 2 14 Partially achieved 1 2 2 1 3 9 Not achieved 0 0 1 1 0 2 Particular areas to highlight where the Trust has achieved strong delivery during the year include: • Delivery of quality priorities in Shared Decision-Making and the roll out of the Patient Safety Incident Response Framework. • Achieving the Trust’s 65-week waiter glide path. • Successful delivery of a number of research and development priorities, including work with the University of Southampton. • Maintaining sickness absence and turnover well below the targets set at the beginning of the year, and successfully delivering the first year of the Trust’s Inclusion and Belonging strategy. • Delivery of the Trust’s full available capital budget and completion of the first year of the Trust’s decarbonisation scheme. 15 Principal risks to our strategy and objectives The Board has identified and manages the principal risks to the delivery of its strategy and objectives through its board assurance framework. The principal risks to the delivery of its strategy and objectives identified by the Trust during 2023/24 were that: • There would be a lack of capacity to appropriately respond to emergency demand, manage the increasing waiting lists for elective demand, and provide timely diagnostics, that results in avoidable harm to patients. • Due to the current challenges, the Trust fails to provide patients and their families or carers with a highquality experience of care and positive patient outcomes. • The Trust would not effectively plan for and implement infection prevention and control measures that reduce the number of hospital-acquired infections and limit the number of nosocomial outbreaks of infection. • The Trust does not take full advantage of its position as a leading university teaching hospital with a growing, reputable and innovative research and development portfolio, attracting the best staff and efficiently delivering the best possible treatments and care for its patients. • The Trust is unable to meet current and planned service requirements due to unavailability of qualified staff to fulfil key roles. • The Trust fails to develop a diverse, compassionate and inclusive workforce, providing a more positive experience for all staff. • The Trust fails to create a sustainable and innovative education and development response to meet the current and future workforce needs identified in the Trust’s longer-term workforce plan. • The Trust does not implement effective models to deliver integrated and networked care, resulting in sub-optimal patient experience and outcomes, increased numbers of admissions and increases in patients’ length of stay. • The Trust is unable to deliver a financial breakeven position, resulting in: inability to move out of the NHS England Recovery Support Programme; NHS England imposing additional controls/undertakings; and a reducing cash balance, impacting the Trust’s ability to invest in line with its capital plan, estates and digital strategies and in transformation initiatives. • The Trust does not adequately maintain, improve and develop its estate to deliver its clinical services and increase capacity. • The Trust fails to introduce and implement new technology and expand the use of existing technology to transform its delivery of care through the funding and delivery of the digital strategy. • The Trust fails to prioritise green initiatives to deliver a trajectory that will reduce its direct and indirect carbon footprint by 80% by 2028-2032 (compared with a 1990 baseline) and reach net zero direct carbon emissions by 2040 and net zero indirect carbon emissions by 2045. During 2023/24, the Trust saw continued increased demand for its services, particularly in the Emergency Department In addition, the number of patients having no clinical criteria to reside in hospital, but unable to be discharged due to a lack of appropriate care packages was higher than anticipated and spiked during winter, which significantly impacted patient flow through the hospital and required the Trust to engage additional temporary staff. The number of patients in this category peaked at 270 during the winter. There were particular challenges in respect of those patients with a primary mental health care need who would be better cared for in a more suitable alternative setting. 16 Performance overview The Trust monitors a broad range of key performance indicators within its departments, divisions, directorates and through Trust executive committees. On a monthly basis, the Board and executive committee receives a performance report containing a variety of indicators intended to provide assurance in respect of the Trust’s strategy and that the care provided is safe, caring, effective, responsive and well-led. This report also includes the Trust’s performance against the national targets set by NHS England. The performance reports include a ‘spotlight’ section, which provides more detailed analysis of a particular area. Typically, this is one of either the national targets or the Trust’s performance against the expectations set out in the NHS Constitution. The monthly performance report is also published on the Trust’s website. The Chief Executive Officer provides a regular report on performance to the Council of Governors, which includes a range of non-financial and financial performance information. Capacity The Trust continued to experience high demand for its services, especially in the Emergency Department, with average demand during the year being around 375 patients presenting per day in the main adult and children’s emergency department. In addition, the Trust experienced a significant impact on flow within the hospital due to a high number of patients having no clinical criteria to reside in hospital but unable to be discharged. This number was as high as 270 at times during winter: an increase of around 50 patients when compared to the prior year. The Trust also saw an increase in the number of referrals with the number of patients on a waiting list under the 18-week Referral to Treatment pathway rising from approximately 55,000 to 58,000 by the end of the year. In common with other trusts, the ongoing industrial action also impacted the Trust’s ability to provide urgent care and deliver on its elective recovery programme. Quality and compliance Despite the challenges, the Trust’s Emergency Department performance was one of the highest in England in March 2024, which resulted in additional capital funding being awarded. In addition, the Trust’s elective recovery performance was one of the best in England at 118% compared to 2019. The Trust continued to monitor the quality of care delivered throughout 2023/24 through a number of established quality assurance programmes. Clinical leaders monitored key quality, safety and patient experience indicators such as falls, pressure ulcers and venous thromboembolisms. Quality peer reviews were carried out, most significantly through Matron-led Quality Walkabouts every week in and out of hours focusing on the five key CQC questions – safe, effective, responsive, caring, and well-led. The Trust’s Clinical Accreditation Scheme builds on this intelligence, with clinical areas completing self-assessments of performance and review teams completing onsite visits. Patient representatives were included in these review teams. Learning was shared at the Clinical Leaders’ Group and via quarterly reports. The Trust was an active partner in a South-East accreditation network, offering advice and a steer to providers who are just setting up or looking to develop their own scheme, and extended that advice and support to other providers in England. 17 On 15 May 2023, the CQC inspected the maternity and midwifery service at Princess Anne Hospital as part of their national maternity inspection programme. The inspection report was published 11 August 2023, and the Trust retained its overall rating of ‘good’. This year UHS introduced its Fundamentals of Care (FOC) initiative. Whilst this is not a new concept, there were concerns that missed fundamental care had been amplified during the COVID- 19 pandemic. This initiative aims to empower and educate staff at all levels to ensure fundamental care is at the heart of what the Trust does. The Trust completed its transition to the Patient Safety Incident Response Framework (PSIRF) and collaborated with the ICB to develop a PSIRF plan and policy to underpin the change. The Trust implemented the requirements in respect of ‘Martha’s Rule’ where patients, relatives and carers have a legal right to a rapid review by a critical care outreach team during an acute deterioration episode in and out of hours. The Trust continued its focus on infection prevention and control, responding rapidly to rises in infection over the winter, and successfully flexing initiatives and innovations to achieve successful management in a responsive manner. The Trust progressed its Always Improving strategy and successfully supported the identification and implementation of further quality improvement projects. This included improvements across theatres, inpatient flow and outpatient programmes. During the year, average length of stay was reduced by 1.64%, day theatre cancellations were reduced by 200, and 42,350 patients were placed onto Patient Initiated Follow Up (PIFU) pathways. Further information can be found in the Quality Account. Partnerships The Trust works within the Hampshire and Isle of Wight Integrated Care System, and is an active member of a number of partner groups including the Acute Provider Collaborative Board and the Health and Wellbeing Board. The Trust develops and agrees its annual financial plans with the Integrated Care Board. The Trust is a member of a number of specific partnership groups for particular services, including the Central and South Genomics Medicine Service, the Children’s Hospital Alliance and the Southern Counties Pathology Network. The Trust works actively as a partner with other provider organisations around clinical networks, particularly with acute Trusts within the Integrated Care System and others closely located geographically. The Trust also links closely with the University of Southampton on a number of topics including research, commercial development and education and has a developed meeting structure to oversee this. 18 Workforce The Trust’s key areas of focus during 2023/24 were in respect of increasing the substantive workforce whilst also reducing reliance on bank and agency usage, and reducing staff turnover and sickness. Although the Trust was successful in recruiting to substantive posts, the expected reduction in reliance on bank and agency staff did not materialise, which meant that the Trust was 331 whole-time equivalents above its plan for 2023/24. The Trust was successful in reducing staff turnover from 13.5% in 2022/23 to 11.4%, achieving the local target of . Cancer Waiting Times - 2 Week Wait Performance Cancer Waiting Times - 2 Week Wait Performance 100% 90% 80% 70% 60% 50% 40% Apr-23 May-23 Jun-23 Jul-23 Aug-23 Sep-23 Oct-23 Nov-23 Dec-23 Jan-24 Feb-24 Mar-24 Performance % standard met The national target was for 96% of patients to commence treatment within 31 days of diagnosis. In March 2024, the Trust achieved 92% and performed in the range of 86%-94% throughout the year. The Trust has continued to make progress against the target for treatment of cancer within 62 days of an urgent GP referral, improving performance from 64% in April 2023 to 76% in March 2024 (NHS average: 69%). First definitive treatment for cancer within 31 days of a decision to treat % standard met Cancer waiting times 31 day RTT performanceUHS vs. NHSE average Cancer waiting times 31 day RTT performance UHS vs. NHSE average 96% 94% 92% 90% 88% 86% 84% 82% 80% 78% 76% Apr-23 May-23 Jun-2 3 Jul-2 3 Aug-23 Sep-2 3 Oct-23 Nov-2 3 Dec-23 Jan-24 Feb-2 4 Mar-24 Performance NHS Average 27 Treatment for Cancer within 62 days of an urgent GP referral to hospital Cancer Waiting Times 62 Day RTT Performance UHS vs NHSE Average Cancer Waiting Times 62 Day RTT Performance UHS vs NHSE Average % standard met 1 00% 80% 60% 40% 20% 0% Apr-23 May-23 Jun-23 Jul-23 Aug-23 Sep-23 Oct-23 Nov-23 Dec-23 Jan-24 Feb-24 Mar-24 Performance NHS Average 28 Quality priorities Priorities for improvement 2023/24 Last year the Trust continued its ambition to deliver the highest quality care shaped by a range of national, regional, local, and Trust-wide factors. During the year the Trust continued to experience unprecedented demand on its services, with flow, capacity, infection prevention and safety all presenting challenges. However, the Trust was confident in its ability to keep a focus on its quality priorities, and its teams worked hard to achieve their goals even in these difficult circumstances. Priorities are aligned to the three core dimensions of quality: • Patient experience – how patients experience the care they receive. • Patient safety – keeping patients safe from harm. • Clinical effectiveness – how successful is the care provided? Out of the six priories set, the Trust achieved five and partially achieved one. Overview of success Quality Priority One Improving care for people with learning disabilities and autistic (LDA) people across the Trust. Supporting staff delivering this care. Outcome against goals: achieved Key achievements: • LDA working group reestablished. • Development of an improvement plan using the NHS Learning Disability Improvement standards. • The LDA team has moved to the virtual enhanced care group in Division B where operational and governance support, leadership, and peer support/learning opportunities has been strengthened. • Sensory Boxes have been introduced for all clinical areas, funded by the Hampshire and Isle of Wight (HIOW) Integrated care board (ICB). These boxes include noise cancelling headphones, fidget toys, communication books and visual cards to support patients and wards. • Recruited additional Learning Disability Champions. • Established links with the parent carer forum (PCF) for the local area and are now attending regular events. A representative from the PCF sits on the LDA working group. The LDA team are working with the Trust lead for patient experience to develop this aspect of the LDA workplan over the next year. Quality Priority Two Supporting patients, service users and staff to overcome their tobacco dependence via a smoking cessation programme. Outcome against goals: achieved Key achievements: • Package of support available to patients who may be smokers and who need to be supported not to smoke during their treatment. • Fully trained team of tobacco advisors working in the hospital and an advisor working in the outpatient setting supporting the patients once they have returned home. • Devised the IT changes the Trust would like to implement to improve its service and referral process. • Recruited 30 smoke-free champions. • Successfully supported 1,131 patients with a self-confirmed quit rate of 45.6% at 28 days. • Supported 109 outpatients who have successfully achieved a 60% quit rate. • On track to achieve the goal to go smoke-free by April 2024 including the removal of smoking shelters. 29 Quality Priority Three Ensure carers are fully supported, involved, and valued across all our services by developing the carers support service across the Trust in partnership with Southampton Hospitals. Outcome against goals: partially achieved Key achievements: • Carers now have a more comprehensive package of concessions and vouchers to help support their cared-for person (e.g. free parking available onsite for blue badge owners is now available). • Listening events were held to put patients at the centre of transforming the way we deliver care is delivered, enabling their voices to improve the quality of care and outcomes for all. • Developed joint working with local partners (e.g. Children’s Society and No Limits to support young carers). Not yet achieved: • The ‘pathway to support, has not yet been developed. Work is ongoing to develop a new strategy. • A charity-funded carers’ support worker has not yet been appointed. • The carers’ training package has not yet been relaunched. Quality Priority Four Put patients at the centre of transforming the way care is delivered, enabling their voices to improve the quality of care and outcomes for all. Outcome against goals: achieved Key achievements: • Work has continued to work across corporate and divisional services to embed patients and carers into quality and service improvement, creating new patient groups (e.g. Mesh Support Group). • Successfully developed our engagement with various local communities, working to ensure that a range of care experiences are considered ( e.g. there is now a Gypsy, Roma, and Irish Traveller community health liaison officer to ensure that these communities are engaged with and brought into work to improve the inclusivity of our services). • Attending multiple public engagement opportunities (Young Carers’ Festival, Mela, University Freshers’ Fayres, Carers’ Listening Lunch, Hoglands Park Play Day, visits to local temples and ‘Love Where You Live’). • Youth and Young Adult Ambassador involvement has increased, including attendance toat meetings of the Council of Governors, and supporting hospital projects. • A Celebration of Carers Week and Volunteers Week were run. • The Trust has analysed its reported outcome measures to identify health inequalities in its services. This information has been used to set a new quality priority for 2024/25. • An SMS friends and family test text survey has been introduced to improve the response rate on patient feedback from the Emergency Department. In the first three months following the survey launch, responses increased from 24 to 424. 30 Quality Priority Five To develop the Trust’s clinical effectiveness process, connecting to the Trust’s Always Improving approach to measuring, understanding, and using outcomes to improve patient care. Outcome against goals: achieved Key achievements: • The Trust has developed its clinical effectiveness process across the Trust with involvement of informatics, governance and management teams, clinical effectiveness leads as well as reporting committees. • Patient representation onhas been included in the clinical assurance meeting for effectiveness and outcomes (CAMEO) to ensure conversations focus on what matters to patients. • The CAMEO template has been changed to focus discussions on areas the specialty is proud of (strong or improving outcomes), areas for improvement (poorly benchmarked or worsening outcomes) and planned actions. • The Trust encourages the use of run and/or statistical process control charts along with benchmarking where available. • Details of NICE and quality standards and national and regional reviews are included to cover breadth of clinical effectiveness. • How the clinical effectiveness team works has been reorganised, aligning each of them to each division giving a named link which helps to deepen understanding and improve links with governance and improvement activities locally. • Working with informatics to establish a core set of clinical outcome measures which are meaningful to patients, which can be reported centrally (starting with surgical specialities). • Starting to develop an education strategy and platform to support staff with a number of tools used in clinical effectiveness as well as clarity on where and how to record and evidence audit and service improvement. • A revised strategy has been drafted. Quality Priority Six Developing a culture where all clinical staff have a basic knowledge of diabetes. Outcome against goals: achieved Key achievements: • Launch of the ‘Start with the Diabasics’ Initiative, designed to help give diabetes visibility across UHS. • Delivered an extensive education programme to clinical staff across the professions and bands, including the introduction of some e-learning and a Diabasics introductory video has been shown at all trust staff inductions since July 2023. • Supported the development of 45 diabetes link nurses, resulting in all ward areas now having a named diabetes link nurse. • Improved triage for referrals. • Established processes for ‘lessons learned’. • Developed IT solutions to improvingimprove alerts and guidance. • A ‘Ketone Wednesdays’ initiative has been created in response to overuse of blood ketone testing (estimated waste cost of £100,000 per year). • The Trust’s lead diabetes specialist nurse and the Diabasics Initiative were both shortlisted for National Quality in the Care Diabetes Awards (October 2023). • The Diabasics Initiative was mentioned as a case study on the Diabetes UK charity website as an example of good practice that could be reproduced elsewhere. More information can be found about how the Trust delivered and measured its quality priorities, including feedback from patients and staff and improvement aims and quality priorities for 2024/25, in the Trust’s Quality Account for 2023/24. 31 Financial performance The Trust delivered a deficit of £4.5m from a revenue position of over £1.3bn, following receipt of £24.6m one-off cash support from NHS England. UHS started the year with an underlying deficit as a result of a number of cost pressures, notably demand for services being above block contract levels and the cost of national pay awards being above funded levels. The Trust has also continued to face a number of pressures, including high numbers of patients who no longer meet the criteria to reside in the hospital, and high demand for patients with a primary mental health need. In 2023/24, the Trust delivered a record savings level of £63.4m (5%) across a range of programmes. Trust operating income rose by £107m from the previous financial year, most notably funding the NHS pay award, as well as additional elective recovery funding. Trust operating expenses rose by £89m, incorporating funded inflationary costs as well as costs relating to the cost pressures outlined above. The Trust has also continued its reinvestment of surplus cash into infrastructure for the Trust, with capital investment of over £75m, including investment in new wards, theatres, decarbonisation, digital infrastructure, neonatal expansion and backlog maintenance. Trust cash and cash equivalents finished the year at £79m, a reduction of £24m from the previous year due to the operating loss and capital investment outlined above. Whilst liquidity remained strong in 2023/24 supported by NHS England cash support, the underlying financial deficit means it is likely to decline further in 2024/25. The Trust is continuing to monitor its cash position closely and is considering whether additional cash support may be required in 2024/25. Sustainability The Trust recognises that everyone has a part to play in responding to the climate crisis. In March 2022, the Trust agreed its own green plan in response to the challenge of the NHS becoming the world’s first health service to reach carbon net zero. Now in its third year, the plan identifies the Trust’s key areas of focus and its ambitions and has seen progress across all areas of the plan. The plan sets out the scale of the challenge, the Trust’s commitment to reducing the impact on the environment and the steps to be taken across the following categories: • Estates and facilities • Clinical and medicines • Digital transformation • Supply chain and procurement • Travel and transport • Waste and resources • Food and nutrition • Adaptation • Biodiversity • Wider sustainability The Trust continues to progress through its green plan and has completed the ‘Greener NHS’ reporting tool for several quarters, which has demonstrated good progress. In addition, the Trust is planning to launch its ‘Our Sustainable UHS’ app for staff, which will give tips on sustainability and create personalised travel plans, including identifying potential contacts for car sharing. In addition, the Trust is considering proposals to implement additional solar power, smart metering and expanding the use of LED lighting. 32 In 2022/23, the Trust was successful in bidding for £29.4m of funding through the Public Sector DeCarbonisation Fund, which will be used to fund green initiatives as part of the Trust’s capital programme. During the year the Trust successfully bid for £823k in National Energy Efficiency Funding which has been used to upgrade the lighting at Princess Anne Hospital. Social, community, anti-bribery and human rights issues The Trust recognises its responsibilities under the European Convention on Human Rights (included in the Human Rights Act 1998 in the UK). These rights include: • right to life • right not to be subjected to inhuman or degrading treatment or punishment • right to liberty and freedom • right to respect for privacy and family life. These are reflected in the duty, set out in the NHS Constitution, to each and every individual that the NHS serves, to respect their human rights and the individual’s right to be treated with dignity and respect. The Trust is committed to ensuring it fully takes into account all aspects of human rights in its work. An equality impact assessment is completed for each Trust policy. For patients, the Trust’s safeguarding policies protect and support the right to live in safety, free from abuse and neglect and other policies and standards are designed to optimise privacy and dignity in all aspects of patient care. Feedback from patients and the review of complaints, concerns, claims, incidents and audit help to monitor how the Trust is achieving these objectives. The Trust’s green plan, approved by the board of directors in March 2022, recognises the Trust’s broader role and responsibility to address the issues of climate change, air pollution, waste and environmental decline present to the city of Southampton and the impact that these issues have on the health and wellbeing of the local population served. Although the Modern Slavery Act 2015 does not apply to the Trust, its green plan sets out an ambition to stop modern slavery. The Trust is also committed to maintaining an honest and open culture within the Trust; ensuring all concerns involving potential fraud, bribery and corruption are identified and rigorously investigated. The Trust has a Fraud, Bribery and Corruption Policy, a Standards of Business Conduct Policy and a Raising Concerns (Whistleblowing) Policy. These apply to all staff and to individuals and organisations who act on behalf of UHS. Anti-bribery is part of the Trust’s work to counter fraud. This work is overseen by the Audit and Risk Committee, which receives regular reports from the local counter fraud specialist on the effectiveness of these policies through its monitoring and reviews, providing recommendations for improvement, as well as an annual report from the freedom to speak up guardian. You can read more about the work of the Audit and Risk Committee and the Trust’s approach to counter fraud in the Accountability Report. Events since the end of the financial year There have been no important events since the end of the financial year affecting the Trust. Overseas operations The Trust does not have any overseas operations. 33 Equality in service delivery NHS trusts have an essential role in tackling health inequalities, both as part of the services they provide, but also through work with the wider system. By working with those in integrated care systems, local authorities and third sector organisations, the Trust can have a significant impact on the health of the local population. The national focus on health inequalities is growing. This comes with new legal duties around reporting information and expectations to report on improvement programmes. In September 2023, a health inequalities steering group was initiated, under the leadership of the Chief Medical Officer, with representation from clinical, operational, transformation, patient experience, research, organisational development and culture, informatics, public health and the Integrated Care Board. The group focused on scoping future priorities aligned to national guidelines, contractual obligations and priorities, regional priorities, feedback from clinical teams and patients, understanding where action is already being taken, and what the data is showing. Overall, the group
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Annual report 2021-2022
Description
2021/22 Incorporating the quality report University Hospital Southampton NHS Foundation Trust Annual Report and Accounts 2021/22 Presented to Parliament pursuant to Schedule 7, paragraph 25(4)(a) of the National Health Service Act 2006 © 2022 University Hospital Southampton NHS Foundation Trust Table of contents Welcome from our chair and chief executive 6 Overview and performance 8 Performance report 9 Overview 10 Accountability report 36 Directors’ report 37 Remuneration report 59 Staff report 72 Annual governance statement 94 Quality report 105 Statement on quality from the chief executive 106 Priorities for improvement and statements of assurance from the board 109 Other information 182 Annual accounts 210 Statement from the chief financial officer 211 Auditor’s report 212 Auditor’s report including audit certificate 218 Foreword to the accounts 220 Statement of Comprehensive Income 221 Statement of Financial Position 222 Statement of Changes in Taxpayers’ Equity 223 Statement of Cash Flows 224 Notes to the accounts 225 5 Welcome from our chair and chief executive As we emerged from the most severe phase of the COVID-19 pandemic, 2021/22 was another challenging year for everyone at University Hospital Southampton NHS Foundation Trust (UHS). It was also a year on which we can look back with pride at what we achieved together in unprecedented circumstances. Amongst many notable achievements over the past twelve months, we have: • Led on globally ground-breaking research trials to inform the country’s COVID-19 vaccine booster strategy, including the world’s first COVID-19 vaccine booster study of mixed schedules. • Successfully managed infection prevention and control, putting us amongst the best in the country for minimising nosocomial spread. This was against a backdrop of, at times, R-rates in our local community that were amongst the highest in the country. • Published new strategies for digital and sustainability, which respectively set out how we are revolutionising our technical capability to meet changing patient needs and responding to the growing threat posed by climate change as part of the NHS-wide commitment to reaching carbon net zero by 2045. The pandemic also highlighted the vital importance of our staff’s wellbeing so we could continue to meet the needs of the most vulnerable and sick within our community and beyond. In response, we launched and have sustained a comprehensive programme of support to help our staff recognise and address the physical and emotional burden of the last two years. In financial terms, the Trust achieved its forecast breakeven position in 2021/22 on a turnover of £1.15 billion. Our strong, long-term financial performance meant we could continue investing in the capacity and condition of our estate. During the last year we have welcomed patients into our new ophthalmology outpatients area, expanded the majors area of our emergency department, built Hamwic House for treating cancer patients and opened four new operating theatres. Our ambition remains to increase capacity and improve facilities so that we can meet rising demand for our services, treating more people in improved settings than ever before. The momentum we are building is informed and driven by our five-year strategic plan, which describes our collective ambitions on our journey to becoming a world-class organisation. Our successes over the last twelve months were set against a backdrop of exceptional pressure on our services, unlike anything we have seen before. Like most hospital trusts, the lifting of COVID-19 restrictions in the wider community saw significant increases in attendances at our emergency department and increased referrals for treatments including surgery and cancer care. Everyone at UHS is working hard to restore services and bring waiting times down, although there are headwinds impacting our elective recovery. As we write this report, we have more than 200 patients in the hospital who no longer need our care but are waiting for discharge, either to a care home or to their own home with domiciliary care packages. Like many sectors, our local authority partners are struggling to buy or directly provide the capacity that is needed due primarily to workforce shortages. On occasion, the number of patients stranded in our hospitals means we have had to cancel scheduled surgery patients due to a lack of beds. Despite this, we are making good progress on recovering our elective performance, for example the number of elective surgery procedures in May 2022 was over 8% higher than in May 2019, prior to the COVID-19 pandemic. 6 Looking back over the year, our achievements would not have been possible without every single one of our 13,000 staff, who have gone above and beyond to put patients first. As a Trust Board we recognise that our people are our greatest asset. The results of this year’s NHS annual staff survey are encouraging, with the percentage of staff recommending UHS as a place to work being the sixth highest across all NHS trusts in England. However, we know we can do even better and our new people strategy will help us achieve this by introducing programmes which enable our people to thrive, excel and belong in a diverse and inclusive environment. We ended the year by saying farewell to Peter Hollins, who completed his second and final term as chair on 31 March 2022. In the six years of his leadership, the Trust has undergone a huge transformation to the benefit of both patients and staff. Peter has been a trusted and respected colleague whose outstanding leadership has set UHS on course to be a world-class organisation with world-class people delivering worldclass care. We welcome the formation of the Hampshire and Isle of Wight integrated care system on 1 July 2022, which will facilitate increased integration and collaboration across health and social care partners. We look forward to continuing strong relationships with all our partners as we work to develop an NHS of which all the communities we serve can be proud. Jane Bailey Interim Chair June 2022 David French Chief Executive Officer June 2022 7 OVERVIEW AND PERFORMANCE Performance report Introduction from our chief executive 2021/22 is the second year that the ways in which the Trust has worked, and the performance it has achieved, have been strongly influenced the COVID-19 pandemic. Our circumstances varied significantly through the year, however, by March 2022: • COVID-19 related restrictions had been removed across the wider community, but remained necessary within healthcare settings; • a combination of partial immunity and improved treatments had reduced the numbers of patients experiencing the most severe symptoms of COVID-19, but the total numbers of people being infected remained very high; and • the numbers of patients attending, or being referred to, healthcare services for other conditions had returned to pre-pandemic levels or higher. Our challenges and priorities have varied through the year in a similar manner, and have included: • providing sufficient urgent care capacity for patients with COVID-19 alongside those with other illnesses or injuries; • running our services with significantly increased levels of COVID-19 related absence amongst our staff, as infection rates have increased in the wider community; and • increasing the numbers of elective treatments provided, back to pre-pandemic levels and higher, to start to reduce patient waiting times and reverse the increases in waiting list sizes caused by COVID-19. Our performance this year has often been impacted by the adversity of the circumstances. We have not always been able to achieve the targets established prior to the pandemic, nor to deliver the standard of service that we would aspire to for our patients. The Trust is proud to have performed well in comparison to other hospital trusts across many performance measures, however, I would like to thank our patients for their understanding and patience, and all our staff for their resilience, commitment and dedication to care for patients and their colleagues. As we begin to emerge from the pandemic, and consider the year ahead, we look forward to working with patients, hospital colleagues, and partners across health and social care to: • continue the recovery from the impacts of the COVID-19 pandemic; • improve our performance against key measures, continuing to perform well in comparison with other hospitals and moving closer to the national targets; and • continue to adapt and improve services such that the outcomes and results achieved for patients will be better than ever before. 9 Overview About the Trust Our services University Hospital Southampton NHS Foundation Trust is one of the largest acute teaching trusts in England with a turnover of more than £1 billion in 2021/22. It is based on the coast in south east England and provides services to over 1.9 million people living in Southampton and south Hampshire and specialist services, including neurosciences, respiratory medicine, cancer care, cardiovascular, obstetrics and specialist children’s services, to more than 3.7 million people in central southern England and the Channel Islands. The Trust is also a designated major trauma centre, one of only two places in the south of England to offer adults and children full major trauma care provision. As a leading centre for teaching and research, the Trust has close working relationships with the University of Southampton, the Medical Research Council, National Institute for Health and Care Research (NIHR), Wellcome Trust and Cancer Research UK. The Trust is consistently one of the UK’s highest recruiting trusts of patients to clinical trials and in the top ten nationally for research study volumes as ranked by the NIHR Clinical Research Network. 12,000 Every year over staff at UHS: treat around 160,000 inpatients and day patients, including about 75,000 emergency admissions see over 650,000 people at outpatient appointments deal with around 150,000 cases in our emergency department deliver more than 100 outpatient clinics across the south of England, keeping services local for patients The Trust provides most of its services from the following locations: • Southampton General Hospital – the Trust’s largest location, where a great number of specialist services are based alongside emergency and critical care and which includes Southampton Children’s Hospital. • Princess Anne Hospital – located across the road from Southampton General Hospital and providing maternity care and specialist care for women with medical problems during pregnancy and babies who need extra care around birth across the region. • Royal South Hants Hospital – although the Trust does not operate this site near the centre of Southampton it provides a smaller number of services from this location. • New Forest Birth Centre – located at Ashurst on the edge of the New Forest and run by experienced midwives and support staff it offers a safe, ‘home away from home’ environment for women having a healthy pregnancy and expecting a straightforward birth. The NHS patient services provided by the Trust are commissioned and paid for by local clinical commissioning groups (CCGs) and, in the case of more specialised services (such as treatments for rare conditions), by NHS England. Just under half of the Trust’s NHS patient services are paid for by CCGs and just over half are paid for by NHS England. We provide these under a standard NHS contract, which incorporates ongoing monitoring of the Trust and the quality of the services provided. 10 Our structure UHS gained foundation trust status on 1 October 2011. A foundation trust is a public benefit corporation providing NHS services in line with the core NHS principles: that care should be universal, comprehensive and free at the point of need. The Trust is licensed as a foundation trust to provide these services by Monitor (the independent regulator, now part of NHS England and NHS Improvement) and the healthcare services we provide are regulated by the Care Quality Commission. Being a foundation trust has enabled greater local accountability and greater financial freedom and has supported the delivery of the Trust’s mission and strategy over a number of years. The Trust has been a university teaching hospital since 1971. The diagram below provides an overview of the overall organisational structure of the Trust. Division A Surgery Critical Care Opthalmology Theatres and Anaesthetics Public and foundation trust members Council of Governors Board of Directors Executive Directors Division B Division C Division D Cancer Care Emergency Medicine Helicopter Emergency Medical Services Medicine and Medicine for Older People Pathology Specialist Medicine Women and Newborn Maternity Child Health Clinical Support Cardiovascular and Thoracic Neurosciences Trauma and Orthopaedics Radiology 11 Trust Headquarters Division Always Improving Central Operations Clinical Outcomes Commercial Development Communications Contracting Corporate Affairs Data and Analytics Education and Workforce Estates, Facilities and Capital Development Finance Health and Safety Human Resources Informatics Medical Examinerss Service Occupational Health Organisational Development Quality Patient Safety Planning and Productivity Procurement and Supply Research and Development Safeguarding Strategy and Partnerships The Trust is also part of an integrated care system in Hampshire and the Isle of Wight, which is a partnership of NHS and local government organisations working together to improve the health and wellbeing of the population across Hampshire and the Isle of Wight. Our values Our values describe how we do things at UHS and act as a guide to all staff working with colleagues to deliver high quality patient care and a great patient experience every day. Our values are: Patients, their families and carers are at the heart of what we do. Their experience of our services will be our measure of success. Partnership between clinicians, patients and carers is critical to achieving our vision, both within hospital teams and extending across organisational boundaries in the NHS, social care and the third sector. We will ensure we are always improving services for patients through research, education, clinical effectiveness and quality improvement. We will continue to incorporate new ideas, technologies and create greater efficiencies in the services we provide. 12 Our strategy 2021-25 The Trust’s strategy was updated during 2020/21 to take account of everything our staff had experienced during the COVID-19 pandemic and what we had learnt from this. The vision for UHS is to continue on its journey to become an organisation of world class people delivering world class care. Our strategy is organised around five themes and for each of these it describes a number of ambitions we aim to achieve by 2025. Theme Ambitions Outstanding patient outcomes, • We will monitor clinical outcomes, safety and experience of our experience and safety patients regularly to ensure they are amongst the best in the UK By 2025 we will strengthen our and the world. national reputation for outstanding • We will reduce harm, learning from all incidents through our patient outcomes, experience and proactive patient safety culture. safety, providing high quality care • We will ensure all patients and relatives have a positive experience and treatment across an extensive of our care, as a result of the environment created by our people range of services from foetal and our facilities. medicine, through all life stages and conditions, to end-of-life care Pioneering research • We will recruit and enable people to deliver pioneering research in and innovation Southampton. We will continue to be a leading teaching hospital with a growing, reputable and innovative research and development portfolio • We will optimise access to clinical research studies for our patients. • We will enable innovation in everything we do, and ensure that ‘cutting edge’ investigations and treatments are delivered in Southampton. that attracts the best staff and efficiently delivers the best possible treatments and care for our patients. World class people • We will recruit and develop enough people with the right Supporting and nurturing our knowledge and skills to meet the needs of our patients. people through a culture that values • We will provide satisfying and fulfilling roles, growing our talent diversity and builds knowledge and through development and opportunity for progression. skills to ensure everyone reaches • We will empower our people, embracing diversity and embedding their full potential. We must provide compassion, inclusion and equity of opportunity. rewarding career paths within empowered, compassionate, and motivated teams. Integrated networks and collaboration We will deliver our services with partners through clinical networks, collaboration and integration across geographical and organisational boundaries. • We will work in partnership with key stakeholders across the Hampshire and Isle of Wight integrated care system. • We will strengthen our acute clinical networks across the region, centralising when necessary and supporting local care when appropriate. • We will foster local integration with primary and community care as well as mental health and social care services for seamless delivery across boundaries. • We will build on our successful partnership with University of Southampton (UoS), growing our reputation as a national leading university teaching hospital. 13 Theme Foundations for the future Making our enabling infrastructure (finance, digital, estate) fit for the future to support a leading university teaching hospital in the 21st century and recognising our responsibility as a major employer in the community of Southampton and our role in broader environmental sustainability. Ambitions • We will deliver best value to the tax payer as a financially efficient and sustainable organisation. • We will support patient self-management and seamless care across organisational boundaries through our ambitious digital programme, including real time data reporting, to inform our care. • We will expand and improve our estate, increasing capacity where needed and providing modern facilities for our patients and our people. • We will strengthen our role in the community as an employer of choice, a partner in delivery of services to our population and by leading the Greener NHS agenda locally. During each year of the strategy the Trust sets out a more detailed series of objectives to achieve and progress towards the delivery of its ambitions. In 2021/22 these objectives included: • Recovery restoration and improvement of clinical services • Introducing a robust and proactive safety culture • Empowering and developing staff to improve services for patients • Implementing the ‘Always Improving’ strategy • Delivering the first year of the research and investment plan • Restoring a full research portfolio and preparing for future growth • Delivering joint research and innovation infrastructure with UoS and Wessex partners • Increasing our people capacity (recruitment, retention, education) • Great place to work including focus on wellbeing • Building an inclusive and compassionate culture • Working in partnership with the integrated care system and primary care networks • Integrated networks and collaboration • Creating a sustainable financial infrastructure • Making our corporate infrastructure (digital, estate) fit for the future to support a leading university teaching hospital in the 21st century • Recognising our responsibility as a major employer in the community of Southampton and our role in delivering a greener NHS. Performance against these objectives will be monitored and reported to the Trust’s board of directors on a quarterly basis. Principal risks to our strategy and objectives The board of directors has identified and manages the principal risks to the delivery of its strategy and objectives through its board assurance framework. The principal risks to the delivery of its strategy and objectives identified by the Trust during 2021/22 were that: • It would have insufficient capacity to respond to emergency demand, reduce waiting lists for planned activity and provide diagnostics results in avoidable harm to patients • It would not be able to provide service users with a safe, high quality experience of care and positive patient outcomes • It would not effectively plan for and implement infection prevention and control measures that reduce the number of hospital-acquired infections and limit the number of nosocomial outbreaks of infection • It would not secure the required ongoing investment to support our pioneering research and innovation, driving clinical services of the future 14 • It would not realise the full benefits of being a University teaching hospital through working with regional partners to accelerate research, innovation and adoption; increasing the number of studies initiated and the patients recruited to participate in these studies and the delivery of new treatments and treatments that would not otherwise be available to patients • It would not be able to increase the UHS workforce to meet current and planned service requirements through recruitment to vacancies and maintaining annual staff turnover below 12% and develop a longerterm workforce plan linked to the delivery of the Trust’s corporate strategy • It would not develop a diverse, compassionate and inclusive workforce, providing a more positive staff experience for all staff • It would not create a sustainable and innovative education and development response to meet the current and future workforce needs • It would not implement effective models to deliver integrated and networked care, resulting in suboptimal patient experience and outcomes, increased numbers of admissions and increases in patients’ length of stay. • It would be unable to deliver a financial breakeven position and support prioritised investment as identified in the Trust’s capital plan within locally available limits (CDEL). • It would not adequately maintain, improve and develop our estate to deliver our clinical services and increase capacity. • It would fail to introduce and implement new technology and expand the use of existing technology to transform our delivery of care through the funding and delivery of the digital strategy. • It would fail to prioritise green initiatives to deliver a trajectory that will reduce our direct and indirect carbon footprint and reach net zero direct carbon emissions by 2040 and net zero indirect carbon emissions by 2045 While the COVID-19 pandemic presented the Trust with new risks as it introduced more stringent infection control processes, stopped certain types of activity and responded quickly to care for large numbers of seriously ill patients who had tested positive for COVID-19, it also prompted innovation across a wide range of areas. However the ongoing impact of the pandemic on both our staff, patients who have had COVID-19 and patients who have waited longer than expected for treatment as a result, have added to the risks facing the Trust. This risk has continued into 2021/22 and has been coupled with increases in referrals for cancer and increased attendances to our emergency department and non-elective activity. National targets for performance have not been amended as a result of the pandemic, although the national plan has focussed on the recovery of activity levels as the first stage in a restoration of elective services. Capacity – The initial and subsequent waves of the COVID-19 pandemic have led to increases in the waiting times for patients and the number of patients waiting more than 52, 78 and 104 weeks has increased significantly. While there was a significant reduction in the number of patients waiting over 104 weeks in 2021/22, with the Trust expecting that no patients will be waiting more than 104 weeks by July 2022, its ability to reduce the overall waiting list and the length of time patients are waiting for treatment remains one of the key risks for the Trust. This may be compounded by future waves of the COVID-19, a continuation of the sustained demand for urgent non-elective activity and an ongoing number of referrals, often requiring more complex treatment due to delays in people visiting their GPs for the first time and presenting with more advanced disease. The Trust utilised the support available from the independent sector to continue cancer treatment and surgery for those patients at highest risk and continues to make use of independent capacity for cardiac surgery. It also increased the number of outpatient attendances which took place by telephone or video call. The Trust developed a clinical assurance framework during the year to better assess the risk of harm to patients as a result of delays in treatment and this has been utilised in decision-making around the allocation of resources to those areas where there is the greatest risk of potential harm to patients. In addition to opening additional capacity during 2021/22 (described in the Estates section below), the Trust also committed expenditure in 2021/22 to open further wards and operating theatres during 2022/23 and 2023/24. These initiatives will contribute to further improvements in elective waiting times in coming years. 15 Quality and compliance – The Trust continued to monitor the quality of care delivered throughout 2021/22. During the COVID-19 pandemic the primary focus became infection prevention and control, with the launch of an award-winning COVID ZERO campaign that saw the Trust reduce the transmission of the virus in hospital (nosocomial transmission). While the Trust continued to perform well overall, the Trust exceeded its annual threshold for Clostridium difficile infections and there was one MRSA bacteraemia during March 2022, the only such event in 2021/22. The Trust continued to develop its proactive patient safety culture during 2021/22 with changes to the way in which patient safety incidents are investigated and the launch of its Always Improving strategy and transformation initiatives in theatre efficiency, patient flow and outpatients. Reporting and investigation of incidents continued during 2021/22. The Trust continues to prepare for the implementation of the new patient safety incident response framework in June 2022/23. Partnerships – During 2021/22, the Trust and its partners continued to work together to discharge patients safely, to ensure patients requiring urgent cancer treatment and surgery were able to continue their treatment in the independent sector and to develop the regional COVID-19 saliva testing programme for local schools, hospitals and other employers. The new arrangements for integrated care systems will be implemented in July 2022. This is expected to reinvigorate work with partners at a system, place and provider level in Hampshire and Isle of Wight. The Trust is already part of an acute provider collaborative with other acute trusts in Hampshire and the Isle of Wight and is progressing a number of projects including the development of an elective hub at Winchester Hospital, diagnostics, pathology, endoscopy and imaging networks. The Trust also continued to progress research activity and opportunities with the University of Southampton and Wessex health partners. Workforce – The Trust continued to recruit nurses from overseas and through targeted recruitment campaigns during 2021/22 meaning that the number of nursing vacancies has remained relatively stable. Vacancies in other areas have increased reflecting a more competitive job market, particularly for lower band roles. The Trust also continued to work with its staff networks and specific focus groups to increase diversity in leadership roles. Staff turnover remained above the 12% target during 2021/22 and retention is a key element of the people strategy. While workforce capacity continues to be one of the biggest challenges faced by the Trust, during 2021/22 we have also focused on supporting our staff to respond to the COVID-19 pandemic and operational pressures by providing both the tools and time to help staff recovery. We are incredibly proud of the way that staff responded to the pandemic and continue to recognise this in whatever ways we can, however, we also want to ensure that staff continue to be able to contribute to patient care at their best and want to stay and develop with the Trust. Technology was also used at levels not previously achieved to continue to deliver training to staff and enable staff to work from home where possible, ensuring a safer environment for patients and staff in the hospitals. Estate – The Trust continued to invest in and develop its estate during 2021/22 including opening a new ophthalmology outpatient area, expansion of the majors area of the emergency department and four new operating theatres. These were part of £65 million of capital expenditure in 2021/22 that also included equipment, digital and the backlog maintenance programme. Innovation and technology – There have been exceptional levels of achievement in relation to COVID-19 related research activity, including in partnership with the universities. You can read more about these in part three of the quality account. The board of directors has also supported the funding of an expansion of research and innovation activity to allow the continued delivery of the Trust’s ambitions to innovate and improve and transform its services. 16 The Trust and its partners also been successful in securing external funding including one of only four successful NHSX awards to test the concept of federated trusted research environments with its Wessex health partners and core funding of £10.5 million for the National Institute for Health and Care Research (NIHR) Southampton Clinical Research Facility (CRF) for the period between September 2022 and August 2027. Sustainable financial model –The Trust achieved its forecast breakeven position in 2021/22. Income was more predictable in 2021/22 as block contract arrangements remained in place in response to the COVID-19 pandemic and ensured that costs were covered, however, funding from the elective recovery fund, particularly, in the first half of 2021/22 introduced a degree of income volatility as did changes to the framework for the elective recovery fund half way through the year. The Trust continues to maintain a strong cash position and to implement improvements and efficiency savings, allowing it to continue to invest in its services. The financial outlook across the NHS looks extremely challenging going into 2022/23 due to the reductions in non-recurrent funding and efficiency targets. The Trust currently has an underlying deficit, with pressures on energy prices and drugs cost growth within block contract arrangements, which had been supported with non-recurrent funding in previous years. While specific funding has been provided to address inflationary pressures there is a risk that inflation could exceed this funding and raw material and supply shortages could also impact on costs. Performance overview The Trust monitors a very wide range of key performance indicators within its departments, divisions, directorates and executive committee. Assurance for our board of directors and executive committee includes an integrated performance report which is reviewed monthly and contains a variety of indicators intended to provide assurance regarding implementation of our strategy and that the care we provide is safe, caring, effective, responsive and wellled. The integrated performance report also includes a monthly ‘spotlight’ section, to enable more detailed consideration of any topics that are of particular interest or concern. The selection of topics is informed by a rolling schedule, any performance concerns and requests from the board of directors. Assurance for our council of governors includes a quarterly Chief executive’s performance report, which includes a range of non-financial and financial performance information. 17 Performance analysis COVID-19 Impacts In 2021/22, the most prominent impacts of COVID-19 have been in relation to occupancy of inpatient beds by patients with a COVID-19 diagnosis and increased levels of staff sickness absence associated with COVID-19, in addition to normal levels of absence due to other causes. The impact of COVID-19 has varied significantly through the year, linked primarily to the prevalence of the disease within the wider community. In comparison to 2020/21: • bed occupancy (all types) did not reach the same exceptional peaks, however, it exceeded 50 patients between August 2021 and March 2022 and reached an average of 83 in March 2022; • the number of patients requiring treatment in intensive care and high care were much reduced, though still significant; • fewer patients were admitted requiring hospital treatment for COVID-19 alone, and greater numbers were admitted requiring treatment for other medical conditions who were also infected with COVID-19 at the same time; • staff sickness absence levels were typically higher, particularly in the second half of the year when national restrictions had been removed and COVID-19 infections in the community increased – the sickness absence rate (from all causes) peaked at 6% in March 2022 All bed types Intensive care/higher care beds 18 Staff sickness absence Emergency access through our emergency department Following a reduction during the first year of the pandemic, the numbers of patients who presented to receive care at our emergency department increased exponentially in 2021/22. Attendance levels exceeded the higher levels seen prior to the pandemic by approximately 10%. All patients presenting to the emergency department This exceptional increase in the clinical demand upon our department has had a significant adverse impact upon the timeliness of care, particularly for those patients who have a less urgent condition. The department has also continued to deliver services separately for those patients who have respiratory symptoms and those who do not, and to implement additional infection control measures. Emergency access performance is measured as the percentage of patients discharged from emergency department care or admitted to a hospital bed within four hours of arrival to the department. The national target of 95% was not achieved and the Trust experienced a large deterioration in our own performance to 64% (main ED/Type 1 attendances) by March 2022. Our performance compared favourably with other acute trusts in England despite this, however. 19 Emergency access four hour performance The number and duration of any ambulance handover delays are another important performance indicator. Ensuring that ambulance staff can ‘hand over’ the patients they convey to our emergency department without delay is important because this releases the staff and their vehicle to meet the needs of other medical emergencies in the community. We are very proud to have an exceptionally good record in this regard, working with colleagues in ambulance services to transfer arriving patients into our emergency department and the care of our staff even when the hospital is already fully occupied. 20 Elective Waiting times Demand 2021/22 has seen a continuation of the trend of increasing elective referrals, following a major reduction which occurred at the start of the COVID-19 pandemic. Referral rates to our services are now typically at, or above, the levels seen before the pandemic. Feedback from clinicians is that they are also seeing more patients with advanced disease than they would normally, because of delays in referral to the service/diagnosis. Accepted referrals The number of patients referred to hospital with suspected cancer increased exceptionally during 2021/22; the number of patients seen for a first consultant-led appointment was 27% higher than in 2020/21 and 18% higher than in 2019/20. Performance remained below the national target of 93% throughout the year, with a deterioration to 74% in December 2021 prior to a recovery to 90% in March 2022. Our performance also declined in comparison with other acute trusts in England. Most of the patients who waited longer than two weeks for their first appointment were within our breast service, which sees a very large number of referrals for suspected cancer and experienced a 22% increase in the number of patients seen compared to 2019/20. Additional consultants who specialise in breast cancer have now been recruited and performance in this service returned to target in April 2022. 21 Performance following ‘Two week wait’ urgent referral for suspected cancer 22 Activity The number of UHS hospital appointments, diagnostic tests and elective admissions all increased significantly during 2021/22. The number of appointments undertaken, and diagnostic tests performed, exceeded activity levels in both 2019/20 and 2020/21. The number of elective and day case admissions increased significantly compared to 2020/21 (the first year of the pandemic) yet remained approximately 10% below the levels achieved between April 2019 and February 2020 (prior to COVID-19). There were a wide range of factors influencing these activity levels, and the lower levels of admitted activity specifically, including: • the availability of beds for the admission of elective patients after emergency patients with COVID-19 and other conditions had been accommodated; • the availability of staff to deliver elective care, during periods of increased COVID-19 bed occupancy, and during periods of increased staff absence related to COVID-19; • additional infection prevention measures which were maintained, particularly within inpatient treatment settings where risks of COVID-19 transmission are otherwise increased. Most of the activity has been delivered within NHS hospitals in 2021/22 (local independent sector hospitals were used to replace NHS elective capacity in 2020/21), and we have recruited additional staff and invested in an additional ward, theatres and outpatient rooms in order to be able increase our treatment activity. The graphs below show 2021/22 activity levels as a percentage of those achieved prior to the COVID-19 pandemic. Elective admissions (including day case) 23 Outpatient attendances Diagnostics Our performance measures for diagnostics report on a total of 15 different frequently used tests. At the end of March 2022, 20% of patients were waiting more than six weeks to receive their investigation. This is a significant improvement compared to 28% of patients waiting more than six weeks at the end of March 2021, yet still significantly worse than the national target (1%) and UHS performance prior to pandemic. At the end of March 2022, the total waiting list size (including patients waiting less than six weeks) had increased by 14% compared to March 2021 and was 34% larger than before the pandemic. These trends reflect a combination of large reductions in diagnostic activity in the first year of the pandemic, followed by record levels of diagnostic tests being performed during 2021/22 (7% higher than before the pandemic) combined with very high levels of referrals for diagnostic testing over the same period. 24 The tests with largest numbers of longer waiting patients are non-obstetric ultrasound, peripheral neurophysiology, MRI and CT. Initiatives to improve performance include the recruitment of additional staff in the relevant professions and investment in additional equipment, in the context of NHS forecasts that diagnostic demand will continue to increase over the longer term. Patients waiting for a diagnostic test to be performed (sum of 15 different frequently used tests) Percentage of patients waiting over 6 weeks for a diagnostic test to be performed 25 Referral to Treatment Our waiting list from referral to treatment increased in size by 27% (9,768 patients) during 2021/22 and is now 36% larger than before the pandemic. Both referrals and hospital activity declined steeply at the start of the pandemic, but referral levels increased more quickly than hospital activity following this. The rate at which the waiting list is increasing has however reduced in the most recent six months. Number of patients waiting between referral and commencement of a treatment for their condition The national target is that at least 92% of patients should be waiting for treatment no more than 18 weeks from their referral to hospital. Our performance has deteriorated from 80% immediately before the pandemic, to 68% at the end of March 2022. Our performance continues to be typical of the major teaching hospital trusts that we benchmark with, and the trend has been similar to that experienced across trusts in England. Percentage of patients waiting up to 18 weeks between referral and treatment 26 The fact that some patients wait significantly longer than the 18 week target is a particular concern. In 2020/21 NHS England targeted the stabilisation of the numbers of patients waiting more than 52 weeks and the elimination of waiting times more than 104 weeks (except when patients choose to wait longer). The percentage of patients waiting more than 52 weeks at UHS reduced from 9% to 4%. The number of patients waiting more than 104 weeks reduced, from a maximum of 171, to 59 at the end of March 2022 (of whom only five were wishing to proceed with treatment at that time). The patients who typically wait longest for treatment continue to be those who require admission for surgical procedures in specialities such as ear nose and throat, orthopaedics and oral surgery. The Trust opened four additional operating theatres during 2020/21 and is working in collaboration with partners in the Hampshire and Isle of Wight integrated care system to implement further elective recovery plans. Percentage of patients waiting more than 52 weeks, between referral and commencement of a treatment for their condition 27 Cancer Waiting Times The timeliness of urgent services for patients with suspected cancer has unfortunately declined during 2021/22. The Trust continues to perform well in comparison with the teaching hospitals that we benchmark with and deliver a similar range of services, however. We have faced a range of challenges including: • a large increase in the number of new patients referred for investigation; • delays in the onward referral (for specialist investigation or treatment) of patients from other trusts which have also experienced increases in referrals; • the need to provide capacity to investigate and treat the full range of other conditions, alongside those patients with suspected cancer; and • an increase in the complexity of treatment required by new and existing patients, potentially because of delays in referral or treatment during the first year of the pandemic The national target is to provide the first definitive treatment to at least 85% of patients with cancer with 62 days of referral to hospital. UHS exceeded this level of performance in April 2021 but has not done so since then, performance deteriorated to 66% in January 2022 before recovering somewhat to 72% by March 2022. Treatment for Cancer within 62 days of an urgent GP referral to hospital The national target is to provide the first definitive treatment to at least 96% of patients within 31 days of a decision to treat being made and agreed with the patients. Trust performance has been very variable in 2021/22, ranging from 89% to 98% in individual months. Likewise, performance has ranged from below average in some months, to amongst the best in the group of teaching hospitals that we benchmark with. 28 First definitive treatment for cancer within 31 days of a decision to treat A range of initiatives are being pursued to maintain and improve the timeliness of our cancer services including: • changes to some of the processes for the referral and initial assessment of patients with suspected cancer, for example the inclusion of high quality photographs within referrals for suspected skin cancer; • projects to refine processes and procedures for the investigation of suspected gynaecological and urological cancers; • an operating services improvement programme designed to improve the flow of patients, and the numbers of patients treated, through our existing theatre facilities; and • staffing level increases and recruitment to clinical roles in specialities where the increases in demand require this. Quality priorities The Trust set four quality priorities in 2021/22, which were aimed at ensuring we continued to deliver the highest quality of care. The quality priorities were shaped by a range of national and regional factors as well as local and Trust‐wide considerations. We recognised the overriding issues of significant operational pressures being felt right across the health and social care system, including those associated with the second year of the COVID-19 pandemic, by limiting the number of priorities to four. We also acknowledged the risk that the delivery of our priorities could be disrupted by the ongoing pandemic and that we needed to be flexible in adapting the priorities to changing circumstances. The Trust set the following four priorities: 1. Introduction of midwifery continuity of carer for women at risk of complications in pregnancy. 2. To support staff wellbeing and recovery. 3. Managing risks to patients delayed for treatment and restoring elective programmes. 4. Reducing healthcare associated infection (HCAI) 29 The Trust achieved three of the quality priorities and partially achieved one priority. In relation to midwifery continuity of carer, the Trust’s performance exceeded the ambition that had been set by NHS England in 2020/21 following its national review of maternity services in 2015 as shown below. NHS England ambition set in 2020/21 35% of women will be booked to receive care in a continuity of carer team 35% of black and minority ethnic women booked to receive care in a continuity of carer team 35% of women living in an IMD-1 area (most deprived areas measured using indices of deprivation) Percentage achieved 41.7% 75% 80% The Trust continued to introduce programmes, interventions and wider support offerings to promote staff wellbeing and recovery in 2021/22. Our 2021/22 annual NHS staff survey results are positive with our scores relating to wellbeing above the benchmark average. Contributing factors to wellbeing such as staff engagement, morale, staff experience in areas such as kindness and respect, feeling valued and trusted to do their job were all above the benchmark average. More information about staff health and wellbeing is included in the staff report below. The Trust only partially achieved the priority relating to managing the risks to patients delayed for treatment and restoring elective programmes. The Trust’s performance against elective waiting time standards are described in more detail above. While the Trust focused on prioritising all patients waiting for surgery to ensure we continued to treat people based on need and urgency, we continue to recognise the impact of delays on people’s quality of life and, at times, outcomes. COVID-19 remained a key area of focus for the Trust in 2021/22 in terms of infection prevention. The Trust implemented a number of awareness campaigns, including its award-winning COVID ZERO campaign, and strategies to reduce in-hospital transmission of COVID-19 and kept these under review throughout the year. The chart below shows the trend of hospital-onset cases of COVID-19, which has broadly followed local and national prevalence of the virus, and the Trust’s performance compared very favourably with its local and national peers. 30 The table below provides an overview of the Trust’s performance against national and other infection prevention standards and limits to minimise infections, the majority of which have been achieved by the Trust. Category National Objectives: MRSA bacteraemia Clostridium difficile infection E coli Bacteraemia End of year RAG Action /Comment R One MRSA bloodstream infection attributable to UHS 2021/22 in March 2022. R 74 cases against a threshold of 64 for the year. G 138 cases in 2021/22 against a threshold of 151. Klebsiella Bacteraemia A 64 cases in 2021/22 against a threshold of 64. Pseudomonas Bacteraemia MSSA G 30 cases in 2021/22 against a threshold of 34. 43 cases in 2021/22 after 48 hours in hospital. Other: Hospital onset, healthcare associated COVID-19 103 hospital-onset probable healthcareassociated cases in 2021/22. 125 hospital onset definite healthcare associated cases in 2021/22. Prudent antibiotic Antimicrobial prescribing Stewardship G The standard contract requirement for reduction in antibiotic usage for 2021/22 was waived, as in 2020/21. Had it been applied as anticipated, the Trust would very likely have met this. Provide Assurance of Infection G The annual infection prevention audit assurance of Prevention Practice programme was reinstated in April 2021 for basic infection Standards the monitoring and assurance of infection prevention prevention and control practices but practice: subsequently suspended in September 2021. You can find more information about how the Trust delivered and measured its quality priorities, including feedback from patients and staff and improvement aims and quality priorities for 2022/23, in the Trust’s quality account for 2021/22, incorporated in the Trust’s annual report and accounts. 31 Financial performance The Trust delivered a surplus of £0.048 million from a revenue position of over £1.2 billion, once items deemed as “below the line” by NHS England and NHS Improvement, su
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BEACON protocol v8.0 07Mar2023 signed
Description
A randomised phase IIb trial of BE AC v izumab added to Temozolomide O ± Irin tecan for children with N refractory/relapsed euroblastoma Version 8.0 dated 07-Mar-2023 Dinutuximab beta amendment Coordinating Sponsor: Sponsor Protocol Number: CAS Code: EudraCT Number: ISRCTN Reference Number: ITCC Number: Roche Study Reference Number: Email: University of Birmingham RG_ 11-087 BN2008 2012-000072-42 40708286 032 MO28245 beacon@trials.bham.ac.uk This application is supported by the facilities funded through Birmingham Science City: Translational Medicine Clinical Research Infrastructure and Trials Platform, an Advantage West Midlands (AWM) funded project which forms part of the Science City University of Warwick and University of Birmingham Research Alliance. BEACON-Neuroblastoma Protocol_vn 8.0_vd 07Mar2023 Page1 of 157 BEACON-Neuroblastoma Trial Protocol AMENDMENTS The following amendments and/or administrative changes have been made to this protocol since the implementation of the first approved version Amendment Date of number amendment Protocol version number Type of amendment SA 1 29-Jan-2013 2.0 Substantial Amendment N/A 23-Apr-2013 2.0a Non-Substantial Amendment N/A 01-Jul-2013 2.0b Non-Substantial Amendment Summary of amendment Introduction of the recommendation of weekly monitoring of blood counts for all patients receiving irinotecan. Addition of planned vaccination with live vaccination to exclusion criteria and prohibited medications section. ITCC Number has been corrected. Roche Study Reference Number and ISRCTN Reference Number have been added. Contact details for Plasma & Tumour Angiogenesis-Related Biomarkers have been amended. Table numbers have been corrected. Addition of guidance for research bone marrow sampling in Schedule of Activities table and sections 7.4.2.2 and 7.5.2. Addition of paragraph to sections 7.2, 7.6.1 – 7.6.4 detailing arrangements for handling dose modifications for Irinotecan + Temozolomide for patients receiving Bevacizumab. Discontinuation rules for osteonecrosis of the jaw and eye disorders added to table 13 in section 7.6.4. Correction to table number references in section 7.6.3. Clarification made in section 13.4.1 concerning Planned Interim Analysis. SA 3 06-Oct-2014 4.0 Substantial Amendment Changes to the Trial Personnel section of the protocol to include the addition of contact details for Denmark and Ireland Lead Investigators. Amendments to reflect the changes in study sampling requirements to Trial Synopsis, Schedule of Activities table and sections 1.2.6, 2.1, 2.2, 5.1, 5.2, 7.3, 7.4.2 and 7.5. Amendment to exclusion criteria in Trial Synopsis and section 4.2. Changes to the Schedule of Activities table to include the addition of an echocardiogram to be performed at screening and Tanner staging at screening and yearly in follow up. Changes to the time line for measuring renal function prior to commencing treatment in the Trial Synopsis, Schedule of Activities and section 4.1. BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 3 of 157 BEACON-Neuroblastoma Trial SA 4 06-Oct-2014 4.0 SA 5 30-Jul-2015 5.0 Substantial Amendment Substantial Amendment Protocol Option to fax emergency randomisation removed. Telephone only in section 6.2 Changes to guidelines in section 7.2 for dose calculation in patients whose weight exceeds the 98th centile for age. Removal of enhanced data collection for Adverse Events of Special Interest (AESI) in section 7.6 and 9.1.2. Addition of option to extend treatment delay with agreement from Sponsor in Section 7.6.1 Addition of necrotising fasciitis as an adverse event requiring bevacizumab discontinuation in section 7.6.4. Changes to section 7.10 concerning the documenting of concomitant medications in patient medical notes and administration of bisphosphonates. Changes to section 9.1 regarding reporting of laboratory adverse events. Clarification on the arrangements for Follow Up Form completion for patients who do not require further follow up visits in section 11. Changes to bevacizumab and irinotecan preparation and dispensing guidelines in sections 8.2.4 and 8.3.3. Clarification on fasting arrangements prior to temozolomide administration added to section 8.4.3. Changes to events that should be reported on an Expected SAR Form in section 9.1.3.1. Clarification on SAEs that should be reported to F.Hoffman-La Roche Ltd in section 9.2.6 Addition of Trial Management Group meeting frequency in section 14.4. Changes to the wording of irinotecan randomisation in section 13.4.2. Addition of guidelines for dose reduction and discontinuation of temozolomide for liver toxicity in tables 8, 9, 10 & 11. Reference to the National Coordinating Centres has been changed to National CoSponsor throughout. Reference to Sponsor has been changed to Coordinating Sponsor. Change of Chief Investigator to Professor Pamela Kearns. Change of Principal Investigator at Royal Marsden Hospital to Dr Sucheta Vaidya. No changes made to the Protocol version. Chief Investigator and UK Lead Investigator changed to Dr Lucas Moreno Switzerland details added Schedule of events table amended for End Of Treatment clarity BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 4 of 157 BEACON-Neuroblastoma Trial N/A 23-Sep-2015 5.0a SA 6 16-Jan-2019 6.0a Protocol Topotecan added to the study as a new trial question and 2 new randomisation arms. The following sections are amended accordingly: Synopsis (Primary Objectives, sample size, Trial Duration, Trial therapy) Section 1 Background and rationale (Trial rationale) Section 3 Trial design (Randomisation) Section7.1 and 7.2 Treatment details Section7.6.1 Dose modifications Table 6 amended, Tables 11 and 12 added Section 8.4 Pharmaceutical Information Section 13 Statistical considerations The following changes were made to the Eligibility: Inclusion criteria – further details regarding birth control Exclusion criteria – Defined wash out period following prior IMP according to IMP half-life or 14 days. Lifestyle guidelines - further details regarding birth control Section 7.6 Dose modifications Figure 1 – reference to “chemo” changed to Temozolomide/Irinotecan/Topotecan” for clarity Section 8.2.4 Reference to “chemo” removed for clarity Section 7.6.4 AEs requiring Bevacizumab discontinuation – additional AEs added following Bevacizumab IB v22 Addendum Additional mRNA and exploratory sampling. Non-Substantial Amendment Substantial amendment The requirement for confirmatory scans was removed from the Schedule of Activities and Response assessment section 7.4.3. Lead Investigator for France amended to Dr Marion Gambart Minor wording corrections and clarifications Schedule of events table corrected Introduction of two new treatment arms (dinutuximab beta) for additional 64 patients Addition of eligibility criteria, schedule of events, treatment details, duration, cross over and dose modification details for new dinutuximab beta arms Adaptation of objectives, trial design, supporting treatment, pharmaceutical information and statistical consideration sections with new, relevant information. BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 5 of 157 BEACON-Neuroblastoma Trial N/A 11-Apr-2019 6.0b SA 7 07-Feb-2020 7.0 SA 22 07-Mar-2023 8.0 Protocol Non-Substantial Amendment Substantial Amendment Substantial Amendment Minor wording corrections and clarifications Version amended from 6.0 to 6.0a to add. Additional rationale to update typographical errors.) Trial Synopsis: Clarification of recruitment targets Clarification of Section 10 title: “Dinutuximab beta and topotecan randomisations” Clarification that not all biological studies will be open at any one time (Section 10.2 and 15.5) Minor wording corrections and clarifications Urgent Safety Measure – implemented on 28th January 2020 Closure of Temozolomide (T) and Dinutuximab beta and Temozolomide (dBT) arms with immediate effect. Section 1.1 Background Section 1.2.3 Benefit Risk assessment Section 3.1 Randomisation Section 10 Headings changed Section 10.3 Trial therapy Update of contact details Change of definition of End of Trial (Section 21). Protocol previously defined two stages of end of trial (6 months after last patient completes treatment and 12 months after last data capture after 5 years follow up). This has been combined into one End of Trial definition: 6 months after last patient last visit (i.e. after 5 years follow up) Also addition of option to email SAE form (Section 18.2.1.2) BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 6 of 157 BEACON-Neuroblastoma Trial Protocol TRIAL PERSONNEL Chief Investigator: Co-Investigators: Exploratory Biomarkers Dr Lucas Moreno Dr. Lucas Moreno, MD, PhD Director Paediatric Oncology & Haematology Division Vall d’Hebron Barcelona Hospital Campus Passeig de la Vall d’Hebron, 119-129, 08035, Barcelona, Spain +34 93 489 3000 +34 93 489 4060 lucas.moreno@vhebron.net Professor Keith Wheatley Professor of Clinical Trials Cancer Research UK Clinical Trials Unit (CRCTU) Institute of Cancer and Genomic Sciences College of Medical and Dental Sciences University of Birmingham Birmingham, UK B15 2TT +44 (0)121 415 9119 k.wheatley@bham.ac.uk Dr Juliet Gray Associate Professor and Consultant in Paediatric Oncology Southampton Children’s Hospital Tremona Road Southampton SO16 6YD +44 (0) 790 1507929 juliet.gray@uhs.nhs.uk Dr Gudrun Schleiermacher Senior Scientist Institute Curie 26 rue d'Ulm 75248 Paris cedex 05 France +33 (0)1 56 24 45 50 +33 (0)1 56 24 66 30 gudrun.schleiermacher@curie.net Professor Louis Chesler Paediatric Tumour Biology Team Institute of Cancer Research and Royal Marsden Hospital (University of London), Downs Road, Sutton Surrey, UK SM2 5PT +44 (0) 208 722 4035 BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 7 of 157 BEACON-Neuroblastoma Trial Protocol louis.chesler@icr.ac.uk Functional Imaging Study: Professor Andrew Peet Institute of Child Health University of Birmingham Whittall Street Birmingham, UK B4 6NH +44 (0) 121 333 8234 +44 (0) 121 333 8241 a.peet@bham.ac.uk Dr Dow-Mu Koh Consultant Radiologist in Functional Imaging Royal Marsden Hospital Downs Road, Sutton, Surrey, UK SM2 5PT +44 (0) 208 6613857 dow-mu.koh@icr.ac.uk Professor Martin Leach Co-Director, Cancer Research UK and EPSRC Centre for Cancer Imaging, Director, NIHR Clinical Research Facility Deputy Head, Division of Radiotherapy and Imaging Institute of Cancer Research and Royal Marsden Hospital (University of London), Downs Road, Sutton Surrey, UK SM2 5PT +44 (0 208 661 3338 Martin.Leach@icr.ac.uk Molecular Monitoring mRNA Study: Professor Sue Burchill Leeds Institute of Cancer & Pathology St. James University Hospital Beckett Street Leeds, UK LS9 7TF +44 (0) 113 206 5873 +44 (0) 113 242 9886 S.A.Burchill@leeds.ac.uk Professor Walter Gregory Clinical Trials Research Unit (CTRU) University of Leeds Clinical Trials Research House 71-75 Clarendon Road Leeds LS2 9PH +44 (0) 113 343 1489 +44 (0) 113 343 1471 BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 8 of 157 BEACON-Neuroblastoma Trial Protocol Trial Statistician: Trial Coordinator & Trial Office: Randomisation Service: SAE Reporting: W.M.Gregory@leeds.ac.uk Miss Grace Holt Cancer Research UK Clinical Trials Unit (CRCTU) Institute of Cancer and Genomic Sciences College of Medical and Dental Sciences University of Birmingham Birmingham, UK B15 2TT +44 (0)121 414 8328 +44 (0)121 414 3700 G.C.Holt@bham.ac.uk Miss Punam Mistry Children’s Cancer Trials Team Cancer Research UK Clinical Trials Unit (CRCTU) Institute of Cancer and Genomic Sciences College of Medical and Dental Sciences University of Birmingham Birmingham, UK B15 2TT +44 (0)121 414 3788 +44 (0)121 414 9520 beacon@trials.bham.ac.uk Provided by the CRCTU at the University of Birmingham Randomisation should be performed by sites online at: https://www.cancertrials.bham.ac.uk/BEACONLive In case of any problems with online randomisation, randomisation can be performed over the phone by the CRCTU on: 0800 371 969 or +44 (0)121 414 3366 SAEs should be faxed to the BEACON-Neuroblastoma Trial Office, CRCTU, University of Birmingham, UK + 44 (0)121 414 9520 or +44 (0)121 414 3700 National Coordinating Investigators: Austria – Lead Investigator: Prof Dr Ruth Ladenstein St. Anna Children’s Hospital and CCRI /Studies and Statistics Department for Integrated Research and Projects (S²IRP) Kinderspitalgasse 6, Zimmermannplatz 10 A-1090 Vienna Austria +43-1-40470-4750 +43-1- 40470- 7430 ruth.ladenstein@ccri.at BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 9 of 157 BEACON-Neuroblastoma Trial Belgium Lead Investigator: Prof Genevieve Laureys Ghent University Hospital 9000 Ghent De Pinterlaan 185 Belgium +32 93 32 34 48 genevieve.laureys@uzgent.be Denmark – Lead Investigator: Dr Karsten Nysom Dept. of Paediatrics & Adolescent Medicine Rigshospitalet Blegdamsvej 9 DK2100 Copenhagen Denmark +45 35 45 08 09 +45 35 45 50 55 Karsten.nysom@regionh.dk France – Lead Investigator: Dr Marion Gambart Unité d'Hémato-Oncologie Hôpital des Enfants 330, avenue de Grande Bretagne TSA 70034 31059 Toulouse Cedex France +33 (0)5 34 55 86 11 +33 (0)5 34 55 86 12 gambart.m@chu-toulouse.fr Germany - Lead Investigator: Dr. Simone Hettmer Zentrum für Kinder- und Jugendmedizin UNIVERSITÄTSKLINIKUM FREIBURG Mathildenstr. 1, 79106 Freiburg Germany +49 761 270-43000 +49 761 270-45180 simone.hettmer@uniklinik-freiburg.de Ireland – Lead Investigator: Dr Cormac Owens Our Lady’s Children’s Hospital Crumlin Road, Crumlin Dublin 12 Ireland +35314096659 +35313453041 Cormac.owens@olchc.ie Protocol BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 10 of 157 BEACON-Neuroblastoma Trial Protocol Italy – Lead Investigator: Dr. Aurora Castellano U.O.Oncoematologia Ospedale Pediatrico Bambino Gesù Pzza S. Onofrio 4 00165 Roma Italy +39 06 68592957-2678 +39 06 68592826 aurora.castellano@opbg.net Netherlands – Lead Investigator: Dr. C Michel Zwaan Erasmus Medical Center Sophia’s Children's Hospital Dr. Molewaterplein 60 3015 GJ Rotterdam +31 (0) 10 703 6691 +31(0) 10 703 6681 c.m.zwaan@erasmusmc.nl Spain – Lead Investigator: Dr. Victoria Castel Instituto de Investigación Sanitaria Unidad de Oncología Pediátrica Hospital Universitario La Fe Bulevar Sur, S/N 46026 Valencia Spain +34 963862758 Ext 50040 +34 963494416 castel_vic@gva.es Switzerland – Lead Investigator: Dr. Nicolas Gerber University Children’s Hospital, Steinwiesstrasse 75, CH-8032 Zurich, Switzerland +41 44 266 31 17 +41 44 266 34 61 Nicolas.gerber@kispi.uzh.ch UK – Lead Investigator: Dr Lucas Moreno Honorary Research Fellow University of Birmingham Birmingham, UK B15 2TT +44 (0)121 414 3788 +44 (0)121 414 9520 lucas.moreno@vhebron.net, lmorenom@ext.cnio.es BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 11 of 157 BEACON-Neuroblastoma Trial Protocol TRIAL SYNOPSIS Title A randomised phase IIb trial of bevacizumab added to temozolomide ± irinotecan for children with refractory/relapsed neuroblastoma – BEACON-Neuroblastoma Trial Trial Design A phase II, randomised, open label, international multicentre 3x2 factorial trial. The dinutuximab beta amendment did utilise a 2x2 factorial design it will now be a simple two-way randomisation. Objectives Primary: - To test whether bevacizumab added to a backbone chemotherapy regimen (temozolomide, irinotecan + temozolomide or temozolomide + topotecan) demonstrates activity in children with relapsed or refractory neuroblastoma - To test whether the addition of irinotecan to temozolomide increases the activity of chemotherapy in children with relapsed or refractory neuroblastoma - To test whether the addition of topotecan to temozolomide increases the activity of chemotherapy in children with relapsed or refractory neuroblastoma (“topotecan randomisation”) - To test whether dinutuximab beta added to a backbone chemotherapy regimen (temozolomide or temozolomide + topotecan) demonstrates activity in children with relapsed or refractory neuroblastoma (“dinutuximab beta randomisation”) Secondary: - To evaluate the safety of the regimens Tertiary: - To undertake preliminary evaluation of the changes in magnetic resonance imaging (MRI) derived functional imaging biomarkers of angiogenesis - To undertake preliminary evaluation of the role of circulating mRNA levels for tyrosine hydroxylase (TH), paired-like homeobox 2b (PHOX2B) and doublecortin (DCX) as prognostic/predictive biomarkers in this refractory/relapsed setting - To undertake a preliminary evaluation of the role of tumour molecular profiles in blood and archival tumour tissue profiles as prognostic and predictive biomarkers - To undertake a preliminary evaluation of biomarkers of response to anti-GD2 therapy (Fc/KIR polymorphisms, Antibody Dependant Cell-Mediated Cytotoxicity (ADCC) and Anti-Drug Antibodies (ADAs) and of dinutuximab beta pharmacokinetics (PK) Outcome Measures Primary Endpoint: - Best response (Complete Response [CR] or Partial Response [PR]) [1] at any time during the first 6 cycles of trial treatment - For the bevacizumab part 2 only: Progression-free survival (PFS) Secondary Endpoints: - Safety of the regimens: Incidence and severity of Adverse Events (AE)s - PFS - Overall survival (OS) - Event-free survival (EFS) BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 12 of 157 BEACON-Neuroblastoma Trial Protocol Exploratory/Tertiary Endpoints: - Changes in (MRI) derived functional imaging biomarkers of angiogenesis measured by quantitative dynamic contrast enhanced (DCE) MRI: primary biomarkers will be the transfer constant Ktrans [min-1] and initial area under the gadolinium uptake curve from 0 to 60 seconds (IAUGC60, mM Gd min) and secondary biomarkers will be tumour apparent diffusion coefficient (ADC, 10-6 cm2 s-1), native T1 and T2 relaxation times (ms) and transverse relaxation rate R2* - Changes in circulating mRNA levels for TH, PHOX2B and DCX in bone marrow and blood samples - Pilot descriptive study of angiogenesis and neuroblastoma markers that may include O6methylguanine-methyltransferase (MGMT) status, immunohistochemistry and immunofluorescence markers on tumour samples (such as microvessel density (MVD), CD31, Ki67, NRP1, VEGFR-1, VEGFR-2, C-KIT), DNA/RNA extraction from tissue sections for tumour mutation screening and tumour expression profiling - A preliminary correlation of the different biomarkers [Fc/KIR polymorphisms, Antibody – Dependent Cellular Toxicity (ADCC), and Anti-Drug Antibodies (ADAs)] will be made with parameters of anti-tumour activity (response rate, PFS and OS). PK parameters (dinutuximab beta trough levels) for this chemo-immunotherapy regimen will be described. Patient Population Children and young adults aged 1 to 21 years of age with relapsed/refractory neuroblastoma. Sample Size Approximately 224 patients, including 160 for the bevacizumab randomisation and 64 for the dinutuximab beta amendment. Trial Duration 8 years of patient recruitment, 5 years of patient follow up BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 13 of 157 BEACON-Neuroblastoma Trial Protocol Abbreviations ADA ANTI-DRUG ANTIBODIES ADCC ANTIBODY – DEPENDENT CELL-MEDIATED CYTOTOXICITY AE ADVERSE EVENT AESI ADVERSE EVENT OF SPECIAL INTEREST AFSAPPS COMPETENT AUTHORITY FOR FRANCE ALT ALANINE AMINOTRANSFERASE ANC ABSOLUTE NEUTROPHIL COUNT APPT ACTIVATED PARTIAL THROMBOPLASTIN TIME ASCT AUTOLOGOUS STEM CELL TRANSPLANTATION AST ASPARTATE AMINOTRANSFERASE AUC AREA UNDER THE CURVE AR ADVERSE REACTION BIT BEVACIZUMAB + IRINOTECAN + TEMOZOLOMIDE ARM BM BONE MARROW BP BLOOD PRESSURE BSA BODY SURFACE AREA BT BEVACIZUMAB + TEMOZOLOMIDE ARM BTTo BEVACIZUMAB + TEMOZOLOMIDE + TOPOTECAN ARM CI CHIEF INVESTIGATOR CIs CONFIDENCE INTERVALS COG CHILDREN’S ONCOLOGY GROUP CNS CENTRAL NERVOUS SYSTEM CR COMPLETE RESPONSE CRF CASE REPORT FORM CR UK CANCER RESEARCH UK CRCTU CANCER RESEARCH UK CLINICAL TRIALS UNIT (UNIVERSITY OF BIRMINGHAM) CRN CLINICAL RESEARCH NETWORK CSR CLINICAL STUDY REPORT CT COMPUTERISED TOMOGRAPHY CTC COMMON TERMINOLOGY CRITERIA CTCAE COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS CXR CHEST X-RAY dBT DINUTUXIMAB BETA + TEMOZOLOMIDE ARM dBTTo DINUTUXIMAB BETA + TEMOZOLOMIDE + TOPOTECAN ARM DCX DOUBLECORTIN DLT DOSE LIMITING TOXICITY DMC DATA MONITORING COMMITTEE DNA DEOXYRIBONUCLEIC ACID ECHO ECHOCARDIOGRAM ECOG EASTERN COOPERATIVE ONCOLOGY GROUP EFS EVENT FREE SURVIVAL EMA EUROPEAN MEDICINES AGENCY ERDC ELECTRONIC REMOTE DATA CAPTURE EOT END OF TREATMENT FFPE FORMALIN-FIXED PARAFFIN EMBEDDED GCP GOOD CLINICAL PRACTICE G-CSF GRANULOCYTE COLONY STIMULATING FACTOR BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 14 of 157 BEACON-Neuroblastoma Trial Protocol GFR GM-CSF GGT GP GPOH HR IB ICF ICH IMP INR INRC INRG INSS IRF ISF IT ITCC IV MGMT MIBG MHRA MRD MRI MSKCC MTD MYCN NANT NCI NCS NR OS OTC PCP PD PFS PHOX2B PI PIS PK PMA PRES PO PPTP PR REC RECIST RNA GLOMERULAR FILTRATION RATE GRANULOCYTE-MONOCYTE COLONY STIMULATING FACTOR GAMMA-GLUTAMYL TRANSPEPTIDASE GENERAL PRACTITIONER GERMAN SOCIETY FOR PAEDIATRIC ONCOLOGY & HAEMATOLOGY HEART RATE INVESTIGATOR BROCHURE INFORMED CONSENT FORM INTERNATIONAL CONFERENCE ON HARMONISATION INVESTIGATIONAL MEDICINAL PRODUCT INTERNATIONAL NORMALISED RATIO INTERNATIONAL NEUROBLASTOMA RESPONSE CRITERIA INTERNATIONAL NEUROBLASTOMA RISK GROUP INTERNATIONAL NEUROBLASTOMA STAGING SYSTEM INSTITUTIONAL REVIEW BOARD INVESTIGATOR SITE FILE IRINOTECAN + TEMOZOLOMIDE ARM INNOVATIVE THERAPIES FOR CHILDREN WITH CANCER INTRAVENOUS O6-METHYGUANINE METHYLTRANSFERASE META-IODO-BENZYL-GUANIDINE MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY MINIMAL RESIDUAL DISEASE MAGNETIC RESONANCE IMAGING MEMORIAL SLOAN KETTERING CANCER CENTRE MAXIMUM TOLERATED DOSE MYELOCYTOMATOSIS VIRAL RELATED ONCOGENE NEW AGENTS FOR NEUROBLASTOMA THERAPY NATIONAL COORDINATING INVESTIGATOR NATIONAL CO-SPONSOR NO RESPONSE OVERALL SURVIVAL OVER THE COUNTER PNEUMOCYSTIS CARNI PNEUMONITIS PROGRESSSIVE DISEASE PROGRESSION FREE SURVIVAL PAIRED-LIKE HOMEOBOX2B PRINCIPAL INVESTIGATOR PATIENT INFORMATION SHEET PHARMACOKINETICS POPULATION-MODELLING ANALYSIS POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME ORALLY PAEDIATRIC PRECLINICAL TESTING PROGRAM PARTIAL RESPONSE RESEARCH ETHICS COMMITTEE RESPONSE EVALUATION CRITERIA IN SOLID TUMOURS RIBONUCLEIC ACID BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 15 of 157 BEACON-Neuroblastoma Trial Protocol RTKI RT-qPCR SAE SAR SCT SD SFOP SIOPEN SNP SPC SUSAR SWFI T TH TMA TMG TSC TTo TVD UAR UKCCSG ULN VTE VEGF VGPR WMA RECEPTOR TYROSINE KINASE INHIBITORS REVERSE TRANSCRIPTASE QUANTITATIVE POLYMERASE CHAIN REACTION SERIOUS ADVERSE EVENT SERIOUS ADVERSE REACTION STEM CELL TRANSPLANT STABLE DISEASE FRENCH SOCIETY OF PAEDIATRIC ONCOLOGY INTERNATIONAL SOCIETY PAEDIATRIC ONCOLOGY EUROPEAN NEUROBLASTOMA GROUP SINGLE NUCLEOTIDE POLYMORPHISM SUMMARY OF PRODUCT CHARACTERISTICS SUSPECTED UNEXPECTED SEVERE ADVERSE REACTION STERILE WATER FOR INJECTION TEMOZOLOMIDE ARM TYROSINE HYDROXYLASE TISSUE MICROARRAY TRIAL MANAGEMENT GROUP TRIAL STEERING COMMITTEE TEMOZOLOMIDE + TOPOTECAN ARM TOPOTECAN, VINCRISTINE & DOXORUBICIN UNEXPECTED ADVERSE REACTION UNITED KINGDOM CHILDREN’S CANCER STUDY GROUP UPPER LIMIT OF NORMAL VENOUS THROMBO-EMBOLISM VASCULAR ENDOTHELIAL GROWTH FACTOR VERY GOOD PARTIAL RESPONSE WORLD MEDICAL ASSOCIATION FORMULAE Mosteller formula: BSA (m²) = BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 16 of 157 BEACON-Neuroblastoma Trial Protocol Table of Contents Trial Synopsis ...................................................................................................................................... 12 Title .................................................................................................................................................... 12 Trial Design ........................................................................................................................................ 12 Objectives .......................................................................................................................................... 12 Outcome Measures............................................................................................................................ 12 Patient Population .............................................................................................................................. 13 Sample Size ....................................................................................................................................... 13 Trial Duration...................................................................................................................................... 13 Abbreviations ..................................................................................................................................... 14 1. Background and Rationale ............................................................................................................. 22 1.1 Background............................................................................................................................ 22 1.1.1 Background for the dinutuximab beta amendment............................................................ 28 1.2 Trial Rational.......................................................................................................................... 29 1.2.1 Justification for design ....................................................................................................... 29 1.2.2 Rationale for patient population ......................................................................................... 30 1.2.3 Benefit-risk assessment .................................................................................................... 31 1.2.4 Rationale for the selected backbone schedules: Temozolomide, irinotecan + temozolomide and temozolomide + topotecan .............................................................................. 31 1.2.5 Rationale for dosing schedule of bevacizumab................................................................. 32 1.2.6 Rationale for evaluating chemo-immunotherapy in the BEACON-Neuroblastoma Trial... 32 1.2.7 Rationale for dosing schedule of dinutuximab beta........................................................... 33 1.2.8 Rationale for the use of biomarker studies ........................................................................ 34 1.3 Relevance and future importance ......................................................................................... 35 2. Objectives and Outcome Measures ............................................................................................. 36 2.1 Objectives .............................................................................................................................. 36 2.2 Outcome Measures ............................................................................................................... 37 3. Trial Design ..................................................................................................................................... 37 3.1 Randomisation....................................................................................................................... 37 3.2 Duration of treatment............................................................................................................. 38 3.3 Frequency and duration of follow-up ..................................................................................... 38 4. Eligibility.......................................................................................................................................... 39 4.1 Lifestyle guidelines ................................................................................................................ 39 5. Schedule of activities..................................................................................................................... 39 6. Screening and Consent ................................................................................................................. 40 6.1 Informed Consent .................................................................................................................. 40 6.2 Screening............................................................................................................................... 41 7. Trial Entry........................................................................................................................................ 42 7.1 Procedure for online patient randomisation........................................................................... 42 7.2 Emergency Randomisation ................................................................................................... 42 8. Treatment Details ........................................................................................................................... 43 8.1 Definition of Investigational Medicinal Products (IMPs) ........................................................ 43 9. Bevacizumab randomisation......................................................................................................... 43 9.1 Eligibility criteria for the bevacizumab randomisation............................................................ 43 9.1.1 Inclusion criteria for the bevacizumab randomisation ....................................................... 43 9.1.2 Exclusion criteria for the bevacizumab randomisation ...................................................... 44 9.2 Schedule of activities for the bevacizumab randomisation ................................................... 45 BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 17 of 157 BEACON-Neuroblastoma Trial Protocol 9.3 Trial Therapy (bevacizumab randomisation) ......................................................................... 49 9.3.1 Bevacizumab randomisation trial treatment ...................................................................... 49 9.4 Treatment Schedule..................................................................................................................... 51 9.4.1 Day 1 of Cycle 1 ................................................................................................................ 51 9.4.2 Day 1 of subsequent cycles............................................................................................... 51 9.4.3 Post Cycle 6 (For patients continuing to Cycle 7-12) ........................................................ 52 9.4.4 End of Treatment ............................................................................................................... 52 9.4.5 Treatment Duration............................................................................................................ 52 9.5 Dose Modifications for the bevacizumab randomisation ....................................................... 53 9.5.1 Dose Modifications for AEs due to chemotherapy - for the bevacizumab randomisation. 56 9.5.2 Bevacizumab – Infusion-related Reaction/Infusional Site Extravasation Management Guidelines ...................................................................................................................................... 62 9.5.3 Bevacizumab - Treatment Delays ..................................................................................... 63 9.5.4 Bevacizumab - Discontinuation ........................................................................................ 64 9.5.5 Bevacizumab - Toxicity Management guidelines .............................................................. 65 9.6 Central Venous Access Device (CVAD)................................................................................ 67 10 Dinutuximab beta and topotecan randomisations...................................................................... 68 10.1 Eligibility for the dinutuximab beta randomisation ................................................................. 68 10.1.1 Inclusion criteria for the dinutuximab beta randomisation ............................................. 68 10.1.2 Exclusion criteria for the dinutuximab beta randomisation ............................................ 69 10.2 Schedule of events for the dinutuximab beta and topotecan randomisations....................... 70 10.3 Trial therapy (dinutuximab beta and topotecan randomisations) .......................................... 74 10.3.1 Dinutuximab beta and topotecan trial treatment................................................................ 75 10.4 Treatment Schedule .............................................................................................................. 76 10.4.1 Day 1 of Cycle 1 ............................................................................................................ 76 10.4.2 Day 1 of subsequent cycles........................................................................................... 76 10.4.3 Post Cycle 6 (For patients continuing to Cycle 7-12 on chemotherapy only) ............... 77 10.4.4 End of Treatment ........................................................................................................... 77 10.4.5 Treatment Duration............................................................................................................ 78 10.4.6 Cross-over ......................................................................................................................... 78 10.5 Dose Modifications – dinutuximab beta and topotecan randomisations ............................... 79 10.5.1 Dose modifications for dinutuximab beta specific toxicities .......................................... 79 10.5.2 Dose modifications for haematological toxicity.............................................................. 81 10.5.3 Dose modifications for hepatic toxicity .......................................................................... 82 11 Treatment Compliance................................................................................................................... 84 12 Supportive Treatment .................................................................................................................... 84 12.1 Nausea and Vomiting ............................................................................................................ 84 12.2 Growth Factors ...................................................................................................................... 84 12.3 Fever and neutropenia .......................................................................................................... 84 12.4 Blood products....................................................................................................................... 84 12.5 Pneumocystis jirovecii pneumonia (PJP) prophylaxis ........................................................... 84 12.6 Management of side effects caused by non-selective NSAIDs as cyclooxygenase (COX) type I and II inhibitors ......................................................................................................................... 84 12.7 Supportive care during Dinutuximab beta infusion................................................................ 85 12.7.1 Pain Management.......................................................................................................... 85 12.7.2 Prevention of dinutuximab beta related infusion reactions............................................ 86 13 Concomitant Medication................................................................................................................ 87 14 Assessments .................................................................................................................................. 87 BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 18 of 157 BEACON-Neuroblastoma Trial Protocol 14.1 Response assessment .......................................................................................................... 88 15 Biomarkers...................................................................................................................................... 88 15.1 Blood sampling safety ........................................................................................................... 88 15.2 MRI-derived functional imaging biomarkers of angiogenesis................................................ 90 15.3 Molecular monitoring mRNA.................................................................................................. 90 15.4 Neuroblastoma exploratory biomarker analyses ................................................................... 90 15.5 Sample Collection.................................................................................................................. 92 15.5.1 Peripheral blood samples .............................................................................................. 92 15.5.2 Bone Marrow Samples .................................................................................................. 92 15.5.3 Archival tumour samples ............................................................................................... 92 16 Patient Follow Up ........................................................................................................................... 93 16.1 Patient Withdrawal................................................................................................................. 93 17 Pharmaceutical Information .......................................................................................................... 94 17.1 Definition of Investigational Medicinal Product ...................................................................... 94 17.2 Bevacizumab ......................................................................................................................... 94 17.2.1 Bevacizumab - Drug Supply .......................................................................................... 94 17.2.2 Bevacizumab - Ordering ............................................................................................... 94 17.2.3 Bevacizumab - Formulation, Packaging and Labelling ................................................. 94 17.2.4 Bevacizumab - Preparation and Dispensing ................................................................. 95 17.2.5 Compatibility information ............................................................................................... 95 17.2.6 Bevacizumab - Administration ....................................................................................... 95 17.2.7 Bevacizumab – Accountability....................................................................................... 96 17.2.8 Bevacizumab - Destruction............................................................................................ 96 17.3 Cyclophosphamide ................................................................................................................ 96 17.4 Dinutuximab beta................................................................................................................... 96 17.5 Irinotecan ............................................................................................................................... 96 17.5.1 Irinotecan - Drug Supply ............................................................................................... 96 17.5.2 Irinotecan - Formulation, Packaging and Labelling ....................................................... 96 17.5.3 Irinotecan - Preparation and Dispensing ....................................................................... 97 17.5.4 Compatibility information ............................................................................................... 97 17.5.5 Irinotecan - Administration ............................................................................................. 97 17.6 Temozolomide ....................................................................................................................... 97 17.6.1 Temozolomide – Drug Supply ....................................................................................... 97 17.6.2 Temozolomide - Formulation, Packaging and Labelling ............................................... 97 17.6.3 Temozolomide - Administration ..................................................................................... 97 17.7 Topotecan.............................................................................................................................. 98 17.7.1 Topotecan - Drug Supply.............................................................................................. 98 17.7.2 Topotecan - Formulation, Packaging and Labelling ..................................................... 98 17.7.3 Topotecan - Preparation and Dispensing ..................................................................... 98 17.7.4 Topotecan - Compatibility information ........................................................................... 98 17.7.5 Topotecan - Administration........................................................................................... 99 18 Adverse Event Reporting .............................................................................................................. 99 18.1 Reporting Requirements........................................................................................................ 99 18.1.1 Adverse Events (AE) ..................................................................................................... 99 18.1.2 AESIs of Bevacizumab .................................................................................................. 99 18.1.3 Serious Adverse Advents (SAE).................................................................................... 99 18.1.4 Reporting period .......................................................................................................... 100 18.2 Reporting Procedure ........................................................................................................... 100 BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 19 of 157 BEACON-Neuroblastoma Trial Protocol 18.2.1 Site............................................................................................................................... 100 18.2.2 Trial Office ................................................................................................................... 102 18.2.3 Reporting to the Competent Authority and main Research Ethics Committee ........... 102 18.2.4 Investigators ................................................................................................................ 102 18.2.5 Data Monitoring Committee ......................................................................................... 102 18.2.6 Manufacturer of Investigational Medicinal Product...................................................... 102 19 Data Handling and Record Keeping ........................................................................................... 103 19.1 Data Collection .................................................................................................................... 103 19.2 Archiving .............................................................................................................................. 103 20 Quality Management .................................................................................................................... 103 20.1 Site Set-up and Initiation ..................................................................................................... 103 20.2 On-site Monitoring ............................................................................................................... 104 20.3 Central Monitoring ............................................................................................................... 104 20.4 Audit and Inspection ............................................................................................................ 104 20.5 Notification of Serious Breaches ......................................................................................... 104 21 End of Trial Definition .................................................................................................................. 105 22 Statistical Considerations ........................................................................................................... 105 22.1 Trial Design.......................................................................................................................... 105 22.2 Definition of Outcome Measures ......................................................................................... 106 22.2.1 Primary ........................................................................................................................ 106 22.2.2 Secondary.................................................................................................................... 106 22.2.3 Exploratory/Tertiary ..................................................................................................... 106 22.3 Sample Size......................................................................................................................... 106 22.4 Interim and Main Analyses of Outcome Measures.............................................................. 108 22.4.1 Planned Interim Analyses ............................................................................................ 108 22.4.2 Main Analysis............................................................................................................... 108 22.5 Stopping Guidelines ............................................................................................................ 110 23 Trial Organisational Structure..................................................................................................... 110 23.1 Coordinating Sponsor .......................................................................................................... 110 23.2 Co-Sponsor Centres ........................................................................................................... 110 23.3 Relationship of trial committees........................................................................................... 112 23.4 Trial Management Group..................................................................................................... 112 23.5 Trial Steering Committee ..................................................................................................... 112 23.6 Data Monitoring Committee................................................................................................. 112 23.7 Finance ................................................................................................................................ 113 23.8 NIHR CRN Portfolio ............................................................................................................. 113 24 Ethical Considerations ................................................................................................................ 113 25 Confidentiality and Data Protection ........................................................................................... 114 26 Insurance and Indemnity ............................................................................................................. 115 27 Publication Policy ........................................................................................................................ 116 28 Reference List............................................................................................................................... 117 Appendix 1 – WMA Declaration of Helsinki .................................................................................... 124 Appendix 2 - Definition of Adverse Events ..................................................................................... 127 Appendix 3 - Common Toxicity Criteria Grading ........................................................................... 129 Appendix 4 – RECIST Criteria 1.1 .................................................................................................... 130 Appendix 5 – Tumor Response at Metastatic Soft Tissue and Bone Sites (Park et al. 2017) ... 133 Appendix 6 - CURIE & SIOPEN scoring methods for neuroblastoma ......................................... 134 Appendix 7 – Temozolomide Dosing............................................................................................... 136 BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 20 of 157 BEACON-Neuroblastoma Trial Protocol Appendix 8 – Blood Pressure Levels by Age and Height Percentile for Children and Adolescents ....................................................................................................................................... 139 Appendix 9 – Height for Age Chart - Girls ...................................................................................... 144 Appendix 10 – Height for Age Chart - Boys.................................................................................... 149 Appendix 11 – Lansky and Karnofsky/ECOG Scales .................................................................... 154 Appendix 12 – Tanner Staging ......................................................................................................... 156 Appendix 13 – Clinical studies of anti-GD2 therapies in combination with chemotherapy ...... 157 LIST OF TABLES Table 1 - Second line chemotherapy regimens tested in phase II in relapsed or refractory neuroblastoma since 2000 ..........
Url
/Media/UHS-website-2019/Docs/PaediatricOncology/beacon-protocol-v8.0-07mar2023-signed.pdf
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