Specialised Services Service Specification: Hepatobiliary Cancer Surgery

Transcription

1 Specialised Services Service Specification: Hepatobiliary Cancer Surgery Document Author: Specialised Services Planner, Cancer and Blood Executive Lead: Medical Director, WHSSC Approved by: Management Group Issue Date: 17 May 2017 Review Date: June 2018 Document No: CP73 Page 1 of 16

2 Document History Revision History Version No. Revision date Summary of Changes Updated to version no.: Draft 0.10 New service specification for 1.0 hepatobiliary cancer surgery /05/2017 Reviewed by Policy Group. Review date extended to June Date of next revision June 2018 Consultation Name Date of Issue Version Number All members of S Wales Hepatobiliary Specialist MDT September 2013 Sent to CEO C&V UHB January 2014 Professor G Poston, Chair, NHS England Hepatobiliary Cancers CRG September 2013 WHSSC C&B Programme Team January 2014 Management Group 13 March 2014 Approvals Name Date of Issue Version No. Executive Team, WHSSC February Management Group 13 March Policy Group 17 May Distribution this document has been distributed to Name By Date of Issue Version No. WHSSC Website Corporate Page 2 of 16

3 Table of Contents 1. Aim Introduction Relationship with other Policy and Service Specifications Service Delivery Regional Hepatobiliary Multidisciplinary Team (MDT) Quality and Patient Safety Quality and Patient Safety Quality Standards Putting Things Right: Raising a Concern Performance Monitoring and Information Requirements Performance Monitoring Key Performance Indicators Equality Impact and Assessment Page 3 of 16

4 1. Aim 1.1 Introduction The document has been developed as the service specification for the planning of hepatobiliary cancer surgery for patients resident in Wales. The document also specifies the regional hepatobiliary MDT which exists in south Wales. The purpose of this document is to: detail the specification for hepatobiliary cancer surgery services for patients who are resident in Wales; and identify which organisations are able to provide a hepatobiliary cancer surgery service for Welsh patients. 1.2 Relationship with other Policy and Service Specifications This document should be read in conjunction with the following documents: Commissioning Policy for PET-CT Commissioning Policy for SIRTEX Microspheres for Unresectable Malignant Liver Disease Commissioning Policy for TACE DEBOX for Unresectable Malignant Liver Disease Page 4 of 16

5 2. Service Delivery Providers The hepatobiliary cancer surgery specialist centre for patients from South Wales is the University Hospital of Wales UHB. The hepatobiliary cancer surgery specialist centre for patients from mid-wales is the University Hospitals Birmingham NHS Foundation Trust. NB. Hepatobiliary cancer surgery for North Wales patients are not currently commissioned by WHSSC and are managed through SLAS with Betsi Cadwalladr University Health Board. 2.2 Aim of the Service The aim of the hepatobiliary cancer surgery service is to provide specialist surgical treatment and care for patients with the hepatobiliary cancers. This will be in accordance with the best available evidence, or in the absence of evidence, in line with best practice or consensus of clinical opinion. The aim of the service is to maximise the health outcomes and quality of life for the patient. The service is commissioned to provide surgery for patients with suspected malignant disease of the liver and biliary tree. The core patient group for the service will have primary or secondary cancers of the liver and/or biliary tree. It is acknowledged that a minority of patients will be found to have benign tumours following further pathological investigation after surgery. The main diagnostic and monitoring methods include blood laboratory diagnostics (e.g. biochemistry, immunology, virology); endoscopy, (e.g. upper and lower, both routine and emergency); histopathology, (e.g. biopsies including of the liver and pancreas); and radiological investigations, (e.g. ultrasound, CT and MRI). The service should also provide follow-up and signposting of patients as required to other adjuvant therapies and services and will form a Page 5 of 16

6 key part of the overall pathway for patients with liver and biliary cancers. 2.3 Regional Hepatobiliary Multidisciplinary Team (MDT) Patients from North Wales and North Powys are managed by the MDTs based in Liverpool. For the purposes of this specification, the Regional MDT referred to in this section is the South Wales Regional MDT. The Regional Hepatobiliary MDT is the group of people from different healthcare disciplines which meets together (either physically or by video-conferencing) to discuss patients and who are each able to contribute independently to the diagnostic and treatment decisions made about a given patient. The MDT will consider the care and treatment of patients with hepatobiliary cancers and patients with complex hepatobiliary disease or acute liver failure. The MDT should operate in accordance with the Welsh Cancer Networks MDT Working Charter published in All patients with suspected liver or biliary tree cancer must be referred from secondary care hospital consultants to the regional hepatobiliary mutli-disciplinary team. The specialist multidisciplinary team will decide on the most effective care and treatment plan for the patient. Without exception, all patients who proceed to surgery for suspected liver or biliary tree cancers must have been assessed and considered by the regional MDT. The regional hepatobiliary MDT must have the following multidisciplinary members who have the appropriate training and experience in hepatobiliary services: Hepatobiliary Surgeon Gastroenterologist Hepatologist Histopathologist Oncologist Interventional Radiologist Diagnostic Radiologist Specialist nurse MDT Co-ordinator Endoscopy practitioner Member of the specialist palliative care team Dietitian Page 6 of 16

7 Cytopathologist Anaesthetist/Intensivist The disciplines in italics are members of the core team. All of these disciplines must be represented at each meeting. An MDT Lead Clinician must be formally elected from amongst the membership for a three year term of office. The Lead Clinician will have the following responsibilities: to ensure that the specialists in the team work effectively together so that all decisions taken by the team are multidisciplinary decisions to ensure that care is given according to recognised guidelines, with appropriate information being collected to inform clinical decision making and to support clinical governance and audit to ensure mechanisms are in place to support the entry of eligible patients into clinical trials, subject to patients giving fully informed consent to ensure attendance levels of core members are maintained at 95% to ensure the MDT s activities are audited annually and the results are reported to WHSSC to ensure the outcomes of the meetings are clearly recorded, clinically validated and recorded on CANISC to ensure each patient is assigned and made aware of, an appropriate key worker (for patients with secondary liver tumours this key worker may be the key worker assigned to them by the referring cancer site specific MDT if appropriate and agreed with the patient and the referring MDT). To ensure each patient is involved in discussions about their care plan and is offered a written copy. The MDT should undertake treatment planning meetings every week unless the meeting falls on a public holiday. In this instance, plans must be in place to ensure that patient care is not delayed. The MDT must have agreed formal links, clinical guidelines and care pathways in place with local secondary care services, interventional radiology, radiotherapy, chemotherapy and palliative care. These should ensure timely referral, diagnosis, treatment and signposting of patients to optimise patient care. Specifically the HPB MDT must have written agreed pathways in place between the local colorectal MDTs and itself for the management of liver metastases of colorectal origin. Page 7 of 16

8 It is essential that all new cases are discussed by the full core membership of the MDT. The MDT should agree and record individual patient treatment plans and the information must be recorded on CANISC. MDT co-ordination and administrative support must be available for preparation of cases, including case note and radiology record retrieval, and the recording of decisions. It is essential that a surgeon from the specialist liver surgery centre in Bristol attends all meetings of the MDT whilst there is locum in post in the Cardiff surgical service (either in person or by video link). The MDT should only consider the range of services commissioned by NHS Wales for patients with liver cancers in formulating care and treatment plans for patients. The services below are NOT commissioned except for patients who are assessed by the All-wales IPFR Panel as exceptional: SIRTEX Microspheres for patients who do not meet the criteria for the FOXFIRE trial TACE DEBOX for unresectable malignant liver disease 2.4 Hepatobiliary Cancer Surgical Service The following treatments and care should be provided by the specialist hepatobiliary surgical centre for patients with primary cancers of the liver and biliary tree (hepatocellular carcinoma and cholangiocarcinoma) and for patients with secondary liver tumours (colorectal, neuroendocrine and others). Assessment and investigation of patients using relevant modalities such as pathology, radiology, nuclear medicine, PET- CT, liver MRI and endoscopy Attendance and participation at the Regional Hepatobiliary MDT to agree treatment and care plans for patients Surgical management (curative resections or palliative bypass surgery) Interventional radiological management (percutaneous ethanol injection, radiofrequency ablation, microwave ablation, focused ultrasound, chemoembolosation) Endoscopic stenting and other endoscopic therapies of biliary tumours Palliative endoscopic stenting Page 8 of 16

9 Minimum Numbers Required Liver surgeons should each perform at least 15 liver surgical procedures per year for neoplastic disease, at least 10 of which should be major (3 or more segments). Liver resections include intrahepatic bile duct resections. If two surgeons share the surgery of a given case, this would count as a case for each in relation to this standard. The surgeon should be scrubbed and in theatre, and named in the operating notes when they are supervising trainees for the case to count as one of their cases against this standard. Cases undertaken in the private or independent sector count against this standard where evidence is provided of the cases. The specialist surgical centre should provide a rota of consultant core surgical members to ensure that one is available for telephone advice and potential face to face patient assessment and intervention, 24/7, 365 days a year for the MDT s post-operative patients. The specialist surgical centre should provide a rota of consultant interventional radiologists to ensure that one is available for telephone advice and potential face to face patient assessment and intervention, 24/7, 365 days a year for the MDT s patients. 2.5 Infrastructure Required The operations and acute post-operative care of the surgical centre should all be carried out at the same hospital which should have ITU and HDU on site. The specialist surgical centre should provide the following infrastructure in order to ensure timely and efficient services: Theatres Outpatient clinics Access to critical care (ITU) facilities Remote / networked access to diagnostics and results; advice and guidance Patients with hepatobiliary conditions and clinicians treating them require extensive access to CT, MRI and PET scanning services. This service specification should therefore be read in conjunction with the PET-CT Commissioning Policy. 2.6 Responsibilities of the Specialist Hepatobiliary Surgical Centre Page 9 of 16

10 The Specialist Centre should ensure that the hepatobiliary services: Provide accurate and timely diagnoses utilising best practice in the assessment of these specialised conditions, with protocols to enable rapid access for new and existing patients Deliver evidence based treatment plans depending on the personal circumstances of the individual and in line with agreed and published standards and guidelines, (or best practice / clinical consensus where limited evidence exists) Ensure treatment is provided consistently and equitably to all individuals independent of social circumstances, behaviour and lifestyle choices Ensure early identification of patients with complex multisystem disease, ensuring that they have timely access to specialist care Ensure the establishment of appropriate shared care arrangements between specialties for the management of comorbidities directly associated with the patients disease / condition Ensure integration of patient care between the specialist centres and local services through the use of standardised shared-care protocols Audit patient outcomes and experience (as per the parameters specified by WHSSC) on a quarterly basis, to be reported to the Medical Director at WHSSC To participate in national (UK) audit in order to ensure the best possible clinical outcomes. All audits should take into account the results of all surgeons in the centre To take immediate action to reduce operative morbidity and mortality if identified To implement the results of national and local audits Enable patients to have access to clinical trials as appropriate Provide appropriately staffed and robust consultant surgical rotas to provide 24/7 cover for specialised HPB surgery patients, in line with the minimum population requirements of the NICE IOG Assign each patient an appropriate key worker involve each patient in decisions about their care plan and is offered a written copy. Offers each patient appropriate information in at least written format regarding all aspects of liver malignancies, treatments and outcomes Page 10 of 16

11 3. Quality and Patient Safety 3.1 Quality and Patient Safety Providers must ensure that safe and high-quality services are provided for patients, to have systems in place to monitor quality and safety, and to be able to demonstrate this. Services must be accessible to all patients with a suspected specialised hepatobiliary disease or condition regardless of sex, race or gender. Staff should attend mandatory training on equality and diversity and the facilities provided should offer appropriate disabled access for patients, family and carers. When required, the providers will use translators and printed information available in multiple languages. 3.2 Quality Standards Providers are expected to plan and provide services in line with the quality standards for hepatobiliary cancer surgical services which are outlined below: NICE (2001) Improving outcomes on upper GI cancers, NICE Cancer Service Guidance NICE (2009) Hepatocellular carcinoma (advanced and metastatic) - sorafenib (first line), NICE Technology Appraisal NICE TA176 (2009) Use of cetuximab in first line treatment of unresectable kras wild type liver limited metastatic colorectal cancer NICE CG131 (2011) Guidance on the management of colorectal cancer Department of Health. Guidance on Commissioning Cancer Services: Improving Outcomes in Upper Gastrointestinal Cancers, London 2001 Association of Upper Gastrointestinal Surgeons, Guidance on minimum surgeon volumes Association of Upper Gastrointestinal Surgeons, The Provision of Services for Upper GI Surgery. Page 11 of 16

12 Welsh Assembly Government. National Standards for Colorectal Cancer Services, 2005 Welsh Assembly Government. National Standards for Upper Gastrointestinal Cancer Services, 2005 Welsh Cancer Networks MDT Working Charter, The following document has also been used a reference: NHS England Improving Quality, National Peer Review Programme HPB Cancer Measures. 3.3 Putting Things Right: Raising a Concern Whilst every effort has been made to ensure that decisions made under this policy are robust and appropriate for the patient group, it is acknowledged that there may be occasions when the patient or their representative are not happy with decisions made or the treatment provided. The patient or their representative should be guided by the clinician, or the member of NHS staff with whom the concern is raised, to the appropriate arrangements for management of their concern: When a patient or their representative is unhappy with the decision that the patient does not meet the criteria for treatment further information can be provided demonstrating exceptionality. The request will then be considered by the All Wales IPFR Panel. If the patient or their representative is not happy with the decision of the All Wales IPFR Panel the patient and/or their representative has a right to ask for this decision to be reviewed. The grounds for the review, which are detailed in the All Wales Policy: Making Decisions on Individual Patient Funding Requests (IPFR), must be clearly stated. The review should be undertaken, by the patient's Local Health Board; When a patient or their representative is unhappy with the care provided during the treatment or the clinical decision to withdraw treatment provided under this policy, the patient and/or their representative should be guided to the LHB for NHS Putting Things Right. For services provided outside NHS Wales the patient or their representative should be guided to the NHS Trust Concerns Procedure with a copy of the concern being sent to WHSSC. Page 12 of 16

13 4. Performance Monitoring and Information Requirements 4.1 Performance Monitoring Providers must provide an annual report to WHSSC on the general outcome indicators specified below. Providers must also provide quarterly audit information for liver surgery to the WHSSC Medical Director as specified below (Table 1). The Chair of the South Wales MDT must also provide quarterly audit information regarding attendance and the proportion of the new cases discussed. An annual Audit Day will be held and providers will be expected to present their annual report and audit results. Waiting list, activity and financial monitoring will take place at the regular SLA meetings between WHSSC and the service providers. 4.2 Key Performance Indicators The provider will be expected to monitor against the outcomes in These should be presented to WHSSC and all of the members of the MDT annually at an annual Audit Day meeting MDT Outcomes Number of cases with confirmed histology Staging - to monitor the stage of diagnosis of liver disease and to monitor the effect on the effectiveness of treatment Mortality to monitor in and out of hospital mortality (including cause of death) and to make a comparison with published survival data Post operative morbidity and mortality Waiting times and numbers weekly time from referral to treatment and weekly numbers waiting Remission and relapse rates - using recognised disease-specific measures of disease activity Disease related damage - using recognised disease-specific damage indices Page 13 of 16

14 Quality of life Patient / carer satisfaction - questionnaire survey Access to support groups and education - questionnaire survey plus patient / carer participation Compliance with maintenance of disease registry(ies) Participation in clinical trials Evidence of programme of joint working with non specialist centres (eg shared care protocols, outreach clinics) Equitable access (by %age LHB population) to specialist hepatobiliary treatment and care services for both elective and acute conditions Transplantation rates by LHB (linked to indicator above) One, two and five year survival rates. Percentage of patients with a key worker (as per national performance measure) Percentage of patients with a written care plan (as per national performance measure) Liver Cancer Surgery Outcomes The outcome measures to be audited on a quarterly basis for liver cancer surgery are below. These should be sent as a written report to the Medical Director of WHSSC on a quarterly basis. Clinical Outcome Measures for Liver Cancer Surgery 1. Total no. of explorations (per quarter) 2. Total no. of resections (as above) 3. Total colorectal cancer (CRC) explorations (as above) 4. Total CRC resections (as above) 5. Repeat resection for CRC metastases (as above) 6. Hospital stay (median length of stay in days) 7. Median blood loss (ml) (during surgical procedure in operating theatre) 8. Allogenic blood transfusion (percentage of patients requiring transfusion related to procedure) Page 14 of 16

15 9. R1 resections in patients with CRC resections (R1 pathological margins graded post surgery) 10. Morbidity (measured on international standard scale Clavien Dindo >3) 11. Mortality specifying and distinguishing intraoperative deaths, early post operative deaths including deaths in ITU, deaths in hospital prior to discharge, deaths within 30 days of surgery deaths up to 90 days at home or in another hospital) Page 15 of 16

16 5. Equality Impact and Assessment The Equality Impact Assessment (EQIA) process has been developed to help promote fair and equal treatment in the delivery of health services. It aims to enable Welsh Health Specialised Services Committee to identify and eliminate detrimental treatment caused by the adverse impact of health service policies upon groups and individuals for reasons of race, gender re-assignment, disability, sex, sexual orientation, age, religion and belief, marriage and civil partnership, pregnancy and maternity and language (welsh). The Specialised Services Service Specification for Hepatobiliary Cancer Surgery has been subjected to an Equality Impact Assessment. The Assessment demonstrates the policy is robust and there is a positive impact on equality as all opportunities to promote equality have been taken. Page 16 of 16