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Cytoreductive surgery for gynaecological cancer - patient information

Description: This factsheet explains what cytoreductive surgery is, what the procedure involves and what the possible risks are.
Url: /Media/UHS-website-2019/Patientinformation/Womenshealth/Cytoreductive-surgery-for-gynaecological-cancer-3842-PIL.pdf

MP000 028 Cellular pathology user handbook v24

Description: University Hospital Southampton NHS Foundation Trust PATHOLOGY DIRECTORATE Cellular Pathology (Management) MP 000 028 Revision 24 Page 1 of 24 Cellular Pathology The cellular pathology department provides a comprehensive service in general histopathology, neuropathology, paediatric and perinatal pathology, and diagnostic cytopathology. Included in the department are the mortuary and the Biomedical Imaging Unit (BIU). The department is integrated with the University of Southampton's department of pathology which has a major role in medical student education and has active research programs in both applied and basic experimental pathology. The department has an important role in the training of junior histopathologists and biomedical scientists. The department is a major referral centre and the consultant pathologists each specialise in one or more area of pathology. Regional departments of paediatric and perinatal pathology and neuropathology are based in the department. The laboratory is recognised by the Institute of Biomedical Science (IBMS) for training. Key contacts Results and General Enquiries: Histopathology: Neuropathology: Paediatric pathology: Cytopathology: cellpath@uhs.nhs.uk 023 8120 6443 Cytology FNAs & clinics at SGH Bleep: Mortuary: Biomedical Imaging Unit: Research unit: 2968 mortuary@uhs.nhs.uk 023 8120 6306 biu@uhs.nhs.uk 023 8120 4807 SRCH@uhs.nhs.uk Dr Rushda Rajak, Joint Clinical Lead: Rushda.rajak@uhs.nhs.uk Dr Leon Veryard, Joint Clinical Lead: Leon.veryard@uhs.nhs.uk Dr Mark Walker, Joint Clinical Lead (Paeds & Neuro): Mark.walker@uhs.nhs.uk Page 1 of 24 University Hospital Southampton NHS Foundation Trust PATHOLOGY DIRECTORATE Cellular Pathology (Management) MP 000 028 Revision 24 Page 2 of 24 About our services Histopathology The histopathology section offers a histological and immunohistochemical diagnostic service for the Wessex region. Discussion and advice on clinico-pathological correlation and therapeutic implications is readily available to all medical staff in both hospitals and in general practice. Neuropathology The neuropathology section offers a specialist tissue diagnostic service for diseases of the brain, spinal cord, nerves, muscle, and eyes for the Wessex region. Discussion and advice on clinico-pathological correlation and therapeutic implications is readily available to all medical staff, both in hospitals in the region and in general practice. Cytopathology Diagnostic cytology includes a wide range of fine needle aspirations, endoscopic brushings and other exfoliative cytology specimens received from clinical directorates and General Practitioners. The Cytopathology department also offers rapid cytological diagnosis for the ENT clinic, Endoscopic Ultrasound clinics for Gastrointestinal, Pancreatic and Bronchial diseases, and for the Thyroid clinic at Southampton General Hospital (SGH). Paediatric and Perinatal Pathology The paediatric and perinatal pathology section offer a Consultant lead service to UHS and other local Trusts. This includes specialist reporting of diagnostic samples from children and a full perinatal/paediatric postmortem service to both local and regional hospitals. Digital pathology As of July 2024, the department provides a digital pathology service for histopathology, which enables reporting on digitally scanned slide images. This also creates opportunities for learning and collaboration with other digitised cellular pathology services. The service has undergone a thorough validation & clinical safety assessment. Please be advised that all slides referred to us will now be digitally scanned. To ensure a smooth and efficient reporting process, we kindly ask that all submitted slides adhere to the following requirements: • No coverslip or cover film overhangs Page 2 of 24 University Hospital Southampton NHS Foundation Trust PATHOLOGY DIRECTORATE Cellular Pathology (Management) MP 000 028 Revision 24 Page 3 of 24 • No slide label overhangs • Slides must be clean and free of debris Thank you for your cooperation. Mortuary The Mortuary at University Hospital Southampton (UHS) provides comprehensive services for both the hospital and the wider community. Acting as the public mortuary, we also support HM Coroner for Southampton and the New Forest. We are proud to hold an HTA (Human Tissue Authority) licence, ensuring compliance with the highest standards for the storage of tissue following postmortem examinations. Our team performs: - Hospital-consented post-mortems - Coroner-directed post-mortems - Home Office-authorised paediatric cases Our facilities include: - Specialist paediatric and perinatal pathology areas - A dedicated containment suite for managing high-risk or infectious cases Opening Hours • Monday to Friday: 07:30 – 16:00 • Weekends & Bank Holidays: On-call service available for emergencies only via switchboard 02380777222 Useful Links • Human Tissue Authority (HTA) • https://www.hants.gov.uk/birthsdeathsandceremonies/coroners • https://staffnet.uhs.nhs.uk/OurTrust/Peopleandplaces/Departments/TrustHQ /Bereavementcare/How-to-arr… • https://staffnet.uhs.nhs.uk/OurTrust/Peopleandplaces/Departments/TrustHQ /Bereavementcare/Post-morte… • https://staffnet.uhs.nhs.uk/TrustDocsMedia/DocsForAllStaff/General/Corpor ate/CareofthePatientAfterD… Biomedical imaging unit The Biomedical Imaging Unit is a multi-disciplinary research and diagnostic facility jointly managed by Cellular Pathology and the University of Southampton. It provides transmission and scanning electron microscopy, X-ray microanalysis, X-ray microCT, confocal laser scanning microscopy, spatial biology, and image analysis services. We are part of the nationally commissioned Primary Ciliary Dyskinesia (PCD) service and provide transmission electron microscopy (TEM) diagnosis of renal, muscle, nerve, and other tissues. Page 3 of 24 University Hospital Southampton NHS Foundation Trust PATHOLOGY DIRECTORATE Cellular Pathology (Management) MP 000 028 Revision 24 Page 4 of 24 We participate in a dedicated UKNEQAS TEM external quality assurance scheme in which we have performed highly, to date, without exception and have a wellestablished, comprehensive quality management system in place. As part of UHS Cellular Pathology, the BIU is accredited to ISO 15189: 2022 (lab no. 6013). The Unit is open and staffed from 06:00 – 18:00 Monday to Friday (except bank holidays). Samples sent via courier/postal service should be sent to arrive within these hours to minimise the risk of undelivered or misplaced samples. Research The Southampton Research and Clinical Histopathology Samples (SRCH) team is a specialist research unit within Cellular Pathology. The department is authorised to release residual tissue for ethically approved academic and commercial research. SRCH plays a key role in clinical trials and employs techniques including tissue microarrays, digital imaging techniques and multiplex immunohistochemistry. For enquiries, please contact SRCH@uhs.nhs.uk Service hours All sections (excluding mortuary, please see above) are open between 7.00am and 6.00pm, Monday to Friday, 7.00am to 5.00pm Saturday and bank holidays (excluding 25th, 26th December, 1st January). Please note there is no pathologist service on Saturdays and bank holidays. Additional out of hours services can be contacted via the operator on extension 100 or 02380777222. Quality management The department of cellular pathology will comply with the standards assessed by UKAS and the Human tissue Authority, and is committed to: • Staff recruitment, training, development, and retention at all levels to provide a full and effective service to its users. • The proper procurement and maintenance of such equipment and other resources needed for the provision of the service. • The collection, transport, and handling of all specimens to assure quality of performance of laboratory examinations. • The use of examination procedures that will ensure the highest achievable quality for all tests performed. • Reporting results of examinations which are timely, confidential, accurate and clinically useful . • Assessment of user satisfaction, in addition to internal audit and external quality assessment to produce continual quality improvement. Page 4 of 24 University Hospital Southampton NHS Foundation Trust PATHOLOGY DIRECTORATE Cellular Pathology (Management) MP 000 028 Revision 24 Page 5 of 24 For a detailed list of tests for which the department is accredited to ISO15189 standards please refer to: https://www.ukas.com/wp-content/uploads/schedule_uploads/00007/8178-MedicalMulitple.pdf New tests Please note, new validated tests will not be accredited until they have an extension to scope assessment. User satisfaction and complaints In order to help improve service, we may ask you to complete a questionnaire. The value of the information obtained from these surveys is appreciated, and advanced thanks is offered in anticipation of your assistance in completing them. For ways to feed back or get involved with patient groups, please visit the website here. The department welcomes constructive comments on any aspect of its services. A Quality Manual describing all aspects of our Quality Management system is available for inspection by users on request. Information on how to raise a complaint and the handling concerns and complaints policy can be found here: https://www.uhs.nhs.uk/contact/tell-us-about-your-experience/raising-concerns-ormaking-a-complaint Consent Please see the following document available on the UHS website: http://staffnet/TrustDocsMedia/DocsForAllStaff/Clinical/Consentpolicy/ConsentPolic y.pdf Patients attending adult venesection services will be asked to give verbal consent prior to blood specimens being collected. Availability of clinical advice Consultants within each discipline are available to provide help with the interpretation of results and other clinical advice. Please refer to 'Key Contacts'. Quality assurance All histopathologists take part in one or more EQA schemes applicable to their scope of practice (including but not limited to general histopathology, neuropathology, Page 5 of 24 University Hospital Southampton NHS Foundation Trust PATHOLOGY DIRECTORATE Cellular Pathology (Management) MP 000 028 Revision 24 Page 6 of 24 paediatric, liver, skin, urological, gastrointestinal, head and neck, urological, lung, lymphoma, and breast pathology). The laboratory participates in technical EQA schemes for the region. The laboratory is signed up to several technical UK NEQAS schemes covering histopathology, diagnostic cytology, immunohistochemistry, and transmission electron microscopy as well as interpretive schemes for crystal analysis in synovial fluids and immunohistochemistry markers. A full list of EQA schemes can be obtained on request. Regular clinico-pathological meetings are held with clinicians from the different specialties, at which pathologists with a specialist interest in the field concerned review and discuss selected cases in the presence of the clinical and radiological teams. Completion of request forms A completed request form must accompany all specimens. This must clearly identify patient, specimen type, requesting clinician / GP and source of the request (ward, clinic, surgery). The date taken and where extra copies of the report should be sent should also be recorded. The request form will be handled by staff outside the laboratory area so must be free of contamination by blood or body fluids. The spelling of names must be correct, with matching details clearly presented on both the specimen and the request form. Specimens that do not meet these requirements cannot be processed by the laboratory until the correct details have been provided by the requesting doctor which will lead to delayed processing of specimens. The requesting doctor will be asked to resolve any issues that arise from incorrect completion of patient specimen/request form details and sign to accept responsibility for identification of the specimen. It is the responsibility of the requesting clinician to ensure that the clinical details section contains complete and accurate clinical information. This should include relevant clinical history, examination findings and radiological and laboratory results. As of November 1st 2020 all histopathology requests from UHS clinicians should be completed using eQuest. Handwritten requests may be rejected by specimen reception and acceptance of the request will be at the discretion of the speciality pathologist on the day the request is received. When multiple specimens are taken from the same patient it must be clear which specimen on the request relates to which pot and the specific site from which it was taken. When labelling specimens, sequential letters may be used to clearly identify them (A,B,C…etc.). For eQuest specimens, please create a separate specimen for each pot so a label can be generated. The patient and specimen details must be on the pot itself and not just the lid of the pot. Page 6 of 24 University Hospital Southampton NHS Foundation Trust PATHOLOGY DIRECTORATE Cellular Pathology (Management) MP 000 028 Revision 24 Page 7 of 24 Please note: Due to the setup of the laboratory information management system the maximum number of pots that can be booked in under one specimen number is 23; if you have more than 23 pots these will need to come in on multiple requests. The importance of accurate and correct labelling, and presentation of samples, cannot be overemphasised - the laboratory may not be able to process samples received without compliance with the full requirements (see below) without which this could result in the sample having to be disposed. Specimens may be rejected (and therefore potentially delay reporting) if the following criteria are not met relating to the labelling of the sample and the request form: Essential Desirable Sample 1. NHS or Hospital number* 2. Patients full name or unique coded identifier 3. Date of birth 4. Patient Identification label MUST be attached to the sample container, NOT just on the lid. 5. Date and time 6. Nature of sample, including qualifying details, e.g. left, distal etc especially if more than one sample per request is submitted Request Form 1. NHS or Hospital number 2. Patient’s full name or unique coded identifier 3. Date of birth 4. Gender 5. Patient’s location and destination for report 6. Patient’s consultant, GP, or name of requesting practitioner 7. Investigation(s) required 8. Clinical information including relevant medication (which is sometimes essential) 9. Date and time sample collected (which is sometimes essential) 10. Patient’s address including postcode 11. Practitioner’s contact number (bleep or extension) Other Required Acceptance Criteria 1. The number of specimens outlined on the form must match the number of specimens received. 2. Specimen received with same details to request card 3. POC specimen must have two copies of the consent form (white and blue) and an application for cremation form. Page 7 of 24 University Hospital Southampton NHS Foundation Trust PATHOLOGY DIRECTORATE Cellular Pathology (Management) MP 000 028 Revision 24 Page 8 of 24 *Use of NHS number of paper/electronic patient records is mandatory requirement included within the NHS Operating Framework 2008/9 Identification of high-risk specimens For the protection of laboratory staff the request form and any specimens collected from patients with known or suspected infection due to a Hazard Group 3 biological agent must be labelled as 'High Risk'. It is the duty of the clinician to inform the laboratory if the patient is high risk. Please note that any specimens which are known to be potentially dangerous of infection may not be rapidly processed and may require prolonged fixation in formalin. The staff completing the respective request form have a duty of care to everyone to ensure that all / any risks the samples present are clearly indicated within the request form. These agents include: • Human Immunodeficiency Virus (HIV) 1 and 2 • Salmonella typhi / Salmonella paratyphi • Hepatitis B virus (HBV) • Hepatitis C virus (HCV) • Mycobacterium tuberculosis • Human T Lymphotropic Virus (HTLV) 1 and 2 • Brucella sp. • COVID-19 and the causative agents of: • Anthrax • Creutzfeldt-Jakob disease • Rabies • Yellow Fever • Plague Histopathology Availability of results UHS: results are available via E-Quest once authorised and printed copies are sent to the source. Please note, results from manual request forms will not be sent back to a clinician worklist but will be available in the results section of CHARTS. It is the responsibility of the requesting clinician to check these results. General Practice: results are available either electronically or by printed copy. Post mortem results: a preliminary cause of death is sent by email to the coroner and a full post mortem report follows later as a printed copy. Page 8 of 24 University Hospital Southampton NHS Foundation Trust PATHOLOGY DIRECTORATE Cellular Pathology (Management) MP 000 028 Revision 24 Page 9 of 24 Please note that any caller's identity must be confirmed before giving results over the telephone. We are unable to give results directly to patients or their relatives. Results are available on E-Quest when they have been authorised by the reporting Consultant Histopathologist. Preliminary results may be available by discussion with the Consultant Histopathologist. Biological reference intervals and clinical decision limits Immunohistochemistry is assessed by the reporting pathologist in the presence of appropriate positive and negative control material as required. For predictive/prognostic immunohistochemistry, reporting will include a numerical score where appropriate, with reference to the latest published evidence in terms of relevant scoring system(s), professional guidelines, and clinical trial data. Please contact the reporting pathologist and/or cellular pathology department if further information is required. Turnaround times The Royal College of Pathologists, in their document “Key assurance indicators for pathology services – November 2019” state “Local patient pathways, agreed with requesters, shall include anticipated turnaround times for all relevant laboratory investigations.” The locally agreed target for UHS Cellular Pathology is that at least 75% of specimens should be reported within 10 calendar days. These targets will be periodically reviewed, and user feedback sought every 2 years via the user feedback survey to ensure ongoing suitability of these targets. In collaboration with local service users, UHS Cellular Pathology will publish its aspirational turnaround times (TAT) and provide quarterly updates to users on actual performance against these targets. Within these guideline periods, the time taken for a result to be available varies depending upon the type, size, and complexity of the specimen as well as the clinical urgency (see below). ***Please note that certain specimen types (those including bone or nail) may take longer to process and the turnaround time target may not be attained for these particular specimen types*** The UHS Cellular Pathology department formally audits specimen turnaround times against the local benchmarks on a weekly and monthly basis. Page 9 of 24 University Hospital Southampton NHS Foundation Trust PATHOLOGY DIRECTORATE Cellular Pathology (Management) MP 000 028 Revision 24 Page 10 of 24 Cases requiring prolonged periods of decalcification fall outside the guidelines, as do cases sent for external reporting/expert opinion or specialist testing. Complex specimens may also require additional time for reporting. Locally agreed TAT for gastrointestinal biopsy specimens The department has a local agreement for gastrointestinal biopsy specimens as follows: Category 1 2 3 Clinical details Malignant biopsies, polyps with suspect features, Ischaemia, GVHD, severe colitis, polyps over 2cm Barrett’s with dysplasia, Gastritis, atrophy Normal mucosa, Barrett’s without dysplasia, Reflux, Candida, coeliac disease, IBD/ colitis (mild/ quiescent disease), eosinophilic oesophagitis Proposed TAT 75% in 10 days 75% in 14 days 75% in 21 days Please note samples are triaged into these categories by the requester and it is down to the requesters discretion whether some samples will fall into a different category based on other suspicious features. Locally agreed TAT for dermatology specimens The department has a local agreement for dermatology specimens as follows: Specimen type 24 hour skins 48 hour skins 72hr urgent biopsies Periorbital rapid paraffins (oculoplastic) One-week turnaround times (from derm or OMF/ENT) (e.g. SCC/BCC excision, wound left open pending pathological assessment of margins) Proposed TAT 100% in 24h 100% in 48h 100% in 72hr 100% in 5 days Melanocytic lesions - e.g. ?MM/DN (biopsies or excisions) Biopsies for ?SCC ? AFX/PDS/sarcoma ? MM 90% in 14 days All other specimens (e.g. BCCs, benign 75% in 21 days cysts, lipomas etc.) Page 10 of 24 University Hospital Southampton NHS Foundation Trust PATHOLOGY DIRECTORATE Cellular Pathology (Management) MP 000 028 Revision 24 Page 11 of 24 Urgent specimens / 2 week wait pathway patients Specimens that require urgent reporting (<7 days) must be delivered to the laboratory as soon as possible after the sample has been obtained from the patient. Contact details of the requesting clinician should be clearly indicated on the request form. The patient request form should be appropriately flagged as urgent to alert the laboratory team. Please include helpful information eg. dates of urgent follow up clinic appointments or surgical reconstruction dates, wherever possible. In the event of very urgent patient samples please telephone and/or email the Cellular Pathology Department to liaise directly with the appropriate subspecialist consultant pathologist (Tel: 023 8120 6443). More rapid processing of very urgent small specimens may be arranged following discussion with the appropriate pathologist, enabling a preliminary result to be available 24-48 hours from the sample being obtained in straightforward cases. However, rapid processing may not be available on tissue known to be danger of infection (see above). Urgent results of FNA cytology and same day results for other cytology specimens may be available by special arrangement with the laboratory. Cases where the microscopic findings are considered by the reporting histopathologist to be of clinical urgency may be communicated to the clinical team by telephone and/or email. Intra-operative Consultation (Frozen section) Service Predictable requests for frozen sections must be arranged in advance by telephoning the laboratory (ext. 8966 for neuropathology, ext. 4879 for histopathology) and giving details of the patient, theatre, and operative procedure. This should take place as soon as the patient is booked for theatre. All Consultant Pathologists have duties in many locations in the hospital and it is important that they are informed of potential frozen section requests so they can be available to deal with the samples. Unpredictable requests should be telephoned to the same numbers as soon as the requirement for frozen section diagnosis is realised. Fresh tissue must be dispatched by theatre / hospital porter for immediate delivery to the laboratory on Level E, South Block, SGH. Request forms should be clearly labelled 'FROZEN SECTION' and the contact telephone number for delivery of results should be clearly stated. The department aspires to report a frozen section within 30 minutes of receipt however the overall TAT depends upon the complexity of each case. We treat every case requiring frozen sections with the utmost urgency. Mohs micrographic skin surgery Page 11 of 24 University Hospital Southampton NHS Foundation Trust PATHOLOGY DIRECTORATE Cellular Pathology (Management) MP 000 028 Revision 24 Page 12 of 24 UHS Cell Path laboratory provides support to the Dermatology Mohs skin clinics held in the Max-fax unit on level C of the main hospital. Mohs micrographic surgery is mainly used for the treatment of basal cell carcinoma (BCC). Indications for Mohs include tumours occurring on the face where a good cosmetic result is required, BCCs that are difficult to see or where there has been a recurrence. All patients are booked through Dermatology for a ‘one-day’ clinic. The lesion is removed and checked for tumour under the microscope, if present then a further piece is removed until no tumour remains. The laboratory provides at least one trained Biomedical scientist for each session. Their role includes handling and orientation of sample, embedding, cryo-sectioning, staining and QC of all skins. Unexpected findings The Royal College of Pathologists has set out guidance for the communication of critical and unexpected results. ‘Pathologists should consider the following examples of situations in which results might need to be communicated urgently to clinicians, outside the normal parameters for the electronic delivery of laboratory results. 1. Cases where there is a predictable degree of urgency. Such cases would include intraoperative frozen sections, some medical renal biopsies, and some biopsies from organ transplant patients where prompt assessment according to local protocols will determine the management of the patients. 2. Cases unexpectedly found to be infectious. The clinical implications and severity of the infection, risk of transmission of infection to staff, other patients and the public, and the need for immediate contact tracing should be considered by the reporting histopathologist. Consideration should also be given as to whether or not the condition is a notifiable disease. 3. Expected malignancy case where no malignancy is found in the specimen. Frequently this will result in extra sections and/or levels being examined by the reporting pathologist. The requesting clinician may benefit from a warning that further laboratory work is underway and may be able to provide additional relevant clinical history. If no malignancy is found at the end of a thorough histopathology search, there may be cases where the possibility of a wrong site surgery never event should be considered. Such cases should be discussed with the requesting clinician in the first instance. 4. Biopsy or removal of an unexpected organ. This is important to communicate immediately to ensure clinical follow up for unexpected clinical complications and repeat biopsy of the correct organ. Please note, some organs are regularly biopsied en passant, e.g. rectal mucosa in transrectal ultrasound biopsies of the prostate; this does not constitute an unexpected finding as covered by this guidance. 5. Unexpected finding of malignancy. This is important where the case would not routinely be scheduled for multidisciplinary meeting discussion and there Page 12 of 24 University Hospital Southampton NHS Foundation Trust PATHOLOGY DIRECTORATE Cellular Pathology (Management) MP 000 028 Revision 24 Page 13 of 24 is a risk that the histopathology report may be missed by the requestor. An example of this would be a melanoma removed by a GP who anticipated that the lesion was a benign lesion. 6. Findings that trigger a particular referral pathway. An example of this would be molar pregnancy identified in products of conception.’ Further guidance can be found at: https://www.rcpath.org/uploads/assets/bb86b370-1545-4c5ab5826a2c431934f5/The-communication-of-critical-and-unexpected-pathologyresults.pdf Out of Hours service There is no Out of Hours Service provided by the Consultants in Cellular Pathology. The Cellular Pathology Laboratory provides an out of hours service for: 1) Receiving of specimens for rapid processing 2) Receiving of specimens for the sampling of fresh tissue (genetics, freezing etc) In the event of the clinical need for rapid processing out of hours then the following steps should be taken: 1) The Clinical Consultant should discuss the case with the on call Biomedical Scientist so that the optimum sample may be obtained and the optimum processing schedule be followed. The Cellular Pathology technical out of hours service can be contacted via the operator on extension 100 or 02380777222. Specimen collection If service users are in any doubt as to how to present a particular sample to the Cellular Pathology laboratory for analysis then it is vital to contact either the laboratory directly or the on-call Biomedical Scientist to avoid inappropriate treatment compromising the sample. Details can also be found in the Transport of pathology specimens by transport services/portering services guidelines, found on Staffnet. The tissue fixative used routinely for histopathology is 10% neutral buffered formalin (formaldehyde). Exceptions are listed in the table below: Specimens for routine histopathology / neuropathology Specimens for frozen section Muscles and nerves Electron microscopy Skins for immunofluorescence studies Formalin Fresh Fresh Glutaraldehyde Fresh or in Michel's solution or wrapped in saline soaked gauze. It is recommended that a sample may be in Page 13 of 24 University Hospital Southampton NHS Foundation Trust PATHOLOGY DIRECTORATE Cellular Pathology (Management) MP 000 028 Revision 24 Page 14 of 24 Rectal biopsies for ? Hirschsprung's disease Lymph nodes for genetic marker studies Michel’s solution for a maximum of 7 days. Fresh Fresh Tissue samples should be placed into 10% Neutral Buffered Formalin solution fixative as soon as possible after removal from the patient. Details as to where to obtain sample containers and this reagent can be obtained from the laboratory. With small biopsies in particular, it is vital not to let the specimen dry out. The recommended volume of fixative is minimum of ten times the volume of the specimen, it is therefore important not to squeeze specimens into small containers. If in doubt, choose a larger container as poor fixation will hinder or prevent accurate histological diagnosis. Fresh and urgent specimens must be clearly marked as such. A 'DANGER OF INFECTION' sticker must be applied to all specimens known to be an infection hazard. Opening or dissecting excised specimens before it is sent to the department must be resisted. Subsequent fixation of a partly incised specimen may cause distortion and hinder anatomical orientation. In the case of excised tumours, it may then be impossible to identify surgical planes of excision. Containers of formalin must be securely closed and users are recommended to read the Trust policy on the transport of specimens. Formaldehyde vapour is a wellrecognised respiratory irritant, so skin contact with formalin solution must be avoided, as repeated exposure may cause dermatitis in some individuals. Fresh specimens It is desirable for some types of specimen to be delivered in a fresh state (without fixative) to the laboratory. These should be clearly marked and the laboratory should be given advance warning of the delivery of such a specimen (023 8120 4879 / 3768) so that staff are prepared for the arrival. If such a specimen is expected to arrive out of normal working hours then the duty Biomedical Scientist should be contacted via the hospital switchboard. The following specimens may be sent fresh (unfixed): Lymph node biopsies and spleens These should be sent FRESH for genetic marker studies. The laboratory must be notified in advance and the specimen transport bag labelled 'URGENT SPECIMEN - DELIVER IMMEDIATELY TO HISTOPATHOLOGY LABORATORY'. Contact the lymphoreticular pathologists regarding these specimens (ext. 6443). Lungs Page 14 of 24 University Hospital Southampton NHS Foundation Trust PATHOLOGY DIRECTORATE Cellular Pathology (Management) MP 000 028 Revision 24 Page 15 of 24 Fresh lungs should be sent to the laboratory in a labelled plastic specimen container (dry) double sealed in plastic bags. The laboratory must be notified in advance and the specimen transport bag must be labelled 'URGENT SPECIMEN - DELIVER IMMEDIATELY TO HISTOPATHOLOGY LABORATORY'. Skin biopsies for immunofluorescence These samples should always be presented to the laboratory fresh between 0900 and 1630 and clearly labelled for IMF testing. All fresh specimens must be clearly labelled as such and sent immediately to histopathology – any delays in transportation will severely compromise the integrity of the sample(s). If sending a sample in Michel’s medium please ensure the sample arrives within 7 days. Please note the laboratory does not provide Michel’s medium. Rectal biopsies ? Hirschsprung's disease The paediatric pathologist must be contacted in advance (ext. 6443). Fresh specimens must be labelled FRESH / URGENT and sent immediately to the laboratory. Where intra-operative frozen sections are required, paediatric pathologist, Dr Bhumita Vadgama (ext. 4502), must be contacted in advance. Frozen section - eye or skin biopsies Requests should be made in writing well in advance to Dr Vidhi Bhargava (ext. 6664). The tissue should be dispatched by theatre / hospital porter for immediate delivery to the laboratory, Level E, South Block, SGH. Specimens for frozen section should be sent fresh. The request form should be clearly marked FROZEN SECTION and should include a telephone / bleep number to be used for telephoning the result. Renal biopsies The renal service is provided by Professor Ian Roberts, Oxford. Instructions for other specimen types (fixed): Colonic mapping biopsies Endoscopic mapping biopsies should be attached to a strip of Millipore (nitrocellulose) filter before fixation. The biopsies should be arranged in order in a single row as close together as possible. Cut off a corner of the filter strip to indicate the first biopsy. A diagram should be stamped (or drawn) on the request form to indicate the site and number of each biopsy. A detailed procedure is available from the laboratory (ext. 4879). Page 15 of 24 University Hospital Southampton NHS Foundation Trust PATHOLOGY DIRECTORATE Cellular Pathology (Management) MP 000 028 Revision 24 Page 16 of 24 Special diagnostic biopsies Contact the appropriate pathologist when the selection of tissue requires special consideration or fixation, or the biopsy is of special interest or difficulty. Products of conception Products of conception (POC) specimens that require cremation after processing must be accompanied by both a 'permission form' and an 'application for cremation' form. The legislation surrounding this is very stringent, and the forms need to be signed and completed with care, the department can not accept these specimens if the correct documentation is not provided. The processing of these samples will be delayed until the consent has been received. Forms can be obtained from the Princess Anne Hospital (PAH). For POC specimens or placentas requiring genetic testing, please send directly to Salisbury. These should be submitted fresh. If both histology and genetics are required the sample should be split into 2 separate samples and the fixed specimen submitted to histology. Time limits for requesting additional information Formalin fixed wet tissue is stored for six weeks after authorisation of the report, before being disposed. Histological slides are stored for at least 10 years. Paraffin wax blocks are stored for a minimum of 15 years. Diagnostic Cytology samples are retained for 3 days after authorisation of the report. Requests for additional investigations should made after discussion and agreement with the reporting Consultant Histopathologists. Referred tests / laboratories A list of referral laboratories used by the department is available by contacting the department. Any specimens/slides referred off site will be referenced within the report. Neuropathology Frozen sections Predictable requests for frozen sections must be arranged in advance by telephoning the laboratory (ext. 8966 for neuropathology) and giving details of the patient, theatre, and operative procedure. This should take place as soon as the patient is booked for theatre. All Consultant Pathologists have duties in many locations in the Page 16 of 24 University Hospital Southampton NHS Foundation Trust PATHOLOGY DIRECTORATE Cellular Pathology (Management) MP 000 028 Revision 24 Page 17 of 24 hospital and it is important that they are informed of potential frozen section requests so they can be available to deal with the samples. Unpredictable requests should be telephoned to the same number as soon as the requirement for frozen section diagnosis is realised. Fresh tissue must be dispatched by theatre / hospital porter for immediate delivery to the laboratory on Level E, South Block, SGH. Request forms should be clearly labelled 'FROZEN SECTION' and the contact telephone number for delivery of results should be clearly stated. Neuropathology frozen section service provides frozen section slides as well as smears from the fresh tissue. A consultant neuropathologist is responsible for the handling and orientation of the sample, as well as the preparation of smears. A biomedical scientist is responsible for embedding cryo-sectioning, staining of frozen sections and smears and QC of the neuropathology frozen. The department aspires to report a frozen section within 30 minutes of receipt however the overall TAT depends upon the complexity of each case. We treat every case sent for frozen sections with the utmost urgency. Muscle and nerve biopsies The clinical details for muscle and nerve biopsies should be discussed with a Neuropathologist by writing / e-mail / telephone before the biopsy is taken. Technical and logistic details for taking muscle and nerve biopsies should be discussed with the laboratory in advance (ext. 4882). Muscle and nerve biopsy specimens MUST be sent fresh NOT in saline and should be clearly marked for attention of Neuropathology. All muscle biopsies must be accompanied with the completed form LF 120 075 – U.H.S MUSCLE BIOPSY REQUEST CHECKLIST, which can be downloaded from the following location: http://www.uhs.nhs.uk/HealthProfessionals/Extranet/Services/SUHTPathologyServi ces/Handbook/CellularPathology.aspx Enucleated globes, evisceration specimens, corneas and orbital exenteration specimens should be fixed in 10% neutral buffered formalin. The request should be marked for Neuropathology. Cytopathology Non-gynaecological specimens Slides where produced must be labelled with patient surname, forename, and DOB. These details should be written on the frosted edge using pencil. Slides should be transported in slide boxes which should have an E-quest label applied to the outside. If a fluid is collected, then the specimen container should be labelled and all required fields completed to match the patient with the request form and laboratory database and specify collection date/time and requesting source. Page 17 of 24 University Hospital Southampton NHS Foundation Trust PATHOLOGY DIRECTORATE Cellular Pathology (Management) MP 000 028 Revision 24 Page 18 of 24 Unlabelled or wrongly labelled specimens must be corrected by the originator of the request i.e. we will ask you to come to the department to correct the details and may even lead to non-invasive samples being discarded if it is considered the risk is too high. Endoscopic brushings Material should be gently rolled onto one or two slides and generously spray fixed without delay. Fine needle aspirates Assistance is available at SGH for FNAs to prepare the slides. Contact the SGH laboratory (Ext. 6443 or Bleep 2968). Urine cytology A 25ml sample, not an early morning specimen, should be forwarded to the laboratory without delay in a sterile bottle. The request form should state time, date of collection and whether it was a catheter or post cystoscopy specimen. Cyst fluids, washings Fluid should be collected into a sterile bottle and forwarded to the laboratory without delay. Do not use powdered gloves when collecting synovial fluid as this may contaminate the specimen. Serous fluids Fluid should be collected into a sterile 25ml bottle. A second bottle of fluid if available will allow for further cytological investigations if required. Do not send large volumes of drained fluid or drainage bottles Sputum An early morning deep cough specimen should be collected into a sterile container and sent without delay. Send each specimen as soon as it is taken. Sputum cytology has low sensitivity and specificity for the diagnosis of bronchial carcinoma. Skin scraping Smear the scraping onto a slide and fix immediately with Cytofix, obtained from the department. Biomedical Imaging Unit (BIU) Page 18 of 24 University Hospital Southampton NHS Foundation Trust PATHOLOGY DIRECTORATE Cellular Pathology (Management) MP 000 028 Revision 24 Page 19 of 24 Specimens for examination under the electron microscope should be discussed with the appropriate pathologist and/or the BIU in advance of sending the sample. Special fixative containing glutaraldehyde and advice regarding fixation methods are below or can be obtained from the BIU. Tissue Sampling Electron microscopy is sensitive to tissue handling procedures. Whilst we recognise and appreciate that non-UHS service users may prefer to determine their own laboratory procedures relating to the fixation and handling of the tissue samples, service users are reminded that fixation and handling procedures affording satisfactory light microscopy fixation may not be suitable for ultrastructural studies. Therefore, we strongly recommend that all service users meet the following specifications for all tissue samples to be processed for EM. Failure to do this is likely to result in sub-optimal tissue preservation and may place limitations on the ultrastructural interpretation of the sample. Deviations from these recommendations by service users should be discussed and agreed with the BIU before specimens are sent. Samples for EM should be sized as follows: • Core biopsy – no more than 1mm in diameter and up to 3mm in length • Other biopsies – no more than 1mm3 Fixative should be stored at 4°C (fridge temperature), removed from the fridge and warmed to room temperature before adding the sample. Tissue samples are placed into fixative immediately upon removal from the patient. Even a small gap between removal and fixation can cause ultrastructural changes. Samples should be fixed at room temperature for a minimum of 1 hour, before storage (if required – information below). Our preferred fixative is 3% glutaraldehyde in 0.1M sodium cacodylate buffer pH 7.4. We can supply this fixative in certain circumstances – please contact us to discuss. Storage of fixed samples prior to transport to UHS If storage is necessary, fixed tissue samples should be stored in fixative at 4°C (fridge temperature) after the minimum of 1 hour at room temperature. However, it is recommended that they are sent to us as soon as is feasible. Prolonged storage may affect ultrastructural detail. Specimen Packaging, Transport and Acceptance Criteria It is requested that samples are not sent without notifying the BIU team. Please contact the BIU using the details below to obtain guidance on specimen packaging, transport, and acceptance criteria. Contact Details Page 19 of 24 University Hospital Southampton NHS Foundation Trust PATHOLOGY DIRECTORATE Cellular Pathology (Management) MP 000 028 Revision 24 Page 20 of 24 If you have any queries or problems, please contact us: • biu@uhs.nhs.uk • +442381 20 4807 Mortuary The mortuary acts as both the Southampton Hospitals and Public mortuary providing a service to HM Coroner for Southampton and the New Forest. It has class leading specialist facilities for both Paediatric pathology and a specific specialist and Category 3 rated post mortem suite for all high risk/infectious other cases. ALL deceased transferred to the Mortuary from wards MUST have identification bracelets attached to the wrist and ankle. The information on the ID bracelet should include: full name, hospital number and date of birth. The mortuary staff MUST be informed of any infection or radiation risk. All ICD/Implants must be recorded on the Notice of Death record sheet accompanying every patient. A deactivation/active record must also be recorded. Referral centres who wish to facilitate the transfer of a deceased to this department must first contact the mortuary with full patient details and agree authorisation/pertinent/specific case criteria that may require additional Operations manager and pathologist consultation. This discussion will include the agreed admission and subsequent date/time collection details prior to the transfer being undertaken. Post mortem Examinations A post-mortem (also known as an autopsy) is a medical examination of the body after death. It helps to: • Determine the cause of death • Identify any medical conditions • Understand how treatments may have affected the patient There are two types of post-mortems: 1. Coroner’s post-mortem Ordered by H.M. coroner when the cause of death is unclear or needs legal investigation. o No consent is needed from the next-of-kin. o If an organ needs to be kept for further examination, the coroner’s officer will inform the family. 2. Hospital (consent) post-mortem Carried out with written consent from the next-of-kin or a significant person not to ascertain cause of death. o A consented post mortem is usually asked for by the patient’s doctor, either to provide information about the illness or cause of death, or to advance Page 20 of 24 University Hospital Southampton NHS Foundation Trust PATHOLOGY DIRECTORATE Cellular Pathology (Management) MP 000 028 Revision 24 Page 21 of 24 medical research. Hospital post mortems can only be carried out with consent from the next of kin. o A hospital post mortem is requested because the clinical team and / or family have questions relating to the deceased’s illness or death that they would like to be answered. o A hospital post mortem may be undertaken to confirm (not establish) the cause of death, to identify other conditions present, to assess the extent of disease or to assess the effects of treatment. o The clinical team must complete a medical certificate of cause of death before a hospital post mortem can take place and if they cannot do so the case must be referred to the coroner. Consent process The consent form has two parts: • Permission for the post-mortem examination • Permission to keep tissue or organs for diagnosis, teaching, or research Always download the latest version of the form from staffnet - post-mortem consent and human tissue disposal policy. Tissue disposal policy • The consent form for a hospital post mortem is extensive but logical. You need to familiarise yourself with it before meeting with the next of kin • Only staff who have completed the appropriate post-mortem consent training are authorised to take consent from families. If you are not trained, please complete the VLE course: adult post-mortem consent training. • Alternatively, you may contact the bereavement and family support Team. A trained team member can support you during the consent process; however, they must not be asked to take consent independently. A member of the clinical team must always be present when consent is being taken. • Responsible clinician should contact the pathologist who will perform the PM, before discussion with relatives so that accurate guidance can be given on which, if any, organs or tissues are likely to be taken. (this can be done by speaking with the mortuary team) • Please do not make promises to relatives that a post mortem will be done the next day. Post mortems are performed in a timely fashion but there are multiple factors determining when they are done. Refer the relatives to the bereavement office 02381204587 or bereavementcare@uhs.nhs.uk for this information. What the examination involves A full post-mortem usually includes examining all major organs. This involves: • An incision is made to access the chest and abdomen • An incision at the back of the head to examine the brain For hospital post-mortems, families can request a limited examination of specific areas (chest, abdominal or head only. However, this may reduce the amount of information available. Page 21 of 24 University Hospital Southampton NHS Foundation Trust PATHOLOGY DIRECTORATE Cellular Pathology (Management) MP 000 028 Revision 24 Page 22 of 24 Small tissue samples (histology) are kept as part of the patient’s medical record. If whole organs are retained, the family’s wishes for their return or respectful disposal must be followed. Important considerations • Families must never be pressured into giving consent. • A death should not be referred to the coroner simply because consent for a hospital post-mortem cannot be obtained. • If the family wishes, the results of the post-mortem should be shared with them—ideally by the doctor who obtained consent or the consultant responsible for the patient’s care. • A follow-up appointment should be offered around six to eight weeks after the death. For more details, please refer to the Trust’s post mortem consent and human tissue disposal policy. H.M. Coroner • Coroners are appointed by local authority with consent of the Lord Chancellor and Lord Chief Justice and function in an independent judicial office. • Coroners are usually have a background as solicitors or barristers for at least five years. • Coroners provide judicially fair, impartial overview and scrutiny of all unnatural and violent death (including deaths of patients in hospital or care environments). Circumstances in which a person’s death should be reported to the coroner (notification of deaths regulations 2019) A person’s death should always be notified to the coroner where there is reasonable cause to suspect that the death was due t
Url: /Media/UHS-website-2019/Docs/Services/Pathology/Cell-path/MP000-028-Cellular-pathology-user-handbook-v24.pdf

Annual-report-201617

Description: ANNUAL REPORT AND ACCOUNTS 2016/17 incorporating the quality account 2016/17 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 2016/17 incorporating the quality account 2016/17 Presented to Parliament pursuant to Schedule 7, paragraph 25 (4) (a) of the National Health Service Act 2006 3 ©2017 University Hospital Southampton NHS Foundation Trust TABLE OF CONTENTS Performance report Statement from the chief executive 7 Statement of purpose and activities 9 History of UHS 9 Key issues and risks 10 Going concern disclosure 10 Performance reporting 11 Regulatory body ratings 15 Environmental matters 16 Social, community and human rights issues 16 Accountability report Directors’ report 18 Introducing the Board of Directors 20 The people 21 Audit and risk committee 25 Disclosures 28 Council of Governors 32 Annual remuneration statement 39 Remuneration and appointments committee 42 Governors’ nomination committee 44 Staffing data 48 Responding to the staff annual attitude survey 50 Statement of chief executive’s responsibilities as the accounting officer 55 Annual governance statement 56 Review of economy, efficiency and effectiveness of the use of resources 62 Equality, diversity and inclusion 66 Southampton Hospital Charity 67 Developments in informatics 68 Leading research into better care 68 Investing for the future 69 Environmental sustainability and climate change 70 Quality account and report Chief executive’s welcome 119 Our approach to quality assurance 121 Our commitment to safety 122 Our commitment to staff 125 Our commitment to education and training 126 Our commitment to technology to support quality 127 Our commitment to the Care Quality Commission 129 Progress against 2016/17 priorities 127 Priorities for improvement 2017/18 141 Review of quality performance 152 Conclusion 155 Responses to our quality account 156 Statement of directors’ responsibilities 163 Independent auditor’s report 164 Appendices Appendix one: Patient Improvement Framework (PIF) priorities 2017/18 168 Appendix two: Definitions of pressure ulcer grading 169 Appendix three: Quality performance data 170 Appendix four: CQUINS data 177 Appendix five: Clinical audit and confidential enquiries data 179 Appendix six: Outcome measures data 190 Appendix seven: Registration with the Care Quality Commission 191 Appendix eight: Pulse KPIs 192 Appendix nine: Glossary of acronyms 195 Annual accounts Statement from the chief financial officer 75 Foreward to the accounts 76 Independent auditor’s report 77 Financial statements 81 5 Statement from the chief executive More patients than ever before were treated at University Hospital Southampton (UHS) during 2016/17. And despite seeing an extra 41,000 patients than the previous year, we have continued to maintain our patient satisfaction scores with more than 95% recommending UHS. This is just one of many outstanding achievements across our hospitals which we are proud to highlight in this annual report. Our ongoing challenge now is tackling the high numbers of patients who could be at home, but who lack support from either health or social care to move out of hospital. There has been some hard work done in this area and we’re already seeing signs of improvement. The latest Friends and Family Test results - the survey which all UHS staff are asked to complete - said that 92% of staff would recommend UHS as a place to be treated, and 77% would recommend it as a place to work. Both these figures are the highest we have ever achieved, and are much better than the national average. We have been able to invest heavily in improved and expanded facilities for patients and for research. For instance, work has started on the radiotherapy bunker which will house the new linear accelerators used to treat cancer patients and the new Cancer Immunology Centre is also progressing well. The ongoing investment into diagnostics – particularly radiology but also more specific schemes such as hysteroscopy – should help patients right across the hospital. We recently received national recognition as a “global digital exemplar”; an award which we anticipate will bring an additional £10 million of national money. Historically, we have spent very little on information technology but, despite this, much has been delivered.This extra national money will make a real difference to patient care through some large-scale informatics projects and will also improve the day to day IT equipment our staff have available to them. Our new main entrance, which opened last summer, now feels like it has been here forever but I think it is still worth remembering what an improvement it is on the old entrance, and that it was rebuilt without spending any NHS money. We have been successful in renewing our NHS research funding, through both our Biomedical Research Centre (BRC) and Clinical Research Facility (CRF). This was a tough competition, as we were competing against every other academic medical centre in the country, and the rules were clear that only “world class research” would be funded. So the Southampton research team (UHS and the University of Southampton), led by Rob Read for the BRC and Saul Faust for the CRF, should be very proud that we were successful, and that Southampton research will continue to help patients receive better care across the world. Children’s services are very important to us and thanks to a combination of NHS funds and very generous donations, we have been able to refurbish and expand Piam Brown (paediatric cancer) ward and our paediatric intensive care unit (PICU). Despite a challenging time for NHS finances, UHS had a successful financial year, ending it with a surplus of £20.4m. This has enabled us to plan increased investment in our estate, particularly for the most vulnerable patients such as refurbishment of high dependency and intensive care facilities for patients of all ages, and theatre and interventional radiology rooms. This means that we will continue to have the facilities to look after the sickest patients in Hampshire and beyond. 7 In 2016/17 we launched our children’s emergency department campaign, alongside the Murray Parish Trust. We’re now well on our way to raising the £2 million needed, which will be fund matched by the Government. We hope to start building this summer. So, while there have been considerable challenges meeting uplifts in demand and managing discharges, there has also been much to celebrate and we look forward to 2017/18. Fiona Dalton Chief executive 23 May 2017 8 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 10,500 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 2016/17 was more than £760m. 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 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 2017/18. 2. Capacity and occupancy, which impacts on patient flow and to 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: • continuing to recruit within Europe and further afield • working with universities to increase student nurses • developing band four posts and apprentices • leveraging the ‘Think UHS’ recruitment brand • 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 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. 10 Performance reporting 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. This begins with the monthly Trust Board meeting where the executive directors of the Trust will present a high level summary to the chairman and non-executive directors, as well as providing greater detail on key performance changes, risks and issues. Below this are a number of executive sub-committees attended by a subset of executive and non-executive directors. These are the audit and risk committee, the strategy and finance committee, and the quality committee. These committees will review issues in greater depth, feeding back to Trust Board as appropriate. In addition, there are regular Trust Board study sessions which focus on specific individual issues with the entire Board present. The Trust executive committee (TEC) meets monthly and is made up of the executive board members and the divisional management teams. Performance and service issues are discussed in greater detail at this meeting. Finally, there are regular performance meetings between the operational management team (led by the chief operating officer) and the division and care group management teams. These meetings focus on the individual patient and service pathways and developing the detailed plans for improvement. Key performance indicators (KPIs) The Trust publishes a monthly Integrated KPI Board Report on its website which provides both the Board and the public with an overview of performance within the Trust. This report is constantly evolving as new areas of monitoring are developed and new areas of national focus become apparent. For the 2016/17 period the most notable development to the monthly report was a restructuring of the format in order to better align the reported metrics to five key Care Quality Commission questions: • Are we safe • Are we effective • Are we caring • Are we responsive • Are we well-led. The monthly report features the following sections: • Executive digest – a textual update on the previous month’s performance across the Trust written by the director of transformation and improvement. • Trust overview – the top KPIs identified by Trust Board, RAG-rates for the previous 13 months (see Appendix eight) • Performance • Activity • Capacity • Emergency department (ED) • Referral to Treatment (RTT/18 weeks) • Cancer waiting times • Finance • Patient experience • Patient safety • Outcomes • Staffing (HR) and estates • Education and training • Research and development 11 This report also includes summary versions of quarterly reports submitted to TEC which go into greater detail about patient experience, patient safety, clinical effectiveness and outcomes, and infection prevention. In addition, a separate Finance Board Report is submitted to Trust Board on a monthly basis. 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 2016/17 we have reviewed the National Model Hospital data published by Lord Carter’s team at NHS Improvement, this includes the Getting it Right First Time Reports. This data and ability to compare our performance has helped to highlight areas of excellent practice and areas where there is potential to improve. This data is reported regularly to the Transformation Board. Detailed analysis and explanation of the development and performance of UHS Over the past three years we have seen significant increases in all types of activity. Some of this is due to an increase in the range of specialist services we offer, becoming a major trauma centre and the building of the helipad, but much of it is due to the increased and aging population in Southampton and the surrounding area. The graphs below demonstrate this increase in activity. Growth iUnHaSctGivritoyw-t2h01in4/A15cttiovi2ty01-62/10714/15 to 2016/17 700,000 600,000 500,000 400,000 300,000 200,000 2014/15 2015/16 2016/17 100,000 - Inpatient Spells (inc Outpatient day cases) Appointments ED Attendances (type 1) Referrals 2014/15 Inpatient spells (inc day cases) 144,934 Outpatient appointments 536,949 ED attendance (type one and two) 94,376 Referrals 182,407 2015/16 146,066 562,972 95,217 191,888 2016/17 155,780 596,621 99,493 204,840 Increase 2014/15 to 2016/17 7.5% 11.1% 5.4% 12.3% 12 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 several ambulances are likely to be delayed for long periods of time, stopping them from responding to 999 calls. In 2014/15 a black alert was recorded 91 times at the twice daily bed meetings. In 2015/16 this was reduced to seven. However, as result of the increasing demand for Trust services this increased to eleven in 2016/17. Contributing to this change has been the increase in Length of Stay (LoS) for elective patients and bed capacity being impacted upon by the increased number of patients requiring a complex package of care after their discharge. These patients can often have their discharges delayed while beds in community care homes are found and supporting community care packages are arranged. The chart below demonstrates the change in LoS for elective and non-elective (emergency) patients over the past three years. 2016/17 saw an increased focus on discharging patients earlier in the day and at the weekend. This will remain a major focus for the Trust in 2017/18. Each of the above metrics will have an impact on the Trust’s performance against the three primary nationally reported targets for Referral to Treatment (RTT, or 18 Weeks) performance, emergency department performance and cancer waiting times performance. Referral to Treatment (18 Weeks) performance Due to a change introduced by the Government in 2015 trusts are only required to achieve the Incomplete Pathways target: 1. Incomplete Pathways – 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. UHS met the target in quarters one, two, and three of 2016/17. In quarter four the target was met in February and March but performance in January meant that the target was not met for the quarter as a whole. Achievement of this target in 2016/17 should be set against the aforementioned rise in patient referrals, which highlights the increased demands being placed on the Trust. It is only due to the increased efficiency shown by the Trust’s inpatient and outpatient services that it has been possible to meet these targets on an ongoing basis. This is an excellent result and goes against the national trend. 13 Emergency department (ED) performance We did not meet the national target of 95% of all ED attendances being treated and either admitted or discharged within four hours of arrival in any month in 2016/17, but we did achieve our nationally agreed trajectory target. This has been a challenging target nationwide with the winter period being the worst performance the NHS in England has ever recorded. There are three types of ED that can be included in these figures: Type one A consultant led 24-hour service with full resuscitation facilities and designated accommodation for the reception of accident and emergency patients. Type two A consultant led single specialty accident and emergency service (e.g. ophthalmology, dental) with designated accommodation for the reception of patients. Type three Other type of accident and emergency/minor injury unity (MIUs/Walk-in Centres, primarily designed for the receiving of accident and emergency patients. A type three department may be doctor led or nurse led. It may be co-located with a major ED or sited in the community. A defining characteristic of a service qualifying as a type three department is that it treats at least minor injuries and illnesses (sprains for example) and can be routinely accessed without appointment. UHS has type one and type two (ophthalmology) departments. The Trust also had a type three (MIU) department until July 2014. Due to the nature of the activity at the MIU, the transfer of this department to another provider reduced UHS performance against the four hour target by approximately 3%. When comparing performance over the long term, it is important to factor this change in. ED performance improved in quarters one, two, and three of 2016/17 compared to 2014/15 and in quarters one and two over 2015/16, despite the increases in activity. In quarter three performance decreased by 0.6% while activity increased by 1,795 attendances, a 7.5% rise. In quarter four performance was 1.2% better than in 2015/16 and matched 2014/15 performance. The graph below shows UHS performance against the four hour target over the past three years. 96.00% 94.00% 92.00% 90.00% 88.00% 86.00% 84.00% 82.00% 80.00% 78.00% 76.00% Year-On-Year ED Performance by Quarter Q1 Q2 Q3 Q4 2014/15 2015/16 2016/17 14 Cancer waiting times There are ten separate cancer waiting times measures that the Trust reports to the Department of Health on a monthly basis, each of which can then be split into tumour site specific performance groups. In 2016/17 the Trust met all but one of these measures. The performance against the targets should be set against the significant rise in activity seen on the cancer pathways. The number of patients referred under the ‘two week wait urgent suspected cancer protocol’ that were seen within two weeks of their referral, rose by 1,058 (6.9%) in 2016/17. The chart below shows the rise in demand for UHS services over the past three years. 18,000 16,000 14,000 12,000 10,000 8,000 6,000 4,000 2,000 - UHS Growth in Cancer Activity - 2014/15 to 2016/17 2014/15 2015/16 2016/17 Two Week Waits 62-Day Target Patients 31-Day Target Patients 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. The Single Oversight Framework applied from quarter three of 2016/17. Prior to this, Monitor’s Risk Assessment Framework (RAF) was in place. Information for the prior year and first two quarters relating to the RAF has not been presented as the basis of accountability was different. This is in line with NHS Improvement’s guidance for annual reports. Segmentation During quarter four of 2016/17 the Trust was placed within segment ‘2’ This segmentation information is the Trust’s position as at 31 March 2017. Current segmentation information for NHS trusts and foundation trusts is published on the NHS Improvement website. 15 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 efficiency Financial controls Overall scoring Metric Capital service capacity Liquidity Income and expenditure margin Distance from financial plan Agency spend 2016/17 Q3 score 2 2 1 1 1 1 2016/17 Q4 score 2 2 1 1 1 1 The Care Quality Commission (CQC) gave us an overall rating of ‘requires improvement’ as at December 2014. You can see further details on page 128 of the quality account or in full by visiting www.uhs.nhs.uk or www.cqc.org.uk. The CQC returned in January 2017 to conduct a follow up inspection. We are currently awaiting their full report. Environmental matters A number of projects were undertaken in 2016/17 to reduce our impact on the environment. We have replaced a significant proportion of our external lighting and much of our internal lighting with LED technology. A number of ventilation systems have been upgraded to enable heat recovery and we have launched an awareness programme to help staff work in more environmentally sustainable ways. In addition to these developments we have implemented a range of measures to ensure that we are using energy more efficiently. For example, we now review and ensure the efficiency of high energy consumption equipment. More information can be found within the environmental sustainability and climate change section of this report. Social, community 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. 16 Directors’ report Composition of the Board The Board is currently comprised as follows: Non-executive directors: Peter Hollins chair Simon Porter senior independent director/deputy chair Professor Iain Cameron Lynne Lockyer Dr David Price Dr Mike Sadler Jenni Douglas Todd Executive directors: Fiona Dalton Gail Byrne Jane Hayward Dr Derek Sandeman Dr Caroline Marshall David French chief executive director of nursing and organisational development director of transformation and improvement medical director chief operating officer chief financial officer Each director confirms that at the time the annual report and accounts is approved: • so far as the director is aware, there is no relevant audit information of which the NHS foundation trust’s auditor is unaware • the director has taken all the steps they ought to have taken as director in order to make themselves aware of any relevant audit information and to establish that the NHS foundation trust’s auditor is aware of that information. 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. Trust Board declarations of interest Peter Hollins Partner in the Jubilee Film Partnership; Chair of CLIC Sargent Cancer Care for Children (a company limited by guarantee); Council Member of University of Southampton. Iain Cameron Dean, Faculty of Medicine and Member, University Executive Board, University of Southampton; Board Member, Wessex Academic Health Sciences Network; Director (Chair), Medical Schools Council (until 1 July 2016); Director, Medical Schools Council Assessment (until 1 July 2016); Director, UK CAT (Clinical Aptitude Test) (until 1 July 2016); Trustee, Wessex Medical Trust; Joint Chair, University Hospital Southampton/University of Southampton Joint Research Strategy Board; Joint Chair, National Institute for Health Research (NIHR) Biomedical Research Centre (BRC) Southampton Executive Board. Simon Porter Former Partner in Ernst & Young LLP; Non-executive Director and Chair of Audit Committee, Radian Group; Non-executive Director and Chair of Audit Committee, Octavia Housing. 18 Lynne Lockyer Board member/trustee of the Brendoncare Foundation. David Price Chair of RTL Materials Ltd; Chair of Telesoft Technologies Ltd; Chair of Optitune Plc; Chair of Symetrica Ltd; Member of Advisory Board, Silverstream Technologies BV; Treasurer, University of Southampton; Chair of Lontra Ltd (from 1 May 2016). Michael Sadler GP Specialist Advisor for the Care Quality Commission (until 31 May 2016); External Clinical Associate for PricewaterhouseCoopers. Jenni Douglas-Todd Managing Director, Diversa Consultancy Limited; Member of the Judicial Conduct Investigative Office; Non-Executive Director, Hampshire Cricket Board (from 2 May 2016). Fiona Dalton NHS representative on Office for the Strategic Co-ordination of Health Research (OSCHR) Board; Director, Southampton Commercial Estates Development Partnership (CEDP) Project Company Limited, a wholly-owned subsidiary of UHSFT. Gail Byrne Husband is a consultant surgeon in the Trust; Trustee of Naomi House Children’s Hospice. Caroline Marshall Nil. Jane Hayward Director, UHS Estates Limited, a wholly-owned subsidiary of UHSFT; Father is Mental Health Act Manager, Southern Health Foundation Trust (voluntary position), member of Assessment Committee for Clinical Excellence Awards South and Public Health England (lay member), a UHSFT Simulated Patient (voluntary position); Mother is a UHSFT Simulated Patient (voluntary position). Derek Sandeman Director of UHS Pharmacy Limited, a wholly-owned subsidiary of UHSFT. David French Non-executive director and chair of audit and risk committee, Sentinel Housing Association (renamed Vivid Housing Limited on 23 April 2017); Governor and chair of Audit Committee, South Wilts Grammar School for Girls (until 8 December 2016); Chair of Hampshire and Isle of Wight NHS Counter Fraud Board; Director, UHS Estates Limited, a wholly-owned subsidiary of UHSFT; Director, Southampton Commercial Estates Development Partnership (CEDP) Project Company Limited, a joint venture between UHS and Interserve Prime. Approved by the Trust Board 23 May 2017. Chief executive 23 May 2017 19 Introducing the Board of Directors Trust Board The Board is made up of the chair, six non-executive directors and six executive directors including the chief executive. Together they bring a wide range of skills and experience to the Trust, such that the board achieves balance and completeness at the highest level. The non-executive directors, including the chair, are people who live or work in the local area and have shown a genuine interest in helping to improve the health of local people. The non-executive directors are determined by the Board to be independent in both character and judgement. The chair, executive directors and non-executive directors have declared any business interests that they have. The Board is satisfied that no conflicts of interest are indicated in any external involvement. The register of Board members’ interests is updated at least annually and is maintained by the company secretary and associate director of corporate affairs. It is available for public inspection from the company secretary and associate director of corporate affairs. The ‘reservation of powers to the Board and delegation of powers policy’ sets out the business to be conducted by the Board, or by one of its committees. Any enquiries should be made to: company secretary and associate director of corporate affairs, Trust Headquarters, Mailpoint 18, University Hospital Southampton NHS Foundation Trust, Tremona Road, Southampton, SO16 6YD or telephone 023 8120 6829. Senior independent director The senior independent director role provides a channel through which foundation trust members and governors are able to express concerns, other than the normal route of the chair or chief executive. Appointments Non-executive directors are appointed via open advertisement in accordance with the ‘Appointment of a foundation trust non-executive director good practice guide’ procedure adopted by the Trust. The process is managed through the governors’ nomination committee, a sub-committee of the Council of Governors. This committee also determines the remuneration and terms and conditions of the non-executive directors. For further details on the appointment of non-executive directors please see page 42-43. Development of the Board The Board held monthly study sessions during 2016/17 where strategic issues, along with emerging issues, were discussed. Meetings of the Board The Board meets once a month in public. Additional private meetings with only the Board, and associated employees of the Trust making presentations to the Board in attendance, are held as required. Other committees of the Board include: remuneration and appointment committee; audit and risk committee, strategy and finance committee; quality committee and charitable funds committee. Generally the other committees of the Board meet monthly with the exception of the audit and risk committee, which meets five times a year and the appointments and remuneration committee which meets every other month. The frequency of the meetings is set out in each committee’s terms of reference. These terms of reference are reviewed at least annually. The performance of individual Board members is reviewed as set out on page 24 of this report. 20 Engagement with Council of Governors The Trust Board engages with the Council of Governors through the chair and senior independent director. Non-executive and executive directors engage with sub-groups of the council where these are related to their portfolios. Board members meet regularly with governors and have an open invitation to attend formal Council of Governor meetings. The people Non-executive directors Peter Hollins, chair 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 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 Nonexecutive director in 2010, became senior independent director and deputy chairman of UHS in 2014, and was appointed chair in April 2016. He has also been the chair of CLIC Sargent Cancer Care for Children and Young People, and a Council Member of Southampton University, since 2014 and 2016 respectively. Simon Porter, senior independent director and deputy chair Simon was born and educated in Southampton and then Oxford, graduating with a degree in modern languages (Italian and French). He is a qualified chartered accountant, having spent most of his career with the London office of Ernst & Young, where he specialised first in audit, then in transactions and finally risk management. He was a partner with Ernst & Young from 1994 to 2010. He joined the Trust Board on 1 January 2011 as a designate non-executive director and became non-executive director from 1 June 2011. He is chair of the audit and risk committee and a member of the strategy and finance committee. He also holds non-executive board positions in the social housing sector. Professor Iain Cameron Iain is professor of obstetrics and gynaecology and dean of the Faculty of Medicine at the University of Southampton. After graduating in medicine at the University of Edinburgh, he underwent postgraduate clinical and research training in Edinburgh, Melbourne and Cambridge. He held the regius chair of obstetrics and gynaecology at the University of Glasgow from 1993 and moved to Southampton in 1999. His main clinical and research interests are reproductive endocrinology and investigation of the impact of the maternal environment on early pregnancy. Iain was chair of Medical Schools Council from 2013-16 and is a member of the UK Clinical Research Collaboration board and the Wessex Academic Health Science Network board. He was appointed as a non-executive director of the MDDUS (Medical and Dental Defence Union Scotland) in April 2017. Lynne Lockyer Lynne’s background is in human resource management and strategic management. She became a nonexecutive director for Southampton and South West Hampshire in 1996 and the vice chair in 2000. She was chair of Eastleigh and Test Valley South PCT from its inception in 2002 until its disestablishment in 2006. She has taken many roles in the local health economy including being a member of Hampshire’s Local Area Agreement Board and nationally was a member of the NHS Confederation Council and the National NHS Leaders Steering Group. She was until recently a course director at the University of Portsmouth and is now an organisation development consultant. She is a trustee of the Brendoncare Foundation. 21 Dr David Price David is a former chief executive of a FTSE-250 company with broad experience within the electronics, chemical, aerospace, defence, marine, and nuclear industries. He has a successful track record of developing highly complex companies in international markets. He is currently non-executive chairman of Symetrica Ltd, Telesoft Technologies Ltd, RTL Materials Ltd, Lontra Ltd and Optitune Plc. He is treasurer of the University of Southampton and a member of the advisory board of Silverstream Technologies BV. David is a chartered engineer and chartered scientist. He has a degree in electronic engineering, a PhD from University College London and, in 2001 he was awarded an honorary doctorate by Cranfield University for his services to science and engineering. David was made a Commander of the Order of the British Empire (CBE) for his services to industry. Dr Mike Sadler Mike joined us as a clinical non-executive director in September 2014, from a similar position at an NHS Foundation Trust providing mental health, learning disability and community services. He has chaired our quality committee since June 2016. He works as an advisor and consultant on health and social care services, recently advising on health reform in the Middle East, and in Ireland. He has been chair and technical adviser to the Diabetes Professional Care Conference since 2015, and also worked for the CQC as a specialist adviser in primary care. Mike graduated from Nottingham University, and was a GP principal in Hampshire before moving into public health medicine. Having achieved an MSc with distinction at the London School of Hygiene and Tropical Medicine, he joined Portsmouth and South East Hampshire Health Authority, holding the joint posts of deputy director of public health and medical adviser. He has since held a series of senior clinical leadership roles in national organisations in both the public and private sector, including as a chief operating officer at NHS Direct and Serco’s health division. His last full time role, up until July 2013 when he commenced his portfolio career, was as director of health and social care at West Sussex County Council. Jenni Douglas-Todd 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 being 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. 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. Executive directors Fiona Dalton, chief executive Fiona was appointed as chief executive in 2013. Prior to re-joining the Trust she held the combined position of deputy chief executive and chief operating officer at Great Ormond Street Hospital for Children. Fiona joined the NHS management training scheme after graduating from Oxford University with a degree in human sciences and began her career in hospital management at Oxford Radcliffe Hospitals NHS Trust in 1996. She then spent four years at UHS as director of strategy and business development before moving to Great Ormond Street Hospital. 22 Gail Byrne, director of nursing and organisational development 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. Jane Hayward, director of transformation and improvement 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. Dr Derek Sandeman, medical director 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. Dr Caroline Marshall, chief operating officer 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. David French, chief financial officer David joined the Trust in February 2016 and leads on finance, procurement, estates and commercial development. 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. Board effectiveness On the basis of the expertise and experience described above, the Trust is confident that the necessary range of knowledge and skills exists within the Board of Directors and that its balance, completeness and appropriateness to the requirements of the NHS Foundation Trust constitutes a high performing and effective Board. A register of interests of Board members is outlined within this report and is also available from the associate director of corporate affairs. The effectiveness of the Board of Directors meetings is reviewed at the end of each meeting. Effectiveness of Board sub-committees is monitored through monthly board reports and annual evaluation/review of the terms of reference and work programmes. Schedule of Decisions Reserved to the Board The NHS Foundation Trust Code of Governance requires that there should be a formal schedule of matters specifically reserved for decision by the Board. The Scheme of Delegation shows the ‘top level’ of delegation within the Trust. The Scheme should be read in conjunction with Trust’s Standing Financial Instructions and Standing Orders. A copy of the Schedule of Matters Reserved for the Board can be obtained from the associate director of corporate affairs. 23 Attendance at board meetings in 2016/17 Board member 12 28 24 Apr Apr May Extra Extra CS CS 26 May 20 Jun Extra CS 28 26 27 11 27 29 16 26 28 28 Jun Jul Sep Oct Oct Nov Dec Jan Feb Mar Extra CS CS only Peter Hollins chair 3 33 33 3 3 3 3 3 3 3 33 3 Simon Porter 3 non-executive director 33 3 telecon 3 333 3 telecon 3 3 3 33 3 Iain Cameron 3 non-executive director 35 35 5 3 3 3 3 3 3 33 5 Lynne Lockyer 3 33 55 non-executive director telecon 3 3 3 3 3 3 3 33 3 David Price 5 non-executive director 33 3 telecon 3 333 3 telecon OS only 3 3 5 33 3 Mike Sadler 3 non-executive director 33 3 telecon 3 333 5 telecon 3 3 3 33 5 OS OS only only Jenni Douglas-Todd 3 non-executive director 33 3 telecon 3 3 53 3 telecon OS only 3 3 3 53 3 Fiona Dalton Chief executive 3 33 33 3 3 3 3 3 3 3 33 3 David French 3 Chief financial officer 33 33 3 3 3 3 3 3 3 33 3 Derek Sandeman Medical director 5 33 33 3 3 3 3 3 3 3 33 3 Gail Byrne Director of nursing and organisational development 3 33 35 3 3 3 3 3 3 3 33 3 Caroline Marshall 3 Chief operating officer 33 33 3 3 3 5 5 5 5 33 5 Jane Hayward Director of transformation and improvement 3 35 33 333 3 telecon 3 3 3 33 3 Telecon = telephone conference OS only = open session only 24 Audit and assurance committee (until May 2016) Board member Peter Hollins NED chair Simon Porter non-executive director senior independent director and deputy chair Iain Cameron non-executive director Lynne Lockyer non-executive director David Price non-executive director Mike Sadler non-executive director May 2016 3 5 3 5 3 3 Audit and risk committee (formerly audit and assurance committee) (from June 2016) Board member Simon Porter non-executive director senior independent director and deputy chair David Price non-executive director Mike Sadler non-executive director David French Chief financial officer 18 Jul 3 3 3 3 17 Oct 3 16 Jan 3 20 Mar 3 3 3 5 3 3 3 3 3 3 Audit and risk committee The audit and risk committee (formerly known as the audit and assurance committee) is a non-executive committee of the Trust Board with delegated authority to review the establishment and maintenance of an effective system of integrated governance, risk management and financial and non-financial control, which supports the achievement of the Trust’s objectives. As part of the Trust’s on-going commitment to continuous improvement the role and responsibilities of the audit and risk committee were subject to in-year review and revision. The principle change arising from the review was the transfer of responsibilities with regards to ‘clinical quality assurance’ to the quality committee. Composition and meetings There are three non-executive director members of the committee. The committee is chaired by Simon Porter. Further information on the chair is available on pages 21. Executive directors attend by invitation, and there is a standing invitation to the chief financial officer. Other executive directors and staff with specialist expertise attend by invitation. The audit and risk committee met five times between May 2016 and March 2017 in relation to matters covered in this annual report. 25 Purpose and remit The committee purpose is the remit of a ‘traditional’ audit committee, including an oversight function in relation to financial reporting, systems of internal control, risk management, effective use of resources, appointment and effectiveness of external and internal auditors. Major topics considered by the committee
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ACCORD-2 example sub-protocol

Description: CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) TITLE PAGE Master Protocol Title: ACCORD-2: A Multicentre, Seamless, Phase 2 Adaptive Randomisation Platform Study to Assess the Efficacy and Safety of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalised Patients Sub-protocol Number: ACCORD-2-002 Sub-protocol for Candidate Agent: Bemcentinib Study Phase: 2 Sponsor Name: University Hospital Southampton NHS Foundation Trust Legal Registered Address: Southampton General Hospital Level E, Laboratory & Pathology Block, SCBR - MP138 Tremona Road Southampton SO16 6YD, UK Regulatory Agency Identifying Number(s): EudraCT: 2020-001736-95 IRAS Number: 282769 RHM Number: Date of Sub-protocol: 22 April 2020 Version: Protocol Amendment 01 Caution: In accordance with cardiac exclusion criteria, in particular Exclusion 13, drugs known to cause QT prolongation should be discontinued/replaced, with sufficient time (5 half-lives) for washout. Patients in these categories of potential risk should be discussed directly by telephone with BerGenBio: Prof Hani Gabra, BerGenBio Chief Medical Officer: +44 7810 576112 Dr Akil Jackson, BerGenBio Medical Director: +44 7810 575037 Final, 22 April 2020 1 CONFIDENTIAL Sponsor Signatory: ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) I have read this sub-protocol in its entirety and agree to conduct this part of the study accordingly: Professor Tom Wilkinson MA Cantab MBBS PhD FRCP Professor of Respiratory Medicine and Honorary NHS Consultant Physician 22/04/2020 Date Final, 22 April 2020 2 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) TABLE OF CONTENTS TABLE OF FIGURES.............................................................................................................4 PROTOCOL AMENDMENT HISTORY .............................................................................5 1.0 SUB-PROTOCOL SUMMARY .................................................................................6 1.1 Overview of Sub-protocol................................................................................6 1.2 Schedule of Activities .......................................................................................8 2.0 BACKGROUND/RATIONALE IN SUPPORT OF BEMCENTINIB FOR COVID-19 .........................................................................................................12 2.1 Preliminary Efficacy Data vs with SARS-CoV-2 In vitro..........................13 2.2 Dose Justification for Bemcentinib...............................................................14 2.3 Human Experience from Trials in Cancer Patients ...................................16 3.0 STUDY POPULATION ............................................................................................18 3.1 Eligibility Criteria ..........................................................................................18 4.0 STUDY ASSESSMENTS AND PROCEDURES ....................................................19 4.1 Efficacy Assessments .....................................................................................19 4.2 Safety Assessments.........................................................................................19 4.2.1 Adverse Events ..................................................................................20 4.2.2 Clinical Safety Laboratory Assessments ...........................................20 4.3 Pharmacokinetic Assessments ......................................................................20 4.4 Pharmacodynamic Assessments ...................................................................20 5.0 STUDY TREATMENT .............................................................................................21 5.1 Conclusions and Risk Benefit Statement .....................................................21 5.2 Bemcentinib Drug Administration ...............................................................21 5.3 Dose Modifications and Toxicity Management ...........................................22 5.4 Prohibited Concomitant Medications ..........................................................22 5.5 Study Drug Information................................................................................22 5.5.1 Study Medication...............................................................................22 5.5.2 Bemcentinib Storage, Dispensing, and Destruction ..........................23 6.0 REFERENCES...........................................................................................................24 7.0 APPENDICES ............................................................................................................26 Appendix 1 Abbreviations ...................................................................................26 Appendix 2 Prohibited Concomitant Medication Due to QT Prolongation Risk or CYP3A4 Interaction with Narrow Therapeutic Index ..........................................................................................27 Final, 22 April 2020 3 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) Appendix 3 Signature of Investigator ................................................................28 Figure 1 Figure 2 Figure 3 TABLE OF FIGURES Bemcentinib Potently Inhibits Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection of Vero E6 Cells .............................14 Complete Inhibition of AXL Kinase Activation (p-Axl) in Two Acute Myeloid Leukaemia Patients Treated at the Recommended Phase 2 Dose (200 mg Maintenance Daily Dosing) .....................................................15 Bemcentinib Plasma Pharmacokinetics in Acute Myeloid Leukaemia Patients .............................................................................................................16 Final, 22 April 2020 4 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) PROTOCOL AMENDMENT HISTORY Protocol amendment 01 (dated 22 April 2020) replaces the original sub-protocol for bemcentinib (dated 20 April 2020). The amendment incorporates the following main changes: • A change of Sponsor, from BerGenBio ASA to University Hospital Southampton NHS Foundation Trust, with a corresponding change to the named Sponsor signatory. • Addition of exclusion criterion for clinically significant hypokalaemia. • Clarification that for the exclusion criterion of inability to swallow capsules, administration via nasogastric tube is permitted. • Clarification that the physical examination at screening includes height and weight (this is part of the Master Protocol). • Addition of samples for cytokine analysis and PBMC phenotyping on the Schedule of Activities (this is part of the Master Protocol). • Removal of specific blood volumes from the Schedule of Activities. • Clarified that analysis of inflammatory cytokines is part of the Master Protocol. • Clarification regarding known adverse events for bemcentinib. Final, 22 April 2020 5 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 1.0 SUB-PROTOCOL SUMMARY 1.1 Overview of Sub-protocol Bemcentinib is a small molecule AXL kinase inhibitor developed by BerGenBio ASA (the candidate agent owner) which has demonstrated potent and selective inhibition of AXL in biochemical and cell-based kinase inhibition assays. AXL is a recognised therapeutic target for the treatment of cancer. AXL regulates cancer cell survival and immunosuppressive modulatory effects, particularly in driving immunosuppressive features of the innate immune compartment in the tumour microenvironment, including activation of the myeloid derived suppressor cells, the M2 macrophage state, and suppressor regulatory dendritic cells that inhibit activated T cell function. Further, AXL is an important negative regulator of type I interferon (IFN) responses that are important for anti-cancer treatments. Bemcentinib is currently being developed for the treatment of cancer, particularly in non-small cell lung carcinoma, acute myeloid leukaemia (AML), myelodysplastic syndrome, and other cancers. The AXL receptor mediates entry of enveloped viruses such as Zika and Ebola through “apoptotic mimicry”. Phosphatidylserine (PS) on the viral envelope is tethered to AXL by its bound ligand, growth arrest-specific 6 (GAS6), leading to viral internalisation. Viruses also activate AXL signal transduction that antagonises anti-viral type-I IFN responses. Preclinical data show that AXL-mediated internalization and IFN suppression may extend to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and that bemcentinib can inhibit coronavirus entry and replication. The hypothesis is therefore that bemcentinib is a potentially effective treatment for COVID-19 disease. Additionally the Sponsor’s understanding of the mechanism supports testing the hypothesis that bemcentinib may be an effective preventive/prophylactic therapy for COVID-19. This sub-protocol describes the approach for study conduct of the bemcentinib arm within the ACCORD-2 multicentre, Phase 2 adaptive randomisation platform study to assess the efficacy and safety of multiple candidate agents for the treatment of COVID-19 in hospitalised patients. Key differentiating features of this sub-protocol include the following: (a) Bemcentinib is an oral 100-mg capsule, recommended Phase 2 dose (RP2D) is 200 mg given once daily, following a loading dose (400 mg) given once daily for 3 days. Although the Master Protocol plans for 15 days of treatment, this sub-protocol can provide up to 21 days of bemcentinib treatment if required for patients. (b) A specific eligibility criterion has been added to exclude patients based on electrocardiogram (ECG) QT interval on screening above 450 msec (a lower exclusion limit than that stated in the Master Protocol, 500 msec), as well as significant cardiac comorbidity. Any concomitant medication with QT prolongation risk must be stopped at screening and direct discussion between the investigator and Sponsor Medical Monitors will allow support in risk management. Serial ECG measurements have been added in Final, 22 April 2020 6 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) order to pragmatically monitor any QT interval change with bemcentinib, coupled to a sparse pharmacokinetic (PK) sample schedule, in the hospitalised COVID-19 population. Within the clinical development programme to date, over 286 patients have been treated without any observed cardiac adverse events (AEs). (c) Translational and pharmacodynamic (PD) sampling is included in this protocol. Detailed procedures for the collection, processing, storage and shipment of the samples will be provided in the Study Laboratory Manual. (d) Selected secondary endpoints from the Master Protocol will be considered as key secondary endpoints for the purposes of this sub-protocol. Final, 22 April 2020 7 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 1.2 Schedule of Activities Screening Baseline Day (± Window) ELIGIBILITY Informed consent Demographics Relevant medical historyb Review SARS-CoV-2 diagnostic tests Inclusion and exclusion criteria STUDY INTERVENTION Randomisation Administration of bemcentinibc Treatment with SoC STUDY PROCEDURES Clinical frailty score Diagnostic imaging (X-ray and/or computed tomography) Physical examination (including presenting symptoms, height, weight) Targeted physical examination (focused on lung auscultation) Day -1 or Day 1 Day 1 X X X X X X Days 1-3 400 mg loading daily X X X X Daily Until Hospital Discharge X 200 mg maintenance X X Day 15a (±2 days) X Day 29a (±3 days) Day 60a Day 90a (±4 days) (±6 days) (Follow-up) (End of Study) Final, 22 April 2020 8 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) Screening Baseline Day (± Window) Vital signs, including oral temperature, pulse rate, blood pressure, respiratory rate, SpO2 Clinical assessmentse Targeted medication review (including use of vasopressors) Adverse event evaluation Disease-related co-infection evaluation (including microbiologic/infectious agent assessment/results; bacteria, viral, fungi) Survival status Blood gases and FiO2 at worst PO2f 12-lead ECGg SAFETY LABORATORY Haematology, chemistry, liver function tests, coagulationh Pregnancy test for females of childbearing potential RESEARCH LABORATORY Blood (SST) for exploratory inflammatory cytokine analysis Blood (sodium heparin tube) for PBMC phenotypingl Day -1 or Day 1 X X Xi Xi Day 1 Xd Xd Xd X X X X X Xd,j X X Daily Until Hospital Discharge X X X X X X X See schedule belowg Days 3, 5, 8, 11 (all ±1 day) if hospitalised Day 8 Day 8 Day 15a (±2 days) X X X X X X Xk X X Day 29a (±3 days) X X X X X Xk X X Day 60a Day 90a (±4 days) (±6 days) (Follow-up) (End of Study) X X X X Final, 22 April 2020 9 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) Screening Baseline Day (± Window) Day -1 or Day 1 Day 1 Daily Until Hospital Discharge Day 15a (±2 days) Day 29a (±3 days) Day 60a Day 90a (±4 days) (±6 days) (Follow-up) (End of Study) Blood (EDTA) for SARS-CoV-2 PCR (qualitative and quantitative) X Days 3, 5, 8, 11 (all ±1 day) if hospitalised X X Oropharyngeal/nasal swab for SARS-CoV-2 PCR (qualitative and quantitative) X Days 3, 5, 8, 11 (all ±1 day) if hospitalised X X Saliva for SARS-CoV-2 PCR (qualitative and quantitative) X Days 3, 5, 8, 11 (all ±1 day) if hospitalised X X Blood (SST) for SARS-CoV-2 serology research (host response) X Day 8 X X X Blood (PAXGENE) for transcriptome analysis (host genome)m X Day 8 X Blood (EDTA) host genome (host DNA)m X Mid-turbinate nasal swab viral genomem X Blood samples for PD and translational studiesn X See schedule belown X X X PK samplingn X See schedule belown X ECG=electrocardiogram; EDTA=ethylenediaminetetraacetic acid; FiO2=fraction of inspired oxygen; PBMC=peripheral blood mononuclear cell; PCR=polymerase chain reaction; PD=pharmacodynamic; PK=pharmacokinetic; PO2=partial pressure of oxygen; RT PCR=reverse transcription polymerase chain reaction; SARS-CoV-2= severe acute respiratory syndrome coronavirus 2; SoC=standard of care; SpO2=oxygen saturation; SST=serum separator tube. a These visits will be performed even if a patient has already been discharged. If discharged prior to scheduled visit, in-person visits are preferred, but recognising that quarantine and other factors may limit the patient’s ability to return to the clinic, these visits may be conducted by telephone or with a home visit by study staff. For visits conducted by telephone, it will not be possible to perform some scheduled assessments (eg, vital signs). The Day 29 assessments will also be performed, where possible, for patients who discontinue the study prematurely. b Medical history includes estimated date and time of first symptoms and number of co-morbidities (eg, respiratory, cardiovascular, metabolic, malignancy, endocrine, gastrointestinal, immunologic, renal). Final, 22 April 2020 10 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) c Although the Master Protocol plans for 15 days treatment, this sub protocol can provide up to 21 days bemcentinib treatment if required for patients. Bemcentinib should be taken once per day, in the morning, on an empty stomach with water. Patients should not consume anything other than water for at least 1 hour after taking study drug. d Baseline assessments should be performed prior to study drug administration. e Includes ordinal score, National Early Warning Score 2 (NEWS2), oxygen requirement, noninvasive or invasive ventilator requirement, including start and stop of low- or high-flow oxygen supply or of any form of ventilation etc. f If done as part of SoC, blood gases results to be fully recorded with date and time. g ECG to coincide with selected PK and PD sampling timepoints, ie, pre-loading dose (Day 1); then pre-maintenance dose and 6 hours postdose (Day 4). Subsequently predose on Days 8 and 15. h For parameters, see Master Protocol i Laboratory tests performed in the 48 hours prior to enrolment will be accepted for determination of eligibility. j Any laboratory tests performed as part of routine clinical care within the specified visit window can be used for safety laboratory testing. k Additional safety laboratory evaluations to be performed on Days 15 and 29 only if patient is still hospitalised. l Samples collected for immediate laboratory processing and frozen storage. m Samples collected dependent on capacity of study centre, need for reduced study burden on staff, and potentially limited access to patients. n Procedures for the collection, processing, storage and shipment of the PK and PD samples will be provided in the Study Laboratory Manual. Sample collection to coincide with the ECGs, ie, pre-loading dose (Day 1); then pre-maintenance dose and 6 hours postdose (Day 4). Subsequently predose on Days 8 and 15. Final, 22 April 2020 11 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 2.0 BACKGROUND/RATIONALE IN SUPPORT OF BEMCENTINIB FOR COVID-19 Nonclinical in vitro and in vivo data suggest that bemcentinib might be useful for the treatment of early SARS-CoV-2 infection for which no medical countermeasures are currently approved, and support testing the efficacy of bemcentinib treatment among hospitalised adults with COVID-19. The AXL receptor tyrosine kinase promotes the infection of a wide range of enveloped viruses including pox-, retro-, flavi-, arena-, filo-, and alpha-viruses (Shimojima 2006, Brindley 2011, Meertens 2012, Dowall 2016, Meertens 2017). AXL increases viral infection through two mechanisms: 1) enhanced viral entry through “apoptotic mimicry”; and 2) suppression of anti-viral type I IFN responses. The AXL receptor and related receptors (Tyro3 and MerTK, collectively TAM) are important for the clearance of apoptotic cells (efferocytosis) by macrophages (Lemke 2019). Enveloped viruses co-opt this mechanism to expand tropism and enhance viral entry. GAS6, the AXL ligand, binds PS exposed on the surface of the viral envelope, tethering the viral particle to the AXL receptor and promoting uptake by phagocytosis. This mechanism of viral entry, based on PS exposure, is common to most enveloped viruses and is termed viral “apoptotic mimicry” (Mercer 2008, Bhattacharyya 2013). Binding of the viral particle to GAS6-AXL potently activates signal transduction through its tyrosine kinase domain to suppress type I IFN signalling and facilitate viral replication (Bhattacharyya 2013, Meertens 2017). AXL expression is induced by inflammation and serves as an innate immune checkpoint. AXL signalling suppresses viral-induced IFN responses via suppressor of cytokine signalling (SOCS)1/3, leading to increased viral replication in infected cells and decreased anti-viral defences of neighbouring cells (Huang 2015, Chen 2018, Strange 2019). Consequently, Axl-null mice are resistant to Zika pathogenesis likely due to a combination of reduced virus entry and enhanced IFN responses (Hastings 2019), indicating a potential role for AXL inhibitors as therapeutics during viral infection. Therapeutic AXL receptor inhibition ameliorated pulmonary pathology resulting from primary viral infection in experimental models, indicating an important role for AXL within the lung (Shibata 2014). During primary respiratory syncytial virus (RSV) infection, AXL inhibition increased the number of IFNg–producing T cells and natural killer (NK) cells, suppressed RSV replication and whole lung levels of interleukin (IL)-4 and IL-13. Also, the lethal effect of intrapulmonary H1N1 infection inflammation was reduced by AXL inhibition. AXL inhibition in infected mice increased the number of IFN-b–producing macrophages and dendritic cells and suppressed neutrophil infiltration. Final, 22 April 2020 12 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) Bemcentinib is a clinical-stage, oral, selective small molecule AXL kinase inhibitor with well documented anti-viral effects in several systems. Bemcentinib is reported to block dengue, Ebola and Zika virus infections in several cell types including epithelial, fibroblast, endothelial, neuronal and myeloid cell types in in vitro cell culture and organoid systems. Bemcentinib treatment is associated with increased IFN signalling and reduced viral replication (Dowall 2016, Meertens 2017, Strange 2019). During the 2013/2014 Ebola virus (EBOV) outbreak, bemcentinib was 1 of 60 compounds evaluated by Public Health England as an experimental therapy for EBOV, using its Biosafety Containment Level 4 facilities at Porton Down. Bemcentinib 200 mg/kg/day starting 6 hours post viral challenge protected 1/6 EBOV infected guinea pigs from weight loss and early mortality in an 18-day in vivo mortality study (Dowall 2016), compared with 1/6 untreated animals surviving to Day 18 but exhibiting weight loss during the observation period. The authors concluded that bemcentinib may have had some protective effect in this model. 2.1 Preliminary Efficacy Data vs with SARS-CoV-2 In vitro Professor Wendy Maury, University of Iowa, conducted a preliminary analysis of the anti-viral effects of bemcentinib on SARS-CoV-2 in a Vero E6 cell line. As shown in Figure 1, bemcentinib incubation starting 1 hour prior to virus inoculation potently inhibited SARS-CoV-2 infection of Vero E6 cells in a dose-dependent manner. Other studies using vesicular stomatitis virus pseudotyped with SARS-CoV spike protein and a mouse betacoronavirus (mouse hepatitis virus [MHV]) showed that bemcentinib may both inhibit uptake and activate the IFN-mediated antiviral gene, ISG15, to control viral infection. SARS-CoV-2 cell tropism is likely to include PS dependent viral uptake and may target critical immune cell populations (eg, macrophages, dendritic cells) that produce IFN and mobilize anti-viral immunity. Importantly, delayed IFN signalling is characteristic of pathogenic human betacoronaviruses and correlates with disease severity in animal models, suggesting that early intervention with IFN-activating treatment may provide therapeutic benefit (Channappanavar 2016). Thus, AXL targeting is expected to attenuate SARS-CoV-2 pathogenesis both by limiting viral uptake and promoting innate antiviral immunity. Final, 22 April 2020 13 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) Figure 1 Bemcentinib Potently Inhibits Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection of Vero E6 Cells Vero E6 cells (60,000) in a 48-well format were incubated (1 hour) with bemcentinib prior to addition of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (MOI 0.0005). Cells were lysed at 24 hours and viral load was analysed by quantitative reverse transcription polymerase chain reaction (RT-PCR) for spike protein gene expression as normalized to the housekeeping gene Cyclophilin. W.Maury et al., unpublished results Importantly, recent data that differentiate SARS-CoV-2 from severe acute respiratory syndrome (SARS) have emerged that support the hypothesis that AXL may have a more dominant role in SARS-CoV-2 infection, and therefore that bemcentinib may have specifically a more important role to play in inhibiting this viral infection: • SARS-CoV-2 has similar replication kinetics to SARS-CoV, but demonstrates differential sensitivity to type I interferon treatment (One of 2 mechanisms of action of Bemcentinib through AXL inhibition) (Lokugamage 2020). • Structural analysis of the spike (S) protein of SARS-CoV-2 showed that its S protein has weaker binding to the angiotensin converting enzyme (ACE)2 receptor on human cells compared with strong affinity of human SARS coronavirus (Dong 2020) – supporting the large magnitude effect we have observed for inhibition of viral replication using clinically appropriate doses of bemcentinib in ACE2 receptor +ve cells. 2.2 Dose Justification for Bemcentinib Bemcentinib’s antiviral action stems from a cellular effect, inhibiting AXL kinase to prevent viral attachment and intracellular viral replication (through maximisation of the early type-I interferon rather than a direct antiviral action). From estimates of pooled data, the half maximal inhibitory concentration (IC50) at 24 hours for bemcentinib inhibition of viral load is approximately 140 nM and the approximate concentration required for 90% of maximum inhibition (IC90) is 650 nM. This broadly corresponds to cancer cell data demonstrating high Final, 22 April 2020 14 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) potency of bemcentinib to inhibit AXL. This high potency is reflected in translational data from clinical trials that demonstrate that at the RP2D steady state, AXL kinase is completely inhibited in myeloblasts from AML patients on bemcentinib (Figure 2). Clinically, at RP2D, AXL kinase target demonstrates complete kinase inhibition (Figure 2), thus the maximal possible antiviral effect with this mechanism of action is accessed at the current clinical dose. Clinically, frequent monotherapy complete responses are observed in AML at RP2D (Figure 2). Bemcentinib PK exhibits a prolonged enteral absorptive phase which overlaps with prolonged elimination kinetics after the second dose, to proportionately reduce peak-to-trough difference in plasma concentration-time profile, over a 24-hour dose interval, resulting in smooth steady state without noticeable peak to trough variation (Figure 3). Thus, at the clinical RP2D it is predicted that bemcentinib would be a highly potent antiviral against SARS-CoV-2, and potentially as efficacious as its main use an anticancer therapeutic. Figure 2 Complete Inhibition of AXL Kinase Activation (p-Axl) in Two Acute Myeloid Leukaemia Patients Treated at the Recommended Phase 2 Dose (200 mg Maintenance Daily Dosing) C=cycle; D=day; Pat=patient Final, 22 April 2020 15 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) Figure 3 Bemcentinib Plasma Pharmacokinetics in Acute Myeloid Leukaemia Patients Bemcentinib is given orally as 100-mg capsules. Early clinical development in oncology patients identified the RP2D; dose administration of bemcentinib in this study will utilise the same dosing regimen, ie, a loading dose (400 mg) given once daily for 3 days followed by a maintenance dose of 200 mg once daily. Planned duration of bemcentinib treatment is for a total of 15 days, with the possibility of extension to 21 days for in-patients, at the discretion of the clinical investigator. In preclinical and Phase 1 clinical studies, it was shown that systemic exposure to bemcentinib increased dose proportionately. The terminal half-life was 45.6 to 88.7 hours in man. Modelling of the PK data from this study indicated that the most effective approach to rapidly achieving steady state is to administer 3 daily loading doses followed by a lower daily maintenance dose. 2.3 Human Experience from Trials in Cancer Patients Experience has been gained in the use of bemcentinib in the treatment of many types of cancer (including over 286 patients treated with AML, lung cancer, breast cancer, melanoma, and pancreatic cancer) in Phase 2 clinical studies. This has helped to define the safety profile, recommended dose and schedule as a monotherapy (Loges et al 2018). The safety profile of bemcentinib, initially ascertained in normal human volunteers is tolerable and allows monotherapy approaches as well as combinations with chemotherapy (low dose cytosine arabinoside or with docetaxel), targeted therapy (epidermal growth factor receptor inhibitors) and immunotherapy (pembrolizumab). Bemcentinib is given as two oral capsules once daily (200 mg) following three daily 400 mg loading doses, to achieve steady state. Its principal significant AEs are a low incidence of diarrhoea (28% , with 6% Grade 3/4), asymptomatic QT prolongation (6% Grade 3/4), asthenia, and nausea at the RP2D (Loges et al 2018). Many patients have received bemcentinib without untoward effects for over 2 years at full dose. In particular, there were no QTc related cardiac sequelae observed with either monotherapy or combination therapy in over 286 cancer patients, including elderly multimorbid patients (as presented in the Investigator’s Brochure). Evidence of monotherapy efficacy has been Final, 22 April 2020 16 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) documented in heavily pre-treated patients with AML. Complete response rates of approximately 40% have been observed in AXL expressing AML patients (Loges et al 2018), indicating on-target potency and specificity of bemcentinib as a monotherapy, through complete inhibition of the AXL kinase target. Treatment was well tolerated by most subjects, including the frail elderly. Bemcentinib was well tolerated when combined with pembrolizumab, demonstrating synergy with programmed cell death-1 (PD-1) antagonists through targeting of AXL-dependent immune suppressive mechanisms (M2 macrophages, suppressor dendritic cells, regulatory T cells, and myeloid derived suppressor cells). Collectively, bemcentinib mediated activation of innate immunity within the tumour microenvironment synergizes with immune checkpoint therapy (Krebs et al 2019). Final, 22 April 2020 17 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 3.0 STUDY POPULATION 3.1 Eligibility Criteria Overall inclusion and exclusion criteria are presented in Sections 5.1 and 5.2 of the Master Protocol, respectively. Additional exclusion criteria that are specific to the sub-protocol are as follows: 12. Inability to swallow capsules (administration via nasogastric tube is permitted) 13. Current treatment with any agent known to cause QT prolongation. See Appendix 2 for list of relevant medications. The treatment can be discontinued, with sufficient time (5 half-lives) for washout, to allow inclusion of the patient. 14. Screening 12-lead ECG with a measurable QTc interval according to Fridericia correction (QTcF) > 450 ms 15. Clinically significant hypokalaemia. Individuals who do not meet this criterion may be rescreened once. 16. Therapeutic anticoagulation with vitamin K antagonists. Note: Patients receiving low doses prescribed to maintain the patency of venous access devices may be included. 17. Previous bowel resection that would interfere with drug absorption Final, 22 April 2020 18 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 4.0 STUDY ASSESSMENTS AND PROCEDURES In addition to the study assessments and procedures described in Section 8.0 of the Master Protocol, assessments specific to the sub-protocol will be performed as described in the following sections. The Schedule of Activities (SoA) for this sub-protocol is presented in Section 1.2. 4.1 Efficacy Assessments Efficacy assessments will be included as per the Master Protocol. The following endpoints, secondary endpoints in the Master Protocol, will be considered as key secondary endpoints for the purposes of this sub-protocol: Table 1. Bemcentinib Sub-protocol Specific Key Objectives and Endpoints Objectives • To evaluate the ability to prevent deterioration according to the ordinal scale by 1, 2, or 3 points • To evaluate the number of oxygen-free days. • To evaluate ventilator-free days and incidence and duration of any form of new ventilation use. • To evaluate SARS-CoV-2 viral load. • To evaluate SARS-CoV-2 viral load. Endpoints • The proportion of patients not deteriorating according to the ordinal scale by 1, 2, or 3 points on Days 2, 8, 15, 22, and 29. • Duration (days) of oxygen use and oxygen-free days. • Duration (days) of ventilation and ventilation-free days. • Incidence of any form of new ventilation use and duration (days) of new ventilation use. • Qualitative and quantitative polymerase chain reaction (PCR) determination of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in oropharyngeal/nasal swab while hospitalised on Days 1, 3, 5, 8, 11, 15, and (optional) Day 29 • Qualitative and quantitative PCR determination of SARS-CoV-2 in blood and saliva (while hospitalised) on Days 1, 3, 5, 8, 11, 15, and (optional) Day 29 (may be become a secondary endpoint once the assays are available). Exploratory studies will define the role of PD biomarkers. Exploratory endpoints relate to the translational plan. 4.2 Safety Assessments For ECG assessments see the SoA (Section 1.2). Timing of the PK and PD evaluations will be matched to the ECG assessments. Final, 22 April 2020 19 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 4.2.1 Adverse Events 4.2.1.1 Adverse Events from Indications Under Investigation Bemcentinib is a relatively safe investigational therapeutic agent. A few patients may experience tiredness and gastrointestinal disturbance (nausea, diarrhoea). Occasionally there may be some changes to blood tests relating to liver function (transaminitis) and some changes on ECG tracing (QT prolongation). These AEs are temporary and lasting only a few days. 4.2.1.2 Adverse Events of Special Interest (AESI) Not applicable. 4.2.1.3 Disease-related Events and/or Disease-related Outcomes Not Qualifying as Adverse Events or Serious Adverse Events Not applicable. 4.2.2 Clinical Safety Laboratory Assessments See Master Protocol for the list of clinical laboratory tests to be performed for this sub-protocol, and the SoA (Section 1.2) for the timing and frequency. 4.3 Pharmacokinetic Assessments Venous blood samples for PK analysis will be collected according to the SoA (Section 1.2). The samples will be analysed for plasma bemcentinib and additionally for bemcentinib metabolites (to be defined). Detailed procedures for the collection, processing, storage and shipment of the samples will be provided in the Study Laboratory Manual. Plasma samples for determination of bemcentinib concentration will be analysed by BerGenBio’s Bioanalytical Services vendor using the validated liquid chromatography with tandem mass spectrometry method. 4.4 Pharmacodynamic Assessments Blood samples for PD analysis will be collected according to the SoA (Section 1.2) and stored for future analysis in both the bemcentinib arm and the control arm. The samples will be analysed for soluble AXL, GAS6 (which could be predictive, PD, and mechanism biomarkers and hence require comparison with control group not receiving bemcentinib), and other blood proteins. Detailed procedures for the collection, processing, storage and shipment of the samples will be provided in the Study Laboratory Manual. This analysis will be in addition to the inflammatory cytokine analysis detailed in the Master Protocol. Final, 22 April 2020 20 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 5.0 STUDY TREATMENT 5.1 Conclusions and Risk Benefit Statement Bemcentinib has shown in vitro evidence of antiviral effect against SARS-CoV-2 infection at concentrations below those achieved at the proposed dose regimen for use in this trial. This dose matches the RP2D derived from multiple studies in various cancer populations. Treatment at this dose in 286 patients over a range of 6 weeks up to 2 years demonstrates that monotherapy or combination is largely well tolerated; therefore short term administration (15 to 21 days) in the context of hospitalized patients with SARS-CoV-2 infection is anticipated to be well tolerated. A non-severe, asymptomatic effect on QTc interval has been noted. Regular ECG/continuous ECG monitoring is included in the clinical trial enabling early identification of prolonged QTc and early stopping rules given the high morbidity and potential mortality of SARS-CoV-2 in hospitalised patients, there is a favourable balance of potential benefit: risk in the proposed clinical investigation of bemcentinib treatment for COVID-19 within the context of this clinical trial. 5.2 Bemcentinib Drug Administration Bemcentinib will be administered as a 400 mg oral loading dose on Days 1, 2, and 3, followed by 200 mg once-daily oral maintenance dose for 15 days with the possibility of extension to 21 days for in patients at the discretion of the clinical investigator. Bemcentinib should be taken once per day, in the morning after an overnight fast. Tablets should be taken with 100 mL water. Patients should not consume anything other than water for at least 1 hour after taking study drug. Final, 22 April 2020 21 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 5.3 Dose Modifications and Toxicity Management Note: this modified guidance has been added to the Investigators’ Brochure under relevant section of treatment of COVID-19 Event Recommended Bemcentinib Dose Modification Estimated creatinine clearance decreases Study medication should be withheld until estimated creatinine by more than ≥50% from baseline clearance returns to baseline ALT or AST increases to > 5 ULN Study medication should be withheld until ALT and AST returns to baseline Dose Modification of Bemcentinib Daily Dose for QTc Prolongation QTcF Recommended Bemcentinib Dose Modification > 501 ms 1st occurrence Discontinue permanently Ventricular arrhythmia 1st occurrence Discontinue permanently ALT=alanine aminotransferase; AST=aspartate aminotransferase; QTcF= QTc interval according to Fridericia correction; ULN=upper limit of normal Notes: Serum calcium, magnesium and potassium should be measured regularly whilst receiving bemcentinib; all abnormal results should be corrected; check for use of concomitant medication that are associated with QT prolongation. 5.4 Prohibited Concomitant Medications Administration of bemcentinib is contraindicated in patients requiring treatment with concomitant medications known to prolong QTc interval and promote Torsade de Points (TdP) listed in Appendix 2. Patients already in receipt of such medications should be excluded unless medications are discontinued and a sufficient wash out period is allowed prior to starting bemcentinib. Medicines with both cytochrome P450 (CYP) 3A4 and TdP liabilities are particularly hazardous and their concomitant use is a reason for exclusion of patients. Concomitant medications that are CYP3A4 substrates are not reasons for exclusion of patients, however they should be discontinued or used with caution. Treatment with histamine receptor 2 inhibitors (cimetidine, ranitidine) or protein pump inhibitors (omeprazole) is permitted provided that administration is in the evening. 5.5 Study Drug Information 5.5.1 Study Medication The drug product is presented in a single strength: 100 mg bemcentinib in size 0, Swedish Orange hydroxypropyl methylcellulose capsules for oral administration. Bemcentinib capsules Final, 22 April 2020 22 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) consists of a wet granulated blend of 40% drug substance with standard excipients (lactose monohydrate, microcrystalline cellulose, crospovidone, polyvinylpyrrolidone, colloidal silicon dioxide, and magnesium stearate). Bemcentinib has been manufactured according to appropriate Good Manufacturing Practice standards. Bemcentinib capsules are packaged in 50-mL white opaque round high density polyethylene bottles containing 22 capsules. The bottles are closed with opaque 32-mm child-resistant screw caps and sealed with tamper-resistant tape. Refer to the current version of the Bemcentinib Investigational Medicinal Product Dossier/Investigator’s Brochure for additional information on the physical, chemical and pharmaceutical properties of bemcentinib. 5.5.2 Bemcentinib Storage, Dispensing, and Destruction Bemcentinib will be shipped to the participating site by PCI Pharma Services, UK, and must be stored at the site in a secure location under ambient temperature conditions (<25°C). Accountability for study treatment is the responsibility of the Investigator. The Investigator/designee must ensure that the bemcentinib will only be dispensed to patients in accordance with the dosing instructions in this protocol. Study staff should refer to the Bemcentinib Pharmacy Manual for specific instructions regarding the handling, storage, dispensing and destruction of bemcentinib. Final, 22 April 2020 23 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 6.0 REFERENCES Bhattacharyya S, Zagórska A, Lew ED, et al. Enveloped viruses disable innate immune responses in dendritic cells by direct activation of TAM receptors. Cell Host Microbe 2013;14:136-47. Brindley MA, Hunt CL, Kondratowicz AS, et al. Tyrosine kinase receptor Axl enhances entry of Zaire ebolavirus without direct interactions with the viral glycoprotein. Virology 2011;415:83-94. Channappanavar R, Fehr AR, Vijay R, et al. Dysregulated Type I Interferon and Inflammatory Monocyte-Macrophage Responses Cause Lethal Pneumonia in SARS-CoV-Infected Mice. Cell 2016;19:181-93. Chen J, Yang YF, Yang Y, et al. AXL promotes Zika virus infection in astrocytes by antagonizing type I interferon signalling. Nat Microbiol 2018;3(3):302-9. Dong N, Yang X, Ye L, Chen K, Chan EW, Chen S. Genomic and protein structure modelling analysis depicts the origin and pathogenicity of 2019-nCoV, a new coronavirus which caused a pneumonia outbreak in Wuhan, China [version 2; peer review: 1 not approved]. F1000Research 2020, 9:121 (https://doi.org/10.12688/f1000research.22357.2) Dowall SD, Bewley K, Watson RJ, et al. Antiviral Screening of Multiple Compounds against Ebola Virus. Viruses 2016;8(11). pii:E277. Hastings AK, Hastings K, Uraki R, et al. Loss of the TAM Receptor Axl Ameliorates Severe Zika Virus Pathogenesis and Reduces Apoptosis in Microglia. iScience 2019;13:339-50. Huang MT, Liu WL, Lu CW, et al. Feedback regulation of IFN-αβ signalling by Axl receptor tyrosine kinase modulates HBV immunity. Eur. J. Immunol. 2015;45:1696-705. Krebs M et al. A phase II study of bemcentinib (BGB324), a first-in- class selective AXL inhibitor, in combination with pembrolizumab in patients with advanced NSCLC: Updated analysis. SITC 2019, oral presentation in High Impact Clinical Trials session. Lemke G. How macrophages deal with death. Nat Rev Immunol. 2019;19(9):539-49. Loges S et al. Comprehensive Analysis of the Dose Escalation, Expansion and Correlates in the Ph I/II Trial BGBC003 with the Selective Oral AXL Inhibitor Bemcentinib (BGB324) in Relapsed/Refractory AML and MDS ASH 2018, presentation. Lokugamage KG, Hage A, Schindewolf C, Rajsbaum R, Menachery VD. SARS-CoV-2 is sensitive to type I interferon pretreatment. bioRxiv preprint doi: https://doi.org/10.1101/2020.03.07.982264.Meertens L, Carnec X, Lecoin MP, et al. The TIM Final, 22 April 2020 24 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) and TAM Families of Phosphatidylserine Receptors Mediate Dengue Virus Entry. Cell Host Microbe 2012;12(4):544-57. Meertens L, Labeau A, Dejarnac O, et al. Axl mediates ZIKA virus entry in human glial cells and modulates innate immune responses. Cell Rep 2017;18(2):324-33. Mercer J, Helenius A. Vaccinia virus uses macropinocytosis and apoptotic mimicry to enter host cells. Science 2008;320(5875):531-5. Shibata T, Habiel DM, Coelho AL, Kunkel SL, Lukacs NW, Hogaboam CM. Axl Receptor Blockade Ameliorates Pulmonary Pathology Resulting from Primary Viral Infection and Viral Exacerbation of Asthma. J Immunol. 2014;192(8):3569-81. Shimojima M, Takada A, Ebihara H, et al. Tyro3 family-mediated cell entry of Ebola and Marburg viruses. J Virol. 2006;80(20):10109-16. Strange DP, Jiyarom B, Pourhabibi Zarandi N, et al. Axl promotes Zika virus entry and modulates the antiviral state of human Sertoli cells. mBio 2019;10(4):e01372-19. Final, 22 April 2020 25 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 7.0 APPENDICES Appendix 1 Abbreviations Abbreviation ACE AE AML BP CYP EBOV ECG GAS6 IC50 IC90 IFN IL MHV NK NYHA PD PD-1 PK PS QTcF RP2D RSV SARS SARS-CoV-2 SoA SOCS TAM TdP Definition Angiotensin-converting enzyme Adverse event Acute myeloid leukaemia Blood pressure Cytochrome P450 Ebola virus Electrocardiogram Growth arrest-specific 6 Half maximal inhibitory concentration Concentration required for 90% of maximum inhibition Interferon Interleukin Mouse hepatitis virus Natural killer New York Heart Association Pharmacodynamic Programmed cell death-1 Pharmacokinetic Phosphatidylserine QTc interval according to Fridericia correction Recommended Phase 2 dose Respiratory syncytial virus Severe acute respiratory syndrome Severe acute respiratory syndrome coronavirus 2 Schedule of Activities Suppressor of cytokine signalling Tyro3, AXL, MerTK Torsade de Points Final, 22 April 2020 26 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) Appendix 2 Prohibited Concomitant Medication Due to QT Prolongation Risk or CYP3A4 Interaction with Narrow Therapeutic Index For any concomitant medication, please check the following website for the drug’s Torsades de Pointes (TdP) risk: https://crediblemeds.org/oncosupport/. Drugs with known (TdP) risk are reason for EXCLUSION. For drugs with a conditional risk, please review the product label and correct any abnormalities, eg, hypokalaemia. Common medication Associated with a Risk of QT Prolongation and TdP – USE PROHIBITED AS CONCOMITANT MEDICATION t½ less than 6 hours Azithromycin 2-4 hours$ Clarithromycin 3-4 hours$ Cocaine 0.6 – 1.3 hours$ Droperidol 2 hours$ Erythromycin 2 hours$ Ondansetron 3 hours$ Procainamide 2.5-4.75 hours$ Terfenadine 3.5 hours** t½ between 6 – 12 hours Cisapride 10 hours ** Disopyramide 6.7 hours$ Ketoconazole 3 – 10 hours$ Moxifloxacin 12 hours$ Quinidine 6 hours **$ Voriconazole 6 hours$ t½ greater than 12 hours Amiodarone 50 days$ Astemizole 24 hours ** Chloroquine 1-2 months$ Citalopram 35 hours$ Escitalopram 30 hours$ Fluconazole 30 hours$ Haloperidol 15 – 27 hours$ Methadone 25 – 55 hours$ Petamidine 10 – 14 days$ **also CYP3A4 substrates $ also TdP risk Pimozide 55 hours ** Sotalol 10 – 20 hours$ Thioridazine 21 – 24 hours$ Sensitive CYP3A4 Substrates With A Narrow Therapeutic Margin THESE MEDICATIONS SHOULD BE DISCONTINUED BEFORE ENROLMENT t½ less than 6 hours t½ between 6 – 12 hours t½ greater than 12 hours alfentanyl 90-111 minutes dihydroergotamine & ergotamine 2 hours Fluticasone 3 – 8hours Terfenadine 3.5 hours astemizole 7 – 9 hours cisapride 12 hours cyclosporine 8.4 hours Fentanyl 8 – 10 hours quinidine 6 hours tacrolimus (FK506) 12 hours pimozide 55 hours sirolimus 63 hours Woosley RL, Heise CW , Gallo T, Tate J, Woosley D and Romero KA, www.CredibleMeds.org, QTdrugs List, [14Apr2020], AZCERT, Inc. 1822 Innovation Park Dr., Oro Valley, AZ 85755 Final, 22 April 2020 27 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) Appendix 3 Signature of Investigator PROTOCOL TITLE: A Multicentre, Seamless, Phase 2 Adaptive Randomisation Platform Study to Assess the Efficacy and Safety of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalised Patients SUB-PROTOCOL NO: ACCORD-2-002 SUB-PROTOCOL FOR CANDIDATE AGENT BEMCENTINIB VERSION: Amendment 01 This sub-protocol is a confidential communication of the Sponsor. I confirm that I have read this sub-protocol, I understand it, and I will work according to this sub-protocol, in conjunction with the Master Protocol for the overall platform study. I will also work consistently with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and the applicable laws and regulations. Acceptance of this document constitutes my agreement that no unpublished information contained herein will be published or disclosed without prior written approval from the Sponsor. Instructions to the Investigator: Please SIGN and DATE this signature page. PRINT your name, title, and the name of the study centre in which the study will be conducted. Return the signed copy to the Contract Research Organization/Sponsor. I have read this sub-protocol in its entirety and agree to conduct this part of the study accordingly: Signature of Investigator: Printed Name: Investigator Title: __________________________ ___________________________ ___________________________ Date: ________ Name/Address of Centre: ___________________________ ___________________________ ___________________________ Final, 22 April 2020 28
Url: /Media/Southampton-Clinical-Research/COVID-19/ACCORD/ACCORD-2-example-sub-protocol.pdf

Your child's sputum induction test - patient information

Description: This factsheet explains what a sputum induction test is and what it involves, so you know what to expect and can help to prepare your child.
Url: /Media/UHS-website-2019/Patientinformation/Childhealth/Your-childs-sputum-induction-test-3899-PIL.pdf

Papers CoG 29.04.2025 v2

Description: Date Time Location Chair Agenda Council of Governors 29/04/2025 14:00 - 15:45 Conference Room, Heartbeat/Microsoft Teams Jenni Douglas-Todd 1 Chair’s Welcome and Opening Comments 14:00 2 Declarations of Interest 14:04 3 Minutes of Previous Meeting 14:05 Approve the minutes of the previous meeting held on 29 January 2025 4 Matters Arising/Summary of Agreed Actions 14:06 5 Strategy, Quality and Performance 5.1 Chief Executive Officer's Performance Report 14:07 Receive and note the report Sponsor: David French, Chief Executive Officer Attendee: Gail Byrne, Chief Nursing Officer 5.2 Annual Report and Quality Accounts Timetable 2024/25 14:27 Note the timetable Sponsor: David French, Chief Executive Officer Attendee: Karen Russell, Council of Governors Business Manager 5.3 Draft Quality Accounts 2024/25 14:32 Review and feedback Sponsor: Gail Byrne, Chief Nursing Officer Attendee: Helena Blake, Head of Clinical Quality Assurance 5.4 Corporate Objectives 14:42 Review and feedback Sponsor: David French, Chief Executive Officer Attendee: Kelly Kent, Head of Strategy and Partnerships 5.5 Non-NHS Activity 14:52 Receive and note the update Sponsor: Ian Howard, Chief Financial Officer Attendee: Pete Baker, Commercial and Enterprise Director 5.6 Break 15:02 6 Governance 6.1 Governor Attendance at Council of Governors' Meetings 15:12 Review governor attendance at Council of Governors' meetings Sponsor: Jenni Douglas-Todd, Trust Chair Attendee: Karen Russell, Council of Governors' Business Manager 6.2 Council of Governors' Elections 2025 15:17 Note the timetable Sponsor: Jenni Douglas-Todd, Trust Chair Attendee: Karen Russell, Council of Governors' Business Manager 6.3 Appointment to the GNC 15:19 Sponsor: Jenni Douglas-Todd, Trust Chair Attendee: Karen Russell, Council of Governors' Business Manager 7 Membership Engagement and Governor Activity 7.1 Membership Engagement 15:21 Receive the report Sponsor: Jenni Douglas-Todd, Trust Chair Attendee: Sam Dolton, Events and Membership Officer 7.2 Governors' Nomination Committee Feedback 15:31 Chair: Jenni Douglas-Todd, Trust Chair 8 Review of Meeting 15:36 Review and feedback on the content of this meeting Sponsor: Jenni Douglas-Todd, Trust Chair 9 Any Other Business 15:41 Raise any relevant or urgent matters that are not on the agenda 10 Date of Next Meeting: 16 July 2025 15:44 Note the date of the next meeting Page 2 Minutes - Council of Governors (CoG) Open Session Date Time Location Chair Present 29 January 2025 14.00-15.30 Conference Room, Heartbeat Education Centre and Microsoft Teams Jenni Douglas-Todd, Trust Chair Jenni Douglas-Todd, Trust Chair Shirley Anderson, Elected, New Forest, Eastleigh and Test Valley Theresa Airiemiokhale, Elected, Southampton City Katherine Barbour, Elected, Southampton City Patricia Crates, Elected, New Forest, Eastleigh and Test Valley Sandra Gidley, Elected, New Forest, Eastleigh and Test Valley Lesley Gilder, Elected, Southampton City Ben Grassby, Elected, Rest of England and Wales Linda Hebdige, Elected, Southampton City Councillor Pam Kenny, Appointed, Southampton City Council Professor Sue Latter, Appointed, University of Southampton Jenny Lawrie, Elected, Southampton City Brian Lovell, Elected, Rest of England and Wales Councillor Louise Parker-Jones, Appointed, Hampshire County Council Cat Rushworth, Elected, Isle of Wight Karen Smith-Baker, Elected, Health Professional and Health Scientist Staff Jake Smokcum, Elected, Nursing and Midwifery Staff Mike Williams, Elected, New Forest, Eastleigh and Test Valley JDT SA TA KB PC SG LG BG LH PK SL JL BL LPJ CR KSB JS MW In attendance Tracey Burt, Minutes TB Sam Dolton, Events and Membership Officer SD David French, Chief Executive Officer (for item 5.1) DF Steve Harris, Chief People Officer (for item 6.1) SHa Craig Machell, Associate Director of Corporate Affairs and CM Company Secretary Karen Russell, Council of Governors’ Business Manager KR Apologies Professor Cathy Barnes, Appointed, Solent University CB Sathish Harinarayanan, Elected, Medical Practitioners and Dental SH Staff Esther O’Sullivan, Elected, New Forest, Eastleigh and Test Valley EO Liz Taylor, Elected, Non-Clinical and Support Staff LT 1 Chair’s Welcome and Opening Comments The Chair welcomed everyone to the meeting and in particular, BG and SL, who were attending their first CoG, although they had attended the strategy day at the end of last year. 1 2 Declarations of Interest There were no new declarations of interest relating to matters on the agenda. 3 Minutes of Previous Meeting The minutes of the meeting held on 23 October 2024 were approved as an accurate record of the meeting. 4 Matters Arising/Summary of Agreed Actions All actions had been completed. 5 Strategy, Quality and Performance 5.1 Chief Executive Officer’s Performance Report The Chair welcomed DAF who joined the meeting to present the performance report. He highlighted the following from the report and commented on various national issues:- • the Trust had been under significant pressure related to urgent and emergency care. Whilst this was also a national problem, attendances at the UHS Emergency Department had been higher than last year, averaging 448 patients a day. During the Christmas period, attendances and admissions had been exacerbated by Covid-19 and flu. Various Trusts had declared critical incidents but UHS had not, although it had been close to doing so. • pressure on the Emergency Department had eased slightly in January but during the last week it had increased again. At midnight on 27 January 2025 there had been 150 patients in the department, which was double the normal capacity. • infection prevention was a greater challenge when the hospital was under intense pressure but the Trust was focussed on it. • the Trust had seen an increase in Never Events. A theme related to invasive procedures and missed opportunities to stop, before procedures had started, had been identified. A plan to mitigate such events had been put in place and the Trust would implement the National Safety Standards for Invasive Procedures (NatSSIPs). • the Trust’s referral to treatment (RTT) waiting list had remained above 60,000 in quarter three. 62% of patients on the waiting list had been waiting less than 18 weeks, which meant that UHS was in the top quartile when compared to peer teaching hospitals. • UHS had delivered elective recovery fund activity (ERF) at 128% of 2019/20 levels, which was 15% above the Trust’s target. • the physical capacity of the UHS estate continued to be a challenge. • the funding mechanism related to how ERF money was paid, continued to be a challenge for the Trust. It was hoped that national planning guidance, due out on 30 January 2025, would provide clarity. • the annual staff survey had now closed and the Trust was beginning to receive initial results. These would be shared in due course. • there had been a slight increase in staff sickness absence, largely due to Covid-19 and flu. • the Trust had a significant financial deficit and needed to get back to breakeven. 2025/26 was likely to be another difficult year and it was known that three national priorities would be safe emergency care, reductions in the elective waiting list and the need for Trusts to live within their means. BL queried whether the Trust had done everything it could, in terms of its financial situation. DAF advised that UHS had recently received productivity benchmarking data, which showed that it was fourth in the country, when compared to others, so the Trust was struggling to see what it could do better. 2 SG queried whether all activity for 2025/26 had been capped. DAF advised that new operations and elective outpatient procedures were presently paid for on a price per unit basis, whilst almost everything else was on a block contract. UHS was generally doing more activity than the block assumed and it was likely that elective activity would also be capped next year. The Trust may, therefore, need to consider pulling back on the things that added the least value. CR noted that people were generally living longer and asked whether that was being considered, from a financial perspective. DAF advised that UHS would always support clinical decisions, regardless of a patient’s age. The Chair thanked DAF for attending CoG. 6 Governance 6.1 Chair and Non-Executive Director Appraisal Process The Chair welcomed SHa to the meeting and noted that as a Foundation Trust, UHS was required to conduct a robust appraisal process. The process started in January and would conclude in April. The governors had a vital role in providing feedback on the work of the Non-Executive Directors (NEDs) and system partners would also be asked to provide feedback on the Chair. The Chair would conduct the NEDs appraisals and Jane Harwood, Senior Independent Director (SID) would undertake the Chair’s appraisal. SHa advised that NHS England was due to launch a new appraisal process, nationally, for NEDs but it was still outstanding. However, a refreshed appraisal process for Chairs had been released in 2024. SA noted that governors often found it difficult to provide feedback on the NEDs and advised that she had some helpful tips to share with them, at the end of the CoG meeting. Decision: The CoG approved the Chair and NED appraisal process for 2024/25. 6.2 Audit and Risk Committee Terms of Reference CM advised that the Audit and Risk Committee had carried out the annual review of its Terms of Reference and two minor amendments had been proposed: • to amend 10.2 to Code of Governance for NHS Provider Trusts. • to remove Charitable Funds Committee from Appendix A. Decision: the CoG supported the proposed changes to the Audit and Risk Committee Terms of Reference. 6.3 Governors’ Nomination Committee Terms of Reference CM advised that the Governors’ Nomination Committee had reviewed its Terms of Reference on the 15 January 2025 and the CoG was asked to approve the removal of the words “deputy chair” from paragraph 3.2. Decision: the CoG approved the proposed, minor change, to paragraph 3.2. 6.4 Council of Governors’ Annual Business Plan 2025/26 KR advised that each year the CoG was required to review its Annual Business Plan for the coming financial year. Decision: the CoG approved its Annual Business Plan for 2025/26. 3 6.5 Non-Executive Director Appointment The Chair reminded the CoG that at its meeting on 15 April 2024 it had approved the appointment of David Liverseidge as a NED, for a three-year term. However, due to his position at Ramsay Health Care UK and the potential conflict of interest, it had been agreed to delay his appointment until his retirement at the end of 2024. The CoG was therefore asked to note that following completion of the Fit and Proper Persons checks and declaration processes, his appointment as a NED had commenced on 1 January 2025. 6.6 Governor Attendance at Council of Governors’ Meetings KR introduced the report and advised that if a governor failed to attend two successive meetings of the CoG, their appointment would be terminated unless the absences were due to reasonable cause. The Chair, CM or KR would contact the governor, to understand the reasons and would then provide confirmation to the CoG that the causes were reasonable. BL said that he would find it difficult to approve the continued tenure of a governor, if he did not know the reasons for their absence. The Chair clarified that the CoG would be asked to confirm that it was satisfied the Chair or Company Secretary had followed the process, rather than be asked to approve the reasons for any absence. SG queried what was meant by a “reasonable period” and the Chair advised that it would depend on the circumstances, which would be discussed with the individual governor. Action: It was agreed that CM and KR would review the constitution to check whether any amendments to the wording were needed. 7 Membership Engagement and Governor Activity 7.1 Membership Engagement SD introduced the Membership Engagement report and highlighted the following:- • the monthly newsletters continued to keep members updated. • the quarterly Connect digital magazines had been sent out in November 2024 and January 2025. There had been an emphasis on health inequalities in the community, in the latter edition. • the open evening and annual members’ meeting had been held, in person, at UHS in November 2024. It had not been as well attended as he would have hoped (it had snowed that day) and going forward, ways to maximise attendance would be considered. However, there had been positive feedback from those who had attended. • during December 2024 a virtual event, focused on healthy ageing, had been held. He encouraged governors to register for the forthcoming virtual event on cancer research. • due to the extreme pressures on the hospital, the team had actively used social media channels to remind people of the alternatives available, rather than attending the emergency department. • the opening of Woodland Ward, special care baby unit at the Princess Anne Hospital, had featured in the quarterly update. • the continued production of the monthly updates and the Spring edition of the Connect quarterly digital magazine were priorities for the team. 4 • attendance at external events (e.g. the Mela Festival) and opportunities to collaborate with other teams, were being planned and governors were encouraged to offer their support. Governors made the following comments:• it was helpful to have an engaging activity available at external events, as these helped to draw people in. • whether it would be appropriate to attend the Southampton marathon, which attracted a large number of people. SD advised that the team had attended in the past but had not found it the ideal event to have conversations with people. He would, however, contact the hospital charity, to see whether there was information that could be handed out. • SL suggested that she and SD discuss ways to recruit students as members. The Chair thanked SD for his informative report. 7.2 Governors’ Nomination Committee Feedback The Chair advised that the Governors’ Nomination Committee had met on the 15 January. It had undertaken the annual review of its Terms of Reference and had looked at the appraisal process for the Chair and NEDs. It had also noted the commencement of David Liverseidge as a NED. 8 Review of Meeting The governors said that they had found the meeting very informative, with the right level of information provided. 9 Any Other Business The following were mentioned by governors:- • the increased aggression towards staff was noted and the Chair advised that greater detail would be available once the annual staff survey results were available. • KB advised that she had visited Heartbeat House (on the edge of the UHS site) where friends and relatives of patients undergoing cardiac surgery could stay. A coffee morning was held every Tuesday morning in Heartbeat House and KB encouraged governors to attend, as it provided a good opportunity to meet members of the public. She also raised awareness of the Heart & Stroll event being held on 29 June 2025 to raise funds towards the renovation of the Heart Failure Unit at UHS. • CM advised that due to changes in the Hampshire and Isle of Wight Integrated Care Board (ICB) and a possible conflict of interest, the ICB did not intend to replace Helen Eggleton, who had previously represented them as a governor on the CoG. It was therefore proposed to reduce the number of governors to 21, which would require the constitution to be amended. The CoG expressed its disappointment at the ICB’s decision and the Chair agreed to discuss the decision, when she next met with the Chair of the ICB. • the Chair advised that with effect from 11th March, all UHS Trust Board meetings would be held in person. A hybrid option would, however, still be available for the CoG meetings. • the Chair asked governors to ensure that they advised KR of any board committees they wished to attend, at least a week in advance. This would enable KR to liaise with the committee Chair, to ensure that it was appropriate for a governor to attend. 10 Date of Next Meeting The next meeting of the CoG would be held on 29 April 2025. 5 List of action items Agenda item Assigned to Deadline Status Council of Governors 29/01/2025 6.6 Governor Attendance at Council of Governors’ Meetings 1199 Governor Attendance at Council of Governors’ Meetings . Machell, Craig Russell, Karen 29/04/2025 Completed Explanation action item Under the Trust’s constitution if a governor failed to attend two successive meetings of the council of governors, his or her tenure of office is to be immediately terminated by the CoG unless the CoG is satisfied that the absences were due to reasonable cause; and he/she will be able to attend meetings of the CoG within such a period as the CoG considers reasonable. The CoG was happy to confirm it was satisfied that the correct process had been carried out but could not comment on the reasons for absence or their ability to attend future meetings within a reasonable period of time, as these had been a confidential part of the discussion with the governor. CM and KR agreed to look at the Trust's constitution to establish if an amendment was required to the wording regarding this. Explanation Russell, Karen The wording in the constitution relating to this issue requires amendment and this will be carried out when the Trust's constitution is reviewed during 2025/26. In the meantime, the wording in future papers relating to governor attendance at CoG meetings will be adjusted accordingly. Item 5.1 Report to the Council of Governors - 29 April 2025 Title: Chief Executive Officer’s Performance Report Sponsor: David French, Chief Executive Officer Author: Sam Dale, Associate Director of Data and Analytics Purpose (type an ‘x’ in the appropriate box(es)) (Re)Assurance Approval Ratification Information x Strategic Theme (type an ‘x’ in the appropriate box(es)) Outstanding patient Pioneering research World class people outcomes, safety and innovation and experience Integrated networks and collaboration Foundations for the future x x x Executive Summary: Information about Trust performance supports the Council of Governors in their role. This report is intended to inform the Council of Governors about aspects of the Trust’s performance. Contents: The Chief Executive Officer’s Performance Report is attached. Risk(s): N/A Equality Impact Consideration: N/A UHS Council of Governors April 2025 Chief Executive’s Performance Report 1. Purpose and Context The purpose of this report is to summarise the Trust’s performance against a range of key indicators. Where available, this report covers data from the period January to March 2025, noting that some performance data is reported further in arrears and therefore unavailable. As the organisation transitions to the national 25/26 NHS priorities, notable features of 24/25 quarter four include: • The financial position of the organisation remains extremely challenging as the trust prioritises the national request to live within its means despite restrictions on funding for emergency activity and elective growth. • Despite the economic challenges, the organisation continues to benchmark well for productivity measures including theatre utilisation and length of stay whilst recognising there remains an opportunity to go further. • The waiting list continued to grow in quarter four, however the trust has maintained performance on 18 week targets and reduced the volume of patients waiting over 65 weeks to a small cohort of services. • The organisation has maintained robust performance on cancer and diagnostic waiting times and anticipates that the validated year end position will place the organisation in the top quartile compared to peer organisations. • The volume of patients with no criteria to reside remains above 200 per day which continues to place a barrier on our bed availability. • The trust ranking for recommendation as a place to work has improved four places placing UHS at 18th out of 122 trusts. 2. Safety Infection Control Clostridium Difficile infection MRSA Bacterium infection Target 78.0% January 2025 39 35 74 70 40 24 33 7 0 January 2025 63.9% February 2025 44 12 56 46 33 19 27 5 0 February 2025 57.4% March 2025 54 25 79 59 43 25 36 2 0 March 2025 60.1% Performance against the emergency access target continues to be challenging with attendances growing by 3.2% compared to the previous financial year. In March 2025, 60.1% of patients spent less than four hours in the department which places the trust in the third quartile when compared to peer teaching hospitals. There is significant focus on improving this, with the plan based on two areas; improving decision making speed within the Emergency Department and improving timely flow from the department when patients need admission. The former is looking at consistency of practice, speciality in-reach into the department, and ensuring rotas reflect known peaks in attendance. The latter is looking at enhanced access, and increased pathways, to same day emergency care, flow and discharge throughout the hospital and embedding internal professional standards. Referral to Treatment (RTT) Target January 2025 % incomplete pathways within 18 weeks in month Total patients on a waiting list => 92% 62.0% 60,910 February 2025 61.5% 61,333 March 2025 62.5% 61,686 Whilst the trust continues to deliver more elective activity year on year, the RTT (referral to treatment) waiting list has continued to climb in each month of quarter four peaking at 61,686 at the end of the financial year. Despite this the organisation has maintained performance of 62% for the percentage of patients on the waiting list who are below 18 weeks. The trust ensures the appropriate prioritisation of our longest waiting patients with those of more urgent clinical need. The hospital reported just one patient waiting over 78 weeks in March 2025 due to the continued national delays for corneal tissue release. There were 21 patients waiting over 65 weeks - whilst some were also corneal transplant patients, others were services impacted by the prioritisation of urgent cancer patients or services managing unexpected emergency demand. Page 3 of 5 The trust is now transitioning focus to new 25/26 national waiting list targets. The organisation is committed to maintaining the strong improvements seen in 24/25 for theatre utilisation, length of stay reduction and optimisation of outpatient clinics. Alongside this, the organisation is closely reviewing referral trends and opportunities to manage them through increased advice and guidance. Cancer Target Faster Diagnosis - within 28 days 31 Day target - decision to treat to first definitive treatment 62 day target - urgent referral to first definitive treatment > =77% => 96% => 70% December 2024 83.6% 94.9% 82.2% January 2025 80.6% 95.1% 79.9% February 2025 84.4% 92.8% 72.1% The organisation continues to prioritise cancer patients and their treatments for all tumour sites and cancer types. The trust has maintained its strong performance against the 28 day faster diagnosis standard, consistently hitting the target and benchmarking in the top quartile compared to peer teaching hospitals across the country. Diagnostic capacity and the impact of provider referrals into UHS specialised services impacted our 62 day performance in February but unvalidated data provides assurance that the position has recovered to above 80% in March 2025. 5. Finance The financial environment remains extremely challenging for UHS. One off income received by the ICB and several technical adjustments have however helped reduce the scale of the deficit to £7m at the end of February 2025. This is £3.7m behind the annual plan of £3.3m deficit. The trust is targeting a breakeven position in March 2025 to ensure the deficit doesn’t further deteriorate and HIOW ICS can achieve a breakeven position for the year. The trust’s underlying position, so removing one off income, is significantly more challenging than this with an underlying deficit of c£6.5m per month. The organisation therefore continues to put significant focus on financial recovery with the aim of ensuring the organisation ‘lives within its means’ and makes progress towards the delivery of a breakeven run rate. The deficit drivers remain similar to those previously reported, focusing on three key areas: 1. Urgent and Emergency activity is in excess of block funding levels by c£2m per month. This has meant surge capacity has been required across all months of the financial year with peak usage in winter months. Demand management schemes are under development with HIOW ICS partners as part of agreeing plans for 2025/26 as is an increased funding envelope. 2. Non-criteria to reside numbers have increased to peaks of 250 from an average of 220. This is c20% of the trusts bed base and has a significant cost in addition to clinical risks of patient deconditioning and infection. This remains a focus of the inpatient flow programme. 3. Mental health patient demands have also increased noticeably over previous years with patients requiring enhanced levels of support often at a significant cost premium to the trust. UHS continues to work with system providers on improvements for this patient group. Despite these pressures however the trust has continued to ensure value for money remains an organisational priority with £73m of savings achieved YTD particularly focused on transforming services under the three workstreams of theatre optimisation, outpatients and inpatient flow. The trust also continues to overperform on the elective recovery target which supports financial sustainability via increased tariff income and helps support waiting list reduction targets. Currently 126% of 2019/20 levels of elective, daycase and outpatient first attendances are being delivered compared to a target of 113%. YTD this has generated over £26m of additional income for the trust. Page 4 of 5 Further to this the trust remains on target to spend its full capital allocation for 2024/25 totalling over £95m including £20m on decarbonisation and improved energy infrastructure which is externally funded. This continued investment in capacity, digital and infrastructure helps support continued ongoing financial sustainability and efficiency improvements. Despite the scale of the financial challenge the trust continues to look forward with optimism that our investments in infrastructure and transformation provide the right “foundations for the future”, including sustainable finances, and supporting “world class people, delivering world class care” as outlined in our strategy. 6. Human Resources Indicator Staff recommend UHS as a place to work Staff survey engagement score (out of 10) Q3 24/25 68.3% 7.0 Q4 24/25 66.4% 6.8 Trust wide, we have maintained our above average position across all the People Promise domains in the annual staff survey (Q3), with results remaining broadly unchanged from 2023 across all questions, with minimal improvements or declines which would be considered statistically significant. Year-on-year results over a three-year period shows there to be continued improvements in relation to satisfaction with immediate managers, opportunities for flexible working, appraisals, and increased confidence in reporting of incidences of unsafe practice, violence, bullying and harassment. However, we continue to see downward trends associated with civility and respect, and team dynamics which align to the themes in recent patient safety events and F2SU themes. Additionally, our national ranking for recommendation as a place to work has improved four places from last year, we now rank 18th out of 122 trusts, compared to 22nd in 2023. Participation rate has continued to decline to 39% from 41% in 2023, a 15% drop since 2022. This represents a total participation of 5,410 people out of a total eligible of 13,795 including subsidiaries. When reviewing the quarterly survey results, such as Q4 above, it must be noted that these results are less representative of views across UHS as we hear from less people. We maintain around a 20% response rate with quarterly surveys, hearing from 2,878 staff in Q4 out of an eligible 14,636 (this number is higher as more staff are eligible to participate in the quarterly surveys. WPL do their own quarterly survey so are not included). Indicator Target January 2025 Staff Turnover (internal target; rolling 12 month) Sickness absence 12 month rolling (internal target) 75% of staff in each area has received training, including neonatal medical team. • Trolley dashes. • Train the trainer. Progress Metrics Audit of compliance: • Has it been undertaken for the appropriate babies? • Was the frequency of observation undertaken correctly? • Was the score accurately calculated? • Did escalation take place if required? • Was the response to escalation appropriate? Quality Improvement Priority Four: Implementation of the National Safety Standards for Invasive Procedures (NatSSIPs) 2 at UHS. Core Dimension Patient Safety Rationale for Selection The new National Safety Standards for Invasive Procedures (NatSSIPs 2) represent the progression of the original NatSSIPs. The key aim to standardise, harmonise and educate (SHE) across organisations and procedural teams remains central to the NatSSIPs purpose. Critical changes include bolstered organisational standards and proportionate checks that recognise different levels of risk during major and minor invasive procedures, and the adaptions to processes that may be necessary in life-threatening situations. This standardisation, harmonisation and education goals are set out in the table below. Investigations into the increase of never events in 2023 and 2024 has identified that the majority of these had contributing factors related to stop points for safety. The key learning identified: All these factors will be addressed through NatSSIPs2 implementation. Safer invasive procedures is to be included as a local quality indicator by the ICB within the 2025/26 national contract. Key Aims • Establish a NatSSIPs oversight committee. • Set up an invasive procedures committee. • Establish the following workstreams: o Audit of stops point for safety in theatres and for minor procedures in outpatient and ward areas o Multi-disciplinary safety walkabouts o VLE and induction workstream • Education: recruitment of medical education led to set up simulation-based MDT training. • Patient involvement • NatSSIPs 8 and communications. • Stop points for safety staff resources. Progress Metrics • Increase in the completion of VLE stop points training. • Develop and implement a programme to deliver non-technical skills to the MDT. • All areas with a never event in the last two years have an up-to-date audit and action plan for compliance with NatSSIPs2. Quality Improvement Priority Five: Fundamentals of Care Core Dimension Patient safety Rationale for selection The term Fundamentals of Care (FoC) describes the eight standards that staff across the Trust have committed to in collaboration with the patient, to support the physical and emotional needs of patients’, relatives, and carers. This is not a new concept, it underpins the core values of what it means to be a healthcare professional, to truly ‘care’ and will build upon our achievements in year one. Operational challenges have led the workforce to become more task-focused and less person-focused, taking away from that personalised care experience but we are committed to changing that culture, following our trust value, Patients First. The FoC exemplifies how the interdisciplinary team connects and builds relationships with our patients, getting to know them and what matters to them as a person, not just as a patient, supporting and encouraging independence and rehabilitation from the beginning of their hospital stay. These activities are the essentials of our daily living such as personal hygiene, skin care, oral hygiene, toileting, eating and drinking, and mobilising. Communication is also essential and includes both listening and hearing patients, understanding what is important to them using communication tools they need, coming to shared decisions with patients about their care and recognising the diversity of our population, embracing accessibility for those with people with learning disabilities, sight/hearing loss or other disabilities, or if English may not be their primary language. In addition, the FoC encourages us as healthcare professionals to consider the whole person, support cultural, spiritual, mental health, emotional wellbeing and dignity needs of people we care for and those that matter to them. We know here at UHS that not everyone experiences this level of care, but we acknowledge the need to change the rhetoric from ‘we are busy’ to ‘we are never too busy to care’ empowering and educating our staff at all levels to challenge the ‘we have not got time’ rhetoric and ensure fundamental care is at the heart of what we do at UHS. Thus improving, patient care and experience. Key Aims We will grow the multi-disciplinary engagement and involvement in workstreams that embrace the FoC and encourage person centred to care. We will continue to pursue the digitalisation of the Friends and Family Test (FFT), using this data and the national inpatient and urgent and emergency care survey as a baseline, while linking with involved patients where required with to encourage feedback on the FoC. We will listen to the voice of our patients, their relatives, and carers to make sure their stories and experiences are heard by our workforce to encourage the organisation wide change. We will ensure the FoC will has clear and measurable improvement metrics as part of a live clinical quality dashboard that will afford ward managers and senior leaders, the opportunity to monitor, review and report on to FoC in their areas. We will embed the FoC into the matron walkabout and CAS processes, supported by consistent evaluation metrics that ask the patients about their experiences and encourage clinical areas to continually assess and evaluate the FoC in their areas through a self-assessment tool. We will enhance the availability of existing resources on our virtual learning wnvironment (VLE) in collaboration with our patient partners for all staff groups and embed the FoC into training across the organisation, to improve the knowledge, skills and awareness ensuring the delivery of quality care. We will continue to test and evaluate the What Matters To Me project, growing our volunteer role to support staff in finding out what is important to the patient and using their personalised board to remind staff of the ‘person’ they are caring for. We will continue to establish project links in child health, maternity and outpatients to ensure a bespoke, but collaborative roll out of FoC, considering how these different care environments may impact care. Progress Metrics • Patient hygiene – We will see an improvement in the number of patients who report having their personal care needs met, particularly within their first 24 hours coming through emergency admission routes. • Skin integrity – We will support the reduction in incidences of avoidable pressure ulcers across the organisation. • Communication – We see an increase in the number of people accessing our interpreting services and a reduction in complaints related to interpretation. • Pain – We will see an improvement in patients reporting that their pain was well controlled when coming through the emergency department. • Mouthcare – We will see a positive uptake in the implementation of the new mouthcare assessment tool and an improvement in patients reporting that their oral hygiene needs have been met. • Nutrition and hydration – We will see an increase in patients reporting they are being offered adequate food and drink provisions throughout their hospital stay, including access to equipment for those with conditions or disabilities that impact their ability to do so independently. • Bowel and bladder care – We will see improved assessment of bowel and bladder habits through increased documentation using the Inpatient Noting system. • Enhancing safe movement – We will support a reduction in the incidence of high harm falls and high harm falls that have preventable causes. • Infection prevention – We will see a reduction in nosocomial infections through increased hand hygiene standards and more effective cleaning of equipment Quality Improvement Priority Six Develop the Trusts’ approach to reducing the impact of health inequalities (HIs) - year two. Core Dimension Clinical effectiveness Rationale for selection Tackling health inequalities is a key priority for the NHS. At UHS we have been working to have an impact on health inequalities for several years. In 2024/25 we formalised these efforts with a governing board, chaired by our chief medical officer and with a clear programme of improvement based on recognised priorities. This formed the basis of our quality priority in 2024/25. This year’s quality priority is a continuation of the work that started in 2024/25. We intend to continue to grow our understanding and actions as an organisation, improving the equity of access, outcomes and experience of our services across our community. Key Aims We are continuing our health inequalities board, with focus on five priorities: enabling our organisation, data and measurement, clinical service priorities, communication and engagement and strategy and approach. Each of these priorities have aligned directors to oversee improvement and a detailed delivery plan. Key priorities and expected outcomes from each of these are listed below: Enabling the organisation: • Developing supporting structures - set up governance so that teams who identify health inequality related issues know where they can go for help, so that we can understand frequently arising challenges and notice when a problem raised might be affecting other of the hospital too. This will aid improvement, learning from issues identified and escalation of issues that cannot be resolved locally • Capability building - develop training for our staff to understand health inequalities, identify them within services and access tools to make improvement. • Delivery of the health inequalities officer role - grow knowledge of the health inequalities officer role across the organisation and utilise this role to share knowledge, training and support improvements. Data and measurement • Continue to develop our understanding of inequalities in access across outpatients and diagnostics, inpatients, theatres and the emergency department. • Enable the measurement of improvement in areas recognised as clinical priorities. • Enable completion of national reporting. Clinical priorities • Improve services and support for patients and staff with obesity (children and adults). • Improve identification and control of hypertension. • Improve services and support for patients and staff who smoke. Communication and engagement • Adopt health inequalities into leadership and decision making. • Learning from our communities and our staff. • Communicating improvements internally and externally. • Staff support campaign. Strategy and approach • Overseeing and agreeing UHS approach and strategy for HIs. • Overseeing annual delivery against priorities. • Aligning programme resource. • Maintaining collaborative working with public health and Integrated Care Board teams and other local healthcare providers. • Keeping up to date with national recommendations and expectations, sharing this knowledge with our organisation. • Overseeing trustwide improvement and health inequalities maturity. Progress Metrics • Increasing numbers of staff trained. • Numbers of health inequalities issues reported (expected to increase through understanding before reducing due to improvement work). • Case studies shared of successful improvement projects. • Increased involvement and collaboration with patients and public on improvement. • Increased use of QEIA templates in decision making. • Demonstration of improved access to care for obesity, tobacco dependency and hypertension. 2.3 Statements of assurance from the Board This section includes mandatory statements about the quality of services that we provide relating to the financial year 2024/25. This information is common to all quality accounts and can be used to compare our performance with that of other organisations. The statements are designed to provide assurance that the board of directors has reviewed and engaged in cross-cutting initiatives which link strongly to quality improvement. 2.3.1 Review of services During 2024/25 UHS provided and/or sub-contracted 118 relevant health services (from total Trust activity by specialty cumulative 2024/25 contractual report). UHS has reviewed all the data available to them on the quality of care in all these relevant health services. The income generated by the relevant health services reviewed in 2024/25 represents 100% of the total income generated from the provision of relevant health services by UHS for 2024/25. 2.3.2 Participation in national clinical audits and confidential enquiries The UHS clinical audit programme was developed in support of the Trust’s vision by putting patients first, working together and always improving. This leads on to a specific strategy for clinical outcomes, to ensure robust and measurable processes are in place to plan locally and participate strategically. Healthcare Quality Improvement Partnership (HQIP) produces a National Clinical Audit & Enquiries Directory which identifies those national audits which are included in the NHS England Quality Account List 2024/25, those audits which are part of National Clinical Audit and Patient Outcomes Programme (NCAPOP). NCAPOP audits are commissioned and managed on behalf of NHS England by HQIP. These collect and analyse data supplied by local clinicians to provide a national picture of care standards for that specific condition. On a local level, NCAPOP audits provide local trusts with individual benchmarked reports on their compliance and performance, feeding back comparative findings to help participants identify necessary improvements for patients. The audits listed on the NCAPOP are ‘must-do’ national audits. The quality accounts national clinical audit list includes audits which we regard as ‘best practice’ to participate in (in addition to those from the NCAPOP) and for that reason we always include these in our corporate audit plans as a priority where they are relevant to our Trust. UHS has a strong history for completing clinical audits. The clinical effectiveness team has a robust approach to governing and supporting the completion. We’ve opened discussions with senior clinical leadership within Hampshire and Isle of Wight Integrated Care Board regarding the current challenges with contributing to and using the outputs of national audits. Benchmarked data resulting from national audits provides strong guidance on areas of excellence and improvement, however completion can be challenging in its complexity and resource intensiveness, and timeliness of outputs can reduce our ability to be responsive to indications. Real time data supports our clinical teams to be proactive in striving to meet our always improving objectives. During 2024/25 68 national clinical audits and four national confidential enquiries covered NHS services that UHS provides. During 2024/25 UHS participated in 97% of national clinical audits and 100% national confidential enquiries of which it was eligible to participate in. NCEPOD studies participated in during 2024/25 were: • Emergency (non-elective) surgery in children and young people. • Juvenile idiopathic arthritis. • Blood sodium (hyponatraemia). • Acute Limb Ischaemic. UHS fully supports the Maternal, Newborn and Infant Clinical Outcome Review Programme (MBRRACE-UK) and all the reviews that take place under this umbrella. The national clinical audits that UHS participated in, and for which data collection was complete during 2024/25, are listed below (Table A) alongside the number of cases submitted to each audit or enquiry as a percentage of the number of registered cases required by the terms of that audit or enquiry if known at time of writing this report. Eligible (68) Participated 66 = 97%) Table A. Total number of NCAs UHS were eligible to participate in (n=68) % Actual cases submitted / expected submissions 1. BAUS Penile Fracture Audit ✓ Not yet started 2. BAUS I-DUNC (impact of Diagnostic Ureteroscopy on Radical ✓X Nephroureterectomy and Compliance with Standard of care practices) 3. BAUS Environmental lessons learned and applied to the bladder cancer ✓ care pathway audit (ELLA) 4. Breast and Cosmetic Implant Registry ✓✓ 5. Case Mix Programme (CMP) (ICNARC) ✓✓ 1677 for 3 quarters 6. Emergency Medicine QIPs – Time critical medications ✓✓ 63 pts 7. Emergency Medicine QIPs – Care of older people ✓✓ 182 pts 8. Falls and Fragility Fractures Audit Programme (FFFAP) national hip ✓✓ 971 all pts fracture database 9. Falls and Fragility Fractures Audit Programme (FFFAP) fracture liaison ✓ ✓ 2910 all pts database 10. Falls and Fragility Fractures Audit Programme (FFFAP) National Audit of ✓ ✓ Inpatient Falls 11. Learning disability and autism programme - Learning from lives and ✓✓ 100% deaths of people with a learning disability and autistic people (LeDeR) 12. National Adult Diabetes Audit – National Diabetes Inpatient Safety ✓✓ audit 13. National Adult Diabetes Audit – National Pregnancy in Diabetes ✓✓ 100% 14. National Diabetes Audit - transition ✓ ✓ Collects data from database 15. National Diabetes audit – gestational diabetes ✓ ✓ Collects data from database 16. National respiratory Audit Programme (NRAP) - asthma in children ✓✓ 17. National respiratory Audit Programme (NRAP) - asthma in adults ✓✓ 18. National respiratory Audit Programme (NRAP) - COPD secondary care ✓ ✓ 19. National respiratory Audit Programme (NRAP) Pulmonary rehabilitation ✓ ✓ 20. National Audit of Care at the End of Life (NACEL) ✓✓ 250 pts 21. National Cancer Audit Collaborating Centre - National Audit of ✓ ✓ Data entry not Metastatic Breast Cancer required 22. National Cancer Audit Collaborating Centre - National Audit of Primary ✓ ✓ collected Breast Cancer nationally 23. National Cancer Audit Collaborating Centre – National Kidney Cancer ✓✓ Audit (NKCA) 24. National Cancer Audit Collaborating Centre – Non-Hodgkin Lymphoma ✓ ✓ Audit (NNHLA) 25. National Cancer Audit Collaborating Centre –National Pancreatic ✓✓ Cancer Audit 26. National Cancer Audit Collaborating Centre - National Bowel Cancer ✓✓ Audit (NBOCA) 27. National Cancer Audit Collaborating Centre - National Oesophago- ✓✓ gastric Cancer (NOGCA) 28. National Cancer Audit Collaborating Centre - National Lung Cancer ✓✓ Audit (NLCA) 29. National Cancer Audit Collaborating Centre - National Prostate Cancer ✓ ✓ Audit (NPCA) 30. National Cardiac Arrest Audit (NCAA) ✓✓ 150 Approx 31. National Cardiac Audit Programme (NCAP) - Adult cardiac surgery ✓✓ 32. National Cardiac Audit Programme (NCAP) - Cardiac Rhythm ✓✓ Management (CRM) 33. National Cardiac Audit Programme (NCAP) - congenital heart disease ✓✓ (CHD) paeds 34. National Cardiac Audit Programme (NCAP) - Heart Failure audit ✓✓ 35. National Cardiac Audit Programme (NCAP) - Acute Coronary Syndrome ✓ ✓ 100% or Acute Myocardial Infarction 36. National Cardiac Audit Programme (NCAP) - Percutaneous coronary ✓✓ 100% interventions (PCI) 37. National Cardiac Audit Programme (NCAP) - The UK Transcatheter ✓✓ Aortic Valve Implantation (TAVI) Registry 38. National Cardiac Audit Programme (NCAP) -Left Atrial Appendage ✓✓ Occlusion (LAAO) Registry 39. National Cardiac Audit Programme (NCAP) – Patent Foramen Ovale ✓✓ Closure (PFOC) Registry 40. National Cardiac Audit Programme (NCAP) – Transcatheter Mitral & ✓✓ Tricuspid Valve (TMTV) Registry 41. National Child Mortality Database (NCMD) ✓✓ 100% 42. National Clinical Audit of Seizures and Epilepsies for Children and ✓✓ *1 pt Young People (Epilepsy12) 43. National Comparative Audit of Blood Transfusion – Audit of NICE ✓✓ Quality Standard QS138 44. National Comparative Audit of Blood Transfusion – Bedside Transfusion ✓ ✓ Audit 45. National Early Inflammatory Arthritis Audit (NEIAA) ✓✓ 46. National Emergency Laparotomy Audit (NELA) - Laparotomy ✓✓ 47. National Emergency Laparotomy Audit (NELA) – No lap ✓✓ 48. National Joint Registry ✓ ✓ 834 (data run to 10/02/2025) 49. National Major Trauma Registry ✓ ✓ 600 for 3 quarters 50. National Maternity and Perinatal Audit (NMPA) ✓✓ 51. National Neonatal Audit Programme (NNAP) (Neonatal Intensive and ✓✓ 100% Special Care) 52. National Ophthalmology Audit Database ✓✓ 53. National Paediatric Diabetes Audit ✓✓ 54. National Vascular Registry (NVR) ✓✓ **100% 55. Paediatric Intensive Care Audit Network (PICANet) ✓✓ 100% 56. Perinatal Mortality Review Tool (PMRT) ✓✓ 100% 57. Perioperative quality improvement programme ✓✓ 12 pts 58. Quality & Outcomes in Oral & Maxillofacial Surgery (QOMS) – Oncology ✓ Data taken & reconstruction straight from 59. Quality & Outcomes in Oral & Maxillofacial Surgery (QOMS) – Trauma ✓ other 60. Quality & Outcomes in Oral & Maxillofacial Surgery (QOMS) – ✓ databases Orthognathic surgery 61. Quality & Outcomes in Oral & Maxillofacial Surgery (QOMS) – Non- ✓ melanoma skin cancers 62. Quality & Outcomes in Oral & Maxillofacial Surgery (QOMS) – Oral & ✓ Dentoalveolar Surgery 63. Sentinel Stroke National Audit Programme (SSNAP) continuous SSNAP ✓ ✓ Clinical patient Audit, organisational audit 64. Serious Hazards of Transfusion (SHOT) UK National haemovigilance ✓✓ scheme 65. Society for Acute Medicine's
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MPF12 HaemOnc request form v10

Description: UHS LAB USE Specimen(s) received (central): BMT / Slides / BMA EDTA / PB EDTA / Cyto / other Specimen(s) distribution: Histo MGG Flow Flow WGLS Sal. Iron WGLS Sot. WGLS Sot. WGLS Sal. WGLS Sal. Date: Specimen(s) received (local): Barcode HaemOnc. Test Request Form Referrer Information Patient Information Referring consultant Surname Hospital First Name Department Date of Birth Gender Departmental Email (secure) Hospital number Telephone number / bleep NHS number ☐ NHS ☐ Private Address Postcode: Diagnosis / clinical details Additional information ( Infection Risk? Yes ☐ No ☐ Priority Urgent ☐ Cancer pathway ☐ Routine☐ Please notify the laboratory if clinically urgent Sample details (see reverse for instructions) Operator: Tel./Bleep Lab reference number (referrals to UHS) Collection date/time Histo. macro. UHS LAB USE UHS lab use only Specimen type Refer to sample requirements overleaf. Please indicate if multiples of the same sample are collected eg. BMx2 PB ☐ BMA ☐ BMT ☐ Cytogenetics ☐ CSF ☐ FFPE ☐ Fresh tissue ☐ Other ☐ (EDTA) (EDTA) Biopsy ☐ Resection ☐ ………………. ☐ Trial (sent direct):…………………… Biopsy Site:….…………… ….…………… Haematology request(s) Histopathology request(s) PB morphology ☐ BM morphology ☐ Iron stain ☐ BMT (haem) ☐ BMT ☐ CD138 IHC ☐ Congo Red ☐ Flow cytometry test request(s) One EDTA per sub-section Acute ☐ Inc. blast enumeration Lymphoid ☐ Ext. B ☐ Ext. T ☐ Progressive B / T panels as required or known disease Plasma cell ☐ Flow MRD ☐ (Send Away – specify BM / PB) u Wessex Genomics Laboratory Service (Southampton) test request(s) One EDTA per sub-section JAK2 V617F only (Monitoring)1 ☐ BRAF V600E ☐ MYD88 L265P ☐ Post allo transplant chimerism2 ☐ FVL/PTM genotyping ☐ CLL IGHV somatic hypermutation * ☐ BCR::ABL1 (IS) ratio monitoring3 ☐ BCR::ABL1 kinase domain mutation** ☐ TKI: Start date: *For IgHV, please provide lymphocyte count: …………………………………………… Whole Genome Sequencing** Eligible tumour** presentation ☐ Paired Germline (approx. day 10-14) ☐ ↳Confirm no circulating tumour cells☐ Must be confirmed before germline sample is collected. Please refer to central NHS England eligibility criteria. Ensure clinical details are entered. Acute leukaemia molecular (genetics) MRD4** AML Follow up ☐ (AML baseline from WGLS Salisbury5) ALL Baseline ☐ Follow up ☐ ADULT AND TYA PATIENTS ONLY6 Date of diagnosis/this timepoint: ..…………………….. MRD Marker: …………………………………………………… Transcript/mutation type: ……..………………………….. Must be provided to ensure timely processing and directing of samples Clonality T cell disease ☐ A progressive testing strategy is used B cell disease ☐ Include histology / immunophenotyping report Wessex Genomics Laboratory Service (Salisbury) test request(s) (see reverse for sample details) Myeloid disorders (MDS, MPN, AML, CML3,#) G-banding ☐ FISH ☐ Myeloid NGS panel ☐ #Baseline CML chronic phase is not a clinical indication for myeloid NGS panel ALL (T- and B-) G-banding ☐ FISH ☐ SNP array ☐ * AML FLT3-ITD ☐ FLT3-TKD ☐ NPM1 ☐ IDH1/IDH2 ☐ TP53 ☐ Lymphoid (Mature: CLL, NHL, etc.) FISH ☐ TP53 sequencing ☐ * MPN (including Myeloid/Lymphoid Neoplasms with Eosinophilia & Mastocytosis) MPN gene panel (JAK2 V617F/CALR/MPL/JAK2 exon 12) (all diagnostic ?MPN)2 ☐ KIT D816V ☐ Extended KIT NGS panel (if D816V neg) ☐ FIP1L1::PDGFRA (diagnosis and monitoring) ☐ Myeloma: CD138-positive separation only (storage) ☐ Myeloma FISH panel ☐ Requester Name Signature Date Email / phone / / Sample transport The referring laboratory is responsible for the safe transfer of tissue and it is thus recommended that Royal Mail Recorded Delivery or an equivalent tracked postal service is used. Transport tracking ID Please send flow samples to: WGLS (Southampton) samples to: WGLS (Salisbury) samples to: BMT samples to: Department of Immunology Laboratory Medicine University Hospital Southampton NHFT, Tremona Road, Southampton, Hampshire, SO16 6YD. Formerly Department of Molecular Pathology Duthie Link Building, Mailpoint 225, University Hospital Southampton NHSFT, Tremona Road, Southampton, Hampshire, SO16 6YD. Formerly Wessex Regional Genetics Laboratory Salisbury District Hospital, Salisbury, Wiltshire, SP2 8BJ Department of Cellular Pathology, Pathology Block, Level E, Mailpoint 002. University Hospital Southampton NHSFT, Tremona Road, Southampton, Hampshire, SO16 6YD. 02381 206615 / 02381 206640 immunologylab@uhs.nhs.uk UKAS ref: 8696 02381 206638 wgls_cancergenomics@uhs.nhs.uk wgs_cancerwgls@uhs.nhs.uk (WGS ONLY) UKAS ref: 9194 01722 429080 shc-tr.WRGLdutyscientist@nhs.net www.wrgl.org.uk UKAS ref: 1175 023 8120 4879 cellpath@uhs.nhs.uk UKAS Ref: 8178 Sample requirements Details on both the referral card and the sample tube should be complete and legible. A minimum of 3 ID points are required. We reserve the right to refuse to process samples with incomplete, illegible or ambiguous patient information. Any samples in the wrong tube or medium, or which are subject to significant delay in transit, are liable to be rejected. Flow cytometry EDTA whole blood, bone marrow or fluid in universal container. Sample must arrive and be tested within 72 hours of collection WGLS (Southampton) Formerly Molecular Pathology FFPE: Send FFPE block (preferred) or tissue scrolls (3 x 20μm). Scrolls should be prepared on a clean microtome, ideally using a fresh blade per case, to avoid the risk of cross-contamination. PB: Send minimum 3.4ml EDTA as an independent sample. This must not have been used previously on an automated laboratory analyser. 1 JAK2 V617F only requested for monitoring of known JAK2 V617F variant allele frequency only. All referrals for suspected/confirmed MPN should go for MPN gene panel at WGLS (Salisbury). 2 This laboratory performs whole PB/BM chimerism. This is not requesting Lineage Specific Chimerism, which is sent directly from clinical teams. 3 BCR::ABL1 (IS) ratio monitoring for CML/TKI monitoring only. For all ?CML or confirmed CML diagnostic referrals, send PB/BM sample for FISH/G-banding at WGLS (Salisbury) (see Myeloid disorders section of the form). For BCR::ABL1 (IS) ratio monitoring, if PB sample, please send minimum 12ml EDTA. 4 For MRD analysis on PB, please send 20ml EDTA; if BM, please send 5ml EDTA. Patients monitored at unusual laboratories must be highlighted and the MRD lab identified. 5 For AML cases where the diagnostic sample identifies a molecular MRD marker as part of the genetic work up, material from the baseline sample is standardly sent from the WGLS Salisbury (the standard cytogenetics sample – no additional sample required specifically for AML baseline MRD) to WGLS Southampton for onward sending to the relevant laboratory. 6Adult patients (>26 years of age), TYA patients (16-25years of age) only. Paediatric patients remain under the care of the CNS/trials team(s). Samples for RNA extraction must arrive in this laboratory within 48 hours of collection. ** This is a send away test. WGLS (Salisbury) Formerly WRGL BM: • Conventional cytogenetics for acute leukaemias, MDS, MPD and aplastic anaemia: 1-2ml in heparinised transport medium or lithium heparin. • For new paediatric acute leukaemias: 1-2ml in heparinised transport medium or lithium heparin + KCH (3 drops of BM in KCH to be fixed at referring laboratory). • Molecular studies of FLT3-ITD, FLT3-TKD, NPM1, IDH1, IDH2, TP53, KIT, JAK2, JAK2 exon 12, CALR, MPL and Myeloid NGS panel: 2-3ml in EDTA; however, material sent in BM heparinised transport medium or lithium heparin is acceptable. PB: • Conventional cytogenetics for new diagnosis CML, myelofibrosis or new acute leukaemias if no BM available: 5-10ml in lithium heparin. • FISH for CLL/MCL and TP53 mutation testing: 5-10ml in lithium heparin. • Molecular studies of JAK2, CALR, MPL, myeloid NGS panel, etc.: 5-10ml in EDTA. • FIP1L1::PDGFRA: 10ml in EDTA. Smears: for CLL or NHL with suitable FISH markers, FISH can be attempted on freshly made, unfixed, unstained smears (at least 4 smears) if no fresh material is available. Please note that FISH can be attempted on smears that have been stored for some time if no other material available. Biopsies: FFPE sections / tumour dabs: slides containing unstained FFPE sections (3-4µm) or tumour dabs should contain at least 2 patient identifiers. Please package in a slide box. For large FFPE sections, please also send H&E slide with the tumour area appropriately marked. Other Tissues: lymph node, spleen, skin etc. should be sent in transport medium upon previous discussion with the laboratory. Please phone as soon as possible if anything is sent by courier which might arrive outside normal working hours. There is an on-call rota for acute presentations and Burkitt lymphoma after hours on a Friday or at the weekend (please phone the switch board on 01722 336262). In submitting samples, the clinician confirms that consent has been obtained for testing and storage. Anonymised stored samples may be used for quality control procedures including validation of new genetic tests. Cellular Pathology Specimen to be submitted in 60ml pot containing 10% neutral buffered formalin (ratio of 10:1). Direct purchase from Genta Medical. MPF12.0 Integrated HaemOnc Request Form Revision 10
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Bevacizumab (15mgkg)

Description: Chemotherapy Protocol GYNAECOLOGICAL CANCER BEVACIZUMAB (15) This protocol may require funding Regimen Ovary-Bevacizumab (15) Indication Recurrent platinum sensitive ovarian, peritoneal or fallopian tube cancer WHO performance status 0, 1, 2 Toxicity Drug Bevacizumab Adverse Effect Haemorrhage, hypertension, proteinuria, impaired wound healing, gastrointestinal perforations, fistulae, arterial thrombosis The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Drugs FBC, LFTs and U&Es prior to each cycle EDTA or calculated creatinine clearance prior to each cycle CA125 prior to each cycle Blood pressure and dipstick urinalysis for proteinuria prior to treatment with bevacizumab Dose Modifications The dose modifications listed are for haematological, liver and renal function and drug specific toxicities only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be re-escalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Version 1.1 (March 2014) Page 1 of 6 Ovary-Bevacizumab (15) Please discuss all dose reductions / delays with the relevant consultant before prescribing, if appropriate. The approach may be different depending on the clinical circumstances. Haematological Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL. There is little need to adjust the dose of bevacizumab for haematological toxicity. Hepatic Impairment Drug Bevacizumab Bilirubin (μmol/L) n/a AST/ALT units n/a Dose No information available Renal Impairment Drug Creatinine Clearance (ml/min) Dose (% of original dose) Bevacizumab n/a No information available Other Dose reductions or interruptions in therapy are not necessary for those toxicities that are considered unlikely to be serious or life threatening. For example, alopecia, altered taste or nail changes. For all other non-haematological NCI-CTC grade 3 and above toxicities delay treatment until the adverse effect has resolved to NCI-CTC grade 1 or below. Bevacizumab Bevacizumab doses should be omitted and not reduced for adverse reactions. If more than two doses are missed due to adverse events treatment should be stopped. It should be noted that the half life of bevacizumab is approximately twenty days. Discontinuation of treatment in response to adverse effects is not expected to influence the short term clinical evolution of the event, symptomatic treatment is often necessary. Bevacizumab should be stopped if the individual develops; Gastrointestinal perforation Arterial thromboembolic events NCI-CTC grade 3 and above haemorrhagic events (requiring a blood transfusion or a major non-elective intervention) NCI-CTC grade 3 and above congestive heart failure or left ventricular function NCI-CTC grade 4 fistula Version 1.1 (March 2014) Page 2 of 6 Ovary-Bevacizumab (15) If a NCI-CTC symptomatic grade 4 venous thromboembolic event occurs bevacizumab should be stopped. However, if this is a pulmonary embolism bevacizumab may be restarted once a full recovery has been made and the individual is anti-coagulated with a subcutaneous low molecular weight heparin. An oral anticoagulant must not be used. Hypertension is a common consequence of bevacizumab therapy. For a NCI-CTC grade 1 hypertension no treatment is necessary. NCI-CTC grade 2 hypertension, consider antihypertensive therapy. For a NCI-CTC grade 3 and above hypertension that is persistent consider stopping treatment. Bevacizumab may be continued for a NCI-CTC grade 1 proteinuria or the first occurrence of a grade 2 proteinuria. For the second occurrence of a NCI-CTC grade 2 proteinuria or any NCI-CTC grade 3 proteinuria give the bevacizumab as scheduled. A 24 hour urine collection or UPCR should be conducted at most three days before the next dose. If there is less than 2g protein per 24 hours or a UPCR 0-1 administer the bevacizumab and return to dipstick monitoring. If there is more than 2g protein per 24 hours omit the bevacizumab. Repeat the 24 hour urine collection prior to the next scheduled dose. If this is less than 2g per 24 hours administer the bevacizumab and continue 24 hour urine collection until the protein is 1g per 24 hours or less. Regimen 21 day cycle until unacceptable toxicity or disease progression occurs (six cycles will be set in Aria) Drug Bevacizumab Dose 15mg/kg Days 1 Administration Intravenous infusion in 100ml sodium chloride 0.9% over 90 minutes (see administration information) Dose Information Bevacizumab will be dose banded according to the CSCCN agreed bands Administration Information Extravasation Bevacizumab – neutral Other The first infusion of bevacizumab will be over 90 minutes. If this is well tolerated the second infusion may be given over 60 minutes. If this is well tolerated subsequent infusions may be given over 30 minutes Additional Therapy Gastric protection with a proton pump inhibitor or a H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed. Version 1.1 (March 2014) Page 3 of 6 Ovary-Bevacizumab (15) Coding (OPCS 14-15) Procurement – X71.5 Delivery – X72.3 References 1. Aghajanian C, Blank SV, Goff BA et al. OCEANS: A randomized double blind placebo controlled phase III trial of chemotherapy with or without bevacizumab in patients with platinum sensitive recurrent epithelial, ovarian, primary peritoneal or fallopian tube cancer. J Clin Oncol 2012; 30 (17): 2039-2045. Version 1.1 (March 2014) Page 4 of 6 Ovary-Bevacizumab (15) REGIMEN SUMMARY Bevacizumab (15) Cycle 1, 2, 3, 4, 5 1. Bevacizumab 15mg/kg intravenous infusion in 100ml sodium chloride 0.9% over 90 minutes Cycle 6 2. Warning – Check further cycles required 3. Bevacizumab 15mg/kg intravenous infusion in 100ml sodium chloride 0.9% over 90 minutes Version 1.1 (March 2014) Page 5 of 6 Ovary-Bevacizumab (15) DOCUMENT CONTROL Version Date Amendment Written By Approved By 1.1 March OPCS updated 2014 Disclaimer updated 1 July 2013 None Dr Deborah Wright Pharmacist Rebecca Wills Pharmacist Dr Deborah Wright Pharmacist Donna Kimber Pharmacy Technician Dr Clare Green Consultant Medical Oncologist Dr Cheng Yeoh Consultant Medical Oncologist This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury Hospital NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Foundation Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors which occur as a result of following these guidelines. Version 1.1 (March 2014) Page 6 of 6 Ovary-Bevacizumab (15)
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Ovarian-cancer/Bevacizumab15mgkg.pdf

Travel information - temporary road diversions at Southampton General Hospital

Description: Due to planned installation works at Southampton General Hospital, the flow of traffic from the orange car park will be temporarily diverted this Saturday, 5 May as well as Saturday, 12 and Sunday, 13 May.
Url: /AboutTheTrust/Newsandpublications/Latestnews/2018/May-2018/Travel-information-temporary-road-diversions-at-Southampton-General-Hospital.aspx

Procedure for obtaining breath samples

Description: NIHR Southampton Biomedical Research Centre The NIHR Southampton Biomedical Research Centre (BRC) has a tight quality assurance system for the writing, reviewing and updating of Standard Operating Procedures. As such, version-controlled and QA authorised Standard Operating Procedures are internal to the BRC. The Standard Operating Procedure from which information in this document has been extracted, is a version controlled document, managed within a Quality Management System. However, extracts that document the technical aspects can be made more widely available. Standard Operating Procedures are more than a set of detailed instructions; they also provide a necessary record of their origination, amendment and usage within the setting in which they are used. They are an important component of any Quality Assurance Framework, but in themselves are insufficient and need to be used and interpreted with care. Alongside the extracts from our Standard Operating Procedures, we have also made available here an example Standard Operating Procedure and a word version of a Standard Operating Procedure template. Using the example and the Standard Operating Procedure template, institutions can generate their own Standard Operating Procedures and customise them, in line with their own institutions. Simply offering a list of instructions to follow does not assure that the user is able to generate a value that is either accurate or precise so here in the BRC we require that Standard Operating Procedures are accompanied by face-to-face training. This is provided by someone with a qualification in the area or by someone with extensive experience in making the measurements. Training is followed by a short competency assessment and performance is monitored and maintained using annual refresher sessions. If you require any extra information, clarification or are interested in attending a training session, please contact Dr Kesta Durkin (k.l.durkin@soton.ac.uk). This document has been prepared from Version 2 of the BRC Standard Operating Procedure for obtaining breath samples. It was last reviewed in October 2015 and the next review date is set for October 2017. The version number only changes if any amendments are made when the document is reviewed. Page 1 of 3 NIHR Southampton Biomedical Research Centre NIHR Southampton Biomedical Research Centre Procedure for OBTAINING BREATH SAMPLES BACKGROUND There are numbers of non-invasive tests available to assess the function of organs in the body, for example the liver and pancreas. These investigations involve collecting substances that are excreted by the body following the ingestion of a compound ? one that is usually modified by the addition of a tracer of marker which is released by a defined physiological or metabolic process. If the test substrate is a form of fat that requires digestion by pancreatic lipase, then the hydrolysis of the fat and subsequent oxidation of the absorbed fatty acid, releases the tracer on the breath and the extent of excretion reflects pancreatic function. Expired breath contains air that has encountered different surfaces of the lung, and therefore different levels of gas exchange will have occurred. The air involved in gas exchange in the base of the lungs will be expired last. It is important to collect this end expiratory breath in the breath samples. Breath samples will then be analysed by mass spectrometry. PURPOSE To ensure the safe and accurate collection of end of expiratory breath samples. The methods described in this procedure include using either a) a drinking straw, or b) the "flute method", by blowing across the tube and capturing end tidal breath. These methods of collecting breath samples have been shown to be effective (i.e. are associated with collecting a sample that contains sufficiently high amounts of carbon as carbon dioxide for analysis). SCOPE This procedure applies to all staff involved in collecting breath samples for analysis by mass spectrometry. Page 2 of 3 NIHR Southampton Biomedical Research Centre RESPONSIBILITIES It is the responsibility of all staff involved in the collection of breath samples for analysis by mass spectrometry to read and follow this procedure. PROCEDURE 1. The breath samples must be collected in tubes (non-evacuated exetainers). Label the tubes appropriately (i.e. patient I.D., date, time, sample number, breath collector's name). 2. Store the tubes in order, in a rack to allow ease of identification. 3. For each time point specified in the study, take three breath samples in 3 separate tubes. 4. Firstly someone (researcher, measurer) needs to demonstrate the procedure of blowing into a tube so that it is made clear to the participant what they are required to do. See sections A and B for procedures for individual sample collection methods. 5. At the time of the breath sample, remove the lids from the three tubes for the appropriate time point. The first three samples collected will be baseline measurements, given prior to administration of the test meal. A) If using the "drinking straw" method: 1. Place a drinking straw into the first tube. 2. Ask the participant to take a breath and then to partially exhale. 3. Then ask the participant to blow the remainder of the breath through the drinking straw into the tube in a continuous stream of breath. 4. At the end of the breath, remove the straw quickly and slide the lid onto the tube in a single motion and then tighten to secure. 5. Repeat the procedure for the next 2 tubes of the same time point. 6. Replace the tubes in the rack in a place that indicates that they now contain samples. B) If using the "flute" method: 1. Ask the participant to take a breath and blow in a single continuous exhalation across the top of the tube, creating a whistling sound so that air enters the tube 2. At the end of the breath, remove the straw quickly and slide the lid onto the tube in a single motion and then tighten to secure. 3. Repeat the procedure for the next 2 tubes of the same time point. 4. Replace the tubes in the rack in a place that indicates that they now contain samples. Page 3 of 3
Url: /Media/Southampton-Clinical-Research/Procedures/BRCProcedures/Procedure-for-obtaining-breath-samples.pdf

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